ML20136B882
| ML20136B882 | |
| Person / Time | |
|---|---|
| Issue date: | 02/03/1997 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20136A699 | List: |
| References | |
| FOIA-97-54 PROC-970203, NUDOCS 9703110180 | |
| Download: ML20136B882 (1) | |
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NUCLEAR REGULATORY COMMISSION wAsnisorow o.c. sosewoo' IM001
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NRC INSPECTION MANUAL PIPB Change Notice 97-001 DELETED: TRANSMITTED:
Number Dats Number Datt
& 2. IP 87100 12/30/91 IP 87100 02/03/97
< 3. IP 87100 App B 01/05/95 IP 87100. App B 02/03/97
' 4. IP 87100. App D 03/07/94 IP 87100. App D 02/03/97
- 5. IP 87100, App G 01/05/95 IP 87100. App G 02/03/97 ;
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- 9. TI 2515/095 03/31/88 ---- ----
- 10. TI 2515/096 03/31/88 ---- ----
- 11. ---- ----
9900 Tech Guidance 02/03/97 (STS L TS Interpretations) l TRAINING: No special training requirements have been identified for any ,
documents issued with this change notice. ;
REMARKS: IP 40500 (Effectiveness of Licensee Controls in Identifying.
Resolving, and Preventing Problems) is revised to implement a recommendation from the PIPB audit of IP 40500 to clarify the ,
inspection procedure objective as a comprehensive review of the !
licensee's ability to identify, correct, and prevent problems. l Because of the fundamental importance of the NRC's evaluation of '
licensee self-assessment, this inspection must be conducted as a systematic and comprehensive inspection that considers, in part, the l results of other inspections performed over the previous 12-24 l months.
r JR i IJ Issue Date: 02/03/97 97-001 i
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! FELTON97-54 PDR l
"P 87103 (Licensed Materials Programs)
P 87100. Aoo B (Nuclear Medicine Inspection Field Nctes) .
- P 87100. Aoo D (Industrial Radiogrh.y inspection Field Notes) l
'P 87100. Aco G (Medical Broad Scope Inspection Field Notes) i P 87100. ADD H (Radiopharmacy Inspection Field Notes)
The procedure and listed appendices were revised to include inspection guidance on the new constraint rule on air emissions (10 CFR 2( .1101). patient release (10 CFR 35.75). and ancillary radiogr aphy equipment (10 CFR 34.20).
LP 871'!.Q (Industrial / Academic /Research Programs)
.'P 871: 0. Anoendix A (Industrial Academic /Research Inspection F"'d Notes)
The above inspection procedure and appendix have been revised to include inspection guidance on the new constraint rule on air emissions (10 CFR 20.1101).
TI 25HIQ25 (Inspection For Verification of BWR Recirculation Pump Trip - Multi-Plant Action Item C-02) is deleted. The inspection requirements identified in this TI have been completed. ,
TI 25&/_0_96 (Inspection Verification of Mark I BWR Drywell Vacuum Breaker Modifications - Multi-Plant Action Item D-20) is deleted.
The irspection requirements identified in this TI have been comple1ed.
2900 Technical Guidance - STS (Licensee Technical Specifications Interpretations) is issued to provide guidance to the inspection staff on technical specification (TS) interpretations. Recent observations of licensee TS interpretations and some particular practices concerning their implementation have highlighted the need for staff clarification and guidance on this subject.
DISTRIBUTION: Statidard END l
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l 97-001 Issue Date: 02/03/97 l
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pa Cec 3 % UNITED STATES
- g NUCLEAR REGULATORY COMMISSION r WASHINGTON, D.C. 20565Q
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NRC INSPECTION MANUAL NMSS/IMNS-
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INSPECTION PROCEDURE 87100 LICENSED MATERIALS PROGRAMS PROGRAM APPLICABILITY: 2800 87100-01 INSPECTION OBJECTIVES 01.01 To determine if licensed programs are being conducted in accordance with NRC requirements.
01.02 To determine if licensed activities are being conducted in a manner that will ensure the health and safety of workers and the general public.
87100-02 INSPECTION REQUIREMENTS Review of the licensed activities should be comnensurate with the scope of the licensee's program. To the extent possible, a determination regarding compliance with an NRC requirement should be based on direct observation of a work activity, interviews with workers, a demonstration by a worker of how he/she performs a l task that is regulated by NRC, or an independent measurement of radiation conditions at the facility (rather than exclusive reliance on a review of records). Specific inspection requirements follow:
02.01 Proaram Administration. Review the following elements in sufficient depth to verify that organization and administrative systems have been established to ensure safe conduct of the licensed activity.
- a. Oraanization.
Reference:
Applicable license conditions.
The organizational structures will be found in license applications and may involve one or more individuals. Examine any changes in the organization with respect to changes that have occurred in personnel, functions, responsibilities and authorities since the previous inspection.
If individuals are n6med in the license application, an amendment must be provided whenever changes in personnel are made (except for some broad and radiography licenses, where only responsibilities are defined). If there have been no changes in the organization since the arevious inspection,
" there is no need to pursue that element in any dept 1, except to ask the licensee if there have been changes and to make inquiries of personnel to confirm (to the inspector's satisfaction) that no changes have taken l place.
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References:
Medical GA program to :
QA Procram and Licensee Audits.
mitigate therapeutic misadministrations (only if the program being inspected has OA requirements in the license). Applicable license i
conditions, The quality assurance program will be in the form of procedures specified ,
in the license and covering a variety of activities and methodologies.
Generally. the procedures will specify limitations "do's." and " don'ts."
and how to perform one or more tasks. In any event. the licensee is bound to the procedures. The inspector should verify (preferably by direct '
observation) the implementation of a selection of procedural activities to the extent'that the inspector is satisfied that procedures are being followed.
The inspector also should verify that internal audits are performed. as required. The results of audits of zctivitia will be found in records of audits. Examine those records with particular attention to deficien.
c.ies found by the auditors and note corrective actions taken as a result- -
of deficiencies found. If no corrective actions were indicated whenever deficiencies were found, ask the licensee's representatives what actions were taken and determine why they were not noted in the records.
Audits of field radiography sites are especially important. If at all practicable. accompany a licensee's auditor to a field site (this may require special scheduling). Other kinds of internal audits for different categories of licensees may involve such determinations as the use of syringe shields (hospitals), whether technetium generators are pro)erly shielded (hospitals). and whether established ALARA programs are 3eing' implemented (all licensees). These are only a few examples; the inspector should examine the licensee's commitments in the license to determine the kinds and extent of audits required.
i As one part of assist inspections the inspector should determine that the licensee's internal inspection program is actually being carried out in that facility. For example, the date of the last internal inspection findings and those corrective actions taken should be determined. The above information should be included in the inspection summary report sent to the home region and if negative, so stated.
Medical Licensees. Radiation safety quality assurance procedures for c.
radioactive drug and device research programs may be found in the US Food and Drug Administration (FDA) accepted investigational new drug (IND) or investigational device exemption (IDE) applications. These procedures should be audited by the RSO and/or the Radiation Safety Committee (RSC).
For nuclear medicine and teletherapy secondary checks of dose calculations should be done to provide assurance that the final treatment plan will provide the dose prescribed on the patient's chart, if required in the license.
- d. Trainina.
References:
10 CFR 19.12. Instructions to workers.
10 CFR 34.31. 35.900-972.'39.61. Training. -
Applicable license conditions,.
Certain kinds of training and instruction are found in the regulations; how they are implemented will be found in the license. The inspector 8/100 Issue Date: 02/03/97
should verify that proper training and initial instructions are being accomplished as specified in the license or regulations. Discuss with
! . licensee *s representatives how and by whom the training is conducted and the content of the training (generally found in the license application).
! Verify pursuant to 10 CFR 1912. that the initial instructions have been ;
given to workers who enter restricted areas. Under the basic instruc- I tions, 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 ,
i the pertinent provisions of NRC regulations and the license and the 1 l requirement to notify management of conditions observed that may, if not corrected. result in a violation of NRC requirements.
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Of the training program elerrents in the license application, training given to 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 that l specified in the license application. For medical licensees, this includes specific training needed to perform infregt.ent medical procedures and prepare and use radioactive material in medical research studies. '
For the radiographers, the initial training should cover 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom instruction in those topics in Appendix A of 10 CFR Part 34.
The 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> classroom training may vary by 20% as long as all topics in Appendix A are covered. To become a radiographer, a radiographer's assistant must have completed 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> of on-the-job training as a mm uru- The training must include the topics in 10 CFR Part 34. Appendix A. an the operating and emergency procedures.
l Rar :-1. examine records of training of personnel and attendant tests or eta irations (1f applicable) to the extent that the inspector is satisfied r3: *v training program is being implemented as required. Where em".3: :c: are required. read a few of the examination questions to as:v;:" :931 they are indicative of what the worker should know to carry 0;; * '<- respons1bilities, f o' r a t rehers, a written test consisting of approximately 50 practical pac" -
troald be taken dealing with the topics in Appendix A of Part 34 i; examination also should be given to determine that the i n:: . ' :ai is competent to perform all assigned operations. The conpe:en:e cf an individual who has been a radiographer for another 11:easee stoJld be determined. As a minimum, that individual must be ins;ru::e: in the operating and emergency procedures and the use of equipren: The indisidual also must take the written and field examinations. Whenever possible, observe a radiographic operation, including the conduct of surveys, to determine the adequacy of a radiographer's training,
- e. Doeratina and Emeroency Procedures. Safety Comoonent Defects.
Reference:
10 CFR 34.32. 10 CFR 39.63. Operating and emergency procedures.
10 CFR 21.21 Notification of failure to comply or existence of a defect and its evaluation.
Applicable license conditions.
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Operating and emergency procedures will be found in license applications and may vary from step-by-step procedures for radiography programs to more generalized procedures for lower inss c tion priority licenses. The procedures will be approved by the NRC and reviewed and updated by the licensee. Any revision requires an amendment to the license except for broad licenses.
Examine the emergency procedures to determine that the procedures are as approved by NRC. Discuss with the licensee's representatives, or observe
'(forthehigherprioritylicensees),theconductofperiodictestsand drills, especial,y for scenarios invoW g fires and large releases of radioactive material. Also verify that ' erational procedures ara Mng~
followed by obs rvation of personnel performing tasks at selected work stations and comparison of their activities'with operational procedure requirement.L For the larger licensees there may be agreements with other agencies to respond to emergencies. Such agreements may be.in writing and. include state regulatory commissions (or equivalent) and hospitals. Generally.
there will be no agreements in writing with fire' departments. Discuss with licensee's representatives what has been done to ensure that agencies (for which agreement.' are in effect) understand their roles in emergency responses. Also, irquire if fire departments are knowledgeable of fires involving large qui.ntities of radioactive materials and high radiation levels and whether the are wpipped to fight such fires.
The inspector may, at his option, visit one or. more agencies or.
departments to determine their understandings of their roles in responding to emergencies.
Inspectors should verify that licensees have procedures for reporting defects. The complexity of the procedures will vary. Manufacturers should have detailed procedures to evaluate the safety significance of identified defects. Other licensees need only to address identification and reporting requirements.
- f. Reoorts and Notifications.
References:
10 CFR 19.13 Notifications and reports to individuals.
10 CFR 20.2201 Reports of theft or loss of 11 censed material.
10 CFR 20.2202 Notifications of incidents.
10 CFR 20.2203 Reports.of exposures, radiation levels, and concentrations of radioactive ' material exceeding the constraints or limits.
10 CFR 20.2206 Reports of individual monitoring.
10 CFR 31.5~ Certain measuring, gauging, or controlling devices.
10 CFR 32.12 Records and material transfer reports.
10 CFR 32.16 Certain items containing byproduct material reports of transfer: Records and reports of transfer 10 CFR 32.20 Records and material transfer reports.
10 CFR 32.25 Conditions of licenses issued under S32.22: Quality control, labeling, and reports of transfer.
10 CFR 32.29 Conditions of licenses issued under S32.26: Quality control, labeling, and reports of transfer.
10 CFR 32.52 Material transfer reports and records.
10 CFR 34.25 Leak testing, repair, tagging, opening, modification and replacement of sealed sources.
87100 Issue Date: 02/03/97
L i o 10 CFR 35.21(a) and'(b)(2)(x1) Internal audits ;r inspections and records I of the audits.
10 CFR 35.33(a) Reports of therapy misadministrations.
10 CFR 35.33(c) Reports of diagnostic misadministrations.
10 CFR 150.20 Recognition of Agreement State licenses.
Applicable license conditions i
- 1. 10 CFR 19.13 recuires that licensees provide individuals with reports l of external and internal exposures on an annual basis.
! For those employees who worked under contract temporarily and for l permanent employees who have left the company, the licensee must i provide the report within 30 days. An exception is that when j licensees file a report to the NRC they must also provide reports j (of excessive exposures) to the workers involved. The regional offices that receive thc r eptr'._ .:hould examine them for accuracy and completeness.
Prompt follow-up of reports of excessive exposures under certain conditions may be necessary: for example, reports filed under 10 CFR 20.2202(a) and (b) may require prompt follow-up to determine if I adequate medical care is being provided. Other essential items (including medical care) that are missing from the reports (initially reported by telephone. telegraph, etc.) may be obtained by telephone or by dispatch of an inspector to the site to determine the causes of overexposure and adequacy of corrective actions. !
In the case of high exposures to personnel. if the exposure is believed to be valid. an inspector must be dispatched to the site to conduct an inspection to support possible escalated enforcement action. In these uses, an inspection should be scheduled as soon ';
as practicable. However. this decision is best left to the judgment i of the region, depending un the. circumstances set forth in the reports and by telephone communications.
During routine inspections, inspectors need only inquire if 10 CFR 1 20.2206 reports have been submitted without going into further depth. l 1 unless the Office of Resuurce Management has requested a follow-up - i because no report was submitted. Those reports should only be :
examined at random so that the inspector is satisfied that the reports are being generated.
- 2. 10 CFR 20.2201 requires licensees to reports losses or theft of l licensed radioactive material when a substantial hazard may result to persons in unrestricted areas. ;
- 3. The remaining reports -listed in 02.01f deal with leak tests above i limits (10 CFR 31.5. 34.25.): materials transfer reports for - i manufacture or transfer of certain items (10 CFR 32.12. 32.16. 32.20. .
32.25. 32.29. 32.52): reports of medical thera !
misadministrations [10 CFR 35.33(a)) and (c)) andpeutic and diagnostic Form 241. reports l of activities conducted in Agreement States (10 CFR 150.20) ,
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- 4. Inspections should be done for therapy misadministrations that result in serious illness or death, etc. Depending on the content of the reports, where'significant cause appears to exist for follow-up, the
- follow up shall be done promptly to gather additional details about
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I occurred. Reports that indicate moderate health and safety problems may be followed up during the next inspection unless there appears to be sufficient cause for possible escalated enforcement actions.
The occurrence of a misadministration is not, in and of itself, the basis for enforcement action unless there is a failure to timely and properly report the misadministration as required in 10 CFR 35.33 or there is a violation of other applicable requirements.
- g. Records.
References:
10 CFR 20 Subpart L -- Records 10 CFR 20.1101 Radiation Protection Programs.
10 CFR 30.41 Transfer of byproduct material. ,
10 CFR 30.51 Records. ,
10 CFR 34.24 Radiation survey instruments.
10 CFR 34.25 Leak testing, repair. tagg?] opening, modification. and replacement of sealed sources.
10 CFR 34.26 Quarterly inventory.
10 CFR 34.27 Utilization logs.
10 CFR 34.28 Inspection and maintenance of radiographic exposure devices. storage containers and source chargers.
10 CFR 34.31 Training.
10 CFR 34.33 Personnel monitoring.
10 CFR 34.43 Radiation surveys.
l 10 CFR 35.33 Notification, reports, and records of misadministrations 10 CFR 35.59(e) Leak testing sealed sources 10 CFR 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
10 CFR 35.632 Full calibration measurements 10 CFR 35.634 Periodic spot checks 10 CFR 35.630 Dosimetry Equipment 10 CFR 35.961 Teletherapy physicist 10 CFR 40.61 Records.
Applicable license conditions.
During the course of an inspection, most items examined will have attendant records to support each portion of the licensed activity. Some records should be only randomly examined; i.e. , spot-checked to the satisfaction of the inspector that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel exposure records) should all be examined.
However, examinations of records should not be construed as the primary part of the inspection program. Rather. observations of areas where personnel work, equipment., usage, etc. , will give the inspector a better idea of what is going on than records review and may also support what the records reveal. During examinations of records. look for trends, such as trends in air sampling. Records such as surveys. waste disposal, effluent l release. receipt and transfer of radioactive materials, training, utilization logs and air sampling may be examined randomly until the i inspector is satisfied that the records are being maintained and are !
complete. q Records that should be examined in their entirety include aersonnel monitoring: leak testing of sealed sources: instrument cali] rations: ,
radiography quarterly inventory of devices and sources; inspection and j maintenance of radiographic exposure devices: source changers used; i storage devices used: receipt and transfer records: final radiation 87100 Issue Date: 02/03/97 l
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4 surveys of radiographic exposure devices upon completion of usage: pocket '
J dosimeter results and calibrations: and for telethera)y units, full i l- calibration, spot-check measurements and records of cali) ration of dose calibrators and checks of dose calibrators. Other records to be examined L may be found in license conditions such as ALARA records, records of safety committee minutes etc.
The extent to which records are to be examined, either randomly or in their entirety, will depend on the category of the licensee as well as the l history of noncompliance of the licensee inspected. In each case.
l judgment will'need to be exercised 50 that the inspector is satisfied that the licensed program is being operated safely to protect the health and i safety of the workers and general public. 1 As a general rule, records should be examined for the preceding three-year period or back to the last inspection, whichever is less. Older records preceding the three-year period should be inspected if warranted by circumstances such as a history of non-compliance or high rad 4 tion l exposures.
02.02 Authorized Materials: Uses. and Users. Determine from reviewing records, observing the.use of radioactive material, and discussing the activities with licensee personnel, that the type, quantity, and use of material at the licensee's facility are authorized by the license. Specific records and areas to be reviewed are as follows:
- a. Receiots. Transfers. and Pack'aae-handlina Procedures.
References:
10 CFR 20.1906 Procedures for receiving 'and opening packtges. l 10 CFR 30.41 Transfer _of byproduct material.
10 CFR 40.51- Transfer of source or byproduct material.
, Applicable license conditions. :
- Depending on the size of the lice'nsed program, the procedures (a few or many) will be found in the license application. The procedures should be carefully reviewed before an inspection is conducted, The reason for such '
,_ a review is to determine completeness, repeated procedures that may be contradictory, and procedures that should be in the application but are missing.
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 upon receipt, and procedures for opening packages, such as where in the facility packages are received, surveyed, and opened.
The procedures also should include what actions are to be taken if packages are contaminated in excess of specified limits and radiation levels are higher than limits (the latter would depend on the package index, i .e. . the dose rate at 3 feet for each category). If packages have arrived during the course of an inspection. ~nbserve the person performing the surveys as an indication of training, i
l The inspector should randomly examine records of surveys of packages L received and also determine if inventories for each licensed nuclide is l within the license limits. In this regard, records of inventories following receipt and transfer should always show that the materials on hand at any one time are within the license limit. The records examined should be compared with the physical inventories of materials possessed.
l Issue Date: 02/03/97 87100 i
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. l By discussions with the licensee, inquire if the procedures have been .;
changed or added to (requiring license amendment except for broad scope a licenses and, in general, meaical 1 n.ensees that can change minor '
- procedures by regulation). Randomly examine procedures used by -the l
. licensee to determine if they are in accordance with those in the license i a) plication (if the licensee's procedures are supplementary to those in l tie license application, or if the changes in certain procedures were 'i minor.) i b, Authorized Users.
References:
10 CFR 33.17 Conditions of specific licenses of broad scope.
10 CFR 34.25 Leak testing, repair, tagging, opening, modification, and i replacement of sealed sources. -l Applicable license conditions. !
Authorized users will normally be named in the license application, or, j if the license is a broad license, will be appointed as authorized users -
by the radiation safety committee or isotopes committee. l The inspector should determine during an inspection that named authorized i users are doing the work authorized rather than someone else not named in i the license. This will depend on the wording in the licen e with phrases i such -as' "used by or under the supervision of" except for radiography j licensees in which supervision for users is defined in 10 CFR Part 34. :
Guidance on the phrase "used by or under the supervision of" may be found :
in the "10 CFR" Section of the IE Manual under 10 CFR Part 30 issued on :
10/1/79" entitled " License Condition '...used by or under the supervision i of. For some specific or broad licenses (Types A, B and C) the !
phrase for users is "under the direct supervision of" which implies the !
authorized user. should be present at the facility for easy contact or to !
observe the individual (s) working under the authorized user. l However; another phrase not often seen in licenses is "under the direct I supervision and physical presence of" which means the authorized user must directly supervise and be present at the work station. . Another phrase ;
used for physicians doing patient therapy states "may only be used by. ;
The inspector must .use more than the usual amount of judgment during j inspections to interpret the role of the authorized users, considering the ,
many license condition phrases used above. First, a determination of' 1 qualifications should be made. Second, for the broad licenses, the '
radiation safety committee appoints the authorized users based on i qualifications j For a determination of required training, see " Training" under 502.01d of ;
this procedure. In general, authorized users must be specifically -
licensed by the Commission or otherwise listed in the license application-and in a license condition for specific tasks that only the individual (s) named can perform. This includes leak testing of sealed sources. ,
replacement of sealed sources, modification and opening for purposes of t repairing or replacing sealed sources in teletherapy . units and for }
radiography programs, changing sources from source changers or containers. ;
Such authorized users may not be those of the licensee but of a separate t firm specifically authorized by the Commission. ,
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- c. Authorized Uses.
References:
10 CFR 33.13 Requirements for the issuance of a Type A specific license of broad scope.
I 10 CFR 33.14 Requirements for the issuance of a Type B specific license of broad scope.
i 10 CFR 34.20 Performance requirements for. radiography equipment. l l
10 CFR 35.100 Medical uses of byproduct material for uptake and dilution l studies. 1 l 10 CFR 35.200 Use of radiopharmaceuticals, generator, and reagent kits i- for imaging and localization studies.
10 CFR 35.300 Use of radiopharmaceuticals for therapy.
10 CFR 35.400 Use of sources for brachytherapy.
10 CFR 35.500 Use of sealed sources for diagnosis.
10 CFR 35.600 Use of a sealed source in a teletherapy unit.
Applicable license condition 3.
Authorized uses of radioactive materials. excluding broad license applications will be found in the licenses and license applications.
Saecific licenses will list the isotopes, physical or chemical forms, and tie maximum quantities. The inspector should physically examine the inventory of radioactive material on hand or. examine Rcords of receipt and transfer to determine that quantities and forms are as authorized.
For medical are listed licenses for (or narrated of broad Type Ascop)e (Type in 10 CFR 33.100.A. B.For C) the maximum broad licenses.quantities any chemical or physical form is authorized.
The inspector must determine that nuclides are used as authorized, particularly for human use.' that could otherwise become a misadministra-tion if not used as authorized. For medical facilities or institutions.
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examine patient log books to determine that radioactive materials are used in proper chemical form on patients.
Inspectors should confirm that all sealed sources (source assemblies).
radiography devices (cameras) and source changers used by the licensees (unless specifically exempted) meet 10 CFR 34.20 requirements. Inspectors should verbally confirm that licensees are aware that associated equipment needs to comply with 10 CFR 34.20. However, inspectors should not attempt to confirm that associated equipment used by licensees complies with 10 CFR 34.20 except when an incident or event may have resulted from equipment failure, the use of an associated equipment component would create an apparent public health and safety threat, a component is being used with a non-compatible system, or if it is clearly obvious to the inspector that an associated equipment does not comply. For example, use of a non-typical drive system or guide tube (a garden hose), or an end stop taped to a guide tube,
- d. Material Control.
References:
10 CFR 20 Subpart I -- Storage and Control of Licensed Materials ! -
10 CFR 34.22 Locking of radiographic exposure devices, storage contain-ers, and source changers.
- 10 CFR 34.23 Storage precautions.
l Applicable license conditions, l
The inspector should examina storage areas in unrestricted and restricted areas. Such storage areas should be locked and have limited and
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controlled access. In general, there will be procedures for access controls. Additional controls should include logging out radioactive t
material from. storage areas and logging it in after use. This is i especially important for medical institutiot.s because of the use of small j 1mplant seeds for therapy. In the past. many seeds have been lost because of the failure of controls. The inspector also should determine that radioactive storage devices and source changers are locked when in storage and that storage areas also are locked when not in use.
- e. Area Radiation and Contamination Control.
References:
10 CFR 19.11. 10 CFR 21.6 Posting of notices to workers.
10 CFR 20 Subpart D -- Radiation Dose Limits for Individual Members of l the Public.
10 CFR 20 Subpart F -- Surveys and Monitoring 10 CFR 20 Subpart G -- Control cf Expos re From External Sources in -
Restricted Areas 10 CFR 20.1901 Caution signs.
10 CFR 20.1902 Posting Requirements.
10 CFR 20.1903 Exceptions to posting requirements.
10 CFR 20.1904 Labeling containers.
10 CFR 20.1905 Exemptions to labeling containers.
Applicable license conditions.
The inspector should ensure, during observation and by direct measurement, that the radiation levels in unrestricted areas are within the limits of l 10 CH 20.1302(b). The limit is 2 mR in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. For this regulation, occupancy is ng1 a factor. The inspector may ask the licensee to spot-ched rad;ation levels in selected areas using the licensee's own instrumentation. However. readings of radiation levels using the ,
licensee's instruments shall not be considered as valid. The ins)ector mun :e *!s/her own instruments that have been calibrated, source clecked pnt :: leaving the regional office and checked upon return to see if the Cai':"d: Ic" is vdlld. '
B, :.r , 4 : ior. surveys of radioactive materials or radiation areas are sur:. ~ De done before the fact, not after an individual gets exposed.
!* :n:* :3 Die. observe how licensees conduct surveys to determine the I ace u .
- surveys, particularly during the conduct of radiography ope %: -
Also, note the types of instruments used. and whether they :
are :e : a for the type of radiation being measured. !
l Du-r; *n+ pnysical operations review (facility walkthrough) observe that j proper :s;;1on signs are being used a+ access points to areas containing 1 racioe:tive materials. radiation i.eas, and those areas containing i airbcene ra:hoactive materials. Ran omly observe labeling on packages or !
other cce. tainers to determine that proper information is recorded such as l 1sotope, cuantity. and date of measurement. 10 CFR 20.1903 provides exceptions to posting caution signs, primarily for medical institutions.
Some types of licenses. such as those for teletherapy rooms radiography (fixed or permanent facilities), and irradiator operations also require signals or alarms, both visible and audible.
The inspector should examine these to determine operability. In addition.
during the walkthrough examine locations where notices to workers are posted. These should be located so that employee may examine them on their way to and from work locations.
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- f. Packaaina and Transoortction.
References:
l 10 CFR Part 71 Packaging of Radioactive Material for Transport and j Transportation of Radioactive Materials Under Certain Conditions.
49 CFR Parts Use Inspction Procedure No. 86740, " Transportation" 170-199 as applicable.
- g. Naste Handlina. Use Inspection Procedure No. 84850, " Radioactive Waste Management - Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61."
- h. Performance Evaluation Factors. Use performance evaluation factors (PEFs) to assess the potential for degraded safety performance in priority 1. 2, and 3 licensees. See Inspection Procedure 87101 for reauirements and guidance concerning PEFs.
02.03 Physical Plant Facilities and fauioment General. Most of the following line items are found in license applications ad will vary, depending on the type of licensed activity, and may not be all inclusive. These items should be inspected during the facility tour (operations review). Other items may be identified in the regulations and also may be repeated in the license application for implementation of the requirements.
References:
10 CFR 20.1003 Unrestricted area (Definitions.) l !
Radiation area High radiation area 10 CFR 20 Subpart I Storage and Control of Licensed Material l 10 CFR 34.21 Limits on levels of radiation for radiographic exposure devices and storage containers. i 10 CFR 34.29 Permanent radiographic installations. 1 10 CFR 34.41 Security.
10 CFR 35.632-647 Teletherapy requirements I
1 Review and verify that the equipment and the physical facility promote safe conduct of the licensed activity. The facility tnd equipment should conform to that described in the license application and the equipment should be operable. 1 Systems, subsystems, and equipment important to the safe handling of materials and protection of operating personnel and the public should be (1) examined for operability and (2) designed to carry out intenaed functions.
Examine records of the most recent five-year teletherapy maintenance program.
Some specific items which may need maintenance include the following, although these are not the only items to be serviced.
- a. Field-light Cord Reel,
- b. Source drawcr solenoids. ,
- c. Low air pressure switch.
l 2
May not be applicable to all types of units.
Issue Date: 02/03/97 87100 2
- d. Air hoses and fittings.
- e. Treatirant timer.
02.04 Radiation Protection.
- a. General. Use Inspection Procedure 83822 Radiati on Protection" as applicable.
FOLLOWING GUIDANCE TO BE USED AFTER 1997 REVISION TO 10 CFR 35.75 8ECOMES EFFECTIVE
- b. Medical Licensees -
References:
10 CFR 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
Determine by observing, and discussing with the licensee, that a process exists to establish that a patient administered radioactive material is releasable from control under 10 CFR 35.75. Determine that written instructions are provided to released individuals on actions recommended to maintain doses ALARA if doses to other individuals are likely to exceed 0.1 rem. Verify that the licensee is recording (a) the basis for release of patients, when necessary, and (b) that instructions were provided to a breast-feeding woman when required.
02.05 Radioactive Effluents and Waste Disoosal. Regulatory references and license applications:
10 CFR 20.1101 Radiation Protection Programs.
10 CFR 20 Subpart D -- Radiation Dose Limits for Individual Members of the Public 10 CFR 20 Subpart K -- Waste Disposal 10 CFR 20.2101 General provisions (Records).
10 CFR 20.2103 Records of surveys.
10 CFR 20.2108 Records of waste disposal.
10 CFR 20.2107 Records of dose to individual members of the public.
10 CFR 20.2110 Form of records.
10 CFR 30.51 Records.
Review and verify that waste-handling equipment, monitoring equipment. 6nd/or administrative controls are adequate to maintain radioactive effluents within the limits established by the license and other regulatory requirements and are ALARA. Verify that the licensee's air effluents, excluding Radon-222 and its daughters, have not exceeded the constraint limit in 10 CFR 20.1101. If the ,
licensee has exceeded the constraint, verify that the licensee has notified the '
NRC as required by 10 CFR 20.2203. If the licensee has notified the NRC that its air effluents have exceeded the constraint limit, review the effectiveness and timeliness of the licensee's corrective actions.
Note. exceeding this constrr 'nt limit' will not result in a Notice of Violation l (NOV). In the case of the wnstraint rule, an NOV will be issued only if and i when (1) a licensee fails to report an actual or estimated dose from airborne effluent releases from a facility that has exceeded the constraint value; or (2) if a licensee fails to institute agreed upon corrective measures intended to prevent further airborne effluents in excess of those which would result in doses exceeding the constraint level.
87100 Issue Date: 02/03/97 1
I
1 4
Examine the waste release records generated since the lost inspection, all annual j 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 procedural steps are being followed. The verification should be made by whatever means are !
available: 1.e.. perform an observation of an operation a review of selected records, etc.
02.06 Confirmatory Measurements. Compare / verify on a sampling basis survey j results or data that are used by the licensee to show compliance with the '
regulations o- license conditions. Examples of confirmatory measurements are:
i
- a. physical surveys. using the region's own instrumentation. 1
\
- b. split samples, etc. '
02.07 Recuired Scoce of Selected Materials Insoections. The attachments contain standard formats for recording the results of inspections of radiography. well logging, nuclear medicine and teletherapy licensees. Individual topics define the required scope of inspection for NRC inspections of these types of licensees. i t
l 87100 03 INSPECTION GUIDANCE j
general. All inspections should include a mix of records and procedures review. I 4
observations, confirmatory measurements, and discussions with personnel involved !
, in the " hands on" work. '
l 03.01 Procram Administration I
- a. The regulatory requirements related to t: ;anization and administration !
of the licensed program will be containea in license conditions. The organization should be examined to verify that the responsibilities and author'.zations of designated individuals comply with license conditions.
- b. The inspection is a verification of implementation of the recuired program. In the review to verify implementation the inspector shou ~ d pay 1 attention to the scope of the programs; frequency of licensee audits; the !
use of qualified auditors: procedure for recording and repcrting deficiencies to management; methods and completion of follow-up actions by management: and the policy regarding announced and unannounced audits.
- c. No guidance.
- d. In verifying the implementation of the approved or required training program. pay attention to completion of requirements related to: initial training, periodic retraining, on-the-job training, and tests and examinations of trainees (if applicable).
Inspectors should verify that procedures have been developed to implement the program, and that the staff has been trained in using these procedures. It is not the intent that inspectors routinely review and cite against internal procedures and protocols for the administration of byproduct material for medical use. Only in instances where there has ,
been an event. misadministration. or evidence of a loss of management control is an in-depth review of internal procedures and protocol indicated. In such cases. the review should determine that necessary procedures are in place.-and that adequate training or instruction has Issue Date: 02/03/97 87100
taken place prior to the administration of Dyproduct material. Failure to provide adequate procedures, and/or training could be a violation of 10 CFR 35.25(a).
In those instances where a performance error :nas resulted in the administration of- byjroduct material not in accordance with the physician's directions and also involves the failure to follow the instructions of the authorized user, or supervising authorized user, tne procedures of the Radiation Safety Officer, or to comply with the regulations or licensing conditions. there could be a violation of 10 CFR 35.25(b) for lack of adequate supervision. If however, the event or misadministration was more clearly an isolated human error, e.g.,
distraction due to heavy workload, picking up the wrong container of radiopharmaceutical, etc., then 10 CFR 35.25 should not be cited.
10 CFR 35.25 should only be cited in instar,ces where no other regulation is applicable to the violation. In other words, this regulation should not De used as a catch-all for poor programmatic management which is not specific to supervision and training. It is imperative to determine whether adequate supervision has been provided, the supervised individual has followed instructions, or whether human error has occurreC. If indicated, the appropriate section of 10 CFR 35.25 should then be cited,
- e. Regulatory requirements related to procedures will be contained in license conditions. It is necessary to verify that operating and emergency procedures have been developed, are adequate and functional. :nd have been reviewed and approved by management,
- f. No guidance,
- g. No guidance.
03.02 Authorized Materials. Uses. and Users General. Authorized materials, uses, and users are generally described and authorized by the license, or as otherwise authorized in 10 CFR 33.
- a. Receipt and transfer of materials should generally be detailed in procedures sufficient to provide assurance of compliance with regulatory l requirements. Specific requirements are set forth in 10 CFR 20.1906. It 4s necessary to assure that only authorized persons are involved in the >
transfer and receipt of materials.
The frequency of inventories is dictated by need or as specifically set forth in certain parts of 10 CFR or in license conditions. License inventories can be used for two purposes: (1) to track the use of material, and (2) to verify that the licensee is only receiving materials authorized in the amounts listed in the license.
i
- b. No guidance.
- c. 10 CFR 34.20 provides that equipment used in industrial radiographic oper-ations meet certain minimum criteria. These criteria include meeting the requirements specified in American National Standards Institute N432-1980 (ANSI-N432), labeling sealed source and devices, additional safety ,
features for " crank-out" radiography devices, performance requirements for associated equipment, and source securing systems on source changers. ,
10 CFR 34.20(e) specifies that all radiographic exposure devices and 87100 Issue Date: 02/03/97
associated equipment in use after January 10. 1996, must comply with the requirements of that section. Associated equipment has been identified as the source drive systems (cables. cranks. control tubes). guide tubes, exposure heads, source stops, and collimators. NRC is re-evaluating the applicability of the standard ANSI N432-1980 to associated equipment. NRC staff is currently developing a proposed rulemaking package in this area.
Pending this review /rulemaking, inspectors should not attempt to confirm that associated equipment used by licensees complies with 10 CFR 34.20 except when an incident or event may have resulted from equipmeilt failure, the use of an associated equipment component would create an apparent public health and safety threat, a component is being used with a non-compatible system, or if it is clearly obvious to the inspector that an associated equipment does not comply,
- d. Various strategies for control of materials should be in place. These are generally defined by procedures and should ensure that use is limited to .
authorized users and that secure storage is provided.
- e. No guidance.
- f. Specific guidance is set forth in Inspection Procedure 86740.
- g. Specific guidance is set forth in Inspection Procedure 84850.
- h. Follow the guidance on PEFs in Inspection Procedure 87101.
03.03 Physical Plant Facilities and Eauioment. Descri)tions of the )hysical plant are generally found in the applications for a 'icense and suasequent 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 facility should include utilities and other services sufficient to cope with emergencies, such as loss of power. loss of contamination control, etc.
Plant equipment is generally described in documents as noted above. Plant equipment should be appropriate to the scope of the licensed program. Processing equipment, associated process control equipment and ventilation and exhaust systems should be sufficient to provide safe use. nandling, and storage of the materials in use.
For the five-year maintenance of teletherapy units, critical repairs and maintenance may be recommended by service representatives. but might not be completed by the licensee. Talk to licensee representatives about any needed repairs. and get commitments to complete repairs immediately.
03.04 Radiation Protection.
- a. Specific guidance is set forth in NRC Inspection Procedure 83822.
FOLLOWING GUIDANCE TO BE USED AFTER 1997 REVISION TO 10 CFR 35.75 BECOMES EFFECTIVE
- b. The inspection of the patient release criteria is to be performance-based.
The inspector should be familiar with the content of Regulatory Guide 8.39. " Release of Patients Administered Redf oactive Materials. Four distinct objectives must be addressed in establishing compliance with 10' CFR 35.75.
Issue Date: 02/03/97 87100
l (1) The patient release criteria permits licensees to release individuals i
! from control if the TEDE to any r9er individual is not likely to ;
exceed 0.5 rem. The quantities of radiopharmaceuticals (dasage) f l
administered to patients for most, if not all. diagnostic studies will deliver less than 0.5 rem to other individuals. The licensee should be familiar with Regulatory Guide 8.39. The inspector should bring this Regulatory Guide to the attention of appropriate ;
individuals if the licensee is not familiar with the Guide. In
~
particular, the licen,ee should be familiar with the table of i activities and dose rates for authorizing patient release and giving instructions. If the licensee is not using the tables in the Regulatory Guides as the basis for releasing the patient, tne ;
licensee's practices should be reviewed.
(2) The licensee should be familiar with the requirements in 10 CFR 35.75(b) to provide instruct ~cns to released individuals if the dose .
to any other iridividual is likely to exceed 0.1 rem. In general. the !
licensee is required to give instructions, including written instructions. on how to maintain doses to other individuals as low i as is reasonably achievable. The inspector should determine how the :
licensee is demonstrating compliance with this requirement by reviewing a sample instruction and/or discussing the content of the instructions with applicable staff. If the licensee is required by the rule to provide instructions to a breast-feeding woman, the inspector should confirm that the instructions include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance.
(3) Verify that the licensee maintains. for three years, a record of the release if the TEDE has been calculated (1) using the retained activity rather than the activity administered. (2) using an occupancy factor less than 0.25 at 1 meter. (3) using the biological j or effective half-life, or (4) considering the shieldir.g by tissue.
If the licensee is not using these criteria. no record of the release is required.
(4) If the TEDE to a breast-feeding child could exceed 0.5 rem if the brea!,t-feeding were continued. verify that the licensee is documenting that instructions are beir; prcaded as required by the ,
03.05 Radioactive Effluents and Waste Disnosal, Review the reports and records for obvious mistakes. anomalous measurements, trends, missing data (compare the recorded data with the requiremer.ts), and verify the accuracy of the data in the report or record with the licensee if any of these aspects are identified or suspected.
Verify that the licensee's air effluents. excluding Radon-222 and its daughters. !
l have not exceeded the constraint limit in 10 CFR 20.1101. Information on ;
evaluating air effluents is available in Regulatory Guide 4.20. " Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other ,
Than Power Reactors." If the licensee estimated or measured a dose to the nearest individual member of the public from air emissions greater than 10 mrem i per year, the licensee should have notified the NRC (10 CFR 20.2203(a)(2)(iv).
! If the licensee has notified the NRC that its air effluents have exceeded the
! constraint limit. the inspector should review the effectiveness and timeliness !
of the licensee's corrective actions. Records of the results of measurements and
~
87100 Issue Date: 02/03/97 i
calculations needed to evaluate the release of radivactive effluents to the environment are required pursuant to 10 CFR 20.2103(b)(4). :
03.06 Confirmatory Measurements. Confirmatory measurements should be in sufficient scope to verify survey results or data as found in the licensee's records. Examples: radiation levels in an unrestricted area; airflow to process or fume hoods; and air samples in process areas. t 87100-04 ADDITIONAL REFERENCES Procram Administration (Section 03.01)
RG 7.1 Administrative Guide for Packaging and Transporting Radioactive Material.
RG 7.7 Administrative Guide for va . lying Compliance With Packaging Requirements for Shipments of Radioactive Materials.
RG 8.2 Administrative Practices in Radiation Monitoring.
RG 8.10 Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable. ,
RG 8.13 Instruction Concerning Prenatal Radiation Exposure. i RG 8.15 Acceptable Programs for Respiratory Protection. 1 RG 8.18 Information Relative to Ensuring That Occupational Radiation :
Exposures at Medical Institutions Will Be As Low As Reasonably I Achievable. I RG 10.1 Compilation of Reporting Pequirements for Persons Subject to NRC Regulations.
RG 10.2 Guidance to Academic Institutions Applying for Specific Byproduct Materials Licenses of Limited Scope.
RG 10.3 Guide for the Preparation of Applications for a Special Nuclear ,
Material License of Less Than Critical Mass Quantities. l RG 10.5 Applications for Type A Licenses of Broad Scope.
RG 10.6 Guide for the Preparation of Applications for Use of Sealed Sources !
and Devices for the Performance of Industrial Radiography.
RG 10.7 Guide for the Preparation of Applications for Licenses for Laboratory Use of Small Quantities of Byproduct Material. !
RG 10.8 Guide for the Preparation of Applications for Medical Programs.
RG 10.9 Guide for the Preparation of Applications for Licenses for the Use of Gamma Irradiators.
DRAFT RG Guide for the Preparation of Applications for Licenses in Medical Teletherapy Programs.
Authorized Materials. Uses. and Users (Section 03.02)
RG 6.1 Leak Testing Radioactive Brachytherapy Sources.
RG 7.2 Packaging and Transporting of Radioactively Contamirated Biological Materials.
RG 7.3 Procedures for Picking up and Receiving Packages of Radioactive -
Material.
RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials.
RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants.
Physical Plant Facilities and Eauioment (Section 03.03) i RG 3.2 Efficiency Testing of Air-Cleaning Systems Containing Devices for r
Removal of Particles.
! RG 8.1 Radiation Symbol.
Issue Date: 02/03/97 87100 4
l RG 8.5 Immediate Evacuation Signal.
Radiation Protection (Section 03.04)
RG 8.3 Film Badge Performance Criteria. j RG 8.4 Direct-Reading and Indirect-Reading Pocket Dosimeters. '
RG 8.6 Standard Test Procedures fcr Geiger-Mueller Counters.
RG 8.7 Occupational Radiation Exposure Recods System.
RG 8.9 Acceptable Concepts Models Equations. Assumptions for a Bioassay Program.
RG 8.14 Personnel Neutron Dosimeters.
RG 8.15 Acceptable Programs for Respiratory Protection.
RG 8.20 Applications'of Bioassay for I-125 and I-131.
RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed i Processing and Manufacturing Plants. '
RG 8.23 Health Physics Surveys at Mecical Inditutions.
RG 8.25 Calibration and Error Limits of Air Sampling Instruments for Total Volume of Air Sampled.
- 8.28 Audible Alarm Dosimeters.
l RG RG 8.39 Release of Patients Administered Radioactive Materials Radioactive Effluents and Waste Disoosal (Section 03.05)
RG 4.15 Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams 6nd the Environment.
RG 4.20 Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Otner Than Power Reactors."
RG 7.1 Administrative Guide for Packaging and Transporting Radioactive Material.
RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials.
Requirements for Shipments of Radioactive Materials.
RG 7.5 Administrative Guide for Obtaining Exemptions From Certain NRC Requirements Over Radioactive Material Shipments.
RG 7.7 Administrative Guide for verifying Compliance with Packaging.
Appendices:
A. Medical' Teletherapy Inspection Field Notes.
B. Nuclear Medicine Inspection Field Notes C. Well Logging Inspection Field Notes D. Industrial Radiography Inspection Field Notes E. Industrial / Academic Inspection Field Notes F. Commercial Irradiator Inspection Field Notes G. Medical Broad-Scope Inspection Field Notes H. Radiopharmacy Inspection Field Notes END 1 l
l l
1 87100 Issue Date: 02/03/97 l I
i i
APPENDIX B NOTE: All areas indicated in field notes are not required to t;e addressed during each inspection NOTE: Any reference to patient is intended to include human researen subject NUCLEAR MEDICINE INSPECTION FIELD NOTES Region Inspection Report No. License No.
Licensee (Name & Address): Docket No.
Licensee Contact Telephone No.
Last Amendment No. Date of Amendment 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 Summary of Findings and Action:
( ) No violations. Clear 591 issued
( ) Violation (s). 591 issued
( ) Violation (s). Regional letter issued
( ) Followup on Previous Violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N Inspector: Date (Signature)
Approved: Date (Signature)
Issue Date: 02/03/97 B-1 87100. Appendix B
- 1. INSPECTION HISTORY ( ) N/A - Initial inspection A. Violations were identified during the last two inspections or two years, whichever is longer ()Y()N B. Response letter (s) or 591(s) dated C. Open violations from previous inspections:
Status -
Rgggirement Violation Corrective Action Taken (YLN1 Open/ Closed '
t D. Explain any previous violations not corrected or repeated ( ) N/A
- 2. ORGANIZATION AND SCOPE OF PROGRAM A. Organizational Structure
+ Individuals contacted during inspection
- Individuals present at exit meeting
- 1. Meets license requirements [L/C] ()Y()N
- 2. Multiple authorized locations of use ()Y()N If so. list location (s) inspected ( ) N/A
- 3. Briefly describe scope of activities, including types and quantities of use involving byproduct material, frequency of use, staff size. etc.
87100. Appendix B B-2 Issue Date: 02/03/97
B. Licensee does limited distribution of pharmaceuticals under Part 35 license 2
()Y()N
- 1. Indicate type of operation: l
- 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 l Board of Pharmacy
- d. Operating as a nuclear pharmacy within a Federal medical institution
- 2. Licensee distributes sealed sources ()Y()N l alpha and beta emitters ()Y( )N i generators ()Y()N i photon emitters ()Y()N Remarks:
C. Research involving human subjects ( ) N/A l 1 Research is conducted. funded, supported, or i regulated by another Federal Agency which has implemented Federal Policy for Protection of Human Subjects2 ? [35.6] ()Y()N If no. does licensee have license amendment authorizing human research? [35.6] ()Y()N
- .icensee obtains informed consent from human s;Djects? [35.6] ()Y()N
. .itensee obtains approval of research a:tivities from an Institutional Review i x rd? [35.6] ()Y()N Remaru 1
1f licensee distributes radiopharmaceuticals to several facilities, the inspector should consider the need to complete the radiopharmacy fieldnotes.
rAgencies: USDA. DOE. NASA. HUD. 00J. D00. VA. EPA. HHS. D0T, Dept. of Commerce. Consumer Product Safety Commission. International Development Cooperation Agency. Agency for International Development. Dept. of Education.
National Science foundation Issue Date: 02/03/97 B-3 87100. Appendix B
. -. . .. . . .-.-.~. - - - , .~. - - - . - . - . .- - -.
l j
i
- D. Radiation Safety Committee ( ) N/A l
- 1. Membershi) as specified [35.22(a)(1)] ()Y()N l
- 2. Meetings 1 eld quarterly [35.22(a)(2)]- ()Y()N
- 3. Record maintained [35.22(a)(4)]- (-) Y ( ) N j
, 4. Quorums established [35.22(a)(3)] ()Y()N
~
- 5. Has sufficient authority {35.23] ()Y()N !
- 6. Approve / disapprove credentiols of individuals !
prior to allowing them to work as an authorized i user or authorized nuclear pharmacist ()Y()N ;
[35.22(b)(2)(ii)]
l i
E. Radiation Safety Officer j
- 1. Appointed [35.21(a). 900) ()Y()N l
- 2. Fulfills duties per [35.21(b)] ()Y()N !
- 3. Has sufficient authority per. [35.23) ()Y()N j F. Radiation Safety Program
- 1. Minor changes pursuant to [35.31] ( ) N/A ( ) Y ( ) N
- 2. Records of changes maintained [35.31(b)] ()Y()N l
- 3. Content and implementation reviewed annually !
by the licensee [20.1101(c). 35.22(b)(6)] ()Y()N ,
- 4. Records of reviews maintained [20.2102] ()Y()N l G. Use by authorized individuals [L/C] ;
i Com liance is established by meeting at least one criteria under l l' eac category.
- 1. Authorized Nuclear Pharmacist .
1
[35.13(b)] ( ) N/A ( ) Y ( ) N i DOES NOT APPLY TO FACILITIES THAT ARE- !'
REGISTERED / LICENSED BY FDA/ STATE AGENCY AS A
~ DRUG MANUFACTURER AND DISTRIBUTION IS REGULATED UNDER FART 32 (a) Certified by organization in 35.980 !
-(b) Identified on NRC or Agreement State license ' !
-(c) Identified on permit issued by broad scope licensee !
Z(d)Listedonfacilitylicense l
- 2. Authorized User-[35.13(b)] ()Y()N (a) Certified by organization in 35.910.920.930.- !
940.950.960 j (b) Identified on NRC or Agreement State license :
Z(c) Identified on permit issued by broad scope licensee
_ d)( Listed on facility license 'l ;
- 3. Radiation Safety Officer [35.13(c)] i Listed on facility license ()Y()N !
Remarks: j l
l 87100. Appendix B B-4 issue Date: 02/03/97 )
I
=
1
H. Mobile Nuclear Medicine Service ( ) N/A ,
- 1. Licensee operates services pEr [35.29, 80] ()Y()N 2
- 2. Compliance with 20.1301 evaluated and met ()Y()N
[ I. Amendments.since last inspection [35.13] '
()Y()N
}- J. Notifications since last inspection [35.14] ;
) 1. Licensee has provided appropriate documentation to 4' -NRC for authorized nuclear pharmacists or user no !
i later thin 30 days after the individual starts l work-[35.14(a)] (-) N/A ( ) Y ( ) N !
3
- 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 j Remarks: ;
4
- 3. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS l
! A. Instructions to workers [19.12] ()Y()N i B. ' Individual's understanding of current procedures and l
[ regulations is adequate ()Y( )N !
C. Training program required [L/C] ()Y()N l
- 1. If so briefly describe training program: !
- 2. Training program implemented ()Y()N i
- 3. Periodic training program required ()Y()N j Periodic training program implemented - ()Y()N
- 4
- 5. Records maintained ()Y()N I D. Supervision of individuals by' authorized user in l
- accordance with [35.25] ()Y()N -
i .
- j. 1. Supervised individuals are instructed
, in preparation of material. principles and procedures for radiation safety and OM Program, !
j as appropriate [35.25(a)(1). 35.25(b)(1)] ( ) Y (.) N <
1
[
Licensee periodically reviews supervised 2.
individuals use of material and records kept'to reflect use [35.25(a)(3)] ()Y()N
- 3. Authorized nuclear pharmacist or user i periodically review work and records i of work of supervised individuals as it !
pertains to preparing byproduct material i
[35.25(b)(3)] ( ) N/A ( ) Y ( ) N
' Applies to individuals that' receive, possess, use, transfer. or prepare byproduct material for medical use under supervision of authorized nuclear pharmacist or user.
Issue Date: 02/03/97 B-5 87100. Appendix B q j
Remarks:
E. Therapy training ( ) N/A
- 1. Safety instruction [35.310. 410. L/C]
- a. Control of patient and visitors ()Y()N
- b. Contamination and waste ()Y()N
- c. Size / appearance of sources ( ) N/A ( ) Y ( ) N
- d. Handling / shielding of sources ( ) N/A ( ) Y ( ) N
- e. RSO notification in emergency or death ()Y()N
- f. Records maintained [35.310(b). 410(b)] ()Y()N
- 2. Manufacturer's instructions available and followed [35.59(a). 400] ()Y()N
- 3. Training for operating and emergency procedures for HDR Remote Afterloaders [L/C] ( ) N/A ()Y()N F. Revised Part 20 Workers cognizant of requirements for:
1 Radiation Safety Program [20.1101] ()Y()N
- Annual dose limits [20.1301. 1302] ()Y()N >
3 New forms 4 and 5 ( ) N/A ( ) Y ( ) N 10% monitoring threshold [20.1502] ()Y()N 5 Dose limits to embryo / fetus and declared .
pregnant worker [20.1208] ( ) N/A ( ) Y ( ) N i
Grave Danger Posting [20.1902] ( ) N/A ( ) Y ( ) N Procedures for opening packages
- 20 1906] ( ) N/A ( ) Y ( ) N
- 5eaer disposal limits [20.2003] ( ) N/A ( ) Y ( ) N r NOTE:
.- -:les in Section 3.F. while not always a violation. should be
- ' r* *o the attention of licensee management at the exit meeting c" : 'r tne cover letter transmitting the inspection report or NOV.
1 Remarks:
i
- 1. Materials secured from unauthorized removal or ;
access [20.1801] ()Y()N
- 2. Licensee controls and maintains constant surveillance of licensed material not in storage
[20.1802] ()Y()N
- 3. Licensee uses process or other engineering controls for volatiles / gases in storage [35.90] ()Y()N 87100. Appendix B B-6 Issue Date: 02/03/97
- 4. Maintenance program implemented for engineering controls (negative pressure, ventilation rates.
filter changes, etc.) [35.205(e). L/C] ()Y()N Remarks:
- 5. E0VIPMENT A. Dose calibrator - Photon-emitting radionuclides
- 1. Possessed and used [35.50(a)] ()Y()N
- 2. Constancy [35.50(M(l']
- a. Performed daily ()Y()N
- b. Dedicated check source used ()Y()N
- 3. Accuracy [35.50(b)(2)]
- a. Performed at installation and annually ()i()N
- b. At least 2 sealed sources used ()Y()N
- 4. Linearity [35.50(b)(3)]
- a. Performed at installation and quarterly thereafter ()Y()N
- b. Includes range between 30 uCi and the highest dosage administered ()Y()N
- 5. Geometry Dependence [35.50(b)(4)]
- a. Performed at installation or relocation ()Y()N
- b. Includes range of volumes and volume configurations used ()Y()N
- 6. Dosage readings mathematically corrected for geometry or linearity errors greater than 10%
[35.50(d)] ( ) N/A ( ) Y ( )N
- 7. Repaired or replaced when constancy or accuracy errors exceeded 10%
[35.50(d)] ( ) N/A ( ) Y ( ) N
- 8. Approved procedures followed [35.21, 25. L/C] ()Y()N
- 9. Records maintained and include identity of the individual performing the test. [35.50(e)(2).(e)(3).(e)(4)] ()Y()N Remarks:
Issue Date: 02/03/97 B-7 87100. Appendix B
B. Instrumentation - Alpha- or beta-emitting radionuclides ( ) N/A
- 1. List type of equipment used to assay alpha and beta particles: ,
l
- 2. Licensee has procedures for use of
~
instrumentation [35.52(b)] ()Y()N
- 3. Accuracy, linearity and geometric dependence tests are performed prior to initial use, periodically,'and following repair.
if applicable [35.52(b)(1). L/C]
()Y()N
- 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] ( ) N/A ( )Y()N
- 6. Records maintained [L/C]
4 Remarks:
C. Licensee uses generators ()Y()N
- 1. Each eluate / extract used for radiopharmaceuticals tested for Mo-99 breakthrough ()Y()N
- 2. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 uC1 per mC1 of Tc-99m ()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 l F. Vial shields labeled [35.61(b)] ()Y()N semarks: ;
- 6. MATERIALS A. Licensee measures activity of each dosage of photon-emitting radionuclide prior to use [35.53(a)] ()Y()N
' Note: Linearity and geometric dependence tests are not applicable if liquid scintillation is used. Linearity is not applicable if sodium iodide is used. ;
87100. Appendix B B-8 Issue Date: 02/03/97
B. Licensee administers alpha- or beta- emitting, radionuclides ()Y()N If yes.
.1. Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization [35.53(b)] ()Y()N
- 2. 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 C. Unsealed material used under 35.100.200.or 300 are
[35.100(b). 35.200(b). 35.300(b):
(1) Obtained from manufacturer or properly licensed organization AND/0R ()Y()N (2) Prepared by authorized nuclear pharmacist or physician user or individual under the supervision of a authorized nuclear pharmacist or physician user [35.920] ()Y()N Remarks:
D. Isotope, chemical form. quantity and use as authorized [31.11, 35.400.500. L/C] ()Y()N Remarks:
E. Use of radiopharmaceuticals [L/C]
- 1. Protective clothing worn ()Y()N
- 2. Personnel routinely monitor their hands ()Y()N
. 3. No eating / drinking in use/ storage areas ()Y()N
- 4. No food. drink. or personal effects kept in use/ storage areas ()Y()N
- 5. Proper dosimetry worn ()Y()N
- 6. Radwaste disposed in proper receptacles ()Y()N F. Leak tests and Inventories
- 1. Leak test performed on sealed sources and !
brachytherapy sources [35.59(b)] ()Y()N l'
- 2. Leak test records in microcuries ()Y()N
- 3. Inventory of sealed sources and brachytherapy sources performed quarterly [35.59(g)] ()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 1
- 5. Records maintained & signed by RSO [35.59, 406] ( ) Y ( ) N !
Remarks: !
. Issue Date: 02/03/97 B-9 87100. Appendix B I
7 RADIATION SURVEYS A. Survey instruments used to show compliance with .Part 35
- 1. Appropriate operable survey instruments possessed [35.120. 220, 320, 420] or available [35.520] ( ) N/A ( )Y()N
- 2. Calibrations [35.51(a,b)]
- a. 1Before first use. annually & after repairs ( ) Y ' ) N
- b. Approved calibration procedure followed to include check source reading determination
[35.51(a)(3). L/C] ()Y()N
- c. Within 20% in each scale or decade of interest [L/C] ()Y()N
- 3. Records maintained [35.51(d)] ()Y()N
- 4. Source-checked each day of use [35.51(c)] ()Y()N B. Radiation surveys performed
- 1. Daily in all areas where radiopharmaceuticals are-pre)ared or administered [35.70(a)] ()Y()N
- 2. Weecly in all areas where radiopharmaceuticals or waste is stored [35.70(b)] ()Y()N
- 3. Weekly wipes in all areas where radiopharmaceuticals are routinely prepared. administered or stored
[35.70(e)] ()Y()N
- 4. Quarterly in brachytherapy source storage area ()Y()N C. Trigger levels [35.70]
- 1. Established ()Y()N
- 2. Exceeded ()Y()N
- 3. Corrective action taken and documented ()Y()N L Techniques can detect 0.1 mR/hr. 2000 dom [35.70] ()Y()N E. Records maintained [35.70(h) L/C] ()Y()N j F. Protection of members of the public l
Note: See IN 94-09 for updated guidance on conflicts i between Parts 20 and 35. I
- 1. Licensee made adequate surveys to demonstrate either (1) that the TEDE to the individual likely i to receive the highest dose does not exceed 100 j mrem in a year, or (2) that if an individual were i 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 Remarks:
1 87100.' Appendix B B-10 Issue Date: 02/03/97 i;
i
- 8. Patient Release ( ) N/A THE FOLLOWING GUIDANCE IS TO BE USED AFTER THE 1997 REVISION OF 10 CFR 35.75 BECOMES EFFECTIVE. IF USING THIS SECTION. DO NOT ANSWER ITEMS 9.C AND 10.C BELOW. i A. Individuals released when TEDE less than
. 0.5 rem [35.75(a)] ()Y()N B. Instructions on ALARA provided to individuals when TEDE exceeds 0.1 rem [35.75(b)] ()Y()N C. Instructions to breast-feeding women include required information [35.75(b)] ()Y()N D. Release records maintained if 35.75(c) criteria are met [35.75(c)] ()Y()N E. Records of instructions given to breast-feeding women maintained, if required [35.75(d)] ()Y()N
- 9. RADI0 PHARMACEUTICAL THERAPY ( ) N/A l A. Safety precautions imphmented to include patient facilities, posting, stay times, patient safety guidance, release and contamination controls [35.315(a). L/C] ()Y()N B. Area dose rate surveys and room contamination surveys [35.315(a)(4), l.7)] ()Y()N C. Release of patients containing radiopharmaceuticals meets <5 mR/hr @ Im .qC < 30 mci [35.75] ()Y()N D. RS0 promptly notified if patient died or had a medical emergency [35.315(b)] ( ) N/A ( ) Y ( ) N Remarks:
l 1
- 10. BRACHYTHERAPY ( ) N/A l A. Safety precautions implemented to include patient facilities, posting. stay times, and area radiation level surveys [35.415. L/C) ()Y()N B. Patients surveyea immediately after implant [35.406] ()Y()N C. Release of patients with oermanent implants meets 5 mR/hr @ Im [35.75] ( ) N/A ( ) Y ( ) N D. 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 '
E. Records maintained [35.404(b). 406(d). 415(a)(4)] ()Y()N Remarks:
Issue Date: 02/03/97 B-11 87100. Appendix B
.t a
'h l? .a e e l 11. RA9iOACTIVE WA.S.TE A. Disposal
- 1. Decay-in-storage ( ) N/A
- a. Approved [20.2001, 35.92. L/C] ()Y()N
- b. Procedures followed [35.92. L/C] ()Y()N
- c. Labels removed or defaced [20.1904. 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 Remarks:
B. Effluents
- 1. Release to sanitary sewer [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 App. B. Table 2 values ()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 [20.2003] ()Y()N
- d. Procedures to ensure representative sampling and analysis implemented [20.1501 L/C] ()Y()N
- 2. Release to septic tanks [20.2003] ( ) N/A ( ) Y ( ) N
- a. Within unrestricted limits [ App B. Table 2]( ) Y ( ) N
- 3. Waste incinerated ( ) N/A ( ) Y ( ) N
- a. License authorizes [20.2004(a)(3)] ()Y()N
- b. Licensee d Pectly monitors exhaust ()Y()N-
- c. Airborne t "*Mes eMuated and controlled
[20.1501. Lu.1701] ()Y()N
- 4. Air effluents and ashes controlled [20.1101.1201.1301 1501. 2001. L/C] ( ) N/A
{SeealsoIP87102.RG8.37}
- a. Air effluent less than 10 mrem constraint limit [20.1101] ()Y()N
- b. If no. licensee reported appropriate information to NRC ()Y()N
- 1. Corrective actions implemented I and on schedule ()Y()N 87100. Appendix B B-12 Issue Date: 02/03/97
. _ . - ._.. _ _ - __ __ _ ~ _ _ . ___ _
- c. Description of effluent program
- 1. Monitoring system hardware adequate ( ) Y ( ) N !
- 2. Equipment calibrated as appropriate ( ) Y ( ) N i
- 3. Air sam 31es/ sampling technique i (i.e. clarcoal. HEPA, etc.)' analyzed l with appropriate instrumentation ()Y()N i l
Remarks:
C. Waste storage
- 1. Protection from elements and fire [L/C] ()Y()N
- 2. Control of waste maintained [20.1801] ()Y()N l
- 3. Containers properly labeled and area properly l posted [20.1902. 1904] ()Y()N l
- 4. Package integrity adequately maintained [L/C] ()Y()N D. Records of surveys and material accountability are l maintained [20.2103, 2108] ()Y()N Remarks:
I
- 12. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL l J A. Describe how packages are received and by whom: ( ) N/A 1
B. Written package opening procedures established and followed [20.1906(e)] ()Y()N C. All incoming packages with a D0T label wiced, unless exempted (gases and special form) [20.1906(b)(1)] ()Y()N D. Incoming packages surveyed [20.1906(b)(2). L/C] ()Y()N E. Monitoring in (C) and (D) performed within time specified [20.1906(c)] ()Y()N F. Transfer (s) between licensees performed per [30.41] ()Y()N '
G. All sources surveyed before shipment and transfer
[20.1501(a). 49 CFR 173.475(i). L/C] ()Y()N H. Records of surveys and receipt / transfer mairtained
[20.2103(a). 30.51] ()Y()N ,
I. Package receipt / distribution activities evaluated for compliance with 20.1301 [20.1302] ()Y()N Remarks:
Issue Date: 02/03/97 B-13 87100, Appendix B l
l l i l
l 13. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 171-189) ( ) 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. Packages ( ) N/A
- 1. Authorized packages used [173.415, 416] ( ) N/A ( ) Y ( ) N
- 2. Performance test records on file ( ) N/A
- a. 00T-7A packages [173.415(a)] ()Y()N
- b. Special form sources [173.476(a)) ()Y()N i
- 3. Two labels (White-I. Yellow-II. Yellow-III) with TI. Nuclide. Activity, and Hazard Class
[172.403. 173.441] ()Y()N
- 4. Properly marked (Shipping Name. UN Number. Package Type. R0. "This End Up" (liquids). Name and Address of consignee) [172.301.306.310.312.324] ( ) Y ( ) N
- 5. Closed and sealed during transport [173.475(f)] ( ) Y ( ) N D. Shipping Papers ( ) N/A
- 1. Prepared and used [172.200(a)] ()Y()N *
- 2. Proper Shipping Name. Hazard Class. UN Number, Quantit . Package Type. Nuclide. R0. Radioactive Materia . Physical and Chemical Fom. Activity.
Category of label. TI. Shipper's Name. Certification and Signature. Emergency Response Phone Number.
" Limited Quantity" (if applicable) " Cargo Aircraft Only" (if applicable [172.200-204] ()Y()N
- 3. Readily accessible during transport [177.817(e)]( ) Y ( ) N Remarks:
87100. Appendix B B-14 Issue Date: 02/03/97 i l l I
- 14. PERSONNEL RADIATION PROTECTION l A. Licensee performed exposure evaluation [20.1501] ()Y()N B. Licensee implemented ALARA program [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. Supplier Frequency
- 4. Supplier 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 workers [20.1502. L/C] ()Y()N
- 2. Briefly describe licensee's program for monitoring and controlling internal exposures
[20.1701, 1702. L/C]: 3 Aerosols and gases sampled [35.205] ()Y()N 4 Monitoring / controlling program implemented
~
(includes bioassays) [35.315(a). 205(d). L/C] ()Y()N Respiratory protection equipment [20.1703] ()Y()N E. 4: -a
. Feviewed by Frequency
- inspector reviewed personnel monitoring records for period to e Prior dose determined for individuals likely to receive doses [20.2104] ()Y()N 4 Maximum exposures TEDE Other E Maximum CDEs Organs 6
Maximum CEDE Licensee sums internal and external [20.1202] ()Y()N 6 TEDEs and TODEs within limits [20.1201] ()Y()N 9- NRC forms or equivalent [20.2104(d). 2106(c)]
- a. NRC-4 ()Y()N Complete: ()Y()N
- b. NRC-5 ()Y()N Complete: ()Y()N
- 10. Worker ' declared her pregnancy in writing during !
( ) N/A ( ) Y ( ) N inspection period (review records) If yes licensee in compliance with [20.1208] ()Y()N and records maintained [20.2106(e)] ()Y()N l I Issue Date: 02/03/97 B-15 87100. Appendix B ; i
F. Who performed any PSEs at this facility (number of people ! involved and doses received) [20.1206, 2104. 2105. 2?04] ( ) N/A i G. Records of exposures surveys, monitoring, and evaluations maintained [20.2102. 2103, 2106, 35.205(d) 315(a)(8). L/C] ()Y()N Remarks: l 15. MISADMINISTRATIONS AND RECORDABl.E EVENTS ( ) N/A A. If-misadministrations or recordable events (defined in 35.2) have occurred since the last inspection, evaluate the incident (s) and the licensee's quality management program (OMP) using the existing guidance. [ Reference TI 2800/025 and IP 87103]
- 1. Event date Information Source -
- 2. Notifications NRC Ops Center ( ) Y ( ) N Region ()Y()N Referring Physician ( ) Y ( ) N Patient ()Y()N In writing ()Y()N If notification did not occur, why not:
- 3. Written Reports [35.33]
- a. Submitted to Region within 15 days ()Y()N ,
- b. Copy to patient within 15 days ()Y()N B. Records maintained [35.33(b)] ()Y()N Remarks:
l 16. NRC INDEPENDENT MEASUREMENTS . A. Survey instrument Serial No. Last calibration B. Inspector's measurements were compared to licensee's ()Y()N C. Describe the type, location and results of measurements: 87100. Appendix B B-16 Issue Date: 02/03/97
- 17. NOTIFICATION AND REPORTS l 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 B. Licensee in compliance with [20.2201. 30.50] '
(theft or loss) ( ) None ( ) Y ( ) N C. Licensee in compliance with [20.2202. 30.50] . (incidents) ( ) None ( ) Y ( ) N D. Licensee in compliance with [20.2203, 39.50] (overexposures and high radiation levels) ( ) None ( ) Y ( ) N E. Licensee aware of NRC Ops Center phone number ()Y()N F. Licensee in compliance with [20.2203]. (Constraint on air emissions) ( ) None ( ) Y ( ) N Remarks:
- 18. POSTING AND LABELING l A. NRC-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 tne licensee is not exempted by [20.1903. 1905] ()Y()N Remarks: 19, RECORDKEEPING FOR DECOMMISSIONING l A. Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until ) license termination [30.35(g)] ()Y()N B. Records include all information outlined in [30.35(g)] ( ). Y ( ) N Remarks:
- 20. BULLETINS AND INFORMATION NOTICES l A. Bulletins. Information Notices, NMSS Newsletters, etc. . received by the licensee ()Y()N B. Licensee took appropriate action in response to Bulletins Generic Letters, etc. ()Y()N Remarks:
I Issue Date: 02/03/97 B-17 B7100 Appendix B a
- . - . - . . - . - . ... . .- .. . . . - - . ~.
l 21. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A A. Special license conditions or issues to be reviewed: l B. Evaluation: l'22. DEBRIEF WITH LICENSING STAFF Inspection findings discussed with licensing staff ( ) N/A ( ) Y ( ) N Items discussed:
. l 23. CONTINUATION OF REPORT ITEMS l 24 '/10LAT10NS. NCVs. AND OTHER ISSUES Note: Briefly state (1) the requirement and (2) how and when the licensee ,
violated the requirement. For non-cited violations, indicate why the violation was not cited.
- 25. PEPr~2*.'r EVALUATION FACTORS Licensee Inspector (name &
location; Inspection Date - A. Lac 6 :' emor management involvement with the radiation safety pro; c r : or Radiation Safety Officer (RS0) oversight ()Y()N B. RSO 100 tu',3- with other assignments ()Y()N C. Insuf::ent staffing ()Y( )N D. Radiatic" Safety Committee fails to meet or functions inadecua:e', ()Y()N , E. Inadeauate ' consulting services or inadequate audits ()Y()N i F. Financial Instability ( )Y()N j Remarks (consider above assessment and/or other pertinent PEFs): Regional follow-up on above PEFs citation: END 87100. Appendix B B-18 Issue Date: 02/03/97
APPENDIX D NOTE: All areas indicated in field notes are not required to be addressed during each inspection INDUSTRIAL RADIOGRAPHY INSPECTION FIELD NOTES Region Inspection Report No. License No. Licensee (Name and Address) Docket No. Licensee Contact Telephone No. Last Amendment No. Date of Amendment Priority: Program Codes: ( ) 03310 - Fixed ( ) 03320 - Temporary Date of Last Inspection Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced ( ) Routine ( ) Special ( ) Initial ( ) Reinspection Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended Summary of. Findings and Action:
~( ) No violations cited. Clear 591 issued
( ) Violation (! b91 issued ( ) Violation (s), Regional letter issued ( ) Followup on Previous Violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N Inspector: Date (Signature) Approved: Date (signature) Issue Date: 02/03/97- D-1 87100, Appendix D 4
- 1. INSPECTION HISTORY ( ) N/A - Initial Inspection A. Violations were identified during the last two inspections or two years, whichever is longer ()Y()N B. Response letter (s) or 591(s) dated C. Open violations from previous inspections:
Status Recuirement Violation Corrective Action Taken (Y/N) Ooen/ Closed D. Explain any previous violations not corrected or repeated ( ) N/A
- 2. ORGANIZATION AND SCOPE OF PROGRAM ,
A. Organizational Structure:
+ Individuals contacted during inspection
- Individuals present at exit meeting
- 1. Meets license requirements [L/C] ()Y()N
- 2. Multiple authorized locations of use and/or Field Sites authorized ( ) Y ( ) N ( ) N/A If so, list location (s) inspected ( ) N/A 3 .. Briefly describe scope of activities. including types of equipment, types and quantities of use involving byproduct material, frequency of use, staff size, etc.
i B. Radiation Safety Officer
- 1. Authorized on license [L/C] ()Y()N
- 2. Fulfills duties as RSO ()Y()N 87100. Appendix D D-2 Issue Date: 02/03/97
- ~ - - _ . . . . _ - ..- - . _ . - - - - - - . . . . . . - . - . - - -
i i . 4 C. Radiographers & Assistants accurately named in license ( ) Y ( ) N t i D. List radiography personnel: ! (Indicate if they are radiographer. or assistants) l i:
~ 3. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS 2
A. Instructions to workers per [10 CFR 19.12] ()Y()N B. Parts 19, 20, 21, 34: the license; and Operating and 1 Emergency Procedures furnished to all radiographers 4 and assistants [34.31(a)(2).(b)(1)] ()Y()N 1 C. Training program [34.31, L/C] -l ! 1. Briefly describe training program: l a 1 \ ! I i
- 2. Training program implemented ()Y()N I 3.. -Written tests completed by all radiographers and assistants [34.31(a)(4). (b)(3)] ()Y()N
, 4. Oral tests [34.31(b)(3)] . (-)-Y ( ) N. Inspector reviewed test results
- 5. ()Y()N i 6. All radiographers completed on-the-job training ( ) Y ( ) N
- 7. Periodic Training program required [34.11(b)] ( ) Y (') N
- 8. Periodic Training program implemented ()Y()N
- 9. Records maintained [34.31(c)] ()Y()N D. Revised Part 20 Workers cognizant of requirements for:
- 1. Radiation Safety Program [20.1101] ()Y()N
- 2. Annual dose limits [20.1301. 1302] ()Y()N
- 3. New forms 4 and 5 ( ) Y ( ) N ( ) N/A-
- 4. 10% monitoring threshold [20.1502] ()Y()N
- 5. Dose limits to embryo / fetus and declared pregnant worker- [20.1208] ()Y()N
- 6. Procedures.1or opening packages [20.1906] ( ) Y ( ) N ( ) N/A HQJTE: Deficiencies in Section 3.D. while not always a violation, should be I brought to the attention of licensee management at the exit meeting I and in the cover . letter transmitting the inspection report or .NOV.
' Remarks:
1 Issue Date: 02/03/97 D-3 87100. Appendix D e i
t k
. 4. OPERATING AND EMERGENCY' PROCEDURES
'A; . Licensee maintains current. procedures-[34.32] ()Y()N B. Procedures contain information as specified [34.32] ()Y()N !
C. Procedures are approved by NRC [34.11] ()Y()N , D. Licensee aware of NRC Ops Center phone number ( ) Y (-) N Remarks: s
- 5. INTEFNAL AUDITS OR INSPECTIONS A. ' Audits or inspections of each radiographer and assistant are conducted per.[34.11(d). L/C] ()Y()N .
B. Equipment check prior to use each day [34.28(a)] ()Y()N : C. Equipment inspection and maintenance performed at , 3-month intervals per procedures [34.28(b)] ()Y()N ; D. Records maintained [34.28(b)] ( ) Y ( )'h
- 6. FACILITIS .
r A. Permanent radiographic installation [34.2] ( ) N/A i
- 1. High Radiation Area posted [20.1902(b)] ()Y()N
- 2. Entrance controls are as described
[34.29. 20.1601(a)] ()Y()N ;
- a. Visible and audible radiation signals ()Y()N .,
- b. Visible signal actuates when source is exposed ()Y()N i
- c. Audible signal actuates if entry is attempted when source is exposed ()Y()N ;
- d. System tested at 3-month intervals ()Y()N
*- Records maintained for 3 years ()Y()N P B. Temporary High Radiation Area entry controlled *
[20.1601(b). 34.41] ( ) Y ( ) N ( ) N/A '
'C. Storage Area '
- l. Storage facilities as described in license [L/C]( ) Y ( ) N i
- 2. Sources locked in devices [34.22] ()Y()N !
- 3. Devices secured to prevent tampering or .l unauthorized removal [34.23.-20.1801] ()Y()N l 1
Remarks: i l 87100. Appendix D D-4 Issue Date: 02/03/97 ! i B l
1
- 7. EQUIPMENT A. Radiography devices, source assemblies. and source l changers in use meet the requirements of [34.20] ()Y()N l B. Associated equipment in use appears to comply with l the requirements of [34.20]
()Y()N C. Licensee is aware that associated equipment must comply with [34.20] ()Y()N D. Source changers and storage containers meet ! radiation level limits per [34.21] ( ) Y (- ) N 1 E. Equipment exempted from [34.20] by specific license l condition used in accordance with license commitments ( ) Y ( ) N i
- 8. MATERIALS A. Isotope, chemical form. quantity and use as authorized [L/C] ()Y()N B. All sealed sources not fastened to or contained in an exposure device are tagged per [34.25(e)] ()Y()N I C. During radiographic operations, sources are secured in !
shielded position each time source is returned to that I position [34.22(a)] ( ) Y (.) N D. Leak tests i
- 1. Leak test method approved [34.25(c)] ()Y()N
- 2. Model of leak test kit
- 3. Leak tests performed at intervals not to exceed six months [34.25(b)] ()Y()N l
- 4. Records maintained for 3 years [34.25(c)] ()Y()N E. Inventories
- 1. Conducted quarterly [34.26] ()Y()N i
- 2. Contain all required information [34.26] ()Y()N
- 3. Most recent inventory conducted on Changer Model Activity Isotooe Source S/N Camera Model and S/N 1.
2.
- 3. ,
4. 5. F Utilization logs
- 1. Utilization logs maintained [34.27] ()Y()N
- 2. Contain all required information [34.27] ()Y()N Remarks:
Issue Date: 02/03/97 D-5 87100. Appendix 0
- 9. INSTRUMENTATION A. Describe the survey instruments possessed by the licensee:
Model Number Serial Number Quantity B. Capable of measuring 2 mR/hr through 1 R/hr [34.24] ()Y()N C. Operable and calibrated survey instruments available
, and used on each job [34.43(a)] ()Y()N D. Calibration performed at intervals not to exceed three months [34.24] ()Y()N E. Records maintained for 3 years [34.24] ()Y()N Remarks:
- 10. RADIATION SURVEYS A. Area or facility surveys conducted to show compliance with 20.1301 and 20.1302(a) [20.1501(a)] ()Y()N B. Records maintained [20.2103] ()Y()N C. Survey after each exposure, including guide tube and entire circumference of device [34.43(b)] ()Y()N D. Survey of device when placed in storage, including entire circumference of device [34.43(c)] ()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 [20.2103, 2107] ()Y()N
- Remarks:
l l 87100. Appendix D D-6 Issue Date: 02/03/97 l l
- 11. PERSONNEL RADIATION PROTECTION A. Dosimetry
- 1. Licensee monitors workers as required ,
[20.1502, 34.33(a). L/C] ()Y()N
- 2. Supplier Frequency
- 3. Supplier is NVLAP-approved [20.1501(c)] ()Y()N
- 4. Dosimeters exchanged at required frequency [L/C]( ) Y ( ) N
- 5. Dosimetry records maintained [20.2106] ()Y()N B. Pocket dosimeters
- 1. Model No. Range
- 2. Recharged at start of each shift L34.33(a)] ()Y()N
- 3. Daily readings recorded [34.33(b)] ()Y()N
- 4. Dosimeters checked for response ( 30%) at intervals not to exceed one year [34.33(c)] ()Y()N C. Alarm ratemeters
- 1. Model No. Range
- 2. Checked at start of each shift [34.33(t)(1)] ()Y()N
- 3. Preset at 500 mr/hr [34.33(f)(2)] ()Y()N
- 4. Calibrated ( 20%) at intervals not to exceed one year [34.33(f)(4)] ()Y()N D. Reports
- 1. Reviewed by Frequency
- 2. Inspector reviewed personnel monitoring records for period to
- 3. Maximum exposures: TEDE other
- 4. NRC forms or equivalent [20.2104(d). 2106(c)]
- a. NRC-4 ( )Y()N Com lete: ()Y()N
- b. NRC-5 ()Y()N Com lete: ()Y()N
- 5. Maximum exposures in compliance [20.1201] ()Y()N
- 6. Worker declared her pregnancy in writing during .
the inspection period (Review records) ( ) Y ( ) N ( ) N/A l If yes. licensee in compliance [20.1208] ( ) Y ( ) N ( ) N/A and records maintained [20.2106(e)] ( ) Y ( ) N ( ) N/A E. Radiation Protection Program
- 1. Licensee's program includes provisions for keeping doses ALARA [20.1101] ()Y()N
- 2. Procedures and engineering controls used to achieve ALARA [20.1101(b)] ()Y()N
- 3. Content and implementation reviewed annually by the licensee [20.1101(c)] ()Y()N
- 4. Records of program reviews maintained
[20.2102(a)(2)] ()Y()N Issue Date: 02/03/97 D-7 87100. Appendix 0
F. PSEs ( ) N/A
- 1. Licensee performed PSEs ()Y()N If so, where?
- 2. Other licensees perforn.ed P5t.s at this facility ( )Y()1 If so, who?
- 3. Records maintained [20.2105. 2106. 2204] ()Y()N Remarks:
- 12. RECEIPT AND TRANSFER OF RADI0 ACTIVE MATERIAL ( ) N/A A. Procedures established and followed for picking up, receiving, and opening packages [20.1906(e)] ()Y()N B. Incoming packages surveyed [20.1906(b)(2). L/C] ()Y()N C. Shipment of sources since last inspection ( ) N/A
- 1. Used container authorized by license [L/C] ()Y()N
- 2. Transfer (s) performed per [30.41] ()Y()N
- 3. All sources surveyed before shipment and transfer [20.1501(a). 49 CFR 173.475(1). L/C] ()Y()N D. Records of surveys and receipt / transfer maintained '
[20.2103(a). 30.51) ()Y()N Remarks:
- 13. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170 lo'" ( ) N/A A. Licensee shipments are:
( ) delivered to common carriers ( ) transported in licensee's own private vehicle ( ) both ( ) no shipments since last inspection B. HAZMAT training [172.700-704] ()"()N C. Packages ( ) M/A
- 1. Authorized packages used [173.415. 416(b)] ()Y()N
- 2. Performance Test records on file ( ) N/A
- a. Special Form Sources [173.476(a)] ()Y()N
- b. DOT-7A packages [173.415(a)] ()Y()N
- 3. CoCs on file with NRC fc.r Type B [71.12(c)(1)] ()Y()N 87100. Appendix D D-8 Issue Date: 02/03/97
1 l l I
- 4. Two labels (White-I. Yellow-II. Yellow-III) with TI. Nuclide. Activity, and Hazard Class
[172.403. 173.441] ()Y()N
- 5. Properly marked (Shipping Name. UN Number. Package Type. RQ. "This End Up" ; liquids). Name and Address of consignee) [172.301.306.310.312.324] ( ) Y ( ) N
- 6. Closed and sea' led during transport [173.475(f)] ( ) Y ( ) N 1 1
D. Shipping Papers ( ) N/A
- 1. Prepared and used [172.200(a)] ()Y()N
- 2. Proper (Shipping name. Hazard Class. UN Number.
Quantity. Package Material. Physica, and Type. Nuclide.
^amical RQ.Activity.
form. Radioactive Category of label. TI. Shipper's Name. Certification and Signature. Emergency Response Phone Number, ,
" Limited Quantity" (if applicable). " Cargo 1 Aircraft Only" (if applicable)) [172.200-204] ()Y()N
- 3. Readily accessible during transport ()Y()N E. Vehicles ( ) N/A i
- 1. Placarded [172.504] ()Y()N
- 2. Cargo blocked and braced [177.842(d)] ()Y()N !'
- 3. Proper overpacks (shipping name. UN Number, label.
statement indicating that inner package complies with specification packaging) [173.25] ()Y()N F. Any incidents reported to DOT [171.15. 16] ()Y()N Remarks: i l 1
- 14. NRC INDEPENDENT MEASUREMENTS A. Survey instrument Serial No. Last calibration l B. Inspector's measurements were compared to licensee's ()Y()N C. Describe the type, location and results of measurements:
- 15. NOTIFICATION AND REPORTS ( ) N/A A. Licensee in compliance with [19.13. 30.50]
(reports to individuals public and occupational, monitored to show compliance with Part 20) ( ) Y ( ) N ( ) N/A Issue Date: 02/03/97 D-9 87100. Appendix D
l l B. Licensee in' compliance with [20.2201. 30.50] ) (theft or loss) ~ . ( ) Y ( ) N ( ) None C. Licensee in compliance with [20.2202. 30.50, 34.30] (incidents) ( ) Y ( ) N ( ) None D. Licensee in compliance with [20.2203, 30.50] i (overexposures and high radiation levels)- ( ) Y ( ) N ( ) None , E. Annual reports furnished to NRC [20.2206(b) (c)] ( ) Y ( ).N '
.16. POSTING AND LABELING A. Radiation Areas posted [20.1902(a)] ()Y()N .
l B. High Radiation Areas posted [20.1902(b)] ( ) Y.( ) N ' C. Use or storage areas posted " Caution - Radioactive ( ) Y (-) N Materials" [20.1902(e)] D. Containers or devices properly labeled [20.1904(a)] ()Y()N ; ( ) Y-( ) N
~
E. NRC-3 " Notice to Workers" is posted [19.11] . F. Parts 19, 20. 21. section 206 of Energy Reorganization 1 Act, procedures adopted pursuant to Part 21. and license > documents are )osted or a notice indicating where . documents can )e examined is posted [19.11. 21.6] ()Y()N G. Other posting and labeling per [20.1902. 1904] ; and the licensee is not exempted by [20.1903. 1905]- ()Y()N ; i Remarks:
- 17. RECORDKEEPING FOR DECOMMISSIONING .
A. Records of information important to the safe and ; effective decommissioning of the facility maintained > in an independent and identifiable location until i license termination [30.35(g)] ()Y()N 1 E. Records include all information outlined in i [30.35(g)] ( ) Y.( ) N,. j Remarks: i
- 18. BULLETINS AND INFORMATION NOTICES A. Bulletins. Information Notices. NMSS Newsletters, f 1 etc.. received by the Licensee ()Y ()N j
. B. Licensee took appropriate action in response to Bulletins. Generic Letters etc. ()Y ()N
- Remarks:
1 t 87100 ' Appendix 0 D-10 Issue Date: 02/03/97 I y <- .e, , - . . , .. _ _ , - , ,
- 19. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A A. Special license conditions or issues to be reviewed:
B. Evaluation: ~
- 20. CONTINUATION OF REPORT ITEMS
- 21. VIOLATIONS. NCVs. AND OTHER ISSUES Note: Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For non-cited violations, indicate why the
, viola + ion was not cited.
- 22. PEPTOM2.TE EVALUATION FACTORS Licensee Inspector (name &
location Inspection Date A. Late c' :en:D- management involvement with the radiation sa e : :; am and/or Radiation Safety Officer (RS0) ose :*- ()Y()N B. RSE - :. . with other assignments ()Y()N C. Ins -
- taf fing ()Y()N D. Racia. 3:fety Committee fails to meet or functions inace:ar L. ( ) Y ( ) N ( ) N/A E. Inaae:.3 c consulting services or inadequate audits ( ) Y ( ) N ( ) N/A Remarks (corsicer above assessment and/or other pertinent PEFs):
Regional follow-up on above PEFs citations: . END Issue Date: 02/63/97 D-11 87100, Appendix D (-
APPENDIX G NOTE: All areas indicated in field notes are not required to be at:ressed during each inspection : NOTE: Any reference to patient is' intended to include human research subject i MEDICAL BROAD-SCOPE INSPECTION FIELD NOTES Region __ Inspection Report No. License No. Licensee (Name & Address): Docket No. Licensee Contact Telephone No. Last Amendment No. Date of Amendment Priority: Program Code Date of Last Inspection 4 Date of This Inspection Type of Inspection: ( ) Announced ( ) Unannounced ( ) Routine ( ) Special ( ) Initial ( ) Reinspection Summary of Findings and Action: ( ) No violations. Clear 591 issued l ( ) Violation (s). 591 issued t ( ) Violation (s). Regional letter issued l ( ) Followup on Previous violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N Inspector Date l T ignature) Approved Date (Signature) Issue Date: 02/03/97 G-1 87100, Appendix G
j B. Licensee does 1,imited distribution of- . pharmaceuticals under Part 35 license. ()Y()N !
'1. Indicate type of operation:
~~~
- a. Registered or licensed witti 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
- sealed sources ()Y()N
- alpha and beta emitters ()Y()N
- generators ()Y()N
- photon emitters ( ) Y (') N C. Research involving human subjects ( ) N/A
- 1. Research is conducted, funded, supported, or regulated by another Federal Agency which has im)lemenped Federal Policy for Protection of Human' Su)jects ? [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] ()Y()N )
3, Licensee obtains approval of research activities from an Institutional Review Board? r.35.6] ()Y()N Remarks: I 21f licensee distributes 'radiopharmaceuticals to several facilities, the inspector should consider the need to complete the radiopharmacy fieldnotes. l 2 Agencies: USDA 00E. NASA. HUD. D0J. D00 VA. EPA. HHS. DOT. Dept. of ! Commerce. Consumer Product Safety Commission. International Development . Cooperation Agency. Agency .for International Development. Dept. of Education. I National Science Foundation i L Issue Date: 02/03/97 G 3' 87100. Appendix G ? l l l i
D. Radiation Safety Committee [33.13, 14. 15] ( ) N/A '
- 1. Membershi) as specified [35.22(a)(1)] ()Y( )N
- 2. Meetings 1 eld quarterly [35.22(a)(2)] ()Y()N
- 3. Quorum 3 established [35 22(a)(3)] ()Y()N
- 4. Has sufficient authority [35.23] ()Y()N
- 5. Record of Committee meetings [35.22(a)(4)] ()Y()N
- 6. Approve / disapprove credentials of individuals prior to allowing them to work as an authorized user or authorized nuclear pharmacist ()Y( )N
[35.22(b)(2)(ii)]
- 7. Approve / disapprove applications for use [L/C] ()Y()N E. Radiation Safety Officer
- 1. Appointed & 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 F. 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. Content and implementation reviewed annually by the licensee [20.1101(c). 35.22(b)(6)] ()Y()N
- 4. Records of reviews maintained [20.2102] ()Y()N G. Use by authorized individuals [L/C) ()Y( )N If no list name/ position of individual H. Mobile Nuclear Medicine Service ( ) N/A
- 1. Licensee operates services per [35.29. 80] ()Y()N
- 2. Compliance with 20.1301 evaluated and met ()Y()N I. Any Amendments or Notifications since last inspection
[35.13, 14] . ()Y()N Licensee has notified NRC within 30 days after RSO stops work or changes name, or mailing i address changes [35.14(b)] ( ) N/A ( ) Y ( ) N l Remarks: 87100 Appendix G G-4 Issue Date: 02/03/97 l l l
- 19. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A A. Special license conditions or issues to be reviewed:
B. Evaluation:
- 20. CONTINUATION OF REPORT ITEMS 1
l
- 21. yl0LATIONS. NCVs. AND OTHER ISSUES i
Note: Briefly state (1) the requirement and (2) how and when the licensee l violated the requirement. For non-cited violations, indicate why the violation was not cited. 22 PEPTO:c'CE EVALUATION FA: TOPS, Licensee Inspector l (name & l location Inspection Date l i A. La: :' en o management involvement with the radiation sa*e: . : :: 6m and/or Radiation Safety Officer (RS0) i o.e :- ()Y()N ' B. RSC * : . . with other assignments ()Y()N C. Int - : ;taffing ()Y()N D. Racta. " c::fety Committee fails to meet or functions inaae:.. : :, . ( ) Y ( ) N ( ) N/A ; E. Inace: 3u consulting services or inadequate audits ( ) Y ( ) N ( ) N/A l Remarks (corsicer above assessment and/or other pertinent PEFs): Regional follow-up on above PEFs citations: i i END . 1 Issue Date: 02/03/97 D-11 87100. Appendix 0
APPENDIX G NOTE: All areas indicated in field notes are not required to be ai:ressed during each inspection NOTE: Any reference to patient is intended to include human research subject MEDICAL BROAD-SCOPE INSPECTION FIELD NOTES Region _ _ Inspection Report No. License No. Licensee (Name & Address): Docket No. ! i i Licensee Contact Telephone No. l 1 Last Amendment No. Date of Amendment ; Priority: Program Code
]
Date of Last Inspection l Date of This Inspection .] Type of Inspection: ( ) Announced ( ) Unann unced ( ) Routine ( ) Special ( ) Initial ( ) Reinspection Summary of Findings and Action: ( ) No violations, Clear 591 issued ( ) Violation (s), 591 issued ( ) Violation (s) Regional letter issued ( ) Followup on Previous violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N 1 Inspector Date (Signature) , Approved Date , (signature) , Issue Date: 02/03/97 G-1 87100, Appendix G I 2: l l
- 1. INSPECTION HISTORY ( ) N/A - Initial inspection A. Violations were identified during the last two inspections or two years. '.shichever is longer ()Y()N B. Response letter (s) or 591(s) dated C. Open violations from previous inspections:
Status Reauirement Violation Corrective Action Taken (Y/N) Ooen/ Closed D. Explain any previous violations not corrected or repeated ( ) N/A
- 2. ORGANLZATION AND SCOPE OF PROGRAM A. Organizational Structure
+ Individuals contacted during inspection
- Individuals present at exit meeting
~
- 1. Meets license requirements [L/C) ()Y()N
- 2. Multiple authorized locations of use ()Y()N If yes, may use ATTACHMENT A as a guide for i
location (s) or lab (s) inspected-and note lab l numbers where violations are found. ( ) N/A l
- 3. Briefly describe scope of activities, including !
types and quantities of use involving byproduct material, frequency of use, staff size, etc. I l > i 87100. Appendix G G-2 Issue Date: 02/03/97 I 1
\
_ __ _. _ __ ._. _ _ _ _._ . _ _ _ . _ ._ .~_._._._ _ ..__._.- _._., i B. Licensee does limited distribution of - -l pharmaceuticals under Part 35 license 2 (-) Y ( ) N l
- 1. Indicate type of operation:
- 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 sealed sources ()Y()N
* . alpha and beta emitters ()Y()N
- generators (') Y ( ) N
- photon emitters ()Y()N C. Research involving human subjects ( ) N/A
- 1. Research is conducted, funded. supported, or 1 regulated by another Federal Agency which has. j implemenpedFederalPolicy-forProtectionofHuman '
Subjects ? [35.6] ( ) Y~( ) N i If no. does licensee have license amendment authorizing human research? [35.6] ( ).Y ( ) N j
- 2. Licensee obtains informed consent from human I subjects? [35.6] ()Y()N
- 3. Licensee obtains approval of research-activities from an Institutional Review Board? [35.6] ()Y()N '
Remarks: , i l 4 21f licensee distributes radiopharmaceuticals to several facilities. the l t inspector should ccasider the need to complete the radiopharmacy fieldnotes.
' Agencies: USDA. 00E. NASA. HUD. D0J. D0D. VA. EPA. HHS. 00T. Dept. of- .
Consumer. Product Safety Commission. International Development ;
- Commerce. i
- Cooperation Agency, Agency for International Development, Dept. of Education.
i; ' National Science Foundation ! Issue Date: 02/03/97 G-3 87100. Appendix G l l I _
D. Radiation Safety Committee [33.13. 14, 15] ( ) N/A
- 1. Membershi) as'specified [35.22(a)(1)]- ()Y()N
- 2. Meetings 1 eld quarterly [35.22(a)(2)] ()Y()N
- 3. Quorums established [35 22(a)(3)] ()Y()N
- 4. Has sufficient authority [35.23] ()Y()N
- 5. Record of Committee meetings [35.22(a)(4)] (.) Y ( ) N
- 6. Approve / disapprove credentials of individuals prior to allowing them to work as an authorized user or authorized nuclear pharmacist ()Y( )N
[35.22(b)(2)(ii)]
- 7. Approve / disapprove applications'for use [L/C)
()Y()N E. Radiation Safety Officer-
- 1. Appointed & on license [33.13. 35.21(a) L/C] ()Y()N
- 2. Fulfills duties per [35.21(b)] ()Y()N-p
- 3. Has sufficient authority per [35.23] ()Y()N F. 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. Content and implementation reviewed annually by the licensee [20.1101(c). 35.22(b)(6)] ()Y()N
- 4. Records of reviews maintained [20.2102] ()Y()N G. Use by authorized individuals [L/C] ()Y()N If no, list name/ position of individual H. Mobile Nuclear Medicine Service .( ) N/A'
- 1. Licensee operates services per [35.29. 80] ()Y()N
- 2. Compliance with 20.1301 evaluated and met -()Y()N
- 1. Any Amendments or. Notifications since last inspection
[35.13, 14] . ()Y()N Licensee has notified NRC within 30 days after RSO stops work or changes name, or mailing address changes [35.14(b)] ( ) N/A ( ) Y ( ) N Remarks: 87100, Appendix G G-4 Issue Date: 02/03/97 t
i
- 3. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers / students per [10 CFR 19.12] ()Y()N B. Individual's understanding of current procedures and d regulations is adequate ()Y()N C. Training program required [L/C] ()Y()N
- 1. If 50. briefly describe training program:
i
- 2. . Training program implemented ()Y()N 1
- 3. Periodic training program required ()Y()N '
4 Periodic training program implemented ()Y()N
- 5. Records maintained ()Y()N Remarks: ,
i i D. Supervision of individuals
- 1. Supervised individuals are instructed !
in preparation of material principles and l procedures for radiation safety and OM Program as appropriate [35.25(a)(1) 35.25(b)(1)] ()Y()N
- 2. Licensee periodically reviews supervised ' !
. individuals use of material and records !
kept to reflect use [35.25(a)(3)] ()Y()N i
- 3. Authorized nuclear pharmacist or user periodically review work and records of work of supervised individuals as it pertains to preparing byproduct material
[35.25(b)(3)] ( ) N/A ( ) Y ( ) N Remarks: E. Therapy training
- 1. Safety instruction [35.310. 410. L/C]
- a. Control of patient and visitors ()Y()N
- b. Contamination and waste ()Y()N
- c. Size / appearance of sources ( ) N/A ( ) Y ( ) N
- d. Handling / shielding of. sources ( ) N/A ( ) Y ( ) N ,
- e. RSO notification in emergency or death ()Y()N !
- f. Records maintained [35.310(b). 410(b)] ()Y()N I
l 8 Applies to individuals that receive, possess. use transfer. or prepare byproduct material for medical use under supervision of authorized nuclear pharmacist or user. Issue Date: 02/03/97 G-5 87100. Appendix G 9
i
- 2. Manufacturer's instructions available and followed [35.59(a). 400] ()Y()N ,l 3; ' Training for operating and emergency procedures for HDR Remote Afterloaders ( ) N/A ()Y()N !
, s
.F. Revised Part 20
. Workers cognizant of requirements for:
- 1. Radiation Safety Program [20.1101] ()Y()N
- 2. Annual dose limits [20.1301,1302] ()Y()N .!
- 3. New forms 4 and 5 ( ) N/A ( ) Y ( ) N
- 4. 10% monitoring threshold [20.1502] ( ) Y (-) N
- 5. Dose licits to embryo / fetus and declared i
.pregnantworker[20.1208] ( ) N/A ( ) / ( ) N .
- 6. Grave Danger Posting [20.1902] ( ) N/A ( ) Y ( ) N ;
- 7. Procedures for opening <
- 8. Sewer disposal limits [ packages [20.1906](
20.2003] ( ) N/A ( ) Y)N/A ( ) N( ) Y (-) N NOTE: Deficiencies in Section 3.F. while not always a violation, should be - brought to the attention of licensee management at the exit meeting and in the cover letter transmitting the inspection report or NOV. t Remarks: : 4 FACIL ! TIES A. Facilities as described in license application ()Y()N :
.B, .Sto-age areas
- Materials secured from unauthorized removal or .
. access [20.1801] ()Y()N
- Licensee controls and maintains constant .
. surveillance of licensed material not in storage i
[20.1802] ()Y()N i
- - Licensee uses process cr other engineering controls !
for airborne concentrations. internal exposures in ; restricted areas, and volatiles / gases in storage l [20.1701,1702,35.90] ()Y()N 4 Maintenance program implemented for: engineering controls (negative pressure. ventilation ~ rates. filter changes, etc.) [35.205(e). L/C] ()Y()N C. Describe any Self-contained dry-source-storage ; irradiators [Part 36] and/or survey instrument calibrators (model, radionuclide, activity, use, etc) ( ) N/A i 1 Maintenance of safety-related components ' performed by authorized persons [L/C] ()Y()N
- 2. Access 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 i 4 Adequate protection of shield integrity. ;
fire protection [L/C] ()Y()N 87100. Appendix G G6 Issue Date: 02/03/97 i
i Remarks:
- 5. EQUIPMENT ,
A. Dose calibrator - Photon-emitting radionuclides
- 1. Possessed and used [35 50(eH ( )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
- b. At least 2 sealed sources used ()Y()N {
- 4. Linearity [35.50(b)(3)]
- a. Performed at installation and quarterly thereafter ()Y()N ;
, b. Includes range between 30 uCi and the ' highest dosage administered ()Y()N
- 5. Geometric Dependence [35.E.0(b)(4)]
- a. Performed at installation or relocation ()Y()N
- b. Includes range of volumes and volume configurations used ()Y()N
- 6. Dosage readings over 10 uCi mathematically corrected for geometry or linearity errors greater than + or - 10% ( ) N/A ( ) Y ( ) N
- 7. Repaired or replaced when constancy or accuracy errors exceeded + or - 10% ( ) N/A ( ) Y ( ) N
- 8. Approved procedures followed [35.22, 25. L/C] ()Y()N
- 9. Records maintained and include identity of the indi"idual performing the test.
[35.50(e)(2)] ()Y()N Remarks: i B. Instrumentation - Air._ vr beta-emitting radionuclides ( ) N/A
- 1. List type of equipment used to assay alpha and beta particles:
Issue Date: 02/03/97 G-7 87100. Appendix G
- 2. Licensee has procedures for use of instrumentation [35.52(b)] ()Y()N
- 3. Accuracy. linearity and geometric dependence tests are performed prier to initial use, periodical}y, and following repair. if applicable [35.52(b)(1),L/C] ()Y()N '
- 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
- 6. Records maintained [L/C] ()Y()N Remarks:
C. Licensee uses generators ()Y()N
- 1. Each eluate / extract used for radiopharmaceuticals tested for Mo-99 breakthrough ()Y()N
- 2. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 uCi per mci of Tc-99m ()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 F. Vial shields labeled [35.61(b)] ()Y()N Remarks:
- 6. MATERIALS .
A. Licensee measures activity of each dosage of photon-emitting radionuclide prior to use [35.53(a)] ( )Y()N B. Licensee administers alpha- or beta-emitting radionuclides ()Y()N If yes,
- 1. Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization [35.53(b)] ()Y()N
'Linearity and geometric dependence tests are not applicable if liquid scintillation 1s used. Linearity is not applicable if sodium lodide is used.
87100 Appendix G G-8 Issue Date: 02/03/97
I
- 2. 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)] ()Y()N 1' C. Unsealed material used under 35.100.200.or 300 are [35.100(b) 35.200(b). 35.300(b): i (1) Obtained from manufacturer or properly licensed i organization AND/0R ()Y()N (2) Prepared by authorized nuclear pharmacist or i physician user or individual under the supervision ' of a authorized nuclear pharmacist or . physician user ()Y()N D. Isotope, chemical form quantity and use as ' authorized [31.11, 35.400.500. L/C] ()Y()N Remarks: 4 E. Use of RAM [L/C] 1
- 1. Protective clothing worn ()Y()N
- 2. Personnel routinely monitor their hands ( ) Y'( ) N
- 3. No eating / drinking in use/ storage areas ()Y()N
- 4. No food, drink, or personal effects kept in use/ storage areas ()Y()N l
- 5. Proper dosimetry worn ()Y()N
- 6. Radwaste disposed in proper receptacles ()Y()N
- 7. No p'ipetting by mouth ()Y()N F. Radioisotopes are used in research in accordance with current procedures [L/C] ()Y()N G. Leak tests and Inventories
- 1. Leak test performed on sealed sources and brachytherapy sources [35.59(b)] ()Y()N
- 2. Leak test records in microcuries ()Y()N
- 3. Inventory of sealed sources and brachytherapy sources performed cuarterly [35.59(g)] ()Y()N
- 4. Inventory performec promptly at the storage area after removing sources from a patient to ensure all sources taken from the storage area are returned [35.406(a)] ()Y()N
- 5. Records maintained and signed by RSO
[35.59. 406] ()Y()N Remarks: Issue Date. 02/03/97 G-9 87100. Appendix G
. _ . _ . _ . . _ __ . _ _ _ _ _ , - _ . _..__._ _ . . _...m. _ _
r i
- 7. RADIATION SURVEYS (') N/A- !
A. Survey instruments .
- 1. Appropriate operable survey instrumentation i' possessed [35.120. 220, 320. 420. L/C) or available [35.520. L/C] ( ) N/A ( ) Y ( ) N ,
- 2. . Calibrations [35.51(a) (b)]
- a. Before first use, annually & after repairs ( ) Y ( ) N -
- b. Approved calibration procedure followed to ;
include check source reading determination ; [35.51(a)(3). L/C] . ()Y()N i
- c. Within-20% in each scale nr decade of 1 interest [L/C] ()Y()N j
- 3. Records maintained [35.51(d)] (.) Y ( ) N i
- 4. Source-checked each day of use [35.51(c)] ()Y()N B. Radiation surveys performed
- 1. Daily in all areas where radiopharmaceuticals are prepared or administered [35.70(a)] ()Y()N '
2, Weekly in all areas where radiopharmaceuticals ! or waste is stored [35.70(b)] ()Y()N .
- 3. Weekly wipes in all areas where !
radiopharmaceuticals are prepared for use. ! administered or stored [35.70(e)] ()Y()N i
- 4. Quarterly in brachytherapy source storage area ()Y()N ;
C. Trigger.1'evels [35.70'(d). (g)]
- 1. Established ( ) Y ( )~N !
- 2. Exceeded .
( ) Y (-) N ;
- 3. Corrective action taken and documented (-) Y (-) N ,j D. Techniques can detect 0.1 mR/hr 2000dpm [35,70) ()Y()N )
E. Records maintained [35.70(h) L/C] ( )Y()N ! F. Protection of members of the public Note: See IN 94-09 for updated guidance on conflicts between Parts'20 and 35.
- 1. Licensee made adequate surveys to demonstrate ;
, either (1) that the TEDE-to the individual likely i to receive the highest dose does not exceed 100 i mrem in a year, or.(2) that if an individual were ; 4 continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour i
. 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 ,
87100. Appendix'G G-10 Issue Date: 02/03/97 h
G. Describe licensee's survey recuirements for research areas ( ) N/A t H. Research areas surveyed as required [20.1501(a). L/C] ( ) Y ( ) N ; I. Research area survey records maintained [20.2103. L/C]( ) Y ( ) N Remarks: l l l
- 8. Patient Release ( ) N/A THE FOLLOWING GUIDANCE IS TO BE USED AFTER THE 1997 REVISION l TO 10 CFR 35.75 BECOMES EFFECTIVE. IF USING THIS SECTION. D0 i NOT ANSWER ITEMS 9.C AND 10.C BELOW.
A. Individuals released when TEDE less than 0.5 mrem [35.75(a)] ()Y()N B. Instructions on ALARA provided to individual when TEDE exceeds 0.1 rem [35.75(b)] ()Y()N C. Instructions to breast-feeding women included reouired information [35.75(b)] ()Y()N D Release records mainatined if 35.75(c) criteria are not met [35.75(c)] ()Y()N E. Records of instructions given to breast-feeding women maintained if required [35.75(d)] ()Y()N
- 9. ROFMNEUTICAL THERAPY ( ) N/A l
- r :. precautions implemented to include patient
- ': ties, posting, stay times, patient safety guidance.
,ne and contamination controls [35.315(a). L/C] ()Y()N E :Ose rate surveys and room contamination surveys
': T.5(a)(4), (7)] ()Y()N
- e of patients containing radiopharmaceuticals C -
<5 mR/hr @ Im or <30 mci [35.75] ()Y()N D. F:. :*omptly notified if patient died or had a e: :al emergency [35.315(b)] ( ) N/A ( ) Y ( ) N Remarks:
1
- 10. BRACHYTHERAPY ( ) N/A l A. Safety precautions implemented to include patient facilities, room posting, stay times, and area radiation level surveys [35.415. L/C] ()Y()N B. Patients surveyed immediately after implant [35.406] ()Y()N C. Release of patients with cermanent implants meets
<5 mR/hr 0 1m [35.75) ( ) N/A ( ) Y ( ) N Issue Date: 02/03/97 G-11 87100. Appendix G
D. Patients surveyed immediately after remwing the last temocrary implant source (required for all manual. LDR, MDR. and HDR therapies) . [35.404(a)] ( ) N/A ( ) Y ( ) N E. Records maintained [35.404(b). 436(d). 415(a)(4)] ()Y()N Remarks: l l l 11. RADIOACTIVE WASTE ( ) N/A A. Disposal
- 1. Decay-in-storage ( ) N/A
- a. Approved [20.2001. 35.92. L/C] ()Y()N
- b. Procedures followed [35.92. L/C] ()Y()N
- c. Labels removed or defaced [20.1904. 35.92]( ) Y ( ) N
- 2. Special procedures performed as recuired [L/C] ()Y()N
- 3. Liquid scintillation (LS) meda anc animal carcasses per [20.2005] ( ) N/A ( ) Y.( ) N
- 4. Impror / unauthorized disposals [20.2001] ()Y()N
- 5. Recoras maintain 3d [20.2103(a). 2108. L/C] ()Y()N B. Effluents ( ) N/A
- 1. Release into sanitary sewer [20.2003] ( ) N/A ( ) Y ( ) N
- a. Material is readily soluble or readily dispersible [20.2003(a)(1)] ()Y()N
- b. Monthly average release conwnb at.lons do not exceed App B. Table 2 values ()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 [20.2003(a)) ()Y()N
- d. Procedures to ensure representative sampling and analysis implemented [20.1501. L/C] ()Y()N
- 2. Release into septic tank [20.2003] ( ) N/A ( ) Y ( ) N
- a. Within unrestricted limits [ App B. Table 2)( ) Y ( ) N
- 3. Waste incinerated ( ) N/A
- a. License authorizes [20.2004(a)(3)] ()Y()N
- b. Licensee directly monitors exhaust ()Y()N
- c. Airborne roleases evaluated and controlled
[20.1501. 1701] ()Y()N 87100. Appendix G G-12 Issue Date: 02/03/97 I
. Remarks:
- 4. Control of' air effluents and ashes [20.1101.1201.1301. l-
-1501,2001.-L/C]
{Seealso-IP87102.RG8.37) ( ) N/A l'
- a. Air effluent less than 10 mrem constraint limit [20.1101] ()Y()N
- b. If no.-licensee' reported appropriate information to NRC ( )-Y ( ) N
~
- 1. Corrective actions implemented and on sched'ile '()Y()N
- c. Description of effluent program 4
- 1. Monitoring system hardware adequate ()Y()N
- 2. Equipment calibrated as appropriate ( ) Y (.) N
- 3. Air samales/ sampling technique (i..e. clarcoal. HEPA. etc.) analyzed with appropriate instrumentation ()Y()N' Remarks:
C. Waste Management '( ) N/A'
- 1. Waste compacted ()Y()N
- 2. Storage area (s) ( ) N/A
- a. Protection from elements and fire [L/C] ()Y()N
- b. Control of waste maintained [20.1801] ( ) Y ( ).N
- c. Containers properly 1abeled and area .
properly posted [20.1902.1904] (:) Y ( ) N i
- d. Package integrity maintained [L/C] ()Y()N .
j
- 3. 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 .
i 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 Issue Date: 02/03/97 G-13 87100. Appendix G I
- 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 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) and 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 Remarks:
I 12. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL A .- . Describe how packages are received and by whom [33.13. L/C] ( ) N/A B. Written package opening procedures established and followed [20.1906(e)] ()Y()N C. All incoming packages with a DOT label wioed, unless exempted (gases and special form) [20.1906(b)(1)] ()Y()N . D. Incoming packages surveyed [20.1906(b)(2). L/C] ()Y()N E. Monitoring in (C) and (D) crove performed within time specified [20.1906(c)] ()Y()N . F, Transfer (s) between licensees performed per [30.41] ()Y()N : G. All sources surveyed before shipment and transfer ! [20.1501(a). 49 CFR 173.475(1). L/C) ()Y()N H. Records of surveys and receipt / transfer maintained [20.2103(a). 30.51] ( ) Y (-) N
- 1. Transfers within licensee's authorized users or locations performed as required [L/C] ( ) N/A ( ) Y ( ) N J. Arrangements made for packages containing quantities of <
radioactive material in excess of Type A quantity. - [20.1906(a)] ()Y()N K. Package receipt / distribution activities evaluated for - compliance with 20.1301 [20.1302] ()Y()N 87100,' Appendix G G-14 Issue Date: 02/03/97 I I
___.__ .._ _ ._ . _ _ _ ._._ _ . . . _ _ _ _ _ _ _ . _ _ _ . _ _ _ . _ _ _ = . . . l Remarks: 1 j
- 13. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 171-189) ( ) N/A l
, A. Licensee shipments are: , ( ) delivered to common carriers ( ) transported in licensee's own private vehicle ! ( ) both l ( ) 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 j responsibilities:
C. Packages i 1. Authorized packages used [173.415, 416] (-) N/A ( ) Y ( ) N [. 2. Performance test records on file ( ) N/A
- a. DOT-7A packages [173.415(a)) ()Y()N
- b. Special form sources [173.476(a)] ()Y()N l 3. Two labels (White-I. Yellow II. Yellow-III) with !
TI. Nuclide. Activity. and Hazard Class [172.403,173.441] ()Y()N
- 4. Properly marked (Shi) ping Name. UN Number, Package Type. R0. "This End Jp" (liquids). Name and Address of consignee) [172.301.306.310.312.324] ( ) Y.( ) N
- 5. Closed and sealed during transport [173.475(f)] ( ) Y ( ) N D. Shipping Papers ( ) N/A
- 1. Prepared and used [172.200(a)] (') Y()N
- 2. Proper.{ShippingName.HazardClass.UNNumber.
Quantity. P:ckage Type Nuclide, RQ. Radioactive Material. Physical and Chemical Form. Activity. Category of label. TI. Shipper's Name, Certification and Signature. Emergency Response Phone Number.
" Limited Quantity" (if applicable). " Cargo
, Aircraft Only" (if applicable}} [172.200-204] ()Y()N L 3. Readily accessible during transport [177.817(e)]( ) Y-( )_ N Remarks: 4 4 i j 1 Issue Date: 02/03/97 G-15 87100. Appendix G E
I l-14. PERSONNEL RADIATION PROTECTION [ A. Licensee performed exposure evaluation [20.1501] ()Y()N
.B. Licensee incorporated ALARA considerations in the l Radiation Protection Program [35.20. 20.1101(b)] ()Y()N C. External Dosimetry ( ) N/A
- 1. Licensee monitors workers [20.1502(a). L/C] (-) Y (-) N l
- 2. External exposures account for contributions ,
from airborne activity [20.1203] ( ) N/A ( ) Y ( ) N i
- 3. Supplier Frequency
- 4. Supplier is NVLAP-approved [20.1501(c)] ()Y()N- .!
- 5. Dosimeters exchanged at required frequency [L/C]( ) Y ( ) N t D. Internal Dosimetry ( ) N/A t
- 1. Licensee monitors workers [20.1502. L/C] ()Y()N :
- 2. . Briefly describe licensee's program.for !
monitoring and controlling internal exposures [20.1701. 1702. L/C]:
- 3. Aerosols and gases sampled [20.1204, 35.205] ()Y()N i
- 4. Monitoring / controlling program implemented !
(includes bioassays) [35.205(d). 315(a)(8). L/C]( ) Y ( ) N i 5 .' Respiratory protection equipment [20.1703] ()Y()N ! E. Reports i
- 1. Reviewed by Frequency -!
- 2. Inspector reviewed personnel monitoring records for period to i
- 3. Prior dose determined for individuals likely to l receive doses [20.2104] ()Y()N
- 4. Maximum exposures'TEDE- Other i
- 5. Maximum CDEs- -Organ (s) 1
- 6. Maximum CEDE
- 7. Licensee sums internal and external [20.1202] ()Y()N i
- 8. TEDEs and TODEs within 20.1201 limits ()Y()N '
- 9. NRC forms or equivalent [20.2104(d) 2106(c)] ;
- a. NRC-4 ()Y()N Complete: ()Y()N
- b. NRC-5 (-) Y ( ) N Complete: ()Y()N 1
- 10. Worker declared her pregnancy in writing during inspection period (review records) ( ) N/A ( ) Y (-) N . t If yes, licensee in compliance with [20.1208] ()Y()N ;
and records maintained ()Y()N F. Who, performed any PSEs at this facility (number of people involved and doses received) , [20.1206. 2104(b). 2105. 2204] ( ) N/A ! G. Records of exposures, surveys, monitoring, and l evaluations maintained [20,2102, 2103. 2106 35.205(d). . )'
~15(a)(8). L/C] ()Y()N l
87100. Appendix G- G-16 Issue Date: 02/03/97 ) 1 l l l
J Remarks:
- 15. MISADMINISTRATIONS AND RECORDABLE EVENTS l l A. If misadministrations or recordable events (defined in 35.2) have occurred since last inspection, evaluate the incident (s) and the licensee's quality management program (OMP) using the existing guidance. [ Reference TI 2800/025 and IP 87103]
- 1. Event date Information Source
- 2. Notifications NRC Ops Center ( ) Y ( ) N Region ()Y()N Referring Physician ( ) Y ( ) N Patient ()Y()N In writing ()Y()N If notification did not occur, why not:
- 3. Written Reports [35.33]
- a. Submitted to Region within 15 days ()Y()N
- b. Copy to patient within 15 days ()Y()N B. Records maintained [35.33(b)] ()Y()N Remarks:
- 16. NRC INDEPENDENT MEASUREMENTS l A. Survey instrument Serial No. Last calibration l
B. Inspector's measurements were compared to licensee's ()Y()N C. Describe the type. location, and results of measurements: l
. 17. NOTIFICATION AND REPORTS l A. Licensee in com)11ance with [19.13] (reports to individuals, pu3lic and occupational, monitored to show compliance with Part 20) ( ) None ( ) Y ( ) N ;
Issue Date: 02/03/97 G-17 87100. Appendix G
B. Licensee in compliance with [20.2201] (theft or loss) ( ) None ( ) Y (.) N C. Licensee in compliance with [20.2202] (incidents) ( ) None ( ) Y ( ) N D. Licensee in compliance with [20.2203] (overexposures and high radiation levels) ( ) None ( ) Y ( ) N E. Licensee aware of NRC Ops Center phone number ( )Y()N F. Licensee in compliance with [20.2203] . (Constraint on air emissions) ( ) None ( ) Y ( ) N l 18. POSTING AND LABELING A. NRC-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 sosted or a notice indicating where ' documents can 3e 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 Remarks: 1 , l i l 19. RE:O O EirING FOR DECOMMISSIONING A ;e:ords of information important to the safe and effe:tive decommissioning of the facility maintained 9 an independent and identifiable location until
+nse termination [30.35(g)]
()Y()N B
~cs include all information outlined in [30.35(g)]( ) Y ( ) N i l
Remark s ! 1 l l 20. BUu r ". E D INFORMATION NOTICES A. E;.ietins. Information Notices. NMSS Newsletters, e:: received by the licensee ()Y()N B. L::ensee took appropriate action in response to Balletins. Generic Letters, etc. ()Y()N Remarks: l 21. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A A. Special license conditions or issues to be reviewed: 87100. Appendix G G-18 Issue Date: 02/03/97
I . l B. Evaluation:
- 22. DEBRIEF WITH LICENSING STAFF l Inspection findings discussed with licensing staff ( ) N/A ( ) Y ( ) N Items discussed:
- 23. CONTINUATION OF REPORT ITEMS l i
- 24. VIOLATIONS. NCVs. AND OTHER ISSUES l Note: Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For non-cited violations, indicate why the violation was not cited.
- 25. PERFORMANCE EVALUATION FACTORS Licensee Inspector '
(name & location) Inspection Date A. Lack of senior management involvement with the radiation safety program and/or Radiation Safety Officer (R50) , oversight ()Y()N B. RSO too busy with other assignments ()Y()N , C. Insufficient staffing ()Y()N D. Radiation Safety Committee fails to meet or functions inadequately ()Y()N E. Inadequate consulting services or inadequate audits ()Y()N F. Financial Instability ()Y()N Remarks (consider above assessment and/or other pertinent PEFs): Regional follow-up on above PEFs citations: END Issue Date: 02/03/97 G-19 87100. Appendix G
1 ATTACHMENT A LABORATORY INSPECTION FIELD NOTES :
- 1. Date Authorized User (s) l 2. Location (s) Building Room (s)
- 3. -Person (s) Contacted
- 4. Describe scope of. lab use (Nuclides, form, frequency, purpose, etc): i i
i
- 5. Training A. Frequency: Ccnducted by: -
B. Individuals interviewed understand safety practices ()Y()N. Remarks: > i
- 6. Surveys ;
A. Types of surveys performed (daily, weekly, monthly, etc.) l L B. Instrumentation properly calibrated and used ()Y()N C. Efficiency of counting system determined . (.) Y ( ) N 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 surveyed ( )Y()N Results satisfactory- ( ) N/A ( ) Y ( ) N Remarks:
- 7. Receipt and Transfer A. Incoming packages properly surveyed ()Y()N B. Interlaboratory transfers performed as specified in the license ( ) N/A ( ) Y ( ) N .
C. Records maintained ()Y()N l Remarks: 8.
~
Personnel Dosimetry 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 Remarks: Issue Date': 02/03/97 A-1 87100 Appendix G Att. A l l
- 9. Handling Wcste i 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 1 E. Compaction ( ) N/A ( ) Y ( ) N F. Sewer discharge ( ) N/A ( ) Y ( ) N G. Records maintained ()Y()N Remarks:
- 10. Inventory conducted ( ) N/A ( ) Y ( ) N Records Maintained. ()Y()N Remarks:
- 11. Storage and use of RAM A. Adecuate method to prevent unauthorized access ()Y()N B. Concition of areas acceptable ()Y()N C. Perscnnel wear disposable gloves and protective clothing while handling material ()Y( )N D. Hands monitored after procedures or before leaving ()Y()N ,
E. No eating, drinking, or smoking in use/ storage areas ()Y()N F. No food, drir.k, or personal items stored in use/ storage areas ()Y()N G. Use of shielding / distance while using/ storing material ( ) Y ( ) N H. RAM is under surveillance and control when not in storage in an unrestricted area ()Y()N Remarks; i
- 12. Posting and Labeling A. NRC-3 " Notice to Workers" ()Y()N B. Parts 19, 20, 21. Section 206 of Energy Reorganization Act, procedures for Part 21 end license documents or a notice indicating where documents can be examined ()Y()N C. Other posting and label;ng requireents met ()Y()N :
Remarks:
- 13. Violations Observed 1
END i 87100. Appendix G. Att. A A-2 Issue Date: 02/03/97 l l l i l
ATTACHMENT A LABORATORY INSPECTION FIELD NOTES
- 1. Date Authorized User (s)
- 2. Location (s) Building Room (s)
- 3. Person (s) Contacted
- 4. Describe scope of lab use (tTuclides, form, frequency. purpose, etc):
- 5. Training A. Frequency: Cunoucted by:
B. Individuals interviewed understand safety practices ()Y()N Remarks:
- 6. Surveys A. Types of surveys performed (daily, weekly, monthly, etc.)
B. Instrumentation properly calibrated and used ( )Y()N C. Efficiency of counting system determined ()Y()N 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 surveyed ()Y()N Results satisfactory ( ) N/A ( )Y()N Remarks:
- 7. Receipt and Transfer A. Incoming packages properly surveyed ()Y()N B. Interlaboratory transfers performed as specified in the license ( ) N/A ( ) Y ( ) N C. Records maintained ( )Y()N Remarks:
- 8. Personnel Dosimetry 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 Remarks:
Issue Date: 02/03/97 A-1 87100 Appendix G. Att. A
- . = - - -. . . - . - - - . . . . . _ - . _ - - . . - . - - . ~ . , ..
I APPENDIX H j l f l NOTE: All areas indicated in field notes
- are not required to be addressed during each inspection RADI0 PHARMACY INSPECTION FIELD NOTES Region Inspection Report No. License No.
Licensee (Name & Address): Docket No. l Licensee Contact Telephone No. Last Amendment No. Date of Amendment ; 1 Priority: Program Code _2500 Nuclear Pharmacy Other (specify) Date of Last Inspection
- Date of This Inspection ;
l l Type of Inspection: ( ) Announced ( ) Unannounced ( ) Routine ( ) Special ( ) Initial ( ) Reinspection Next Inspection Date ( ) Normal ( ) Reduced ( ) Extended Summary of Findings and Action: 1 ( ) No violations. Clear 591 issued ( ) Violation (s). 591 issued i' ( ) Violation (s). Regional letter issued ( ) Followup on Previous Violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the ,. inspector? ()Y()N Inspector: Date (Signature) l Approved: Date - l (Signature) 1 Issue Date: 02/03/97 H-1 87100. Appendix H I
- 1. INSPECTION HISTORY ( ) N/A - Initial inspection A. Violations were identified during the last two inspections or two years, whichever is longer ()Y()N B. NOV or 591 dated C.- Licensees response to NOV dated ( ) N/A D. Open violations from previous inspections:
Status Recuirement Violation Corrective Action Taken (Y/N1 Doen/ Closed E. Explain any previous violations not corrected or repeated ( ) N/A
- 2. ORGANIZATION AND SCOPE OF PROGRAM A. Organizational Structure Describe List individuals contacted during inspection
+ Individuals contacted during inspection
- Individuals present at exit meeting
- 1. Multiple authorized locations of use ( ) N/A ( ) Y ( ) N If so list location (s) inspected
- 2. Briefly describe scope of activities. including types and quantities of use involving by material, frequency of use, staff size # of product group medical licensees and physicians served, work hours, etc.
- 3. Licensee distributes / redistributes
- sealed sources ()Y()N
- alpha and beta emitters ()Y()N
- generators ()Y()N
- photon emitters ()Y/)N 87100. Appendix H H-2 Issue Date: 02/03/97
- 4. Licensee is registered / licensed by FDA/St8te Agency as a drug manufacturer or a nuclear l pharmacy ()Y()N l
If yes, is registration / license current? i ()Y()N B. Radiation Safety Officer i 1. Named a., license [L/C] ()Y()N , ! 2. Fulfills duties as described in 1 ! license [L/C] ()Y()N
- 3. Has sufficient authority to carry l out duties [L/C] ()Y()N l
l C. Radiation Safety Program 1
- 1. Content ana implementation reviewed annually-by the liter.see [20.1101(c). L/C] ()Y()N
- 2. Records of. reviews maintained [20.2102] '( ) Y ( ) N
- 3. Independent Audit Program [L/C] ( ) N/A ( ) Y ( ) N (a) Audits conducted by (b) Frequency
! 4. Corrective actions taken in response to audit findings ( ) N/A ( ) Y ( ) N 1 D. Use/ preparation bv authorized individuals [L/C] ()Y()N ITEMS 1 AND 2 APPLY TO LICENSED PHARMACIES OR PHARMACIES WITHIN FEDERAL INSTITUTIONS AND NOT T0 FACILITIES THAT ARE , REGISTERED / LICENSED BY FDA/ STATE AGENCY AS A DRUG MANUFACTURER
- 1. ' Authorized Nuclear Pharmacist (ANP) [32.72(b)]
A. - ANP must meet at least one criteria (1) Qualifies as nucle 3r pharmacist as ( defined in 35.2 [32.72(b)(1)]- Identified as ANP on NRC or Agreement State nuclear pharmacy
, license ( ) Y (') N
- Identified as ANP on permit issued by NRC or Agreement State l Broad Scope license ()Y()N (2) listed on license
( [32.72(b)(2)(i)] ()Y()N ! l (3) Grandfathered - Listed as authorized user I
- on a nuclear pharmacy licensed issued I L by NRC prior to 12/2/94 ;
i [32.72(b)(4)] ()Y()N- ' l 2. Drugs are prepared by ANP or individual under j the supervision of an ANP [32.72(b)(1)] ()Y()N 1 l , l 3. Sufficient number of authorized users on staff to cover [ all shifts ()Y()N i . ! Ir w s Date: 02/03/97 H-3 87100. Appendix H I 1
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- 4. Licensee has ]rovided NRC with appropriate documentation to support AN)*s credentials no later than 30 days after individual starts work as an ANP 1
[32.72(b)(5)] ( ) N/A ( ) Y ( ) N Remarks:
- 3. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers [19.12] ()Y()N B. Individual's understanding of current procedures and ,
regulations is adequate (2rormal and emergency) (-) Y ( ) N C. Training program required [L/C. 30.33(a)(3)] ()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 D. Supervision of individuals by authorized user in accordance with [L/C] ()Y()N Supervising ANP periodically reviews work of supervised individuals and recordt kept :
to reflect work [L/C] ()Y()N Authorized nuclear pharmacist present during i drug preparation if required by State Board [L/C] ()Y()N Remarks: 2 Not applicable if licensee has obtained a license amendment listing individual as ANP. [35.72(b)(2)(ii)] i rInspector should consider reviewing training program for pharmacists, technicians, dispatchers, and drivers. , 87100, Appendix H H-4 Issue Date: 02/03/97 I
i E. Revised N rt 20 ; Workers cognizant of requirements for: j
- 1. Radiation Safety Program [20.1101] ( ) Y ( )'N !
- 2. Annual dose limits [20.1301.1302] ( ) Y ( .) N
- 3. New forms 4 and 5 .
( ) N/A ( ) Y (~) N l
- 4. 10% monitoring threshold [20.1502] ()Y()N _
j
- 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 l 7.. Procedures for opening ,
packages [20.1906]. ( ) N/A ( ) Y ( ) N l ( ) N/A ( ) Y ( ) N
- 8. Sewer disposal limits [20.2003]
glIE: Deficiencies in Section 3.E. while not always a violation, should be brought to the attention of licensee management at the exit meeting . and in the cover letter transmitting the inspection report or NOV. Remarks:
- 4. FACILITIES A. Facilities as described in license application [30.33(a)(2)] ()Y()N B. -Security
- 1. Materials secured from unauthorized removal or access [20.1801] ()Y()N
- 2. Licensee controls and maintains constant surveillance of licensed material not in storage .
[20.1802] ()Y()N C. Engineering Controls
- 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 controls (neg uive pressure, ventilation rates, filter changes, etc.) [L/C] .()Y()N
- 3. Ventilation rates in accordance with license .J limits [L/C) ( ) N/A ( ) Y ( ) N l Frequency air filtration system checked: l Remarks:
i .
-Issue Date: 02/03/97 H-5 87100. Appendix H ,
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- 5. EQUIPMENT A. Dose Calibrator - Photon-emitting radionuclides
- 1. Possessed and used [32.72(c)] ()Y()N ,
- 2. Calibration procedures developed and followed [32.72(c)] ()Y()N ,
- 3. Constancy [32.72(c)(2). L/C]
- a. Performed daily prior to use ()Y()N
- b. Dedicated check source used ()Y()N
- 4. Accuracy [32.72(c)(1). L/C]
- a. Performed a: in t:T; tion, after repair and annually ()Y()N ;
- b. At least 2 sealed sources used ()Y()N
- 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 repair ()Y()N !
- b. Includes range of volumes and volume !
configurations used ()Y()N
- 7. Dosage readings mathematically corrected for linearity errors greater than 10% l
[L/C] ( ) N/A ( ) Y ( ) N q
- 8. Dosage readings mathematically corrected for j geometry errors greater than 2% !
[L/C] ( ) N/A ( ) Y ( ) N I l
- 9. Repaired or replaced when constancy or accuracy errors exceeded 10% [L/C] ( ) N/A ( ) Y ( ) N
- 10. Records maintained [L/C] ()Y()N Remarks:
B. Instrumentation - Alpha- or beta-emitting radionuclides ( ) N/A
- 1. Calibration procedures developed and followed [32.7?(c)] ()Y()N !
- 2. List type of equipment used to assay alpha and beta particles: .
l I l 87100. Appendix H H-6 Issue Date: 02/03/97 ! l l [
r
- 3. Constancy / proper operation (32.72(c)(2)]
- a. Performed daily prior to use ()Y()N
- 4. Accuracy [32.72(c)(1). L/C]
- a. Performed at installation. after, repair, and periodically ()Y()N
- 5. Linearity [32.72(c)(1). L/C] ( ) N/A
- a. Performed at installation, after repair, and periodically ()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 volumer and volume configurations used ()Y()N
- 7. Appropriate action taken when calibration errors in excess of license limits are ;
identified [L/C] ( ) N/A ( ) Y ( ) N '
- 8. Records maintained [L/C] ()Y()N Remarks:
C. Licensee use of generators 1 Each eluate / extract used for ' radiopharmaceuticals tested for Mo-99 breakthrough [30.34(g). L/C] ()Y()N
- No radiopharmaceuticals distributed with Mo-99 i concentrations over 0.15 uC1 per mci of Tc-99m ()Y()N )
- Records maintained [30.34(g). L/C] ()Y()N ,
.: Frequency of generator receipt:
Maximum activity of generator: D % : ort radiation shield (cn transfers for ;
. : bution) labelled with radiation symbol. l
' * 'iOf. [or DANGER). RADI0 ACTIVE MATERIAL,"
I na + and cuantity at specified date and time3
- 3a)(4)(i). L/C] ()Y()N E. 53-inges. vials, or other containers labelled with rad:ation symbol. " CAUTION [or DANGER]. RADI0 ACTIVE !
MATERI AL." and an identifier to correlate with the l information on the transport radiation shield label l [32.72(a)(4)(ii). L/C] _()Y()N , l 3 The time may be omitted for drugs with a half life greater than 100 days. Issue Date: 02/03/97 H-7 87100. Appendix H
I l F. Syringes and vials kept in a shield l [20.1101(b) L/C] ()Y()N G. A)propriate shielding available for p10 ton, and beta emitters [L/C] ()Y()N Remarks: i
- 6. MATERIALS A. Isotope, chemical form quantity and use as authorized [L/C] ()Y()N B. Iodine capsule compound performed ()Y()N Frequency:
C. Preparation of liquid radiciodine for distribution
- 1. Iodine-131 ()Y()N
- 2. Iodine-125 ()Y()N D. Use/ preparation of radionuclides / drugs [L/C]
- 1. Protective clothing worn ()Y()N
- 2. Personnel routinely monitor their hands and feet ()Y()N
- 3. No eating / drinking in use/ storage areas ()Y()N
- 4. No food, drink or personal effects kept in use/ storage areas ()Y()N j
- 5. Proper dosimetr worn ()Y()N
- 6. Radwaste dispc'- in proper receptacles ()Y()N Remarks:
- 7. EMERGENCY PROCEDURES )
A. Written emergency procedures established and >osted [L/C] ()Y()N B. Decontamination cit stocked l and present [L/C] ()Y()N l C. 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 a signed by RSO [L/C] ()Y()N :
Remarks: 1 I 87100. Appendix H H-8 Issue Date: 02/03/97
t r
. Remarks:
- 19. SPECIAL LICENSE CONDITIONS OR TSSUES ( ) N/A A. Special license conditions or issues to be reviewed:
B. Evaluation: ; i
. 20. CONTINUATION OF REPORT ITEMS
'l I
- 21. VI0lATIONS. NCVs. AND OTHER ISSUES f Note: Briefly state (1) the requirement and (2) how and when the licensee
- violated the requirement. For non-cited violations, indicate why !
the violation was not cited. f i
- 22. DEBiilEFWITHLICENSINGSTAFF Inspection findings discussed with licensing staff ( ) N/A (-) Y (-)-N i Items discussed:
f I f I
- 23. PERFORMANCE EVALUATION FACTORS.
i ^ Licensee Inspector ; (name & i
~~
location) Inspecticn1 Date : l A. Lack of senior management involvement with the radiation safety ! program and/or Radiation Safety Officer (RS0) oversight ()Y()N B. R00 too busy with other assignments ( ) Y'( ) N i
,C. Insufficient staffing ()Y()N !
D. Inadequate consulting services or inadequate audits ()Y()N ; E. Financial Instability- ()Y()N l Remarks (consider above assessment and/or other pertinent PEFs): . : i Regional follow-up on above PEFs citations: I 1 END 87100 Appendix H H-l6 Issue Date: 02/03/r .l
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- 8. RADIATION SURVEYS j
A. Survey instruments used to show compliance with Parts 20 and 30
- 1. Appropriate operable survey instruments !
possessed or available [30.33(a)(2), L/C] ()Y()N l 1
- 2. Calibrations [20.1501(a) 30.33(a)(2). L/C] j
- a. Before first use, annually & 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 j
- 3. Records maintained [L/C] ()Y()N
- 4. Source-checked each day of use [L/C) ()Y()N B. Rt.Jiation surveys performed
- 1. Daily in all areas where radiopharmaceuticals are prepared (rad. levels.' [L/C] ()Y()N
- 2. Weekly in all areas where radiopharmaceuticals or waste is stored (rad. levels) [L/C] ( ) Y ( )_N l
- 3. Weekly wipes in all areas where radiopharmaceuticals are routinely prepared or stored [L/C] ()Y()N
- 4. Proper corrective action taken if contamination /
excess levels detected [L/C] ()Y()N
- 5. Trigger levels established [L/C] ()Y()N
- 6. Vehicles used to transport radioactive material surveyed [L/C] ()Y()N C. Techniques can detect 0.1 mR/hr. 2200dpm/100 2cm [L/C]( ) Y ( ) N D. Records maintained [L/C] ()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 a'rea, the extemal 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 Remarks: -
Issue Date: 02/03/97 H-9 87100. Appendix H}}