ML20138G483
| ML20138G483 | |
| Person / Time | |
|---|---|
| Issue date: | 11/22/1996 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hehl C, Lieberman J, Mallett B NRC OFFICE OF ENFORCEMENT (OE), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| Shared Package | |
| ML20136A699 | List: |
| References | |
| FOIA-97-54 NUDOCS 9611290077 | |
| Download: ML20138G483 (303) | |
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- g. - UNITED STATES g NUCLEAR REGULATORY COMMISSION
- WASHINGTON D.C. 20666 0001
%.....[ November 22, 1996 MEMORANDUM T0: Those on the Attached List .
FROM: Donald A. Cool. Direct r '!
DivisionofIndustrialfand Medical Nuclear Safety < MSS \ p ('
SUBJECT:
REQUEST FOR COMMENTS ON DRAFT INSPE'CTION PROCEDURES 87115-87119 Attached for review and comment are revised inspection procedures (IP) for five medical materials programs: nuclear medicine, teletherapy.
radio)harmacy, brachytherapy, and medical broad scope. These draft procedures and t7eir associated draft field notes were developed by the regional and headquarters task force that was established to revise and update IP 87100.
" Licensed Materials Programs." The revised non-medical inspection procedures ;
were transmitted for your review and comment on November 12. 1996. 1 The final IPs for medical programs will also incorporate two current rulemakings. " Constraint Level for Air Emissions of Radionuclides" (10 CFR ,
Part 20) and " Criteria for the Release of Patients Administered Radioactive l Material" (10 CFR Parts 20 and 35): and TI 2800/025. " Quality Management !
Program and Misadministration Rule." The IPs and field notes for these three '
areas are currently being developeG and will be transmitted separately for your review and comment.
IP 87118. " Brachytherapy Programs." incorporates TI 2800/024. " Remote After?oading Brachytherapy Inspections." as well as elements in the current Appendix B. " Nuclear Medicine Inspection Field Notes." which includes both nuclear medicine and brachytherapy. The task group decided to separate nuclear medicine and brachytherapy, because the material that needed to be incorporated from TI 2800/024 would not apply to a large number of nuclear i medicine licensees. Your comments are sought on whether combined or separate IPs would be more useful to the ins)ectors. Either way. issuance of the revised IPs will make TI 2800/024 03solete and it will be retracted upon )
publication of the revised IP 87100 series.
CONTACT: Diane S. Flack. NMSS .
(301) 415-5681 i l
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Multiple Addressees 2 November 22, 1996 i
Please provide comments on the medical inspection procedures by December 20, 1996 (comments on non-medical programs are due December 6). Adherence to the comment due dates is very important, because the revised IPs will be an agenda item at the materials counterpart meeting for Division Directors on January 8 '
i and 9. 1997.
Attachments: 1. Draft IP 87115.
j Nuclear Medicine Programs r 4
- 2. Draft IP 87116.
- Medical Teletherapy Programs
- 3. Draft IP 87117. Radiopharmacy Programs ;
- 4. Draft IP 87118. Brachytherapy Programs
- 5. Draft IP 87119. Medical Broad-Scope Programs .
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- November 22, 1996 MEMORANDUM T0: Those on Attached List l
SUBJECT:
REQUEST FOR COMMENTS ON DRAFT INSPECTION l PROCEDURES 87115-87119 James Lieberman. Director Office of Enforcement C. W. Hehl. Director Division of Nuclear Materials Safety. RI I
Bruce S. Mallett. Director Division of Nuclear Materials Safety. RII Cynthia D. Pederson. Director . l 4
Division of Nuclear Materials Safety. RIII l
Ross A. Scarano. Director Division of Nuclear Materials Safety. RIV John T. Greeves. Director Division of Waste Management. NMSS Charles J. Haughney. Acting Director l l Spent Fuel Project Office. NMSS Larry W. Camper.-Chief
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Medical. Academic, and Commercial ,
Use Safety Branch I Division of Industrial and Medical Nuclear Safety, NMSS 4
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OFiAFT 1
4 ATTACHMENT 1 IP 87115 NUCLEAR MEDICINE PROGRAMS l
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- NRC INSPECTION MANUAL iMos t l INSPECTION PROCEDURE 87115 NUCLEAR MEDICINE PROGRAMS j PROGRAM APPLICABILITY
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I 87115-01
- INSPECTION OBJECTIVES 4
i 01.01 To determine if licensed activities are being ,n<fucted in a manner.that will protect the health and safety of workers and tne general public.
01.02 To determine if licensed programs are being conducted in accordance with NRC requirements.
87115-02 INSPECTION REQUIREMENTS A review of the licensed activities will be comensurate with the scope of the ,
licensee's program. A determination regarding safety and compliance with NRC '
requirements will be based on direct observation of work activities, interviews ,
with workers, demonstrations by workers performing tasks regulated by NRC, and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.
In reviewing the licensee's perfonnance, the inspector should cover the period from the last to current inspections. However, olde- esues preceding the last inspection should be reviewed if warranted by circui :Fces, such as incidents, noncompliance, or high radiation exposures.
Some of the following areas may not be applicable to all nuclear medicine licensees. -
02.01 Preoaration. The inspector should allow adequate time to pre)are for the inspection. Preparation will include reviewing documents, macing travel .
arrangements. coordinating with appropriate staff, notifying appropriate State agencies, and selecting necessary equipment. In particular, the inspector shall identify whether any license amendments have been issued since the last inspection, or whether the licensee ha~s informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensee had any incidents or events since the last inspectica.
02.02 En1rance n Briefina. When the inspector arrives at the licensee's facility, he/she will inform an available senior management representative of the purpose and scope of the inspection. For nuclear medicine inspections, it is not always possible to meet with licensee management upon arrival because of the early hours Issue Date: XX/XX/XX 87115
l that the inspection may be conducted. However, the entrance briefing should be ;
conducted as soon as practicable.
Oz.uS General Overview
- a. Oraanization. Interview cognizant licensee representatives about the current organization of the program. Examine the licensee's organization with respect to changes that have occurred in personnel, functions, responsibilities, and authorities since the previous inspection. i Identify the reporting relationshin and management structure between the licensee's executive management, the Radiation Safety Officer (R50), the Chairperson of the Radiation Safety Comittee (RSC). and the other members of the RSC.
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- b. Scooe of Proaram. Interview cognizant personnel to determine the types and quantities of licensed byproduct material used for medical uses, frequency of use, staff size. etc.
- c. Manaaement Oversiah.t.. In the course of interviewing cognizant personnel, i determine if management oversight is sufficient to provide the licensee i staff with adeq" ate resources and authority to administer the licensed program.
- 1. RSC - Review the committee meeting minutes for topics of discussion, mert.bership, frequency, and attendance. Inspector should interview some RSC members to determine their involvement in the radiation safety program.
- 2. RSO - Determine whether the RSO has been appointed, is named on the license, has sufficient authority, and fulfills the appropriate duties commensurate with the size and scope of licensed activities.
- 3. Audits - Verify that audits are performed as required. Verify that the results of the audits are reviewed and addressed. l
- 4. ALARA (As Low As Is Reasonably Achievable) - Verify that the licensee's radiation protection program includes provisions for keeping doses ALARA and that ALARA reviews are conducted, as required by 10 CFR 35.20.
- d. Authorized Users Determine that only authorized individuals perform and/or supervise licensed activities. Verify that these users are qualified. Also verify that authorized users perfonn an appropriate level of supervision, as required by 10 CFR 35.25.
02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the l licensed facility to make general observations of the condition of the facility '
and the licensed activities being performed.
l 02.05 Facilities. Verify that the facility conforms to that described in the license application: that material receipt. use, and storage areas are secured; and that the licensee uses processes or other engineering controls to maintain doses ALARA.
87115 Issue Date: XX/XX/XX I l
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02.06 Eauioment and Instrumentation
- a. Verify that equipment and instrumentation are appropriate, operable, calibrated, adequately maintained, and conform to tne description in the 4 license. ,
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- b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 CFR Part 21.
02.07 Materials i
- a. Receiot and Transfer of Licensed Material. Verify that the licensee is receiving packages and making transfers of licensed material in 4 accordance with NRC and applicable U.S. Department of Transportation .
(D0T) regulations and license conditions. l
- b. Authorized Uses. Determine from observing the use of licensed material. !
discussing the activities with licensee personnel, and reviewing records. !
that the type, quantity. and use of licensed material at the licensee's i facility are authorized by the license. To the extent practical. assure i)y physical confirmation that the licensee's inventory is complete and
. accurate.
- c. Material Security and Control. Verify that the licensee has established procedures for maintaining security and control of licensed material, and that these procedures are understood and implemented by appropriate personnel. Verify that licensed material, in storage, in controlled or unrestricted areas is secure from unauthorized removal or access. Verify that licensed material, not in storage, in controlled or unrestricted areas is controlled and under constant surveillance. Verify that access to restricted areas is limited by the licensee. j 02.08 Trainina l
- a. General Trainina. Verify that appropriate training and initial instructions are being accomplished as specified in the license and/or i regulations,
- b. Doeratina and Emeraency Procedures. Verify that operational procedures are being followed by observing licensee personnel perform tasks at ,
selected work stations and by a comparison of their activities with '
established procedures.
Examine the licensee's emergency procedures to determine that these procedures are as approved by NRC. Through discussions with workers, verify that licensee personnel understand and implemert the established procedures and are aware of procedural revisions. Document in the inspection field notes what activities the inspector observed.
- c. Radiocharmaceutical Theraov Trainina. Verify that the licensee provides radiation safety instruction for all personnel caring for patients '
receiving radiopharmaceutical therapy in accordance with 10 CFR 35.310.
The instructions must describe the licensee's procedures for control of patients, visitors, contamination and waste and for notification of the RSO in case of the patient's death or medical emergency.
Issue Date: XX/XX/XX 87115 l
02.09 Area Radiation and Contamination Control
- a. Area Surveyg. Verify, during observations and by direct measurements.
that the radiation levels are within the limits of 10 CFR Part 20. and that surveys are performed, as required by 10 CFR 35.70.
- b. Leak Tests. Verify that the procedures for and frequency of leak tests of sealed sources are in accordance with 10 CFR 35.59. Also verify that the leak test is analyzed in accordance with the license. If records of leak test results show contamination in excess of the regulatory requirements, verify that the licensee made appropriate notifications and removed the source from service.
- c. n Q_n_t. amination Control. Verify that the licensee performs weekly surveys for removable contamination in all areas where radiopharmaceuticals are routinely prepared, administered, or stored. If the licensee has had spills or other incidents of contamination exceeding the licensee's trigger levels, verify that the licensee has taken appropriate actions.
- d. Protective Clothina. Verify that radiation workers are provided with, and wear, the appropriate protective clothing comensurate with activities being performed.
02.10 Radiation Protection
- a. Radiation Protection Procram. Verify that the licensee has developed and ;
1mplemented a written radiation protection program comensurate with the licensee's activities, that the program includes ALARA provisions. and I that the program is reviewed at least annually, both for content and )
implementation. ;
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- b. Radiation Protection Procedures. Verify that changes in the radiological protection procedures made since the last inspection are consistent with regulations and license requirements. Determine whether the licensee was ,
required by 10 CFR ,35.13 to apply for license a'nendments for any of these l changes.
- c. Instruments and Eauiomant. Verify that radiation protection instruments and equipment are possessed, operable, calibrated, and checked for i appropriate response in accordance with 10 CFR 35.50, 35.51. and 35.52 !
requirements, license requirements, and licensee procedures. ;
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- d. Personnel Dosimeters. Verify that wrsonal dosimetry devices are worn by appropriate licensee personnel, bsimetry devices appropriate to the i type, energy, or emitted radiation, and the anticipated radiation fields should have been issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved and accredited processor.
Verify that pursuant to 10 CFR 19.13(b) the licensee advises each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106. " Records of individual monitoring results."
87115 Issue Date: XX/XX/XX
02.11 Ouality Manaaement Proaram NOTE: This section is being revised by the Division of Industrial and Medical
- Nuclear Safety (INNS) and is bei .g separately transmitted for comment.
4 02.12 Waste Manaaement
- a. Waste Storaae and 01soosal. Verify that i.ne waste is stored and controlled in a secure and safe manner, and that radiation levels in l- unrestricted areas st.rrounding the storage area do not exceed the limits of 10 CFR 20.1301. " Dose limits for individual members of the public."
Verify that disposal of decay-in-storage waste is performed in accordance with 10 CFR 35.92 and license conditions (medical licensees are specifically authorized to dispose of waste by decay-in-storage for waste with a half life of less than 65 days). Verify that the licensee is 4 conducting appropriate surveys and defacing radioactive material labels prior to disposing of the waste.
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- Review the licensee's procedures and records to verify that each shipment
- of raduste intended for off-site disposal is accompanied by a shipment j nanifest that includes all the required information.
a j Review the licensee's procedures and records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is labeled, as appropriate, to identify it as Class A. B or C waste in 4
accordance with the classification criteria of 10 CFR 61.55 [ Subsection i III.A.2 of Appendix F to 10 CFR 20.1001-20.2401].
i b. Effluents. Verify that effluent releases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003, respectively, and that treatment or disposal of waste by incineration is according to 10 CFR 20.2004.
j Review and verify that waste-handling eq;ipment, monitoring ecuipment, and/or administrative controls are adequste to maintain racioactive effluents within the limits established by the license and other regulatory requirements and are ALARA 4 Determine the quality of the relevant procedures and the degree to which ALARA techniques are incorporated into them. Determine the extent to 4 which process and engineering controls are used to min?n;ize effluents.
4 Determine whether effluent monitoring systems and tiee associated i analytical equipment are adecuate to detect and cluantify effluents with l sufficient sensitivity, and w1 ether they are maintained, calibrated, and operated in accordance with manufacturer's recomendations and good
- health physics practices.
Determine if all significant release pathways are monitored, all
- un-monitored pathways have been characterized, and all surveillance procedures for effluents are being implemented.
j Additional inspection recuirements are specified in Inspection Procedure .
(IP) 87102. " Maintaining Effluents from Materials Facilities As low As Is Reasonably Achievable (ALARA)." Verify whether EPA referral forms for air effluents have been sent to the appropriate EPA regional office, with a copy to NRC headquarters. per IP 87102.
Issue Date: XX/XX/XX 87115
- c. Transfer. Verify that wastes are transferred to an authorized recipient specifically licensed to receive radioactive waste.
- d. Records. Verify snat records of waste storage, transfer, and disposal are maintained in accordance with the requirements of 10 CFR Part 20 and the license. ;
- e. Financial Assurance and Decommission 1no. Review the licensee's records of information important to the safe and effective decommissioning of the '
facility. Verify that the records are complete, updated. and assembled ,
appropriately. in accordance with the recuirements in 10 CFR 30.35(g).
Review the licensee's list of restrictec areas required under 10 CFR !
30.35(g)(3) and determine whether laboratories or other rooms have been '
released since the last inspection. If areas have been released. verify ;
that the licensee has adequately decontaminated each room and documented t the basis for releasing each room. Document the location of the released -
rooms in the field notes and document your findings regarding the e adequacy of the licensee's decontamination. '
P Verify whether radiological conditions at the facility have changed since the financial assurance instrument and/or decomissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents such as spills or process upsets. Unauthorized changes by the licensee to processes, types of licensed materials. possession limits, or chemical or physical forms of licensed materials may also prompt a ,
reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect the financial assurance instrument or !'
decomissioning plan. he/she should immediately notify regional management.
If a parent company guarantee or a self-guarantee is used to ensure decomissioning financial assurance, review the licensee s financial assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met,
- f. Deconmissionino Timeliness. Review compliance with the Decomissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the field notes that should be completed on all insxctions. If the license to conduct principal activities has expired or aeen revoked:
if the licensee has made a decision to permanently cease principal activities at the site or in any separate building; or if there has been a 24-month duration when no )rincipal activities were conducted at the site or in any separate bui' ding, then the decomissioning timeliness requirements in 10 CFR 30.36, 40.42, 70.38, or Part 72 apply. If this is the case, complete in full the " Decommissioning Timeliness Inspection Field Notes." Attachment A to Appendix A.
02.13 Transoortation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with 10 CFR Part 71 and DOT regulations for transportation of radioactive materials.
02.14 Postina and labelina. Verify that the licensee has posted the appropriate documents, notices, forms and caution signs as required. Also verify that containers of licensed material are labeled appropriately.
87115 Issue Date: XX/XX/XX
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02.15 Generic Communications of Information. Cortfirm that the licensee is receiving the applicable bulletins. Information notices. NMSS Newsletter, etc. i krify that the licensee has taken appropriate action in response to these ;
notices. t 02.16 Notifications and Reoorts. Determine compliance with the regulations and ;
license requirements for notification and reports to NRC and individuals. Verify !
that the licensee is in compliance with the requirements in 10 CFR 35.14 for ;
medical licens9s to notify the Commission about changes in the authorized user. i authorized nuclear pharmacist. or RSO. i 02.17 Soecial License Conditions. If applicable, review the licensee's !
compliance with any special license conditions.
02.18 Indeoendent and Confirmatory Measurements. Compare and verify, on a -i sampling basis, survey results or data that are used by the licensee to show }
compliance with the regulations or license conditions. Conduct independent !
measurements to ascertain the radiological conditions of the facility. Conduct !
these inde measurements .on all inspections under this inspection l procedure, pendent unless warranted by special circumstances. If independent i measurements were not made, provide a justificatior. in the field notes explaining -l why independent measurements were not performed. The inspector shall use !
radid*n detection instruments that are calibrated, at a Wimum, on an annual .
basis.
02 19 Exit Meetina. The inspector will conduct an exit meeting with senior ;
licensee management and the RSO to discuss the preliminary inspection findings, !
including any apparent violations, safety-related concerns, and any unresolved l iter.:s identified during the inspection. Discuss any negative Performance -j Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of i concern. For further guidance. refer to IP 87101 " Performance Evaluation i Factors."
x 02.20 Post Insoection Actions. After an inspection the iripector shall !
sumarize the findings with his/her appropriate NRC supervisor. This - i: !
especially important if there are, or are expected to be, controversial issues !
arising from the findings. ;
Inspectors shall also meet with regional licensing staff when any pertinent ;
licensing issues are raised during the inspection, when inspection findings ,
impact on any licensing actions. to discuss the licensee's PEF results, or to i give feedback on how the licensee has addressed recent licensing actions. This l meeting shall be documented in the field notes.
l Additionally, in some instances, inspection findings will warrant comunication with NRC Enforcement staff. Office of Investigations staff. State liaison staff. !
and other Federal agencies with whom NRC has Memoranda of Understanding (M0Us).
The inspector will ensure that inspection findings are clearly documented, and ;
reported to the licensee as appropriate. The inspector shall also follow the !
requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and Records." regarding notifying the licensee that retained information is subject ,
to public disclosure and giving the licensee the opportunity to request -
withholding it (see IMC 0620. Section 04.06.b.). l l
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Issue Date: XX/XX/XX 87115 l t
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87115-03 INSPECTION GUIDANCE 2
i General. An examination of the licensee's records should not be considered the ;
primary part of the inspection program. Rather, observations of activities in '
progress, equipment, facilities and use areas. etc. will be a better indicator 3
.! of the licensee's overall radiation safety program than a review of records '
- alone. -
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Some of the requirement and guidance sections of this procedure instruct the ;
inspector to " verify" the adequacy of certain aspects of the licensee's program. )
Whenever possible, verification should be accomplished through discussions, j observations, and demonstrations.
In the records reviewed, look for trends such as increasing doses or effluent i releases. Records such as surveys, waste disposal. effluent releases, receipt l
, and transfer of radioactive materials, training, utilization logs, and air i
. sampling may be examined randomly until the inspector is satisfied that the i records are being maintained and are complete. Other records that are more -
l closely related to health and safety (such as personnel dose-monitoring records '
.' and incident reports) should be examined in cetail. The type of records that
, were reviewed and the time >eriods covered by these records should be noted in ,
the appropriate " Basis for ;indings" section(s) of the inspection field notes. '
i Retain a copy of each pertinent record that is needed to substantiate an inspection finding, such as a violation. Those copies shall be attached to the !
, inspection field notes or, when applicable to a written inspection report. When an inspector identifies an apparent violation, he/she should gather copies from the licensee while on-site of all records that are needed to support the apparent violation. In general, inspectors should use caution before retaining copies of licensee documents. unless they are needed to support apparent violations, expedite the inspection (e.g. licensee materials inventories), or make the licensing file more complete. In all cases where licensee documents are retained beyond the inspection, follow the requirements of IMC 0620. Especially ensure 3 that the licensee understands that the retained record will become publicly ,
available, and give the licensee the opportunity to recuest withholding the '
1- information pursuant to the requirements of 10 CFR 2.790())(1).
1 The inspectcr shouid keep the licensee apprised of the inspection findings j throughout the course of the inspection and not wait until the exit meeting. l j Whenever possible the inspector should kee informed of significant findings (e.g. , safety hazards, p NRC management willful violations, and other potential escalated enforcement issues) identified during the course of the 1 inspection. l l
03.01 Preoaration. Prior to the inspection. the inspector should do the
- following
- i j e Review the licensee's previous inspection history (at a minimum review l the past two inspections), the license, and the status of any allegations '
- or incidents. Note the licensee *s comitments in response to previous '
violations for follow-up during the inspection:
o Review regional event / incident logs, event / incident files, and the docket i file to determine whether the licensee was involved in any incidents, recordable events, or misadministrations. If NRC did receive !
notification of an incident, review that incident during the inspection i and document the licensee *s follow-up in the field notes: -
87115 Issue Date: XX/XX/XX i
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e In the field notes, complete the administrative information, the inspection compliance history, the listing of any license amendments or !
program changes since the last inspection, and the description of any I incidents or events that have occurred since the last inspection:
e Determine the dates that the licensee submitted the most recent financial assurance instrument and decommissioning plan (if applicable);
e Discuss the licensee's program with previous inspector (s) and/or license )
reviewer (s) as necessary: l e Notify the appropriate State radiation control program personnel: l e Review pending licensing actions: I e Obtain a map of the area and/or directions: I e Make travel arrangements and prepare itinerary; e Select calibrated instruments and perform source check:
- Select appropriate documents: and
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- Select appropriate equipment to take.
In selecting the appropriate documents, the inspector should consider taking the j applicable regulations, field notes, generic communications, license. NRC forms, etc.
In selecting the appropriate equipment the inspector should consider the licensed activities to be inspected. The equipment may include sample vials, wipes, pocket dosimeters, etc. ,
During the inspection, focus (among other areas) on whether the licensee is in compliance witl1 any license amendments issued since the last inspection or with i any program changes described by the licensee since the last inspection. This requires review of documentation submitted in support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.
03.02 Entrance Briefina. After arriving on site, the inspector should inform i the licensee's management representative of the purpose and scope of the inspection to be performed. This notification s1ould be made as soon as practical after arriving on site. However, in certain instances (e.g. ,
unannounced inspections at hospitals which may begin at early hours before .
I management arrives on site) the . inspector may choose to inform the licensee of his/her presence on site after initial observations of the licensed activities l currently in progress. l The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for discussing or reviewing selected inspection items with various licensee staff personnel. However, in some instances, the inspector may only need to inform 1 management of NRC's presence on site, and apprise management that an exit j briefing will be conducted, at the end of the inspection, which will detail the )
inspection findings. i Issue Date: XX/XX/XX 87115
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This is often an opportune time for the inspector to identify personnel to be interviewed. Scheduling interviews will enhance inspector. efficiency and give the licensee the opportunity to have tne most knowledgeable individuals present to respond in the areas being inspected.
i Certain inspection items involving visual observations and/or records review are better performed unannounced; therefore, these types of items should not be discussed during the entrance briefing.
00.03 General Overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.
2 a. Oroanization. The licensee's organizational structure will usually be found in the license application and may involve one or more individuals. ;
Determine the reporting structure between executive management, the RS0, i the Chair)erson of the RSC, and the other members of the RSC. Determine whether t1e RSO has sufficient access to licensee management. Through l discussions with licensee staff, the inspector should determine if l changes in ownership or staffing have occurred. If the owner or individuals named in the license have changed, determine whether the ,
licensee has submitted appropriate notification to NRC. This inwnnation !
must be provided whenever changes in ownership or personnel are made. '
Ask licensee management if changes have occurred, or are anticipated, and ask personnel to confirm (to the inspector's satisfaction) that no changes have taken place. If there have- been no changes in the organization since the previous inspection. there is no need to pursue
, this element in f& ther detail.
The inspector should review any organizational change in the R50 position, authorities, responsibilities, and reporting chains. The Inspector should be sensitive to changes that reduce the ability of the RSO to resolve concerns or issues related to the safe conduct of the radiation protection program. The inspector should ask licensee management and the RSO about the RSO's authority and about any changes
- . that may im upon the RS0's duties, responsibilities, or effectiveness. pact
- b. Scooe of Procram. Through discussions with licensee personnel, the inspector can obtain useful information about the types and quantities of material, frequency of use, ir.cidents etc. which can not always be gained by reviewing records alane. This is also an opportunity for the inspector to discern the actual size and scope of the licensee's program, and to determine if significant changes have occurred since the previous inspection.
If a mobile nuclear medicine program is being inspected, information concerning letters of contract with the licensee's client management J
should be discussed and reviewed.
- c. Manaaement Oversiaht. The inspection is a verification of the licensee's implementation of the required program. In the review to verify implementation, the inspector should pay particular attention to the scope of the program; frequency of licensee audits and the use of qualified auditors: procedures for recording and reporting deficiencies to management: and methods and completion of follow-up actions by management.
87115 Issue Date: XX/XX/XX
- 1. RSC - If a RSC is applicable to this licensee, topics of discussion should include ALARA reviews, incidents, generic comunications, authorized users and uses, waste issues. audits. and misadministrations and recordable events, as defined in 10 CFR 35.2.
The RSC must consist of at least three individuals and must include an authorized user from each ty)e of use permitted by the license, the RSO. a representative from t1e nursing service, and a management representative who is neither the RSO or an authorized user: and must meet at least quarterly. The inspector should review meeting minutes (and interview selected comittee members when practical) to determine the comittee's effectiveness.
Determine if the comittee has been aggressive in seeking out areas needing improvement, rather that just responding to events and information from outside sources. Determine whether the RSC has recomended any specific actions and assess the implementation of those recomendations. The inspector's review should be of sufficient depth and detail to provide an overall assessment of the comittee's ability to identify. assess, and resolve issues. Also consider the effectiveness of the RSC to communicate the results of i
audits and trending analyses to appropriate personnel performing licensed activities.
- 2. RSO - All medical licensees, ir.cluding nuclear medicine licensees, must have an R50. The RSO is the individual, appointed by licensee management and identified on the license, who is responsible for implementing the radiation safety program. The inspector should verify that this individual is knowledgeable about the program, and ensures that activities are being performed in accordance with approved procedures and the regulations. The inspector should verify that, when deficiencies are identified. the RSO has sufficient authority, without prior approval of the RSC. to implement corrective actions. including termination of operations that pose a threat to health and safety.
- 3. Audits - The frequency and scope of audits of the licensed program will vary. However note that at a minimum, medical institution licensees are required by 10 CFR 35.22(b)(6) to review the radiation safety program content and implementation at least annually. The l results of audits should be documented. Examine these records with !
particular attention to deficiencies identified by the auditors, and l note any corrective actions taken as a result of deficiencies found. 1 If no corrective actions were taken, detennine why the licensee l disregarded deficiencies identified during audits, and whether the lack of corrective actions caused the licensee to be in non-compliance with regulatory requirements.
- 4. ALARA - The inspector should detennine if the licensee's written radW1on protection program includes provisions for keeping doses
/A Medical licensees must conduct reviews to ensure that i et hcs are made to maintain individual and collective doses ALARA l
- d. Authorized Users. Authorized users may either be named in the license application or be appointed by the licensee, depending on the type of license issued and/or the wording in the license. For those appointed by the licensee. verify that the authorized user is trained in accordance 4 with the approved criteria and has knowledge comensurate with operational duties.
Issue Date: XX/XX/XX 87115 l l
1 The regulations in 10 CFR 35.11(b) allow an individual to receive.
possess, use, or transfer byproduct material for medical use "under the supervision of" the authorized user, unless prohibited by license condition. The regulations in IC CFR 35.11(c) allow an individual to prepare unsealed byproduct material for medical use "under the supervision of" an authorized nuclear pharmacist or authorized user.
These regulations do not specifically require that the authorized i user / nuclear pharmacist be present at all times during the use of such materials. The authorized user / supervisor is responsible for assuring that personnel under his/her supervision have been properly trained and instructed, pursuant to 10 CFR 35.25(a and b) and is responsible for the supervision of operations involving the preparation /use of radioactive materials whether he/she is present or absent.
03.04 Walk-Throuah Orientation Tour. The inspector should make initial observations of hcensed activities to determine that materials are being safely handled and that good health ' physics practices are followed. The inspector should look at areas of use storage, and disposal to make an initial assessment of the licensee's ALARA program with regard to facility design, engineering controls, house-keep.ing practices etc. The inspector should ensure that observations of activities are documented in the inspection field notes.
03.05 Facilities. Descriptions of the facilities are generally found in the ;
application for a license and subsequent amendments that dre usually tied down l to a license condition. The actual or as-built facility should be configured to ,
provide safe working areas separated from unrestricted areas and sufficient 1 access controls to preclude unauthorized entry. The inspector should also be aware of potential industrial safety hazards for referral to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA).
03.06 Eauioment and Instrumentation
- a. Equipment and instrumentation should be appropriate to the scox of the licensed program. The inspector should verify that operable survey instrumentation is possessed and readily accessible per 10 CFR 35.120, 35.220, 35.320. or 35.520. or is available, per license conditions to show compliance with Part 35. The inspector should also verify that the survey instruments are calibrated before first use, annually, and after repairs and checked for response with a dedicated check source each day of use. All survey, sampling and monitoring instruments should have current calibrations appropriate to the types and energies of radiation 1 to be detected. The technical adecuacy of calibration procedures at i facilities that perform their own ca:ibrations s,hould be examined. l
- b. The inspector should determine if dose calibrators for >hoton-emitting l radionuclides and equipment used to assay alpha- anc beta-emitting i radionuclides are ;ossessed, used, and tested at the appropriate l intervals, in accorcance with 10 CFR 35.50 and 35.52. respectively, and the licensee *s procedures: and if appropriate actions are taken when errors are identified. Tests to be conducted are linearity. geometric dependence, accuracy and constancy. If generators are used. determine that each eluate / extract used for radiopharmacy is tested for molybdenum-99 breakthrough in accordance with 10 CFR 35.204. Also determine that I vials and syringes are properly labeled and shielded per 10 CFR 35.60 and ;
35.61 r~ oectively. l l
I 87115 Issue Date: XX/XX/XX J
l I
- c. Processing equipment, ventilation, and exhaust systems should be sufficient to provide safe use, handling, and storage of the materials in l use. Examination of periodic flow rate checks of ventilation and exhaust j systems should be performed. -
d.
. E
'Q Inspectors should verify that licensees have procedures for identifying - ,
and reporting defects in accordance with 10 CFR Part 21. The complexity l of the procedures will vary.
03.07 Materials 1
- a. Receipt and Transfer of Licensed Materials. Depending on the size of the i
, licensed program, the package receipt and transfer procedures ( a few or many) will be found in the license application. These procedures should be carefully reviewed before an inspection is conducted. By discussions ,
with the licensee, determine if the procedures have been changed or l modified. Some changes will require a license amendment whereas other j minor changes (updating telephone numbers, editing procedures for i clarity, etc.) may not require NRC approval. Randomly examine procedures i used by the licensee to determine if they are in accordance with those identified in the license application, and determine whether these changes warrant a license amendment. i The procedures for picking up, receiving. and opening packages should 1 include how and when packages will be picked up, radiation surveys and wipe tests of packages to be done u)on receipt, and procedures for l opening packages (such as the location n the facility where packages are ,
received, surveyed, and opened). The procedures also should include what l actions are to be taken if surveys reveal Jackages that are contaminated '
in excess of specified limits, and/or raciation levels that are higher l than expected. If Jackages arrive during the course of an inspection, the inspector shou' d observe, when practical personnel perform the ,
package receipt surveys. l The inspector should randomly examine records of package surveys and also determine if inventories for each radionuclide are within the license limits. In this regard, records of inventories following receipt and transfer should indicate / demonstrate that the materials on hand at any one time are within the licensee's possession limit. When practical, the records examined should be compared with a physical inventory of materials possessed.
Examine the licensed materials accounting system. A relatively small facility will generally need to maintain receipt records, disposal records, and records of any transfers of material. However, a large facility will need a sophisticated accounting system which provides accurate infonnation on the receipt of material, its location, the .
quantity used and disposed of, the amount transferred to other !
laboratories operating under the same license, and the amount remaining after decay. The accounting systems should also consider radioactive material held for decay-in-storage near-term disposal. or trarisfer to other licensees. In both types of accounting systems, the licensee should perform routine physical audits to ensure the accuracy of the i '
system.
- b. Authorized Uses. Authorized uses of licensed material will be found in the licenses and license applications. Licenses will list the isotopes, physical or chemical forms, and the maximum possession limits. The issue Date: XX/XX/XX 87115
inspector should physically examine the inventory of r Jioactive material on hand or examine records of receipt and transfer to determine that quantities and forms are as authorized. Additionally, the inspector 4
should verify that the licensee's use of licensed material is limited to L that which is authorized in the license. .
t
- c. Material Security and Control. Examine areas where radioactive materials are used and stored. Storage areas should be locked and have limited and
- controlled access. Radioactive material use areas should be under constant surveillance or physically secured The licensee should have *
- procedures for access controls. Controls may include a utilization log to indicate when radioactive material is taken from and returned to storage areas. The inspector should verify that adequate controls are in .
place and working effectively. ;
03.08 Trainina
- a. General Trainina. Certain kinds of training and instruction are found in the regulations: how they are implemented will be found in the license.
Discuss with the licensee how, and by whom. training is conducted and the content of the training provided to workers (generally found in the license application).
Verify, pursuant to 10 CFR 19.12 that instructions have been given to individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv). IJnder the basic instructions, it is management's responsibility to inform the workers of precautions to take when entering a restricted area, kinds and uses of radioactive materials in that area, exposure levels, and the types of protective equipment to be used. The workers should also be informed of the pertinent provisions of NRC regulations and the license. 1 and the requirement to notify management of conditions observed that may.
if not corrected, result in a violation of NRC requirements. Also verify that authorized users and workers understand the mechanism for raising safety concerns.
Of the training program elements in the license application, training given to authorized users, and those individuals under the supervision of authorized users, is of primary importance. One or more users of radioactive materials should be interviewed to determine that they have received the required training, both in the basic instructions and in that specified in the license application. For some licensees, this includes specific training needed to perform infrequent procedures and prepare and use radioactive material in research studies. Note that the !
tra'ining should be (and in most cases is required to be) provided to workers prior to the individual's performance of licensed activities.
i Randomly examine records of trainirig of personnel and attendant examinations or tests (if applicable) to the extent that the inspector is satisfied that the training program is being iglemented as required.
Where examinations are required, read a few of the examination cuestions to ascertain that they are indicative of what the worker shoulc. know to carry out his/her responsibilities.
The inspector should also observe related activities and discuss the radiation safety training received by selected individuals to assure that appropriate training was actually received by these individuals.
Authorized users and supervised individuals should understand the 87115 Issue Date: XX/XX/XX
radiation protection re associated with their assigned activities. The licensee'quirements s radiation safety training may include, but is not limited to. demonstrations by cognizant facility personnel, formal lectures. testing. films, and " dry runs" for more complex or hazardous operations.
- b. Ooeratino and Emeroency Procedures. Operating procedures will be found in license applications and may vary from ste)-by-step procedures to more generalized procedures. The operating procecures will be approved by the NRC and reviewed and updated by the licensee. Hinor changes in radiation safety procedures may be made in accordance with 10 CFR 35.21(b)(6). 10 CFR 35.22. and 10 CFR 35.31. Any major revisions recuire an amendment to the license in accordance with 10 CFR 35.13. T1e inspector should examine. records of procedure revisions.
Emergency procedures will be found in license applications and may vary from step-by-step procedures to more generalized procedures for lower inspection priority licenses. The emergency arocedures will be approved by the NRC and reviewed and updated by the l'censee.
Some licensees may have agreements with other agencies (e.g., fire. . law enforcement, and medical organizations) regarding response to j emergencies. Discuss with the licensee's representatives what has been done to ensure that agencies (involved in such agreements) understand l their roles in emergency responses. j
- c. Radiocharmaceutical Theraov Trainino. Licensees that administer radiopharmaceutical therapy must provide radiation safety instructions for all personnel caring for such therapy patients and retain records of such training for three years. :
03.09 Area Radiation and Contamination Control
- a. Area Surveys. The inspector may ask the licensee to spot-check radiation levels in selected areas using the licensee's own instrumentation.
, However, the inspector must use NRC's instruments for independent i verification of the licensee's measurements. (The inspector's l instruments shall be calibrated and source-checked before he/she leaves the regional office.)
If practical. observe how licensees conduct surveys to determine the adequacy of surveys. Also, note the types of instrumerts used, and whether they are designed and calibrated for the type of radiation being measured. The inspector should assure that the licensee has established trigger levels and that the licensee decontaminates at the appropriate trigger levels.
The inspector shculd determine if workers take smears or instrument readings in areas that are readily accessible to facility personnel.
Particular attention should be given to released patient rooms, hot lab bench toos sinks used for disposal, and storage areas. The survey activities should be performed in accordance with 10 CFR 35.70. The inspector should also perform independent measurements as needed to verify licensee assumptions or measurements.
- b. Leak Tests. Through discussions with licensee personnel and/or by demonstration of leak test procedures, the inspector should verify that leak tests are performed in accordance with 10 CFR 35.59. .
Issue Date: XX/XX/XX 87115
1 I
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- c. Contamination Control. The inspector should verify that the licensee's l survey procedures and counting equipment are adequate to detect and I control radionuclide contamination. The inspector may choose to examine l the instrument calibration records (efficiency checks. lower limit of i detection calculations. geometry, linearity, etc.). physical location of
, counting instruments, methods of detection, and wipe sample locations.
] Additionally, when appropriate the inspector should consider taking 4
confirmatory wipe samples.
- d. Protective Clothina. Observation of the protective clothing worn by nuclear medicine personnel or other applicable staff during their work activities should provide the inspector with an acceptable means of reviewing this requirement. Requirements for protective clothing may be found in the licensee's procedures.
03.10 Radiation Protection. Specific guidance is set forth in IP 83822.
" Radiation Protection."
NOTE: Inspection guidance for 10 CFR 35.75, patient release criteria. is being
- revised by IMNS and is being separately transmitted for comment.
10 CFR 19.13(b) requires that each licensee shall advise each worker annually of i the worker's dose as shown in dose records maintained by the licensee. Verify through discussions with workers and marugement, and through records review, that 4 the licensee has advised workers of their doses annually. The licensee must i advise all workers for whom monitoring is required (and, therefore, dose records l are required). The licensee must advise these workers of internal and external j doses from routine operations, and doses received during planned special l exposures, accidents, and emergencies. The report to the individual must be in !
- writing and must contain all of the information required in 10 CFR 19.13(a).
03.11 Ouality Manaaement Proaram 1
3 NOTE: This section is being revised by INNS and is being separately transmitted i for connent.
03.12 Waste Manaaem e
- a. Waste Storace and Disoosal. Verify that the waste is >rotected from fire and the elements, that package integrity is adequate'y maintained, that the storage area is properly ventilated, and that adequate controls are
- in effect to minimize the risk from other hazardous materials. Verify that the licensee has appropriate methods to track the items in storage.
Inspection effort should be directed at verifying that written procedures have been established in a manner approved by management. The procedures should be readily available to any persons having responsibility for low-level waste classification and preparation for transfer of such wastes to land disposal facilities.
Generally radionuclides used in nuclear medicine facilities have half
. lives of 65 days or less and can be decayed in storage for 10 half lives.
surveyed and when indistinguishable from background can be disposed of in ordinary trash.
For further inspection guidance, refer to IP 84850 " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61."
87115 Issue Date: XX/XX/XX
i
- b. Ef fluents. Examine the waste release records generated since the last i inspection. all annual or semiannual reports, all pertinent non-routine event reports, and a random selection of liquid and airborne waste release records. ' Randomly select procedures for both liquid and airborne systems and verify that the licensee's procedures are being followed. i The verification can be made by observations of an operation, a review of l selected records, interviews with workers, etc. l Review the licensee's ALARA goals, and determine if they are sufficMr.tly i challenging yet realistic. Determine if the licensee understands and I implements these goals. Determine if the licensee has calculated annual !
doses resulting from air effluents and if the doses: (1) are within the '
licensee's ALARA goals (as described in their radiation protection i arogram): (2) exceed the licensee's ALARA goals; or (3) are uncertain '
Jecause there is insufficient information or basis for determination. i Review the licensee's history in meeting ALARA goals, and its corrective i actions when the goals were not met. 1 For further inspection guidance, refer to IP 87102.
1
- c. Transfer. Ascertain if the licensee has an adequate method of determining that recipients of radioactive wastes are licensed to receive such waste (i.e.. licensee obtains a copy of the waste recipient's current license before the transfer).
- d. Records. Each licensee is required to maintain records of the disposal of licensed material made under 10 CFR 20.2002-2005,10 CFR Part 61, and ;
disposal by burial in soil. These records must be retained until the i Commission terminates each pertinent license requiring the record. The '
inspector should review these records to verify that disposals are made '
in accordance with the applicable regulations, and that records are complete and accurate for each type of disposal. For nuclear medicine i waste that is decayed in storage for ten half lives, surveyed, and '
disposed to the normal waste stream, records are required to be retained for three years from the date of disposal.
- e. Financial Acsurance and Decomissionina. The decomissioning record- )
keeping requirements are applicable to all materials licensees including l licensees with only sealed sources, and are specified in 10 CFR 30.35(g).
These records should contain, among other information: (1) records of l spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site (when contamination 1 remains after cleanup, or when contaminates may have w e_d to I inaccessible areas): (2) as-built drawings and modifications of ;
structures and equipment in restricted areas where radioactive materials i are used and/or stored, and locations of possible inaccessible contamination: (3) except for areas with only non-leaking sealed sources or byproduct materials with half lives of less than 65-days a single document detailing restricted areas and formerly restricted areas, buried waste, areas requiring decontamination that are outside of restricted areas, and areas outside of restricted areas that, if the license expired. would have to be decontaminated or approved for disposal: and (4) records of the cost estimate performed for a decomissioning funding plan or the amount certified for decommissioning. This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g).
On all inspections the inspector should ensure that the licensee has such decommissioning records, that the records are complete. that they are Issue Date: XX/XX/XX 87115
i l
updated as required and that the decomissioning records are assembled or referenced in an identified location.
4 Some licensees may release laboratories or other rooms within a building for unrestricted use, without a license amendment. The release of these ;
areas - may . fall outside of the reporting requirements in the '
Decommissioning Timeliness Rule if the licensee continues to conduct other activities in the same building. Inspectors should identify the 1
rooms that have been released since the last inspection and perform confirmatory measurements to verify that radiation and contamination levels are below release limits. Licensee survey records and other documentation should be reviewed to verify that the basis for releasing 1 each room is adequately documented in the licensee's decomissioning J records.
4 Licensees submit financial assurance instruments and/or decommissioning plans for a specific set of conditions. Occasionally. those conditions may change over time and the licensee may not notify NRC. The inspector should be aware of changes in rcdiological conditions while inspecting a
, licensee's facility that would necessitate a change in the financial
- assurance instrument and/or decomissioning plan, especially where the
- radiological conditions deteriorate and the financial assurance instrument or decomissioning plan may no longer be sufficient. In preparation for the inspection, the inspector should determine the dates i that the financial assurance instrument and decomissioning plan (if a
a)plicable) were submitted to NRC. Then during the inspection, through 0)servations, discussions with licensee personnel, and records review, the inspector should determine whether the radiological conditions at the licensee's facility have changed since the documents were submitted to NRC. If conditions have changed and the adecuacy of the financial assurance instrument and/or decommissioning plan is in doubt. the jl inspector should immediately contact regional management from the
- licensee's site to discuss the situation.
Additionally, some licensees are required to maintain decommissioning cost estimates and funding methods on file. If the licensee uses a
, parent company guarantee or a self-guarantee as a funding method the inspector should verify that the licensee has a Certified Public '
Accountant certify each year that the licensea passes a financial test.
The financial test ratios for parent conpany guarantees and self-
, guarantees are specified in Section II. Appendix A and Appendix C. !
respectively. to 10 CFR Part 30. j
- f. Decomissionino Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license remains in effect. determine if the licensee has made a decision to cease principal activities at the site or in any separate building. Finally.
,i determine if there has been a 24-month duration in which no principal activities have been conducted in such areas. A principal activity is one which is essential to the purpose for which a license was issued or
- amended, and does not include storage incidental to decontamination or decommissioning. If the licensee meets any of the above conditions, the 4
' decomissioning timeliness requirements apply, and the inspector must complete in full the "Decomissioning Timeliness Inspection Field Notes."
4 Attachment A to Appendix A.
The requirements of 10 CFR 30.36, 40.42, and 70.38 do not apply to released rooms within a building where principal activities are still on-87115 Issue Date: XX/XX/XX l
going in other parts of the same building. However,inthosecases,ihb RQ inspector should follow the guidance in 03.12.e. regarding confirmatory measurements of the released area. Once principal activities have ceased in the entire building, then the decomissioning timeliness requirements will take effect. .
The Decommissioning Timeliness Rule became effective on August 15. 1994.
In corrpleting the Attachment A field notes, specific guidance is needed regarding the timing of the notification requirements. If the license has expired or been revoked. or if the licensee has made a decision to permanently cease principal activities, and the licensee orovided NRC notification before Aucust 15. 1994 then August 15. 1994 is considered to be the date for initiating the decommissioning calendar (i.e.. date of notification). If there has been a 24-month duration in which no principal activities have beer conducted at the location before the effective date of the rule, but the licensee did not notify NRC. then the 24-month time period of inactivity is considered to be initiated on August 15. 1994, and the licensee must provide notification to NRC within either 30 or 60 days of August 15,1996 (depending on whether the licensee requests a delay).
NRC has a stringent enforcement policy with respect to violations of the decomissioning timeliness requirements. Failure to comply with the Decommissioning Timeliness Rule (failure to notify NRC. failure to meet decomissioning standards, failure to complete decomissioning activities in accordance with regulation or license condition, or failure to meet required decommissioning schedules without adequate justification) may be classified as a Severity Level III violation and may result in consideration of monetary civil penalties or other enforcement actions, as appropriate.
Decomissioning timeliness issues can be complex. For situations where an inspector has questions about the licensee's status and whether the decomissioning timeliness standards apply, he/she should imediately contact regional management.
For planning and conducting inspections of licensees undergoing !
decommissioning, refer to IMC 2602. " Decommissioning Inspection Program {
for Fuel Cycle Facilities and Materials Licensees:" IP 87104
" Decommissioning Inspection Procedure for Materials Licensees:" and the .
draft D70missioning Manual Chapter and Handbook. )
03.13 "ransoortation. The inspector should review: the licensee's hazardous materia' training: packages and associated documentation: vehicles (including i placarding. cargo biccking and bracing. etc.): shipping papers; and any incidents I reported to 00T ihis is an ideal area for the insactor to make observations '
of licensee practices. The DOT and NRC regulat'ons for transportation of radioactive materials were recently revised, and the revisions generally became effective April 1. 1996.
For further inspection guidance, refer to IP 86740 " Inspection of Transportation Activities." Inspectors should also refer closely to " Hazard Comunications for Class 7 (Radioactive) Materials." the NRC field reference charts on hazard I communications for transportation of radioactive materials, which contain references to the new transportation requirements and are useful field references for determining compliance with the transportation rules on labeling, placarding, shipping papers. and package markings.
Issue Date: XX/XX/XX 87115
,nW 03.14 Postina and labelina. The inspector should determine whether proper caution signs are being used at access points to areas containing radioactive materials, radiation areas, and those areas containing airborne radioactive materials. 10 CFR 20.1903 provides exceptions to posting caution signs. When applicable. the inspector should also randomly examine signals and alarms to determine aerability. The ins)ector should also randomly observe labeling on packages or other containers to cetermine that proper information (e.g. , isotope, quantity, and date of measurement) is recorded. ;
Areas with radiation hazards should be conspicuously posted, as required by 10 CFR 20.1902. Depending on the associated hazard, controls may include tape rope ,
or structural barriers to prevent access. If volatile radioactive materials are I used in an area, such an area should be controlled for airborne contamination. ;
High radiation areas should be strictly controlled to prevent unauthorized or ;
inadvertent access. Such controls may include, but are not limited to, direct surveillance, locking the high radiation area, warning lights, and audible alarms. Areas occupied by radiation workers for long periods of time and coninon- ;
use areas should be controlled in accordance with licensee procedures and be !
consistent with the licensee's ALARA program.
l The inspector should also examine locations where notices to workers are posted.
Applicable documents, notices, or forms should be posted in a sufficient number l of places to permit individuals engaged in licensed activities to observe them !
on the way to or from any particular licensed activity location to which the I posting would apply.
03.15 Generic Communications of Information. Through discussions with licensee !
management and the RSO. the inspector should verify that the licensee is l receiving the applicable bulletins, information netices. M61 Newsletter, etc., i and that the information contained in these documents is disseminated to i appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC communications, when a response is required. ;
03.16 Notifications and Reoorts. The inspector should determine the licensee's :
compliance for notifications and reports to the Commission. The licensee may be l required to make notifications after loss or theft of material, overexposures.
incidents, high radiation levels, safety-related equipment failure, etc. Through discussions with licensee personnel, and by a review of representative records, the inspector should verify that notifications and/or reports were appropriately submitted to NRC.
03.17 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of equipment used by the licensee. In these instances the inspector should verify that the licensee understands the additional requirements, and maintains coupliance with the special license conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC requirement.
03.18 Indeoendent and Confirmatory Measurements. The inspector should perform independent and confirmatory measurements in restricted and unrestricted areas of the licensee's facility. Independent measurements should be performed on all I inspections, unless exceptional circumstances make it impossible to perform the q measurements (e.g. , inspector's detection equipment malfunctions during an l inspection trip). Measurements of dose rates at the boundary of the unrestricted I areas should be performed at the surface of the most accessible plane. Examples I of measurements that may be performed include area radiation surveys, wi)e (
samples, leak tests, air flow measurements, etc. These measurements should 3e l l
87115 Issue Date: XX/XX/XX l l
l f
taken in licensed material use areas, storage areas, effluent release points, etc. Confirmatory measurements are those whereby the inspector compares his/her i
measurements with those of the licensee's. Independent measurements are those performed by the inspector independently of the licensee's measurements. To
! perform the independent or confirmatory measurement. use NRC radiation detection l instruments that are calibrated at a minimum, on an annual basis. l 03.19 Exit Meetina. When the inspection is over, there should be an exit meeting with the most senior licensee representative present at the facility.
If a senior management representative is unavailable for the exit meeting the ,
inspector may hold a preliminary exit meeting with appropriate staff on site. i However, there must be a formal' exit meeting with a senior management l l representative (and the licensee's RS0, if not present at the preliminary exit 1 4
meeting) .as soon as practical after the inspection. This meeting will usually be performed by telephone conference call.
During the exit meeting the licensee representatives should be made aware of the preliminary inspection findings. including any negative PEFs. any apparent t vio!ations of regulatory recuirements, any safety-related concerns or unresolved
- items identified during tae inspection, and the status of any previously identified violations. The licensee must immediately address any significant i safety concerns.
If the insoector identifies safety concerns or violations of significant
! regulatory rewireaents that affect safe operation of a licensee's facility the licensee must initiate prompt corrective action. The inspector should not leave
. the site until the concern is fully understood by the licensee and corrective 5
action has been initiated. If the inspector and the licensee disagree over how significantly the concern impacts continued safe o j
- regional management should be notified immediately. peration of the facility,
]
While deficiencies identified in some areas (e.g., workers' knowledge of the Part 20 requirements) are not always violations the inspector should bring such i deficiencies to the attention of licensee management at the exit meeting and also
- in the cover letter transmitting the inspection report or NOV.
i
- 03.20 Post Insoection Actions. Regional office policy will dictate with whom the inspector will review his or her inspection findings (e.g. the inspector's supervisnr). following the. guidance in IMC 2800. " Materials Inspection Program."
i The inspector should discuss the findings in detail that is commensurate with the ;
scope of the licensee's program. Violations items of concern (e.g., negative I i PEFs), and unresolved items should be discussed in sufficient depth for '
3 management to make appropriate decisions regarding enforcement actions, referral 1 to other State and Federal agencies, and decisions on the scheduling of future
- inspections of the licensee's facility.
The inspector should also discuss insxction findings with licensing staff. This information exchange can be particularly useful if the licensee is having its license renewed or has recently submitted a license amendment request. The inspector should inform licensing staff about how the licensee has addressed (or failed to address) special license amendments or recent licensing actions.
Licensing information requested by the licensee should also be discussed with the licensing staff.
Inspectors should be aware that NRC has entered into several MOUs. with other i Federal agencies. that outline agreements on items such as exchange of information and evidence in criminal proceedings. The inspector should ensure Issue Date: XX/XX/XX 87115 i
i
J that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.
The inspector may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following i
' the guidance in IMC 2800. The inspector must also ensure that the findings are documented in the inspection field Ttes and/or inspection report in sufficient detail for the reader to determiw what requirement was violated, how it was violated, who violated the requirement. and when it was violated. Copies of all licer.see documents needed to support the violation snould be attached to the
- inspection field notes and/or inspection report. The field notes should not be 4
' used as merely a checklist to note areas reviewed but should be used to describe ,
what procedures or activities were observed and/or demonstrated by the licensee l during the inspection, and any items of concern identified that were not cited !
as a violation of regulatory requirements. i
, Inspectors may complete the field notes either by hand or electronically. If the inspector is documenting the field notes in electronic format, the sub-items '
under major sections that are not applicable or not reviewed may be deleted.
However, the heading itself (e.g.. " Radioactive Waste Management." or
? " Transportation") should remain in the field notes, and the inspector should enter a)propriate remarks about why the section is not applicable or not )
- reviewec .
4 For further inspection guidance, refer to Section 07.04 of IMC 2800. I 87115-04 REFERENCES A listing of IMCs and IPs. applicable to the inspection program for materials licensees. can be found in Section 2800-11 of IMC 2800. These documents are to be used as guidelines for inspectors in determining the inspection requirements for operational and radiological safety aspects of various types of licensee activities.
Specific references to regulatory requirements can be located in the " Nuclear Medicine Inspection Field Notes" appendix to this IP.
END Appendix:
A. " Nuclear Medicine Inspection Field Notes" 87115 Issue Date: XX/XX/XX-
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l ATTACHMENT 1 APPENDIX A NUCLEAR MEDICINE INSPECTION FIELD NOTES i
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APPENDIX A ggf.f b NUCLEAR MEDICINE INSPECTION FIELD NOTES Region ,
Inspection Report No. License No.
Licensee (Name & Address): Docket No. _
Licensee Contact Telephone No.
Amendments Issued Since Last Inspection: ' Numbers) I Dates of Above Amendments
, Priority Program Co<1e l Date of Last Inspection l Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced
( ) Routine ( ) Special
( ) Initial ( ) Reinspection Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended Justification for change in normal inspection frequency:
i l
i Sumary of Findings and Action:
( ) No violations cited. Clear NRC Form 591 or regional letter issued
( ) Violation (s). Form 591 issued
( ) Violation (s), regional letter issued
( ) Follow-up on previous violations Inspector Date (Signature)
Approved Date (Signature)
Issue Date: XX/XX/XX A-1 87115. Appendix A
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Field notes are to be used by the inspector to assist with the performance of the inspection. Note that all areas indicated in the field notes are not required to be addressed during each inspection. However. for those areas not covered during the inspection, a notat?on ("Not Reviewed") should be made in each section where applicable. Additionally all areas covered
, during the inspection should be docunented in' sufficient detail to describe i e
what activities and/or records the inspector observed. For exanple. cne i
- types of records that were reviewed and the time periods covered by these
- records should be noted in the appropriate. " Basis for Findings" section(s). '
- If the licensee denonstrated any practices at your request, describe those ;
, denonstrations. The observations and danonstrations you describe in this \
report, along with measurenents and sme records review, should substantiate i j your inspection findings.
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- 1. INSPECTION. LICENSING. AND INCIDENT HISTORY '
i A. Violations were identified during any of )
l the last two inspections or two years. !
whichever is longer. (N/A = Initial insp.) ( ) N/A ( ) Y ( ) N B. Response letter (s) or Form 591(s) dated .
! C. Violations from previous inspection (s): ;
I REQUIREMENT CITED STATUS
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! D. Any repeat violation (s) identified? ()Y()N If "Yes " explain:
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87115. Appendix A A-2 Issue Date: XX/XX/XX
E. License amendments issued since last ir.spection [35.13 ].
or program changes noted in the license:
AMENDMENT # QATE SUBJECT 9
4 l F. During this inspection, was the licensee *s implementation of all of the above amendments or
- program changes inspected / observed? ( ) N/A ( ) Y ( ) N G. During this iaspection, were any violations identified involving any of the above amendments or program changes? ( ) N/A ( ) Y ( ) N H. List any incidents, misadministrations. or events
' ' reported to NRC since the last inspection (Note:
"None" indicates that regional event logs, event files, and the licensing file have no evidence of any incidents or events since the last inspection): ( ) None INCIDENT OR EVENT l
I. During this inspection were the incidents / events reviewed with the licensee, and was the licensee's follow-up .
to the incidents / events examined? ( ) N/A ( ) Y ( ) N 2
Here and throughout the field notes, sections of 10 CFR are referenced only by their section numbers.
Issue Date: XX/XX/XX A-3 87115. Appendix A
.-.. .-. ~. . . - - _ - - - - . - - - . - - . .
t J. Describe the licensee's follow-up in response to the events / incidents listed in 1.H.:
i j Basis for Findings:
- 2. ORGANIZATION AND SCOPE OF PROGRAM A. Describe the licensee's organizational structure to indicate the
" chain-of-comand" from senior licensee management to authorized users of licensed material. Show or describe where the RSO and l Chairperson of the RSC are located in the licensee's organization '
and to whom they report.
87115, Appendix A A-4 Issue Date: X"/XX/XX
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B. Identify licensee personnel. contacted during the ;
inspection (including those individuals contacted oy '
telephone). i t
)
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t Use the following identification symbols:
- Individual (s) present at entrance meeting
- Individual (s) present at exit meeting i
+ Individual (s) contacted by telephone :
C. Authorized for multiple. locations of use ()Y()N If "Yes." list locations inspected:
D. Authorized for multiple pennanent field office locations ( ) Y (.) N (1) Inspection performed at multiple field offices ( ) Y.( ) N (2) If "Yes." list office locations inspected:
E. Briefly describe scope of activities, including types and quantities of byproduct material used for medical l use, frequency of use. staff size, etc.
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i Issue Date: XX/XX/XX A-5 87115. Appendix A
F. Mobile Nuclear Medicine Service ( ) N/A (1) . Location (s) of use and scope of activities:
(2) Licensee operates services per [35.29. 80] ()Y()N (3) 'Comaliance with 20.1301 dose limits for mem)ers of the public evaluated and met ()Y()N (4) Records of surveys maintained [35.80] ()Y()N G. Licensee does limited distribution of pharmaceuticals under Part 35 license? ()Y()N (1) Indicate type of operatior:
(a) Registered or licensed with FDA as a drug manufacturer (b) Registered or licensed with State agency as a drug manufacturer (c) Licensed as a pharmacy by State Board of Pharmacy (d) Operating as a nuclear pharmacy within a Federal medical institution (2) Licensee distributes (a) Sealed sources ()Y()N (b) Alpha and beta emitters ()Y()N (c) Generators ()Y()N (d) Photon emitters ()Y()N
~
H. Research involving human subjects ( ) N/A (1) Research is conducted, funded, supported. or regulated by another Federal agency which has implemerited Federal Policy for Protection of Human Subjects [35.6] ()Y()N If "No." does licensee have license amendment authorizing human research? [35.6] ()Y()N (2) Licensee obtains informed consent from human subjects [35.6. L/C'] ()Y()N 2
If the licensee distributes radiopharmaceuticals to several facilities, the inspector should consider the need to complete IP 87117. Appendix A. " Radiopharmacy Inspection Field Notes."
2 Agencies: USDA 00E NASA. HUD. D0J. D00. DVA. EPA. HHS. 00C.
Consumer Product Safety Commission. International Development Coo >eration Agency. Agency for International Development. Department of Education. National Science Foundation Here and throughout the field notes. "L/C" means " license condition." . i 87115. Appendix A A-o Issue Date: XX/XX/XX
)
DRA,M,,a (3) Licensee obtains approval of research '
activities from an Institutional Review Board or Radioactive Drug Research Committee [35.6. L/C] ()Y()N (4) Licensee has participated in research studies :
since the last inspection ()Y()N :
i Basis for Findings: !
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- 3. MANAGEMENT OVERSIGHT A. Radiation Safety Comittee [35.22. L/C] ( ) N/A
- (1) Membershi) as specified [35.22(a)(1)] ()Y()N
, (2) Meetings 1 eld quarterly [35.22(a)(2)] ()Y()N l (3) Quorums established [35.22(a)(3)] ()Y()N Records of meetings maintained [35.22(a)(4)]
(4) ()Y()N (5) Has sufficient authority [35 23] ()Y()N (6) Approve / disapprove credentials of individuals ;
prior to allowing them to work as an authorized I q user or authorized nuclear pharmacist I
- [35.22(b)(2)(ii)] ()Y()N i B. Radiation Safety Officer
. (1) Appointed [35.21(a). 900) ()Y()N
- (2) Fulfills duties per [35.21(b)] ()Y()N l (3) Has sufficient authrelty per [35.23] ()Y()N C. Radiation Safety Program l
! (1) Minor changes pursuant to [35.31] ( ) N/A ( ) Y ( ) N a
(2) Records of changes maintained [35.31(b)] ()Y()N D. Audits. Reviews, or Inspections i (1) Audits are required [L/C] ()Y()N 1
(2) Audits or inspections are conducted ()Y()N I
. Audits conducted by
! Frequency a !
l Scope of audits I i i (3) Review of ALARA program [35.22] ()Y()N (4) Content and implementation of the radiation safety program reviewed annually by the
, licensee [20.1101(c). 35.22(b)(6)] ()Y()N (4) Records of reviews maintained [20.2102] ()Y()N
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Issue Date: XX/XX/XX A-7 87115. Appendix A'
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E. Use/ preparation of licensed material by authorized individuals [L/C] ()Y()N Comaliance is established by meeting at least one criteria under eac1 category.
(1) Authorized user [35.13(b)] ()Y()N (a) Certified by organization in 35.910.
920. 930, 940, 950. 960 (b) Identified on NRC or Agreement State license .
(c) Identified on permit issued by broad scope licensee 4 (d) Listed on facility license 1 (2) Authorized nuclear pharmacist [35.13(b)] ()Y()N DOES NOT APPLY TO FACILITIES THAT ARE REGISTERED /
LICENSED BY FDA/ STATE AGENCY AS A DRUG MANUFACTURER AND
- DISTRIBUTION IS REGULATED UNDER PART 32. i (a) Certified by organization in 35.980 (b) Identified on NRC or Agreement State license (c) Identified on permit issued by broad scope
, licensee :
(d) Listed on facility license ;
(3) Radiation Safety Officer [35.13(c)]
l Listed on facility license ()Y()N I Basis for Findings: .
l 1 4. FACILITIES
! I A. Facilities as described in license application [L/C] ()Y()N i B. Facilities are secured to prevent unauthorized access [L/C] ';y()N C. Describe any self-contained dry-source-storage irradiators and/or survey instrument calibrators (model, radionuclide, activity, use etc.) ( ) N/A e
(1) Maintenance of safety-related com)onents j performed by authorized persons [./C] ()Y()N (2) Access to high radiation areas controlled
[20.1601. L/C] ()Y()N
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l 87115. Appendix A A-8 Issue Date: XX/XX/XX
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D. Engineering Controls l l
- (1) Licensee uses process or other engineering j 3 controls for volatiles / gases in storage
[20.1701,35.90] ()Y()N (2) Maintenance program implemented for engineering 1 controls (negative pressare, ventilation rates. l filter changes. etc.) [35.205(e). L/C] ()Y()N j Basis for Findings:
- 5. E0UIPMENT AND INSTRUMENTATION A. Dose calibrator - Photon-emitting radionuclides ( ) N/A (1) Possessed and used [35.50(a)] ()Y()N (2) Constancy [35.50(b)(1)]
(a) Performed daily prior to assay of first dose ()Y()N (b) Dedicated check source used ()Y()N (3) Accuracy [35.50(b)(2)]
(a) Performed at installation and annually ()Y()N (b) At least 2 sealed sources used ()Y()N (4) Linearity [35.50(b)(3)] ;
(a) Performed at installation and quarterly (') Y ( ) N (b) Includes range between 30 uCi and the j highest dosage administered ()Y()N J l
(5) Geometry Dependence [35.50(b)(4) .L/C] l l
(a) Performed at installation or relocation, if applicable ()Y()N !
(b) Includes range of volumes and volume configurations used ()Y()N (6) Performed appropriate checks and tests i following adjustment or repair of the !
dose calibrator [35.50(c)] ()Y()N (7) Dosage readings over 10 uC1 mathematically corrected for geometry or linearity :
errors greater than 10% [35.50(d)] ( ) N/A ( ) Y ( ) N !
(8) Repaired or replaced when constancy or accuracy errors exceeded 10% [35.50(d)] ( ) N/A ()Y()N ;
(9) Approved procedures followed [35.21, 25. L/C] ()Y()N (10) Records maintained and include identity _
of individual performing test [35.50(e)] ()Y()N Issue Date: XX/XX/XX A-9 87115 Appendix A
B .' Instrumentation - Alpha- or beta-emitting radionuclides ( ) N/A l
- (1) List type of equipment used to assay alpha and beta
particles:
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i (2) Licensee has procedures for use of 4 instrumentation [35.52(b)] ()Y()N :
(3) Accuracy, linearity, and geometric dependence i tests are rformed prior to initial use. :
- periodical y and following repair, if I applicable [35.52(b)(1) L/C] ()Y()N I I
(4) Instruments are checked for constancy and '
proper operation at the beginning of each
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, day of use [35.52(b)(2), L/C] ()Y()N Appropriate action taken when calibration (5) ,
errors in excess of limits are l
- identi fied. [L/C] ( ) N/A ( ) Y ( ) N l
'(6) Records maintained [L/C] ()Y()N l C. Licensee uses generators ()Y()N (1). No radiophaniaceuticals administered with Mo-99 concentrations over 0.15 uCi per mci of Tc-99m [35.204(a)) ()Y()N (2) Each eluate / extract used for radiocharmaceuticals tested for Mo-99 breakthrough [35.204(b)] ()Y()N (3) Records maintained [35.204(c)] ()Y()N D. Syringes properly labeled and shielded [35.60] ()Y()N E. Vials Kept in a shield [35.61(a)] ()Y()N j (1)
(2) Shields labeled [35.61(b)] .. ()Y()N i F. Survey instruments l (1) Appropriate operable survey instrumentation possessed and readily accessible [35.120.
220. 320. 520: or available (L/C)] ()Y()N ;
5 Note that linearity and geometric dependence tests are not applicable if liquid scintillation is used. Linearity is not applicable if sodium iodide is used.
87115, Appendix A A-10 Issue Date: XX/XX/XX
(2) Calibrated per [35.51. L/C] ()Y()N (a) Before first use, annually, and after repairs [35.51(a))
Odk
()Y()N (b) Calibration procedure includes check source reading [35.51(a)(3). L/C] ()Y()N (c) Within 20% in each scale or decade of interest [35.51(b). L/C] ()Y()N (d) Calibration records maintained
[35.51(d)] ()Y()N (3) Response checked with dedicated check source each day of use [35.51(c)] ()Y()N G. Procedures established to icentify and report safety component defects [21.21] ()Y()N Basis for Findings:
- 6. MATERIALS RECEIPT. USE. TRANSFER. AND CONTROL A. Isotope, chemical form. quantity and use as authorized [31.11. 35.100. 200. 300. 500.L/C] ()Y()N B. Licensee uses unit doses ()Y()N C. Use of radiopharmaceuticals [L/C]
(1) Licensee measures activity of each dosage of photon-emitting radionuclide prior to use [35.53(a)] ()Y()N (2) Li.ensee administers alpha- or beta- emitting radionucli. des ()Y()N If "Yes."
(a) Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization [35.53(b)] ()Y()N (b) Licensee measures by direct measurements or combination of measurement and calculation each dosage of alpha or beta-emitting radionuclide prior to medical use [35.53(b) L/C] ()Y()N (3) Unsealed material used under 35.100. 200 or 300 is 1
[35.100(b). 200(b). 300(b)]:
(a) Obtained from manufacturer or properly licensed '
organization AND/0R ()Y()N (b) Prepared by authorized nuclear pharmacist or physician user or individual under the supervision of an authorized nuclear pharmacist or physician user [35.920] ()Y()N Issue Date: XX/XX/XX A-11 871'.5. Appendix A I
, D. Licensed materials secured to prevent unauthorized
- removal or access [20.1801. 1602] ()Y()N (1) Licensed material in storage in controlled or unrestricted areas is secured from unauthorized removal or access [20.1801] ()Y()N (2) Licensed material in controlled or i unrestricted areas and not in storage is controlled and under constant i
, surveillance [20.1802] ()Y()N f (3) Access to restricted areas is limited
[20.1003] ()Y()N E. Describe how packages are received and by whom:
F. Written package opening procedures established and followed [20.1906(e)] ( ) Y_( ) N G. Incoming packages with DOT labels wiped, unless l exempted (gases and special form) [20.1906(b)(1)] ()Y()N 2
H. Incoming packages surveyed per [20.1906(b)(2)] ()Y()N
- 1. Monitoring in (G) and (H) above performed within time f specified [20.1906(c)] ()Y()N
- J. Transfer (s) of licensed material per [30.41] ()Y()N l i
K. All sources surveyed before shipment and transfer
[20.1501(a). L/C] ()Y()N l L. Records of surveys and receipt / transfer maintained l [20.2103(a). 30.51] ()Y()N M. Transfers among licensee's authorized users or locaticas performed as required [L/C] ( ) N/A ( ) Y ( ) N N. Arrangements made for packages containing quantities of radioactive material in excess I
. of Type A quantity [20.1906(a)] ( ) N/A ( ) Y ( ) N '
O. Package receipt / distribution activities evaluated
, for compliance with 20.1301 [20.1302] ( ) N/A ( ) Y ( ) N i Basis for Findings:
.I 87115. Appendix A. A-12 Issue Date: XX/XX/XX
, 7. RADIOPkARMACEUTICAL THERAPY ( ) N/A l A. Safety p"ecautions implemented to include patient facilities, posting, stay times, patient safety guidance, 4
' release and contamination controls E35.315(a). L/C] ()Y()N B. Area dose rate surveys and room contamination t
surveys-[35.315(a)(4),(7)] ()Y()N i j C. Patients released in accordance with [35.75]
release limits ()Y()N
, D. RSO prgtly notified if patient dies or has a medical emergency L36.316(o;; ( ) N/A ( ) Y ( ) N Basis for Findings: '
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- 0. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers [19.12] ()Y()N B. Training program required [L/C] ()Y()N (1) If so, briefly describe training program:
(2) Training program implemented ()Y()N (3) Periodic training program required ()Y()N (4) Periodic training program implemented ()Y()N (5) Records maintained ()Y()N C. Individual's understanding of procedures and regulations is adequate ()Y()N (1) Current operating procedures ()Y()N (2) Emergency procedures ()Y()N (3) Use of survey instrumentation ()Y()N Issue Date: XX/XX/XX A-13 87115, Appendix A
D. Supervision of individuals by authorized user in
, aCLordance with [35.25] ()Y()N (1) Supervised individuals' are instructed in preparation of material, principles and procedures for radiation safety and OM Program as appropriate [35.25(a)(1), 25(b)(1)] ()Y()N (2) Licensee periodically reviews supervised individuals use of byproduct material and records kept to reflect this use [35.25(a)(3)] ()Y()N (3) Authorized nuclear pharmacist or user periodically reviews work and records
- of work of supervised individual as it pertains to reparing byproduct material
[35.25(b)(3) ( ) N/A ( ) Y ( ) N t
E. Therapy training ( ) N/A (1) Safety instruction [35.310, L/C]
(a) Control of patient and visitors ()Y()N (b) Contamination and waste ()Y()N (c) RS0 notification in emergency or death ()Y()N i (d) Records maintained [35.310(b)] ()Y()N i (2) Manufacturer's instructions available and followed for sealed sources [35.59(a)) ()Y()N F. Workers cognizant of Part 20 requirements for:
(1) Radiation safety program [20.1101] ()Y()N (2) Annual dose limits [20.1301, 1302] ()Y()N (3) NRC Forms 4 and 5 ( ) N/A ( ) Y ( ) N (4) 10% monitoring threshold [20.1502] ()Y()N (5) Dose limits to embryo / fetus and declarec pregnant worker [20.1208] ( ) N/A ( ) Y ( ) N (6) Procedures for opening packages [20.1906] ( ) N/A ( ) Y ( ) N (7) Sewer disposal limits [20.2003] ( ) N/A ( ) Y ( ) N Basis for Findings:
4 Applies to individuals that receive. >ossess. use, transfer, or pre)are byproduct material for medica' use under supervision of autlorized user or nuclear pharmacist.
87115 Appendix A A-14 Issue Date: XX/XX/XX
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- 9. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL >
A. Briefly describe area survey requirements [20.1501(a). 35.70, i L/C]: '
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i B. Surveys erformed as required [20.1501(a).
35.70. L C] ()Y()N l (1) Daily with survey instruments in all areas where radiopharmaceuticals are l preaared or administered [35.70(a)] ()Y()N !
(2) Weetly with survey instruments in all {
areas where radiopharmaceuticals or radiopharmacy waste are stored [35.70(b)] ()Y()N (3) Weekly with wises for removable contamination in all areas w1ere radiopharmaceuticals are routinely prepared administered, or stored
[35.70(e)] ()Y()N (4) Survey techniques can detect 0.1 mrem /hr.
2000 dpm [35.70(c & d)] ()Y()N (5) Trigger levels [35.70(d)]
(a) Established ()Y()N (b) Exceeded ()Y()N (c) Corrective action taken -
()Y()N (6) Records maintained [35.70(h). 20.2103. L/C] ()Y()N C. Handling and use of radioactive materials [L/C]
(1) Protective clothing worn ( ) Y (-) N (2) Personnel routinely monitor themselves after procedures or before leaving ()Y()N (3) Eating / drinking / smoking in use/ storage areas ()Y()N (4) Food, drink, or personal effects kept in use/ storage areas ()Y()N (5) Proper dosimetry worn ()Y()N (6) Radioactive waste disposed of in 3 roper containers ()Y()N (7) Jse of shielding / distance while using/ storing material ()Y()N Issue Date: XX/XX/XX A-15 87115.. Appendix A
D. Protection of members of the public i (1) Licensee made adequate surveys to demonstrate i either (1) that the TEDE to the individual likely '
to receive the highest dose does not exceed 100 :
- mrem in a year. or (2) that if an individual were 1 continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour and 50 mrem in a year [20.1301(a)(1). 1302(b)] ( ) Y (-) N (2) Unrestricted' area radiation levels do not exceed 2 mrem in any one hour [20.1301(a)(2)] ()Y()N i (3) Records maintained [20.2103. 2107] ()Y()N j E. Leak tests and inventories ( ) N/A (1) Leak tests performed on sealed sources .
as required [35 59(b)] ()Y()N (2) Leak test procedures per [35.59(c)] ()Y()N (3) Records maintained & signed by RSO [35.59(d)] ()Y()N (4) Inventory of sealed sources performed ,
quarterly [35.59(g)] ()Y()N Basis for Findings:
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- 10. RADIATION PROTECTION A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee implemented radiation protection program that includes ALARA provisions [35.20. 20.1101(b)] ()Y()N C. External dosimetry ( ) N/A (1) Licensee monitors workers [20.1502(a). L/C] ()Y()N !
(2) External exposures account for contributions from airborne activity [20.1203] ( ) N/A ( ) Y ( ) N (3) Processor Frequency, ,
I (4) ProcessorisNVLAP-approved [20.1501(c)] ()Y()N !
(5) Dosimeters exchanged at required ;
frequency [L/C] ()Y()N '
D. Internal dosimetry ( ) N/A (1) Licensee monitors workers [20.1502(b). L/C) ()Y()N l (2) Briefly describe licensee's program for ,
monitoring and controlling internal exposures
[20.1701. 1702, 35.315. L/C]:
87115. Appendix A A-16 Issue Date: XX/XX/XX
1
- (3) Air sampling performed [L/C. 20.1204] ()Y()N i (4) Monitoring / controlling program implemented [35.205. 315(a)] ()Y()N ;
(5) Respiratory protection equipment [20.1703. L/C] ( ) Y ( ) N E. Reports ( ) N/A i 1
(1) Reviewe' d by Frequency !
(2) Inspector reviewed personnel monitoring records '
for period to ;
(3) Prior dose determined for individuals likely to '
i receive doses [20.2104] ()Y()N
- (4) Maximum exposures TEDE Other
. (5) Maximum CDEs Organs .
1 (6) Maximum CEDE (7) Licensee sums internal and external [20.1202] ()Y()N (8) TEDEs'and TODEs within limits [20.1201] ()Y()N I j (9) NRC forms or equivalent [20.2104(d). 2106(c))
(a) NRC Form 4 ()Y()N Complete ()Y()N l
(b) NRC Form 5 ()Y()N Complete ( )'Y ( ) N i
, (10) Worker declared her pregnancy in writing during ,
q inspection period (review records) (- ) N/A ( ) Y ( ) N
. If "Yes." licensee in compliance with
- dose to embryo / fetus [20.1208] ()Y()N l
and records maintained [20.2106(e)] ()Y()N F. Who performed PSEs at this facility (number of people involved and doses received)-[20.1206. 2104. 2105. 2204] ( ) N/A l
l G. Records of exposures, surveys, monitoring. and ,
evaluations maintained [20.2102. 2103, 2106. L/C] ()Y()N i i H. Licensee advises each worker annually of worker's d
dose [19.13(b)] .()Y()N Basis for Findings:
I 4
Issue Date: XX/XX/XX A-17 87115. Appendix A
2
- 11. QUALITY MANAGEMENT PROGRAM. MISADMINISTRATIONS. AND RECORDABLE EVENTS
[35.32. 33]
7 .,
NOTE: This section is being revised by IMAB and is being sepbfely C
(
transmitted for coment.
4 12. RADI0 ACTIVE WASTE MANAGEMENT ( ) N/A i A. Disposal ( ) N/A (1) Decay-in-storage [35.92] ( ) N/A (a) Procedures a 35.92. L/C] pproved [20.2001(a)(2). ()Y()N (b) Procedures followed in accordance with [35.92. L/C] ()Y()N (c) Labels removed or defaced
[20.1904(b). 35.92] ()Y()N (2) Special procedures performed as required [L/C] ()Y()N (3) Improper / unauthorized disposals [20.2001] ()Y()N (4) Records maintained.[20.2103(a). 2108. L/C] ()Y()N B. Effluents ( ) N/A ;
(1) Release into sanitary sewer [20.2003] ()Y()N (a) Material is readily soluble or readily dispersible [20.2003(a)(1)] ()Y()N (b) Monthly average release concentrations do not exceed Appendix B values
[20.2003(a)(2). (3)] ()Y()N (c) No more than 5 Ci of H-3. 1 Ci cf C-14 and 1 Ci of all other radionuclides .
combined released in a year :
[20,2003(a)(4)] (/Y()N i (d) Procedures to ensure representative sampling and analysis properly implemented
[20.1501. L/C] ()Y()N (2) Release to septic tanks [20.1003] ( ) Y.( ) N ]
(a) Within unrestricted limits [ App B. Table 2] ()Y()N (3) Waste incinerated [20.2004] ()Y()N I (a) License authorizes [20.2004(a)(3)] ()Y()N (b) Licensee directly monitors exhaust ()Y()N (c) Airborne releases evaluated and controlled [20.1501. 1701] ()Y()N l
87115. Appendix A A-18 Issue Date: XX/XX/XX I
- .. . __ _ - . - _ . = . ~ . - - - - . - - .- . - . _
(4) Control of air effluents and ashes [20.1201.1301.
1501. 2001. L/C]{SeealsoIP87102.RG8.37} ()Y()N
! (a) Compliance with air emissions requirements in Part 20:
Licensee has demonstrated compliance with air emission requirements in Part 20 ()Y()N j Basis for compliance determination (check one or more: provide basis below)
, (i) Measured concentrations of radionuclides in air effluents are below Appendix 8.
, Table 2 concentrations (and external dose
< 50 mrem /yr)
(ii) Bounding calculations show that air
. effluents - could not exceed Appendix B.
Table 2 concentrations (and external dose
< 50 mrem /yr)
(iii) Dose modeling shows that dose equivalent to the individual likely to receive the highest dose does not exceed 10 mrem /yr 3 (iv) Licensee does not possess sufficient radio-active material to exceed Part 20 i requirements l Basis for Determination:
(b) Description of effluent monitoring program (i) Monitoring system hardware equipment adequate ()Y()N (ii) Equipment calibrated as appropriate ( ) Y ( ) N (iii) Air samples / sampling technique
. (charcoal. HEPA etc.) analyzed with appropriate equipment ()Y()N (5) EPA referral form for air effluents sent to a)propriate EPA regional office, with copy to NRC headquarters. per IP 87102 ( ) N/A ( ) Y ( ) N j Basis for Findings: l 4
Issue Date: XX/XX/XX A-19 87115. Appendix A
C. Waste Management ( ) N/A (1) Waste compacted [L/C]' ()Y()N (2) Waste storage area (s)
(a) Protection from elements and fire [L/C] ()v()N (b) Control of waste maintained [20.1801] ()Y()N l (c) Containers properly labeled and area pro)erly posted [20.1902, 1904] ()Y()N i (d) PacTage integrity maintained [L/C] ()Y()N (3) Packaging Control and Tracking [ App. F.III]
[20.2006(d)]:
Note: The licensee's waste is likely to be Class A. .
i (a) Not packaged for disposal in cardboard or fiberboard boxes [61.56(a)] ()Y()N (b) Liquid wastes solidified. i .e. . less than 1% freestanding liquid, and void spaces minimized [61.56(a) (b)] ()Y()N (c) Does not generate harmful vapors [61.56] ()Y()N (d) Structurally stable (will maintain its physical dimensions and form under expected disposal conditions) [61.56(b)] ()Y()N (e) Packages properly labeled
[ App. F.III.A.2] ()Y()N l (f) Licensee conducts a OC program to ensure compliance with [61.55. 56] and includes management evaluation of audits [ App. F.III.A.3] ()Y()N (g) Shipments not acknowledged within 20 days after transfer are ;
investigated and reported
[ App. F.III.A.8] ( ) N/A ( ) Y ( ) N (4) Transfers to land disposal facilities ( ) N/A (a) Transferred to person specifically ,
licensed to receive waste
[30.41, 20.2001(b)] ()Y()N (b) Each shipment accompanied by a manifest prepared as specified in Section I of Appendix F [20.2006(b). App. F.III.A.4] ()Y()N (c) Manifests certified as specified in Section II of Appendix F [20.2006(c)] ()Y()N D. Records of surveys and material accountability are maintained [20.2103. 2108] ()Y()N Basis for Findings:
87115. Appendix A A-20 Issue Date: XX/XX/XX
- 13. RECORDKtEPING FOR DECOMMISSIONING
$ q:rW :- 1 A. Records of information important to the safe and effective decomissioning of the facility maintained in an independent and identif,3ble location until license termination. ()Y()N B. Records include all required information [30.35(g)] ()Y()N (1) List of restricted areas [30.35(g)(3)]
indicates that laboratories or other rooms have been released since the last inspection ()Y()N (2) Confirmatory measurements show that each room is within release limits ar.d licensee records adequately document tne Dasis for releasing each room ()Y()N 1
C. Copies of the licensee's decommissioning cost estimates and funding methods on file ()Y()N D. If the licensee uses a parent company guarantee l or a self-guarantee as funding method, does the l file contain a copy of the financial test performed for the licensee's most recently completed fiscal year? ( ) N/A ( ) Y ( ) N E. If "Yes" to D., do the financial test ratios meet the criteria in Part 30.
Appendix A. Section II for parent company guarantees and Appendix C. Section II for self guarantees? ()Y()N F. Date that licensee's financial assurance instrument ( ) N/A was submitted to NRC if applicable:
G. Date that licensee's decomissioning plan was ( ) N/A submitted to NRC. if applicable:
H. Have radiological conditions at the licensee's facility changed since the financial assurance mechanism and/or decomissioning plan was i submitted due to.
(1) Incidents or events? ( ) N/A ( ) Y ( ) N (2) Unplanned process upsets or changes? ( ) N/A ( ) Y ( ) N (3) Unauthorized material. form, or possession limit changes? ( ) N/A ( ) Y ( ) N (4) Any other changes? ( ) N/A ( ) Y ( ) N If "Yes" to any of the above (1)-(4),
notify regional management.
Basis for Findings (include comments and measurements on any areas the licensee released for unrestricted use):
Issue Date: XX/XX/XX A-21 87115. Appendix A !
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- 14. ~ COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE A. License to conduct a principle activity has ;
expired or been revoked ()Y()N 1 1
B. Licensee h n made a decision to permanently l cease principal activities at the entire site or at any separate buildings ()Y()N {
C. A 24-month duration has passed in which no principal activities have been conducted under ;
the license at the site or at any separate !
buildings ()Y()N l D. If "Yes" to either A or B or C above: l (1) Identify Site / Bldg / Area:
-(2) Date of occurrence of A..B. or C: ;
NOTE: If "No" to A and B and C. Decomissioning Timeliness Rule does not :
apply. If "Yes" to either A or B or C. then complete Attachment A. l "Decomissioning Timeliness Inspection Field Notes." for this licensee. '
Basis for Findings: ;
- 15. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189) ( ) N/A A. Licensee shipments are:
() delivered to common carriers
() transported in licensee's own private vehicle
() both
() no shipments since last inspection B. Licensee returns radiopharmacy doses ( ) N/A ( ) Y ( ) N (1) Licensee assumes shipping responsibility ()Y()N
-(2) If "No " describe arrangements made between licensee and radiopharmacy for shipping responsibilities: ,
C. Licensee Transoorts: [carplete sections (1) - (4), as applicable]
(1) Limited Quantities, and/or Instruments and ( ) N/A Manufactured Articles: (Radioactive Material, excepted package. [ additional info). 7. UN 2910)
(a) Package meets general design requirements [173.410] ()Y()N 87115. Appendix A A-22 Issue Date: XX/XX/XX
l I
(b) Radiation level 5 0.005 mSv/hr i (0.5 mrem /hr) (Exclusive use instruments l and articles. 2 mrem /hr) ()Y()N l (c) Contamination less than 173.443 limits.
OC enmination/ test performed prior to each shipment [173.475(I)] ()Y()N 1 (d) Limited quantity package marked !
" Radioactive" [173.421(a)(4)] ()Y()N (e) 173.422 certification statement l attached / enclosed ("This package i conforms to the conditions and I limitations specified in. . .") ()Y()N l (2) Type A Quantities (Radioactive Material, nos. ( ) N/A !
- 7. UN 2982) '
(a) Packaging:
(i) Packaging is proper for contents (i .e. . DOT 7A), is unimpaired. and is prepared correctly l
[173.475(c)-(f)] ()Y()N (ii) All packages meet general design requirements [173.410] ()Y()N (iii) DOT 7A package meets additional Type A design requirements
[173.412. 178.350] ()Y()N (b) Recordkeeping:
(i) Special form source records
[173.476(a)] ()Y()N (ii) D0T 7A performance / design '
documentation [173.415(a)] ()Y()N (c) Hazards communications requirements (consult the "NRC field reference charts" that correspond to elements 1 (i) through (v). below): 1 (i) Shi) ping pa mrs [172.200-205] ()Y()N (ii) Marcing paccages [172.300-338] ()Y()N (iii) Labeling packages [172.400-450] ()Y()N (iv) Placarding vehicles [172.500-560] ()Y()N (v) Emergency response informatim I and guidance [172.600-604] ()Y()N (d) Radiation level / Contamination limits
[173.441,173.443] 1 (i) Package levels within limits ()Y()N (ii) QC examination / test performed prior !
to each shipment [173.475(I)] ()Y()N 1
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Issue Date: XX/XX/XX A-23 87115. Appendix A I
1 (3) Type B Ouantities (Radioactive Material, nos. ( ) N/A
- 7. UN 2982)
(a) _ Packaging is proper for contents (i.e., ,
Type B). is unimpaired, and is prepared '
correctly [173.475(a)-(f)] ()Y()N (b) Inspector.must complete Section 2 of IP 86740 (c) Sections 2.c. and 2.d., shown in the pre- i vious section for Type A Quantities, also '
apply. Complete those sections.
(4) LSA Material and SCO (Radioactive Material. ( ) N/A '
LSA nos. 7. UN 2912) or (Radioactive Material. ,'
SCO. nos. 7. UN 2913)
(a) If licensee makes significant LSA/SCO l
shipments, inspector should complete Inspection Requirement 03.02 of Temporary Instruction (TI) 2515/133 (issued 3/15/96) :
(b) Otherwise. if licensee has a minor LSA/SCO
. program:
(1) Licensee properly characterizing material as LSA/SCO [173.403] ()Y()N (ii) All packages meet general design requirements [173.410] ()Y()N (iii) Proper LSA/SCO packaging selected and used [173.475. 173.427] ()Y()N (iv) Placarding exclusive use vehicles. ;
marking package " Radioactive-LSA" or " Radioactive-SCO." as appropriate [173.427(a)(6)] ()Y()N (v) Slipping papers [172.200-205]
(see "NRC field reference charts" for content and exceptions) ()Y()9 D. DOT HAZMAT Emoloyee Trainino Proaram [49 CFR 172.700-704] ( ) N/A (1) Each HAZMAT employee receives training and is
! tested [172.702] ()Y()N l (2) Recurrent training at least every 2 years
[172.704(c)(4)] ()Y()N l (3) HAZMAT employee training includes general ,
awareness. function-specific, and safety I training [172.704] ()Y()N
, (4) HAZMAT employer recordkeeping includes i employee name, completion date.
! description / copy / location of training :
materials, name and address of training l provider, and certification [172.704(d)] ()Y()N r i 87115. Appendix A -
A-24 Issue Date: XX/XX/XX
. - - - - - - _ - - - . _ - . _ . . . .. - . - - . .- .= . --_.----
C. Carrier Hodal Soecific Reauirements. Hiohway ( ) N/A Transoortation [49 CFR Part 177] !
(1) Driver training, or CDL w/ HAZMAT endorsement
[177.800. 177.816] ()Y()N >
. (2) Incident reporting to 00T [177.807. see also j 171.15 and 171.16] ()Y()N i (3) Shipping paper accessibility (on seat or in :
driver's side door pocket *eadily visible) ()Y()N (4) Placarded vehicles routins jnd driver training requirements [177.825 and 49 CFR 397 Subpart D (i.e., the motor carrier regs)] .
()Y()N (5) Sum of total package tis on non-exclusive use vehicle < 50 [177.842(a)] ()Y()N (6) Packages blocked / braced for transport-
[177.842(c)] ( ).Y ( ) N ,
D. Miscellaneous Reauirements ( ) N/A (1) No labeled packages carried in passenger compartments [173.448(c)] ()Y()N ;
(2) Overpack requirements observed, if packages are offered in overpack. Overpack marked w/ proper shipping name and number, package and overpack labeled as needed marked " inner package complies ... " [173.24] ()Y()N -
(3) Expanded and changed A1/A2 values from the 4/1/% rule changes have been i lemented
[173.435] (verify only once per icensee) ()Y()N (4) Written instructions included with exclusive use shipments [173.403] ()Y()N Basis for Findings: -
i
- 16. POSTING AND LABELING i l
A. NRC Form 3. " Notice to Workers." is posted [19.11] ()Y()N B. Parts 19, 20, 21. Section 206 of Energy Reorganization Act, procedures adopted pursuant to Part 21. and license documents are msted or a notice indicating where documents can a examined is posted [19.11. 21.6] ()Y()N C. Other posting and labeling per [20.1902, 1904]
and the licensee is not exempted by [20.1903, 1905] ( ) Y (-) N Basis for Findings:
Issue Date: XX/XX/XX A-25 87115. Appendix A
- 17. GENERIC COMMUNICATION OF INFORMATION A. Bulletins information notices. NMSS Newsletter.
etc. received by the licensee ()Y ()N B. Licensee took appropriate action in response to .
bulletins, generic letters, etc. ()Y ()N Basis for Findings:
i
- 18. NOTIFICATION AND REPORTS j l A. Notifications since last inspection [35.14]
(1) Licensee has provided appropriate documentation to NRC for authorized user or nuclear pharmacist l no later than 30 days after the individual i starts work [35.14(a)] ( ) N/A ( ) Y ( ) N l (2) Licensee has notified NRC within 30 days after
- authorized user or nuclear pharmacist or RSO '
! stops work or changes name or licensee's mailing address changes [35.14(b)] ( ) N/A ()Y()N B. Licensee in compliance with [19.13, 30.50] (reports ,
to individuals.public and occupational, monitored 3
to show compliance with Part 20) ( ) N/A ( ) Y ( ) N 1 C. Licensee in compliance with [20.2201. 30 60] ;
( ) N/A ( ) Y ( ) N (theft or loss) n Licensee in compliance witn [20.2202, 30.50]
(incidents) ( ) N/A ( ) Y ( ) N E. Licensee in compliance with [20.2203, 30.50]
(overexposures and high radiation levels) ( ) N/A ( ) Y ( ) N l F. Licensee aware of NRC Ops Center phone number ()Y()N
[(301)-816-5100] l.
Basis for Findings:
i 87115. Appendix A A-26 Issue Date: XX/XX/XX 1
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- 19. YEAR 2000 EFFECT ON COMPUTER SYSTEM SOFTWARE A. Licensee has reviewed the effect of the year 2000 on !
computer software programs thdt are used to meet licensing requirements or those that have safety significance [IN 96-XX] ()Y()N If "No," licensee is aware of notice to do so ()Y()N NOTE: A deficiency in this area should not be cited as a violation.
- 20. SPECIAL L' CENSE CONDITIONS OR ISSUES ( ) N/A A. Special license conditions or issues to be reviewed:
B. Evaluation: 1 1
Issue Date: XX/XX/XX A-27 87115. Appendix A
A 4.e+,! .198 4- < w>ep- - + + - nns--ano wA-+b---J---> - 4 sm __b- A s-4A-i
- 21. QQSERVATIONS/ DEMONSTRATIONS OF LICENSED ACTIVITIES
- Briefly describe the activities and procedures observed and/or demonstrated during the inspection. For examle if you observed licensee personnel t wrking in radfation areas using 1icensed material or performing functions associated with radiation safety such as receiving or transporting licensed material
- conducting or receiving training: disposing of radioactive waste:
conducting surveys: or making measurements, then describe what you saw, If
~
the licensee denonstrated any practices at your request, describe those deronstrations. The observations and demonstrations you describe here, and
, elsewhere in the " Basis for Findings" sections of this report. along with ;
measurements and sane records review. should substantiate your inspection f findings.
Describe what activities or procedures were observed and/or demonstrated by the licensee during the inspection:
i .
4 87115. Appendix A A-28 Issue Date: XX/XX/XX
F-The following sections should be completed in a narrative format by the inspector to brief:y describe the measurements performed by the inspector. '
inspection findings, and any post-inspection comunications with regional
. staff. l
- 22. NRC INSPECTOR'S MEASUREMENTS ( ) N/A A. Survey instrument Serial No. Date of calibration l t
- 8. Inspector performed CONFIRMATORY measurements ()Y()N C Inspector performed INDEPENDENT measurements ()Y()N f
D. Briefly describe the types of measurements performed (i.e.. ;
exposure rates, wipe tests, air flow measurements etc.), i locations where measurementa aere taken, the results of these !
measurements (mR/h.. dpm. etc.), and whether inspector's results :
conflicted with the licensee's measurements. If independent ;
measurements were not made, justify why they were not performed on :
this inspection:
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- 23. CONTINUATION OF REPORT ITEMS ( ) N/A 1
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Issue Date: XX/XX/XX A-29 87115. Appendix A
l i 24. VIOLATIONS NON-CITED VIOLATIONS (NCVs). AND OTHER ISSUES ( ) N/A NOTE: Briefly state (1) the requirement and (2) how and when the .
licensee violated the re For NCVs. indicate why the !
l violation was not cited.quirement.
Attach copies of all licensee documents i needed to support the violation. '
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- 25. DEBRIEF WITH REGIONAL STAFF i A. Was inspection feedback provided to regional l licensing staff? ()Y()N l If "Yes." name of individual on the licensing l staff:
- If "Yes." describe issues discussed
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B. Briefly describe post-inspection communications with other regional staff (inspector's supervisor. Agreement State ,
officer. State liaison officer. etc.)- i i l l
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l 87115. Appendix A A-30 Issue Date: XX/XX/XX l
- 26. ELRFORMANCE EVALUATION FACTORS l
A. Lack of senior management involvement with the ;
radiation safety program and/or RSO oversight ()Y()N B. RSO too busy with other assignments ()Y()N ;
C. Insufficient staffing ()Y( )N >
D. RSC fails to meet or functions inadequately ( ) N/A ( ) Y ( ) N ;
E. Inadequate consulting services or inadequate .
audits conducted ( ) N/A ( ) Y ( ) N Remarks (consider the above assessment and/or other pertinent PEFs with regard ,
to the licensee's oversight of the radiation safety program): ;
t l
Regional follow-up on above PEFs citations:
END
Attachment:
A. " Decommissioning Timliness Inspection Field Notes" l
j Issue Date: XX/XX/XX A-31 87115. Appendix A
APPENDIX A - ATTACHMENT A DECOMMISSIONING TIMELINESS FIELO NOTES kh Licensee:
Date of Inspection:
- 1. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE (NOTE: Repeat the ans ers given in Section 12 of the main body of the field notes. The issues in subsequent sections are dependent on the answers to these questions.)
A. License to conduct a principle activity &
expired or been revoked ( ) Y ( )'N B. Licensee M made a decision to permanently cease principal activities at the entire site or at any separate buildings ()Y()N C. A 24-month duration has passed in which no principal activities have been conducted under the license at the site or at any separate buildings ()Y()N
- 0. If "Yes" to either A or B or C above:
(1) Identify Site / Bldg / Area:
(2) Date of occurrence of A. B or C:
- 2. NOTIFICATION RE0VIREMENTS A. Licensee has provided written notification to NRC within 60 days of the occurrence of 1.A. 1.B., or 1.C. above ()Y()N If "Yes." date of notification:
B. If the licensee is requesting to delay initiation of the decomissioning process, the licensee M provided written notification to NRC within 30 days of occurrence of 1.A., 1.B., or 1.C. above
( ) N/A ( ) Y ( ) N If "Yes " date of notification:
Comments:
1 Issue Date: XX/XX/XX Att. A-1 87115. Appendix A. Att. A
- 3. DEC0W ISSIONING PLAN / SCHEDULE RE0VIREMENTS A. Licensee is required to submit a decomissioning plan xr 10 CFR 30.36(g). 40.42(g) 70.38(g), or 10 CFR Part 72? ()Y()N If "No" to 3.A., answer the following items B. - F.:
B. The decomissioning work scope is covered by current license conditions ()Y()N C. Decomissioning has been initiated within 60 days of notification to NRC. or NRC has granted a delay ()Y()N-D. If licensee has initiated decomissioning, give date the decomissioning was initiated:
Initiation date:
E. If decomissioning has been completed, it was completed within 24 months of notification to NRC ( ) N/A ( ) Y ( ) N F. If decomissioning is still scheduled to be comaleted, it is on schedule to be completed wit 11n 24 months of notification to NRC ( ) N/A ( ) Y ( ) N Comments:
If "Yes" to 3. A. , answer the following items G. - J. :
G. The decommissioning plan has been submitted to NRC within 12 months of notification ()Y()N If "Yes." date of submittal:
If NRC approved, date of NRC approval.
H. Has the licensee submitted an alternative schedule request? ()Y()N If "Yes," date of submittal:
87115. Appendix A. Att. A Att. A-2 Issue Dato: XX/XX/XX
I. If decommissioning has been completed, it was completed within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N J. If decommissioning is still scheduled to be completed, it is on schedule to be completed wit 1in 24 months after approval of. the decommissioning plan ( ) N/A ( ) Y ( ) N Comments:
Violations identified, if any:
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I Issue Date: XX/XX/XX Att. A-3 87115. Appendix A. A,tt. A
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j j ATTACHMENT 2
!P 87116 4
i MEDICAL TELETHERAPY PROGRAMS i
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DN NRC INSPECTION MANUAL IMDB INSPECTION PROCEDURE 87116 MEDICAL TELETHERAPY PROGRAMS PROGRAM APPLICABILITY: 2801) 87116-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that will protect.the health and safety of workers and the general public.
01.02 To determine if licensed programs are being conducted in accordance with NRC requirements.
87116-02 INSPECTION REQUIREMENTS A review of the licensed activities will be commensurate with the scope of the licensee's program. A determination regarding safety and compliance with NRC requirements will be based on direct observation of work activities, interviews with workers demonstrations by workers performing tasks regulated by NRC. and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.
In reviewing the licensee's performance, the inspector should cover the period from the last to current inspections. However, older issues preceding the last inspection should be reviewed, if warranted by circumstances, such as incidents, noncompliance, or high radiation exposures.
Some of the following areas may not be applicable to all medical teletherapy licensees.
02.01 Prenaration. The inspector should allow adequate time to prepare for the inspection. Preparation will include reviewing documents, mating travel arrangements, coordinating with appropriate staff, notifying appropriate State agencies, and selecting necessary equipment. In particular, the inspector shall identify whether any license amendments have been issued since the last inspection, or whether the licensae has informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensee had any incidents or events since the last inspection.
02.02 Entrance Briefino. When the inspector arrives at the licensee's facility.
he/she will inform an available senior management representative of the purpose and scope of the inspection.
Issue Date: XX/XX/XX 87116
i
- 02.03 General Overview j a. Oraanization. Interview cognizant licensee :epresentatives about the
, current organization of the program. Examine the licensee's organization with respect to changes that have occurred in personnel, functions, responsibilities, and authorities since the previous inspection.
n Identify the reporting relationship and management structure between the l licensee's executive management, tie Radiation Safety Officer (RS0), the '
4 Chairperson of the Radiation Safety Comittee (RSC), and the other members of the RSC.
- b. Scooe of Procram. Interview cognizant personnel to determine the types. I quantities, and use of byproduct material, frequency of use staff size,
- etc.
- c. Manaaement Oversiaht. In the cour sc u. interviewing cognizant personnel. I determine if management oversight is sufficient to provide the licensee i staff with adequate resources and authority to administer the licensed f program, i
- 1. RSC - Review the committee meeting minutes for topics of discussion. 1 4
membership, frequency, and attendance. Inspector should interview ,
some RSC members to determine their involvement in the radiation
- safety program, i
- 2. RS0 - Determine whether the RSO has been appointed, is named on the license. has sufficient authority, and fulfills the appropriate i duties comensurate with the size and scope of licensed activities.
- 3. Audits - Verify that audits are performed as required. Verify that l 4 the results of the audits are reviewed and addressed, i 1 i
- d. Authorized Users. Determine that only authorized individuals perform j
! and/or supervise licensed activities. Verify th.it these users are ;
! quali fied. Also verify that authorized users perform an appropriate l level of supervision as required by 10 CFR 35.25. i 4
02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the ;
- licensed facility to make general observations of the condition of the facility and tie licensed activities being performed. J 02.05 Facilities. Verify that the facility conforms to that described in the L license application: that material receipt. use, and storage areas are secured; j j and that the licensee uses processes or other engineering controls to maintain doses as low as is reasonably achievable (ALARA).
02.06 Eouioment and Instrumentation j
- a. Verify that equipment and instrumentation are appropriate, operable.
calibrated, adequately maintained. and conform to those described in the license.
- 1. Verify that the survey instruments meet the requirements of 10 CFR :
j 35.620. and have been calibrated per 10 CFR 35.51.
, 2. Verify that the dosimetry system used to perform full calibration measurements meets the requirements of 10 CFR 35.630. 4 l
I 87116 Issue Date: XX/XX/XX
l
- 3. Verify that the safety systems required by 10 CFR 35.615 are checked I as required in 10 CFR 35.634 and 35.636.
- b. Verify that the licensee has established and implemented prhehr[s identify and report safety component defects per the requirements oP10 )
CFR Part 21. ,
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02.07 Materials
, i
- a. Receiot and Transfer of Licensed Material. Verify that the licensee is i receiving packages and making transfers of licensed material in accordance with NRC and applicable U.S. Department of Transportation (DOT) regulations and license conditions. l
- b. Authorized Uses. Determine from observing the use of licensed material.
discussing the activities with licensee personnel, and reviewing records.
that the type, quantity, and use of licensed material at the licensee's 4
- facility are authorized by the license.
' l
- 1. Verify that the teletherapy source activity does not exceed the :
maximum activity authorized either in the license or in the design )
- specifications of the device's sealed source device registration )
certificate. i I 2. Verify that the license authorizes depleted uranium shielding if i
used in the shielding of the teletherapy unit.
- c. Material Security and Control. Verify that the licensee has established )
procedures for maintaining security and control of licensed material, and I that these procedures are understood and implemented by appropriate personnel. Verify that licensed material, in storage, in controlled or unrestricted areas is secure from unauthorized removal or access. Verify ,
that licensed material, not in storage, in controlled or unrestricted '
areas is controlled and under constant surveillance. Verify that access to restricted areas is limited by the licensee.
- d. Teletheraov Jnit Insoection and Servicina. Verify that the teletherapy unit has been inspected and serviced at the frequency required under 10 CFR 35.647 and NRC Bulletin 92-02, by persons specifically licensed to 1 do so by NRC or an Agreement State. !
l 02.08 Trainina
- a. General Trainino. Verify that appropriate ' training and initial instructions are being accomplished as specified in the license and/or regulations.
- b. Ooeratina and Emeraency Procedures. Verify that operational pocedures are being followed by observing licensee personnel perform tasks at selected work stations and by a comparison of their activities with established procedures. Also examine the licensee's emergency procedures to determine that these procedures are as approved by NRC. These procedures are required by 10 CFR 35.610 to be posted at the teletherapy unit console. Through discussions with workers, verify that licensee personnel understand and implement the established procedures and are aware of procedural revisions. Document in the inspection field notes what activities the inspector observed.
Issue Date: XX/XX/XX 87116
. . . . - ~ . -
Discuss with the licensee's representatives, or observe, the conduct of periodic tests and drills.. especially for scenarios involving fires and stuck sources. ,
- c. Teletheraov Physicist Trainino. Verify that teletherapy physicists meet the training and experience requirements of 10 CFR 35.961.
02.09 Area Radiation and Ccntamination Control
- a. Area Survevs. Verify during observations and by direct measurements.
that the radiation levels are within the limits of 10 CFR Part 20. and that these areas are properly posted.
- b. Leak Tests. Verify that leak tests of sealed sources are performed at the required frequency found in 10 CFR 35.59(b)(2). Also, verify that
. the leak test is analyzed in accordance with the license. If records c' leak test results show removable contamination in excess of the regulatory requirements of 0.005 microcuries (200 becquerels). verify ;
, that the licensee made the appropriate notifications per 10 CFR 35.59 (e) ;
and removed the source from service.
l
! c. Source Reolacement Survevs. Verify that the licensee performed the surveys required in 10 CFR 35.641 following the last source replacement.
4 02.10 Radiation Protection
- a. Radiation Protection Proaram. Verify that the licensee has developed and i
'mplemented a radiation protection program commensurate with the 1 licensee's activities, that the program includes ALARA provisions, and that the program is being reviewed at least annually, both for content and implementation.
- b. Radiation Protection Procedures. Verify that changes in the radiological
, protection procedures made since the last inspection are consistent with regulations and license requirements. Determine whether the licensee is required by 10 CFR 35.13 to apply for license amendments for any of these changes.
~
- c. Instruments and Eauioment. Verify that radiation protection instruments and equipment are operable, have the proper alarm settings (if applica-ble), and are calibrated and checked for appropriate response in accordance with 10 CFR 35.51. license requirements, and licensee procedures.
4
- d. Personnel Dosimeters. Verify that Mrsonal dosimetry devices are worn by appropriate licensee personnel, bsimetry devices appropriate to the type, energy or emitted radiation, and the anticipated radiation fields should have been issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved and accredited processor.-
4 that pursuant to 10 CFR 19.13(b) the licensee advises each worker
' Verif{ly annua. of the worker's dose as shown in records maintained by the
. licensee pursuant to the provisions of 10 CFR 20.2106. " Records of individual monitoring results."
87116 Issue Date: XX/XX/XX
1
! l 02.11 Quality Manaaement Proaram j NOTF: This section is being revised by the Divicion of Industrial and :
Medical Nuclear Safoty (INNS) and is being separately transmitted for !
coment.
02.I2 Waste Manaaement l
- a. Transfer. Verify that replaced teletherapy sources are transferred to an l authorized recipient specifically licensed to receive teletherapy l sources. l
- b. Records. Verify that records of source transfer are maintained in accordance with the requirements of 10 CFR Part 20 and the license. !
- c. Financial Assurance and Decomissionino. For all licensees, including sealed source licensees, review the licensee's records of information 4 important to the safe and effective decomissioning of the facility.
Verify that the records are complete, updated, and assembled i
appropriately, in accordance with the recuirements in 10 CFR 30.35(g). !
Review the licensee's list of restrictec areas required under 10 CFR l 30.35(g)(3) and determine whether rooms have been released since the last '
inspection. If areas have been released verify that the licensee has i adequately decontaminated each room and documented the basis for i releasing each room. Document the location of the released rooms in the 1
- field notes, and document your findings regarding the adequacy of the .
licensee's decontamination.
]
Verify whether radiological conditions at the facility have changed since l the financial assurance instrument and/or decomissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents, such as process upsets. Unauthorized changes by the licensee to processes, ty')es of licensed materials, or possession limits of licensed materia s may also prompt a reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect the 4
financial assurance instrument or decomissioning plan, he/she should immediately notify regional management.
s If a parent company guarantee or a self-guarantee is used to ensure decommissionmg financial assurance, review the licensee's financial assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met.
- d. Decommissionina Timeliness. Review compliance with the Decomissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the field notes that should be completed on all ins)ections. If the license to conduct principal activities has expired or aeen revoked:
if the licensee has made a decision to permanently cease principal activities at the site or in any separate building; or if there has been a 24-month duration when no arjncipal activities were conducted at the site or in any separate bui' ding, then the decomissioning timeliness requirements in 10 CFR 30.36. 40.42. 70.38, or Part 72 apply. If this is the case, complete in full the "Decomissioning Timeliness Inspection Field Notes." Attachment A to Appendix A.
Issue Date: XX/XX/XX 87116
02.13 Transoortation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with 10 CFR Part 71 and DOT regulations for transportation of radioactive materials.
02.14 Postina and Labelina. Verify that the licensee has posted the appropriate documents, notices, forms, and ccution signs as required. Also verify that containers of licensed material are labeled appropriately.
02.15 Generic Communications of Information. Confirm that the licensee is receiving the applicable bulletins, information notices. NMSS Newsletter, etc.
Verify that the licensee has taken appropriate action in response to tmse notices.
02.16 Notifications and Reoorts. Determine compliance with the regulations and license requirements for notification and reports to NRC and individuals. Verify that the licensee is in compliance with the requirements in 10 CFR 35.14 for medical licensees to notify the Commission about any changes in the authorized user (s) or RSO.
02.17 Soecial License Conditions. If applicable, review the licensee's compliance with any special license conditions. specifically thc. e dealing with inspection of cast iron C-arms, and restriction of occupancy in areas where dose limits to members of the public may exceed 10 CFR 20.1301.
, 02.18 Indeoendent and Confirmatory Measurements. Compare and verify, on a sampling basis, survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this inspection procedure, unless warranted by special circumstances. If independent measurements were not made, provide a justification in the field notes explaining ;
why independent measurements were not performed. The inspector shall use
- ~
radiation detection instruments that are calibrated. at a minimum, on an annual l basis. ;
l 02.19 Exit Meetina. The inspector will conduct an exit meeting with senior ;
licensee management and the RSO to discuss the preliminary inspection findings. l' including any apparent violations, safety-related concerns, and any unresolved items identified during the inspection. Discuss any negative Performance Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of concern. For further guidance, refer to IP 87101. " Performance Evaluation Factors."
02.20 Post Insoection Actions. After an inspection. the inspector shall summarize the findings with his/her appropriate NRC supervisor. This is
. especially important if there are, or are expected to be, controversial issues arising from the findings. l l
Inspectors shall also meet with regional licensing staff when any pertinent licensing issues are raised during the inspection, when inspection findings .l impact on any licensing actions, to discuss the licensee's PEF results, or to i give feedback on how the licensee has addressed recent licensing actions. This ;
meeting shall be documented in the field notes.
Additionally, in some instances, inspection findings will warrant communication l with enforcement staff. Office of Investigations staff. State liaison staff, or i Federal agencies with whom NRC has Memoranda of Understanding (MOUs).
87116 Issue Date: XX/XX/XX l
Tne inspector will ensure that inspection finalngs are ciearly documented. and reported to the licensee as appropriate. The inspector shall also follow the requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and Records." regarding notifying the licensee that retained information is subject to public disclosure and giving the licensee the opportunity to request withholdir,g it (see IMC 0620. Section 04 06.b.).
87116-03 INSPECTION GUIDANCE General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather, observations of activities in progress, equipment, facilities and use areas, etc., will be a better indicator of the licensee's overall radiation safety program than a review of records alone.
Some of the requirement and guidance sections of this procedure instruct the inspector to " verify" the adequacy of certain aspects of the licensee's program.
Whenever possible, verification should be accomplished through discussions, observations, and demonstrations.
In the records reviewed, look for trends, such as increasing doses. Records such as surveys, receipt and transfer of licensed materials, training, and utilization logs may be examined randomly until the inspector is satisfied that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel dose-monitoring records and incident reports) should be examined in detail. The type of records that were reviewed and the time periods covered by these records should be noted in the appropriate " Basis for Findings" section(s) of the inspection field notes.
Retain a copy of each pertinent record that is needed to substantiate an inspection finding, such as a violation. Those copies shall be attached to the inspection field notes or, when applicable, to a written inspection report. When an inspector identifies an apparent violation, he/she should gather copies from the licensee while on-site of all records that are needed to support the apparent violation. In general, inspectors should use caution before retaining copies of licensee documents, unless they are needed to support apparent violations, expedite the inspection (e.g.. licensee materials inventories), or make the licensing file more complete. In all cases where licensee documents are retained beyond the inspection follow the requirnents of IMC 0620. Especially ensure that the licensee understands that the etained record will become publicly available, and give the licensee the oppcrtunity to recuest withholding the information pursuant to the requirements of 10 CFR 2.790())(1).
The inspector should keep the licensee apprised of the inspection findings throughout the course of the inspection and not wait until the exit meeting.
Whenever possible the inspector should keep NRC management informed of significant findings (e.g. , safety hazards. willful violations, and oi.her potential escalated enforcement issues) identified during the course of the inspection.
03.01 Preoaration. Prior to the inspection, the inspector should do the following:
e Review the licensee's previous inspection history (at a minimum review the past two inspections), the license, and the status of any allegations Issue Date: XX/XX/XX 87116
or incidents.
Notethelicensee'scommitmentsinresponsetorprevioys violations for follow-up during the inspection:
s . h.i e Review regional event / incident logs, event / incident files, and the docket file to determine whether the licensee was involved in any incidents,
, recordable. events, or misadministrations. If NRC did receive notification of an incident, revicw that incident during the inspection !
and document the licensee's follow-up in the field notes:
e In the field notes, complete the administrative information, the inspection compliance history, the listing of any license amendments or program changes since the last inspection, and the description of any incidents or events that have occurred since the last inspection:
4 e Determine the dates that the licensee submitted the most recent financial
- assurance instrument and decommissioning plan (if applicable)
- ,
o Discuss the licensee's program with previous inspector (s) and/or license reviewer (s) as necessary; e Notify the appropriate State radiation control program personnel:
e Review pending licensing actions; e Obtain a map of the area and/or directions; e Make travel arrangements and prepare itinerary e Select calibrated instruments and perform source check:
e Select appropriate documents: and e Select appropriate equipment to take.
In selecting the appropriate documents, the inspector should consider taking the applicable regulations, field notes, generic communications,' license NRC forms, etc.
In selecting the appropriate equipment the inspector should consider the type of licensee to be inspected. The equipment may include safety glasses and safety shoes, sample vials, wipes, pocket dosimeters, alarming rate meters, etc.
During the inspection, focus (among other areas) on whether the licensee is in compliance wit 1 any license amendTnts issued since the last inspection or with any program changes described by the licensee since the last inspection. This requires review of documentation submitted in support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.
03.02 Entrance Briefina After arriving on site. the inspector should inform the licensee's management representative of the purpose and scope of the inspection to be performed. This notification should be made as soon as practical after arriving on site. However, in certain instances (i.e., unannounced inspections) the inspector may choose to inform the licensee of his/her presence on site following initial observations of licensed activities currently in progress.
The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedul,e for 87116 Issue Date: XX/XX/XX
discussing or reviewing selected inspection items eith various licensee staff '
personnel. However, in some instances, the inspector may only need to inform management of NRC's presence on site, and apprise management that an exit briefing will be conducted, at the end of the inspection, which will detail the inspection findings.
This is often an opportune time for the inspector to identify personnel to be !'
interviewed. Scheduling interviews will enhance inspector efficiency and give
- the licensee the opportunity to have the most knowledgeable individuals present to respond in the areas being inspected.
Certain inspection items involving visual observations and/or records review are better performed unannounced: therefore, these types of items should not be j discussed during the entrance briefing. !
1
- 03.03 General Overview. The inspector will interview the cognizant licensee i representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.
i a. Oraanization. The licensee's organizational structure will usually be found in the license application and may involve one or more individuals.
l Determine the reporting structure between executive management. the RSO.
] the Chairperson of the RSC. and the other members of the RSC. Determine whether the RS0 has sufficient access to licensee management. Through
, discussions with licensee staff, the inspector should determine if changes in ownership or staffing have occurred. If the owner or individuals named in the license have changed. determine whether the licensee has submitted appropriate notification to NRC. This information must be provided whenever changes in ownership or personnel named in the license are made. Ask licensee management if changes have occurred, or are anticipated, and ask personnel to confinn (to the inspector's satisfaction) that no changes have taken place. If there have been no changes in the organization since the previous inspection, there is no need to pursue this element in further detail.
The inspector should review any organizational change in the RSO position, authorities responsibilities, and reporting ch. ;ns. The <
inspector should be sensitive to changes that reduce the ability of the RSO to resolve concerns or issues related to the safe conduct of the radiation protection program. The inspector should ask licensee management and the RSO about the RS0's authority and about any changes that may impact upon the RS0's duties, responsibilities, or effectiveness.
- b. Scooe of Proaram. Through discussions with licensee personr.el, the inspector can obtain useful information about the types and quantities of material, frequency of use, incidents, etc. which can not always be gained by reviewing records alone. This is also an opportunity for the inspector to discern the actual size and scope of the licensee *s program, and to determine if significant changes have occurred since the previous .
inspection
- c. Manaaement Oversicht. The inspection is a verific.ation of the licensee's implementation of the required program. In the review to verify implementation, the inspector should pay particular attention to the scope of the program; frequency of licensee audits and the use of qualified auditors: procedures for recording and reporting deficiencies Issue Date: XX/XX/XX 87116
I to management: 'and methods and completion of follow-up actions by )
management ~ .
generic communications, authorized users and uses, audits. I misadministrations and recordable events, as defined in 10 CFR 35.2. !
etc. The committee should be made up of a representatives from each type of program area, the RSO. and a representative from management.
The inspector should review meeting minutes (and interview selected i committee members when practical) to determine the committee's I effectiveness. The RSC must meet at least quarterly. !
Determine if the committee has been aggressive in seeking out areas needing improvement, rather that just responding to events and 1 information from outside sources. Determine whether the RSC has I recommended any specific actions and assess the implementation of those recomendations. The- in m ctor's review should be of i sufficient depth and detail to provide an overall assessment of the l comittee's ability to identify a:sess, and resolve issues. Also l consider the effectiveness of the RSC to communicate the re.sults of I audits and trending analyses to appropriate personnel performing licensed activities.
- 2. RSO - The RSO is the individual, appointed by licensee management and identified on the license, who is responsible for implementing the radiation safety program. The inspector should verify that this
. individual is knowledgeable about the program, and ensures that activities are being performed in accordance with. approved procedures and the regulations. The inspector should verify that. !
when deficiencies are identified, the RSO has sufficient authority. I without prior approval of the RSC. to implement corrective actions. 1 including termination of operations that pose a' threat to health and 4 safety. I
- 3. Audits - The frequency and scope of audits of the licensed program will vary. However. note that at a minimum, medical licensees are l require' by 10 CFR 20.1101(c) to review the radiation safety program content and implementation at least annually. The results of audits !
should be documented. Examine these records with particular i attention to deficiencies identified by the auditors, and note any !
corrective actions taken as a result of deficiencies found. If no corrective actions were taken, determine why the licensee disregarded deficiencies identified during audits, and whether the lack of corrective actions caused the licensee to be in non-compliance with regulatory requirements. l
- d. Aui.her 17ed Users. Authorized users (teletherapy physicians and
)hysicists) may either be named in the license application or appointed
)y the licensee. For those appointed by the licensee, verify that the authorized user is trained in accordance with the approved criteria and has knowledge commensurate with operational duties. 1 The regulations in 10 CFR 35.11(b) allow an individual to receive.
possess, use. or transfer byproduct material for medical use "under the supervision of" the authorized user, unless prohibited by license condition. These regulations do not specifically require that the authorized user be present at all times during the use of such materials.
The authorized user / supervisor is responsible for assuring that personnel 87116 Issue Date: XX/XX/XX
under his/her supervision have been properly trained and instructed, pursuant to 10 CFR 35.25(a). and is respon:,ible for the supervision of
. operations involving the use of radioactive materials whether he/she is present or absent.
03.04 )4alk-Throuah Orientation Tour. The inspector should make initial observations of licensed activities to detEriaine that materials are being safely handled and that good health physics practices are followed. The inspector should look at areas of use, storage, and disposal to make an initial assessment of the licensee's ALARA program with regard to facility design, engineering controls, house-keeping practices, etc. The inspector should ensure that 1 observations of activities are documented in the inspection field notes.
l 03.05 Facilities. Descriptions of the facilities are generally found in the j application for a license and subsequent amendments that are usually tied down I to a license condition. The actual o as b""t facility should be configured to l provide safe working areas separated from unrestricted areas and sufficient l access controls to preclude unauthorized entry. The inspector should also be aware of potential industrial safety hazards for referral to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA).
03.06 Ecuioment and Instrumentation.
- a. Equipment and instrumentation should be appropriate to the scope of the licensed program. The inspector should verify that survey instrumentation has the appropriate range of use, found in 10 CFR 35.620. I The inspector should also verify that the survey instruments are '
calibrated at the required frequency and checked for operability before use. in accordance with 10 CFR 35.51. All survey and monitoring instruments should have current calibrations appropriate to the types and energies of radiation to be detected. The technical adecuacy of calibration procedures e facilities that perform their own cali) rations should be examined.
Inspectors should verify that the licensee has access to a dosimetry system for performing the full calibration and spot-check measurements of the telethe apy unit output. The system must be calibrated in accordsnce with the requirements of 10 CFR 35.630. The inspector should review a few of the dosimetry worksheets from the previous full calibration measurements required by 10 CFR 35.632. Mistakes often made when performing these calibrations are misreading of barometric pressure and using the wrong value for the chamber composition and volume. The local weather station or airport can give a good indication of the accuracy of the licensee's barometer readings to the actual air pressure. If the licensee participates in intercomparison of dosimetry measurements, review the licensee's performance results to determine that systemic measurement errors are identified and corrected.
- b. Inspectors should verify that licensees have procedures for reporting defects in accordance with 10 CFR 21. The complexity of the procedures -
will vary.
03.07 Materials
- a. ReceiDt and Transfer of Licensed Materials. The source receipt and transfer procedures will be found in the license application. These procedures should be carefully reviewed before an inspection is conducted. By discussions with the licensee, determine if the procedures Issue Date: XX/XX/XX 87116
have been changed or modified. Some changes will require a license amendment whereas other minor changes (updating telephone numbers, editing procedures for clarity, etc.) may not require NRC approval.
Randomly examine procedures used by the licensee to determine if they are in accordance with those identified in the license application and whether any of these changes warrant a license amendment.
The procedures for receiving replacement teletherapy sources should include how and when they will be picked up, radiation surveys and wipe tests of source containers to be done upon receipt, and procedures for owning source containers (such as the location in the facility where taey are received, surveyed, and opened). The procedures also should include what actions are to be taken if surveys reveal source containers that are contaminated in excess of specified limits, and/or radiation levels that are higher than expected. If replacement sources arrive during the course of an inspection, the inspector should observe, when practical, personnel perform the receipt surveys.
- b. Authorized Uses. The inspector should verify that the licensee's use of byproduct material is limited to that which is authorized in the license.
Uses of teletherapy units for other than human use would require the licensee to comply with 10 CFR Part 36.
- c. Material Security and Lontrol. The teletherapy suite should be under constant surveillance or physically secured. The licensee should have procedures for access controls. The inspector should verify that adequate controls are in place and working effectively.
The key to the teletherapy unit console is often left in the console over the course of the day. Interview the operators to determine their normal control of the console key during the periods that they are away from the console.
- d. Teletheraov Unit Insoection and Servicina Visually inspect the control console and unit for indications that alterations have been performed by unauthorize persons. These indications include off-the-shelf switches and timers, as well as wire jumpers and taped micro switches to bspass safety systems of the unit. The inspector sheuld ask the licensee to demonstrate that stops and electronic . controls used to limit the orientation of the head are operational.
If the unit is a Theratron-60 or Theratron-80 with a cast iron arm the licensee was required by NRC Bulletin 92-02, to comit to perform the special inspections per Theratronic's revised " Survey and Inspection I 1024 G091G10 REV C."
03.08 Trainina
- a. General Trainino. Certain kinds of training and irstructir,n are found in the regulations; how they are implemented will be found in the license. .
Discuss with the licensee how, and by whom. training is conducted and the content of the training provided to workers (generally found in the license application). ,
Verify, pursuant to 10 CFR 19.12. that instructions have been given to individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv). Under the basic instructions, it is management's responsibility to inform the workers of 87116 Issue Date: XX/XX/XX
i precautions to take when entering a restricte'd area. kinds and uses of radioactive materials in that area, exposure levels, and the types of i proi.ective equipment to be used. The workers should also be informed of the pertinent provisions of NRC regulations and the license, and the ,
requirement to notify management of conditions observed that may. if not '
! corrected, result in a violation of NRC requirement's. Also verify that authorized users and workers understand the mechanism for raising safety -
- concerns. ;
Of the training program elements in the license application, training ,
- given to authorized users and those individuals under the supervision of ,
, authorized users, is of_ primary importance. One or more users of i
radioactive materials should be interviewed to determine that they have -
received the required training, both in the basic instructions and in !
that specified in the license application. Note that the training should !
, be (and in most cases is required tc be) provided to workers prior to the t individual's performance of licensed activities. ,
i
! Randomly examine records of personnel training to the extent that the -
i inspector is satisfied that the training program is being implemented as required. ;
j The inspector should also observe related activities and discuss the ;
- radiation safety. training received by selected individuals to assure that -
- appropriate training 'was actually received by these individuals. ;
g Authorized users and supervised individuals should understand the :
4 radiation protection requirements associated with their assigned i activities. The licensee's radiation safety training may include, but is ;
! not limited to, demonstrations by cognizant facility personnel, formal :
1 lectures, testing, films, and " dry runs" for more complex or hazardous 1 1
. operations. i,
- b. Doeratina and Emercency Procedures. Operat'ing and emergency procedures I i will be found in 'icense applications and may ~ vary from step-by-step :
- 3rocedures to more generalized procedures. The emergency procedures will
- 3e approved by the NRC and reviewed and updated by the l'icensee. These '
procedures are required by regulation and. license condition to be posted i at the teletherapy unit console. Any non-ministerial- revision requires j an amendment to the license. Interview the operators of the unit to
- determine that actions required to be performed in the event of abnormal ,
- operation of the device are known, i
- _ Some licensees may have agreements with other agencies ( e.g. fire, law enforcement, and medical organizations) regarding response to
- - emergencies. Discuss with the licensee *s representatives what has been done to ensure that agencies (involved in such agreements) understand l
[
their roles in emergency responses. !
- c. Teletheraov Physicist Trainina. The inspector should verify that the ,
- teletherapy >hysicist(s) meet (s) the certification requirement or i education anc work experience requirement. in accordance with 10 CFR
- 35.961.
. 03.09 Area Radiation and Contamination Control
- a. Area Surveys. The inspector may ask the licensee to spot-check radiation i
- levels in selected areas using the licensee's own instrumentation.-
i Issue Date: XX/XX/XX 87116 ,
i However, the inspector must use NRC's .nstruments for independent verification of the licensee's measurements. (The inspector's ir.:truments shall be calibrated and source-checked before he/she leaves the regional office.) l If practical, observe how licensees conduct surveys to determine the adequacy of surveys. Also, cote the types of instruments used, and whether they are designed and calibrated for the type of radiation being measured. When measuring dose rates near a teletherapy unit head, the inspector should not use an open window Geiger-Muller tube, because the depleted uranium used in the trimmer' bars. collimators, and shielding is a beta emitter that will cause the survey instrument to give a faulty measurement. The survey activities should be at a specified frequency in l accordance with the related licensee procedures. The inspector should also perform independent measurements, as needed to verify licensee assumptions or measurements.
- b. Leak Tests. Through discussions with licensee personnel and/or by demonstration of leak test 3rocedures, the inspector should verify that leak tests are performec in accordance with the manufacturer's recommendations and/or license.
- c. Source Reolacement Surveys. Verify by direct measurement that shiciding surveys of the unit head and treatment room are in compliance with the requirements of 10 CFR 35.641. Indications of higher than expected dose levels may indicate that the source is a higher activity than authorized or that the source is not fully shielded upon retraction. ;
03.10 Radiation Protection. Specific guidance is set forth in IP 83822. ;
" Radiation Protection. ,
10 CFR 19.13(b) requires that each licensee shall advise each worker annually of l the worker's dose as shown in dose records maintained by the licensee. Verify l through discussions with workers and management, and through records review, that j the licensee has advised workers of their doses annually. The licensee must 1 advise all workers for whom monitoring is required (and, therefore dose records i are required). The licensee must advise these workers of doses from routine i operations, and doses received during planned special exposures, accidents, and emergencies. The report to the individual must be in writing and must contain all of the information required in 10 CFR 19.13(a).
03.11 Ouality Manaaement Proaram NOTE: This section is being revised by IMNS and is being separately transmitted for comment.
03.12 Waste Manaaement
- a. Transfer. Ascertain if the licensee has an adequate method of determining that recipients of replaced sources are licensed to receive them. Ordinarily this is not a concern because sources are replaced by a service company authorized by NRC or an Agreement State.
- b. Records. Each licensee is required to maintain records of transfer in accordance with the requirements of 10 CFR 30.51. The inspector should review these records as appropriate.
87116 Issue Date: XX/XX/XX
- c. Financial Assurance and Decommissionina. The decommissioning record-keeping requirements are applicable to all materials licensees, including '
licensees with only sealed sources, and are specified in 10 CFR 30.35(g). .
These records should contain, among other information: (1) records of ;
unusual occurrences involving the spread of contamination in and around the facility, equipment or site: (2) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and locations of possible inaccessible contamination: and (3) records of the cost estimate performed for a decomissioning funding plan or the amount certified for decomissioning.
This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). The inspector should ensure that the licensee has ;
such decomissioning records, that the records are complete, that they are updated as required, and that the decomissioning records are e assembled or referenced in an identified location.
Some licensees may release rooms within a building for unrestricted use, without a license amendment. The release of these areas may fall outside of the reporting requirements in the Decommissioning Timeliness Rule if ,
the licensee continues to conduct other activities in the same building. !
Inspectors shoula identify the rooms that have been released since the last inspection and perform confirmatory measurements to verify that l radiation and contamination levels are below release limits. Licensee !
survey records and other documentation should be rWiewea to verify that !
the basis for releasing each room is adequately documented in the licensee's decomissioning records.
Licensees submit financial assurance instruments and/or decomissioning !
plans for a specific set of conditions. Occasionally, those cor.ditions '
may change over time and the licensee may not notify NRC The inspector t should be aware of changes in radiological conditions while inspecting a licensee's facility that would necessitate a change 1 ; +he financial assurance instrument and/or decomissioning plan, especially where the radiological conditions deteriorate and the financial assurance instrument er decommissioning plan may no longcr be sufficient. In ,
preparation f0r the inspectior, the inspector should' determine the dates !
that the financial assurance instrument and decomissioning plan (if :
a)plicable) were submitted to NRC. Then during the inspection, through !
o)servations, discussions with licensee personr.el, and records review, i the inspector should determine whether the radiological conditions at the licensee *s facility have changed since the documents were submitted to NRC. If conditions have changed and the adecuacy of the financial ;
assurance instrument and/or decomissioning plan is in doubt, the inspector should immediately contact regional management from the licensee's site to discuss the situation. ,
I Additionally, some licensees are required to maintain decomissioning cost estimates and funding . methods on file. If the licensee uses a ;
parent company guarantee or a self-guarantee as a funding method, the
. inspector should verify that the licensee has a Certified Public .
Accountant certify each year that the licensee passes a financial test. l The financial test ratios for parent company guarantees and self-guarantees are specified in Section II. Appendix A and Appendix C.
respectively, to 10 CFR Part 30.
- d. Decomissionino Timeliness. Determine whether the license to ccnduct a :
principal activity has expired or been revoked. If the license remains j in effect, determine if the licensee has made a decision to cease '
l Issue Date: XX/XX/XX - 15 87116 l 1
principal activities at the site or in any separate building: 'FinaUfMn determine if there has been a 24-month duration in which no principal #
activities have been conducted in such areas. A principal activity is one which is essential to the purpose for which a license was issued or amended. and does not include storage incidental to decontamination or decomissioning. If the licensee maets any of the above conditions the decomissioning timeliness requirements apply, and the inspector must complete in full the " Decommissioning Timeliness Inspection Field Notes."
Attachment A to @pendix A.
The requirements of 10 CFR 30.36, 40.42, and 70.38 do not apply to releesed rooms within a building where principal activities are still on-going in other parts of the same building. However, in those cases, the inspector should follow the guidance in 03.12.c. regarding confirmatory measurements of the released area. Once principal activities have ceased in the entire building, then the decommissioning timeliness requirements will take effect.
The Decomissioning Timeliness Rule became effective on August 15. 1994. I In completing the Attachment A field notes, specific guidance is needed regarding the timing of the notification requirements. If the license has expired or been revoked, or if the licensee has made a decision to permanently cease principal activities, and the licensee provided NRC notification before Auoust 15. 1994, then August 15. 1994 is considered to be the date for initiating the decomissioning calendar (i .e. . date of noti fication) . If there has been a 24-month duration in which no principal activities have been conducted at the location before the effective date of the rule, but the licensee did not notify NRC, then the 24-month time period of inactivity is considered to be initiated on August 15, 1994 and the licensee must provide notification to NRC within either 30 or 60 days of August 15.1996 (depending on whether the licensee requests a delay).
NRC has a stringent enforcement policy with respect to violations of the decommissioning timeliness requirements. Failure to comply with the Decomissioning Timeliness Rule (failure to notify NRC failure to meet decomissioning standards, failure to complete decomissioning activities in accordance with regulation or license condition. or failure to meet required decomissioning schedules without adequate justification) may be classified as a Severity Level III violation and may result in consideration of monetary civil penalties or other enforcement actions, as appropriate.
Decomissioning timeliness issues can be complex. For situations where .
an inspector has questions about the licensee's status and whether the 1 decommissioning timeliness standards apply, he/she should imediately contact regional management. ;
)
For planning and conducting inspections of licensees undergoing decomissioning, refer to IMC 2602. " Decommissioning Inspection Program l for Fuel Cycle Facilities and Materials Licensees:" IP 87104 l
" Decommissioning Inspection Procedure for Materials Licensees:" and the l
draft Decomissioning Manual Chapter and Handbook.
03.13 Transoortation. The inspector should review: the licensee's hazardous material training: Jackages and associated documentation: vehicles (including placarding, cargo ) locking, and bracing, etc.): shipping papers; and any incidents reported to DOT. The DOT and NRC regulations for transportation of 87116 Issue Date: XX/XX/XX
radioactive materials were recently revised. and the revisions generally became effective April 1. 1996. However, this area is not a concern for most teletherapy licensee's because most of them are not authorized to perform these operations.
For further inspection guidance, refer to IP 86740 " Inspection of Transportation Activities." Inspectors should also refer closely to " Hazard Communications for Class 7 (Radioactive) Materials." the NRC field reference charts on hazard communications for transportation of radioactive materials, which contain references to the new transportation requirements, and are useful field references for determining compliance with the transportation rules on labeling, placarding, shipping papers, and package markings.
03.14 Postino and Labelino. The inspector should determine whether proper caution signs are being used at access points to areas containing radioactive materials and radiation areas. 10 CFR 20.1903 provides exceptions to posting caution signs. The inspector should also randomly examine signals and alarms to determine operability.
Areas with radiation hazards should be conspicuously posted, as required by 10 CFR 20.1902. High radiation areas should be strictly controlled to prevent unauthorized or inadvertent access. Such controls may include, but are not limited to. direct surveillance locking the high radiation area, warning lights and audible alarms. Due.to the nature of the prospect for the cure of patients undergoing teletherapy treatments, many licenses have received exemptions from the requirement to post the treatment room with the sign " GRAVE DANGER. VERY HIGH RADIATION AREA" required by 10 CFR 20.1902, due to its unsettling effect. This exemption will be noted in the license. Areas occupied by radiation workers for long periods of time and common-use areas should be controlled in accordance with licensee procedures and be consistent with the licensee's ALARA program.
The inspector should also examine locations where notices to ~ workers are posted.
Applicable documents, notices, or forms should be posted in a sufficient number of places to permit individuals engaged in licensed activities to observe them on the way to or from any particular licensed activity location to which the ;
postings would apply.
03.15 Generic Comunications of Information. Through discussions with licensee ;
management and the RSO the inspector should verify that the licensee is i receiving the applicable bulletins, information notices. NHSS Newsletter, etc.. !
and that the information contained in these documents is disseminated to l appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC communications, when a response is required.
03.16 Notifications and Reoorts. The inspector should determine the licensee's compliance for notifications and reports to the Commission. The licensee may be required to make notifications following loss or theft of material, overexposures. incidents, high radiation levels, safety related equipment failure, misadministrations and recordable events, etc.
Through discussions with licensee personnel, and by a review of representative records, the inspector should verify that notifications and/or reports were appropriately submitted to NRC and individuals.
03.17 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice or procedure. such as the use of teletherapy equipment for nonmedical purposes. In these instances, the inspector should verify that the licensee understands the additional !
Issue Date: XX/XX/XX 87116 l
I requirements. and maintains compliance with the special license conditions. The inspector should.also note that some special license conditions will state an l
exemption to a particular NRC requiren.ent. l 03.18 Indeoendent ard Confirmatory Measurements. The inspector should perform independent and confirmatory measurements in restricted and unrestricted areas of the licensee's facility. Independent measurements should be performed on all inspections, unless exceptional circumstances make it impossible to perform the measurements (e.g. , inspector's detection equipment malfunctions during an inspection trip). Measurements of dose rates at the boundary of the unrestricted i areas should be performed at the surface of the most accessible plane. Examples of measurements that may be performed include area radiation surveys, wipe samples. leak tests, etc. These measurements should be taken in licensed material use areas, storage areas, etc. Confirmatory measurements are those i whereby the inspector compares his/her measurements with those of the licensee's. l Independent measurements are those performed by the inspector independently of the licensee's measurements. To perform the independent or confirmatory measurement, use NRC radiation detection instruments that are calibrated, at a minimum, on an annual basis.
03.19 Exit Meetina. When the inspection is over, there should be an exit ;
meeting with the most senior licensee representative present at the facility. 1 If a senior management r.epresentative it unavailable for the exit meeting, the '
inspector may hold a preliminary exit meeting with appropriate staff on site.
However, there must be a formal exit meeting with a senior management l representative (and the licensee's RSO. if not present at the preliminary exit I meeting) as soon as practical after the inspection. This meeting will usually be held by telephone conference call.
During the exit meeting. the licensee representatives should be told of the preliminary inspection findings--including any negative PEFs. any apparent violations of regulatory requirements, safety-related concerns, or unresolved items identified during the inspection--and the status of any previously identified violations. The licensee must immediately address any significant safety concerns.
If the inspector 'Jentifies safety concerns or violations of significant :
regulatory requirements that affect safe operation of a licensee facility, the licensee must initiate prompt corrective action. The inspector should not leave the site until the licensee fully understands the concern and has initiated corrective action. If the inspector and the licensee disagree over how !
significantly the concern impacts the continued safe operation of the facility.
regional management should be notified imediately.
While deficiencies ioentified in some areas (e.g. , workers' knowledge of the Part l 20 requirements) are not always violations, the inspector should bring such deficiencies to the attention of licensee management at the exit meeting and also 1 in the cover letter transmitting the inspection report or NOV.
03.20 Post Insoection Actions. Regional office policy will dictate with whom the inspector will review his or her inspection findings (e.g., the inspector's supervisor), following the guidance in IMC 2800. " Materials Inspection Program."
The inspector should discuss the findings in detail that is commensurate with the ,
scope of the licensee's program. Violations. items of concern (e.g.. negative l PEFs) and unresolved items should be discussed in sufficient depth for management I to make appropriate decisions regarding enforcement actions referral to other l State and Federal agencies, and decisions on the scheduling of future inspections .
l of the licensee's facility. l 87116 Issue Date: XX/XX/XX 1
$6J %
The inspector should also discuss ins]ectio:1 findings with licensing sta'ff.d:ThTsg information exchange can be particularly useful if tne licensee is having its license renewed or has recently submitted a license amendment request. The inspector should inform licensing staff about how the licensee has addressed (or failed 'to address) special license amendments or recent licensing actions.
Licensing information requested by the licensee should also be discussed with the licensing staff.
Inspectors should be aware that NRC has entered into several MOUs. with other Federal agencies, that outline agreements on items such as exchange of information and evidence in criminal proceedings. The inspector should ensure that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.
The inspectors may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional offim letter to the licensee, following the guidance in IMC 2800. The inspector must also ensure that the findings are documented in the inspection field notes and/or inspection report in sufficient detail for the reader to determine what requirement was violated, how it was violated, who violated the requirement. and when it was violated. Copies of all licensee documents needed to support the violation should be attached to the inspection field notes and/or inspection report. The field notes should not be used as merely a checklist to note areas reviewed, but should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the inspection, and any items of concern identified that were not cited as a violation of regulatory requirements.
Inspectors may complete the field notes either by hand or electronically. If the inspector is documenting the field notes in electronic format the sub-items under major sections that are not applicable or not reviewed gay be deleted.
However, the heading itself (e.g.. " Radioactive Waste Management." or
" Transportation") should remain in the field notes. and the inspector should enter a)propriate remarks about why the section is not applicable or not reviewec .
For further inspection guidance, refer to Section 07.04 of IMC 2800.
87116-04 REFERENC' ,
A listing of IMCs and IPs. applicable to the inspection program for materials licensees, can be found in Section 2800-11 of IMC 2800. These documents are to be used as guidelines for inspectors in determining the inspection requirements for operational and radiological safety aspects of various types of licensee activities.
Specific references to regulatory requirements can be located in the " Medical Teletherapy Inspection Field Notes" appendix to this IP.
END Appendix:
A. " Medical Teletherapy Inspection Field Notes" Issue Date: XX/XX/XX 87116 i
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t I ATTACHMENT 2 4 :
l APPENDIX A i
! MEDICAL TELETHERAPY INSPECTION FIELD NOTES
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APPENDIX A f l
MEDICAL TELETHERAPY INSPECTION FIELD NOTES Region Inspection Report No. License No. !
Licensee (Name & Address): Docket No.
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Licensee Contact ielephone No. !
I Amendments Issued Since last Inspection: (Numbers) i Dates of Above Amendments !
l Priority: ( ) 02300 - Teletherapy - Human Use Only
( ) Other - Teletherapy - Other uses authorized Date of Last Inspection Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced
( ) Routine ( ) Special j
( ) Initial ( ) Reinspection -
Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended Justification for change in normal inspection frequency:
r Summary of Findings and Action:
l ( ) No violations cited. Clear NRC Form 591 or regional letter issued
( ) Violation (s). Form 591 issued i ( ) Violation (s). regional letter issued
( ) Follow-up on previous violations Inspector Date (Signature) l Approved Date (Signature)
Issue Date: XX/XX/XX A-1 87116. Appendix A l
Field notes are to be used by the inspector to assist with the performance of the inspection. Note that all areas indicated in the field notes are not required to be addressed during each inspection. However for those areas not covered during the inspection c notation ("Not Reviewed") should be made in each section where applicable. Additionally, all areas covered during the inspection should be documented in sufficient detai1 to describe what activities and/or records the inspector observed. For example. the types of records that were reviewed and the period covered by those records should be noted in the appropriate " Basis for Findings" section(s). If the licensee demonstrated any practices at your request. describe those dwonstrations. The observations and demonstrations you describe in this report, along with measurements and sme records review should substantiate your inspection findings.
- 1. INSPECTION. LICENSING. AND INCIDENT HISTORY A. Violations were identified during any of the last two inspections or two years, whichever is longer. (N/A = Initial insp.) ( ) N/A ( ) Y ( ) N B. Response letter (s) or Form 591(s) dated C. Violations from previous inspection (s):
REOUIREMENT CITED STATUS D. Any repeat violation (s') identified? ()Y()N l If "Yes." explain: l l
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1 l
l 87116. Appendix A A-2 Issue Date: XX/XX/XX ;
1 j I E.
License' inspectionamendmentp]
(35.13 issuedchanges or program since last noted in the license:
i
- AMENDMENT #QATE SUBJECT i
1 F. During this inspection, was the licensee *s implementation of all of the above amendments or program changes inspected / observed? ( ) N/A ( ) Y ( ) N G. During this inspection, were any violations identified involving any of the above amendments or program changes? ( ) N/A ( ) Y ( ) N H. List any incidents, misadministrations.
. or events reported to NRC since the last l inspection (Note: "None" indicates that
- regional event logs, event files, and the 4 licensing file have no evidence of any
- incidents or events since the last inspection)
- ( ) None INCIDENT OR EVENT 5
i l
i
- i I. During this inspection, were the j incidents / events reviewed with the 1 licensee, and was the licensee's follow-up !
to the incidents / events examined? ( ) N/A ( ) Y ( ) N l l
1 Here and throughout the field notes, sections of 10 CFR are l referenced only by their section numbers. l
- Issue Date: XX/XX/XX A-3 87116. Appendix A
-_, I
- J. Describe the licensee's follow-up in response to the events / incidents listed in 1.H.
Basis for Findings:
t
- 2. ORGANIZATION AND SCOPE OF PROGRAM A. Describe the licensee's organizational structt.. to indicate the
" chain-of-command" from senior licensee management to authorized users of licensed material. Show or describe where the RSO and
, Chairperson of the RSC are located in the licensee's organization and to whom they report.
1 A
A 87116. Appendix A. A-4 Issue Date: XX/XX/XX
. i B. Identi fy licensee personnel contacted during the !
i inspection (including those individuals contacted by telephone), t i
i Use the following identification symbols: ,
- Individual (s) present at entrance meeting l
- Individual (s) present at exit meeting i
+ Individual (s) contacted by telephone :
J C. Authorized for multiple locations of use
.at the licensee's primary location ()Y()N If "Yes." list locations inspected:
D. Authorized for other permanent office locations ( ) Y ( ) 14 (1) Inspections performed at other offices ()Y()N I (2) If "Yes " list office locations inspected:
E. Briefly describe scope of activities, including types and quantities of use involving licensed material, frequency of use, staff size, etc.
1 Issue Date: XX/XX/XX A-5 87116. Appendix A l
- 3. MANAGEMENT OVERSIGHT A. Radiation Safety' Committee required [35.22. L/C]r ()Y()N (1) RSC fulfills license requirements [L/C] -()Y()N (2) Records maintained [L/C] ()Y()N B. Radiation Safety Officer (1) Appointed [35.21(a). 900] ()Y()N (2) Fulfills duties per [35.21(b)] ()Y()N (3) Has sufficient authority per [35.23] ()Y()N C. Radiation Safety Program (1) Minor changes pursuant to [35.31] ( ) N/A ( ) Y ( ) N (2) Records of changes maintained [35.31(b)] ()Y()N (3) Records of reviews maintained [20.2102(a)(2)] ()Y()N D. Audits. Reviews or Inspections (1) Audits are required [L/C] ()Y()N (2) Audits or inspections are conducted ()Y()N Audits conducted by Frequency (3) Content and implementation of the radiation protection program reviewed annually by the licensee [20.1101(c). 35.22(b)(6)] ()Y()N (4) Records maintained [20.2102] ()Y()N E. Authorized Users (1) Teletherapy Physicist
. (a) Named on license [L/C] ()Y()N (b) Certified per [35.961(a)] OR meets requirements in [35.961(b) or (c)] ()Y()N (2) Authorized individuals [35.960. L/C] ()Y()N Basis for Findings:
Here and throughout the field notes. "L/C" means " license condition."
87116. Appendix A A-6 Issue Date: XX/XX/XX
. ~ . . . . . . . . .- - - . .. -_. - . . . _ _ .
- 4. FACILITIES ,,
5 A. Facilities as described in license application [L/C] ()Y hk / l (1) Provided with electrical interlock system !
[35.615(b)] ()Y()N i (2) Equipped with functioning beam condition l indicator light [35.615(c)] ()Y()N l
, (3) Provided with system to permit continuous
.- observation of patient [35.615(e)] ()Y()N i
- B. Unit Operation (1) Console keys controlled adequately [L/C] ()Y()N (2) Restricted to certain sousce head orientations and/or gantry angles [L/C] ( ) N/A ( ) Y ( ) N ;
(3) Ceases to operate in restricted j
( ) N/A ( ) Y ( ) N.
orientation (s) [L/C]
4 C. Facilities are secured to prevent unauthorized *
- access [L/C] ()Y()N D. Describe any self-contained dry-source-storage irradiators and/or survey instrument calibrators (model, radionuclide, activity, use, etc.) . ( ) N/A l
l l
1 l
(1) Maintenance of safety-related components performed by authorized persons.[L/C] ()Y()N l (2) Arcess to keys and/or material controlled ;
[20.1801. 1802. L/C] ()Y()N '
(3) Access to high/very high radiation areas controlled [20.1601. 1602. L/C] ()Y()N !
(4) Adequate protection of shield integrity. ,
fire protection [L/C] ()Y()N '
I Basis for Findings:
l Issue Date: XX/XX/XX A7 87116. Appendix A
4 1
- 5. E0VIPMENT AND INSTRUMENTATION A. Instruments and equipment !
- j (1) Appropriate operable survey instrumentation '
- possessed and readily accessible [35.620. L/C] ()Y()N Calibrated as required [20.1501(b). L/C]'
(2) ()Y()N i i- (3) Calibration records maintained [20.2103(a)) ()Y()N l l (4) Procedures established to identify and report j l safety component defects [21.21] ()Y()N 1
- 8. Dosimetry System (1) Calibrated system available for use [35.630(a)] ( )-Y ( ) N l 4
(2) Calibrated by NIST or an AAPM-accredited lab within previous two years and after servicing
[35.630(a)(1)] OR calibrated by intercomparison per [35.630(a)(2)] ()Y()N j
~
C. Facility equipped with permanent radiation monitor
[35.615(d)] ()Y()N i
. (1) Monitor provides visible notice of malfunction resulting in exposed source and is observable
, upon entry into the teletherapy room
[35.615(d)(1)] ()Y()N (2) Monitor equipped with a functional backup L power supply [35.615(d)(2)] ()Y()N 2
(3) Monitor is checked each day of use prior to i treatments [35.615(d)(3)] ()Y()N j (4) Records of monitor checks maintained
[35.615(d)(4)] ()Y()N (5) If monitor malfunctioned. was survey meter used [35.615(d)(5)] ( ) N/A ( ) Y ( ) N (6) Mnitor was repaired / replaced promptly 2
L35.615(d)(6)] ( ) N/A ( ) Y ( ) N
- Basis for Findings:
i
. 6. TELETHERAPY FULL CALIBRATION A. Licensee utilizes one of the proper procedures (SCRAD or TG-21) [35.632(d)] ()Y()N !
1 B. Performed prior to first patient use [35.632(a)(1)] ()Y()N C. At intervals not to exceed one year [35.632(a)(3)] ()Y()N D. Whenever spot checks indicate output differs from l expected by 5% [35.632(a)(2)(i)] ( ) N/A ( ) Y ( ) N E. After source exchange. relocation and major repair or modification [35.632(a)(2)(ii). (iii)] ( ) N/A ( ) Y ( ) N 87116. Appendix A A-8 Issue Date: XX/XX/XX
F. Performed with properly calibrated instrument ()Y()N l G. Includes: l i
(1) Output measured within 3% of expected for i the range of field seizes, distance or range ;
of distances used for medical use
[35.632(b)(1)] ()Y()N l (2) Coincidence of radiation field and field light localizer [35.632(b)(2)] ()Y()N (3) Uniformity of radiation field and beam angle dependence [35.632(b)(3)] ( ) Y_( ) N (4) Timer constancy and linearity over the range of ,
use [35.632(b)(4)] ()Y()N (5) On-off error [35.632(b)(5)] ()Y()N (6) Accuracy of all measuring and localization devices [35.632(b)(6)] (.) Y ( ) N l H. Output corrected mathematically, monthly for Co-60 i and at six month intervals for Cs-137 [35.632(e)] ()Y()N I. Records maintained per [35.632(g)] ()Y()N Basis for Findings:
l l
- 7. TELETHERAPY SPOT CHECKS )
A. Periodic spot checks (1). Performed once each calendar month [35.634(a)] ()Y()N (2) Procedures established by teletherapy physicist
[35.634(b)] ()Y()N (3) Procedures followed .
()Y()N (4) Teletherapy physicist reviews results 4 within 15 days L35.634(c)] ( ) N/A ( ) Y ( ) N (5) Performed with properly calibrated instrument ()Y()N B. Output spot checks include: ..
(1) Timer constancy and linearity over the range of use [35.634(a)(1)] ( ) Y ( ).N (2) On-off error [35:634(a)(2)] ()Y()N i (3) Coincidence of radiation field and field light !
localizer [35.634(a)(3)] ()Y()N (4) Accuracy of all measuring and localization devices [35.634(a)(4)] ()Y()N (5) The output for one typical set of operating ,
conditions [35.634(a)(5)] ()Y()N '
(6) Difference between measured and expected i output [35.634(a)(6)] ()Y()N l Issue Date: XX/XX/XX A-9 87116. Appendix A
C. Safety spot checks include:
(1) Interlock systems [35.634(d)(1)] ()Y()N (2) Beam stops and dead-man switches [35.634(d)(2)] ( ) Y ( ) N-(3) Beam condition indicator lights [35.634(d)(3)] ()Y()N (4) Viewing systems [35.634(d)(4)] ()Y()N (5) Treatment room doors, inside and out
[35.634(d)(5)] ()Y()N (6) Electrical treatment doors with power shut off
[35.634(d)(6)] ()Y()N D. Licensee promptly repaired items found to be not I operating properly and did not use unit until repaired [35.634(e)] ( ) N/A ( ) Y ( ) N E. Records maintained per [35.634(f)] ()Y()N Basis for Findings:
- 8. TELETHERAPY SERVICING )
A: Inspection and servicing performed following source replacement or at intervals not to exceed 5 years
[35.647(a)] ()Y()N B. Licensee arranged for needed service identified during the inspection ()Y()N j C. Service performed by persons specifically authorized to do so [35.647(b)] ()Y()N l Basis for Findings:
- 9. MATERIALS RECEIPT. USE. TRANSFER. AND CONTROL A. Isotope, chemical form. quantity and ,
use as authorized [35.600. L/C] ()Y()N i
B. Possession and use of depleted uranium as !
shielding as authorized ( ) N/A ( ) Y ( ) N !
C. Licensed materials secured to prevent unauthorized removal or access [20.1801, 1802] ()Y()N (1) Licensed material in storage in controlled .'
or unrestricted areas is secured from unauthorized removal or access [20.1801] ()Y()N 87116. Appendix A A-10 Issue Date: XX/XX/XX
. (2) Licensed material in controlled or :
unrestricted areas and not in storace '
- is controlled and under constant ;
surveillance [20.1802] ()Y()N j (3) Access to restric:ed areas is limited ,
[20.1003] ()Y()N l D. Package containing replacement source !
received by the licensee in accordance with [20.1906] ( ) N/A ( ) Y ( ) N ,
E. Transfer of licensed material per [30.41] ( ) N/A ( ) Y ( ) N ,
F. Records maintained [30.51(a)] ( ) N/A ( ) Y ( ) N 4
Basis for Findings:
4
- 10. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers [19.12] ()Y()N !
i
- B. Individual's und'erstanding of procedures and regulations is adequate ()Y()N i C. Training program implemented [35.610) ()Y()N i
(1) Operating procedures [35.610(a)(1)] ()Y()N (2) Emergency procedures [35.610(a)(2)] ()Y()N
] (3) Periodic training required [L/C] ()Y()N
~
(4) Periodic training implemented ()Y()N i (5) Recoros maintained ()Y()N D. Supervision of individuals by authorized user in accordance with [35.25] ()Y()N E. Training for authorized users of teletherapy unit (s) per [35.960] ()Y()N F. Training for teletherapy physicist (s) per [35.961] ()Y()N G. . Workers cognizant of Part 20 requirements for:
(1) Radiation safety program [20.1101] ()Y()N ,
(2) Annual dose limits [20.1301, 1302] ()Y()N ,i (3) NRC Forms 4 and 5 ( ) N/A ( ) Y ( ) N 1 (4) 10% monitoring threshold [20.1502] ()Y()N (5) Dose limits to embryo / fetus and declared pregnant worker [20.1208] ()Y()N (6) Grave danger posting [20.1902] ( ) N/A ( ) Y ( ) N (7) Procedures for opening packages
[20.1906) ( ) N/A ( ) Y ( ) N Issue Date: XX/XX/XX A-11 87116. Appendix A w
, Basis for Findings: :
- 11. AREA RADIATION SURVEYS FOR TELETHERAPY FACILITIS A. Survey Instiuments ;
(1) Appropriate operable survey instruments possessed per [35.620] ()Y()N (2) Calibrated per.[35.51] ()Y()N B. Surveys' conducted around source head (with source off) and in adjacent areas to treatment room (with source on) [35.641(a)]
(1) Prior to first patient treatment ()Y()N (2) After new source installation ( ) N/A ( ) Y ( ) N (3) After any changes in room shielding, location of the unit within room, or use of the unit such that radiation levels outside the room could increase ( ) N/A ( ) Y ( ) N C. Records maintained [35.641(c)] ()Y()N D. Survey reports submitted to NRC [35.645] ()Y()N E. Protection of members of the public (1) Licensee made adequate surveys to demonstrate either (1) that the TEDE to the-individual likely to receive the highest dose does not exceed 100 mrem in a year or (2) that if an individual were continuously present in an unrestricted area. the external dose would not exceed 2 mrem in any hour and 50 mrem in a year [20.1301(a)(1).
1302(b)] ()Y()N (2) Unrestricted area radiation levels do not exceed 2 mrem in any one hour
[20.1301(a)(2)] ()Y()N (3) Records maintained [20.2102. 2107] ()Y()N F. Leak tests and inventories ( ) N/A (1) Performed per [35.59(b). (c)] ()Y()N (2) Adequate analysis methodology and sensitivity ( ) N/A ( ) Y ( ) N (3) Records maintained [35.59(d)]
and signed by RSO ()Y()N Basis for Findings:
87116. Appendix A A-12 Issue Date: XX/XX/XX
- 12. RADIATION PROTECTION k
, A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee incorporated ALARA considerations in the radiation protection program [20.1101(b)] ()Y()N j C. External dosimetry ( ) N/A (1) Licensee monitors workers [20.1502(a). L/C] ()Y()N '
- (2) External exposures account for contributions
- from airborne activity [20.1203] ( ) N/A ( ) Y ( ) N (3) Processor Frequency 4
(4) Processor is NVLAP-approved [20.1501(c)] ()Y()N ;
(5) Dosimeters exchanged at required i
- frequency [L/C] .( ) Y ( ) N D. Reports ( ) N/A
! (1) Reviewed by Frequency !
(2) Inspector' reviewed personnel monitoring records for period to (3) Prior dose determined for individuals likely to !
receive doses [20.2104] ()Y()N (4) Maximum exposures TEDE Other l (5) TEDEs within limits [20.1201] ()Y()N i
(6) NRC forms or equivalent [20.2104(d) 2106(c)]
(a) Form 4 ()Y()N Complete: ()Y()N (b) Form 5 ()Y()N Complete: ()Y()N (7) Worker declared her pregnancy in writing during inspection period (review records) ( ) N/A ( ) Y ( ) N If "yes." licensee in compliance with [20.1208] ( ) Y ( ) N I and records maintained [20.2106(e)] ()Y()N l l
Who performed PSEs at this facility (number of people E.
involved and doses received) [20.1206. 2104. 2105. 2204] ( ) N/A i
F. Records of exposures, surveys. monitoring and !
evaluations rr.aintained [20.2102. 2103, 2106. L/C] ()Y()N !
G. Licensee advises each worker annually of worker's dose [19.13(b)] ()Y()N Basis for Findings: !
Issue Date: XX/XX/XX A-13 87116. Appendix A
. 1
- 13. QUALITY MANAGEMENT PROGRAM. MISADMINISTRATIONS. AND RECORDABLE EVENTS
[35.32,33) .
NOTE: _ This section is being revised by IMAB and is being separately
, transmitted for comment. !
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- 14. RECORDKEEPING FOR DECOMMISSIONING
~
i t A. Records of information important to the safe and i
^
effective decommissioning of the facility maintained in an independent and identifiable location until '
j license termination. ()Y()N l
B. Records include all required information [30.35(g)] ()Y()N List of restricted areas [30.35(g)(3)]
(1) indicates that rooms have been released i since the last inspection ( ) Y ( ).N
] (2) Confirmatory measurements show that each room is within release limits. and licensee records adequately document the basis for releasing j each room ()Y()N C. Copies of the licensee's decommissioning cost estimates and funding methods on file ()Y()N L D. If the licensee uses a parent company guarantee '
i or a self-guarantee as funding method. does the l file contain a copy of the financial test performed
. for the licensee's most recently completed fiscal j year? ( ) N/A ( ) Y ( ) N
' E. If "Yes" to D. . do the financial test ratios meet the criteria in 10 CFR Part 30.
Appendix A. Section II for parent company guarantees and Appendix C. Section II for self guarantees? ()Y()N F. Date that licensee's financial assurance instrument ( ) N/A was submitted to NRC. if applicable:
G. Date that licensee's decommissioning plan was ( ) N/A submitted to NRC. if applicable:
H. Have radiological conditions at the licensee's facility changed since the financial assurance !
mechanism and/or decommissioning plan was submitted due to: ,
4 (1) Incidents or events? ( ) N/A ( ) Y ( ) N (2) Unplanned process upsets or changes? ( ) N/A ( ) Y ( ) N (3) Unauthorized material form, or possession limit changes? ( ) N/A ( ) Y ( ) N (4) Any other changes? ( ) N/A ( ) Y ( ) N 87116. Appendix A A-14 Issue Date: XX/XX/XX
i !
i If "Yes" to any of the above (1)-(4). l notify regional management. '
, Basis for Findings (include comments and measurements on any areas the licensee l
, released for unrestricted use):
l 15. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE A. License to conduct a principle activity has j expired or been revoked ()Y()N B. Licensee !gs made a decisica w permanently l Cease principal activities at the entire site or at any separate buildings ()Y()N C. A 24-month duration has passed in which no l principal activities have been conducted under l
. the license at the site or at any separate buildings
()Y()N D. If."Yes" to either A or B or C above:
4 (1) Identify Site / Bldg / Area: )
(2) Date of occurrence of A. B. or C: ;
NOTE: If "No" to A and B and C. Decomissioning Timeliness Rule does not apply.
If "Yes" to either A or B or C. then complete Attachment A.
j "Decomissioning Timeli :w Inspection Field Notes." for this licensee. ;
! Basis for Findings:
l
- 16. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189) ( ) N/A a
A. Licensee Transoorts: [ complete sections (1) - (4), as applicable]
(1) Limited Quantities and/or Instruments and ( ) N/A Manufactured Articles: (Radioactive Material. l excepted package. [ additional info]. 7. UN 2910)
(a) Package meets general design requirements [173.410] ()Y()N (b) Radiation level 5 0.005 mSv/hr (0.5 mrem /hr) (Exclusive use instruments and articles. 2 mrem /hr) ()Y()N (c) Contamination less than 173.443 limits.
OC examination / test performed prior to each shipment [173.475(I)] ()Y()N Issue Date: XX/XX/XX A-15 87116. Appendix A
(d) Limited Quantity Package marked
" Radioactive" [173.421(a)(4)] ()Y()N (e) 173.422 certification statement attached / enclosed ("This package '
conforms to the conditions and i limitations specified in. . ") ()Y()N (2) Type A Quantities (Radioactive Material, nos. ( ) N/A
- 7. UN 2982)
(a) Packaging:
(1) Packaging is proper for contents l-(i.e.. DOT 7A). is unim l is prepared correctly paired, and l
[173.475(a)-(f)] ()Y()N (ii) All packages meet general design requirements [173.410] ()Y()N (iii) DOT 7A package meets additional ,
Type A design requirements l
[173.412. 178.350] ()Y()N (b) Recordkeeping:
(i) Special form source records (173.476(a)] ()Y()N (ii) DOT 7A performance / design documentation [173.415(a)] ()Y()N (c) Hazards communications requirements (consult. the "NRC field reference i charts" that correspond to elements l (i) through (v). below):
(i) Shi> ping payers [172.200-205] ()Y()N (ii) Marcing pace. ages [172.300-338] ()Y()N (iii) Labeling packages [172.400-450] ()Y()N (iv) Placarding vehicles [172.500-560] ()Y()N ;
(v) Emergency response information I and guidance [172.600.-604] ()Y()N (d) Radiation level / Contamination limits i (173.441. 173.443]
(i) Package levels within limits ()Y()N I (ii) QC examination / test performed prior to each shipment [173.475(I)] ( ) Y ( ).N (3) Type B Ouantities (Radioactive Material, nos. ( ) N/A
- 7. UN 2982)
(a) Packaging is proper for contents (i.e.. '
Type B). is unimpaired, and is prepared i correctly [173.475(a)-(f)] ()Y()N ,
(b) Inspector must complete Section 2 of NRC '
Inspection Procedure (IP) 86740 ;
(c) Sections 2.c. and 2.d.. shown in the pre-vious section for Type A Quantities, also apply. Complete those sections.
87116. Appendix A A-16 Issue Date: XX/XX/XX
. . _ - . ._ _ _ __ .. _ _ _~ _ _.
(4) LSA Material and SCO (Radioactive Material. ( ) N/A LSA. nos. 7. UN 2912) or (Radioactive Material.
SCO. nos. 7. UN 2913)
(a) If licensee makes significant LSA/$C0 I shipments. inspector should complete !
Inspection Requirement 03.02 of Temporary '
Instruction (TI) 2515/133 (issued 3/15/96)
(b) Otherwise, if licensee has a minor LSA/SCO program:
i (i) Licensee properly characterizing j material as LSA/SCO [173.403] ()Y()N 4 (ii) All packages meet general design requirements [173.410] ()Y()N (iii) Proper LSA/SCO packaging selected and used [173.475. 173.427] ()Y()N ;
(iv) Placarding exclusive use vehicles.
, marking package " Radioactive-LSA" 2
or " Radioactive-SCO." as aapropriate [173.427(a)(6)] ()Y()N (v) Slipping papers [172.200-205]
(see "NRC field reference chart" i
, for content and exceptions) ()Y()N B. DOT HAZMAT Emoloyee Trainino Proaram [49 CFR 172.700-704] ( ) N/A (1) Each HAZMAT employee receives training and is tested [172.702] ()Y()N (2) Recurrent training at least every 2 years
[172.704(c)(4)] ()Y()N (3) HAZMAT employee training includes general awareness, function-specific, and safety training [172.704] ()Y()N l (4) HAZMAT employer recordkeeping includes employee name, completion date, description / copy / location of training materials. name and address of training provider, and certification [172.704(d)] ()Y()N ,
C. Carrier Modal Soecific Reauirements. Hiahway ( ) N/A Transoortation [49 CFR Part 177]
(1) Driver training, or CDL w/ HAZMAT endorsement
[177.800. 177.816] ()Y()N (2) Incident reporting to DOT [177.807, see also 171.15 and 171.16] ()Y()N (3) Shipping paper accessibility (on seat or in driver's side door pocket, readily visible) ()Y()N (4) Placarded vehicles routing and driver training requirements [177.825 and 49 CFR 397 Subpart D (i.e., the motor carrier regs)] ()Y()N (5) Sum of total package tis on non-exclusive use vehicle < 50 [177.842(a)] ()Y()N (6) Packages blocked / braced for transport
[177.842(c)] ()Y()N Issue Date: XX/XX/XX A-17 87116. Appendix A
D. H_iscellaneous Recuirements ( ) N/A i (1) No labeled packages carried in passenger compartments [173.448(c)] ()Y()N (2) Overpack requirements observed, if packages are .
offered in overpack. Overpack marked w/ proper j shipping name and number. package and overpack labeled as needed. marked " inner package complies ...." [173.24] ()Y()N j (3) Expanded and changed A1/A2 values from the 4/1/96 rule changes have been implemented i i
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[173.435] (verify only once per licensee) ()Y()N '
(4) Written instructions included with exclusive !
use shipments [173.403] ()Y()N Basis for Findings: I 4
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- 17. POSTING AND LABELING l 1
A. NRC Form 3. " Notice to Workers." posted [19.11] ()Y()N 1 i
B. Emergency procedures posted at console [35.610(a)] ()Y()N C. Parts 19. 20, 21. Section 206 of Energy Reorganization Act, procedures adopted pursuant to Part 21. and license
- documents are sosted or a notice indicating where
- documents can se examined is posted [19.11, 21.6] ()Y()N D. Other posting and labeling per [20.1902. 1904] )
and the licensee is not exempted by [20.1903. 1905] ()Y()N l Basis for Findings:
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- 18. GENERIC COMMUNICATION OF INFORMATION A. Bulletins, information notices. NMSS Newsletter. ;
etc. received by the licensee ()Y()N- '
B. Licensee took appropriate action in response to bulletins, generic letters, etc.
()Y()N Basis for Findings:
4 87116. Appendix A A-18 Issue Date: XX/XX/XX
- 19. MTIFICATIONANDREPORTS i A. Notifications since last inspection [35.14] ()Y()N (1) Licensee has provided appropriate documentation to NRC for authorized user no later than 30 days after the individual starts work [35.14(a)] ( ) N/A ( ) r ( )N (2) Licensee has notified NRC within 30 days after authorized user or RSO stops work or changes r,ame or licensee's i mailing address changes [35.14(b)] ( ) N/A ( ) Y ( ) N j B. Licensee in compliance with [19.13, 30.50] (reports i to individuals.public and occupational, monitored to show compliance with Part 20) ( ) N/A ( ) Y ( ) N l C. Licensee in compliance with [20.2201. 30.50]
(theft or loss) ( ) None ( ) Y ( ) N :
D. Licensee in compliance with [20.2202, 30.50] l (incidents) ( ) None ( ) Y ( ) N E. Licensee in compliance with [20.2203, 30.50] l (overexposures and high radiation levels) ( ) None ( ) Y ( ) N F. Licensee aware of NRC Ops Center phone number ()Y()N
[(301)-816-5100]
- 20. YEAR 2000 EFFECT ON COMPUTER SYSTEM SOFTWARE i
A. Licensee has reviewed the effect of the year 2000 on computer software programs that are used to meet licensing requirements or those that have safety significance [IN 96-XX] ()Y()N If "No." licensee is aware of notice to do so ()Y()N NOTE: A deficiency in this area should not be cited as a violation. ;
- 21. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A
- A. Special license conditions or issues to be reviewed:
A l
. B. Evaluation:
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Issue Date: XX/XX/XX A-19 87116. Appendix A
- 22. OBSERVATIONS / DEMONSTRATIONS OF LICENSED ACTIVITIES _
Briefly describe the activities and procedures observed and/or demons'.heh during the inspection. For exanple. it you observed 1icensee personnel working in radiation areas using 1icensed material or performing functions associated with radiation safety such is receiving or transporting licensed material: conducting or receiving training: disposing of radioactive waste:
conducting surveys: or making measurements. then describe what you saw. If the licensee demonstrated any practices at your request. describe those demonstrations. The observations and denonstrations you describe here. and elsewhere in the " Basis for Findings" sections of this report along with measurenents and sane records review, should substantiate your inspection findings.
I Describe what activities or procedures were observed and/or demonstrated by the licensee during the inspection:
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87116. Appendix A A-20 Issue Date: XX/XX/XX
DRAM .
The following sections should be cmpleted in a narrative format by the inspector to briefly describe the measurements performed by the inspector, inspection findings, and any post-inspection cmmunications with regional sta ff.
- 23. NRC INSPECTOR'S MEASUREMENTS ( ) N/A A. Survey instrument Serial No. Date of calibration B. Inspector performed CONFIRMATORY measurements ()Y()N C Inspector performed INDEPENDENT measurements ()Y()N D. Briefly describe the types of measurements performed (i.e.. exposure rates, wipe tests. soil samples, air flow measurements, etc.).
locations where measurements were taken, the results of these measurements (mR/hr. dpm. etc. ). and whether inspector's results conflicted with the licensee's measurements. If independent measurements were not made, justify why they were not performed on this inspection.
- 24. CONTINUATION OF REPORT ITEMS ( ) N/A
- 25. VIOLATIONS. NOTICE OF VIOLATIONS (NCVs). AND OTHER ISSUES ( ) N/A Note: Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For NCVs. indicate why the violation was not cited. Attach copies of all licensee documents needed to l
support the violation.
i Issue Date: XX/XX/XX A-21 87116. Appendix A
- 26. DEBRIEF WITH REGIONAL STAFF l
A. Was inspection feedback provided to regional licensing staff? ()Y()N :
If "Yes." name of individual on the licensing staff:
If "Yes." describe-issues discussed:
- 8. Briefly describe post-inspection communications with other regional staff (inspector's supervisor, Agreement State officer. State liaison officer, etc.):
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i 87116. Appendix A A-22 Issue Date: XX/XX/XX
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12 7 . PERFORMANCE EVALUATION FACTORS ~
A. Lack of senior management involvement with the ,
radiation safety program and/or RSO oversight ()Y()N j B. RSO too busy with.other assignments ()Y()N -)
C. Insufficient staffing ( ) Y (-) N D. RSC fails to meet or functions inadequately ( ) N/A ( ) Y ( ) N .
i E. Inadequate consulting services or inadequate audits conducted ( ) N/A ( ) Y ( ) N Remarks (consider the above assessment and/or other pertinent PEFs with regard' j to the licensee's oversight of the radiation safety program):
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Regional follow-up on above PEFs citations: l
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END
Attachment:
A. " Decommissioning Timeliness Inspection Field Notes" 1
Issue Date: XX/XX/XX A-23 87116. Appendix A
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APPENDIX A - ATTACHMENT A DECOMMISSIONING TIMELINESS INSPECTION FIELD NOTES ' -
Licensee:
Date of Inspection:
- 1. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE (NOTE: Repeat the answers given in Section 12 of the main body of the field notes. The issues in subsequent sections are dependent on the ;
answers to these questions.)
A. License to conduct a principle activity has expired or been revoked ()Y()N B. Licensee has made a decision to permanently cease principal activities at the entire site t or any separate buildings ()Y()N C. A 24-month duration has passed in which no principal activities have been conducted under the license at the site or at any separate buildings ()Y()N D. If "Yes" to either A or B or C above:
(1) Identify Site / Bldg / Area: !
(2) Date of occurence of A. B. or C: ,
- 2. NOTIFICATION RE0VIREMENTS A. Licensee has provided written notification to NRC within 60 days of the occurrence of 1.A., 1.B., or 1.C. above ()Y()N l
If "Yes " date of notification:
B. If the licensee is requesting to delay initiation l of the decommissioning process, the licensee hag '
provided written notification to NRC within 30 days of occurrence of 1.A., 1.B., or 1.C. above ( ) N/A ( ) Y ( ) N If "Yes " date of notification:
Basis for Findings:
I i l
Issue Date: XX/XX/XX Att. A-1 87116. Appendix A. Att. A
t t
3 DECOMMISSIONING PLAN / SCHEDULE REOUIREMENTS :
A. Licensee is required to submit a decommissioning i
. plan per 10 CFR 30.36(g). 40.42(g) 70.38(g).,or
- 10 CFR Part 72? ()Y()N ;
4 F
If "No" to 3.A., answer the following items B. - F.
B. The decomissioning work scope is covered by
, current license conditions (-) Y ( ) N C. Decommissioning has been initiated within 60 days ,
of notification to NRC. or NRC has granted a delay ()Y()N '
D. If licensee has initiated decort<nissioning, give date ;
the decommissioning was initir.ted: '
i Initiation date:
t E. If decomissioning has been completed, it was completed within 24 months of notification to NRC ( ) N/A ( ) Y ( )-N F. If decommissioning is still scheduled to be !'
completed, it is on schedule to be completed within 24 months of notification to NRC' ( ) N/A ( ) Y ( ) N Basis for Findings: ,
I l
If "Yei to 3.A. answer the following items G. - J.:
G. The decomissioning plan has been submitted to NRC within 12 months of notification ()Y()N If "Yes." date of submittal: .
If NRC approved, date of NRC approval:
H. Has the licensee submitted an alternative schedule request? ()Y()N
.If "Yes." date of submittal:
87116. Appendix A. Att. A Att. A-2 Issue Date: XX/XX/XX
I. If decommissioning has been completed. it wac coi.pleted within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N J. If decommissioning is stil' scheduled to be comaleted. it is on schedule to be completed witlin 24 months after approval of the
' decommissioning plan ( ) N/A ( ) Y ( ) N Basis for Findings:
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l Violations identified, if any:
Issue Date: XX/XX/XX Att. A-3 87116. Appendix A. Att. A
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4 I, ATTACHMENT 3 a
IP 87117 RADIOPHARMACY PROGRAMS f
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I DRAPT NRC INSPECTION MANUAL IMos INSPECTION PROCEDURE 87117 RADI0 PHARMACY PROGRAMS PROGRAM APPLICABILITY: 2800 .
87117-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers and the general public.
01.02 To determine if licensed programs are being conducted in accordance with l NRC requirements.
87117-02 INSPECTION REQUIREMENTS A review of the licensed activities will be comensurate with the scope of the licensee's program. A determination regarding safety and compliance with NRC requirements will be based on direct observation cf work activities, interviews with workers, demonstrations by workers performing tasks regulated by NRC. and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a rer.ew of records. l In reviewing the licensee's performance. the inspector should cover the period j from the last to wrrent inspections. However, older issues preceding the last insoection shoula N reviewed, if warranted by circumstances, such as incidents, nor. compliance, or nigh radiation exposures. ,
Some of the following areas may not be applicable to all radiopharmacy licensees.
02.01 Prenaration. The inspector should allow adequate time to prepare for the inspection. Preparation will include reviewing documents, making travel '
arrangements, coordinating with appropriate personnel, notifying appropriate state agencies, and selecting necessary equipment. In particular, the inspector '
shall identify whether any license amendments have been issued since the last inspection, or whether the licensee has informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensee had any incidents or events since the last inspection.
02.02 Entrance Briefina. When the inspector arrives at the licensee's facility, he/she will inform the radiopharmacy manager of the purpose and scope of the inspection. .
Issue Date: XX/XX/XX 87117
. .- - . ~ . -. - . .. -. - - - - . .. _ - . ._. - --
02.03 General Overview
- a. Orconization. Interview cognizant licensee representatives about the :
current organization of the program. Examine the licensee's organization )
with res3cct to changes that may have occurred in personnel, functions, responsi]ilities, and authorities since the previous inspection. Identify the reporting relationship and manager,ent structure between the licensee's I executive management and the Radiation Safety Officer (RS0). j
- b. Scoce of Procram. Interview the cognizant personnel to determine the types and quantities of licensed materials received, distributed, and j redistributed, numbers of facilities served, staff size. etc.
1
- c. Manaaement Oversicht. In the course of interviewing cognizant personnel, i
, determine if management oversight is sufficient to provide the licensee staff with adequate resources and authority to administer the licensed 4
program.
, the appropriate duties commensurate with the size and scope of l licensed activities. I
- 2. Audits - Verify that audits are performed as required. Verify that the results of the audit are reviewed and addressed.
- d. Authorized Nuclear Pharmacists (ANPL Verify that ANPs meet the criteria described in 10 CFR 32.72(b), and have been approved by the licensee to 2
perform and/or supervise licensed activities. Ensure that notifications regarding changes in ANPs, if applicable, have been made in accordance )
with 10 CFR 35.14 Determine that the licensee is registered / licensed by
, FDA or a State agency as a nuclear pharmacy.
4 02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed facility to make general observations of the condition of the facility and the licensed activities being performed.
, 02.05 Facilities. Verify that the facility conforms to that described in the
! license application: that material receipt, use, and storage areas are
- secured
- and that the licensee uses processes or other engineering controls (e.g. , negative pressure) to maintain doses as low as is reasonably achievable (ALARA).
02.06 Eauioment and Instrumentation
- a. Verify that equipment and instrumentation is apprnpriate. operable, calibrated, adequately maintained, and conforms to that described in the license.
- b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 j
CFR Part 21.
02.07 Materials l a. Receiot and Transfer of Licensed Material. Verify that the licensee is i receiving packages and making transfers of licensed material in accordance with NRC and applicable U.S. Department of Transportation (DOT) regulations and 11 cense conditions. Verify that the licensee has an
. 87117 Issue Date: XX/XX/XX
l Dynn. I adequate method to account for all materials received, possessed, storeN and used to ensure compliance with possession limits. '
- b. Authorized Useg. Determine by observing the use of licensed material. I discussing the activities with licensee personnel, and reviewing records. l that the type, quantity, and use of licensed material at the licensee's '
facility is authorized by the license. To the extent practical, ensure, by physical confirmation, that the licensee's inventory is complete and accurate. .
- c. Material Security and Control. Verify that the licensee has established !
procedures for maintaining security and control of licensed material, and '
that these procedures are understood and implemented by appropriate l personnel. Verify that licensed material, in storage in controlled or unrestricted areas is secure from unauthorized removal or access. Verify that licensed material, not in storage in controlled or unrestricted '
areas is controlled and under constant surveillance. Verify that access to restricted areas is limited by the licensee. j 02.08 Trainina
- a. General Trainina. Verify that appropriate training and initial ,
instructions are being accomplished as specified in the license and/or !
regulations. ;
l
- b. Doeratina and Emeroency Procedures. Verify that operational procedures are being followed by -observing licensee personnel perform tasks at selected work stations and by a comparison of their activities with established procedures. Also examine the licensee *s emergency procedures l to determine that these procedures are as approved by NRC. Through i discussions with workers, verify that licensee personnel understand and 1 implement the established procedures and are aware of procedural )
revisions. Document in the inspection field notes what activities the inspector observed.
Discuss with the licensee's representatives, or observe, the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of radioactive material.
02.09 Area Radiation and Contamination Control
- a. Area Surveys. Verify. during observations and by direct measurements, that the radiation levels are within the limits of 10 CFR Part 20. and that these areas are properly posted. Confirm that the licensee representatives conduct surveys in accordance with procedures described in the license documents.
- b. Leak Tests. Verify that leak. tests of sealed sources are performed at the required frequency. Also verify that leak tests are analyzed in accordance with the license. If records of leak test results show -
3 contamination in excess of the regulatory recuirements, verify that the '
licensee made appropriate notifications anc removed the source from service.
- c. Contamination Control. Verify that the licensee performs weekly surveys for removable contamination in all areas where radiopharmaceuticals are routinely prepared, administered, or stored. If the licensee has had Issue Date: XX/XX/XX 87117
spills or other incidents of coctamination exceeding the licensee's trigger levels, verify that the licensee h?s t.aken appropriate actions.
- d. Protective Clothina. Verify that radiation workers are provided with, and wear, the appropriate protective clothing, commensurate with activities being performed.
02.10 Radiation Protection
- a. Radiation Protection Proaram. Verify that the licensee has developed and implemented a written radiation protection program comensurate with the licensee's activities, that the program includes ALARA provisions, and that the program is being reviewed at least annually, both for content and implementation.
- b. Radiation Protection Proegiurgs Varify that changes in the radiological protection procedures made since tne last inspection are consistent with regulations and license requirements. [ Note that some procedures may require prior NRC approval before the licensee can make changes.]
- c. Instruments and Eauioment. Verify that radiation protection instruments and e ble),quipment and areare operable,and calibrated have the proper checked alarm settings for appropriate (if applica-response in accordance with 10 CFR 32.72 requirements, license requirements and licensee procedures.
- d. Personnel Dosim?ters. Verify that personnel dosimetry devices are worn by appropriate 'icenses personnel. Dosimetry devices appropriate to the type, energy or emitted radiation, and the anticipated radiation fields should have been issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved and accredited processor.
Verify that pursuant to 10 CFR 19.13(b) the licensee advises each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106, " Records of individual monitoring results."
- e. Bioassays. Verify that bioassays are performed in accordance with license and regulatory requirements. Verify that the methods and the equipment used to perform bioassays have been approved and calibrated.
02.11 Waste Manaaement
- a. Waste Storaae and Disoosal. Verify that the waste is stored and controlled in a secure and safe manner, and that radiation levels in unrestricted areas surrounding the storage area do not exceed the limits of 10 CFR 20.1301, " Dose limits for individual members of the public."
Verify that disposal of decay-in-storage waste is performed in accordance with the regulations and license conditions. Verify that the licensee is .
conducting appropriate surveys and defacing radioactive material labels prior to disposing of the waste.
Review the licensee's procedures and records to verify that each shipment of radwaste intended for offsite disposal is accompanied by a shipment manifest that includes all the required information.
87117 Issue Date: XX/XX/XX
Review the licensee *s procedures and records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is .
labeled, as appropriate, to identify it as Class A. B. or C waste (in l accordance with the classification criteria of 10 CFR 61.55 [ Subsection i
III. A.2 of Appendix F to 10 CFR 20.1001-20.2401]).
l
- b. Effluents. Verify that effluent releases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003. respectively, and that ;
treatment or disposal of waste by incineration is according to 10 CFR 20.2004.
Review and verify that waste-handling equipment. monitoring ecuipment, and/or administrative controls are adequate to maintain racioactive
- effluents within the limits established Dy the license and other regulatory requirements and are ALARA.
Determine the quality of the relevant procedures and the degree to which ALARA techniques are incorporated into them. Determine the extent to which process and engineering controls are used to minimize effluents.
Determine whether effluent monitoring systems and the associated analytical equipment are adecuate to detect 'and quantify effluents with sufficient sensitivity, and w1 ether they are maintained, calibrated, and owrated in accordance with manufacturer's recommendations and good health p1ysics practices.
Determine if all significant release pathways are monitored. all un-monitored pathways have been characterized, and all surveillance ,
procedures for effluents are being implemented, i Additional inspection requirements are specified in Inspection Procedure (IP) 87102 " Maintaining Effluents from Materials Facilities As low As Is Reasonably Achievable (ALARA)." Verify whether EPA referral forms for air effluents have been sent to the appropriate EPA regional office, with a copy to NRC headquarters, per IP 87102.
- c. Transfer. Verify that wastes are transferred to an authorizem recipient specifically licensed to receive radioactive waste. I
- d. Records. Verify that records of waste storage. transfer. and disposal are maintained in accordance with the requirements of 10 CFR Part 20 and the license.
- e. Financial Assurance and Decomissionino. For a'11 licensees, including '
sealed source licensees, review the licensee's records of information important to the safe and effective decomissioning of the facility.
Verify that the records are complete, updated, and assembled ;
appropriately, in accordance with the recuirements in 10 CFR 30.35(g). j Review the licensee's list of restrictec areas required under 10 CFR -
30.35(g)(3) and determine whether laboratories or other rooms have been H released since the last inspection. If areas have been released, verify l that the licensee has adequately decontaminated each room and documented i the basis for releasing each room. Document the location of the released rooms in the field notes, and document your findings regarding the adequacy of the licensee's decontamination.
Verify whether radiological conditions at the facility have changed since !
the financial assurance instrument and/or decomissioning plan was Issue Date: XX/XX/XX 87117
I submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents such as spills or process upsets. Unautho ked changes by the licensee i to processes, types of licensed materials, possession limits, or chemical '
or physical forms of licensed materials may also prompt a reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect .
the financial assurance instrument or decommissioning plan. he/she should I imediately notify regional management. l t
If a parent company guarantee or a self-guarantee is used to ensure decommissioning financial assurance review the licensee's financial l
assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met.
- f. Decomissionino Timeliness. Review compliance with the Decomissicning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the field notes that should be completed on all inspections. If the license to conduct principal activities has expired or been revoked:
if the licensee has made a decision to permanently cease principal activities at the site or in any separate building; or if there has been a 24-month duration when no principal activities were conducted at the site or in any separate building, then the decomissioning timeliness requirements in 10 CFR 30.36, 40.42. 70.38, or Part 72 apply. If this is the case, complete in full the "Decomissioning Timeliness Inspection Field Notes." Attachment A to Appendix A.
02.12 Transoortation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with 10 CFR Part 71 and DDT regulations for transportation of radioactive materials.
02.13 Postino and Labelina. Verify that the licensee has posted the appropriate l documents. notices, forms, and caution signs as requirhi. Also verify that containers of licensed material are labeled appropriately.
02.14 Generic Communications of Information. Confirm that the licensee is receiving the applic ole bulletins information notices. NMSS New!1etter, etc.
Verify that the licensee has taken appropriate action in respcnse to these notices.
02.15 Notifications and Reoorts. Determine compliance with the regulations and license requirements for notification and reports to NRC.
02.16 Soecial License Conditions. If applicable, review the licensee *s compliance with any special license conditions.
02.17 Indeoendent and Confirmatory Measurements. Compare and verify, on a sampling basis. survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this inspection procedure, unless warranted by special circumstances. If indeperident measurements were not made, provide a justification in the field notes explaining why independent measurements were not performed. The inspector shall use radiation detection instruments that are calibrated. at a minimum, on an annual basis.
87117 Issue Date: XX/XX/XX
02.18 Exit Meetina.
DRAFT The inspector will cv.idJCt an OX1 t meeting With radiopharmacy management and the RSO to discuss the preliminary inspection findings including any apparent violations safety-related concerns, and any unresolved items identified during the inspection. Discuss any negative Performance Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of concern. For further guidance, refer to IP 87101 " Performance Evaluation Factors."
02.19 Post Insoection Actions. After an inspection, the inspector shall summarize the findings with his/her appropriate NRC supervisor. This is especially important if there are, or are expected to be controversial issues i arising from the findings.
Inspectors shall also meet with regional licensing staff when any pertinent licensing 1ssues are raised during the inspection, when ins)ection findings impact on any licensing actions, to discuss the licensee's PE: results, or to give feedback on how the licensee has addressed recent licensing actions. This meeting shall be documented in the field notes.
Additionally, in some instances, inspection findings will warrant communication with enforcement staff. Office of Investigations staff. State liaison staff, or Federal agencies with whom NRC has Memoranda of Understanding (MOUs).
The inspector will ensure that inspection findings are clearly documented and reported to the licensee as appropriate. The inspector shall also follow the requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and Records." regarding notifying the licensee that retained information is subject to public disclosure and giving the licensee the opportunity to request withholding it (see IMC 0620. Section 04.06.b.).
87117-03 INSPECTION GUIDANCE j General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather, observations of activities in progress, equipment facilities and use areas, etc. will be a better indicator of the licensee's overall radiation safety program than a review of records alone.
Some of the requirement and guidance sections of this procedure instruct the l inspector to " verify" the adequacy of certain aspects of the licensee's program. ;
Whenever possible, verification should be accomplished through discussions.
observations and demonstrations.
In the records reviewed look for trends such as increasing doses or effluent releases. Records such as surveys, waste disposal, effluent releases, receipt and transfer of licensed materials, training, utilization logs, and air sampling may be examined randomly until the inspector is satisfied that the records are being maintained and are complete. Other records that are more closely related I to health and safety (such as personnel dose-monitoring records and incident reports) should be examined in detail. The type of records that were reviewed and the time periods covered by these records should be noted in the appropriate
" Basis for Findings" section(s) of the inspection field notes. ,
Retain a copy of each pertinent record that is needed to substantiate an inspection finding, such as a violation. Those copies shall be attached to the inspection field notes or, when applicable. to a written inspection report. When an inspector identifies an apparent violation. he/she should gather copies from Issue Date: XX/XX/XX 87n7
the licensee while on-site of all reccrds that are needed to support the apparent vicl: tion. In general, inspectors should use caution before retaining copies of 1 kensee documents, unless the expedite the inspection (e.g.,y are needed to support apparent violations, licensee licensing file more complete. In all cases where licensee documents are retained beyond the inspection, follow the requirements of IMC 0620. Especially ensure that the licensee understands that the retained record will become publicly available, and give the licensee the opportunity to recuest withholding the information pursuant to the requirements of 10 CFR 2.790(J)(1).
The inspector should keep the licensee apprised of the inspection findings throughout the course of the inspection and not wait until the exit meeting.
Whenever possible the inspector should keep NRC management informed of significant findings (e.g. , safety hazards, willful violations, and other potential escalated enforcement issues) identified during the course of the inspection.
03.01 Preoaration. Prior to the inspection, the inspector should do the following:
e Review the licensee's previous inspection history (at a minimum review the past two inspections), the license, and the status of any allegations or incidents. Note the licensee's commitments in response to previous violations, for follow-up during the inspection:
e Review regior.al event / incident logs, event / incident files, and the docket file to determine whether the licensee was involved in any incidents or events. If NRC did receive notification of an incident, review that incident during the inspection and document the licensee's follow-up in the field notes:
e In the field notes, complete the administrative information, the inspection compliance history, the listing of any license amendments or program changes since the last inspection, and the description of any incidents or events that have occurred since the last inspection; e Determine the dates that the licensee submitted the most recent financial assurance instrument and decomissioning plan (if applicable):
e Discuss the licensee's program with previous inspector (s) and/or license reviewer (s) as necessary; e Notify the appropriate State radiation control program personnel:
e Review pending licensing actions:
e Obtain a map of the area and/or directions; e Make travel arrangements and prepare itinerary; e Select calibrated instruments and perform source check:
- Select appropriate documents: and e Select appropriate equipment to take.
87117 Issue Date: XX/XX/XX
In selecting the appropriate documents, tne inspector should consider taking the applicable regulations, field notes. generic conrnunications. license. NRC forms, etc.
In selecting the appropriate equipment the inspector should consider the type of licensee to be inspected. The equipment aay include safety glasses and shoes.
sample vials, wipes, pocket dosimeters, alarming rate meters, etc.
During the inspection. #ccus (among other areas) on whether the licensee is in compliance with any license amendments issued since the last inspection or with any program changes described by the licensee since the last inspection. This i requires review of documentation submitted in support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.
03.02 Entrance Briefina. After arriving on site, the inspector should inform the licensee's management representative of the purpose and scope of the inspection to be performed. Radiopharmacies are open for business very early in the morning, e.g. ,1:00 a.m. Occasionally an inspection should be performed during the processing of the first run doses. This would be an excellent time to observe the licensee's activities even though the pharmacy staff will be very busy and the manager may not be available. When early morning inspections are performed. the inspector should not disrupt the flow of production. but should use this time to observe the activities of the pharmacists, drivers, dispatchers, and office personnel.
The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for discussing or reviewing selected inspect 1on items with various licensee staff personnel. However, in some instances, the inspector may only need to inform ,
management of NRC's presence on site, and apprise management that an exit I briefing will be conducted. at the end of tM inspection, which will detail the inspection findings.
03.03 General Overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.
- a. Oraanization. The licensee's organizational structure will usually be found in the license application and may involve one or more individuals.
Determine the reporting structure among executive management, the RSO. and :
the other members of the staff. Determine whether the RSO has sufficient access to licensee management. Through discussions with licensee staff, the inspector should determine if changes in ownership or staffing have l occurred. If the owner or individuals named in the license have changed.
determine whether the licensee has submitted appro)riate notification to NRC. This information must be provided whenever clanges in ownership or personnel are made (except for some licenses where only responsibilities are defined). Ask licensee management if changes have occurred, or are anticipated, and ask personnel to confinn (to the inspector's satisfac-tion) that no changes have taken place. If there have been no changes in the organization since the previous inspection, there is no need to pursue this element in further detail.
The inspector should review any organizational change in the RSO position. -
authorities, responsibilities, and reporting chains. The inspector should be sensitive to changes that reduce the ability of the RSO to resolve concerns or issues related to the safe conduct of the radiation protection Issue Date: XX/XX/XX 87117
DRAFT program. The inspector should ask licensee management and the RSO about the RSO's authority and about any changes that may impact on the RS0's duues, responsibilities, or effectiveness.
- b. Scope of Procram. Through discussions with licensee personnel, the inspector can obtain useful information about the types and quantities of material, frequency of use, incider.ts, etc. which can not always be gained by reviewing records alone. This is also an opportunity for the inspector to discern the actual size and scope of the licensee's program, and to determine if significant changes in activities have occurred since the previous inspection. The information obtained should include the number of staff, number of customers served, number of doses dispensed daily, pharmacy duty hours, number and activity of generators received etc.
- c. Manacement Oversicht. The inspection is a verification of the licensee's implementation of the required program. In the review to verify implementation, the inspector should pay particular attention to the scope of the program; frequency of licensee audits and the use of qualified auditors: procedures for recording and reporting deficiencies to management; and methods and completion of follow-up actions by management.
- 1. RS0 - The RS0 is the individual, appointed by licensee management and identified on the license, who is responsible for implementing the radiation safety program. The inspector should verify that this individual is knowledgeable about the program, and ensures that activities are being performed in accordance with approved procedures and the regulations. The inspector should verify that, when deficiencies are identified, the RSO has sufficient authority, without prior management approval, to implement corrective actions, including termination of operations that pose a threat to health and safety.
- 2. Audits - The frequency and scope of audits of the licensed program will vary. However, note that, at a minimum, licensees are requirea by 10 CFR 20.1101(c) to review the radiation safety program content and implementation at least annually. Typically, larger radiopharmacy licensees have a corporate radiation safety staff who conduct periodic audits covering all aspects of the licensed program.
The results of all audits should be documented. Examine these records with particular attention to deficiencies identified by the auditors, and note any corrective actions taken as a result of deficiencies found. If no corrective actions were taken, determine why the licensee disregarded deficiencies identified during audits, and whether the lack cf corrective actions caused the licensee to be in non-compliance with regulatory requirements,
- d. Authorized Nuclear Pharmacists (ANP). ANPs may either be named on the license or appointed by the licensee. For those apaointed by the licensee, verify that these individuals are cualifiec. as ANP(s) in accordance with 10 CFR 32.72 (b) and have know' edge commensurate with their operational duties.
The regulations in 10 CFR 32.72(b)(2) permit the nuclear pharmacy licensee ,
to have an individual "under the supervision of" an authorized nuclear l pharmacist prepare radioactive drugs for medical use. These regulations do not specifically require that the authorized user tu present at all times during the use of such materials. However, the authorized user / supervisor is responsible for assuring that personnel under his/her l 87117 Issue Date: XX/XX/XX
supervision have been properly trained and instructed, pursuant to 10 CFR 35.25(b), and is responsible for the supervision of operations involving
, the use of radioactive materials whether he/she is present or absent.
03.04 Walk-Throuah Orientation Tour. The inspector should make initial
- observations of licensed activities to determine that materials are being safely i handled and that good health physics practices are followed. The inspector '
, should look at areas of use, storage. and disposal to make an initial assessment of the licensee *s ALARA program with regard to facility design. engineering 4
controls, housekeeping practices, etc. In addition, observations should include l J
dose preparation and quality control activities, package surveys prior to transfer to the end users, waste handling, and iodine encapsulations. The inspector should ensure that observations of activities are documented in the inspection field notes. l 4
l 03.05 Facilities. Descriptions of the facilities are generally found in the '
application for a license and subsequent amendments that are usually tied down to a license condition. The actual or as-built facility should be configured to ;
provide safe working areas separated from unrestricted areas and sufficient l access controls to preclude unauthorized entry. The inspector should also be aware of potential industrial safety hazards for referral to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA).
1 05.06 Eauioment and Instrumentation I i a. Equipment and instrumentation should be appropriate to measuring the radioactivity of radioactive drugs and be in accordance with 10 CFR 32.72(c). The inspector should verify that survey instrumentation has the !
appropriate range of use. The inspector should also verify that the survey instruments are calibrated at the appropriate frequency and checked l for operability before use. All survey. sampling, and monitoring i instruments should have current calibrations a>propriate to the types and energies cf radiation to be detected. T1e technical adecuacy of calibration procedures at facilities that perform their own calirations should be examined. Processing equipment, fume hoods ventilation, and exhaust systems should be sufficient to provide safe use, handling, and
, storage of the materials in use.
The inspector should verify that dose calibrators are calibrated in accordance with procedures and at the appropriate intervals. These calibrations include linearity, geometric dependence, accuracy, and constancy tests. If generators are used, the inspector should verify that molybdenum-99 breakthrough tests are performed on each elution in
, accordance with 10 CFR 30.34(g) and licensed procedures. If practical, the inspector should ask licensee representatives to demonstrate a constancy test and/or breakthrough procedure to ensure compliance with
- procedures.
J b. Inspectors should verify that licensees have procedures for reporting i defects in accordance with 10 CFR Part 21. The complexity of the -
procedures will vary.
j 03.07 Materials j a. Receiot and Transfer of Licensed Materials. Package receipt and transfer procedures will be found in the license documents. These procedures should be carefully reviewed before an inspection .is conducted. By discussions with the licensee, determine if the procedures have been Issue Date: XX/XX/XX 87117
%m changed or modified.
Some (updating whereas other minor changes changes till remaire telephone numbers,a licensdNhien editi procedures for clarity, etc.) may not require NRC approval. Randomly examine procedures used by the licensee to determine if they are in accordance with those identified in the license documents, and determine whether these changes warrant a license amendment.
The procedures for picking up, receiving, opening, and transferring packages should include how and when packages will be picked up, radiation surveys and wise tests, and procedures for opening packages (such as the location in t1e facility where packages are received, surveyed, and opened). The procedures also should include what actions are to be taken if surveys reveal packages that are contaminated in excess of specified limits, and/or radiation levels that are higher than expected limits. The inspector should, when practical, observe personnel perform the package receipt and transfer proceires.
The inspector should randomly examine records of package surveys and also determine if inventories for each radionuclide are within the license limits. In this regard, records of inventories after receipt and transfer should indicate / demonstrate that the materials on hand at any one time are within the licensee's possession limit. When practical, the records examined should be compared with a physical inventory of materials possessed.
The licensee should have a system that accounts for all licensed material .
The accounting system should provide accurate information on the receipt l and transfer of material. its location, the quantity used and disposed of. l and the amount transferred to customers. The accounting system should ;
also consider radioactive material held for decay-in-storage.
- b. Authorized Uses. Authorized uses of licensed mater' i al will be found in the license and referenced license documents. Licenses will list the isotopes, physical or chemical forms, and the maximum possession limits.
The ins 3ector should physically examine the inventory of radioactive materia' on hand or examine records of receipt and transfer to determine that quantities and forms are as authorized. Additionally the inspector should verify that the licensee's use of licensed material is limited to that which is authorized in the license.
- c. Material Security and Control . Examine areas where licensed materials are !
used and stored. Storage areas should be locked and have limited and j controlled access. Licensed material use areas should be under constant 4 surveillance or physically secured. The license'e should have procedures for access controls. Controls may include a utilization log to indicate I when licensed material is taken from and returned to storage areas. The i inspector should verify that adequate controls are in place and working effectively.
03.08 Trainina i
- a. General Trainina. Certain kinds of training and instruction are found in the regulatir.ns; how they are implemented will be found in the license.
Discuss with the licensee how, and by whom. training is conducted and the ,
content of the training provided to workers (generally found in the j license documents).
87117 Issue Date: XX/XX/XX
1 Verify, pursuant to 10 CFR 19.12 that initial instructions have been given to individuals who in the course of employment are likely to receive in excess of 100 millirem (1 mSv) in a year. Under the basic instructions, it is management's responsibility to inform the workers of precautions to take when entering a restricted area, kinds and uses of radioactive materials in that area, exposure levels, and the types of protective equipment to be usea. Tne workers should also be informed of the pertinent provisions of NRC regulations and the license, and the requirement to notify management of conditions observed that may. if not corrected result in a violation of NRC requirements. Also verify that authorized users and workers understand the mechanism for raising safety 1 concerns.
Of the training program elements in the license application, training given to authorized users, and those individuals under the supervision of authorized users, is of primary importance. One or more users of licensed materials should be interviewed to determine that they have received the required training, both in the basic instructions, and in that specified I in the license application. For some licensees. this includes specific training needed to perform infrecuent procedures and prepare and use licensed material in research stucies or in production. Note that the training should be (and in most cases is required to be) provided to workers before the individual's performance of licensed activities.
Randomly examine records of training of personnel and attendant examinations or tests (if applicable) to the extent that the inspector is l' satisfied that the training program is being implemented as required.
Where examinations are required. read a few of the examination cuestions to ascertain that they are indicative of what the worker shoulc know to carry out his/her responsibilities.
The inspector should also observe related activities and discuss the radiation safety training received by selected individuals to ensure that appropriate training was actually received by these individuals.
Authorized users and supervised individuals should understand the radiation protection requirements associated with their assigned activities. ihe licensee's radiation safety training may include, but is not limited to, demonstrations by cognizant facility personnel, formal lectures, testing, films, and " dry runs" for more complex or hazardous operations. Specialized training should be provided for drivers, disaatchers, and other personnel involved in such activities as delivery of licensed material to customers, handling and processing of radioactive waste, quality control of products, and production of iodine-131 capsules.
- b. Doeratina and Emeraency Procedures. Operating and emergency procedures will be found in license applications and may vary from step-by-step procedures to more generalized procedures for lower inspection priority licenses. The emergency procedures will be approved by the NRC and reviewed and updated by the licensee. Any revtsion requires an amendment to the license.
Some licensees may have agreements with other agencies (e.g., fire, law enforcement, and medical organizations) regarding response to emergencies.
Discuss with the licensee's representatives what has been done to ensure that agencies (involved in such agreements) understand their roles in emergency responses.
Issue Date: XX/XX/XX 87117
03.09 Area Radiation and Contamination Control i
- a. Area Surveys. The inspector may ask the licensee to spot-check radiation 1 4
levels in selected areas, using the licensee's own instrumentation.
However, the inspector must use NRC's instruments for independent ,
verification of the licensee's measurements. (The inspector's instruments !
- shall be calibrated and source-checked before he/she leaves the regional ;
office. ) !
If practical, observe how licensees conduct surveys to determine the {
adequacy of surveys. Also, note the types of instruments used, and I whether they are designed and calibrated for the type of radiation being '
measured.
The inspector should determine if workers take smears or instrument readings in areas that are readily accessible to facility personnel.
Particular attention should be given to counter tops, dispensing areas, desks, waste processing rooms, and storage areas. The survey activities should be at a specified frequency in accordance with the related licensee procedures. Observe how tests are analyzed and the results obtained. The inspector should also perform independent measurements, as needed to verify licensee assumptions or measurements.
- b. Leak Tests. Through discussions with licer:see personnel and/or by demonstration of leak test 3rocedures, the inspector should verify that leak tests are performec in accordance with the manufacturer's recommendations and/or license,
- c. Contamination Control. The inspector should verify that the licensee's ;
survey procedures and counting equipment are adequate to detect and !
control radionuclide contamination. The inspector may choose to examine '
the instrument calibration records (efficiency checks, lower limit of detection calculations, geometry, linearity, etc.), physical location of counting instruments, methods of detection, and wipe sample locations.
Additionally, when appropriate, the inspector should consider taking confirmatory wipe samples.
- d. Protective Clothina. If practical, the observation of the protective clothing that personnel wear during their wo'k activities should provide the inspector with an acceptable means of reviewing this requirement.
Requirements for protective clothing and other devices may be found in the licensee's procedures or on precautions posted at the entrance to controlled areas.
03.10 Rndiation Protection. Specific guidance is set forth in IP 83822." Radiation Protection."
10 CFR 19.13(b) requires that each licensee shall advise each worker annually of the worker's dose as shown in dose records maintained by the licensee. Verify through discussions with workers and management, and through records review, that the licensee has advised workers of their doses annually. The licensee must advise all workers for whom monitoring is required (and, therefore. dose records are required). The licensee must advise these workers of internal and external doses from routine operations, and doses received during planned special exposures, accidents, and emergencies. The report to the individual must be in writing and must contain all of the information required in 10 CFR 19.13(a).
87117 Issue Date: XX/XX/XX
- _ . . _ _ . ~ _ _ _ ___ _ _.__ ___- . . _ .. _ .._ __.
03.11 Paste Manaaement '
- . %1ste Storace and Disoosal. Verify that the waste is )rotected from fire and the elements, that package integrity is adequate ~y maintained that the storage area is properly ventilated and that adequate controls are in effect to minimize the risk from other hazardous materials. Veri fy 1
that the licensee has appropri6te methods to track the items in storage.
, Inspection effort should be directed at verifying that written procedures i
have been established in a manner approved by management. The procedures should be readily available to any persons having responsibility fo,r low-level waste classification and preparation for transfer of such wastes to land disposal facilities. '
For further inspection guidance, refer to IP 84850. " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61."
l b. Effluents. Examine the radioactive material release records generated since the last inspection. all annual or semiannual reports, all pertinent
! non-routine event reports, and a random selection of liquid and airborne waste release records. Although radiopharmacy's rarely release 4
radioactive liquid effluents, the inspector should determine if such
- releases occur and whether are in accordance with 10 CFR Part 20 limits.
4 i Review the licensee's ALARA goals. and determine if they are sufficiently
,~
challenging yet realistic. Determine if the licensee understands and implements these goals. Determine if the licensee has calculated annual doses resulting from air effluents and if the doses are: (1) within the
- licensee's ALARA goals (as described in its radiation protection program)
, (2) exceed the licensee's ALARA goals, or (3) uncertain because there is insufficient information or basis for determination.
Review the licensee's history in meeting ALARA goals, and their corrective ~ actions when the goals were not met.
For further :nspection guidance, refer to IP 87102.
- c. Iransfer. Ascertain if the licensee has an adequate method of determining i that recipients of radioactive wastes are licensed to receive such waste i (i.e. licensee obtains a copy of the waste recipient's current license prior to the transfer).
i d. Records. Each licensee is required to maintain records of the disposal of licensed material made under 10 CFR 20.2002-2005.10 CFR part 61, and disposal by burial in soil. These records must be retained until the ;
Comission terminates each pertinent license requiring the record. The I
! inspector should review these records to verify that disposals are made 4 in accordance with the applicable regulations. and that records are complete and accurate for each type of disposal
- e. Financial Aswrance and Decommissionina. The decomissioning record-
- keeping requirements are applicable to all materials licensees. including
, licensees with only sealed sources, and are specified in 10 CFR 30.35(g). 1 These records should contain, among other information: (1) records of spills or other unusual occurrences involving the spread of contamination in and around the facility. equipment, or site (when contamination remains after cleanup, or when contaminates may have spread to inaccessible areas, t
1
- Issue Date: XX/XX/XX 87117
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l ATTACHMENT 5 IP 87119 MEDICAL BROAD-SCOPE PROGRAMS l
~
J:.iAFT NRC INSPECTION MANUAL IM0s INSPECTION PROCEDURE 87119 MEDICAL BROAD-SCOPE PROGRAMS PROGRAM APPLICABILITY: 2800 87119-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that i
will protect the health and safety of workers and the general public.
01.02 To determine if licensed programs are being conducted in accordance with NRC requirements.
87119-02 INSPECTION REQUIREMENTS A review of the licensed activities will be commensurate with the scope of the licensee's program. A determination regarding safety and compliance with NRC requirements will be based on direct observation of work activities, interviews with workers, demonstrations by workers performing tasks regulated by NRC. and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.
In reviewing the licensee's performance. the inspector should cover the period from the last to the current inspections. However, older issues preceding the last inspection should be reviewed, if warranted by circumstances, such as incidents, noncompliance, or high radiation exposures.
Some of the following areas may not be applicable to all medical broad-scope licensees.
02.01 Preoaration. The inspector should allow adequate time to pre)are for the inspection. Preparation will include reviewing documents, macing travel arrangements, coordinating with appropriate staff, notifying appropriate State agencies, and selecting necessary equipment. In particular, the inspector shall identify whether any license amendments have been issued since the last inspection. or whether the licensee has informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensee had any incidents or events since the last inspection.
02.02 Entrance Briefina. When the inspector arrives at the licensee's facility.
he/she will inform an available senior management representative of the purpose and scope of the inspection.
Issue Date: XX/XX/XX 87119
. _, _ _ _ _ . _ _ _ _ _ ___ ~ __ __ .. __
t C2.03 General Overview l
- a. Oraanization. Interview cognizant licensx representatives about the ,
current organization of the program. Examine the licensee's organization with respect to changes that have occurred in personnel, functions. >
responsibilities, and authorities since the previous inspection. Identify ,
the reporting relationship and management structure between the licensee's executive management. the Radiation Safety Officer (RS0). the Chairperson !
of the Radiation Safety Comittee (RSC). and the other members of "'a RSC. i i b. Scope of Proaram. Interview the cognizant personnel to determine the types, quantities, and use of licensed material, frequency of use, staff i size, etc.
l
- c. Manaaement Oversicht. In the course of interviewing cognizant personnel, f determine if management oversight is sufficient to provide the licensee staff with adequate resources and authority to administer the licensed ,
4- program. l t
, 1. RSC - Review the committee meeting minutes for topics of discussion. ,
membership, frequency and attendance. Inspector should interview some RSC members to determine their involvement in the radiation safety program. l
i license: has sufficient authority, adequate assistance and support
- , of the RSC and management to ensure that radiation safety activities
i are performed in accordance with ap3 roved policies, procedures, and !
regulatory requirements; and ful fills the appropriate duties t
- comensurate with the size and scope of licensed activities. ,
! r 3'
- 3. Audits - Verify that audits are performed as required and are of sufficient detail and scope to cover all major facets of the broad a
scope program. Verify that the results of the audits are reviewed l and addressed. l l
- 4. Human RJearch Subcomittees - If licensed material is being used for l human research studies, determine whether the licensee has estab- l lished the appropriate comittees in accordance with the U. S. Food and Drug Administration criteria, e.g., Radioactive Drug .Research 4
Comittee(s) (RDRC) or Institutional Review Boards (IRB) to evaluate Verify that the appropriate committee has research requests.
reviewed current protocols.
- d. Authorized Users. Determine that only authorized individuals perform l and/or supervise licensed activities. Verify that these users are <
qualified. Also verify that authorized users perform an appropriate level of supervision, as required by the license or regulations. q 02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed I facility to make general observations of the condition of the facility and the licensed activities being performed.
02.05 Facilities. Verify that the facility conforms to that described in the ,
license application; that material receipt, use, and storage areas are secured: i and that the licensee uses processes or other engineering controls to maintain ,
doses as low as is reasonably achievable (ALARA). l
'87119 Issue Date: XX/XX/XX
02.06 Eauioment and Instrumentation
- a. Verify that equipment and instrumentation are appropriate, operable. l calibrated adequately maintained, and conform to that described in the
- license. .
- b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 CFR Part 21. ;
02.07 Materials )
- a. Receiot and Transfer of Licensed Material. Verify that the licensee is receiving packages and making transfers of licensed material in accordance with NRC and applicable U.S. Department of Transportation (00T) j regulations and license conditions. Verify that the licensee has a system ,
to account for all materials received. possessed, stored, and used to ensure compliance with possession limits. j
- b. Authorized Uses. Determine from observing the use of licensed material. l discussing the activities with licensee personnel, and reviewing records. I that the type. quantity, and use of licensed material at the licensee's facility is authorized by the license. To the extent practical, ensure by physical confirmation that the licensee's inventory is complete and accurate. l
- c. Material Security and Control. Verify that the licensee has established ,
procedures for maintaining security and control of licensed material, and l that these procedures are understood and implemented by appropriate personnel. Verify that licensed material, in storage, in controlled or unrestricted areas is secure from unauthorized removal or access. Verify that licensed material, not in storage. in controlled or unrestricted dreas is Controlled and under Constant surveillance. Verify that access to restricted areas is limited by the licensee. )
02.08 Trainina
- a. General Trainina. Verify that appropriate training and initial instructions are being accomplished as specified in the license and/or regulations,
- b. Ooeratino and Emeraency Procedures. Verify that operational procedures are being followed by observing licensee personnel perform tasks at se.lected work stations and by a c.omparison of their activities with ,
established procedures. Also examine the licensee's emergency procedures I to determine that these procedures are as approved by NRC. Through discussions with workers, verify that licensee personnel understand and implement the established procedures and are aware of procedural revisions. Document in the inspection field notes what activities the .
inspector observed.
When applicable, discuss with the licensee's representatives, or observe.
the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of radioactive material, i
- c. Soecialized Trainina. Specialized, duty-specific training is generally required for individuals involved in such activities as radioactive waste handling and processing, incinerator operations., animal research, and Issue Date: XX/XX/XX 87119
4 4
individuals attending patients receiving therapeutic quantities of
- radioactive material. Verify through discussion, observation, and record 3
review that these individuals receive the appropriate training.
! d. Radicoharmaceutical TheraDv Trainina. Verify that the licensee provides radiation safety instruction for all personnel caring for patients receiving radiopharmaceutical therapy in accordance with 10 CFR 35.310.
lb) instructions must describe the licensee's procedures for control of f
. patients visitors, contamination and waste and for notification of the 4 RS0 in case of the patient's death or medical emergency. '
i- 02.09 Area Radiation and Contamination Control l
- a. Area Surveys. Verify, during observations and by direct measurements.
that the radiation levels are within the limits of 10 CFR Part 20. and that these areas are properly posted. Confirm that area surveys are performed in accordance with 10 CFR 35.70 and procedures described in the
- license documents.
i
- b. Leak Tests. Verify that leak tests of sealed sources are performed at ths
, required frequency. Also verify that the leak test is analyzed in accordance with the license. If records of leak test results show
- contamination in excess of the regulatory requirements, verify that the
, licensee made appropr*. ate notifications and removed the source from service.
$ c. Contamination Control. Verify that the licensee performs surveys for "
removable contamination at the required frequencies, e.g. , weekly surveys -
1 for contamination control must be made in all areas where radiopharmaceut-icals are routinely prepared, administered, or stored. If t1e licensee 4 has had spills or other incidents of contamination exceeding the i licensee's action levels, verify that the licensee has taken appropriate
- actions. ,
1 d. Protective Clothina. Verify that radiation workers are provided with, and
- wear, the appropriate protective clothing, gloves, shields, etc.
- comensurate with activities being performed.
02.10 Radiation Protection
- a. Radiation Protection Proaram. Verify that the licensee has developed and i implemented a written radiation protection program commensurate with the
, licensee's activities, that the program includes ALARA provisions, and a
that the program is revived at least annually, both for content and i implementation.
1
- b. Radiation Protection Procedures. Verify that changes in the radiological protection procedures made since the last inspection are consistent with regulations and license requirements. Determine whether the licensee was required by 10 CFR 35.13 to apply for license amendments for any of these
- change.s .
i c. Instruments and Eauioment. Verify that radiation protection instruments and equipment are operable, have the proper alarm settings (if applica-ble), and are calibrated and checked for appropriate response in
- accordance with license requirements and licensee procedures, i
87119 Issue Date: XX/XX/XX
- d. External Dosimetry. Verify that personnel dosimetry devices are worn by appropriate licensee personnel. Dosimetry devices appropriate to the type. energy, or emitted radiation and the anticipated radiation fields should have been issued to facility personnel . Verify that dosimeters are i processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved and accredited processor.
Verify that pursuant to 10 CFR 19.13(b) the licensee advises each worker :
annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106. " Records of individual monitoring results." :
- e. Internal Dosimetry. Verify that measurements for internal deposition !
of licensed materials are performed and evaluated in accordance with license and regulatory requirements.
02.11 Ouality Manaaement Procram NOTE: This section is being revised by the Division of Industrial and Medical Nuclear Safety (INNS) and is being separately transmitted for coment.
02.12 Waste Manaaement
- a. Waste Storaae and Disoosal. Verify that the waste is stored and .
controlled in a secure and safe manner, and that radiation levels in unrestricted areas surrounding the storage area do not exceed the limits of 10 CFR 20.1301. Dose limits for individual members of the public."
Verify that disposal of decay-in-storage waste is performed in accordance :'
with 10 CFR 36.92 and license conditions (medical licensees .are specifically authorized to dispose of waste by decay-in-storage for waste with a half life of less than 65 days). Verify that the licensee is -
conducting appropriate surveys and defacing radioactive material labels prior to disposing of the waste, ,
Review the licensee's proceoures and records to verify that each shipment !
of radwaste intended for off-site disposal is accompanied by a shipment !
manifest that includes all the required information.
Review the licensee's procedures and records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is i labeled as appropriate, to identify it as Class A. B, or C waste, in l accordance with the classification criteria of 10 CFR 61.55 [ Subsection ,
III.A.2 of Appendix F to 10 CFR 20.1001-20.2401]. i l
- b. Effluents. Verify that effluent releases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003. respectively, and that treatment or disposal of waste by incineration is according to 10 CFR 20.2004.
Review and verify that waste-handling equipment. monitoring ecuipment, and/or administrative controls are adequate to maintain racioactive effluents within the limits established by the license and other regulatory requirements and are ALARA.
Determine the quality of the relevant procedures and the degree to which ALARA techniques are incorporated into them. Determine the extent to which process and engineering controls are used to minimize effluents.
Issue Date: XX/XX/XX 87119
l Determine whether effluent mo:11toring s.y :' ms and the associated i analytical equipment are adequate to detect and quantify effluents with sufficient sensitivity, and whether they are maintained, calibrated. and operated in accordance with manufacturer's recommendations and good health physics practices.
Determine if all significant release pathways 'are monitored. all un-monitored pathways have been characterized, and all surveillance procedures for effluents are being implemented.
Additional inspection requirements are specified in Inspection Procedure (IP) 87102. " Maintaining Effluents from Materials Facilities As Low As Is
! Reasonably Achievable (ALARA)." Verify whether EPA referral forms for air effluents have been sent to the appropriate EPA regional office, with a copy to NRC headquarters, per IP 87102
- c. Transfer. Verify that wastes are transferred to an authorized recipient specifically licensed to receive radioactive waste.
- d. Records. Verify that records of waste storage, transfer, and disposal are maintained in accordance with the requirements of 10 CFR Part 20 and the license.
- e. Financial Assurance and Decommissionino. For all licensees, including sealed source licensees, review the licensee's records of information l important to the safe and effective decommissioning of the facility.
Veri fy that the records are complete, updated, and assembled appropriately, in accordance with the requirements in 10 CFR 30.35(g).
Review the licensee's list of restricted areas required under 10 CFR 30.35(g)(3) and determine whether laboratories or other rooms have been released since the last inspection. If areas have been released. verify that the licensee has adequately decontaminated each room and documented the basis for releasing each room. Document the location of the released rooms in the field notes, and document your findings regarding the adequacy of the licensee's decontamination.
Verify whether radiological conditions at the facility have changed since the financial assurance instrument and/or decommissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents such as spills or process upsets. Unauthorized changes by the licensee to processes, types of licensed materials, possession limits. or chemical or physical forms of licensed materials may also prompt a reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect the financial assurance instrument or decomissioning plan. he/she should immediately notify regional management.
If a parent company guarantee or a self-guarantee is used to ensure l decommissioning financial assurance review the licensee's financial
, assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met,
- f. Decommissionina Timeliness. Review compliance with the Decommissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the field notes that should be completed on all inspections. If the license to conduct principal activities has expired or been revoked:
l if the licensee has made a decision to permanently cease principal 87119 Issue Date: XX/XX/XX
activities at the site or in any separate building; or if there has been a 24-month duration when no principal activit'es were conducted at the site or in any separate bui' ding, then the decommissioning timeliness requirements in 10 CFR 30.36. 40.42, 70.38, or Part 72 apply. If this is the case, complete in full the " Decommissioning Timeliness Inspection Field Notes." Attachment B to Appendix A.
02.13 Transoortation. Verify that the licensee's p ocedures and documentation are sufficient to ensure that licensed material is transported in accordaace with 10 CFR Part 71 and DOT regulations for transportation of radioactive materials.
02.14 Postino and Labelina. Verify that the licensee has posted the appropriate documents, notices forms, and caution signs as required. Also verify that containers of licensed material are labeled appropriately.
02.15 Generic Communications of Infovation. Confirm that the licensee is receiving the applicable bulletins. information notices. NMSS Newsletter, etc.
Verify that the licensee has taken aporopriate action in response to these notices.
02.16 Notifications and Reoorts. Determine compliance with the regulations and license requirements for notif1 cation and reports to NRC and individuals. Verify that the licensee is in compliance with th; cequir;~nts in 10 CFR 35.14 for medical licensees to notify the Commission about changes in the authorized user, authorized nuclear pharmacist, or RSO.
02.17 Soecial License Conditions. If applicable, review the licensee's compliance with any special license conditions.
02.18 Indeoendent and Confirmatory Measurements. Compare and verify on a sampling basis. survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this inspection procedure. unless warranted by special circumstances. If independent measurements were not made, provide a ,)ustification in the field notes explaining why independent measurements were not performed. The inspector shall use radiation detection instruments that are calibrated, at a minimum, on an annual basis.
02.19 Exit Meetina. The inspector will conduct an exit meeting with senior licensee management and the RSO to discuss the preliminary inspection findings.
These will include any apparent violations, safety-related concerns, and any unresolved items identified during the inspection. Discuss any negative Performance Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of concern. For further guidance, refer to IP 87101. " Performance Evaluation Factors."
02.20 Post Insoection Actions. After an inspection. the inspector shall i
summarize the findings with his/her appropriate NRC supervisor. This is l especially important if there are. or are expected to be, controversial issues arising from the findinas.
Inspectors shall also meet with regional licensing staff when any pertinent i licensing issues are raised during the inspection, when inspection findings impact on any licensing actions, to discuss the licensee's PEF results, or to give feedback on how the licensee has addressed recent licensing actions. This meeting shall be documented in the field notes.
Issue Date: XX/XX/XX 87119
Additionally, in some instances, insper. tion f"dMgs will warrant communication with enforcement staff. Office of Investigations staff. State liaison staff, or :'
Federal agencies with whom NRC has Memoranda of Understanding (MOUs).
The inspector will ensure that inspection findings are clearly documented and ;
reported to the licensee as appropriate. The inspector shall also follow the -
reouirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and :
Records " regarding notifying the licensee that retained information is subject '
to public disclosure and giving the licensee the opportunity to request withholding it (see IMC 0620. Section 04.06.b.).
87119-03 INSPECTION GUIDANCE General. An examination of the licensee's records should not be considered the :
primary part of the inspection program. Rather, observations of activities in progress, equipment, facilities and use areas, etc.. will be a better indicator ;
of the licensee's overall radiation safety program than a review of records
~
alone.
Some of the requirement and guidance sections of this procedure instruct the '
inspector to " verify" the adequacy of certain aspects of the licensee's program.
Whenever. possible, verification should be accomplished through discussions, observations, and demonstrations.
In the records reviewed. look for trends such as increasing doses or effluent releases. Records such as surveys, waste disposal, effluent releases, receipt and transfer of licensed materials, training utilization logs, and air sampling may be examined randomly until the inspector is satisfied that the records are i being maintained and are complete. Other records that are more closely related to health and safety (such as personnel dose-monitoring records and incident i
reports) should be examined in detail. The type of records that were reviewed .i' and the time periods covered by these records should be noted in the appropriate
" Basis for Findings" section(s) of the inspection field notes. ,
l Retain a copy of each pertinent record that is neeoed to substantiate an :
inspection finding such as a violation. Those copies shall be attached to the j inspection field notes or, when applicable, to a written inspection report. When ;
an inspector identifies an apparent violation, he/she should gather copies from !
the licensee while on-site of all records that are needed to support the apparent I
- violation. In general inspectors should use caution before retaining copies of I l licensee documents, unless they are needed to support apparent violations.
expedite the inspection (e.g.. licensee materials inventories), or make the licensing file more complete. In all cases where licensse documents are retained beyond the inspection, follow the requirements of IMC 0620. Especially ensure that the licensee understands that the retained record will become publicly available, and give the licensee the opportunity to recuest withholding the information pursuant to the requirements of 10 CFR 2.790())(1).
! The inspector should keep the licensee apprised of the inspection findings
- throughout the course of the inspection and not wait until the exit meeting.
I Whenever possible the inspector should keep NRC management informed of
! significant findings '(e.g. . safety hazards, willful violations, and other potential escalated enforcement issues) identified during the course of the l inspection.
- i l
03.01 Preoaration. Prior to the inspection, the inspector should do the following: ,
o Review the licensee's previous inspection history (at a minimum review the !
past two inspections), the license, and the status of any allegations or ;
incidents. Note the licensee *s commitments in response to previous ;
violations for follow-up during the inspectior: ;
e Review regional event / incident logs, event / incident files, and the docket file to determir.e whether the licensee was involved in any incidents, recordable events, or misadministrations. If NRC did receive notification of an incident, review that incident during the inspection and document '
the licensee's follow-up in the field notes; e- In the field notes, complete the administrative information. the !
inspection compliance history. the listing of any license amendments or program changes since the last inspection, and the description of any incidents or events that have occurred since the last inspection-e Determine the dates that the licensee submitted the most recent financial assurance instrument and decommissioning plan (if applicable): j e Discuss the licensee's program with previous inspector (s) and/or license !
reviewer (s) as necessary:
l e Prepare an inspection plan: !
e Notify the appropriate State radiation control program personnel: ,
e Review pending licensing actions: j e Obtain a map of the area and/or directions:
e Make travel arrangements and prepare itinerary; e Select calibrated instruments and perform source check; e Select appropriate documents: and j e Select appropriate equipment to take.
In selecting the appropriate documents, the inspector should consider taking the i applicable regulations, field notes, generic comunications license. NRC forms.
etc. ]
l In selecting the appropriate equipment the inspector should consider the type of I facility to be inspected. The equipment may include safety glasses, sample vials, wipes, pocket dosimeters, alarming rate meters. etc.
During the inspection, focus (among other areas) on whether the licensee is in compliance with any license amendments issued since the last inspection or with any program changes described by the licensee since the last inspection. This requires review of documentation submitted in support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.
03.02 Entrance Briefina After arriving on site the inspector should contact the RSO or radiation safety staff to arrange an entrance briefing with licensee Issue Date: XX/XX/XX 87119 l
management. This notification should be made as soon as practical after arriving on site. However, in certain instances (e.g. . unannounced inspections at hospitals which may begin at early hours before mamement arrives on site) the inspector may choose to inform the licensee of his/her presence on site after initial observations of the licensed activities currently in progress.
The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for discussing or reviewing selected inspection items with various licensee . staff personnel. However, in some instances, the inspector may only need to inform management of NRC's presence on site, and apprise management that an exit briefing will be conducted, at the end of the inspection, which will detail the inspection findings.
This is often an opportune time for the inspector to identify personnel to be '
interviewed. Scheduling interviews will enhance inspector efficiency and give the licensee the opportunity to have the most knowledgeable individuals present to respond in the areas being inspected.
Certain inspection items involving visual observrions and/or records review are better performed unannounced; therefore, these types of items should not be 4
discussed during the entrance briefing.
03.03 General Overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization. scope, and i management oversight of the radiation safety program.
- a. Oroanization. The licensee's organizational structure will usually be found in the license documents. Determine the reporting structure among executive management, the RSO. the Chairperson of the RSC. and the other members of the RSC. Determine whether the RSO has sufficient access to 1
licensee management. Through discussions with licensee staff, the inspector should determine if changes in ownership or staffing have occurred. If individuals named in the license have changed, determine whether the licensee has submitted appropriate notification to NRC. Ask licensee management if changes have occurred, or are anticipated, and ask personnel to onfirm (to the inspector's satisfaction) that no changes have taken place. If there have been no changes in the organization since the previous inspection, there is no need to pursue this element in further detail.
The inspector should review any organizational change in the RSO position, authorities, responsibilities, and reporting chains. The inspector should be sensitive to changes that reduce the ability of the RSO to resolve concerns or issues related to the safe conduct of the radiation protection program. The inspector should ask licensee management and the RSO about the RS0's authority and about any changes that may impact upon the RS0's duties, responsibilities, or effectiveness.
- b. Scooe of Proaram. Through discussions with licensee personnel, the inspector can obtain useful information about the types and quantities of
- material. frequency of use, incidents, etc. which can not always be gained by reviewing records alone. This is also an opportunity for the inspector to discern the actual size and scope of the licensee's program, and to determine if significant changes in activities have occurred since the previous inspection. To determine program scope, the information obtained should include the numbers of laboratories, permit holders, lab personnel .
87119 Tscoa nato- YY/YX/XY
e and locations of use: human research and medical use activities: and
- principal types and quantities of licensed materials used.
- c. "anaaement Oversiaht. - The inspection is a verification of the licensee's implementatio', of the required program.- In the review to verify implementatien. the inspector shouF pay particular attention to the scope of the program: frequency of. licensee audits and the use of qualified auditors: procedures for recording and reporting deficiencies to ;
, management: and methods and completion of follow-up actions by management.
generic communications, authorized users and uses, waste issues.
3 audits, misadministrations and recordable events, as defined in 10 CFR 35.2. etc. The committee should be made up of a representative .
from each type of program area. the RSO. and a representative from i
, management. The inspector should review meeting minutes (and ,
interview selected comittee members when practical) to determine the
, comittee's effectiveness. The RSC must meet at least quarterly.
i.
Determine if the RSC has been aggressive in seeking out areas needing improvement, rather than just responding to events and information from outside sources. Determine whether the committee has ,
recommended any specific actions and assess the implementation of The inspector's review should be of 4
those recommendations. 3 sufficient depth and detail to provide an overail assessment of the l comittee's ability to identify. assess, and resolve issues.
The
, inspector should also consider the effectiveness of the RSC to .
- communicate the results of audits and trending analyses to 4 appropriate personnel performing licensed activities. !
Broad-scope medical programs may be authorized to condect research i
involving the use of radioactive drugs or radiation-emitting devices in humans. Such research may require TDA approval. In addition, approval to conduct research studies alsu requires input from an i Institutional Review Board (IRB). a Radioactive Drug Research i Committee (RDRC) or other appropriate comittee(s), including the 4
RSC. The inspector should confirm that the licensee has received FDA 4
, approval, if required, and that studies involving the use of radioac- .
tivity in humans have been reviewed by the appropriate comittee(s).
, The inspector should review the interaction between the RSC and the IRB and/or RDPsC to assure that patient safety, ethical :
considerations. and scientific merit are examined. ,
i
- identified on the license, who is responsible for implementing the
! radiation safety program. The inspector should verify that this '
individual is knowledgeable about the program, and ensures that activities are being performed in accordance with approved procedures and the regulations. The inspector should verify that, when deficiencies are identified, the RSO has sufficient authority. .
, without prior approval of the RSC. to implement corrective actions.
, including termination of operations that pose a threat to health and
- safety. ,
The RS0 should be supported by a staff of health physics professionals who assist in the maintenance and control of the licensed program. The number and qualifications of these ,
i, professionals will vary with the size of the program. The inspector.
Issue Date: XX/XX/XX 87119 i
should, through observation and interviews with staff. evaluate
'y whether staffing is sufficient to adequately administer the program.
- 3. Audits - The frequency and scope of audits of the licensed program will vary. However, note that at a minimum, medical institution licensees are required by 10 CFR 20.1101(c) and 10 CFR 35.32(b)(1) to review the radiation safety program content, implementation, and Quality Management Program at least annually. The results of audits should be documented. Examine these records with particular attention to deficiencies identified by the auditors, and note any corrective actions taken as a result of deficiencies found. If no corrective actions were taken, determine why the licensee disregarded deficiencies identified during audits, and whether the lack of corrective actions caused the licensee to be in non-compliance with regulatory requirements.
- d. Authorized Users. Authorized users of licensed material for non-human use are generally designated by the RSC. The inspector should review the process of approving users through interviews with users. RSC members, and the RSO. The procedure for designating users can be found in the license documents. Authorized users of licensed material for medical purposes and human research may either be named in the license or designated by the RSC. For those designated by the licensee verify that the authorized user received training in accordance with approved criteria and/or 10 CFR Part 35, and has knowledge commensurate with operational duties.
The regulations in 10 CFR 35.11(b) allow an individual to receive, possess, use. or transfer byproduct material for medical use "under the supervision of" the authorized user, unless prohibited by license condition. These regulations do not specifically require that the authorized user be present at all times during the use of such materials.
The authorized user / supervisor is responsible for assuring that personnel ender his/her supervision have been properly trained and instructed.
pursuant to 10 CFR 35.25(a) and is responsible for the supervision of operations involving the use of radioactive materials whether he/she is present or absent.
03.04 Walk-Throuah Orientation Tour. The inspector should make initial observations of licensed activities to determine that materials are being safely handled and that good health physics practices are followed. The inspector should look at areas of receipt. use, storage, and disposal to make an initial assessment of the licensee's ALARA program with regard to facility design, engineering controls, house-keeping practices, etc.
During the course of the inspection, the inspector should randomly visit a number of research laboratories to observe workers using all types and quantities of licensed material. This is an excellent time to ask workers to demonstrate certain procedures or to observe activities in an effort to evaluate the effectiveness of the licensee's training program. The inspector should ensure that observations of activities are documented in the inspection field notes.
03.05 Facilities. Descriptions of the facilities are generally found in the application for a license and subsequent amendments that are usually tied down to a license condition. The actual or as-built facility should be configured to provide safe working areas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry. The inspector should also be aware of potential industrial safety hazards, for referral to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA).
87119 Issue Date: Xy/XX/XX
i
- 03. 0t; Eauioment and Instrumentation i a. Equipment and instrumentation should be approprise to the scope of the licensed program. The inspector should verify that survey instrumentation J
has the approoriate range of use. The inspector should also verify that the survey instruments are celibrated at the appropriate frequency and checked "or operability prior to use. All survey, sampling, and.
monitoring instruments should have current calibrations appropriate to the types and energies of radiation to be detected. The technical adequacy
. of calibration procedures at facilities that perform their own
. calibrations should be examined. Processing equipment, fume hoods.
ventilation. and exhaust systems should be sufficient to provide safe use.
handling. and storage of the materials in use.
l
- b. The inspector should determine if dose calibrators for ahoton-emitting
- radionuclides and equipment used to assay alpha- anc beta-emitting radionuclides are possessed, used. and tested at the appropriate
. intervals. in accordance with 10 CFR 35.50 and 35.52 respectively, and the licensee's procedures: and if appropriate actions are taken when
- errors are identified. Tests to be conducted are linearity, geometric i dependence, accuracy, and constancy.' If generators are used. determine j that each eluate / extract used for radiopharmacy is tested for molybdenum-3 99 breakthrough in accordance with 10 CFR 35.204. Also determine that l vials and syringes are properly idoeied and shielded per 10 CFR 35.60 and 35.61. respectively.
, c. Inspectors should verify that licensees have procedures for reporting 1
- defects in accordance with 10 CFR Part 21. The complexity of the j procedures will vary.
03.07 Materials
- a. Receiot and Transfer of Licenced Materials. Depending on the size of the i licensed program, the packaoe receipt and transfer procedures (a few or many) will be found in the license application. These procedures should ,
be carefully reviewed before an inspection is conducted. By discussions '
with the licensee determine if the procedures have been changed or modi fied. Some changes may require a license amendment, whereas other minor changes (updating telephone numbers, editing procedures for clarity, etc.) may not require NRC approval. Randomly examine procedures used by '
the licensee to determine if they are in accordance with those identified in the license application, or if they warrant a license amendment. If procedural changes have occurred. verify that they were approved by the RSC.
The procedures for picking up. receiving, and opening packages should include how.and.when packages will be picked up, radiation surveys and wipe tests of packages to be done on receipt. and procedures for opening !
packages (such as the location in the facility where packages are !
received surveyed, and opened). The procedures also should include what actions are to be taken if surveys reveal packages that are contaminated !
in excess of specified limits, and/or radiation levels that are higher
~
than expected. If packages arrive during the course of an inspection, the ,
inspector should observe. when practical, personnel perform the package .
receipt surveys.
The inspector should randomly examine records of package surveys and also determine if inventorics for each radionuclide are within the license Issue Date: XX/XX/XX 87119 ;
l l limits. In this regard, records of inventories after receipt and transfer
! should indicate / demonstrate that the materials on hand at any one time are i within the licensee's possession limit. When practical, the records :
, examined should be compared with a physical inventory of the materials l possessed.
The licensee should have an accounting system that suits the type of I l licensed program. For example, a relatively small facility will generally J l need to maintain receipt records. disposal records, and records of any l l transfers of material. However, a large facility will need a i sophisticated accounting system for all licensed material that provides l accurate information on the receipt. location. the quantity used and l l disposed of, the amount transferred to other laboratories operating under 1 the same license, and the amount remaining after decay. The accounting l systems should also consider licensed material held for decay-in-storage. !
near-term disposal, or transfer to other licensees. In both types of I accounting systems. the licensee should perform routine physical audits. l l to ensure the accuracy of the system. l 1
- b. Authorized Uses. Authorized uses of radioactive material will be found ;
in the license and referenced license documents. Licenses list the isotopes, physical form, and the maximum possession limit. The inspector should physically examine the inventory of radioactive material on hand or examine records of receipt and transfer to determine that possession limits have not been exceeded. Additionally. the inspector should verify that the licensee's use of licensed material (i .e. , cell labeling, iodinations, animal research) is limited to that which is authorized in the license.
l c. Material Security and Control. Examine areas where licensed materials are used and stored. Storage areas should be locked and have limited and controlled access. Licensed material use areas should be under constant surveillance or physically secured. The licensee should have procedures for access controls. Controls may include a utilization log to indicate when licensed material is taken from and returned to storage areas. The I inspector should verify that adequate controls are in place and working effectively.
03.08 Trainino
- a. General Trainina. Certain kinds of training and instruction are found in the regulations; how they are implemented will be found in the license. l Discuss with the licensee now, and by whom training is conducted and the content of the training pr3vided to workers (generally found in the license application).
, Verify pursuant to 10 CFR 19.12 that initial instructions have been l l given to individuals who in the course of employment are likely to receive l l in a year an occupational dose in excess of 100 mrem (1 mSv). Under the l
basic instructions. it is management's responsibility to inform the .l
- workers of precautions to take when entering a restricted area kinds and l uses of radioactive materials in that area. exposure levels, and the types of protective equipment to be used. The workers should also be informed of the pertinent provisions of NRC regulations and the license, and the requirement to notify management of conditions observed that may, if not corrected, result in a violation of NRC requirements. Also verify that ;
authorized users and workers understand the mechanism for raising safety '
concerns, 87119 Issue Date: XX/XX/XX
such as seepage into concrete >: (2) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and locations of possible inaccessible contamination (e.g., buried pipes): (3) except for areas with only non-leaking sealed sources or byproduct materials with half lives of less than 65-days, a single document detailing restricted areas and formerly restricted areas, buried waste. areas requiring decontamination that are outside of restricted areas. and areas outside of restricted areas that, if the license expired, would have to be decontaminated or approved for disposal: and (4) records of the cost estimate performed for a decomissioning funding plan or the amount certified for decomissioning.
This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). On all inspections, including inspections of sealed source licensees. the inspector should ensure that the licensee has such decommissioning records. that the records are complete. that they are updated as required, and that the decommissioning records are assembled or referenced in an identified location.
Some licensees may release laboratories or other rooms within a building for unrestricted use, without a license amendment. The release of these areas may fall outside of the reporting requirements in the Decomissioning Timeliness Rule if the licensee continues to conduct other activities in the same building. Inspectors should identify the rooms that have been released since the last inspection and perform confirmatory measurements to verify that radiation and contamination levels are below release limits. Licensee survey records and other documentation should be reviewed to verify that the basis for releasing each room is adequately documented in the licensee's decomissioning records.
Licensees submit financial assurance instruments and/or decomissioning plans for a specific set of conditions. Occasionally. those conditions may change over time and the licensee may not notify NRC. The inspector should be aware of changes in radiological conditions while inspecting a licensee's facility that would necessitate a change in the financial assurance instrument and/or decomissioning plan, especially where the radiological conditions deteriorate and the financial assurance instrument or decomissioning plan may no longer be sufficient. In preparation for the inspection. the inspector should determine the dates that the financial assurance instrument and decomissioning plan (if applicable) were submitted to NRC. Then during the inspection, through observations, discussions with licensee 3ersonnel, and records review, the inspector should determine whether tie radiological conditions at the licensee's facility have changed since the documents were submitted to NRC. If conditions have changed and the adequacy of the financial assurance instrument and/or decommissioning plan is in doubt, the inspector should imediately contact regional management from the licensee's site to discuss the situation.
Additionally, some licensees are required to maintain decomissioning cost estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as a funding method, the inspector should verify that the licensee has a Certified Public Accountant certify each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in Section II. Appendix A and Appendix C. respectively, to 10 CFR Part 30.
- f. Decomissionina Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license remains 87117 Issue Date: XX/XX/XX
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radiation levels, safety related equipment failure, etc. Additionally. some !
licensees are required to make annual reports to NRC.
Through discussions with licensee personnel, and by a review of representative records, the inspector should verify that notifications and/or reports were appropriately submitted to NRC. .
1 03.16 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of ;
equipment used by the licensee. In these instances, the inspector should varify !
that the licensee understands the additional requirements, and maintains compliance with the special license conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC .
requirement. l 03.17 Indeoendent and Confirmatorv Heasuremgnis. The inspector should perform I independent and confirmatory measurements in restricted and unrestricted areas l of the licensee's facility. Independent measurements should be performed on ali i inspections, unless exceptional circumstances make it impossible to perform the I measurements (e.g. , inspector's detection equipment malfunctions during an inspection trip). Heaturements of dose rates at the boundary of the unrestricted areas should be performed at the surface of the most accessible plane. Examples of measurements that may. be performed include area radiation surveys wipe samples, soil samples. leak tests. air flow measurements, etc. These I measurements should be taken in licensed material use areas. storage areas, i effluent release points, etc. Confirmatory measurements are those whereby the inspector compares his/her measurements with those of the licensee's. .
Independent measurements are those performed by the inspector independently of !
the licensee's measurements. To perform the independent or confirmatory ,
measurement, use NRC radiation detection equipment that is calibrated, at a I minimum, on an annual basis.
03.18 Exit Meetina. When the inspection is over, there should be an exit meeting with the most senior licensee representative present at the facility.
If a senior management representative is unavailable for the exit meeting, the inspector may hold a preliminary exit meeting with appropriate staff on site.
However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO. if not present at the preliminary exit meeting) as soon as practical after the inspection. This meeting will usually be held by telephone conference call.
During the exit meeting, the licensee representatives should be told the preliminary inspection findings -- including any negative PEFs. apparent violations of regulatory requirements, safety related concerns, or unresolved items identified during the inspection -- and the status of any previously identified violations. The licensee must immediately address any sighificant safety concerns.
If the inspector identifies safety concerns or violations of significant regulatory requirements that~ affect safe operation of a licensee facility, the licensee must initiate prompt corrective action. The inspector should not leave the site until the licensee fully understands the concern and has initiated corrective action. If the inspector and the licensee disagree over how significantly the concern impacts continued safe operation of the facility, regional management should be notified inmediately.
While deficiencies identified in some areas (e.g. , workers' knowledge of the Part 20 requirements) are not always violations. the inspector should bring such Issue Date: XX/XX/XX 87117
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such as seepage into concrete): (2) as-built drawings and modifications j of structures and equipment in restricted areas where radioactive ;
materials are used and/or stored, and locations of possible inaccessible ;
contamination (e.g. , buried pipes): (3) except for areas with only non- j leaking sealed sources or byproduct materials with half lives of less than !
65-days, a single document detailing restricted areas and formerly i restricted areas, buried waste, areas requiring decontamination that are l outside of restricted areas. and areas outside of restricted areas that. l if the license expired. would have to be decontaminated or approved for )
disposal; and (4) records of the cost estimate performed for a decommissioning funding plan or the amount certified for decommissioning.
4 This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). On all inspections, including inspections of sealed source licensees, the inspector should ensure that the licensee has such decomissioning records. that the records are complete. that they are i updated as required, and that the decomissioning records are assembled 4
or referenced in an identified location.
- Some licensees may release laboratories or other rooms within a building !
for unrestricted use without a license amendment. The release of these
- areas may fall outside of the reporting requirements in the Decomissioning Timeliness Rule if the licensee continues to conduct other activities in the same building. Inspectors should identify the rooms that have been released since the last inspection and perform confirmatory measurements to verify that radiation and contamination levels are below '
release limits. Licensee survey records and other documentation should !
be reviewed to verify that the basis for releasing each room is adequately l documented in the licensee's decommissioning records. ]
Licensees submit financial assurance instruments and/or decommissioning i
- plans for a specific set of conditions. Occasionally, those conditions l
- may change over time and the licensee may not notify NRC. The inspector ;
- should be aware of changes in radiological conditions while inspecting a l
- licensee's facility that would necessitate a change in the financial j
- assurance instrument and/or decomissioning plan, especially where the j
^
radiological conditions deteriorate and the financial assurance instrument '
a or decomissioning plan may no longer be sufficient. In preparation for
- the inspection, the inspector should determine the dates that the
- financial assurance instrument and decommissioning plan (if applicable) were submitted to NRC. Then during the inspection, through observations.
discussions with licensee wrsonnel, and records review. the inspector should determine whether tie radiological conditions at the licensee's facility have changed since the doceents were submitted to NRC. If
~ '
conditions have changed and the adequacy of the financial assurance instrument and/or decomissioning plan is in doubt, the inspector should immediately contact regional management from the licensee *s site to i discuss the situation.
4 Additionally, some licensees are required to maintain decomissioning cost 4
estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as a funding method, the inspector should verify that the licensee has a Certified Public Accountant certify 4
each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in Section II. Appendix A and Appendix C. respectively, to 10 CFR Part 30.
4
- f. Decomissionina Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license remains !
87117 Issue Date: XX/XX/XX
in effect determine if the licensee nos made a decisipn t'on.cp principal activities at the site or in any separate building ' ort '
ares, ircluding burial grounds. Finally, determina if there has been a' 24-month duration in which no principal activities have been conducted in such areas. A principal activity is one which is essential to the purpose for which a license was issued or amended, and does not include storage incidental to decontamination or decomissioning. If the licensee meets any of the above conditions. the decommissioning timeliness requirements apply, and the inspector must complete the " Decommissioning Timaliness -
Inspection Field Notes." Attachment A to Appendix A.
The requirements of 10 CFR 30.36, 40.42. and 70.38 do not apply to released rooms within a building where principal activities are still on- !
going in other parts of the same building. However, in those cases the inspector should follow the guidance in 03.11.e. regarding confirmatory measurenents of the released area. Once principal activities have ceased in the entire building. then the decomissioning timeliness requirements
. will take effect. ,
The Decomissioning Timeliness Rule became effective on August 15. 1994.
In completing the Attachment A field notes, specific guidance is needed ,
regarding the timing of the notification requirements. If the license has !
expired or been revoked, or if the licensee has made a decision to permanently cease principal activities, and the licensee orovided NRC l notification before Aucust 15. 1994, then August 15, 1994 is considered to be the date for initiating the decomissioning calendar (i.e.. date of noti fication). If there has been a 24-month duration in which no principal activities have been conducted at the location before the effective date of the rule. but the licensee did not notify NRC then the 24-month time period of inactivity is considered to be initiated on August
- 15. 1994, and the licensee must provide notification to NRC within either 30 or 60 days of August 15.1996 (depending on whether the licensee -
requests a delay). i There is an exemption to the decomissioning ti'=N5s requirements. The provisions in the Decomissioning Timeliness Rule in 10 CFR 40.42(d)(4) i for the 24-month pcriod of inactivity. 40.42(f) for the content of the .
decomissioning plan, and 40.42(g) for the timing of completion of the l plan do not apply to the reclamation of waste disposal areas and/or ;
tailings impoundments at uranium recovery facilities and thorium mills. !
l NRC has a stringent enforcement policy with respect to violations of the decomissioning timeliness requirements. Failure to comply with the Decomissioning Timeliness Rule (failure to notify NRC failure to meet decomissioning standards, failure to complete decomissioning activities in accordance with regulation or license condition, or failure to meet required decomissioning schedules without adequate justification) may be classified as a Severity . Level III violation and may result in consideration of monetary civil penalties or other enforcement actions. !
as appropriate. i Decomissioning timeliness issues can be complex. For situations where an inspector has questions about the licensee's status and whether the decomissioning timeliness standards apply, he/she should immediately contact regional management.
For planning and conducting inspections of licensees undergoing decomissioning, refer to IMC 2602. " Decommissioning Inspection Program Issue Date: XX/XX/XX 87117
l for Fuel Cycle Facilities anu Materials Licensees:
IP 87104
" Decommissioning Inspection Procedure for Materials Licensees:" and the dr:ft Decomissioning Manual Chapter and Handbook.
03.12 Transoortation. The inspector should review: the licensee's hazardous material training: Jackages and associated documentation: vehicles (including i placarding. cargo ) locking, and bracing. etc.); shipping papers; and any incidents reported to DOT. This is an ideal area for the inspector to make observations of the licensee's drivers / couriers practices. The DOT and NRC regulations for transportation of radioactive materials were recently revised, and the revisions generally became effective April 1.1996.
For further inspection guidance, refer to IP 86740 " Inspection of Transportation I Activities." Inspectors should also refer closely to " Hazard Communications for I Class 7 (Radioactive) daterials." the NRC field reference charts on hazard communications for transportation of radioactive materials, which contain references to the new transportation requirements, and are useful field references for determining compliance with the transportation rules on labeling.
placarding, shipping papers, and package markings. '
03.13 Postina and Labelina. The inspector should determine whether proper caution signs are being used at access points to areas containing licensed materials, radiatinn areas, and those areas containing airborne radioactive materials. 10 CFR 20.1903 provides exceptions to posting caution signs. When applicable, the inspector should also randomly examine signals and alarms to determine operability. The inspector should also randomly observe labeling on packages or other containers to determine that proper information (e.g. , isotope, quantity, and date of measurement) is recorded.
Areas with radiation hazards should be conspicuously posted, as required by 10 i 2
CFR 20.1902. Depending on the associated hazard. controls may include tape. !
, rope, or structural barriers to prevent access. If vol3 tile licensed materials '
are used in an area. such an area should be controlled for airborne
. contamination. High radiation areas should be strictly controlled to prevent unauthorized or inadvertent access. Such controls may include, but are not limited to direct surveillance. locking the high radiativ. area, warning lights, and audible alarms. Areas occupied by radiation workers for long periods of time 4
and comon-use areas should be controlled in accordance with licensee procedures i and be consistent with the licensee's ALARA program.
The inspector should also examine locations where notices to workers are posted. I Applicable documents, notices. or forms should be posted in a sufficient number of places to permit individuals engaged in licensed activities to observe them on the way to or from any particular licensed activity location to which the postings would apply. 4 03.14 Generic Comunications of Information. Through discussions with licensee
- management and the RSO. the inspector should verify that the licensee is receiving the applicable bulletins, information notices. NMSS Newsletter, etc.,
, and that the information contained in these documents is disseminated to appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC comunications, when a response is required.
03.15 Notifications and Reoorts. The inspector should determine the licensee's compliance for notifications and reports to the Comission. For example.10 CFR
. 32.72 requires the licensee to notify the Comission within 30 days of approving an ANP as user of licensed material. The licensee may be required to make notifications after loss or theft of material, overexposures, incidents. high 87117 Issue Date; XX/XX/XX
iddlation levels, safety related equipmerit failure. etc. Additionally, some licensees are required to make annual reports to NRC.
Through discussions with licensee personnel, and by a review of representative records, the inspector should verify that notifications and/or reports were appropriately submitted to NRC.
03.16 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of equipment used by the licensee. In these instances. the inspector should verify that the licensee understands the additional requirements, and maintains compliance with the special license conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC
~
requirement.
1 03.17 Indeoendent and Confirmatory Measuremfats The inspector should perform independent and confirmatory measurements in restricted and unrestricted areas of the licensee's facility. Independent measurements should be performed on all inspections, unless exceptional circumstances make it impossible to perform the measurements (e.g. , inspector's detection equipment malfunctions during an inspection trip). Measurements of dose rates at the boundary of the unrestricted areas should be performed at the surface of the most accessible plane. Examples of measurements that may. be performed include area radiation surveys, wipe samples, soil samples.. leak tests, air flow measurements. etc. These measurements should be taken in licensed material use areas storage areas, effluent release points, etc. Confirmatory measurements are those whereby the inspector compares his/her measurements with those of the licensee's.
Independent measurements are those performed by the inspector independently of the licensee's measurements. To perform the independent or confirmatory measurement, use NRC radiation detection equipment that is calibrated, at a minimum, on an annual basis.
03.18 Exit Meetina. When the inspection is over, there should be an exit meeting with the most senior licensee representative present at the facility.
If a senior management representative is unavailable for the exit meeting. the inspector may hold a preliminary exit meeting with appropriate staff on site.
However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO. if not present at the preliminary exit meeting) as soon as practical after the inspection. This meeting will usually be held by telephone conference call.
During the exit meeting, the licensee representatives should be told the preliminary inspection findings -- including any negative PEFs. apparent violations of regulatory requirements, safety related concerns, or unresolved items identified during the inspection -- and the status of any previously identified violations. The licensee must immediately address any significant safety concerns. j If the inspector identifies safety concerns or violations of significant regulatory requirements that affect safe operation of a licensee facility. the licensee must initiate prompt corrective action. The inspector should not leave the site until the licensee fully understands the concern and has initiated corrective action. If the inspector and the licensee disagree over how k significantly the concern impacts continued safe operation of the facility.
regional management should be notified imediately.
While deficiencies identified in some areas (e.g. , workers' knowledge of the Part 20 requirements) are not always violations, the inspector should bring such 1
Issue Date: XX/XX/XX 87117 ;
deficienc;as to the attention of licensee a.anagement at the exit meeting and also in the cover letter transmitting the inspection report or NOV.
03.19 Post Insoection Actions. Regional office policy will dictate with whom the inspector will review his or her inspection findings (e.g. , the inspector's supervisor), following the guidance in IMC 2800. " Materials Inspection Program."
The inspector should discuss the findings m the detail that is commensurate with the scope of the licensee's program. Violations items of concern (e.g. ,
negative PEFs), and unresolved items should be discussed in sufficient depth for management to make appropriate decisions regarding enforcement actions, referral to other State and Federal agencies, and decisions on the scheduling of future :
inspections of the licensee's facility. l The inspector should also discuss ins)ection findings with licensing staff. This information exchange can be particu'arly useful if the licensee is having its license renewed or has recently submitted a license awndment request. The inspector should inform licensing staff about how the licensee has addressed (or failed to address) special license amendments or recent licensing actions.
Licensing information requested by the licensee should also be discussed with the
- licensing staff.
Inspectors should be aware that NRC has entered into several MOUs. with other Federal agencies, that outline agreemets on items such as exchange of information and evidence in criminal proceedings. The inspect::r should ensure that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.
The inspector may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following the guidance in IMC 2800. The inspector must also ensure that the findings are ,
documented in the inspection field notes and/or inspection report, in sufficient i detail for the reader to determine what requirement was violated. how it was .
violated, who violated the requirement, and when it was violated. Copies of all licensee documents needed to support the violation should be attached to the .
inspection field notes and/or inspection report. The field notes should not be l used as merely a checklist to note areas reviewed. It should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the inspection, and any items of concern identified that were not cited as a violation of regulatory requirements.
Inspectors may complete the field notes either by hand or electronically. If the inspector is documenting the field notes in eledronic format, the sub-items under major sections that are not applicable or not reviewed my be deleted.
However, the heading itself (e.g., " Radioactive Waste Management." or I
" Transportation") should remain in the field notes, and the inspector should enter a)propriate remarks about why the section is not applicable or not reviewec .
For further inspection guidance. refer to Section 07.04 of IMC 2800.
87117-04 REFERENCES A listing of IMCs and IPs applicable to the inspection program for materials licensees can be found in Section 2800-11 of IMC 2800. Inspectors are to use these documents as guidelines in determining the inspection requirements for operational and radiological safety aspects of various types of licensee activities.
87117 Issue Date: XX/XX/XX
f iSpecific references to . regulatory requirements can be found in the i
" Radiopharmacy Inspection Field Notes" appendix, following this IP.
END i Appendix: ,
Al " Radiopharmacy Inspection Field Notes"
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1 Tccesa nato. YY/YY/YY . 71 . R7117
m._ 1Ma4 - a m , . - - -a u - - - - - ean s- - -
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DBAFT ATTACHMENT 3 APPENDIX A !
l RADIOPHARMACY INSPECTION FIELD NOTES
. . . . . . . . . . - . . . - - . . - . . ~ - - .- -
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APPENDIX A RADI0 PHARMACY INSPECTION FIELD NOTES h Region Inspection Report No. License No.
Licensee (Name & Address): Docket No.
Licensee Contact Telephone No. __
Amendments Issued Since Last Inspection:(Numbers)
Dates of Above Amendments Priority Program Code Date of Last Inspection Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced
( ) Routine ( ) Special
( ) Initial ( ) Reinspection Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended Justification for change in normal inspection frequency:
Summary of Findings and Action:
( ) No violations, Clear NRC Form 591 or regional 1etter issued -
( ) Violation (s). NRC Form 591 issued
( ) Violation (s), regional letter issued
( ) Follow-up on previous violations Inspector Date (signature:-
Approved Date (Signature)
Issue Date: XX/XX/XX A-1 87117 Appendix A
Field notes are to be used by the inspector to assist with the performance of the inspection. Note that all areas indicated in the field notes are not required to be addressed during each inspection. However, for those areas not covered during the inspection. 3 notation ("Not Reviewed") should be made in each section where applicable. Additionally. all areas covered during the inspection should be docurnented in sufficient detail to describe
- what activities and/or records the inspector observed. For exanple, the types of records that were reviewed and the time periods covered by these records should be.noted in the approprfate " Basis for Findings" section(s).
If the licensee denonstrates any practices at your request, describe those denonstrations. The observations and denonstrations you describe in this report. along with measurenents and some records review. Should substantiate your inspection findings.
NOTE: For inspections of pharmaceutical processors, use IP 87111. " Materials Processor Programs." and complete all applicable sections of IP 87111.
Attachment A. "Radiopharmaceutical Processor Inspection Field Notes."
- 1. INSPECTION. LICENSING. AND INCIDENT HISTORY A. Violations were identified during any of the last two inspections or two years.
w'lichever is longer (N/A = Initial insp.) ( ) N/A ( ) Y ( ) N B Response letter (s) or NRC Form 591(s) dated C. Violations from previous incoection(s):
REQUIREMENT CITED STATUS D. Any repeat violation (s) identified? ()Y()N If "Yes." explain:
87117. Appendix A A-2 Isda Date: XX/XX/XX
E. License amendments issued since last inspection or program changes noted in the license:
AMENDMENT # DATE SUBICT F. During this inspection..was the licensee's implementation of all of the above amendments or program changes inspected / observed? ( ) N/A ( ) Y ( ) N G. During this inspection, were any violations identified involvinc any of the above amendments or progr5m changes? ( ) N/A ( ) Y ( ) N H. List any incidents or events reported to NRC since the last inspection (Note: "None" indicates that regional event logs, event files, and the licensing file have no evidence of any incidents or events since the last inspection): ( ) None INCIDENT OR EVENT l
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Issue Date: XX/XX/XX A-3 87117, Appendix A
. .. ~_ - _ - - . . _ - . . - _ _ - .. - . ... ... - . . - . . _. . - - - .
t E
I. During this inspection, were the incidents / events reviewed with the
< licensee and was the licensee's follow-up l
to the incidents / events examined? ( ) N/A ( ) Y ( ) N J. Describe the licensee's follow-up .in response to the events / incidents listed in 1.H.:
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Basis for' Findings: i l
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- 2. ORGANIZATION AND SCOPE OF PROGRAM 3
A. Describe the licensee's organizational structure to indicate the
" chain-of-comand" from senior licensee management to authorized t users of licensed material. Show where the RSO is located in the j licensee's organization and to whom he/she reports.
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87117. Appendix A A-4 Issue Date: XX/XX/XX
i
- B. Identify licensee personnel contacted during the inspection i (including those individuals contacted by telephone).
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.I Use-the following identification symbols.
- . # Individual (s) present at entrance meeting
- Individual (s) present at exit meeting l
+ Individual (s) contacted by telephone ,
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C. Authorized for multiple locations of use ( ) N/A ( ) Y ( ) N ]
, If "Yes." list office locations inspected ,
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l O. Briefly describe scope of activities, including types and quantities of use involving licensed material. frequency of use, staff size, i
number of customers served. number of doses dispensed per day, work hours. etc.
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I F. . Licensee distributes / redistributes (1) Sealed sources ()Y()N i (2) Alpha and beta emitters ()Y()N (3) Generators ()Y()N (4) Photon emitters ()Y()N F. Licensee registered / licensed by FDA/ State Agency as a drug manufacturer or a nuclear pharmacy ()Y()N If "Yes." is registration / license current? ()Y()N Issue Date: XX/XX/XX A-5 87117. Appendix A
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- 3. MANAGEMENT OVERSIGHT A. Radiation Safety Officer (RS0)
! (1) Authorized on license [L/C] ()Y()N i (2) Fulfills duties as RSO [L/C] ()Y()N ,
(3) Has sufficient authority [L/C] ()Y()N B. Audits. Reviews. or Inspections (1) Audits are required [L/C]- ()Y()N 4
(2) Audits or inspections are conducted ()Y()N Audits conducted by i Frequency i Scope of audits ,
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(3) Deficiencies identif'.1 and addrassed [L/C] ()Y()N )
, (4) Content and implementation of the radiation 4
protection program reviewed annually by the licensee [20.1101(c). L/C] ()Y()N (5) Records of reviews maintained [20.2102] ()Y()N C. Use/ Preparation of licensed material by authorized individuals
' 1 l (1) ANP must meet at least one criteria [32.72(b)] !
i (a) Qualifies as nuclear pharmacist as defined in 35.2
[32.72(b)(1)]
(i) Identified as ANP on NRC or Agreement l State nuclear pharmacy license ()Y()N
- (ii) Identified as ANP on NRC or Agreement State Broad Scope License Permit ()Y()N (b) Listed on license [32.72(b)(2)(1)] ()Y()N (c) Grandfathered - Listed as authorized user on.a nuclear pharmacy license issued by NRC prior to 12/2/94 [32.72(b)(4)] ()Y()N (2) Drugs are prepared by ANP or individual under the supervision of an ANP [32.72(b)(1)] ()Y()N (3) Sufficient number of ANPs on staff to cover all shifts ()Y()N 87117. Appendix A A-6 Issue Date: XX/XX/XX
(4) - Licensee provided NRC documentacion to support ANP's credentials within 30 days after individual ;
started work as ANP [32.72(b)(5)] ( ) N/A ( ) Y ( ) N i i
Basis for Findings: !
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! 4. . FACILITIES j t
A. Facilities as described in license application
- 3. [30.33(a)(2), L/C] ()Y()N . ,
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B. Engineering Controls ,
3 I l (1) Licensee uses process or other engineering ;
controls for volatiles / gases in storage
[20.1701. L/C] ()Y()N (2) Maintenance program implemented for engineering l controls (negative pressure. ventilation rates. !
filter changes, etc.) [L/C] ()Y()N 1 (3) Ventilation rates in accordance with license limits [L/C] ( ) N/A ( ) Y ( ) N (4) Frequency air filtration system checked Basis for Findings: l l
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- 5. EQUIPMENT AND INSTRUMENTATION l A. Dose Calibrator - Photon-emitting radionuclides (1) Possessed and used [32.72(c)] ()Y()N t (2) Calibration procedures developed and followed !
[32.72(c)] .
()Y()N l (3) Constancy [32.72(c)(2). L/C] ;
a (a) Performed daily prior to use ()Y()N l (b) Dedicated check source used ()Y()N ,
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'Not applicable if licensee has obtained a license amendment listing !
individual as ANP [35.72(b)(2)(ii)] -
l Issue.Date: XX/XX/XX A-7 87117 Appendix A
, (4)- Accuracy-[32.72(c)(1). L/C] '
(a) Performed at installation, after repair 1
and annually ()Y()N (b) At least 2 sealed sources used ()Y()N
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(5) Linearity [32.72(c)(1). L/C]
^
(a) Performed at installation, after repair and quarterly ()Y()N (b) Tested over range of use ()Y()N (6) Geometry dependence [32.72(c)(1). L/C]
-(a) Performed at installation or after repair ()Y()N (b) Includes range of volumes and volume configurations used ()Y()N
! (7) Dosage readings mathematically corrected for i linearity errors greater than 110% [L/C]( ) N/A ( ) Y ( ) N
- (8) Dosage readings mathematically corrected for geometry errors greater than t2% [L/C] ( ) N/A ( , Y ( ) N i (9) Repaired or replaced when constancy or accuracy errors exceeded 10% [L/C] ( ) N/A ( ) Y ( ) N (10) Records maintained [L/C] ()Y()N
- 3 B. Instrumentation - Alpha or beta et.itting radionuclides ( ) N/A
, (1) List type of equipment used to assay alpha and beta emitting radioisotopes:
i i
. (2) Calibration procedures developed and followed
[32.72(c)] ()Y()N (3) Constancy / proper operation performed daily ;
prior to use [32.72(c)(2)] ()Y()N (4) Accuracy performed at installation, after ,
repair, and periodically [32.72(c)(1). L/C] ()Y()N '
l (5) Linearity performed at installation, after repair, and periodically [32.72(c)(1). L/C] ()Y()N
< (6) Geometry dependence [32.72(c)(1). L/C] ( ) N/A (a) Performed at installation, after repair, and periodically ()Y()N (b) Includes range of volumes and volume configurations useo ()Y()N 87117. Appendix A A-8 Issue Date: XX/XX/XX
1 I
i (7) Appropriate action taken when calibration errors in excess of limits are identified [L/C] ( ) N/A ( ) Y ( ) N i
4 (8) Records maintained [L/C] ,
()Y()N C. Licensee use of generators i
(1) Each eluate / extract used for radiopharmaceuticals tested for Mo-99 breakthrough [30.34(g). L/C] ()Y()N (2) No radiopharmaceuticals distributed with Mo-99 concentrations over 0.15 uCi per mci of Tc-99m ()Y()N (3) Records maintained [30.34(g). L/C] ()Y()N (4) Frequency of gene'rator receipt i
Maximum activity of generator
~
(5) 1 D. Syringes, vials, or other containers labelled with l radiation symbol. " CAUTION [or DANGER]. RADI0 ACTIVE !
MATERIAL." and an identifier to correlate with the i
. information on the transport radiation shield label !
[32.72(a)(4)(ii). L/C] ()Y()N E. Syringes & vials kept in shield [20.1101(b). L/C] ()Y()N F. Appropriate shielding available for photon and beta emitters [L/C] ()Y()N 1
G. Survey instruments used to show compliance with Parts 20 and 30
! (1) Appropriate operable survey instruirentation
- possessed and readily accanible a
[30.33(a)(2). L/C] ()Y()N ;
i (2) Calibrated as required [20.1501(b). '
30.33(a)(2). L/C] l (a) Before first use, annually and after repairs ()Y()N (b) Approved calibration procedure followed to include check source reading determination '
[L/C] ()Y()N !
(c) Within 20% in each scale or decade of interest [L/C] ( ) Y (') N ;
(3) Source-checked each day of use [L/C] ()Y()N (4) Records maintained [20.2103(a). L/C] ()Y()N H. Procedures established to identify and report safety component defects [21.21] ()Y()N Basis for Findings:
Issue Date XX/XX/XX A-9 87117. Appendix A
- 6. MATERIALS RECEIPT. USE. TRANSFER. AND CONTROL A. Isotope. chemical form. quantity and use as authorized [L/C] ()Y()N B. Iodine capsule compound _ performed ()Y()N (1) Frequency j C. Preparation of liquid radioiodine for distribution
'(1) Iodine-125 dispensed ()Y()N (2) Iodine-131 dispensed -()Y()N ,
D. Licensed materials secured to prevent unauthorized removal or access [20.1801. 1802] ( ) Y (-) N (1) Materials in storage secured from unauthorized i removal or access [20.1801] ()Y()N ,
- (2) Licensee controls and maintains constant ,
a: surveillance of licensed material not :
l in-storage [20.1802] ( ) Y-( ) N i I- E. Describe how packages are received and by whom: !
i !
! j i
F. . Written package opening' procedures established. !
- and followed [20.1906(e)] ( ).Y (') N t G. All incor ng packages with a' DOT label wiped, i- unless exempted (gases and special form) !
- [20.1906(b)(1). L/C] ()Y()N H. Incoming packages surveyed per [20.1906(b)(2). L/C] ()Y()N j I. Monitoring required in (G) and (H) above performed i' l- within time specified [20.1906(c)] ()Y()N
- 'J. Arrangements made for receipt of packages
. containing material in excess of Type A i
- quantity [20.1906(a)] (-) Y ( ) N !
1 i '
i )
y 1 l-I 87117. Appendix A A-10 Issue Date: XX/XX/XX l
- . - - =- - _ _ . - - - . . . . - --
K. Transfer of radiopharmaceuticals (1) Transport radiation shield (on transfers for distribution) labelled with radiation symbol.
" CAUTION name. [or DANGER].
and quantity RADI0date at specified ACTIVE MATERIAL." z and time
[32.72(a)(4)(i). L/C] ()Y()N (2) Radioactive drugs are assayed by direct measurement or comb'ination of measurement and calculatic.. ,
prior to commercial distribution [32.72(c)] ()Y()N (3) Transfer (s) between licensees meet [30.41] ()Y()N (4) All sources surveyed before shipment and transfer
[20.1501(a). L/C] ( ) Y~( ) N (5) Records of surveys and receipt / transfer maintained [20.2103(a). 30.51] ()Y()N L. Package receipt / distribution activities evaluated for compliance with 20.1301 [20.1302] ( ) Y-( ) N Basis for Findings:
- 7. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS I
l A. Instructions to workers [19.12] -()Y()N B. Training program required' [L/C. 30.33(a)(3)] ()Y()N (1) If so, briefly describe training program:
(2)
- Training program implemented ()Y()N l l (3) Periodic training program required ()Y()N !
(4) Periodic training program implemented ()Y()N l (5) Records maintained .
()Y()N j
- C. Individual's u'derstanding of current procedures and f l
regulations is adequate ()Y()N i
(1) Current operating procedures ()Y()N (2) Emergency procedures ()Y()N' (3) Use of survey instrumentation ()Y()N
- l 2
Time may be omitted for drugs with a half life greater than 100 days.
3 Inspector should consider reviewing training program for pharmacists technicians. dispatchers and drivers Issue Date: XX/XX/XX A-11 87117. Appendix A
D .- Supervision of individuals by authorized user in accordance with [L/C] ()Y()N )
(1) Supervising ANP periodically reviews work of l supervised individuals o.,J records kept to '
reflect work [L/C] ()Y()N i ANP prasent during drug preparation if required (2) by Stata Board [L/C] ()Y()N E. Workers cognizant of Part 20 requirements for:
(1) Radiation safety program [20.1101] ()Y()N l' (2) Annual dose limits [20.1301. 1302] ()Y()N (3) NRC Forms 4 and 5 ()Y()N (4) 10% monitoring threshold [20.1502] ()Y()N (5) Dose limits to embryo / fetus and declared i pregnant worker [20.1208] ( ) N/A ( ) Y ( ) N (6) Grave danger posting [20.1902] ( ) N/A ( ) Y ( ) N !
(7) Procedures for opening packages [20.1906] ()Y()N (8) Sewer disposal limits [20.2003] ( ) N/A ( ) Y ( ) N j Basis for Findings: ;
i l
- 8. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL A. Radiation surveys performed (1) Daily in all areas where radiopharmaceuticals
, are prepared (ambient dose rates) [L/C] ()Y()N
- (2) Weekly in all areas where radiopharmaceuticals or waste are stored (ambient dose rates) [L/C] ()Y()N i (3) Weekly wipes in all areas where radiopharmaceuticals are routinely prepared or stored [L/C] ()Y()N i (4) Proper rorrective action taken if contamination 1 or excessive dose rates detected [L/C] ()Y()N ,
(5) Trigger levels established [L/C] ()Y()N (6) Vehicles used to transport RAM surveyed [L/C] ()Y()N 2
B. Techniques detect 0.1 mR/hr. 2200 dpm/100 cm [L/C] ()Y()N i
. C. Records maintained [L/C] ()Y()N D. Use/ preparation of radionuclides / drugs [L/C]
, (1) Protective clothing worn ()Y()N (2) Personnel routinely monitor hands and feet before leaving work area ()Y()N (3) Eating / drinking / smoking in use/ storage areas ()Y()N (4) Food, drink, or personal effects stored in use/ storage areas ()Y()N (5) Proper dosimetry worn ()Y()N l (6) Radioactive waste disposed in proper containers ( ) Y ( ) N j (7) Pipetting by mouth ()Y()N !
(8) Use of shielding / distance while using/ storing material ()Y()N 87117. ADnendix A A-12 Issue Date: XX/XX/XX
i
)
i E. Protection of members of the public (1) Licensee made adequate surveys to demonstrate l either (1) that the TEDE to the individual likely I to receive the highest dose does not exceed 100 t mrem in a year. or (2) that if an individual were continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour
)
and 50 mrem in a year [20.1301(a)(1). 1302(b)] ()Y()N '
(2) Unrestricted area radiation levels do not exceed 2 mrem in any one hour [20.1301(a)(2)] ()Y()N
-(3) Records maintained [20.2103. 2107) ()Y()N F. Emergency procedures i i
(1) Written procedures established & posted [L/C] ()Y()N !
(2) Decontamination kit stocked and present [L/C] ()Y()N G. Leak tests and inventories (1) Leak test performed on sealed sources [L/C] ()Y()N (2) Leak test records in microcuries [L/C] ()Y()N (3) Inventory of sealed sources performed .
quarterly [L/C) ()Y()N '
(4) Records maintained & signed by RSO [L/C] ()Y()N l
Basis for Findings: !
l
)
- 9. RADIATION PROTECTION A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee incorporated ALARA considerations in the !
radiation protection program [20.1101(b)] ()Y()N '
C. External Dosimetry ( ) N/A (1) Licensee monitors workers [20.1502(a). L/C] ()Y()N j (2) External exposures account for contributions l from airborne activity [20.1203] ( ) N/A ( ) Y ( ) N j (3) Processor Frequency (4) Processor is NVLAP-approved [20.1501(c)] ()Y()N (5) Dosimeters exchanged at required frequency [L/C]( ) Y ( ) N ;
D. Internal Dosimetry ( ) N/A i (1) Licensee monitors workers [20.1502. L/C] ()Y()N' i
Issue Date: XX/XX/XX A-13 87117. Appendix A
\
(2) Briefly describe licensee's program for !
~
monitoring and controlling internal exposures
[20.1701. 1702. L/C]- r (3) Air sampling performed [20.1204] ()Y()N !
(4) Monitoring / controlling program implemented (includes bioassays) [L/C] . ()Y()N !
(5) If respiratory protection equipment used. .
program meets [20.1703. L/C] ()Y()N l E. Reports ( ) N/A f (1) Reviewed by Frequency (2) Inspector reviewed personnel monitoring records for period to (3) Prior dose determined for individuals likely to receive doses [20.2104] ()Y()N, (4) Maximum exposures TEDE Other (5) Maximum CDEs Organs i
(6) Maximum CEDE (7) Licensee sums internal and external [20.1202] ()Y()N (8) TEDEs and TODEs within limits [20.1201] ()Y()N 1 (9) NRC Forms or equivalent [20.2104(d). 2106(c)] l (a) NRC Form 4 ()Y()N C lete ( ) Y-( ) N (b) NRC Form 5 ()Y()N C lete ()Y()N (10) Worker declared her pregnancy in writing during inspection period (review records) ( ) N/A ( ) Y ( ) N If "Yes," licensee in compliance with dose to embryo / fetus [20.1208] ()Y()N and records maintained [20.2106(e)] ()Y()N F. Who performed PSEs at this facility (number of people involved and doses received)? [20.1206, 2104. 2105, 2204] ( ) N/A l '
, G. Records of exposures, surveys, monitoring, and
, evaluations maintained [20.2102. 2103. 2106. L/C] ()Y()N l H. Licensee advises each worker annually of werker's dose [19.13(b)] ()Y()N 87117. Appendix A A-14 Issue Date: XX/XX/XX l - .
i Basis for Finaings:
!: 10. 'RADI0 ACTIVE WASTE MANAGEMENT ( ) N/A l 1
A. Disposal , ( ) N/A j (1) Decay-in-storage ( ) N/A $
1 (a) Procedures approved [20.2001(a)(2). L/C] ( ) Y '( ) N i
, (b) .In accordance with [L/C] ()Y()N i j (c) ' Labels removed or defaced [20.1904(b)] ()Y()N 4
(2) Special procedures performed as i 4
required [L/C] ()Y()N l (3) Liquid scintillation (LS) media and .
l animal carcasses [20.2005] ( ) N/A ( ) Y ( ) N '
, (4) Improper / unauthorized duposals
[20.2001] ()Y()N (5) Records maintained [20.2103(a). 2108. L/C] ()Y()N B. Effluents ( ) N/A
! (1) Release-into sanitary sewer [20.2003] ( ) N/A ( ) Y ( ) N l
, (a) Material is readily soluble or readily j dispersible [20.2003(a)(1)] ()Y()N J (b) Monthly average release concentrations
- do not exceed Appendix B values
[20.2003(a)(2)] ()Y()N (c) No more than 5 Ci of H-3.1 Ci of C-14 and 1 Ci of all other radionuclides
- combined released in a year i [20.2003(a)(4)] ()Y()N
. (d) Procedures to ensure representative
! sampling and analysis properly 1
implemented [20.1501(a)(2). L/C] ()Y()N I
(2) Release to septic tanks [20.1003] ( ) N/A ( ) Y ( ) N I (a) Within unrestricted limits
[ App B. Table 2: L/C] ()Y()N ;
- (3) Waste incinerated [20.2004] .( ) N/A ( ) Y ( ) N i i (a) License authorizes [20.2004(a)(3)] ()Y()N
, (b) Licensee directly monitors exhaust ()Y()N !
4 (c) Airborne releases evaluated and l
- controlled [20.1501. 1701] ()Y()N 'l d
(4) Control of effluents and ashes [20.1201.
1301. 1501. 2001. L/C]
i
{SeealsoIP87102.RG8.37} ()Y()N i
l' isttle Data- YY/YY/YY _
A.M _
A7117 Annondiv A
a (a) Compliance with air emissions requirements in Part 20:
l Licensee has demonstrated compliance with air emission requirements in Part 20 ( ) Y ( ) N Basis for compliance determination (check one or more: provide basis below)
(i) Measured concentrations of radionuclides in air effluents are below Appendix B.
Table 2 concentrations (and external dose
< 50 mrem /yr)
(ii) Bounding calculations show that air effluents could not exceed Appendix B.
Table 2 concentrations (and external dose
< 50 mrem /yr)
(iii) Dose modeling shows that dose equivalent l to the individual likely to receive the highest dose does not exceed 10 mrem /yr (iv) Licensee does not possess sufficient radio-active material to exceed Part 20 l requirements i Basis for Determination:
I (b) Description of effluent monitoring program (i) Monitoring-system hardware equipment I adequate ()Y()N (ii) Equipment calibrated as appropriate ( ) Y ( ) N -
(iii) Air samples / sampling technique (charcoal. HEPA. etc.) analyzed ,
l with appropriate equipment ()Y()N i I
(5) EPA referral form for air effluents sent to appropriate EPA regional office, with a copy to headquarters, per IP 87102 ( ) N/A ( ) Y ( ) N :
l C. Waste Management ( ) N/A !
- (1) Protection from elements and fire [L/C] ()Y()N (2) Control of waste maintained [20.1801] ()Y()N (3) Containers properly labeled and area pro mrly posted [20.1902, 1904) ()Y()N (4) Paccage integrity maintained [L/C) ()Y()N
[ D. Records of surveys and material accountability are j maintained [20.2103. 2108] ( ) Y (-) N Basis for Findings:
1 87117. Appendix A A-16 Issue Date: XX/XX/XX
1
- 11. RECORDKEEPING FOR DECOMMISSIONIN(i o ^] '
, A. Records of information important to the safe and
- effective decommissioning of the facility maintained in an independent and identifiable location unti'l license termination. ()Y()N B. Records include all required information [30.35(g)] ()Y()N (1) List of restricted areas [30.35(g)(3)]
indicates that laboratories or other rooms have been released since the last inspection ()Y()N (2) Confirmatory measurements show that each room is within release limits, and licensee records adequately document the. basis fur releasing each room ()Y()N C. Copies of the licensee's decomissioning cost estimates and funding methods on file ()Y()N D.- If the licensee uses a parent company guarantee or a self-guarantee as funding method. does the file contain a copy of the financial test performed for the licensee's most recently completed fiscal year? ( ) N/A ( ) Y ( ) N E. If "Yes" to D. . do the financial test ratios
- meet the criteria in 10 CFR Part 30.
i Appendix A. Section II for parent company guarantees and Appendix C. Section II for self guarantees?
()Y()N F. Date that licensee's financial assurance instrument ( ) N/A was submitted to NRC. if applicable:
l G. Date that 'icensee's decommissioning plan was ( ) N/A submitted to NRC. if applicable:
[ H. Have radiological conditions at the licensee's facility changed since the financial assurance mechanism and/or decomt.'.ssioning plan was submitted due to:
(1) Incidents or events? ( ) N/A ( ) Y ( ) N (2) Unplanned process upsets or changes? ( ) N/A ( ) Y ( ) N !
(3) Unauthorized material, form. or
- possession limit changes? ( ) N/A ( ) Y ( ) N i (4) Any other changes? ( ) N/A ( ) Y ( ) N .
If "Yes" to any of the above (1)-(4).
notify regional management.
Basis for Findings (include comments and measurements on any areas the licensee released.for unrestricted use):
Issue Date: XX/Xe XX A-17 87117. Appendix A i
r 12 r0MPLIANCE WITH DECOMMISSIONING TIMELINESS RULE i
A. License to conduct a principle activity has !
expired or been revoked ()Y()N B. Licensee.hmi made a decision to permanently f' cease principal activities. at t1e entire site.
or any separate buildings. or any outdoor areas.
including inactive burial grounds ()Y()N !
C. A 24-month duration has passed in which no principal activities. have been conducted under ;
the license at the site. or at any separate ;
buildings, or any outdoor areas including inactive burial grounds ()Y()N ;
D. If "Yes" to either A or B or C: ,
(1) Identify Site / Bldg / Area: l (2) Date of occurrence of A. B. or C: ,
NOTE: If "No" to A and 8 and C. decomissioning timeliness rule does not apply. If "Yes" to either A or 8 or C. then complete Attachment A. '
"Decomissioning Timeliness Field Notes." for this licensee. j Basis for Findings:
l l
- 13. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189) ( ) N/A A. Licensee -hipments are:
() delivered to common carriers
() transported in licensee's own private vehicle
() both
(-) no shipments since last inspection B. Licensee accepts returned radiopharmacy doses- ()Y()N (1) Licensee assumes shipping responsibility ()Y()N (2) If "No." describe arrangements made between licensee and client for shipping responsibilities:
I 1
(3) If 'Yes." licensee provides written instructions on returning shipments to customers [L/C] ()Y()N (4) Incoming packages conform with pharmacy procedures ()Y()N j j
87117, Appendix A A-18 Issue Date: XX/XX/XX i
I f
C. Licensee Transoorts: [ complete sections (1) - (4 ). as applicable] l (1) Limited Quantities, and/or Instruments and ( ) N/A Manufactured Articles: (Radioactive Material. !
excepted package. [ additional info). 7. UN 2910)
(a) Package meets general design requirements [173.410] () )N ;
(b) Radiation level 5 0.005 mSv/hr !
(0.5 mrem /hr) (Exclusive use instruments and articles. 2 airem/hr) ()Y()N (c) Contamination le.ss than 173.443 limits.
OC examination / test erformed prior to each shipment [173.4 5(I)] ()Y()N (d) Limited Quantity Package marked l
" Radioactive" [173.421(a)(4)] ()Y()N !
(e) 173.422 certification statement attached / enclosed ("This package conforms to the conditions and i limitations specified in. . .") ()Y()N i (2) Type A Quantities (Radioa:tive Material, nos. ( ) N/A i
- 7. UN 2982) ,
(a) Packaging:
(i) Packaging is proper for contents (i.e.. DOT 7A). is unimpaired, and is prepared correctly
[173.475(a)-(f)] ()Y()N ;
(ii) All packages meet genesal design requirwents [173.410] ()Y()N
- (iii) 00T 7A package meets additional Type A design requirements
[173.412. 178.350] ()Y()N (b) Recordkeeping:
(i) Special Form source records
[173.476(a)] ()Y()N (ii) 00T.7A performance / design documentation (173.415(a)] ()Y()N ,
(c) Hazards comunications requirements (consult the "NRC field reference charts" that correspond to elements -
(i) through (v). below):
- (i) Shiaping pa>ers [172.200-205] ()Y()N (ii) Marcing paccages [172.300-338] ()Y()N t (iii) Labeli - ackages [172.400-450] ()Y()N i (iv) Place, vehicles [172.500-560] ()Y()N (v) Emersuicy response information and guidance [172.600-604] ()Y()N i
Issue Date: XX/XX/XX A-19 87117. Appendix A <
l
1 l
(d) Radiation level / Contamination limits
[173.441. 173.443]
(i) Package levels within. limits ()Y()N l (ii) OC examination / test performed prior to each shiunent [173.475(I)] ()Y()N L (3) Type B Ouantities (Radioactive Material, nos. ( ) N/A l
! 7. UN 2982) l
\
(a) Packaging is proper for contents (i.e..
i Type B). is unimpaired. and is prepared correctly [173.475(a)-(f)] ()Y()N (b) Inspector must complete Section 2 of NRC i Inspection Procedure (IP) 86740 l
(c) Sections 2.c. and 2.d. shown in the pre- '
vious section for Type A Quantities, also apply. Complete those sections.
(4) LSA Material and SCO (Radioactive Material. ( ) N/A l LSA, nos. 7. UN 2912) or (Radioactive Material, ,
SCO. nos. 7. UN 2913) i (a) If licensee makes significant LSA/SCO l shipments. inspector should complete j Inspection Requirement 03.02 of Temporary 1 Instruction (TI) 2515/133 (issued 3/15/96-)
l (b) Otherwise, if licensee has a minor LSA/SCO ;
program- 1 l
i (i) Licensee promrly characterizing l material as _SA/SCO [173.403] ()Y()N !
(ii) All packages meet general design requirements [173.410] ()Y()N (iii) Proper LSA/SCO packaging selected j and used [173.475. 173.427] ()Y()N (i") Placarding exclusive use vehicles, marking package " Radioactive-LSA" or " Radioactive-SCO." as appropriate [173.427(a)(6)] ()Y()N (v) Slipping Papers [172.200-205]
(see "NRC field reference charts" -
for content and exceptions) ()Y()N l D. DOT HAZMAT Emoloyee Trainina Proaram [49 CFR 172.700-704] ( ) N/A (1) Each HAZMAT employee receives training and is
- tested [172.702] ()Y()N ;
(2) Recurrent training at least every 2 years
[172.704(c)(4)] ()Y()N (3) HAZMAT employee training includes general i awareness. function-specific, and safety )
' training [172.704] ()Y()N i (4) HAZMAT employer recordkeeping includes !
employee name. completion date, i description / copy / location of training i i materials. name and address of training provider, and certification [172.704(d)] ()Y()N !
l 87117. Appendix A A-20 Issue Date: XX/XX/XX
t
. 1 E. rarrier Modal Soecific Reauirements. Hiahwav
( ) N/A Transoortation- [49 CFR Part 177] i...
(1) Driver training, or CDL w/ HAZMAT endorsement
[177.800. 177.816] ()Y()N (2) Incident reporting to 00T [177.807, see also 171.15 and 171.16] ()Y()N (3) Shipping paper accessibility (on seat or in driver's side door pocket, readily visible) ()Y()N
-(4) Placarded vehicles routing and driver training requirements [177.825 and 49 CFR 397 Subpart 0 (i.e.. the motor carrier regs)] ()Y()N ,
.(5) Sum of total package tis on non-exclusive use !
vehicle < 50 [177.842(a)] ()Y()N I (6) Packages blocked / braced for transport
[177.842(c)] ()Y()N .
(7) No labeled packages carried in passenger compartments [173.448(c)] ()Y()N F. Miscellaneous Reauirements ( ) N/A (1) No labeled packages carried in passenger compartments [173.448(c)] ()Y()N (2) Overpack requirements observed, if packages are offered in overpack. Overpack marked w/ proper shipping name and number package and overpack labeled as needed. marked " inner package complies ...." [173.24] ()Y()N l (3) Expanded and changed A1/A2 values from the '
4/1/% rule changes have been implemented
[173.435] (verify only once per licensee) ()Y()N (4) Written instructions included with exclusive use shipments [173.403] ()Y()N Basis for Findings:
14, MISADMINISTRATIONS A. Misadministrations have occurred that were attributed to pharmacy ()Y()N B. Appropriate action taken to prevent recurrence ( ) N/A ( ) Y ( ) N Basis for Findings: )
4 i
i Issue Date: XX/XX/XX A-21 87117. Appendix A
i l 15. POSTING AND LABELING A. NRC Form 3. " Notice to Workers." is posted [19.11] ()Y()N -
B. Parts 19. 20. 21. Section 206 of Energy Reorganization Act, procedures adopted pursuant to
- Part 21. and license documents are posted or a notice
! Indicating where documents can be examined is posted
[19.11. 21.6] ( ) Y (.) N '
C. Other posting and labeling per [20.1902, 1904]
and the licensee is not exempted by
[20.1903,1905] ()Y()N l L Basis for Findings:
- 16. GENERIC COMMUNICATION OF INFORMATION I A. Bulletins, information notices. NMSS Newsletter.
! etc. received by the licensee ()Y()N :
l 8. Licensee took appropriate aci.va in respc.nc tc !
bulletins, generic letters, etc. ()Y()N Basis for Findings: !
i
- 17. NOTIFICATION AND REPORTS A. Licensee in compliance with [19.13, 30.50] (reports to individuals, public and occupational. monitored to show compliance with Part 20) ( ) N/A ( ) Y ( ) N 1
Licensee in compliance with [20.2201. 30.50]
B.
(theft or loss) ( ) None ( ) Y ( ) N C. Licensee in compliance with [20.2202, 30.50)
(incidents) ( ) None ( ) Y ( ) N l
l D. Licensee in compliance with [20.2203, 30.50]
- l. (overexposures and high radiation levels) ( ) None ( ) Y ( ) N i
E. Licensee aware of NRC Ops Center phone number ()Y()N
[(301)-816-5100]
- Basis for Findings
)
i s
l- 87117. Appendix A A-22 Issue Date: XX/XX/XX l
- i
)
! l' i
- 18. YEAR 2000 EFFECT ON COMPUTER SYSTEM SOFTWARE.
]
- A. L1censee has reviewed the effect of the year 2000 on l 1
computer software programs that are used to meet
- licensing requirements or those that have safety j significance [IN 96-XX] -( ) Y (-) N '
t If "No," licensee is aware of notice to do so ()Y()N l j NOTE: A deficiency in this area should not be cited as a violation. !
j 19. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A l A. Special license conditions or issues to be reviewed:
t i
i i 1
i i l'- B. Evaluation: i i
s
, i 4 ;
1 !
i 3 !'
I
! i 1 i 4 t l
1 i !
l I
I 1
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issuo Date- XX/XX/XX- A-73 87117 Annendix A
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- 20. ' OBSERVATIONS / DEMONSTRATIONS OF LICENSED ACTIVITIES l
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I Briefly describe the activities and procedures observed and/or denonstrated I
! during the inspection. For exanple if you observed licensee personnel working in radfation areas using 1icensed material or performing functions associated with radiation safety such as receiving or transporting licensed ;
material; conducting or receiving training; disposing of radioactive waste: J conducting surveys; or making measurenents, then describe what you saw. If !
the licensee demonstrated any practices at your request, describe those demonstrations. The observations and demonstrations you describe here, and elsewhere in the " Basis for Findings" sections of this report along with !
measurements and'some records review, should substantlate your inspection findings. t Describe what activities or procedures were observed and/or i demoristrated by the licensee during the inspection:
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87117. Appendix A A-24 Issue Date: XX/XX/XX l l
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ll The following sections should be cmpleted in a narrative format by the inspector to briefly describe the measurements performed by the inspector.
Inspection findings, and any post-inspection cmmunications with regional staff.
- 21. NRC INSPECTOR'S MEASUREMENTS ( ) N/A A. Survey instrument Serial No. Date of calibration i
- 8. Inspector performed CONFIRMATORY measurements ()Y()N C Inspector performed INDEPENDENT measurements ( ) Y.( ) N l D. Briefly describe the types of measurements performed ,
(i.e., exposure rates, wipe tests, soil samples, air flow measurements, etc.), locations where measurements :
were taken, the results of these measurements (mR/hr, dpm. etc.), and whether inspector's results conflicted ;
with the licensee's measurements. If independent '
measurements were not made, justify why they were not performed on this inspection- :
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- 22. CONTINUATION OF REPORT ITEMS ( ) N/A Issue Date: XX/XX/XX A-25 87117. Appendix A
23 VIOLATIONS. NON-CITED VIOLATIONS (NCVs). AND OTHER ISSUES ( ) N/
NOTE: Briefly state (1) the requirement and (2) how andpNbhe licensee violated the requirement. For non-cited violations (NCVs), indicate why the violation was not cited. Attach copies of all licensee documents needed to support the violation.
- 24. DEBRIEF WITH REGIONAL STAFF {
A. Was inspection feedback provided to regional licensing staff? ()Y()N j If "Yes." name of individual on the licensing ;
staff: '
If "Yes," describe issues discussed: I F
B. Briefly describe post-inspection communications with other regional staff (inspector's supervisor. Agreement State officer. State liaison officer, etc.):
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87117_ Appendix A A-26 Issue Date: XX/XX/XX
26 PERFORMANCE EVALUATION FACTORS (PEFs)
A. Lack of senior management involvement with the radiation safety program and/or RSO oversight ()Y()N B. RSO too busy with other assignments ()Y()N C. Insufficient staffing ()- .)N D. RSC ' fails to meet or functions inadequately. ( ) N/A ( ) Y ( ) N E. Inadequate consulting services or inadequate audits conducted ( ) N/A ( ) Y ( ) N Remarks (consider the above assessment and/or other pertinent PEFs with regard to the licensee's oversight of the radiation safety program):
1 Regional follow-up on above PEFs citations:
END
Attachment:
A. " Decommissioning Timeliness Inspection Field Notes" Issue Date: XX/XX/XX A-27 87117. Appendix A
APPENDIX A - ATTACHMENT A DECOMMISSIONING TIMELINESS FIELD NOTES DRAET Licensee: ..
Date of Inspection:
- 1. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE (NOTE: Repeat the answers given in Section 12 of the main body of the field notes. The issues in subsequent sections are dependent on the answers to these questions.)
A. License to conduct a principle activity h.d1 expired or been revoked ()Y()N B. Licensee bal made a decision to armanently cease principal activities, at t3e entire site.
or any separate buildings or any outdoor areas, including inactive burial grounds ()Y()N C. A 24-month duration has passed in which no principal activities. have been conducted under the license at the site, or at any separate buildings. or any outdoor areas, including inactive burial grounds ()Y( )N D. If "Yes" to either A or B or C above:
(1) Identify Site / Bldg / Area:
(2) Date of occurrence of A. B or C:
- 2. NOTIFICATION REQUIREMENTS A. Licensee has provided written notification to NRC within 60 days of the occurrence of 1. A. 1.B. , or 1.C. above ()Y()N If "Yes." date of notification:
B. If the licensee is requesting to delay initiation of the decomissioning process, the licensee has provided written notification to NRC within 30 days of occurrence of 1.A. 1.B.. or 1.C. above ( ) N/A ( ) Y ( ) N ,
If "Yes." date of notification:
Comments:
Issue Date: XX/XX/XX Att. A-1 87117. Appendix A. Att. A
- 3. D1 COMMISSIONING PLAN / SCHEDULE RE0VIREMENTS
, A. Licensee is required to submit a decomissioning plan per 10 CFR 30.36(g) 40.42(g). 70.38(g). or 10 CFR Part 72? ()Y()N If "No" to 3.A. answer the following items 8. - F.-
- 8. The decomissioning work scope is covered by current license conditions ()Y()N C. Decommissioning has been initiated within 60 days of notification to NRC or NRC has granted a ' delay ()Y()N D. If licensee has initiated decommissioning, give date the decomissioning was initiated:
Initiation date:
E. If decommissioning has been completed, it was completed within 24 months of notification to NRC ( ) N/A ( ) Y ( ) N F. If decomissioning is still scheduled to.be l com)leted. it is on schedule to be completed witlin 24 months of notification to NRC ( ) N/A ( ) Y (-) N ,
4 Comments-If "Yes" to 3.A., answer the following items G. - J.:
G. The decomissioning plan has been submitted to NRC within 12 months of notification ()Y()N If "Yes." date of submittal:
If NRC approved. date of NRC approval:
H. Has the licensee submitted an alternative schedule request?
()Y()N If "Yes." date of submittal: !
87117. Appendix A. Att. A Att. A-2 Issue Date: XX/XX/XX
I. If decommissioning has been completed, it was completed witnin 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N J. If decommissioning is still scheduled to be completed. it is on schedule to be completed within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N Comments:
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Violations identified. if any: )
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Issue Date: XX/XX/XX Att. A-3 87117. Appendix A. Att. A
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ATTACHMENT 4 1 IP 87118 i BRACHYTHERAPY PROGRAMS
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NRC INSPECTION MANUAL 1808 INSPECTION PROCEDURE 87118 BRACHYTHERAPY PROGRAMS PROGRAM APPLICABILITY: 2800 87118-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers and the general public.
01.02 To determine if licensed programs are beir.g conducted in accordance with NRC requirements.
87118-02 INSPECTION REQUIREMENTS A review of the licensed activities will be commensurate with the scope of the licensee's program. A determination regarcing safety and compliance with NRC requirements will be based on direct observa:icn of work activities interviews with workers, demonstrations by workers performing tasks regulated by NRC, and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.
In reviewing the licensee's performance, the inspector should cover the period from the last to current inspections. However, older issues preceding the last inspection should be reviewed. if warranted by circumstances, such as incidents.
non-compliance, or high radittion exposures.
This inspection procedure is applicable to all forms of brachytherapy (temporary and permanent implants, remote afterloaders, eye applicators and plaques, etc.).
However, all of the following areas may not be app'icable to each brachytherapy program.
02.01 Preoaration. The inspector should allow adequate time to pre)are for the inspection. Preparation will include reviewing documents, macing travel arrangements. coordinating with appropriate staff, notifying appropriate State ,
i agencies, and selecting necessary equipment. In particular, the inspector shall identify whether any license amendments have been issued since the last inspection, or whether the licensee has informed NRC of any major program changas since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensea had any incidents or events since the last inspection.
87118 Issue Date: XX/XX/XX
02.02 Entrance Briefina. When the inspector arrives at the licensee's facility, he/she will inform an available senior management representative of the purpose and scope of the inspection. For brachytherapy program inspections. it is not always practical to meet with licensee management upon arrival because of the early hours that the inspection may be conducted. However the entrance briefing should be conducted as soon as practicable.
02.03 General Overview
- a. Oraanization. Interview cognizant licensee representatives about the current organization of the program. Examine the licensee's organization with respect to changes that have occurred in personnel, functions, responsibilities. and authorities since the previous inspection. Identify the reporting relationship and management structure between the licensee's executive management, the Radiation Safety Officer (RS0), the Chairperson of the Radiation Safety Comittee (PSC), and the other members of the RSC.
- b. ScoDe of Proaram. Interview cognizant personnel to determine the types, quantities, and use of licensed material, frequency of use, staff size, etc. Determine if the licensee has multiple places of use, especially for licensees with remote afterloaders, and verify that all locations are authorized by the license. If warranted, consider performing inspections at all sites of use.
- c. Manaaement Oversiaht. In the course of interviewing cognizant personnel .
determine if management oversight is sufficient to provide the licensee staff with adequate resources and authority to administer the licensed program.
- 1. RSC .If the licensee is required to have an RSC. review the comittee meeting minutes for topics of discussion, membership, frequency, and attendance. The inspector should interview some members of the RSC to determine their involvement in the radiation safety program. For licensees with remote afterloaders, verify that the RSC: (1) has approved any afterloaders currently in use: (2) reviews the use of afterloaders at each quarterly RSC meeting: (3) reviews the remote afterloader program during annual audits of the As Low As Is Reasonably Achievable (ALARA) program; and (4) implements corrective actions recomended for ceficiencies noted during audits.
- 2. RSO - Determine whether the RSO has been appointed, is named on the license, has sufficient authority, and fulfills the appropriate duties comensurate with the size and scope of licensed activities.
- 3. Audits - Verify that audits are performed as required. Verify that the results of the audits are reviewed and addressed.
- d. Authorized Users. Determine that only qualified, authorized individuals perform and/or supervise licensed activities. Verify that authorized users of brachytherapy sources perform an appropriate level of supervision, as required by 10 CFR 35.25. Verify that remote afterloaders are used by or under the direct supervision of an authorized user.
02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed facility to make general observations of the condition of the facility and the licensed activities being performed.
87118 Issue Date: XX/XX/XX
02.05 Estcilities,
- a. Reauirements for All Brachytheraov Licensees. Verify that the facility conforms to that described in the license application: that material receipt, use, and storage areds are secured; and that the licensee uses processes or other engineering controls to maintain doses ALARA.
- b. ' Additional Reauirements for Licensees with Remote Afterloaders. Verify that unauthorized individuals are prevented from entering the use area, that the device and all associated sources are stored against unauthorized use or removal, and that the console keys are inaccessible to unauthorized persons. Also, if other radiation-producing devices are located within the treatment room, ensure that only one device can be placed in operation at a time.
- c. Additional Reauirements for Licensees with Hiah . Medium . and Pulsed-Dose Rate Remote Afterloaders. Verify that use of the afterloaders is limited to the areas approved by the license. Determine whether each dedicated treatment room is equipped with a continuous viewing and intercom system to allow for patient observation and communication dering treatment.
Verify that these systems are checked for operation at the beginning of each day of use, and that either a backup system is available or the licensee suspends further treatments if the primary system requires repairs.
Verify that electrical interlock systems are installed and operational at each entry. The activation of the interlock will result in the source automatically being retracted. Also verify that, once activated the automatic interlock must be reset before the afterloading device can be j activated. Determine whether interlocks are tested daily for proper i operation, and whether records verifying interlock operation are maintained for three years.
- d. Additional Reauirements for Licensees with Low-Dose Rate Remote I Afterloaders. Verify that such devices are only used in locations (rooms) within a single building that are approved by the license and that the licensee possesses and uses either fixed or portable shi lds during i procedures. Determine whether the licensee has the capability to monitor the patient and device during treatment to ensure that the sources and catheter guide tubes are not disturbed during treatment /use.
02.06 Eauioment and Instrumentation.
- a. Verify that equipment and instrumentation are appropriate, operable, calibrated, adequately maintained, and conform to that described in the license.
- b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 CFR Part 21. .
- c. Additional Recuirements for Licensees with Remote Afterloaders. Verify that the licensee has only used the remote afterloader authorized by the license. Verify that (1) the backup battery for the remote afterloader is tested monthly. in accordance with the manufacturer's instructions to verify emergency source retraction capability upon power failure; and (2) the source position indicators are checked periodically using a dedicated Issue Date: XX/XX/XX 87118 ,
check source or the afterloader's sourw to verify proper operation and accuracy. j Only persons licensed by the NRC or an Agreement State may perform maintenance, repair, and inspection on remote afterloaders. Verify that each afterloader is fully inspected and serviced at intervals not to i exceed one year to ensure proper function of the device and to ensure that i scheduled service recomended by the manufacturer has been performed in accordance with the manufacturer's instructions. ;
Verify that the licensee has implemented a calibration 3rogram for their remote afterloaders. Calibrations are to be performed )y the authorized
>hysicist or other individual specified in the license application either l ay name or by training and experience. Verify that these calibrations are performed following installation of a new source, before patient treatment 1 is resumed, and monthly thereafter. Also verify that the dosimetry ystem ,
used to perform calibration measurements has been calibrated National Institute of Standards and Technology (NIST) or the ,
Association of Physicists in Medicine (AAPM) within the previous ars and after any servicing that may have affected system calibration.
02.07 Materials
- a. Receiot and Transfer of Licensed Material. Verify that the licensee is :
receiving packages and making transfers of licensed material in accordance I with NRC and applicable U.S. Department of Transportation 'TT) regulations and license conditions. j
- b. Authorized Uses. Determine from observing the use of licensed material, i discussing the activities with licensee personnel, and reviewing records, that the type, quantity, and use of licensed material at the licensee's l facility are authorized by the license. ,
- c. Inventories. Verify that the licensee is conducting inventories of all sealed sources and brachytherapy sources in accordance with 10 CFR 35.59 and 35.406. To the extent practical, assure by physical confirmation that the licenses. s inventory is complete and accurate and that inventory records are maintained as required. i
- d. Material Security and Control. Verify that the licensee has established procedures for maintaining security and control of licensed material, and that these procedures are understood and implemented by appropriate personnel. Verify that licensed material, in storage, in controlled or unrestricted areas is secure from unauthorized removal or access. Verify that licensed material, not in storage, in controlled or unrestricted areas is controlled and under constant surveillance. Verify that access to restricted areas is limited by the licensee. !
- e. Additioral Reauirements for Licensees with Remote Afterloaders. Verify
- that on'y those sources approved by the license are possessed by the licensee. Sources used in afterloaders should be checked by the licensee for source homogeneity and be leak tested at intervals not to exceed six months. Inventories of all sources. including those in use, in storage.
and any depleted uranium used as shielding, must be conducted quarterly. ,
Verify that installation and/or replacement of sealed sources contained in remote afterloaders is only performed by persons specifically authorized by the NRC or a'n Agreement State.
R711R 4 Tssue Date: XX/XX/XX
L i)2.ud Trainina ,
- a. General Trainina. Verify that appropriate training and initial instructions are being provided to personnel as specified in the license and as required by 10 CFR 19.12 and 35.410.
- b. Doeratina Procedures. Verify that licensee personnel are aware of-operating procedures by observing personnel perform tasks at selected work stations and by a comparison of their activities with established procedures,
- c. .Emeroency Procedures. Through discussions with workers. verify that licensee personnel understand and implement the established emergency procedures and are aware of procedural revisions. Document in the inspection field notes what activities the inspector observed.
When applicable, discuss with the licensee *s representatives, or observe (for the higher priority licensees), the conduct of periodic tests and drills, especially for scenarios involving fires and incidents involving '
device failures or loss of sources.
- d. Safety Instruction. Verify that the licensee is providing and documenting radiation safety instructions in accordance with 10 CFR 35.410. for all l personnel caring for patients or human research subjects undergoing implant therapy. 1
- e. Guidance for Permanent Imolants. Verify that the licensee is providing radiation safety guidance, in accordance with 10 CFR 35.415(a)(5). to all patients or human research subjects administered permanent implants. ]
- f. Additional Reauirements for Licensees with Remote Afterloaders. The administrative and technical staff. Including device operators should be provided initial training and periodic retraining specific to the device model(s), at intervals not to exceed 12 months. This should include routine training required by 10 CFR 19.12 and training described in the i license application. The licensee should also provide ancillary staff l
(nurses, saurity staff custodians, etc.) with initial training and refresher training. at intervals not to exceed 12 months. Verify that the required training is being provided, that the individual (s) providing instruction in the use of the afterloader is (are) named in the license application, and that records of the training are maintained for three years.
Also verify that device operators, physicians and medical physicists are provided emergency training, including a dry run.
02.09 Ooeratina and Emeraency Procedures for Remote Afterloaders
- a. Doeratina Procedures Common to All Remote Afterloaders. Verify that
, operating procedures are available at the console used to owrate the .
i remote afterloader. Posted operating procedures should be t1e same as those approved by the NRC in the licensing process. If they are not the same. verify that any revisions to the procedures do not relax restrictiveness or degrade safe operation of the unit and have been approved by the RSC. Note, if the licensee is not required to have an
- RSC. the RS0 should approve procedure changes. In addition, the licensee should submit revised procedures to the NRC for review.
Issue Date: XX/XX/XX 87118
- b. Ooerations Soecific to Hiah . Medium . and Puised-Dose Rate Remote Afterloaders. At least one individual trained in the safe use of the device and who has practiced the emergency procedures for use of the device must be physically present while the device is in use. Verify that both the authorized user and either a medical physicist or the RSO is physically present while the device is in use. Confirm that only the patient is in the treatment rocia during activation of the remote afterloader.
- c. Operations SDecific to low-Dose Rate Remote Afterloaders. During patient i treatments that extend over a period of several hours. a device operator trained in the emergency procedures must be physically present at the i licensee's facility or be available by telephone. Verify tilat the medical !
physicist or RSO and the authorized user are available for prompt l assistance in the event that a source appears to have decoupled or becomes '
jamed in the catheter guide tube. Also verify that written instructions ,
are provided to nurses prior to use of the afterloading device. I l
- d. Emeroency Procedures Comon to All Remote Afterloaders. Observe whether l emergency procedures are posted at the device console or in a conspicuous location within the treatment area. Individuals entering a treatment room should carry a functional radiation detection survey meter if the room monitor is non-functional . Verify that appropriate source recovery I equipment is available for use.
02.10 Area Radiation and Contamination Control .
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- a. Area Surveys.
- 1. For All Brachytheraov Procrams. Verify. by observations and direct measurements, that the radiation levels are within the limits of 10 CFR Part 20. and that survey instruments are possessed in accordance with 10 CFR 35.420.
Immediately upon completion of the therapy procedure, and before removal of the patient from the treatment room (or removal of the portable shields used during low-dose rate remote afterloader procedures). licensees should perform a radiation survey of the device and the patient to ensure that the source has been returned to the shielded position. Examine the' licensee's records of these surveys to verify that these surveys are performed and that records of these surveys are maintained for three years.
- 2. Additional Recairements for Licensees with Hich- and Medium-Dose Rate Afterloaders. Verify that surveys are conducted to ensure compliance with 10 CFR 20.1301 prior to initiating a treatment program and subsequent to each source exchange or replacement or relocation of the device. Also verify that survey records are retained for three years. -
- 3. Additional Reauirements for Licensees with Low- and Pulsed-Dose Rate Afterloaders. Verify that surveys are conducted to ensure compliance with 10 CFR 20.1301 at the time of treatment program initiation and subsequent to each source exchange or replacement or relocation of the device. Also verify that survey records are retained for three years.
87118 Issue Date: XX/XX/XX
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- b. Leak Tests. Verify that leak tests of sealed sources are performed at the required frequency and are analyzed in accordance with the license. If records of leak test results show contaminaLon in excess of the regulatory requirements, verify that the licensee made appropriate l notifications and removed the source from service. !
! c. Protective Clothina. Verify that radiation workers are provided with, and l l wear, the appropriate protective clothing commensurate with activities l being performed.
l 02.11 Radiation Protection l
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- a. Radiation Protection Proaram. Verify that the licensee has developed and e
implemented a written radiation protection program comensurate with the 4
licensee's activities, that the program includes ALARA provisions, and
, that the program is reviewed at least annually, both for content and l
implementation.
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i b. Radiation Protection Procedures. Verify that changes in the radiological l protection procedures made since the last inspection are consistent with regulations and license requirements. Determine whether the licensee was
- required by 10 CFR 35.13 to apply for license amendments for any of these changes.
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- c. Instruments and Ecujoment. Verify that radiation protection instruments 1 and equipment are operable. have the proper alarm settings. if applicable, ,
and are calibrated and checked for appropriate response in accordance with l license requirements and licensee procedures. !
1 1. Additional Recuirements for Licensees with Remote Afterloaders.
. Verify that the licensee has in its possession portable survey instruments as specified in 10 CFR 35.420. These instruments must
. be calibrated in accordance with 10 CFR 35.51. and they must be
- checked for proper oper ation with a Jedicated check source each day.
- 2. Additional Reauirements for Licensees with Hich . Medium . and
, Pulsed-Dose Fate Remote Afterloaders. Verify that the licensee has installed a permanent radiation monitor capable of continuously
) monitoring the source status in each dedicated treatment room. The monitor must: provide visible notice when the source is exposed or
'. partially exposed; be visible to an individual entering the treatment room; and be provided with a backup power supply separate from the
, power supply used to operate the remote afterloader. Verify that the radiation monitor is checked daily, or on an as-used basis, for proper operation with a dedicated check source, and that records verifying the radiation monitor's operation are maintained for three years.
- d. Personnel Dosimeters. Verify that personnel dosimetry dr mes are worn by appropriate licensee personnel. For licensees with remote afterloaders. verify that all >ersonnel entering restricted areas (treatment rooms) wear whole body 3adges. Dosimetry devices appropriate to the type, energy, or emitted radiation, and the anticipated radiation fields should be issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved and accredited processor.
Issue Date: XX/XX/XX -7 87118
Verify that pursuant to 10 CFR 19.13(b) the i L.:nsee advises each worker !
annually of the worker's dose as shown ir records maintained by the l licensee pursuant to the provisions of 10 CFR 20.2106. " Records of individual monitoring results."
02.12 Quality Manaaement Procram NOTE: This section is being revised by the Division of Industrial and Medical Nuclear Safety (IMNS) and is being separately transmitted for comment 02.13 Waste Manaaement
- a. Waste Storaae and Disoosal. Verify that the waste is stored and controlled in a secure and safe manner, and that radiation levels in unrestricted areas surroundmg tr.a mrage area do not exceed the limits of 10 CFR 20.1301. " Dose limits for individual members of the public."
Verify that disposals of decay-in-storage waste are performed in accordance with the regulations and license conditions (medical licensees are specifically authorized to dispose of waste by decay in storage for waste with a half life of less than 65 days). If applicable, review the licensee's procedures and records to verify that each shipment of radwaste intended for off-site disposal is accompanied by a shipment manifest that includes all the required information.
Review the licensee's procedures and records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is labeled, as appropriate, to identify it as Class A. B. or C waste in accordance with the classification criteria of 10 CFR 61.55 [ Subsection III.A.2 of Appendix F to 10 CFR 20.1001-20.2401].
- b. Transfer. Veri fy that radioactive sources are transferred to an authorized recipient and that wastes, if any, are transferred to a recipient specifically licensed to receive radioactive waste.
- c. Records. Verify that records of waste storage, transfer and disposal are maintained in accordance with the requirements of 10 CFR Part 20 and the license.
- d. Financial Assurance and Decommissionina. Review the licensee's records of information important to the safe and effective decommissioning of the facility. Verify that the records are complete, updated, and assembled appropriately, in accordance with the requirements in 10 CFR 30.35(g).
Review the licensee's list of restricted areas required under 10 CFR >
30.35(g)(3) and determine whether rooms. laboratories. etc., have been released since the last inspection. If areas have been released, verify that the licensee has adequately decontaminated each room and documented the basis for releasing each room. Document the location of the released rooms in the field notes, and document your findings regarding the adequacy of the licensee's decontamination.
Verify whether radiological conditions at the facility have changed since the financial assurance instrument and/or decomissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents such as process upsets. Unauthorized changes by the licensee to processes, types of licensed materials possession limits, or chemical or physical forms of licensed materiais may also prompt a reevaluation of 87118 Issue Date: XX/XX/XX
whether the financial assurance instrument and/or decommissionin plan remains sufficient. If the inspector identifies changes that ma- fect the financial assurance instrument or decommissioning plan. he/g uld ,
immediately notify regional management. , ., W i l
If a parent company guarantee or a self-guarantee is used to ensure !
decomissioning financial assurance review the licensee's financial I assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met.
- e. Decommissionino Timeliness. Review compliance with the Decomissioning Timeliness Rule requirements in 10 CFR 30.35(d) through (h). This is one area of the field notes that should be completed on all inspections. If the license to conduct principal activities has expired or been revoked: )
if the licensee has made a decision to permanently cease principal !
activities at the site or in any separate building: or if there has been i a 24-month duration when no principal activities were conducted at the ;
site or in any separate building then the decomissioning timeliness I requirements in 10 CFR 30.36. 40.42. 70.38. or Part 72 apply. If this is the case, complete in full the "Decomissioning Timeliness Inspection Field Notes." Attachment A to Appendix A.
l 02.14 Transoortation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with l 10 CFR Part 71 and DOT regulations for transportation of radioactive materials.
02.15 Postino and Labelino. Verify that the licensee has posted the appropriate I documents. notices, forms, and caution signs as required. Also verify that containers of licensed material, along with remote afterloaders and/or any associated source storage containers, are labeled appropriately.
02.16 Generic Comunications of Information. Confirm that the licensee is receiving the applicable bulletins, information notices. NMSS Newsletter, etc. l Verify that the licensee has taken appropriate action in response to these notices. '
02.17 Notifications and Reoorts. Determine compliance with the regulations and license requirements for notification and reports to NRC and individuals. Verify that the licensee is in compliance with the requirements in 10 CFR 35.14 for medical licensees to notify the Comission about changes in the authorized user or RSO.
02.18 Soecial License Conditions. If applicable, review the licensee's compliance with any special license conditions.
02.19 Indeoendent and Confirmatory Measurements. Compare and verify on a sampling basis, survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. In particular, confirm that radiation levels in restricted and unrestricted areas adjacent to treatment rooms meet the requirements of 10 CFR 20.1201 or 20.1301.
Conduct independent measurements on all inspections under this inspection procedure, unless warranted by special circumstances. If independent measurements were not made, provide a justification in the field notes explaining why independent measurements were not performed. The inspector shall use radiation detection instruments that are calibrated, at a minimum, on an annual basis.
Issue Date: XX/XX/XX 87118
02.20 Exit Meetina. The inspector will conduct 'an exit meeting with senior licensee management and the RS0 to discuss the preliminary inspection findings including any apparent violations, safety-related concerns, and any unresolved items identified during the inspection. Discuss any , negative Performance Evaluation. Factors (PEFs) and encourage the licensee to respond to the PEFs of corcern. For further guidance. refer to IP 87101. " Performance Evaluation j Factors."
02.21 Post' InsDettion Actions. After an inspection, tne inspector shall summarize the findings with his/her appropriate NRC supervisor. This is especially important .if there are or are expected to be. controversial issues arising from the findings. J Inspectors shall also meet with regional licensing' staff when any- pertinent licensing issues are raised during the inspecuen, when inspection findings impact on any licensing actions. to discuss the licensee's PEF results, or to give feedback on how the licensee has addressed recent licensing actions. This meeting shall be documented in the field notes.
Additionally in some instances inspection findings will warrant communication with NRC licensing staff. enforcement staff. Office of. Investigations staff.
state liaison staff, and other Federal agencies with whom NRC has Memoranda of ,
Understanding (MOUs). l 1
The inspector will ensure that inspection findings are clearly documented, and l reported to the licensee as appropriate. The inspector shall also follow the requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and Records." regarding notifying the licensee that retained information is subject to public disclosure and giving the licensee the opportunity. to request l
L withholding it (see IMC 0620. Section 04.06.b,). ,
1 1
87118-03 INSPECTION GUIDANCE
! General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather, observations of. activities in progress equipment, facilities and use areas. etc. will be a better indicator i of the licensee's overall radiation safety program than a review of records 1
- alone.
Some of the, requirement and guicance sections of this procedure instruct the inspector to " verify" the adequacy of certain aspects of the licensee's program.
Whenever possible, verification should be accomplished through discussions, observations, and demonstrations.
In the records reviewed, look for trends such as increasing doses. Records such as surveys. waste disposal, receipt and transfer of radioactive materials.
training, and utilization logs may be examined randomly until the inspector is -
J satisfied that the records are being maintained and are complete. Other records !
that are more closely related to health and safety (such as personnel dose- i j monitoring records and incident reports) should be examined in detail . The type 1
- of records that were reviewed and the time periods covered by these records !
i should be noted in the appropriate " Basis for Findings" section(s) of the inspection field notes.
- ' Retain a copy of each pertinent record that is needed to substantiate an j
j inspection finding. such as a violatior. Those copies shall be attached to the inspection field notes or. when applicable. to a written inspection report. When l
an inspector identifies an apparent violation, he/she'should gather copies from the licensee while on-site of all records that are needed to support the apparent violation. In general, inspectors should use caution before retaining copies of licensee documents, unless they are needed to support apparent violations.
expedite the inspection (e.g.. licensee materials inventories). or make the licensing file more complete. 70 all cases where licensee documents are retained beyond the inspection follow the requirements of IMC 0620. Especially ensure that the licensee understands that the retained record will become publicly available, and give the licensee the opportunity to request withholding the information pursuant to the requirements of 10 CFR 2.790(b)(1).
l The inspector should keep the licensee apprised of the inspection findings ;
throughout the course of the inspection and not wait until the exit meeting. 1 Whenever possible the inspector should keep NRC management informed of !
significant findings (e.g. . safety hazards, willful violations. and other potential escalated enforcement issues) identified during the course of the ,
l inspection.
03.01 Preoaration. Prior to the inspection. the inspector should do the i following: l e Review the licensee's previous inspection history (at a minimum review the past two inspections). the license, and the status of any allegations or ,
incidents. Note the licensee's commitments in response to previous i violations for follow-up during the inspection: l 1
e Review regional event / incident logs, event / incident files, and the docket l file to determine whether the licensee was involved in any incidents. i recordable events, or misadministrations. If NRC did receive notification !
of an incident review that incident during the inspection and document j the licensee's follow-up in the field notes. 1 l
e In the field notes, complete the administrative information. the !
inspection compliance history. the listing of any license amendments or program changes since the last inspection, and the description of any incidents or events that have occurred since the last inspec ion:
e Determine the dates that the licensee submitted the most recent financial assurance instrument and decommissioning plan (1f applicable);
e Discuss the licensee's program with previous inspector (s) and/or license reviewer (s) as necessary; e Notify the appropriate State radiation control program personnel:
e Review pending licensing actions; e Obtain a map of the area and/or directions:
e Make travel arrangements and prepare itinerary; e Select calibrated instruments and perform source check; e Select appropriate documents; and e Select appropriate equipment to take.
Issue Date: XX/XX/XX 87118 l
i 1
in selecting the appropriate documents. the inspector should consider taking the ,
applicable regulations, field notes, generic comuniations, license. NRC forms. I etc.
In selecting the appropriate equipment the inspector should consider the licensed i activities to be inspected. '
1 During the inspection focus (among other areas) on whether the licensee is in compliance with any license amenoinents issued since the last inspection ~ uith any program changes described by the licensee since the last inspection. This requires review of documentation submitted in support of the licensing action. l before the inspection. The inspection represents NRC's first opportunity to l verify whether the licensee has enacted the most recent changes to the license. l 03.02 Entrance Briefino. After arriving on site, the inspector should inform the licensee's management representative of the purpose and scope of the inspection to be performed. This notification should be made as soon as practical after arriving on site.
However, in certain instances (e.g. . l unannounced inspections at hospitals which begin at early hours before management ;
arrives on site) the inspector may choose to inform the licensee of his/her !
presence on site following initial observations of licensed activities currently in progress.
The purpose of the entrance briefing is to inform. licensee management that an inspection is being conducted. and to indicate the tentative schedule for discussing or reviewing selected inspection items with various licensee staff personnel. However, in some instances. the inspector may only need to inform management of NRC's presence on site, and apprise management that an exit briefing will be conducted, at the end of the inspection, which will detail the inspection findings. ,
This is often an opportune time for the inspector to identify personnel to be interviewed. Scheduling interviews will enhance inspector efficiency and give the licensee the opportunity to have the most knowledgeable individuals present to respond in the areas being inspected.
Certain inspection i cms involving visual observations and/or records review are better performed unannounced: therefore, these types of items should not be discussed during the entrance briefing.
03.03 General Overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.
- a. Oraanization. The licensee's organizational structure will usually be found in the license application and may involve one or more individuals.
Determine the reporting structure between executive management. the RSO.
the Chairperson of the RSC, and the other members of the RSC. Determine whether the RSO has sufficient access to licensee mar 3gement. Through discussions with licensee staff. the inspector should determine if changes in ownership or staffing have occurred. If the owner or individuals named in the license have changed, determine whether the licensee has submitted appropriate notification to NRC. This information must be provided whenever changes in ownership or personnel are made. Ask licensee management if changes have occurred or are anticipated, and ask personnel to confirm (to the inspector's satisfaction) that no changes have taken place. If there have been no changes in the organization since the 87118 Issue Cate: XX/XX/XX
previous inspection. there is no need to pursue this element in further ,
detail.
The inspector- should review any organizational change in the RSO position, authorities, responsibilities, and reporting chains. The inspector should be sensit4ve to changes that redre the ability of the RSO to resolve concerns or issues related to the sofe conduct or the radiation protection i program. The inspector should ask licensee management and the RSO about I the RS0's authority and about any changes that may impact upon the RS0's-duties, responsibilities, or effectiveness.
- b. Scoce of Procram. Through discussions with licensee personnel, the inspector can obtain useful information about the types and quantities of . I material, frequency of use, incidents. etc. which can not always be gained j by reviewing records alone. This is also an opportunity for the inspector l to discern the actual size and scope of the licensee's program, and to - '
determine if significant changes have occurred since the previous inspection.
The inspector should determine if multiple places of use are listed on the ,
license. This information should be confirmed with knowledgeable onsite !
individuals. In cases where there are multiple sites / satellite j facilities, the inspector should determine if inspections should be l performed at all sites. This decision should be based on IMC 2800.
" Materials Inspection Program.'" and regional policy for performing inspections at satellite facilities.
If the licensee authorizes use at satellite facilities. the inspector should determine if the licensee's radiation safety program adequately :
controls use of materials and devices at all locations. If onsite visits :
are performed auring the inspection. the inspector should review all ,
aspects of the radiation safety program to verify that the radiation i safety programs at the satellite facilities are maintained in compliance .
with the radiation safety program described in the license application. !
- c. Manaaement Oversiaht. The inspection is a verification of the licensee's implementat.an of the required program. In the review to verify implementation, the inspector should pay particular attention to the scope of the program: frequency of licensee audits and the use of qualified auditors: procedures for recording and ' reporting deficiencies to management: and methods and completion of follow-up actions by management.
- 1. RSC - If an RSC is applicable to this licensee topics of discussion should include ALARA reviews, incidents generic communications, authorized users and uses, waste issues, audits, and !
misadministrations and recordable events, as defined in 10 CFR 35.2.
The RSC must consist of at least three individuals and must include an authorized user from.each type of use permitted by the license (if applicable, one of these authorized users should be directly involved with remote afterloader usage), the RSO. a representative from the nursing service. and a management representative who is neither the RSO nor an authorized user: and must meet at least quarterly. The inspector should review meeting minutes (and interview selected committee members when practical) to determine the committee's effectiveness.
Determine if the committee has been aggressive in seeking out areas needing improvement. rather that just responding to events and Issue Date: XX/XX/XX 13 - 87118
information from outside sources. Determine whether the RSC has recommended any specific actions and assess the implementation of those recommendations. The inspector's review should be of sufficient depth and detail to provide an overall assessment of the l committee's ability to identify. assess, and resolve issues. Also l consider the effectiveness of the RSC to comunicate the results audits and trending analyses to appropriate personnQer, -
licensed activities. [; de '
- 2. RSO - All medical licensees, including brachytherapy and remote afterloader licensees, must have an RSO. The RS0 is the individual.
appointed by licensee management and identified on the license, who is responsible for implementing the radiation safety program. The inspector should verify that this individual is knowledgeable about the program, and ensures that activities are being performed in accordance with approved procedures and the regulations. The inspector should verify that, when deficiencies are identified, the RSO has sufficient authority, without prior approval of the RSC. to implement corrective actions. including termination of operations that pose a threat to health and safety.
- 3. Audits - The frequency and scope of audits of the licensed program will vary. However, note that. at a minimum. medical institution licensees are required by 10 CFR 35.22(b)(6) to review the radiation safety program content and implementation at least annually. If applicable, the inspector should verify that the remote afterloader program is included in any programatic radiation safety audits. The results of audits should be documented. Examine these records with particular attention to deficiencies identified by the auditors, and note any corrective actions taken as a result of deficiencies found.
If no corrective actions were taken. determine why the licensee disregarded deficiencies identified during audits, and whether the lack of corrective actions caused the licensee to be in non-compliance with regulatory requirements.
- d. Authorized Users. Authorized users may either be named in the license application or be appointed by the 1icensee. For those appointed b, the licensee verify that the authorized user is trained in accordance with the approved criteria and has knowledge commensurate with operational duties.
The regulations in 10 CFR 35.11(b) allow an individual to receive, possess, use, or transfer byproduct material for medical use "under the supervision of" the authorized user, unless prohibited by license condition. These regulations do not specifically require that the authorized user be present at all times during the use of such materials.
The authorized user / supervisor is responsible for assuring that personnel under his/her supervision have been properly trained and instructed.
pursuant to 10 CFR 35.25(a), and is responsible for the supervision of operations involving the use of radioactive materials whether he/she is present or absent.
For remote afterloader programs, verify that the afterloaders are used by or under the direct supervision of an authorized user through direct observation and interviews or through review of utilization logs and written directives. It is important to note whether the appropriate individuals are present or available for assistance during treatments.
87118 !ssue Date: XX/XX/XX
03.04 Walk-Throuah Orientation Tour. The inspector should make initial ;
observations of licensed activities to determine that materials are being safely handled and that good health physics practices are folicwed. The inspector :
l should look at areas of use, storage, and disposal to make an initial assessment t l of the licensee's ALGA program with regard to facility design. engineering
! controls, house-keeping practices. etc. The inspector should ensure that observations of activities are documented in the inspection field notes.
03.05 Facilities i
- a. Recuirements for All Brachytheraov Licensees. Descriptions . of the facilities are generally found in the application for a license and subsequent amendments that are usually tied down to a license condition.
The actual or as-built facility should be configured to provide safe "
working areas se]arated from unrestricted areas and sufficient access controls to prec'ude unauthorized entry. The inspector should also be aware of potential i~dustrial safety hazards for referral to the U.S.
Department of Labor's Occupational Safety and Health Administration (OSHA).
- b. Additional Reauirements for Licensees with Remote Afterloaders. Veri fy !
that console keys are inaccessible to unauthorized persons. The inspector should keep an eye out for remote Tterloaders placed in treatment rooms :
with other radiation-producing devices and ask autnerized licensee personnel to demonstrate that only one device can be placed in operation at a time.
- c. Additional Reauirements for Licensees with Hiah . Medium-; and Pulsed-Dose Rate Remote Afterloaders. The inspector should ask an authorized licensee ;
representative to demonstrate that interlock systems are operational and ,
should inquire about what action is taken by the staff when the interlock !
systems are found to be non-operational . The inspector should also confirm that the backup system used to observe patients is operational and inquire about what action is taken by the 3taff when the backup system is non-operational.
- d. Additional Reauirunents for Licensees with Low-Dose Rate Remote Afterloaders. The inspector should visually confirm that the licensee has portable shields and should interview staff to confirm that the shields are used during procedures.
03.06 Eauioment and Instrumentation i
- a. Ra.diation Detection Eauioment. The inspector sho'uld be familiar with the radiation detection equipment that the licensee is required by regulation
.or license condition to have in its possession. The inspector should visually inspect the equipment and have a licensee's representative demonstrate that the equipment is operational. The inspector should ask ,
several staff members to deinonstrate how instruments are operated and how 1 daily checks are performed. The inspector should also ask what actions are taken when radiation detection equipment is non-functional.
- b. Inspectors should verify that licensees have procedures for identifying )
and reporting defects in accordance with 10 CFR Part 21. The complexity l of the procedures will vary. , j Issue Date: XX/XX/XX 87118
i l
C. Additional Reauirements for all Licensees wi" Remote Afterloaders The inspector should visually inspect the reraote afterloading device and/or any source storage devices to verify that only authorized devices are in use and that they are properly labelled.
The inspector should consider asklog the licensee's staff to demonstrate how the backup battery for the device and the source position indicators are checked for proper operation.
In reviewing the maintenance logs. the inspector should look for recurring problems / repairs and generic problems. If recurring problems are j identified, the inspector should note them in the field notes and if !
significant notify NHSS. The inspector should verify that the RSC is l aware of the problem and evaluate the action taken by the licensee to i address the problems. In renw.. 3 the reports. the inspector should 1 determine if any malfunctions should have been reported to the NRC .
pursuant to 10 CFR Part 21. j The inspector should also review the calibration log to verify that the l calibration procedures stated in the license application are followed. I The inspector should ask the licensee to demonstrate the actual perfonrance of the calibration procedures. l 03.07 Materials
- a. Receiot and Transfer of Licensed Materials. Depending on the size of the licensed program, the package receipt and transfer procedures (a few or many) will be found in the license application. These procedures should be carefully reviewed before an inspection is conducted. By discussions i with the 'Wnsee, determine if the procedures have been changed or j modi fied. ie changes will require a license amendment whereas other 1 minor chan9e (updating telephone numbers. editing procedures for clarity. !
etc.) may not require NRC approval. Randomly examine procedures used by I the licensee to determine if they are in accordance with those identified in the license application or if they warrant a license amendment. When practical, the records of receipt ar.d transfer should be compared with a physical inventory of materials possessed.
The procedures for picking up. receiving, and opening packages should include how and when packages will be picked up. radiation surveys and wipe tests of packages to be done upon receipt, and procedures for opening packages (such as the location in the facility where packages are received, surveyed, and opened). The procedures also should include what actions are to be taken if surveys reveal Jackages that are contaminated in excess of specified limits, and/or raciation levels that are higher than expected. If packages arrive during the course of an inspection, the inspector should, when practical, observe personnel perform the package receipt surveys. The inspector should randomly examine records of package -
surveys.
Examine the licensed materials accounting system. A relatively small I facility will generally need to maintain receipt records, disposal records, and records of any transfers of material. However, a large facility will need a sophisticated accounting system which provides accurate information on the receipt of material. its location, the quantity used and disposea of. the amount transferred to other laboratories operating under the same license, and the amount remaining 87118 Issue Date: XX/XX/XX
1 i
after decay. The accounting systems should also consider radioactive material held for decay-in-storage, near-term disposal, or transfer to other licensees. In both types of accounting systems, the licensee should perform routine audits to ensure the accuracy of the system. l
- b. Authorized Uses. Authorized uses of licensed material will be fou n ,
the licenses and license applications. Licenses will list the isotopes, physical or chemical forms, and the maximum possession limits.
Additionally, the inspector should verify that the licensee's use of byproduct material is limited to that which is authorized in the license. ,
- c. Inventories. Verify that the licensee is conducting a quarterly inventory of all sealed sources and brachytherapy sources in accordance with 10 CFR 35.59. The inspector should physically examine the inventory of ,
radioactive material on hand or examine records of receipt and transfer to determine that quantities and farms are as authorized. !
- d. Material Security and Control. Examine areas where radioactive materials are used and stored. Storage areas should be locked and have limited and controlled access. Radioactive material use areas should be under '
constant surveillance or physically secured. The licensee should have procedures for access controls. Controls may include a utilization log :'
to indicate when radioactive material is taken from and returned to storage areas. The inspector should verify that adequate controls are in place and working effectively.
- e. Additional Recuirements for Licensees with Remote Afterloaders. The inspector should review the method used by the licensee to confirm source homogeneity for sources used in the afterloading device. One acceptable ;
method is autoradiography.
03.08 Trainina ;
- a. General Trainina. Certain kinds of training and instruction are found in the regulations; how they are implemented will be found in the license. ,
Discuss with the licensee how, and by whom, training is conducted and the content of the training provided to workers (generally found in the .
license application). '
Verify. pursuant to 10 CFR 19.12. that instructions have been given to individuals who in the course of employment are likely to receive in a j year an occupational dose in excess of 100 mrem (1 mSv). Under the basic :
instructions, it is management's responsibility to inform the workers of l precautions to take when entering a restricted area, kinds and uses of !
radioactive materials in that area, exposure levels, and the types of j protective equipment to be used. The workers should also be informed of ;
the pertinent provisions of NRC regulations and the license and the i requirement to notify management of conditions observed that may if not corrected, result in a violation of NRC requirements. Also verify that authorized users and workers understand the mechanism for raising safety concerns.
l Of the training program elements in the license application, training ,
given to authorized users, and those individuals under the supervision of authorized users, is of primary importance. One or more users of radioactive materials should be interviewed to determine that they have received the required training, both in the basic instructions and in that specified in the license application. For some licensees this includes Issue Date: XX/XX/XX 87118 I
_~ . _ _ . _ __ _ _ _ _ _. _. _ . _ .
i specific training needed to perform infrequent ' procedures. Note that the ,
training should be (and in most cases is required to be) provided to
, workers prior to the individual's performance of licensed activities.
Randomly examine records of personnel training and tests (if applicable) !
j- to the extent that the inspector is satisfied that the training program '
is being implemented as required. Where examinations are required, read i
a few of the examination questions to ascertain that they are indicative ;
of what the worker should know to carry out his/her responsibilities.
The inspector should also observe related activities and discuss the radiation safety training received by selected individuals to assure that j approoriate training was actually received by these individuals. For interview nursing staff to verify that radiation safety l example, ;
instruction required under 10 CFR 35.410 is provided. Authorized users '
, and supervised individuals should understand the radiation protection :
recuirements associated with their assigned activities. The licensee's raciation safety training may include, but is not ' limited to, demonstrations by cognizant facility personnel, formal lectures. testing'.
films, and " dry runs" for more complex or hazardous operations. .
- b. Ooeratina Procedures. Operating procedures will be found in license
, applications and may vary from step-by-step procedures to more generalized procedures. The operating procedures will be approved by the NRC and i reviewed and updated by the licensee. Minor changes in radiation safety 1 procedures may be made in accordance with 10 CFR 35.21(b)(6) or 35.31. '
Any major revision requires an amendment to the license in accordance with ,
10 CFR 35.13. The inspector should examine records of procedure :
1 revisions.
The inspector should interview staff to determine if they are aware of the I
- location of the operating procedures and if they follow the operating ,
i procedures. In particular, the inspector should place emphasis on ;
i determining if radiation surveys of the device and the patient are performed after a procedure is completed. ;
- c. Emeraency Procedures. Emergency procedures will be found in license !
applications and may vary from step-by-step procedures to more generalized procedures. The emergency procedures will be approved by the NRC and ,
i
. reviewed and u) dated by the licensee. For remote afterloaders, the inspector shou'd verify that each operator has received a copy of the emergency procedures and that the procedures are posted at the afterloader console.
Some licensees may have agreements with other agencies (i.e., fire. law
, enforcement, and medical organizations) regarding response to emergencies.
Discuss with the licensee's representatives what has been done to ensure that agencies (involved in such agreements) understand their roles in emergency responses.
. 03.09 Ooeration of Remote Afterloaders
- a. Doeratina Procedures Conynon to All Remote Afterloaders. For remote afterloaders, the inspector should verify that afterloader devices and the associated sources are approved, authorized on the license, properly labeled and: that device calibrations are only performed by qualified authorized individuals (medical physicists): that device calibration measurements were performed following installation of a new source, before-4711R .1A. Tuiio nat o- YY/YY/YY
patient treatment and monthly thereafter; verify that the a fterloader is inspected annually.
- b. Ooerations Soecific to Hich . Medium . and Pulsed-Do2 Rate Remote Afterloaders. The inspector should confirm by observation and/or interviewing staff that at least one individual trained in the safe use of the device and who has practiced the emergency procedure for use of the device. is physically present whilt the device is in use. In addition, confirm that both the authorized user and either a medical physicist or radiation safety officer are physically present while the device is in use. For the purpose of this IP physically present is defined as within audible range of normal human speech.
. c. Doerations Soecific to Low-Dose Rate Remote Afterloaders. The inspector should confirm by observation and or interviewing staff that at least one device operator trained in emergency procedures is physically present at the licensee's facility or available by telephone during device use. In i addition, confirm that the medical :)hysicist or radiation safety officer and the authorized user is available for prompt assistance in the event that a source appears to have decoupled or becomes Jamed in the catheter guide tube.
The inspector should review the written instructions that are provided to nurses prior to use of the afterloading device. As part of this review. l the inspector should attempt to interview nurses that have been involved l in treatments using the device to determine their familiarity with the !
instructions.
- d. Emeraency Procedures Comon to All Remote Afterloaders. The inspector ,
should determine if any incloents have occurred at the facility that i resulted in staff implementing facility emergency procedures. If so, the !
inspector should interview the staff that was involved in the procedures and determine how the incident was handled. In particular, the inspector should determine if NRC was notified and if not, why not.
The inspector should interview staff regarding the anticipated actions that would be taken in an emergency situation. In part.cular the inspector should determine if staff is aware of the requirement to carry a functional radiation detection devices into the room if the room monitor is non-functional. The inspector should determine if the staff is aware of the location of the alternative radiation detection devices since in an emergency the staff would not have time to look for the monitor.
The inspector should also interview staff to determine if they are aware of the location of emergency source recovery equipment. At a minimum, emergency equipment should include shielded storage containers, remote handling tools, and if appropriate, supplies necessary to surgically remove applicators or sources from the patient. including scissors and cable cutters.
03.10 Area Radiation and Contamination Control
- a. Area Surveys. By interviews and review of records, the inspector should examire the licensee's performance in conducting timely patient and area surveys for brachytherapies (both permanent and temporary implants) as well ac source removal and patient release and room release surveys. For most brachytherapy procedures, a radiation survey must be performed of the patient immediately after source removal. In addition to timely surveys.
Issue Date: XX/XX/XX 87118
for afterloaders, the inspector 5hould 50 verify that back up batteries for the source retract systems are tested monthly and that source position indicators are checked periodically.
The inspector may ask the licensee to spot check radiation levels in selected areas, using the licensee's own instrumentation. For example.
if a brachytherapy procedure is currently going on, make measurements in adjacent unrestricted areas to confirm that the requirements of 10 FR 20.1301 are met. However, the inspector must use NRC's instruments for independent verification of the licensee's measurements.. (The inspet.t.or's instruments shall be calibrated and source checked before he/she leaves the regional office.)
If practical, observe how licensas conduct surveys to determine the adequacy of surveys. Note the types of instruments used, and whether they are designed and calibrated for the type of radiation being measured.
Also, for remote afterloader programs the inspector should verify through interviews and/or record reviews that the licensee has performed surveys following source changes device repair, or device maintenance.
- b. Leak Tests. Through discussions with licensee personnel and/or by demonstration of leak test procedures. the inspector should verify that leak tests are performed in accordance with 10 CFR 35.59.
- c. Protective Clothina. Observation of the arotective clothing worn by brachytherapy personnel or other applicab'e staff during their work activities should provide the inspector with an acceptable means of reviewing this requirement Requirements for protective clothing may be found in the licensee's procedures or in precautions posted at the entrance to controlled areas.
03.11 Radiation Protection. Specific guidance is set forth in IP 83822.
" Radiation Protection."
NOTE: Inspection guidance for 10 CFR 35.75, patient release criteria is being revised by IMNS and is being separately transmitted for comment.
10 CFR 19.13(b) requires that each licensee shall advise each worker annually of the worker's dose as shown in dose records maintained by the licensee. Verify through discussions with workers and management, and through records review, that the licensee has advised workers of their doses annually. The licensee must advise all workers for whom monitoring is required (and, therefore, dose records are required). The licensee must advise these workers of internal and external doses from routine operations, and doses received during planned special exposures, accidents and emergencies. The report to the individual must be in writing and must contain all of the information required in 10 CFR 19.13(a).
! 03.12 Quality Manaaement Proaram NOTE: This section is being revised by IMNS and is being separately transmitted for coment.
03.13 Waste Manaaement
- a. Waste Storaae and Discosal . Verify that the waste is arote:ted from fire and the elements. that package integrity is adequate'y maintained. that the storage area is properly ventilated. and that adequate controls are 87118 Issue Date: XX/XX/XX
in effect to minimize the ris( from other nazardous materials. Veri fy that the licensee has appropriate methods to track the items iri storage.
Inspection effort should be directed at verifying that written procedures have been established in a manner approved by management. The procedures should be readily available to any persons having resoonsibility for low-level waste classificat'on and preparation for transfer of such wastes to land disposal facilitim.
For further in.gection guidance, refer to IP 84850. " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61."
- b. Transfer. Ascertain if the licensee has an adequate method of determining that recipients of radioactive wastes are licensed to receive such waste (i.e.. licensee obtains a copy of the wsste recipient's current license prior to the transfer). Generally, sources used for brachytherapy. ;
including seeds and ribbons are returned to the manufacturer. Sealed ;
sources, used in afterloaders, are exchanged upon receipt of a new source. 1 1
- c. Records. Each licensee is reo; ired to maintain records of the disposal ;
of licensed material made unde'r 10 CFR 20.2002-2005.10 CFR Part 61. and >
disposal by burial in soil. These records must be retained until the ,
Comission terminates each pertinent license requiring the record. The l inspector should review these records to verify that disposals are made l in accordance with the applicable regulations, and that records are complete and accurate for each type of disposal.
- d. Financial Assurance and Decomissionino. The decomissioning record-keeping requirements are applicable to all materials licensees, including licensees with only sealed sources, and are specified in 10 CFR 30.35(g).
These records should contain, among other information: (1) records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment or site (when contamination remains after cleanup. or when contaminates may have spread to inaccessible areas); (2) as-built drawings and modifications of structures and equipment it, restricted areas where radioactive materials are used ancor stored, and locations of possible inaccessible contamination: (3) except for areas with only non-leaking seaied sources or byproduct materials with i half lives of less than 65-days, a single document detailing restricted areas and formerly restricted areas, buried waste, areas requiring decontamination that are outside of restricted areas and areas outside of restricted areas that, if the license expired, would have to be decontaminated or approved for disposal: and (4) records of the cost estimate performed for a decomissioning funding plan or the amount certified for decomissioning. This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). On all inspections, including inspections of sealed source licensees. the inspector should ensure that the licensee has such decomissioning records, that the records are complete. that they are updated as required.
and that the decomissioning records are assembled or referenced in an identified location.
Some licensees may release laboratories or other rooms within a building for unrestricted use, without a license amendment. The release of these areas may fall outside of the reporting requirements in the Decomissioning Timeliness Rule if the licensee continues to conduct other activities in the same building. Inspectors should identify the rooms Issue Date: XX/XX/XX 87118
a - -. - --A- J.l-..A-. +_& 4- ---a-. - aA+- . +- = * < - - - - --
, that have been released since the last inspection and perform conf' matory measurement.s to verify that radiation and contamination levels are below release limits. Licensee survey records and other documentation should be reviewed to verify that the basis for releasing each room is.adequat documented in the licensee's decommissioning records. [ g
! Licensees submit financial assurance instruments and/or decommissioning plans for a specific set of conditions. Occasionally, those conditions may change over time and the licensee may not notify NRC. The inspector should be aware of changes in radiological conditions while inspecting a licensee's facility that would necessitate a change in the financial assurance instrument and/or decomissioning plan, especialy where the radiological conditions deteriorate and the financial assurance instrument or decomissioning plan may no longer be sufficient. In preparation for the inspection, the inspector should determine the dates that the financial assurance instrument and decomissioning plan (if applicable) were submitted to NRC. Then during the inspection. through observations, discussions with licensee 3ersonnel, and records review, the inspector should determine whether t1e radiological conditions at the licensee *s facility have changed since the documents were submitted to NRC. If conditions have changed and the adequacy of the financial assurance 1 instrument and/or decomissioning plan is in doubt, the inspector should i immediately contact regional management from the licensee *s site to I discuss the situation.
Additionally, some licensees are required to maintain decomissioning cost i estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as a funding method the inspector should verify that the licensee has a Certified Public Accountant certify each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in l Section II. Appendix A and Appendix C. respectively, to 10 CFR Part 30.
- e. Decomissionina Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license r eains in effect. determine if the licensee has made a decision to cease principal activities at the site or in any separate building. Finolly. l determine if there has been a 24-month duration in which no principal activities have been conducted in such areas. A principal activity is one which is essential to the purpose for 'which a license was issued or l amended. and does not include storage incidental to decontamination or i decomissioning. If the licensee meets any of the above conditions. the decommissioning timeliness requirements apply.. and the inspector must complete the "Decomissioning Timeliness Inspection Field Notes."
Attachment A to Appendix A.
The requirements of 10 CFR 30.36. 40.42, and 70.38 do not apply to l released rooms within a building where principal activities are still on-l going in other parts of the same building. However, in those cases, the inspector should follow the guidance in 03.13.d. regarding confirmatory measurements of the released area. Once principal activities have ceased in the entire building, then the decomissioning timeliness requirements will take effect.
I The Decommissioning Timeliness Rule became effective on August 15. 1994.
In completing the Attachment A field notes, specific guidance is needed regarding the timing of the notification requirements. If the license has l
expired or been revoked, or if the licensee has made a decision to L 87118 - ?? - Tuno Ono- Xt/XY/XX
permanently cease-principal activities. and the licensee orovided NRC notification before Auaust 15. 1994 then August 15. 1994 1s considered to be the date for initiating the decommissioning calendar (i.e. . date of notification) If there has been a 24-month duration in which no principal activities have been conducted at the location before the effective date of the rule, but tM licensee did not notify NRC. then the 24-month tirre period of inactivity is considered to be initiated on August 15, 1994. and the licensee must provide notification to NRC within either 30 or 60 days of August 15,1996 (depending on whether the licensee requests a delay).
NRC has a stringent enforcement policy with respect to violations of the decomissioning timeliness requirements. Failure to comply with the Decommissioning Timeliness Rule (failure to notify NRC failure to meet decommissioning standards, failure to complete decommissioning activities in accordance with regulation or license condition. or failure to meet required decomissioning schedules without adequate justification) may be classified as a Severity Level III violation and may_ result in consideration of monetary civil penalties or other enforcement actions, as appropriate.
Decomissioning timeliness issues can be complex. For situations where an inspector has questions abou' 'S? licensee's status and whether the decommissioning timeliness standards apply, he/she shccid immediately contact regional management.
For planning and conducting inspections of licensees undergcing decomissioning, refer to IMC 2602. " Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees:" IP 87104
" Decommissioning Inspection Procedure for Materials Licensees:" and the draft Decommissioning Manual Chapter and Handbook.
03.14 Transoortation. If applicable, the inspector should review: the licensee's hazardous material trair.ing: packages and associated documentation:
vehicles (including placarding. cargo blocking and bracing, etc.); shipping papers. and any incidents reported to DOT. This is an ideal area for the inspector to make obser,ations of licensee practices. The ' DOT and NRC regulations for transportation of radioactive materials were recently revised, and the revisions generally became effective April 1.1996.
For further inspectica guidance, refer to IP 86740. " Inspection of Transportation Activities." Inspectors should also refer closely to " Hazard Comunications for Class 7 (Radioactive Materials)." the NRC field reference charts on hazard comunications for transportation of radioactive materials, which contain >
references to the new transportation requirements and are useful field references for determining compliance with the transportation rules on labeling, placarding, shipping papers, and package markings.
03.15 Postina and labelina. The inspector should determine whether proper caution signs are being used at access points to areas containing radioactive materials and radiation areas. 10 CFR 20.1903 provides exceptions to posting caution signs. When applicable. the inspector should randomly examine signals and alarms to determine operability. The inspector should also randomly observe labeling on packages or other containers to determine that proper information (e.g.. isotope. quantity. and date of measurement) is recorded.
I s
Areas with radiation hazards should be conspicuously posted. as required by 10 CFR 20.1902. Depending on the associated hazard, controls may include tape.
1 Issue Date: XX/XX/XX 87118
]
1 rope or structural berriers to prevent access. High radiation areas should be strictly controlled to prevent unauthorized or ina6ertent access. Such controls may incLde, but are not limited to. direct surveillance, locking the high Ndiation area, warning lights, and audible alarms. Areas occupied by radiation vorkers for long periods of time and common-use areas should be controlled in accordance with licensee procedures end be consistent with the licensee's ALARA program.
The inspector should also examine locations where notices to workers are posted.
Applicable documents, notices, or forms should be posted in a sufficient number of places to permit individuals engaged in licensed activities to observe them on the way to or from any particular licensed activity location to which the posting would apply.
03.16 Generic Comunications of Information. Through discussions with licensee management and the RSO. the ' inspector should verify that the licensee is receiving the applicable bulletins, information notices. NMSS Newsletter, etc. .
and that the information contained in these documents is disseminated to appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC comunications, when a response is required.
03.17 Notifications and Reoorts. Through discussions with licensee personnel dnd by a review of representative records, the inspector should verify the licensee's compliance with submitting notifications and reports to the Commission. The licensee may be required to make notifications after loss or theft of material, overexposures, incidents, misadministrations and recordable events, high radiation levels, safety-related equipment failure etc.
03.18 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of equipment used by the licensee. In these instances. the inspector should verify that the licensee understands the . additional requirements, and maintains compliance with the special license conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC requirement.
03.19 Indeoendent and Confirmatory Measurements. Confirmatory measurements are those whereby the inspector compares his/her measurements with those of the licensee *s. Independent measurements are those performed by the inspector independently of the licensee's measurements. The inspector should perform independent and confirmatory measurements in restricted and unrestricted areas of the licensee's facility. Independent measurements should be performed on all inspections, unless exceptional circumstances make it impossible to perfe:m the measurements (e .. inspector's detection equipment malfunctions during an inspection trip). Measurements of dose rates at the boundary of the unrestricted areas should be performed at the surface of the most accessible plane. In addition, measurements should be taken in licensed material use and storage areas. To perform the independent or confirmatory measurements, use NRC radiation detection instruments that are calibrated at least as frequently as required for the licensee being inspected.
03.20 Exit Meetina. When the inspection is over, there should be an exit meeting with the most senior licensee representative present at the facility.
If a senior management representative is unavailable for the exit meeting, the inspector may hold a preliminary exit meeting with appropriate staff on site.
However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO, if not present at the preliminary exit 87118 -N- ic<no nato- YY/YY/YY j m
meeting) as soon as practical after the inspection. 'This meeting will usually be performed by telephone conference call During the exit meeting. the licensee representatives should be told the preliminary inspection findings, including any negative PEFs. any apparent violations of regulatory requirements any safety-related concerns, or unresolved items identified during the inspection. and the status of any previously identified violations. The licensee must immediately address any significant safety concerns.
If the inspector identifies safety concerns or violations of significant regulatory requirements that affect safe operation of a licensee facility. the licensee must initiate prompt corrective action. The inspector should not leave the site until the concern is fully understood by the licensee and corrective action has been initiated. If the inspector and the licensee disagree over how significantly the concern impacts contin;ed safe operation of the facility.
regional management should be notified imediately.
While deficiencies identified in some areas (e.g. , workers' knowledge of the Part 20 requirements) are not always violations, the inspector should bring such deficiencies to the attention of licensee management at the exit meeting and.also in the cover letter transmitting the inspection report or NOV.
03.21 Post InsDection Actions. Regional office policy will dictate with whom the inspector will review his/her inspection findings (e.g. the inspector's supervisor), following the guidance in IMC 2800. The inspector should discuss the findings in the detail that is comensurate with the scope of the licensee's program. Violations, items of concern (e.g. , negative PEFs). and unresolved items should be discussed in sufficient depth for management to make appropriate decisions regarding enforcement actions, referral to other State and Federal agencies, and decisions on the scheduling of future inspections of the licensee's facility.
The inspector should also discuss insaection findings with licensing staff. This information exchange can be particularly useful if the licensee is having its license renewed or has recently submitted a license amendment request. The inspector should inform licensing staff about how the licensee has addressed (or failed to address) special license amendments or recent licensing actions.
Licensing information requested by the licensee should also be discussed with the licensing staff.
Inspectors should be aware that NRC has er r ered into several MOUs. with other Federal agencies, that outline agreements on items such as exchange of information and evidence in criminal proceedings. The inspector should ensure that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.
The inspector may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following -
the guidance in IMC 2800. The inspector must also ensure that the findings are documented in the inspection field notes and/or inspection report, in sufficient detail for the reader to determine what requirement was violated, how it was violated who violated the requirement and when it was violated. Copies of all licensee documents needed to support the violation should be attached to the inspection field notes and/or inspection recort. The field notes should not be used as merely a checklist to note areas reviewed, but should be used to describe what procedures or activities were observed and/or demonstrated by the licensee Issue Date: XX/XX/XX 87118
~
during the inspection, and any items of concern ide"ified that were not cited as a violation of regulatory requirements.
Inspectors may complete the field notes either by hand or electronically. If the inspector is documenting the field notes in electronic format, the sub-items under ma However,jor thesections heading that are not(e.g..
itself applicable or not reviewed may be deleted.
' Radioactive Waste Management." or
" Transportation") should remain in the field notes, and the inspector should enter appropriate remarks about why the section is not applicable or not reviewec.
For further inspection guidance, refer to Section 07.04 of IMC 2800.
87118-04 REFERENCES A listing of IMCs and IPs. applicable to the inspection program for materials
. licensees, can be found in Section 2800-11 of IMC 2800. These documents are to be used as guidelines for inspectors in determining the inspection requirements for operational'and radiological safety aspects-of various types of licensee activities.
Specific references to regulatory requirements can be located in the
" Brachytherapy Inspection Field Notes" appendix to this IP.
END.
Appendix:
A. " Brachytherapy Inspection Field Notes"
~
87118 Issue Date: XX/XX/XX
1 1
DRAEL l
i 1
I ATTACHMENT 4 l APPENDIX A ;
BRACHYTHERAPY INSPECTION FIELD NOTES i
n . . , , . . . . . . - ~ - . -
.m ._. . ___ _ _ _ _ _ _ _ - _ _ . . _ _ _ _ _ . _ _ _ _ _ . _ . . . . _ . _ _ _
APPENDIX A-
{f(
BRACHYTHERAPY INSPECTION FIELD NOTES Region Inspection Report No. License No.
Licensee (Name and Address): Docket No.
l Licensee Contact (s) Telephone No.
Amendments Issued Since Last Inspection: (Numbers) ,
Dates of Above Amendments:
Priority L
Program Code:
( ) 2120 Medical Institution - OMP Required
( ) 2230 High Medium . and Pulsed-Dose Rate Remote Afterloaders
( )-2231 Mobile High , Medium and Pulsed-Dose Rate Remote Afterloaders
( ) Other Date of Last Inspection Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced
( ) Routine ( ) Soecidl
( ) Initial ( ) Reinspection j Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended 1
Justification for change in normal inspection frequency:
J Summary of Findings and Action:
( ) No violations. Clear NRC Form 591 or regional letter issued
( ) Violation (s). Form 591 issued
( ) Violation (s), regional letter issued
( ) Follow-up on previous violations i l-
, Inspector: Date (Signature)
Approved: Date '
(Signature)
Issue Date: XX/XX/XX A-1 87118. Appendix A
3
,f J
Field notes are to be used by the inspector to assist with the performance l Of the inspection. Note that all areas indicated in the field notes are not required to be addressed during eau inspection'. However. ' for those areas ;
not covered during the inspection. a notation ("Not Reviewed") should be i made in each section where applicable. Additionally. all areas covered :
during the inspection should be documented in sufficient detail to describe what activitles andfor records the inspector observed. For example the !
. types of records that were reviewed and the time periods covered by these records should be noted in the appropriate " Basis for Findings" section(s). ,
if the licensee demonstrated any practices at your request. describe those }
demonstrations. The observations and demonstrations, you describe in this l report. along'with measurements and some rec'ros review. should substantiate i your inspection findings.
l
- l
- 1. INSPECTION. LICENSING. AND INCIDENT HISTORY
'A. Violations were identified during any of the last two inspections or two years. .
whichever is longer. (N/A ' Initial insp.) ( ) N/A ( ) Y ( )_ N
- 8. Response letter (s) or Form 591(s) dated C. Violations from previous inspection (s):
REQUIREMENT CITED STATUS D. Any repeat violation (s) identified? )Y()N If "Yes." explain:
l 87118. Appendix A A-2 Issue Date: XX/XX/XX
l J. Describe the licensee's follow-up in response to the events / incidents listed in 1.H.
i l
l Basis for Findings:
l l
l i
- 2. ORGANIZATION AND SCOPE OF PROGRAM I 1
A. Describe the licensee's organizational structure to indicate the l
" chain-of-command" from senior management to authorized users of :
licensed material, Show or describe where the RSO and Chairperson ;
of the RSC. if applicable, are located in the licensee's organization and to whom they report.
87118. Appendix A A-4 Issue Date: XX/XX/XX
l d
j B. Identify licensee personnel contacted during the inspection
- (including those individuals contacted by telephone).
Use the following identification symbols:
- # Individual (s) present at entrance meeting
- Individual (s) present at exit meeting
+ Individual (s) contacted by telephone
! C. Authorized for multiple locations of use ()Y()N i If "Yes." list locations inspected:
1 L
Are all locations listed on the (1) license [L/C]'? ( ) N/A ( ) Y ( ) N i (2) Were onsite inspections performed at j each location? ( ) N/A ( ) Y ( ) N
~
- 0. Authorized for use at satellite facilities ()Y()N t If "Yes," list satellite facilities inspected:
i
! (1) Are all satellite facilities listed on i the license [L/C)? ( ) N/A ( ) Y'( ) N l
- (2) Were onsite inspections performed at ,
s each location? ( ) N/A ( ) Y ( ) N 4
E. Briefly describe scope of activities, including i types and quantities of use involving licensed -
i material frequency of use. staff size, etc.
i l
.i l
I Here and throughout the field notes. "L/C" means " license condition." j Issue Date: XX/XX/XX A-5 87118. Appendix A
. _ - . - ._. _ _ _ __.- ,_ ~ _ _.
t f
- 3. MANAGEMENTOVERSIGH1 7 A. Radiation Safety Committee (RSC) [35.22. L/C] ( ) N/A (1) RSC fulfills license requirements [L/C] ()Y()N ,
(2) Membership as specified [35.22(a)(1)] ()Y()N (3) Meetings 1 eld quarterly [35.22(a)(2)] ()Y()N (4) Quorums established [35.22(a)(3)] ()Y()N
, (5) Records of meetings maintained l
[ 35.22(a)(4). L/C] ()Y()N ,
(6) Has sufficient authority [35.23] ()Y()N (7) Approve / disapprove credentials of individuals. ,
prior to allowing them to work as authorized ;
users [35.22(b)(2)(ii)] (-) Y ( ) N.
j (8) RSC approved use of afterloader and -
reviews use at RSC meetings [35.22] ( ) N/A ( )'i t )N (9) RSC reviews use of afterloaders in annua' program auait [35.22. 20.1101] (-) N/A (-) Y ( ) N (10) RSC us implemented corrective actions [L/C] ( ) N/A ( ) Y ( ) N
- 8. Radiation Safety Officer [35.21]
(1) Appointed [35.21(a), 900) ( ) Y (-) N (2) Authorized on license [L/C] ()Y()N (3) Fulfills duties per [35.21(b)] ( ) Y.( ) N (4) Has sufficient authority per [35.23] ()Y()N C. Radiation Safety program (1)- Minor changes pursuant to [35.31] ( ) N/A ( ) Y ( ) N (2) Records of changes maintained [35.31(b)] ( ) Y'( ) 4 D. Audits, Reviews. or Inspections [35.22(b)(6)]
(1) Audits are required [L/C] .
()Y()N ;
(2) Audits or inspections are conducted ()Y()N Audits conducted by Frequency ,
Scope of audits (3). Review of ALARA program ()Y()N (4) Content and implementation of the radiation protection program reviewed annually by the licensee [20.1101(c), 35.22(b)(6)] ()Y()N-(5) Records of reviews maintained [20.T.O.:] ()Y()N 87118. Appendix A A-6 issue Date: XX/XX/XX
i E. Authorized Users 1
3 g c=[
%'tf
( ) Y'( ) N
^
(1) Certified per [35.940(a)] OR meets requirements in [35.949'.b)]
(2) For ophthalmic use of Sr-90 only, meets requirements in [35.941] ( ) Y-( ) N l
(3) Names of users
- Basis for Findings:
i
, 4. . FACILITIES
) A. Facilities as described in license application [L/C] ()Y()N (1) Maintenance of safety-related components-performed by authorized persons [L/C] ()Y()N
! (2) Access to keys and/or material controlled and/or secured to prevent unauthorized access 3 ^[20.1801. 1802. L/C] ()Y()N !
Access to high/very high radiation areas
~
(3) i controlled [20.1601. 1602 L/C] ()Y()N
! (4) Adequate protection of shield integrity. l l fire protection [L/C] ()Y()N l
- f. B. Facilities with remote afterloading device (s) ( ) N/A
! (1) General requirements
! (a) Devices are authorized by license ()Y()N (b) Device. sources, and keys are stored against unauthorized use and removal
[20.1801. 1802] ()Y()N i (c) Devices used in authorized locations ()Y()N i
'(d) Unauthorized individual (s) prevented ,
from entering use area [L/C] ()Y()N i
- (e) Only one radiation device can be 4 placed in operation at a time within one treatment room [L/C] ( ) N/A ( ) Y-( ) N "
(f) Devices and places of use or-storage i properly labelled and/or posted
[20.203. 1902. 1905] ()Y()N l (2) High . medium, or pulsed-dose rate remote afterloaders ( ) N/A (a) Use is limited to locations approved in license [L/C] ()Y()N i Issue.Date: ~XX/XX/XX A-7 87118. Appendix A
. . ~ - . .. . . .
I l
(b) De.11cated treatment rooms are equipped with continuous viewing and intercom systems [L/C] ()Y()N (c)- Viewing and intercom systems are checked at the beginning of each day of use [L/C] ()Y()N Back-up system is available to observe
-(d) patients during treatment [L/C] ()Y()N If "No." treatments are suspended ()Y()N ,
(e) Electrical interlock system !
installed at each entry [L/C] ()Y()N
( f) Interlock is operational ()Y()N (g) Once activated donr interlock must be reset [L/C] ()Y()N (h) Interlock operation tested daily [L/C] ()Y()N (1) Records of interlock operaticn are maintained for 3 years. )Y()N (3) Low-dose rate remote afterloaders ( ) N/A (a) Devices are used in locations within a single building approved on license [L/C] ()Y( )N (b) Portable shields are available for use [L/C] ( ) Y (-) N (c) Licensee has capability to monitor patient during treatment [L/C]. ()Y()N Basis for Findings:
- 5. EQUIPMENT AND INSTRUMENTATION
~
A. Survey Instruments used to show compliance with Part 35 (1) Appropriate operable survey instrumentation possessed and readily accessible [L/C. 20.420] ()Y()N (2) Calibrated as required [20.1501, 35.51. L/C] ()Y()N (3) Calibration records maintained [20.2103(a)] ()Y()N j 1
i B. Radiation Detection Equipment (1) Permanent radiation monitor - All afterloaders l l
excapt inw-dose rate ( ) N/A (a) Monitor is installed in dedicated treatment room [L/C] ()Y()N Make: Model:
87118, Appendix A A-8 Issue Date: XX/XX/XX !
I
i ry , um (b) Monitor has/does the following [L/C): LS T .:. - "i ;
(i) Visible retice when source is exposed or partially exposed ()Y()N i (ii) Visible to someone entering room (.) Y ( ) N (iii) Has backup power supply separate l from power supply to afterloader ()"')N-(c) Monitor operation is checked daily before use [L/C] ()Y()N i (d) Records of monitor checks are maintained ;
for 3 years ()Y()N (2) Portable survey instruments used with remote !
afterloaders ( ) N/A >
(a)- Meters required by [35.420] ()Y()N l (b)- Meter range is adequate [L/C] ()Y()N ,
(c) Meters are calibrated before.first use. t annually and following repair ;
[L/C. 35.51] ()Y()N ;
(d) Meter checked with dedicated .
check source daily before use [L/C]. ()Y()N ;
C. Remote afterloaders I (1) Equipment checks (a) Back-up battery (source retraction) l is tested monthly for operation [L/C]' ()Y()N -
(b) Source position indicators are checked :
periodically [L/C] ()Y()N (2) Maintenance (a) Only authorized individuals perform maintenance, repair and inspection [L/C] ()Y()N (b) Records of maintenance, inspection, and service maintained for duration of device use [L/C] ()Y()N (c) Afterloaders inspected annually [L/C] ()Y()N (d) Manufacturer's schedule for service is followed [L/C] ()(()N Frequency: ,
Date of last service:
i Issue Date: XX/XX/XX A-9 87118. Appendix A
(3) Calibration
$_ (a) Only qualified or authorized individuals 4 perform cali._ ations [L/C] ()Y()N L (b) Device calibration measurements i are performed following installation of i-
-. e source, before. patient treatment and monthly therearter [L/C) ( ) Y ( ).N Date of last source replacement:
Date of last monthly calibration:
D. Dosimetry system (1) Calibrated by NIST or AAPM lab.
every two years [L/C] ()Y()N Last date of calibration:
E. Emergency equipment (Shielded containers. ( ) N/A ( )Y ( ) N remote handling tools, scissors. cable cutters etc.)' possessed as required [L/C]
F. Procedures established to identify and report safety component defects [21,21] ()Y( )N Basis for Findings:
- 6. MATERIALS RECEIPT. USE. TRANSFER. AND CONTROL A. Isotope, chemical form quantity and use as authorized [35.400. L/C] ()Y()N ,
B. Remote afterloaders ( ) N/A ( ) Y ( ) N (1) Approved sources are used/ possessed [L/C] ()Y()N (2) Source homogeneity is confirmed [L/C] ( ) N/A ( ) Y ( ) N
-(3) Afterloaders and storage devices are properly labelled [L/C] ()Y()N (4) Source installation and replacement by authorized individuals only [L/C] ( ) N/A ( ) Y ( ) N -
C. Manual Brachytherapy ( ) N/A
'1) Safety precautions implemented to include patient facilities, posting. stay times.
and area radiation level surveys-[35.415. L/C] ()Y()N' (2) Patients surveyed immediately after implant (35.406] ()Y()N 87118. Appendix A A-10 Issue Date: XX/XX/XX
(3) Patients released in accordance with
[35.75] release limits ( ) N/A ( ) Y ( ) N (4) Patients surveyed immediately after removing the last temocrary implant source (required for all manual. LDR.
MDR and HDR therapies) [35.404(a)] ( ) N/A ( ) Y ( ) N (5) Records maintained
[35.404(b). 406(d). 415(a)(4)] ()Y()N D. Licensed materials secured to prevent unauthorized removal or access
[20.1801. 1802] ( ) N/A ( ) Y ( ) N (1) Licensed material in storage in controlled or unrestricted areas is secured from unauthorized removal er access [20.1801] ()Y()N (2) Licensed material in controlled or unrestricted areas and not in storage is controlled and under constant surveillance [20.1802] ()Y()N (3) Access to restricted areas is limited
[20.1003). ()Y()N E. Describe how packages are received and by whom:
W l
- F. Written package opening procedures established i and followed [20.1906(e)] ()Y()N G. All incor'ng packages with DOT labels wioed, unless exempted (special form) [20.1906(b)(1)] ()Y()N i H. Incoming packages surveyed per [20.1906(b)(2)] ()Y()N I. Monitoring in (G) and (H) above, performed within ()Y()N l time specified [20.1906(c)] I J. Transfer (s) of licensed material per [30.41) ()Y()N K. All sources surveyed before shipment and transfer '
[20.1501(a). L/C) ()Y()N L. Records of surveys and receipt / transfer maintained
[20.2103(a) 30.51) ()Y()N :
M. Transfers among licensee's authorized users or locations performed as required [L/C] ( ) N/A ( ) Y ( ) N N. Arrangements made for packages containing quantities of radioactive material in excess of Type A quantity [20.1906(a)) ( ) N/A ( ) Y ( ) N Issur Date: XX/XX/XX A-11 87118. Appendix A )
b O Package receipt / distribution activities ;
evaluated for compliance with !
20.1301 (20.1302] ( ) N/A ( ) Y ( ) N Basis for Findings:
P 7 TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers / students [19.12] ()Y()N B. Training program required [L/C) ()Y()N (1) If so, briefly describe training / retraining l program: :
l I
(2) Training program implemented ()Y()N '
(3) Periodic training program required ()Y()N ;
(4) Periodic training program implemented ()Y()N ;
(5) Records maintained ()Y()N C. Individual's understanding of procedures and i regulations is adequate ()Y()N 1 l
(1) Current operating procedures .
()Y()N (2) Emergency procedures ()Y()N (3) Use of survey instrumentation ()Y()N D, Training for authorized users of brachytherapy sources per [35.940) ()Y()N E. Training for authorized user of only Sr-90 for ophthalmic radiotherapy per [35.941) ( ) N/A ( ) Y ( ) N F -. Brachytherapy training (seeds, ribbons, sources) ( ) N/A i (1) Safety instruction [35.410. L/C) i (a) Size / appearance of sources ( ) N/A-( ) Y ( ) N
- (b) Handling / shielding of sources ( ) N/A ( ) Y ( )N
! (c) Control of patient and visitors ()Y()N (d) RSO notification in medical
~
emergency or death ()Y()N (e) Records maintained [35.410(b)) ()Y()N 87118. Appendix A A-12 Issue Date: XX/XX/XX j
(2) Manufacturer's instructions available and ()Y()N followed [35.59(a). 400]
G .. Remote afterloader facilitie ( ) N/A (1) Individuals receive initial and periodic training on proper use of remote i afterloader [L/C] ( ) N/A ( ) Y ( ) N (2) Trainer's name/ trainer's qualifications are listed in license application [L/C] ( ) N/A ( ) Y ( ) N j Name of individual (s): ;
I (3) Periodic retraining (interval s 12 months) l is provided to device operators [L/C] ()Y()N j (4) 0]erators. 3hysicians nurses, and medical !
p1ysicists lave been given emergency training ;
including dry run [L/C] ()Y()N Briefly describe remote afterloader (5) '
training / retraining program: ;
r i
H. Supervision of individuals by authorized user in ()Y()N accordance with [35.25]
(1) Supervised individuals3 are instructed in principles and procedures for radiation safety and licensee's OM Program [35.25(a)(1)] ()Y()N (2) Licensee periodically reviews supervised individuals use of byproduct material and records kept to reflect this use [35.25(a)(3)]
requirements in [35.941] ()Y()N (3) Remote afterloader(s) used by or under direct supervision'of an authorized user [L/C] ( ) N/A ( ) Y ( ) N I. Workers cognizant of Part 20 requirements for:
(1) Radiation safety program [20.1101] ()Y()N (2) Annual dose limits [20.1301, 1302] ()Y()N (3) NRC Forms 4 and 5 ( ) N/A ( ) Y ( ) N (4) _10% monitoring threshold [20.1502] ()Y()N (5) Dose limits to embryo / fetus and declared pregnant worker [20.1208] ()Y()N (6) Grave danger posting [20.1902] ( ) N/A ( ) Y ( ) N (7) Procedures for opening packages
[20.1906] ( ) N/A ( ) Y ( ) N 3
Applies to individuals that receive. possess, use. or transfer byproduct material for medical use under supervision of authorized user.
Issue Date: XX/XX/XX A-13 87118. Appendix A
l Basis for Findings: l 1
- 8. OPERATINGANDEMERGENCYPROCEDURESFORREMOTEAFTERL0ADERS ( ) N/A A. Operating procedures applicable to all remote afterloaders (1) Procedures are posted.[L/C] ()Y()N (2) Procedures are identica' or more restrictive than those submitted with license [L/C] -()Y()N i (3) Procedures are approved by RSC [L/C] ( ) Y (') N ;
(4) Radiation survey of device and patient.is i performed to ensure source is returned to !
shielded position [35.404(a). L/C] ()Y()N i (5) Records of radiation surveys maintained for !
three years [35.404(b) L/C] ()Y()N
~
B. High . medium . and pulsed-dose rate remote ;
afterloaders ( ) N/A -!
(1) At least one individual trained in safe use and emergency procedures is physically '
present while afterloader is in use [L/C] ()Y()N (2) Authorized user and either medical physicist or RSO is physically present while afterloader in use [L/C] ()Y()N (3) Only patient is in treatment room during afterloader use [L/C] ()Y()N C. Low-dose rate remote afterloaders ( ) N/A (1) Device operator trained in emergency procedures is physically present or available by telephone during treatment [L/C] ()Y()N (2) Medical physicist or RSO and authorized user available for prompt assistance in emergency ()Y()N Written operating procedures are provided (3) to nurses prior to device use [L/C] ()Y()N l
D. Emergency procedures ( ) N/A
- (1) Procedures are posted in conspicuous I location [L/C] ()Y()N (2) Individuals will carry radiation monitor if
, room monitor is non-functional [L/C] ( ) N/A ( ) Y ( ) N (3) Emergency source recovery equipment
< available [L/C] ( )Y()N 87118 Appendix A A-14 Issue Date: XX/XX/XX l' _ .- -
i (4) Have incidents occijrred requiring
, implementation of facility emergency
) procedures? ()Y()N
.. If "Yes," '
(a) Describe actions taken. individuals involved and notifications made:
! (b) Authorized user and medical physicist or RSO notified ()Y()N
- (c) NRC notified [L/C ()Y()N If "No " describe why not Basis for Findings
- 9. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL A. Briefly describe area survey requirements [20.1501(a). L/C]:
P B. Surveys : 2rformed as required [20.1501(a).
35.415. L/C] ()Y()N (1) Quarterly in brachytherapy storage area ()Y()N (2) Promptly after implant in contiguous unrestricted areas ( ) N/A ( ) Y (-) N (3) Immediately following removal of sources ( ) N/A ( ) Y ( ) N (4) Corrective action taken and documented ()Y()N (5). Records maintained [20.2103. 35.70(h). L/C] ()Y()N C. Handling and use of radioactive materials [L/C]
(1) Protective clothing worn ()Y()N (2) Proper dosimetry worn ()Y()N (3) Eating / drinking /smokir.g in use/ storage areas ()Y()N (4) Food, drink, or personal effects stored in use/ storage areas (-) Y ( ) N (5) Radioactive waste disposed in proper containers ( ) Y ( ) N (6) Use of shielding / distance while using/ storing material ()Y()N Issue Date: XX/XX/XX A-15 87118. Appendix A
l
- 0. Protection of members of the public (1) Licensee trade adequate surveys to demonstrate either (U that the TECE to the individual likely to receive the highest dose does not er.ceed 100 mrem in a year or (2) that if an individual were continuously present
-in an unrestricted area, the external dose would not exceed 2. mrem in any hour and '
50 mrem in a year [20.1301(a)(1). 1302(b)] ()Y()N (2) Unrestricted area radiation levels do not exceed 2 mrem in any one hour [20.1301(a)(2)] ()Y()N l (3) Radiation levels in unrestricted areas are l monitored after remote afterloader source exchange / replacement or unit relocation [L/C] ()Y()N Date of last source exchange:
Date of radiation survey:
(4) Records maintained [20.2103. 2107] ()Y()N E. Leak tests and inventories [L/C. 35.59] )
l (1) Performed on brachytherepy sources as l required [35.59(b)] ( ) N/A ( ) Y ( ) N j (2) Adequate analysis >
methodology / sensitivity ( ) N/A ( ) Y ( ) N (3) Inventory of brachytherapy sources performed quarterly ()Y()N (4) Inventory performed promptly at the storage area after removing sources from a patient !
and includes required information [35.406(a)] ()Y()N !
(5) Records maintained and signed by RSO
[35.59. L/C] ()Y()N Basis for Findings:
- 9. PERSONNEL RADIATION PROTECTION A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee incorporated ALARA considerations in the radiation protection program [20.1101(b)] ()Y()N C. External dosimetry ( ) N/A l
(1) Licensee monitors workers [20.1502(a). L/C] ()Y()N (2) Processor Frequency 87118. Appendix A A-16 Issue Date: XX/XX/XX
{ l (3) Processor is NVLAP-approved [20.1501(c)] ()Y()N !
(4) Dosimeters exchanged at required frequency [L/C] ( )Y()N 1 D. Reports ( ) N/A (1) Reviewed by frequency (2) Inspector reviewed personnel monitoring records for period to l i
(3) Prior dose determined for individuals likely to j receive doses [20.2104] ()Y( )N -
(4) Maximum exposures TEDE Other (5) TEDEs within limits [20.1201] ()Y()N (6) NRC Forms or equivalent [20.2104(d) 2106(c)]
(a) NRC Form 4 ( )Y( )N Complete ()Y( )N (b) NRC Form 5 ()Y()N Complete ()Y()N (7) Worker declared her pregnancy in writing during l inspection period (review records) ( ) N/A ( )Y()N If "Yes." licensee in compliance with [20.1208] ( ) Y ( ) N l and records maintained [10.2106(e)] ()Y()N !
E. Who performed PSEs at this facility (number of people )
involved and doses received) [20.1206. 2104. 2105, 2204] ( ) N/A i F. Records of exposures, surveys, monitoring. and evaluations maintained [20.2'02, 2103. 2106. L/C]
. ()Y()N G. Licensee advises each worker annually of worker's dose [19.13(b)] ()Y()N Basis for F1ndings:
- 10. OUALITY MANAGEMENT PROGRAM. MISADMINISTRATIONS. AND RECORDABLE EVENTS
[35.32. 33]
NOTE: This section is being revised by IMNS and is being separately transmitted for coment.
Issue Date: XX/XX/XX A-17 87118. Appendix A
1
- 11. RADI0ALTIVE WASTE MANAGEMENT ( ) N/A A. Disposal ( ) N/A (1) Decay-in-storage ( ) N/A (a) orecedures approved [20.2001(a)(2). L/C] ()Y()N (b) Procedures followed in accordance with [L/C] ()Y()N (c) Labels removed or defaced [20.1904(b)] ()Y()N (2) Special procedures performed as required [L/C] ()Y()N (3) Remote afterloader sources t ansferred to authorized recipient (20.2001) ()Y()N Name of organization:
(4) Improper / unauthorized disposals [20.2001] ()Y()N (5) Records maintained [20.2103(a), 2108, L/C] ()Y()N B. Waste Management ( ) N/A (1) Storage area (s) ( ) N/A l l
(a) Protection from elements and fire [L/C] (.) Y ( ) N ;
(b) Control of waste maintained [20.1801] ()Y()N (c) Containers properly labeled and area pro)erly posted [20.1902, 1904] ()Y()N (d) Paccage integrity maintained [L/C] ()Y()N (2) Packaging. Control and Tracking [ App. F.III]
[20.2006(d)]:
NOTE: The licensee's waste is likely to be Class A.
(a) Not packaged for disposal in cardboard or fiberboard boxes [61.56(a)] ()Y()N (b) Structurally stable (will maintain its physical dimensions and form under expected disposal conditions) [61.56(b)] ()Y()N (c) Packages properly labeled
[ App. F.III.A.2] ()' /)N (d) Licensee conducts a OC program to ensure compliance with [61.55. 56] and includes management evaluation of audits
( ',
l [ App. F.III.A.3] )N (e) Shipments not acknowledged within 20 days after transfer are investigated and l reported [ App. F.III.A.8) ( ) N/A ( ) Y ( ) N (3) Transfers to land disposal facilities ( ) N/A (a) Transferred to person specifically licensed l to receive waste [30.41. 20.2001(b)] ()Y()N 87118. Appendix A A-18 Issue Date: XX/XX/XX
I l
(b) Each shipment accompanied by a manifest ,
prepared as specified in Section I of j Appendix F (20.2006(b). App. F.III.A.4) ()Y()N' i (c) Manifests certified aq specified in Section II of Appendix F [20.2006(c)] ()Y()N C. Records of surveys and material accountability are maintained [20.2103, 2108] ()Y()N j Basis for Findings:
I
- 12. RECORDKEEPING FOR DECOMMISSIONING A. Records of information important to the safe and l effective decommissioning of the facility maintained in an independent and identifiable location until license termination. ()Y()N
- 8. Records include all required information [30.35(g)] ()Y()N (1) List of restricted areas [30.35(g)(3)]
indicates that laboratories or other rooms have been released since the last inspection ()Y()N 4 (2) Confirmatory measurements show that each room l is within release limits, and licensee records ;
adequately document the basis for releasing l each room ()Y()N '
4 C. Copies of the licensee's decommissioning cost.
estimater and funding methods on file ()Y()N
. D. If the licensee uses a parent company guarantee or a self-guarantee as funding method. does the file contain a copy of the financial test performed for the licensee's most recently completed fiscal year? ( ) N/A ( ) Y ( ) N E. If "Yes" to D. do the financial test ratios meet the criteria in 10 CFR Part 30.
Appendix A. Section II for parent company guarantees and Appendix C. Sectiori Il for self guarantees? ()Y()N F. Date that licensee's financial assurance instrument was submitted to NRC. if applicable: ( ) N/A G. Date that licensee's decommissioning plan was submitted to NRC. if applicable: ( ) N/A Issue Date: XX/XX/XX A 19 87118. Appendix A
l t H. Have radiological conditions at the licensee's h.f[.. [
facility changed since the financial assurance !
mechanis.n and/or decommissioning plan was submitted due to: l (1) Incidents or events? ( ) N/A ( ) Y ( ) N- !
(2) Unplannea process upsets or changes? ( ) N/A ( ) Y ( ) N i (3) Unauthorized material. form. or i possession limit changes? ( ) N/A ( ) Y ( ) N !
(4) Any other changes? ( ) N/A ( ) Y ( ) N !
If "Yes" to any of the above (1)-(4). !'
notify regional management.
Basis for Findings (Include comments and measurements on any areas the licensee !
released for unrestricted use): !
6
- 13. COMPLIANCE WITH DECOMMISS'ONING TIMELINESS RULE ;
A. License to conduct a principle activity has _i expired or.been revoked ()Y()N {
B. Licensee hat'made a decision to aermanently l Cease principal activities. at t1e entire site !
or any separate buildings ()Y()N l C. A 24-month duration has passed in which no-. f principal activities have been conducted under ;
the license at the site or at any separate :
buildings ()Y()N I l
D. If "Yes" to either A or B or C:
(1) Identify Site / Bldg / Area:
(2) Date of occurrence of A. B, or C:
NOTE: If "No" to A and B and C. Decommissioning Timeliness Rule does not apply.
If "Yes" to either A or B or C. then complete Attachment A.
" Decommissioning Timeliness Inspection field Notes." for this licensee.
Basis,for Findings:
I i-1 l
87118, Appendix A A-20 Issue Date: XX/XX/XX i
- 14. 1RANSPORTATION (10 CFR 71 5(a) and 49 CFR 170-189) ( ) N/A A. Licensee Transoorts: [cornplete sections (1) - (4), as applicable]
l (1) Limited Quantities, and/or Instruments and ( ) N/A Manufactured Articles: (Radioactive Material, i excepted package. [ additional info], 7. UN 2910) l (a) Package meets general design recuirements [173.410] ()Y()N (b) Raciation level 5 0.005 mSv/hr (0.5 mrem /hr)
(Exclusive use instruments and articles, 2 mrem /br) ()Y()N (c) Contamination less than 173.443 limits.
OC examination / test' performed prior to each shipment [173.475(I)] ()Y()N (d) Limited Quantity Package marked
" Radioactive" [173.421(a)(4)] . ()Y()N.
(e) 173.422 certification statement attached /
enclosed ("This package conforms to the conditions and limitations speci fied in. . ") (-) Y ( )N (2) Type A Quantities (Radioactive Material, nos, ( ) N/A
- 7. UN 2982)
(a) Packaging:
(i) Packaging 1s proper for contents (i .e. , DOT 7A), is unimpaired, and-is prepared correctly
[173.475(a)-(f)] (-) Y ( ) N o (ii) All packages meet general design requirements [173.410] . ()Y()N (iii) DOT 7A package meets additional Type A design requirements 1
[173.412, 178.350] ()Y()N (b) Recordkeeping:
(i) Special form source records
[173.476(a)) ()Y()N (ii) DOT 7A performance / design documentation [173.415(a)) ()Y()N (c) Hazards communications requirements .l
- (consult the "NRC field reference i l
charts" that correspond to elements (i) through (v), below):
~
(i) Shioping pacers [172.200-205] ()Y()N )
i (ii) Marcing paccages [172.300-338) ()Y()N j (iii) Labeling packages [172.400-450] ()Y()N l
~(iv) Placarding vehicles [172.500-560] ()Y()N lssue Date: XX/XX/XX A-21 87118. Appendix A ,
.I t
(v) Emergency response information :
- and guidance [172.600-604] ()Y()N I
(d) Radiation level /C;ntamination. limits
[173.441. 173.443)
(1) Package levels within limits ()Y()N (ii) OC examination / test performed prior to each shipment [173.475(I)] ()Y()N !
(3) Type B Ouantities (Radioactive Material. nos. ( ) N/A
- 7. UN 2982) ;
(a) Packaging is proper for contents (i.e..
Type B). is unimpaired, and is prepared correctly [173.475(a)-(f)] ()Y()N i (b) Inspector must complete Section 2 of NRC i Inspection Procedure (IP) 86740 !
(c) Sections 2.c. and 2.d., shown in the pre- i vious section for Type A Quantities also l apply. Complete those sections. j (4) LSA Material and SCO (Radioactive Material. ( ) N/A l LSA. nos. 7. UN 2912) or (Radioactive Material. l SCO. nos, 7. UN 2913)
(a) _If licensee makes significant LSA/SCO shipments. inspector should complete -
Inspection Requirement 03.02 of Temporary Instruction ; I) 2515/133 (issued 3/15/96) i (b) Otherwise, if licensee has a minor LSA/SCO program:
(i) Licensee properly characterizing material as LSA/SCO [173.403] ()Y()N (ii) All packages meet general design _
requirements [173.410] ()Y()N (iii) Proper LSA/SCO packaging selected !
and used [173.475. 173.427] ()Y()N (iv) Placarding exclusive use vehicles.
marking package " Radioactive-LSA" or " Radioactive-SCO." as a>propriate [173.427(a)(6)] ()Y()N (v) Slipping papers [172.200-205]
(see "NRC field reference charts" :
for content and exceptions) ()Y()N ,
6l l
l I
i l
87118. Appendix A A 22 Issue Date: XX/XX/XX i
a I
~
B. DOT HAZMAT Emoloyee Trainino Prooram [49 CFR 172.700-704] ( ) N/A (1) Each HAZMAT employee raceives training and is tested [172.702] ()Y()N (2) Recurrent training at least every 2 years-
[172.704(c)(4)] ()Y()N (3) HAZMAT employee training includes general awareness, function-specific, and safety training [172.704] ()Y()N (4) HAZMAT employer recordkeeping includes employee name, completion date.
l description / copy / location of training l materials, namc r.d d' ':s of training provider, and certification [172 704(d)] ()Y()N C, Carrier Modal Soecific Reacirements. Hiohway ( ' N/A l Transoortation [49 CFR Part 177]
(1) Driver training, or CDL w/ HAZMAT endorsement l [177.800,177.816] ()Y()N l (2) Incident reporting to 00T [177.807. see also i 171.15 and 171,16] ( ) Y (') N
! (3) Shipping paper accessibility (on seat or in driver's side door pocket, readily visible) ()Y()N (4) Placarded vehicles routing and driver training .i requirements [177.825 and 49 CFR 397 Subpart 0 (i.e., the motor carrier regs)) ()Y()N (5) Sum of total package tis on non-exclusive use vehicle < 50 [177.842(a)] ()Y()N I
-(6) Packages blocked / braced for transport
[177.842(c)] ( ) Y'( ) N i
l 0, ti.1scellar ?ous Reauirements ( ) N/A l l
(1) No labeled packages carried in passenger l
compartments [173.448(c)] ()Y()N j l
(2) Overpack requirements observed. if packages are l l offered in overpack. Overpack marked w/ proper l l shipping name and number, package and overpack i labeled as needed, marked " inner package complies ..." [173.24] ( ) Y (') N l (3) Expanded and changed A1/A2 values from the
) 4/1/96 rule changes have been implemented
[173.435] (verify only once per licensee) ()Y()N.
(4) Written instructions included with exclusive use shipments (173.403] ()Y()N ,
Basis for. Findings: ,
l.
1 Issue Date: XX/XX/XX A-23 87118, Appendix A i
- 15. POSTING AND LABELING-A. NRC Form 3. " Notice to Workers." is posted [19.11] ()Y()N B. Parts 19. 20. 21. Section 205 of Energy Reorganization Act,. procedures adopted pursuant to Part 21. and license documents are )osted or a notice indicating where documents can Je examined is posted [19.11, 21.6] ( ) Y (-) N C. Other posting and labeling per [20.1902, 1904]
and the licensee is not exempted by [20.1903, 1905] ()Y()N Basis for Findings:
- 16. GENERIC COMMUNICATION OF INFORMATION A. Bulle;. ins information notices, NMSS Newsletter, etc. received by the licensee ()Y()N B, . Licensee took appropriate action in response to bulletins, generic letters, etc. ()Y()N Basis for_ Findings:
- 17. NOTIFICATION AND REPORTS A. Notifications since last inspection [35.14]
(1) Licensee has provided appropriate documentation to NRC for authorized user no later than 30 days after the individual starts work [35.14(a)] ( ) N/A (') Y ( ) N (2) Licensee has notified NRC within 30 days after authorized user or
- RS0 stops work or stops work or changes name or licensee's mailing address changes [35.14(b)] ( ) N/A ( ) Y ( ) N B. Licensee in compliance with [19.13. 30.50]
(reports to individuals.public and occupational, monitored to show compliance with Part 20) ( ) N/A ( ) Y ( ) N 87118, Appendix A A-24 Issue Date: XX/XX/XX
C. Licensee in compliance with [20.2201. 30.50]
(theft or loss) ( ) None ( )Y()N D. Licensee in compliance with [20.2202. 30.50]
(incidents) ( ) None ( ) Y ( ) N E. If applicable licensee in compliance with Part 21 requirements for reporting failures / i problems with remote afterloading arachytherapy devices ( ) None (-) Y ( ) N F. Licensee in compliance with [20.2203, 30.50)
(overexposures and high radda' ion le'.'is) ( ) None ( ) Y ( ) N G. Licensee aware of NRC Ops Center phone number
[(301) 816-5100) ()Y()N Basis for Findings:
- 18. YEAR 2000 EFFECT ON COMPUTER SYSTEM SOFTWARE A. Licensee has reviewed the effect of the year 2000 on computer software programs that are used to meet licensing requirements or those that have safety significance [IN 96-XX] ()Y()N If "No." licensee is aware of notice to do so ()Y()N NOTE: A ceficie[ icy in this area should not be cited as a violation.
- 19. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A A. Special 1;rense conditions or issues to be reviewed:
B. Evaluation:
l l
i Issue Date: XX/XX/XX. A-25 87118. Appendix A
- r
. l i ;
- 20. - OBSERVATIONS / DEMONSTRATIONS OF LICENSED ACTIVITIES l l Briefly describe the activities anu procedures observed and/or demonstrated- ;
during the inspection. For example, if you observea licensee persor.nel '
i working in radiation areas using 1icensed matertal or performing functions associated with radie: ion safety such as receiving or transporting licensed
( material: conducting or receiving training; disposing of radioactive waste: l conducting surveys: or making measurements, then describe what you saw. If -
, the licensee demonstrated any practices at your request, describe those i
' demonstrations. The observations and demonstrations you describe here, and elsewhere in the " Basis for Findings" sections of this report, along with l 'measuranents and some records revled. shoula substantiate your inspection findings, ,
I i I Describe what activities or procedures were observed and/or '
demonstrated by the licensee during the inspection:
l l
l l l 4
87118. Appendix A A-26 issue Date: XX/XX/XX
l l
The following sections should be canpleted in a narrative format by the inspector to briefly describe the measurevents perfcrmed by the inspector.
1 inspection findings, and any post-inspection cannunications with regional l staff.
l
- 21. NRC INSPECTOR'S MEASUREMENTS ( ) N/A-A. Survey instrument Serial No. Date of calibration B. Inspector performed CONFIRMATORY measurements ()Y()N C Inspector performed INDEPENDENT measurements ()Y()N D. Briefly describe the types of measurements performed (e.g. .
exposure rates) locations where measurements were taken, the i results of these measurements (mR/hr. dpm. etc.) and whether 1 inspector's results conflicted with the licensee's measurements. If independent measurements were not made, justify why they were not performed on this inspection:
l
- 22. CONTINUATION OF REPORT ITEMS ( ) N/A i l
l l
4 l \
\
Issue Date: XX/XX/XX A-27 87118. Appendix A
i l
l
- 23. VTOLATIONS. NON-CITED VIOLATIONS (NCVs). AND OTHER ISSUES ( ) N/A NOTE: Briefly state (1) the requirement and (2) how and when the licensee violated the requiremer,t. For NCVs. indicate ;
why the violation was not cited. Attach copies of all licensee l documents needed to support the violation.
l l
l
- 24. DEBRIEF WITH REGIONAL STAFF A. Was inspection feedback provided to regional !
licensing staff? ()Y() N If "Yes." name of individual on the licensing i staff:
If "Yes." describe issues discussed:
B. Briefly describe post-inspection conmunications with other regional staff (inspector's supervisor. Agreement State officer. State liaison officer, etc.):
l l
l
\
l 87118. Appendix A A-28 Issue Date: XX/XX/XX
i l
l
- 25. PERFORMANCE EVALUATION FACTORS A. Lack of senior management involvement with the radiation safety program and/ar RSO oversight ()Y()N B RSO too busy with other assignments ()Y( )N C. Insufficient staf fing ()Y()N
- 0. RSC fails to meet or functions inadequately ( ) N/A ( ) Y ( ) N E. Inadequate consulting services or inadequate audits conducted ( ) N/A ( ) Y ( ) N Remarks (consider the above assessment and/or other pertinent PEFs with regard to the licensee's oversight of the radiation safety program):
Regional follow-up on above PEFs citations:
END
Attachment:
A. " Decommissioning Timeliness inspection Field Notes" l
Issue Date: XX/XX/XX A-29 87118. Appendix A I
APPENDIX A - A'ITACHMENT A D M E" ~ r DECOMMISSIONING TIMELINESS INSPECTION FIELD NOTES i
Licensee: ;
1 l Date of Inspection:
l l
- 1. [QMPLIANCEWITHDECOMMISSIONINGTIMELINESSRULE l (NUTE: Repeat the answers given in Section 12 of the main body of the ;
field notes. The issues in : subsequent sections are dependent on the answers to these questions.) ]
i A. License to conduct a principle activity has J expired or been revoked ()Y()N B. Licensee has made a decision to permanently cease principal activities at the entire site or at any separate buildingr ()Y()N C. A 24-month duration has passed in which no ,
principal activities have been conducted under '
the license at the site or at any separate buildings ()Y()N
~
D. If "Yes" to either A or B or C above:
L (1) Identify Site / Bldg / Area:
(2) Date of occurrence of A. B or C: !
l
- 2. NOTIFICATION REQUIREMENTS A. Licensee has provided written notification to NRC within 60 days of the occurrence of 1.A., 1.B.. or ;
i 1.C. above ()Y()N If "Yes." date of notification: !
B. If the licensee is requesting to delay initiation I of the decommissioning process. the licensee has provided written notification to NRC within 30 days of occurrence of 1.A. 1.B., or 1.C. above ( ) N/A ( ) Y ( ) N j If "Yes." date of notification:
i Comments:
4 1
i Issue Date: XX/XX/XX Att. A-1 87118. Appendix A, Att. A i
..__.i
- 3. DECOMMISSIONING PLAN / SCHEDULE REOUIREMENTS A. Licensee is required to submit a decomissioning -
plan ser 10 CFR 30.36(g) 40.;2(g) 70.38(g). or 10 CF.R Part 72? ()Y()N~
If "No" to 3. A. answer the following items B. - F. : J
- 8. The cecommissioning work scope is covered by l current license conditi;;.b ( ) Y-( ) N !
C. Decommissioning has been initiated within 60 days of notification to NRC. or NRC has granted a delay ()Y()N D. If licensee has initiated decommissioning, give date the decomissioning was initiated: !
Initiation date: 1 E. If decommissioning has been completed, it was completed within 24 months of notification to NRC ( ) N/A ( ) Y-( ) N l F. If decomissioning is still scheduled to be j com)leted. it is on schedule to be completed witlin 24 months of notification to NRC ( ) N/A ( ) Y ( ) N Coments: :
l If "Yes" to 3.A., answer the following items G. - J.-
G. The decomissioning plan has been submitted to NRC within 12 months of notification ()Y()N If "Yes." date of submittal:
If NRC approved, date of NRC approval:
H. Has the licensee submitted an alternative schedule request? ()Y()N If "Yes." date of submittal:
87118. Appendix A. Att. A Att. A-2 Issue Date: XX/XX/XX
)
awasi-kJ"i r
I. If deconmissioning has been completed. it was completed within 24 r,onths after approval of the decommissioning plan ( ) N/A ( )Y( )N J. If decommissioning is still scheduled to be comaleted it is on schedule to be completed '
witain 24 months after 6pproval of the decommissioning plan ( ) N/A ( ) Y ( ) N Comments:
Violations identified, if any:
0 l
l l
Issue Date: XX/XX/XX Att. A-3 87118. Appendix A. Att. A
03.09 Area Radiation and Contamination Control ~]
- a. Area Surveys. The inspector may ask the licensee to spot-check radiation levels in selected areas. using the licensee's om instrumentation.
However, the inspector must use NRC's instruments for independent verification of the licensee's measurcants. (The inspector's instruments shall be calibrated and source-checked before he/she leaves the regional of fice. )
If practical, observe how licensees conduct surveys to determine the adequacy of surveys. Also, note the types of instruments used, and whether they are designed and calibrated for the type of radiation being measured.
The inspector should determine if unders take smears or instrument readings in areas that are readily accessible to facility personnel.
Particular attention should be given to released patients rooms, bench tops, sinks used for disposal. and storage areas. The survey activities should be performed in accordance with 10 CFR 35.70. The inspector should also perform independent measurements, as needed to verify licensee assumptions or measurements.
- b. l.eak Tests. Through discussions with licensee personnel and/or by demonstration of leak test 3rocedures, the inspector should verify that leak tests are performec in accordance with the manufacturer's recommendations and/or license.
- c. Contamination Control. The inspector should verify that the licensee's survey procedures and counting equipment are adequate to detect and control radionuclide contamination. The inspector may choose to examine the instrument calibration records (efficiency checks lower limit of detection calculations, geometry. linearity, etc.). physical location of counting instruments, methods of detection, and wipe sample locations.
Additionally, when appropriate, the inspector should consider taking confirmatory wipe samples,
- d. Protective Clothina. If practical, the observation of the protective clothing that research lab personnel or other applicable staff wear during {
their work activities should provide the inspector with an acceptable 1 means of reviewing this requirement. Requirements for protective clothing may be found in the licensee's procedures or on precautions posted at the entrance to controlled areas.
03.10 Radiation Protection. Specific guidance is set forth in IP 83822.
" Radiation Protection."
NOTE: Inspection guidance for 10 CFR 35.75, patient release criteria, is being l revised by IMNS and is being separately transmitted for comment. i 10 CFR 19.13(b) requires that each licensee shall advise each worker annually of the worker's dose as shown in dose records maintained by the licensee. Verify through discussions with workers and management, and through records review, that the licensee has advised workers of their doses annually. The licensee must advise all workers for whom monitoring is required (and, therefore, dose records j are required). The licensee must advise these workers of internal and external ;
doses from routine operations. and doses received during planned special j 87119 Issue Date: XX/XX/XX j l
expo ures, accidents, and emergencies. The report to the individual must be in writing and must contain all of the information required in 10 CFR 19.13(a).
03.11 Ouality Manaaement Procram NOTE: This section is being revised by INNS and is being separately transmitted for comment. !
03.12 Waste Manaaement
- a. Waste Storace and Disoosal. Verify that the waste is arotected from fire and the elements, that package integrity is adequate'y maintained. that .
the storage area is properly ventilated.. and that adequate controls are in effect to minimize the risk from other hazardous materials. Verify that the licensee has appropriate methods to track the items in storage.
Inspection effort should be directed at verifying that written procedures have been established in a manner approved by management. The procedures should be readily cyailable to any persons having responsibility for i lcw-level waste class 1fication and preparation for transfer of such wastes 1 to land disposal facilities.
]
For further inspection guidance, refer to IP 84850 " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61." l
- b. Effluents. Examine the waste release records generated since the last inspection, all annual or semiannual reports, all pertinent non-routine event reports, and a random selection of liquid and airborne waste release records. Randomly select procedures for both liquid and airborne systems and verify that the licensee's procedures are being followed. The verification can be made.by observations of an operation, a review of selected records', interviews with workers etc.
For liquid wastes, determine if the licensee has identified all sources of liquid waste evaluated treatment methods to minimi.7.e concentrations (such as the use of retention tanks), and complies with the regulatory requirements for disposal into sanitary sewerage.
For airborne radioactivity, determine if the license has identified all routes of airborne releases to the environment and complies with the regulations and all applicable license restrictions. For those licensees authorized to dispose of radioactive material by incineration, determine compliance with 10 CFR 20.2004 and license requirements.
Review the licensee's ALARA goals, and determine if they are sufficiently challenging yet realistic. Determine if the licensee understands and implements these goals. Determine if the licensee has calculated annual doses resulting from air effluents and if the doses: (1) are within the licensee's ALARA goals (as described in its radiation protection program):
(2) exceed the licensee's ALARA goals; or (3) are uncertain because there is insufficient information or basis for determination. Review the licensee's history in meeting ALARA goals, and its corrective actions when the goals were not met.
~ For further inspection guidance, refer to IP 87102.
l Issue Date: XX/XX/XX 87119
- c. Transfer. Ascertain if the licensee has an adequate method of determining that recipients of radioactive wastes are licensed to receive such waste (i.e.. licensee obtains a copy of the wasta wipient's current license before the transfer).
d Records. Each licensee is required to maintain records of the disposal l of licensed material made under 10 CFR 20.2002-2005 and 10 CFR Part 61.
l and by disposal by burial in soil. These records must be retained until the Commission terminates each pertiner,t license requiring the record.
The inspector sho"ld review these records to verify that disposals are made in accordance with the applicabic regulations and that records are complete and accurate for each type of disposal. For medical waste that is decayed in storage for ten half lives, surveyed and disposed to the normal waste stream, records are required to be retained for three years from the date of disposal.
- e. inancial Assurance and Decomissionino. The decommissioning record-l ceeping requirements are applicable to all materials licensees. including licensees with only sealed sources, and are specified in 10 CFR 30.35(g).
These records should contain, a nong other information: (1) records of spills or other unusual occurrences involving the spread of contamination in and around the facility. equipment or site (when contamination remains after cleanup or when contaminates may have spread to inaccessible areas.
e.g. . seepage into concrete): (2) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used' and/or stored. and locations of possible inaccessible contamination (e.g. , buried pipes): (3) except for areas with only non-leaking sealed sources or byproduct materials with half lives of less than 65-days, a single document detailing restricted areas and formerly restricted areas, buried waste, areas requiring decontamination that are outside of restricted areas. and areas outside of restricted areas that, if the license expired, would have to be decontaminated or approved for disposal: and (4) records of the cost estimate performed for a decomissioning funding plan or the amount certified for decomissioning. ;
This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). On all inspections, including inspections of sealed source licensnes, the inspector should ensure that the licensee has such i decomissioning records, that the records are complete that they are l unted as required, and that the decomissioning records are assembled e referenced in an identified location.
l Some licensees may release laboratories or other rooms within a building for unrestricted use, without a license amendment. The release of these areas may fall outside of the reporting requirements in the Decomissioning Timeliness Rule if the licensee continues to conduct other activities in the same building. Inspectors should identify the rooms that have been released since the last inspection and perform confirmatory measurements to verify that radiation and contamination levels are below i l release limits. Licensee survey records and other documentation should I l be reviewed to Prify that the basis for releasing each room is adequately
! documented in t9 licensee's decomissioning records.
Licensees submit f tnancial assurance instruments and/or decomissioning ,
plans for a specd ic set of conditions. Occasionally, those conditions !
may change over time and the licensee may not notify NRC. The inspector should be aware of changes in radiological conditions while inspecting a j l licensee's facility that would necessitate a change in the financial '
l assurance instrument and/or decommissioning plan. especially where the 87119 Issue Date: XX/XX/XX
s s, radiological conditions deteriorate and the Dr.ancial assurance instrume or decommissioning plan may no longer be sufficient. In preparation for the inspection, the inspector should determine the dates that the financial assurance instrument and decommissioning plan (if applicable) were submitted to NRC. Then during the inspection, through observations.
discussions with licensee personnel, and records review, the inspector should determine whether the :ediological conditions at the license ('s facility have changed since the documents were submitted to NRC. If conditions have changed and the adequacy of the financial assurance instrument and/or decommissioning plan is in doubt, the inspector should immediately contact regional management from the licensee's site to discuss the situation.
Additionally, some licensees are required to maintain decommissioning cost estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as a funding method, the inspector should verify that the licensee har a Certified Public Accountant certify each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in Section II. Appendix A and Appendix C. respectively, to 10 CFR Part 30.
- f. Decomissionino Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license remains in effect. determine if the licensee has made a decision to cease principal activities at the site or in any separate building. Finally. ,
determine if there has been a 24-month duration in which no principal activities have been conducted in such areas. A principal activity is one which is essential to the purpose for which a license was issued or amended, and does not include storage incidental to decontamination or decommissioning. If the licensee meets any of the above conditions. the decommissioning timeliness requirements apply, and the inspector must complete in full the 'Decomissioning Timeliness Inspection Field Notes."
Attachment B to Appendix A.
The requirements of 10 CFR 30.36. 40.42, and 70.38 do not apply to released rooms within a building where principal activities are still on-going in other parts of the same building. However, in those cases, the inspector snould follow the guidance in 03.12.e. regarding confirmatory measurements of the released area. Once principal activities have ceased in the entire building, then the decommissioning timeliness requirements will take effect.
The Decomissioning Timeliness Rule became effective on August 15. 1994.
In completing the Attachment B field notes, specific guidance is needed regarding the timing of the notification requirements. If the license has expired or been revoked, or if the licensee has made a decision to permanently cease principal activities, and the licensee orovided NRC notification before Auaust 15. 1994 then August 15, 1994 is considered to be the date for initiating the decommissioning calendar (i .e. . date of notification) . If there has been a 24-month duration in which no principal activities have been conducted at the location before the effective date of the rule, but the licensee did not notify NRC. then the 24-month time period of inactivity is considered to be initiated on August
- 15. 1994 and the licensee must provide notification to NRC within either 30 or 60 days of August 15,1996 (depending cn whether the licensee requests a delay).
Issue Date: XX/XX/XX 87119
NRC has a stringent enforcement policy with respect to violations of the decommissioning timeliness requirements. Failure to comply with the Decommissioning Timeliness Rule (failure to notify NRC. failure to meet decommissioning standards, failure to complete decommissioning activities in accordance with regulation or license condition, or failure to meet required decornissioning schedules without adequate justification) may be classified as a Severit." Level III violation and may result in consideration of monetary civil penalties or other enforcement actions.
as appropriate.
Decommissioning timeliness issues can be complex. For situations where an inspector has questions about the licensee's status and whether the decommissioning timeliness standards apply, he/she should immediately contact regional management.
For planning and conducting inspections of licensees undergoing decomissioning, refer to IMC 2602. " Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees:" IP 87104. ,
" Decommissioning Inspection Procedure for Materials Licensees:" and the !
draft Decommissioning Manual Chapter and Handbook.
1 1
03.13 Transoortation. The inspector should review: the licensee's hazardous material training: Jackages ar d associctd documentation: vehicles (including placarding. cargo ] locking, and bracing, etc.): shipping papers; and any incidents reported to DOT. This is an ideal area for the inspector to make i observations of licensee practices. The DOT and NRC regulations for i transportation of radioactive materials were recently revised, and the revisions generally became effective April 1. 1996.
For further inspection guidance refer to IP 86740. " Inspection of Transportation Activities." Inspectors should also refer closely to " Hazard Communications for Class 7 (Radioactive) Materials." the NRC field reference charts on hazard communications for transportation of radioactive materials. which contain references to the new transportation requirements, and are useful field references for determining compliance with the transportation rules on labeling, placarding, shipping papers. and package markings.
03.14 Postina and Labelino. The inspector should determine whether proper caution signs are being used at access points' t'o areas containing licensed materials, radiation areas. and those areas containing airborne radioactive materials. 10 CFR 20.1903 provides exceptions to posting caution signs. When applicable. the inspector should also randomly examine signals and alarms to determine operability. The inspector should also randomly observe labeling on packages or other containers to determine that proper information (e.g. , isotope, quantity, and date of measurement) is recorded.
Areas with radiation hazards should be conspicuously posted, as required by 10 CFR 20.1902. Depending on the associated hazard, controls may include tape, rope, or structural barriers to prevent access. If volatile licensed materials are used in an area, such an area should be controlled for airborne contamination. High radiation areas should be strictly controlled to prevent unauthorized or inadvertent access. Such controls may include, but are not limited to. direct surveillance, locking the high radiation area. warning lights, and audible alarms. Areas occupied by radiation workers for long periods of time and comon-use areas should be controlled in accordance with licensee procedures and be consistent with the licensee's ALARA program.
87119 Issue Date: XX/XX/XX
I I
The inspector should also examine locations where notices to workers are posted.
3 Applicable documents, notices. or forms should be posted in a sufficient number of places.to permit individuals engaged in licensed activities to observe them !
on the way to or from any particular licensed activity location to which the .i L postings would apply. :
I- 03.15 Generic Comunications of Information. Through discussions with licensee i management . and the RSO. the inspector should verify that the licensee is
- receiving the applicable bulletins, information notices. NMSS Newsletter, etc. . I and that the information contained in these documents is disseminated to 3
'; appropriate staff personnel. Also verify that the licensee has taken appropriate '
action in response to these NRC communications, when a response is required.
j 03.16 Notifications and Reoorts. The inspector should determine the licensee's i i
compliance for notifications and reports to the Comission. The licensee may be required to make notifications after loss or theft of material, overexposures.
- incidents. high radiation levels, safety-related equipment failure, etc.
2-Additionally, some licensees are required to make annual reports to NRC.
l Verify that notifications and/or reports were appropriately submitted to NRC.
- - Through observations and discussions with licensee personnel, the inspector ,
should gather information concerning events that were reported to NRC. The depth i 1
of on-site follow-up should be proportional to the severity of the event.
03.17 Soecial License Conditions. Some licenses will contain special license j' conditions that are unique to a particular practice, procedure, or piece of !
l equipment use by the licensee. In these instances, the inspector should verify j that the 4. Le see understands the additional requirements, and maintains I
, compliance witn the special license conditions. The inspector should also note :
that some special license conditions will-state an exemption to a particular NRC t requirement.
03.18 Indeoendent and Confirmatory Measurements. The inspector should perform
- independent and confirmatory measurements in restricted and unrestricted areas of the licensee's facility. Independent measurements should be performed on all i inspections unless exceptional circumstances make it impossible to perform the measurements (e.g., inspector's detection equipment malfunctions during an inspection trip). Measurements of dose rates at the boundary of the unrestricted l g areas should be performed at the surface of the most accessible plane. Examples 3 of. measurements that may be performed include area radiation surveys, wipe i samples, soil samples. leak tests, air flow measurements, etc. These 1
measurements should be taken in licensed material use areas, storage areas.
effluent release points, etc. Confirmatory measurements are those whereby the.
inspector compares his/her measurements with those of the licensee's.
Inde the pendent licensee's measurements are those measurements. performed To perform thebyindependent the inspectororindependently confirmatoryof measurement, use NRC radiation detection instruments that are calibrated, at a minimum, on an annual basis.
03.19 Exit Meetina. When the inspection is over, there should be an exit i meeting with the most senior licensee representative present at the facility.
If a senior management representative is unavailable for the exit meeting, the inspector may hold a preliminary exit meeting with appropriate staff on site. 1 However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO. if not present at the preliminary exit meeting) as soon as practical after the inspection. This meeting will usually be held by telephone conference call- .
Issue Date: XX/XX/XX 87119 j
During the exit meeting. the licensee representatived should be told the preliminary inspection findings -- including any ; negative PEFs. apparent ;
violations of regulatory requirements, safety-related concerns or unresolved ;
items identified during the inspection -- and the status of any previously t identified violations. The licensee must immediately address any significant >
safety concerns. '
If the inspector identifies safety concerns or violations of significant i regulatory requirements that affect safe operation of a licensee facility, the ,
licensee must initiate prompt corrective action. The inspector should not leave r the site until the licensee fully understands the concern and has initiated ;
corrective action. If the inspector and the licensee disagree over how ,
significantly the concern impacts continued safe operation of the facility, regional management should be notified immediately. -
While deficiencies identified in some areas (e.g. , workers' knowledge of the Part 20 requirements) are not always violations, the inspector should bring such i deficiencies to the attention of licensee management at the exit meeting and also in the cover letter transmitting the inspection report or NOV.
03.20 Post Inspection Actions. Regional office policy will dictate with whom the inspector will review his or her inspection findings (e.g. , the inspector's !
supervisor), following the guidance in IMC 2800. " Materials Inspection Program." ,
The inspector should discuss the findings in the detail that is commensurate with !
the scope of the licensee's program. Violations, items of concern ( e.g. . i negative PEFs), and unresolved items should be discussed in sufficient depth for l management to make appropriate decisions regarding enforcement actions, referral l to other State and Federal agencies, and decisions on the scheduling of future l inspections of the licensee's facility. '
The inspector should also discuss ins]ection findings with licensing staff. This information exchange can be pcrticu'arly useful if the licensee is having its license renewed or has recently submitted a license amendment request. The inspector should inform licensing staff about how the licensee has addressed (or failed to address) special license amendments or recent licensing actions.
Licensing information requested by the licensee should also be discussed with the licensing staff.
Inspectors should be aware that NRC has entered into several MOUs, with other l Federal agencies, that outline agreements on items such as exchange of '
information and evidence in criminal proceedings. The inspector should ensure that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.
The inspector may report the results of inspections to' the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following the guidance in IMC 2800. The inspector must also ensure that the findings are '
documented in the inspection field notes and/or inspection report, in sufficient detail for the reader to determine what requirement was violated, how it was violated, who violated the requirement, and when it was violated. Copies of all licensee documents needed to support the violation should be attached to the inspection field notes and/or inspection report. The field notes should not be used as merely a checklist to note areas reviewed. It should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the inspection, and any items of concern identified that were not cited as a violation of regulatory requirements.
Inspectors may complete the field notes either by hand or electronically. If the inspector is documenting the field notes in electronic format, the sub-items 87119 Issue Date: XX/XX/XX
1 l under major sections that are not applicable or not reviewed may be deleted.
l However, the heading itself (e.g., " Radioactive Waste Management." or i " Transportation") should remain in the field notes, and the inspector should l enter appropriate remarks about why the section is not applicable or not reviewed.
For further inspection guidance, refer to Section 07.04 of IMC 2800.
L 87119-04 REFERENCES MT l
A listing of IMCs and IPs applicable to the inspection program for materials licensees can be found in Section 2800-11 of IMC 2800. Inspectors are to use these documents as guidelines in determining the inspection requirements for operational and. radiological safety aspects of various types of licensee 1 activities. I i
Specific references to regulatory requirements can be found in the " Medical Broad-Scope Inspection Field Notes" appendix, following this IP.
l END Appendix:
A. " Medical Broad-Scope Inspection Field Notes" l
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l Issue Date: XX/XX/XX 87119
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ATTACHMENT 5 APPENDIX A MEDICAL BROAD-SCOPE INSPECTION FIELD NOTES I
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APPENDIX A MEDICAL BROAD-SCOPE INSPECTION FIELD NOTES h /A F T i j Region L
. NOTE: 1-. For inspection of licensees with brachytherapy sources, also '
complete " Brachytherapy Inspection Field Notes." Appendix A to IP 87118. i
- 2. Any reference to patient is intended to include human research subject.
Inspection Report No. License No.
Licensee (Name & Address): Docket No.
Licensee Contact Telephone No.
Amendments Issued Since Last Inspectioni (Numbers)
Dates of Above Amendments Priority Program Code Date of Last Inspection ~
Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced 1
( ) Routine ( ) Special i
( ) Initial ( ) Reinspection Next inspection Date ( ) Normal ( ) Reduced ( ) Extended i
Justification for change in normal inspection frequency: l 4
Summary of Findings and Action: ;
( ) No violations cited. Clear NRC Form 591 or regional letter issued
( ) Violation (s). NRC Form 591 issued
( ) Violation (s), regional letter issued
( ) Follow-up on previous violations Inspector Date (signature)
Approved Date
-(Signature) i Issue Date: XX/XX/96 A-1 87119. Appendix A
. ~ . .- .- - . - - - . - - - ---.-- - -.-. - . - .
I 1
Field notes are to be used by the inspector to assist with the performance of the inspection. Note that all areas indicated in the field notes are not -
required to be addressed during ggh inspection. However. for those areas not covered during the inspection, a notation ("Not Peviewed") should be made in each section where applicable. Additionally, all areas covered during the inspection should be docwented in sufficient detail to describe i what activities and/or records the insoector observed. For exanple, the 1 types of records that were reviewed an'd the time periods covered by these l records should be noted in the appropriate " Basis for Findings" section(s). l If the licensee demonstrates any practices at your request. describe those i demonstrations. The observations and demonstrations you describe in this 1 report, along with measurements and sme records review, should substantiate \
your inspectton findings. i
- 1. INSPECTION. LICENSING. AND INCIDENT HISTORY l A. Violations were identified during any of 1
! the last two inspections or two years. !
- whichever is longer. (N/A - Initial insp.) ( ) N/A ( ) Y ( ) N l B. Response letter (s) or Form 591(s) dated C. Violations from previous inspection (s)
- 1 REQUIREMENT CITED STATUS 1
I i
i D. Any repeat violation (s) identified? ()Y()N k If "Yes." explain:
i
^
i i
)
l 87119.' Appendix A A-2 Issue Date: XX/XX/96 i
T E. License amendments issued since last inspection [35.13]1 .
or program changes noted ia tue licen:s; AMENDNENT # MTE SUBJECT j- l l
l l- ___
F. During this inspection, was the licensee's
- implementation of all of the above amendments or i
- program changes inspected / observed? ( ) N/A ( ) Y ( ) N l 1
G. During this inspection, were any violations l identified involving any of the above amendments or program changes? ( ) N/A ( ) Y ( ) N List any incidents, misadministrations, or events H.
reported to NRC since the last inspection (Note:
"None" indicates that regional event logs, event files, and the licensing file have no evidence of any incidents or events since the last inspection): ( ) None INCIDENT OR EVENT l
i
- 1. During this inspection, were the ,
incidents / events reviewed wiuh the licensee, and was the licensee's follow-up to the incidents / events examined? ( ) N/A ( ) Y ( ) N 2
Here and throughout the field notes, sections of 10 CFR are referenced only by their section numbers.
Issue Date: XX/XX/96 A-3 87119 Appendix A
J. Describe the licensee's follow-up in response to the events / incidents listed in 1.H.
i Basis for Findings:
l i
i
- 2. ORGANIZATION AND SCOPE OF PROGRAM A. Describe the licensee's organizational structure to indicate the
" chain-of-command" from senior management to authorized users of licensed material. Show or describe where the RSO and Chairperson of the RSC are located in the licensee's organization and to whom they report.
J l
87119. Appendix A A-4 Issue Date: XX/XX/96
B. Identify licensee personnel contacted during the inspection :
(including those individuals contacted by telephor,e). q I
haff i i
i t
use the followin
- Individual (s) gpresent identifica . "e1ance at et symbols:
meeting
- Individual (s) present at eut meeting
+ Individual (s) contacted by telephone C. Authorized for multiple locations of use ( ) Y ( ).N l If"Yes."majuseATTACHMENTAasaguide '
for i.nspecting labaratories. -
(1) Inspection performed at multiple offices ()Y()N i (2) If "Yes." list office locations inspected:
D. Briefly describe scope of activities, including' ;
types and quantities of use involving licensed material, frequency of use, staff size, etc. :
l i
l I ;
6 E. Mobile Nuclear Medicine Service ( ) N/A i
(1) location (s) of use and scope of activities: .:
1 (2) Licensee operates services per [35.29. 80] ()Y()N (3) Com)liance with 20.1301 dose limits for mem)ers of the public evaluated and met ()Y()N (4) Records of surveys maintained [35.80] ()Y()N Issue Date: XX/XX/96 A-5 87119. Appendix A
. - - - . . - - _ _ -. -- . - _ - - - - - _ - - . - - ~
2 I F. Licensee does limited distribution of2 pharmaceuticals under Part 35 license ( ) N/A (1) Indicate type of operation:
3 (d) Registered or licensed with FDA as a drug manufacturer l (b) Registered or licensed with State Agency as a drug manufacturer 1 (c) Licensed as,a pharmacy by State Board of Pharmacy i 4 (d) Operating as a nuclear pharmacy within a Federal medical l institution 1
l
- (2) Licensee distributes
- j 1
1 (a) Sealed sources ()Y()N i (b) Alpha and beta emitters ( ) Y ( )'N l
' (c) Generators ()Y()N !
(d) Photon emitters ()Y()N l G. Research involving human subjects ( ) N/A. l (1) Research is conducted. funded, supported, or regulated by another Federal Agency which has implemented Federal Policy for Protection of )
4 Human Subjects [35.6] ()Y()N i If "No." does licensee have license amendment !
authorizing human research [35.6] ()Y()N (2) Licensee obtains informed consent from human subjects [35.6] ()Y()N (3) Licensee obtains approval of research activities from an Institutional Review Board or Radioactive
. Drug Research Comittee [35.6. L/C]* ()Y()N ,
(4) Licensee has participated in research studies J i since the last inspection ()Y()N l
- 3. MANAGEMENT OVERSIGHT A. Radiation Safety Committee (RSC) [33.13, 35.n L/C] ()Y()N (1) Membership as specified [35.22(a)(1)] ()Y()N ;
j (2) Meetings held auarterly [35.22(a)(2)] ()Y()N !
4 (3) Quorums established [35.22(a)(3)] ()Y()N 2
If the licensee distributes radiophannaceuticals to several I facilities, the inspector should conside: the need to complete IP i l
87117. Appendix A. " Radiopharmacy Inspection Field Notes."
Agencies: USDA. DOE. NASA. HUD. D0J. D00. DVA. EPA. HHS. 00T. 00C.
Consumer Product Safety Comission. International Development Cooperation Agency. Agency for International Development. Department of Education. National Science Foundation.
Here and throughout the field notes. "L/C" means " license l condition."
) 87119. Appendix A A-6 Issue Date: XX/XX/96
(4) Records of meetings. maintained [35.22(a)(4)] ()Y()N (5) Has sufficient authority [35.23] ()Y()N (6) Approve / disapprove credentials of individuals prior to allowing work as an Authorized User or Authorized Nuclear Pharmacist [35.22(b)(2)(ii)] ( .) Y ( ) N
.(7) Approve / disapprove applications for use'[L/C] ()Y()N B. Radiation Safety Officer (R$0)
(1) Authorized on license [33.13. 35.21(a). L/C] ()Y()N (2) Fulfills duties per [35.21(b)] ()Y()N (3) Has sufficient authority per [35.23] ()Y()N C. Radiation Safety Program (1) Minor changes pursuant to [35.31] ( ) N/A ( ) Y ( ) N (2) Records of changes maintained [35.31(b)] ()Y()N D. Audits. Reviews, or Inspections (1) Audits are required [L/C] ()Y()N (2) Audits or inspections are conducted ()Y()N Audits conducted by Frequency Scope of audits (3) RSC/RSO review of audit results - timely actions taken ()Y()N (4) Content and implementation of the radiation protection program reviewed annually by the I
licensee [20.1101(c). 35.22(b)(6)] ()Y()N (5) Records of reviews maintained [20.2102] ()Y()N E. Use of licensed material by authorized individuals i [L/C] ()Y()N ,
- 4. FACILITIES A. ' Facilities as described in license application
()Y()N-B. Facilities are secured to prevent unauthorized access [L/C) ()Y()N C. Describe any .self-contained dry-source-storage irradiators and/or survey instrument calibrators (model, radionuclide, activity, use, etc) ( ) N/A (1) Maintenance of safety-related components l performed by authorized persons [L/C] ()Y()N (2)- Access to keys and/or material controlled
[20.1801, 1802. L/C] ()Y()N Issue Date: XX/XX/96 A-7 87119. Appendix A
.. k((
(3) Access to high/very high radiation areas :
controlled [20.1601. 1602. L/C] ()Y()N i (4) Adequate protection of shield integrity, i fire protection [L/C] ()Y()N D. Engineering Controls (1) Licensee uses process or other engineering controls for airborne concentrations.
- internal exposures in restricted areas and volatiles / gases in storage [20.1701. 1702.
35.90] ()Y()N (2) Maintenance program implemented for engineering controls (negativa pressure, ventilation rates. -
[ filter changes. etc., too.205(e). L/C] ()Y()N 3 i
- Basis for Findings:
- 5. EQUIPMENT AND INSTRUMENTATION. .
A. Dose calibrator - Photon-emitting radionuclides ( ) N/A (1) Possessed and used [35.50(a)] ()Y()N (2) Constancy [35.50(b)(1)]
- a. Performed daily prior to use ()Y()N
- b. Dedicated check source used ()Y()N (3) Accuracy [35.50(b)(2)]
- a. Performed at installation and annually ()Y()N l
- b. At least 2 sealed sources used ()Y()N i (4) Linearity [35.50(b)(3)] l
- a. Performed at installation and quarterly ()Y()N i
- b. Includes range between 30 uCi and the I highest dosage administered ()Y()N (5) Geometry Dependence [35.50(b)(4). L/C] !
a Performed at installation or relocation, if applicable ( ) Y (- ) N
- b. Includes range of volumes and volume ,
configurations used ()Y()N (6) Performed appropriate checks and tests following adjustment or repair of the dose calibrator [35.50(c)] ()Y()N
.(7) Dosage readings over 10 uCi mathematically corrected for geometry or linearity errors ,
greater than 10% [35.50(d)] ( ) N/A ( ) Y ( ) N .
i 87119. Appendix A A-8 Issue Date: XX/XX/96
i !
(8) Repaired or replaced when constancy or !
- accuracy errors exceeded 10% ( ) N/A ( ) Y ( ) N !
(9) Approved procedures followed [35.22, 25. L/C] ()Y()N !
(10) Records maintained and include identity of ;
individual performing test [35.50(e)] ()Y()N !
- 8. Instrumentation - Alpha- or beta-emitting radionuclides ( ) N/A (1) List type of equipment used to assay alpha and beta particles:
, e (2) Licensee has procedures for use of instru~nentation [35.52(b)] ()Y()N (3) Accur6cy, linearity, and geometric dependence i tests are performed pricr to initial use. !
periodically, and following repair, if ;
applicable [35.52(b)(1). L/C]
5
()Y()N i (4) Instruments are checked for constancy and proper operation at the beginning of each day of use [35.52(b)(2). L/C] ()Y()N (5) Appropriate action taken when calibration !
errors in excess of limits are ;
identified [L/C] ()Y()N j (6) Records maintained [L/C] ()Y()N j C. Licensee uses generators ()Y()N P
(1) No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 uCi per mC1 t of Tc-99m [35.204(a) ()Y()N 9L !
(2) Each eluate / extract used for radiopharmaceuticals _"
tested for Mo-99 breakthrough [35.204(b)] ()Y()N (3) Records maintained [35.204(c)] ()Y()N D. Syringes properly labeled and shielded [35.60] ()Y()N E. Vials
~
(1) Kept in a shield [35.61(a)] ()Y()N (2) Shields labeled [35.61(b)] ()Y()N F. Survey instruments ]
(1) Appropriate operable survey instrumentation j possessed and readily accessible [35.120. i 220. 320. 520). or available [L/C] ()Y()N :
.1 5
Note that linearity and geometric dependence tests are not l applicable if liquid scintiliation is used. Linearity is not applicable if sodium iodide is used.
Issue Date: XX/XX/96 A-9 87119. Appendix A
(2) Calibrations per [35.51(a). (b)] ;
(a) Before first use annually and after repairs [35.51(a)] ()Y()N (b) Calibration procedure includes check source reading [35.51(a)(3). L/C] ()Y()N (c) Within 20% in each scale or decade of interest [35.51(b). L/C] ()Y()N (d) Calibration records maintained [35.51(d)] ( ) Y ( ) N (3) Response checked with dedicated check source each day of use [35.51(c)] ()Y()N G. Other equipment / instruments used for qualitative and quantitative aurposes are calibrated and/or tested in accordance wit 1 manufacturers recommendations [L/C]( ) Y ( ) N H. Procedures established to identify and report safety compone:- defects [21.21]
()Y()N '
Basis for Findings:
- 6. MATERIALS RECEIPT. USE. TRANSFER. AND CONTROL A. Isotope, chemical form. quantity, and use, as authorized [31.11. 35.400. 500. L/C] ()Y()N B. Radioisotopes are used in research in accordance with current procedures [L/C] ()Y()N C. Use of pharmaceuticals [L/C]
(1) Licensee measures activity of each dosage of photon emitting radionuclide prior to use [35.53(a)] ()Y()N (2) Licensee administers alpha- or beta-emitting radionuclides . ()Y()N If "Yes."
(a) Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization [35.53(b)] ()Y()N (b) Licensee measures by direct measurement or combination of measurement and calculation each dosage of alpha or beta emitting radionuclide prior to medical use [35.53(b)] ()Y()N (3) Unsealed material used under 35.100. 200. or 300 is [35.100(b). 200(b). 300(b)]:
(a) Obtained from manufacturer or properly licensed organization AND/OR ()Y()N (b) Prepared by authorized nuclear pharmacist / user or individual under the supervision of authorized j nuclear pharmacist / user ()Y()N ;
87119. Appendix A A-10 Issue Date: XX/XX/96 i I
D.
Licensed materials secured to prevent unauthorized ()Y()N removal or access [20.1801, 1802]
(1) Licensed material in storage in controlled or unrestricted areas is secured from ( ).Y ( ) N unauthorized removal or access (20.1801]
(2) Licensed material in controlled or unrestricted areas and not.in storage is controlled and under constant ()Y()N surveillance [20.1802]
(3) Access to restricted areas is limited ()Y()N
[20.1003]
E. Describe how-packages are received and by whom [L/C]:
F. Written package opening procedures established ()Y()N and followed [20.1906(e)]
G. Incoming packages with a DOT label wiped, unless ()Y()N exempted (gases and special form) [20.1906(b)(1)]
Incoming packages surveyed [20.1906(b)(2). L/C] ()Y()N H.
I. Monitoring in (G) and (H) above performed within time ()Y()N specified [20.1906(c)]
Transfer (s) of licensed material per [30.41] ()Y()N J.
K. All source.; surveyed before shipment and transfer ()Y()N
[20.1501(a). L/C]
L. Records of surveys and receipt / transfer maintained ()Y()N
[20.2103(a). 30.51]
Transfer among licensee's authorized users M.
or locations performed as required [L/C] ( ) N/A ( ) Y ( ) N N. Arrangements made for packages containing quantities of radioactive material in excess ()Y()N of Type A quantity (20.1906(a)]-
- 0. Package receipt / distribution activities evaluated for ()Y()N compliance with 20.1301 [20.1302]
Basis for Findings:
( ) N/A
- 7. RADI0 PHARMACEUTICAL THERAPY A. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance,()Y()N release and contamination controls [35.315(a). L/C]
87119. Appendix A XX/XX/96 A-11 Issue Date:
B. Area dose rate surveys and room contamination surveys [35.315(a)] ()Y()N l C. Patients released in accordance with [35.75] l release limits ()Y()N D. RSO promptly notified if patient dies or has a medical emergency [35.315(b)~ ( ) N/A ( ) Y ( ) N ,
4
- 8. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to employees / students per [19.12] ()Y()N B. Training program required [L/C] ()Y()N (1) If so, briefly describe training program:
(2) Training program implemented ()Y()N (3) Periodic training pronram required ()Y()N (4) Periodic training program implemented ()Y()N (5) Records maintained ()Y()N C. ' Describe training provided for ancillary personnel (such ..
housekeeping. maintenance security. and receiving) [L/C]
D. Describe hands-on training received by research laboratory ,
workers [L/C] j l
E. Supervision of individuals by authorized user in accordance with [35.25. L/C] . ()Y()N 6
(1) Supervised individuals instructed in preparation of material, principles and procedures for radiation safety and OM Program, as appropriate
[35.25(a)(1) (b)(1)] ()Y()N (2) Licensee periodically reviews supervised individual's use of material and records kept to ref W t use [35.25(a)(3)] ()Y()N (3) AutF zed nuclear pharmacist or user periodically revi. .; work and records of work of supervised ,
individuals as it pertains to preparing byproduct i material [35.25(b)(3)] ()Y()N 6
Applies to individuals that receive. >ossess, use, transfer, or ;
pre)are byproduct material for medica ~ use under supervision or autlorized nuclear pharmacist or user 87119. Appendix A A-12 Issue Date: XX/XX/96
I F. Therapy training I
-(1) Safety instruction [35.310. L/C]
(a) Control of patien. and visitors- ()Y()N l (b) Contamination and waste (,Y()N (c) RSO notification in emergency or death ()Y()N .
(d) Records maintained [35.310'b)] ( ) Y (') N J (2) Manufacturer's instructions available and followed for sealed sources [35.59(a)) ()Y()N G. Workers cognizant of Part 20 requirements for:
(1) Radiation safety prograir [20.1101] ()Y()N (2) Annual dose limits [20.1301. 1302] ()Y()N (3) NRC Forms 4 and 5 ( ) N/A ( ) Y ( ) N (4) 10% monitoring threshold [20.1502] ()Y()N (5) Dose limits to embryo / fetus and declared pregnant worker [20.1208] ( ) N/A ( ) Y ( )-N (6) Grave danger posting [20.1902] ( ) N/A ( ) Y ( ) N (7) Procedures for opening packages
[20.1906] ( ) N/A ( ) Y ( ) N ,
(8) Sewer disposal limits [20.2003]- ( ) N/A ( ) Y ( ) N )
Basis for Findings:
- 9. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL ( ) N/A A. Briefly describe area survey requirements [20.1501(a). 35.70. L/C]:
B. Surveys performeci as required [20.1501(a).
35.70. L/C] ()Y()N (1) Daily with survey instruments in all areas where radiopharmaceuticals are pre)ared or administered [35.70(a)] ()Y()N (2) Weecly with survey instruments in all areas where radiopharmaceuticals or radiopharmacy waste are stored [35.70(b)] ()Y{)N (3) Weekly with wiyes for removable contamination in all areas w1ere radiopharmaceuticals are routinely prepared, administered, or stored
[35.70(e)] ()Y()N (4) Survey techniques can detect 0.1 mrem /hr.
2000 dpm [35.70(c). (d)] ()Y()N Issue Date: XX/XX/96 A-13 87119. Appendix A
)
< ~
, s gy !
(5) Trigger. levels [35.70(d). (g)] ': a I i
. (a) Established ()Y()N
! (b) Exceeded ()Y()N l (c) Corrective action taken ()Y()N 5
l (6) Records maintained [35.70(h), 20.2103. L/C] ( ) Y ( ).N ,
E. Handling and use of radioactive materials [L/C]
4 i' (1) Protective clothing worn .
()Y()N (2) Personnel routinely monitor or frisk themselves after procedures or before leaving ()Y()N
- (3) Eating / drinking / smoking in use/ storage areas ()Y()N
! (4) Food, drink, or personal effects stored in use/ storage areas ()Y()N 1 (5) Proper dosimetry worn ()Y()N
- (6) Radioactive waste disposed in proper containers ( )-Y ( ) N (7) Pipetting by mouth -( ) Y ( )~N i (8) Use of shielding / distance while using/ storing
- j. material ()Y()N F. Protection of members of the public '
! (1) Licensee made adequate surveys to demonstrate either: (1) that the TEDE to the individual likely
, to receive the highest dose does not exceed 100
. mrem in a year: 'or (2) that if an individual were continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour and 50 mrem in a year [20.1301(a)(1). 1302(b)] ()Y()N _
l (2) Unrestricted area radiation levels do not exceed l 2 mrem in any one hour [20.1301(a)(2)] ()Y()N
( ) Y (') N (3) Records maintained [20.2103, 2107]
c H. Leak tests and inventories ( ) N/A (1) Leak tests performed on sealed sources
! as required [35.59(b)] ()Y()N
- (2) Leak test procedures per [35.59(c)] ()Y()N
- (3) Records maintained & signed by RS0 [35.59(d))) ()Y()N
- (4) Inventory of sealed sources performed quarterly [35.E9(g)] ()Y()N
- Basis for' Findings
i
- 10. RADIATION PROTECTION A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee incorporated ALARA considerations in the radiation protection program [35.20, 20.1101(b)] ()Y()N
! 87119. Appendix A A-14 Issue Date: XX/XX/96
l l
C. External Dosimetry ( ) N/A (1) Licensee monitors workers [20.1502(a). L/C] ()Y()N (2) External exposures account for contributions from airborne activity [20.1203] ,( ) N/A ( ) Y ( ) N (3) Processor Frequency (4) Processor is NVLAP-approved [20.1501(c)] ()Y()N (5) Dosimeters exchanged at required frequency [L/C] ()Y()N D. Internal Dosimetry ( ) N/A (1) Licensee monitors workerr [20.1502(b). L/C] ()Y()N (2) Briefly describe licensee's program for .
monitoring and controlling' internal exposures
[20.1701, 1702. L/C]:
(3) Air sampling performed [20.1204. 35.205] ()Y()N .
(4) Monitoring / controlling 3rogram implemented l
[35.205(d). 315(a)(8). _/C] ()Y()N l (5) Respiratory protection equipment [20.1703] ()Y()N E. Reports ( ) N/A (1) Reviewed by Frequency (2) Inspector reviewed personnel monitoring records for period to (3) Prior dose determined for individuals likely ,
to receive doses [20.2104]
()Y()N l (4) Maximum exposures TEDE Other (5) Maximum CDEs Organs (6) Maximum CEDE _,
(7) Licensee sums internal and external [20.1202] ()Y()N (8) TEDEs and.TODEs within limits [20.1201] ()Y()N l (9) NRC Forms or equivalent [20.2104(d), 2106(c)]
(a) NRC Form 4 ()Y()N C lete ()Y()N (b) NRC Form 5 ()Y()N C lete ()Y()N (10) Worker declared her pregnancy in writing during inspection period (review records) ( ) N/A ( ) Y ( ) N If "Yes " licensee in compliance with dose to embryo / fetus [20.1208] ()Y()N and records maintained [20.2106(e)] ()Y()N, Issue Date: XX/XX/96 A-15 87119. Appendix A
l F. Who performed PSEs at this facility (number of people involved and doses received)? [20.1206. 2104. 2105.
l 2204] ( ) N/A l
, G. Records of exposures, surveys, monitoring. and evaluations maintained [20.2102. 2103. 2106.
l 35.205(d). 315(a)(8). L/C] ()Y()N H. Licensee advises each worker annually of worker's dose [19.13(b)] ()Y()N Basis for Findings:
- 11. 00ALITY MANAGEMENT PROGRAM. MISADMINISTRATIONS. AND RECORDABLE EVENTS
[35.32. 33]
NO- This section is being revised by IMAB and is being separately transmitted for comment.
- 12. RADIOACTIVE WASTE MANAGEMENT ( ) N/A A. Disposal ( ) N/A (1) Decay-in-storage [35.92] ( ) N/A ,
(a) Procedures a 35.92. L/C] pproved [20.2001(a)(2). ()Y()N (b) In accordance with [35.92. L/C] ()Y()N ,
(c) Labels removed or defaced [20.1904(b). 1 35.92] ()Y()N l (2) Special procedures performed as required [L/C] ()Y()N (3) Liquid scintillation (LS) media and animal carcasses per [20.2005] ( ) N/A ( ) Y ( ) N (4) Improper / unauthorized disposals [20.2001] ()Y()N
. (5) Records maintained [20.2103(a). 2108. L/C] ()Y()N B. Effluents ( ) N/A (1) Release into sanitary sewerage [20.2003]( ) N/A ( ) Y ( ) N (a) Material is readily soluble or readily dispersible [20.2003(a)(1)] ()Y()N (b) Monthly average release concentrations do not exceed Appendix B values
. [20.2003(a)(2) (3)] ()Y()N l (c) No more than 5 Ci of H-3. 1 Ci of C-14
' and 1 Ci of all other radionuclides combined released in a year
[20.2003(a)(4)] ()Y()N 87119. Appendix A A-16 Issue Date: XX/XX/96
t (d) Procedures to ensure representative sampling and analysis properly implemented [20.1501(a)(2). L/C] ()Y()N '
l, (2) Release to septic tanks [20.1003] ( ) N/A ( ) Y ( ) N (a) Within unrestricted limits [ App B. Table 2] ( ) Y ( ) N
- i 2
(3) ' Waste incinerated [20.2004] ( ) N/A ( ) ( )N (a) License authorizes [20.2004(a)(3)] ()Y()N (b) Licensee directly monitors exhaust ()Y()N (c) Airborne releasas evaluated and 4
controlled-[20.1501, 1701] ()Y()N ,
, (4) Control of effluents and ashes [20.1201.
1301. 1501. 2001. L/C]
{SeealsoIP87102.RG8.37} ()Y()N (a) Compliance with air emissions requirements in Part 20:
- j. Licensee has demonstrated compliance with air emission requirements in Part 20 ( ) Y ( ) N 4
Basis for compliance determination (check one or more: provide basis below)
(i) Measured concentrations of radionuclides in air effluents are below Appendix B. Table 2 concentrations (and external dose < 50 l mrem /yr)
- (ii) Bounding calculations show that air effluents could not exceed Appendix 8.
Table 2 concentrations.(and external dose <
L 50 mrem /yr)
, (iii) Dose modeling shows that dose equivalent to 2
the individual likely to receive the
, highest dose.does not exceed 10 mrem /yr (iv) Licensee does not possess sufficient radio-l active material to exceed Part 20 requirements Basis for Determination:
l' (b) Description of effluent monitoring program (i) Monitoring-system hardware equipment
- adequate ()Y()N
('i) Equipment calibrated as appropriate ( ) Y ( ) N
- (iii) Air samples / sampling technique (charcoal. HEPA. etc.) analyzed
- with appropriate equipment ()Y()N Issue Date
- XX/XX/96 A-17 87119. Appendix A
4 (5) EPA referral form for air effluents sent
'. WT .
i to appropriate EPA regional office, with copy !
to NRC headquarters.-per IP 87102 ( ) N/A ( ) Y ( ) N
~
C. Waste Management ( ) N/A .
(1) Waste compacted [L/C] ( ) Y_( ) N (2) Storage area (s) ( ) N/A l (a) Protection from elements and fire [L/C] ( ) Y (-) N (b) Control of waste maintained [20.1801] ()Y()N i (c) Containers properly labeled and area pro)erly posted [20.1902. 1904] ()Y()N :
(d) Paccage integrity maintained [L/C] ()Y()N (3) Packaging, Control and Tracking
- 4 [Part 20. App. F.III.] [20.2006(d)]
Note: The licensee's waste is likely to be Class A. l (a) Not packaged for' disposal in cardboard or fiberboard boxes [61.56(a)] ()Y()N t (b) Liquid wastes solidified. (i.e.. less {
than 1% freestanding liquid) and void spaces minimized [61.56(a). (b)] ()Y()N (c) Does not generate harmful vapors [61.56] ()Y()N (d) Structurally stable (will maintain its i.
physical dimensions and form under expected disposal conditions) [61.56(b)] ()Y()N (e) Packages properly labeled
[ App. F.III.A.2] ()Y()N :
(f) Licensee conducts a QC program to ensure compliance with [61.55.56] and includes management evaluation of audits [ App. F.III.A.3] ()Y()N (g) Shipments not acknowledged within 20 days after transfer are investigated and reported
[ App. F.III.A.8]
( ) N/A ( ) Y ( ) N *
(4) Transfers to land disposal facilities ( ) N/A (a) Transferred to person specifically licensed to receive waste
[30.41,20.2001(b)] ()Y()N (b) Each shipment accompanied by a manifest prepared as specified in Section I of _
Appendix F [20.2006(b). App. F.III.A.4] ()Y()N (c) Manifests certified as specified in Section II of Appendix F [20.2006(c)] ()Y()N D. Records of surveys and material accountability are maintained [20.2103, 2108] ()Y()N ,
Basis for Findings 1
87119. Appendix A A-18 Issue Date: XX/XX/96 l 1
i
- 12. RECORDKEEPDK3 FOR DECOMMISSIONING ,
A .- Records of information important to the safe and effective decommissioning of the facility maintained l in an independent and identifiable location until license termination. ()Y()N B. Records include all required information [30.35(g)] ()Y()N ,
(1) List of restricted areas [30.35(g)(3)] '
indicates that laboratories or other rooms have been released since the last inspection ()Y()N (2) Confirmatory measurements show that each room is within release limits, and licensee records adequately document the basis for releasing each room ()Y()N C. Copies of the licensee's decommissioning cost estimates and funding methods on file ()Y()N D. If the licensee uses a parent company guarantee or a self-guarantee as funding method, does the file contain a copy of the financial test performed for the licensee's most recently completed fiscal year? ( ) N/A ( ) Y ( ) N E. If "Yes to D. , do the financial test ratios meet the criteria in 10 CFR Part 30.
Appendix A. Section II for parent company guarantees and Appendix C. Section II for self guarantees? (') Y ( ) N F. Date that licensee's financial assurance instrument ( ) N/A was submitted to NRC. if applicable:
G. Date that licensee's decommissioning plan was ( ) N/A submittai to NRC. if applicable:
H. Have radiological conditions at the licensee *s facility changed since the financial assurance mechanism and/or decommissioning plan was submitted due to:
(1) Incidents or events? ( ) N/A ( ) Y ( ) N (2) Unplanned process upsets or changes? ( ) N/A ( ) Y ( ) N (3) Unauthorized material, form, or possession limit changes? ( ) N/A ( ) Y ( ) N (4) Any other changes? ( ) N/A ( ) Y ( ) N If "Yes" to any of the above (1)-(4) notify regional management.
Basis for Findings (include coments and measurements on any areas the licensee released for unrestricted use): .
Issue Date: XX/XX/96 A-19 87119. Appendix A
- 13. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE
, A. License to conduct a principle activity has expired or been revoked ( ) Y (-) N 7 B. Licensee hm made a decision to permanently cease principal activities, at t1e entire site.
+
or any separate buildings, or any outdoor areas. !
j- including inactive burial' grounds ()Y()N I
- C. A 24-month duration has passed in which no
, principal activities, have been conducted under the license at the site, or at any separate i
- buildings. or any outdoor areas, including
[
inactive burial grounds ()Y()N ;
D. If "Yes" to either A or B or C:
q l (1) Identify Site /81dg/ Area- l
! (2) Date of occurrence of A. B. or C:
NOTE: If "No".to A and B and C. decommissioning timeliness rule does not apply.
If "Yes" to either A or B or C. then complete Attachment B. l
- "Decomissioning Timeliness Inspection Field Notes." for this licensee. !
l Basis for Findings: '
l i
- 14. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 171-189) ( ) N/A A. Licensee shipments are: )
() delivered to common carriers
- () +ransported in licensee's own private vehicle
() both i' () no shipments since last inspection 4
- 8. Licensee returns radiopharmacy doses ( ) N/A ( ) N ( ) N
- (1) Licensee assumes shipping responsibility ()Y()N l 1 (2) If "No." describe arrangements made between licensee and radiopharmacy for shipping
- responsibilities
0 t- C. Licensee Transoorts: [ complete sections (1) - (4). as applicable]
- (1) Limited Quantities and/or Instruments and ( ) N/A Manufactured Articles: (Radioactive Material.
- excepted package. [ additional info]. 7. UN 2910) 3 (a) Package meets general design requirements [173.410] ()Y()N 87119. Appendix A A-20 Issue Date
- XX/XX/96
l l
(b) Radiation level < 0.005 mSv/hr (0.5 mrem /hr) (Exclusive use instruments and articles. 2 mrem /hr) ()Y()N (c) Contamination le a than 173.443 limits.
OC examination / test performed prior to each shipment [173.475(I)] ()Y()N (d) Limited Quantity Package marked
" Radioactive" [173.421(a)(4)] ()Y()N (e) 173.422 certification statement i attached / enclosed ("This package l conforms to the conditions and '
limitations specified in. . ") ()Y()N 1
(2) Type A Quantities (Radioactive Material, i nos.7. UN 2982) ( ) N/A
-(a) Packaging: l (1) Packaging is proper for contents 1 (i.e.. DOT 7A) is unimpaired, and i is prepared correctly l
[173.475(a)-(f)] ()Y()N (ii) All packages meet general design ;
requirements [173.410] ()Y()N !
(iii) DOT 7A package meets additional ;
Type A design requirements
[173.412. 178.350] ()Y()N (b) Recordkeeping:
(i) Special form source records
[173.476(a)] ()Y()N (ii) 00T 7A performance / design documentation [173.415(a)] ()Y()N (c) Hazards communications requirements :
, (consult the "NRC field reference l charts" that correspond to elements l (i) through (v). below): !
(i) Shi) ping pa)ers [172.200-205] ()Y()N (ii) Marcing paccages [172.300-338] ()Y()N (iii) Labeling packages [172.400-450] ()Y()N (iv) Placarding vehicles [172.500-560] ()Y()N (v) Emergency response information and guidance [172.600-604] ()Y()N .
(d) Radiation level / Contamination limits
[173.441. 173.443]
(i) Package levels within limits ()Y()N 1 (ii) OC examination / test performed prior to each shipment [173.475(I)] ()Y()N 1
Issue Date: XX/XX/96 A-21 87119. Appendix A
(3) Type B Ouantities (Radioactive Material. nos. ( ) N/A
- 7. UN 2982)
(a)- Packaging is proper for contents (i.e., .
Type B). is unimoaired. and is prepared !
correctly [173.475(a)-(f)] ()Y()N !
(b) Inspector must complete Section 2 of NRC 5 IP 86740 (c) Sections 2.c. and 2.d. 50 ,9 in the pre- :
vious section for Type A Quantities. also apply. Complete those sections. ;
i (4) LSA Material and SCO (Radioactive Material. ( ) N/A LSA, nos. 7. UN 2912) or (Radioactive Material.
SCO. nos. 7. UN 2913)
(a) If licensee makes significant LSA/SCO shipments inspector should complete Inspection Requirement 03.02 of Temporary Instruction (TI) 2515/133 (issued 3/15/96)
(b) Otherwise, if licensee has a minor LSA/SCO program:
(i) Licensee properly characterizing material as LSA/SCO [173.403] ()Y()N (ii) All packages meet general design requirements [173.410] ()Y()N
.(iii) Proper LSA/SCO packaging selected
-and used [173.475. 173.427] ()Y()N (iv) Placarding exclusive use vehicles.
marking package " Radioactive-LSA" or " Radioactive-SCO." as .!
a3propriate [173.427(a)(6)] ()Y()N !
(v) Slipping Papers [172.200-205]
(see "NRC field reference charts"
, for content and exceptions) ()Y()N i D. 00T HAZMAT Emoloyee Trainino Proaram [49 CFR 172.700-704] ( ) N/A {
l (1) Each HAZMAT employee receives training and is tested [172.702] ()Y()N
! (2) Recurrent training at least every 2 years l [172.704(c)(4)] ()Y()N l (3) HAZMAT employee training includes general i awareness. function-specific, and safety training [172.704] ()Y()N (4) HAZMAT employer recordkeeping includes employee name, completion date.
l description / copy / location of training
- materials, name and address of training
- provider, and certification [172.704(d)] ()Y()N 87119.. Appendix A A-22 Issue Date: XX/XX/96
.- . . - . = .
D. Carrier Modal Soecific Reauirements. Hiahway ( ) N/A I Transoortation [49 CFR Part 177]
(1) Driver training, or COL w/ HAZMAT endorsement
[177.800. 177.816] . ()Y()N ,
(2) Incident reporting to 00T [177.807, see also 171.15 and 171.16] ()Y()N (3) Shipping paper accessibility (on seat or in driver's side door pocket, readily visible) (-) Y ( ) N (4) Placarded vehicles routing and driver training requirements [177.825 and 49 CFR 397 Subpart D (i.e. the motor carrier regs)) ()Y()N (5) Sum of total package tis on non-exclusive use <
vehicle < 50 [177.842(a)] ()Y()N f (6) Packages blocked / braced for transport .
[177.842(c)] ()Y()N E. Miscellaneous Reauirements ( ) N/A (1) No labeled packages carried in passenger compartments [173.448(c)] ()Y()N (2) Overpack requirements observed, if packages are offered in overpack. Overpack marked w/ proper shipping name and number, package and overpack labeled as needed, marked " inner package complies ...." [173.24] ()Y()N (3) Expanded and changed A1/A2 values from the 4/1/96 rule changes have been implemented
[173.435] (verify only once per licensee) ()Y()N (4) Written instructions included with exclusive use shipments [173.403] ()Y()N Basis for Findings:
- 16. POSTING AND LABELING A. NRC Form 3. " Notice to Workers." is posted [19.11] ()Y()N B. Parts 19. 20. 21. Section 206 of Energy ,
Reorganization Act, procedures adopted pursuant to L Part 21. and license documents are posted or a notice indicating where documents can be examined is posted
[19.11. 21.6] ()Y()N j C. Other posting and labeling per [20.1902, 1904] l and the licensee is not exempted by-[20.1903, 1905] ()Y()N j Basis for Findings:
Issue Date: XX/XX/96 A-23 87119. Appendix A L
_ _ . _ . - . _ . . . _ . _ _ . _ _ _ _ . . . _ _ _ _ _. . _ ___ ._ . ..___m. __
- 17. GENERIC COMMUNICATION OF INFORMATION 0" A. Bulletins, information notices. NMSS Newsletter, etc. received by the licensee ()Y()N B. Licensee took appropriate action in response to bulletins, generic letters etc. ( ) Y (.) N Basis for Findings:
- 18. NOTIFICATION AND REPORTS A. Notifications since last inspection [35.141 (1) Licensee has provided appropriate documentation to NRC for authorized user or nuclear pharmacist no later than 30 days after the individual starts work [35.14(a)] ( ) N/A ( ) Y ( ) N (2) Licensee has notified NRC within 30 days after ,
authorized user or nuclear pharmacist or RSO .!
stops work or changes nace or licensee's mailing address changes [35.14(b)] ( ).N/A ( ) Y ( ) N B. Licensee in com to individuals,pliance withoccupational, public and [19.13. 30.50] (reports monitored to show compliance with Part 20) ( ) N/A ( ) Y ( ) N C. Licensee in compliance with [20.2201, 30.50]
(theft or loss) ( ) None ( ) Y ( ) N D. Licensee in compliance with [20.2202, 30.50]
(incidents) ( ) None ( ) Y ( ) N E. Licensee in compliance with [20.2203. 30.50]
(overexposures and high radiation levels) ( ) None ( ) Y ( ) N F. Licensee aware of NRC Ops Center phone number ()Y()N
[(301)-816-5100)
-Basis for Findings:
87119. Appendix A A-24 Issue Date: XX/XX/96
l
- 19. YEAR 2000 EFFECT ON COMPUTER SYSTEM SOFTWARE i
A. Licensee has reviewed the effect of the year 2000 on i computer software programs that are used to meet '
licensing requirements or those that have safety significance [IN 96-XX] ()Y()N .
If "No," licensee is aware of notice to do so ()Y()N.
NOTE: A deficiency in this area should not be cited as a violation. .
- 20. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A >
A. Special license conditions or issues to be reviewed: !
5 B. Evaluation: .
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l Issue Date: XX/XX/96 A-25 87119 Appendix A i
- 21. OBSERVATIONS / DEMONSTRATIONS OF LICENSED ACTIVITIES i
Briefly describe the activities and procedures observed and/or denonstrated during the inspection. For exauple, if you observed licensee personnel working in radiation areas using 1icensed material or performing functions associated with radiation safety such as receiving or transporting licensed ,
material: conducting or receiving training: disposing of radioactive waste: ;
conducting surveys: or maxing measurenents. then describe what you saw. If '
the 1icensee denonstrated any practices at your request, describe those denonstrations. The observations and denonstrations you describe here, and elsewhere in the " Basis for Findings" sections of this report, along with measurenents and sane records review. should substantiate your inspection findings.
Describe what -activities or procedures were observed and/or demonstrated by the licensee during the inspection: i l
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i 87119. Appendix A A-26 Issue Date: XX/XX/96
The following sections should be completed in a xrrative format by the inspector to briefly describe the measurements performed by the inspector, inspection findings, and any post-inspection conmunications with regional staff.
.22. NRC INSPECTOR'S MEASUREMENTS ( ) N/A A. Survey instrument Serial No. Date of calibration B. Inspector performed CONFIRMATORY measurements (-) Y ( )'N C. Inspector performed INDEPENDENT measurements ()Y()N D. Briefly describe the types of measurements performed (i.e. .
exposure rates, wipe tests, air flow measurements, etc.).
locations where measurements were taken, the results of these measurements (mR/hr. dpm. etc.), and whether inspector's results conflicted with the licensee's measurements. If independent measurements were not made, justify why they were not perfonned on this inspection:
- 23. CONTINUATION OF REPORT ITEMS ( ) N/A l l l
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l l Issue Date: XX/XX/96 A-27 87119. Appendix A
- 24. VIOLATIONS NON-CITED VIOLATIONS INCVs). AND OTHER ISSUES ( ) N/A NOTE: Briefly state (1) the requirement and (2) how and when the licensee
, violateo the requirement. For NCVs. indicate why the violation was not cited. Attach ccpies of all licensee documents needed to support the vio'lation.
- 25. DEBRIEF WITH REGIONAL STAEE A. Was inspection feedback proviaed to regional licensing staff? ()Y()N i If "Yes," name of individual on the licensing
't staff:
If "Yes." describe issues discussed:
t l I f
B. Briefly describe post-inspection communications with other regional staff (inspector's supervisor, Agreement State officer State liaison ufficer, etc.):
87119, Appendix A A-28 Issue Date: XX/XX/96
- 26. PERFORMANCE EVALUATION FACTORS hfd[hf A. Lack of senior management involvement with the radiation safety program a6d/or RSO oversight ()Y()N B. RSO too busy with other assignments ()Y()N C. Insufficient staffing ()Y()N
-D. RSC fails to meet or functions inadequately ()Y()N E. Inadequate consulting services or inadequate audits ()Y()N Remarks (consider the above assessment and/or other pertinent PEFs with regard to the licensee's oversight of the radiation safety program):
Regional follow-up on above PEFs citations:
END l
Attachments:
A. " Laboratory Inspection Field Notes" B. " Decommissioning Timeliness Inspection Field Notes" Issue Date: XX/XX/96 A-29 87119. Appendix A
APPENDIX A - ATTACHMENT A LABORATORY INSPECTION FIELO NOTES hkkp{
- 1. Date Authorized User (s)
- 2. Location (s) Building . Room (s)
- 3. Person (s) Contacted
- 4. Describe'scooe of lab use (nuclides, form, frequency.. purpose, etc):
- 5. TRAINING A. Frequency: Conducted by:
B. Individuals interviewed understand safety practices ()Y()N Basis for Findings:
- 6. SURVEYS A. Types of surveys performed (daily, weekly, monthly, etc.)
B. Instrumentation properly calibrated and used (=) Y ( ) N ;
C. Efficiency of counting system (s) determined ()Y()N l D. Hood airflow adequate and checked as required ( ) N/A ( ) Y ( ) N
. E. Records maintained: trigger levels established, area diagram.. instrument used individual performing survey, results in proper units, decontamination performed as necessary, etc. ()Y()N F. Inspector performed independent and/or confirmatory measurements ()Y()N Basis for Findings: 1 Issue Date: XX/XX/XX Att. A-1 87119. Appendix A. Att A
V 1
rn m y > , On'y j tr.uw.
l 4 7 RECEIPT AND TRANSFER- l
- A. Incoming packages properly surveyed ()Y()N
! B. Interlaboratory transfers performed as specified j in the license (,) N/A ( ) Y ( ) N C. Records maintained ()Y()N l Basis for Findings:
i i
- 8. PERSONNEL DOSIMETRY 4
A. ~ Appropriate dosimetry assigned and worn ( ) N/A ( ) Y ( ) N B. Results available to lab personnel ()Y()N C. Bioassays performed ( ) N/A ( ) Y ( ) N 1 i
Basis for Findings: J l
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- 9. HANDLIfL WASTE A. Procedures followed ()Y()N B. Proper storage (area, containers, labeling etc.) ()Y()N C. Liquid / solid waste disposal ()Y()N D. Incineration ( ) N/A ( ) Y ( ) N E. Compaction ( ) N/A ( ) Y ( ) N ,
F. Sewer discharge ( ) N/A (.) Y ( ) N i G. Records maintained ()Y()N J Basis' for Findings:
- 10. INVENTORY ( ) N/A A. Inventory conducted ()Y()N B. Records maintained ()Y()N.
Basis for Findings:
87119. Appendix A. Att. A Att. A-2 Issue Date: XX/XX/XX
t I
- 11. STORAGE AND USE OF LICENSED MATERIAL A. Adecuate method to prevent unauthorized access -( ) Y ( ) N l B. Concition of areas acceptable ()Y()N ;
C. ' Personnel wear disposable glaves and protective clothing while handling material ()Y()N !
D. Personnel routinely monitor or frisk.themselves after procedures or before leaving ()Y()N l E. No eating / drinking / smoking in use/ storage areas ()Y()N :
F. No food, drin',- or personal items stored in -
use/ storage areas ()Y()N s G. Use of shielding / distance while using/ storing material ( ) Y ( ) N .
H. RAM is under surveillance and control (when not in I storage) in an unrestricted area ()Y()N i l '. Proper dosimetry worn - ()Y()N ,
J. Radioactive waste disposed of in proper containers (,) Y (-) N !
K. No pipetting by mouth ()Y()N i Basis for Findings: ;
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- 12. POSTING AND LABELING A. NRC Form 3 " Notice to Workers" ()Y()N B. Parts 19. 20. 21. Section 206 of Energy Reorganization Act, procedures for Part 21. and license documents or a notice indicating where documents can be examined ()Y()N C. Other posting and labeling requirements met ()Y()N Basis for Findings:
I j
- 13. VIOLATIONS IDENTIFIED: j l
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I l j It,;a Date: XX/XX/XX Att. A-3 87119, Appendix A, Att. A
APPENDIX A - ATTACHMENT B -
DECOMMISSIONING TIMELINESS INSPECTION FIELD NOTES Licensee:
Date of Inspection:
- 1. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE (NOTE: Repeat the answers given in Section 12 of the main body of the field notes. The issues in subsequent sections are dependent on the answers to these questions.)
A. License to conduct a principle activity has expired or been revoked ()Y()N B. Licensee has made a decision to permanently cease principal activities, a; the entire site, or any separate buildings, or any outdoor areas.
including inactive burial grounds ()Y()N C. A 24-month duration has passed in which no principal activities have been conducted under the license at the site, or at any separate buildings or any' outdoor areas, including inactive burial grounds ()Y()N D. If "Yes" to either A or B or C above:
(1) Identify Site / Bldg / Area:
(2) Date of occurrence of A. B, or C: _
l
- 2. NOTIFICATION REQUIREMENTS A. Licensee has provided written notification to NRC within 60 days of the occurrence of 1.A. ,1.B. . or 1.C. above ()Y()N If "Yes. date of notification:
B. If the licensee is requesting to delay initiation of the decommissioning process the licensee has provided written notification to NRC within 30 days of occurrence of 1.A., 1.B.. or 1.C. above ( ) N/A ( ) Y ( ) N If "Yes " date of notification:
Comments:
Issue Date: XX/XX/XX Att. B-1 87119. Appendix A. Att. B
- 3. DECOMMISSIONING PLAN / SCHEDULE REQUIREMENTS A. Licensee is required to submit a decommissioning plan per 10 CFR 30.36(g). 40.42(g). 70.38(g). or 10 CFR Part 72? ( ) Y.( ) N If "No" to 3.A.. answer the following items B. - F.:
B. The decomissioning work scope is covered by current license conditions ( ) Y-( ) N C. Decomissioning has been initiateo within 60 days of notification to NRC. or NRC has granted a delay ()Y()N D. If licensee has initiated decommissioning. give date the decommissioning was initiated:
Initiation date:
E .- If decomissioning has been completed. It was completed within 24 months.of notification to NRC ( ) N/A ( ) Y ( ) N F. If decommissioning is still scheduled to be completed, it is on schedule to be completed within 24 months of notification to NRC ( ) N/A ( ) Y ( ) N Comments:
If "Yes" to 3.A., answer the following items G. - J.:
G. The ~decomissioning plan has been submitted to NRC within 12 months of notification ()Y()N If "Yes." date of submittal:
If NRC approved, date of NRC approval:
H. Has the licensee submitted an alternative schedule request? ()Y()N If "Yes," date of submittal:
87119. Appendix A. Att. B Att. B-2 Issue Date: XX/XX/XX
LRAFT I. If decomissioning has been completed. it was completed within 24 mnths after apprcy;l of ( ) N/A ( ) Y ( ) N the decomissioning plan J. If decomissioning is sti'l scheduled to be 3:
completed, it is on schedule to be completed ll within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N Coments: !
l Violations identified, if any:
Att. B-3 87119. Appendix A. Att. B Issue Date: XX/XX/XX