ML20217Q721

Requests That Encl Draft Insp Procedure 87115, Nuclear Medicine Programs Be Issued for Use by Regions.Summary of Comments & Resolutions Also Encl

ML20217Q721
Person / Time
Issue date:	04/29/1998
From:	Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Gillespie F NRC (Affiliation Not Assigned)
References
NUDOCS 9805110036
Download: ML20217Q721 (61)

Text

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I b^ MEMORANDUM TO: Frank P. Gillespie, Director l Division of Inspection and Support Programs, NRR FROM: Donald A. Cool, Director (orig. signed by)

Division of Industrial and Medical Nuclear Safety, NMSS

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 87115, NUCLEAR MEDICINE PROGRAMS We request that you issue the attached Inspection Procedure 87115 for use by the regions. It was issued for review, comment, and, in the regions, for pilot use on July 14,1997. A summary of comments and resolutions is also attached.

This is one in a series of inspection procedures that will result from revision of the inspection procedures in IP 87100 to eliminate the checklist approach and substitute a performance based approach using an " Inspection Record" and " Inspection References." This document, when issued, will replace the existing guidance for inspection of nuclear medicine programs contained in IP 87100.

Attachments: As stated.

cc: R. Blough, RI D. Collins, Ril C. Pederson, Rlli R. Scarano, RIV R. Bangart, OSP J. Ricci, TTC CONTACT: Ronald E. Zelac, NMSS/IMNS (301)415-6316 h' DISTRIBUTION:

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MEMORANDUM TO: Frank P. Gillespie, Director Division of Inspection and Support Programs, NRR FROM: Donald A. Cool, Director -  !

Division of Industrial and /

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Medical Nuclear Safety, NMSS M [-

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 87115, NUCLEAR MEDICINE PROGRAMS We request that you issue the attached Inspection Procedure 87115 for use by the regions. It was issued for review, comment, and, in the regions, for pilot use on July 14,1997. A summary of comments and resolutions is also attached.

This is one in a series of inspection procedures that will result from revision of the inspection procedures in IP 87100 to eliminate the checklist approach and substitute a performance based approach using an " Inspection Record and " Inspection References." This document, when issued, will replace the existing guidance for inspection of nuclear medicine programs contained in IP 87100.

Attachments: As stated.

cc: R. Blough, Rl D. Collins, Rll C. Pederson, Rlli R. Scarano, RIV R. Bangart, OSP J. Ricci, TTC CONTACT: Ronald E. Zelac, NMSS/IMNS (301) 415-6316 I

DOCUMENT ISSUING FORM To: NRR. DISP. Director From: Donald A. Cool. Director. Division of Industrial and Medical Nuclear Safety NMSS (Originating Director)

1. Number and title of document 87115. Nuclear Medicine Proarams

2. Type of document 3. Type of action

_ Manual Chapter (MC) 1. Inspection Procedure (IP) .2LNew document (number)

_ Appendix _ Temporary Instruction (TI) _X. Revision (of IP 87100)

_ Technical Guidance _10 CFR Guidance _ Deletion 4.a. If a new IP is being prepared, state its need or purpose, whether it is for the " Core" inspection Program, the SALP categoryit applies to, the direct insoection hours needed to perform it, and the inspection frequency.

b. If a Tl or IP is being revised, state the reason for the revision, and if applicable,the resulting change in direct inspection hours or FTE, if any.

Core Program: X._Yes _No SALP Category: N/A DIE: N/A Inspection Frequency: N/A Statement: This orocedure is to be used in olace of IP 87100 for the insoection of nuclear medicine licensee oroarams. It reflects a cerformance based insoection aooroach.

Comoared to IP 87100. it chances the format. eliminates the field notes. adds an insoection record section. and adds a references section.

c. For any proposed addition in direct inspection hours that results from a or b above, state the increase in proposed hours and identify where the proposed corresponding reduction in direct inspection hours is to occur (Note: the total " Core" hours is a fixed number and cannot be increased without permission from the NRR Office Director).

DIE increase resulting from 4a or 4b: N/A Proposed reduction, IP No.:N/A Details of reduction: N/A b

l I d. If new training requirements or the revision of current training requirements are.needed as the result of the new IP, Tl or revision of existing procedures, these should be identified.

The group responsible for establishing and presenting the training should also be identified New training course required? _Yes XNo Revision to existing training course? XYes _No i

Lead Branch for establishing training: Reoions Training to be given by: Reoions Brief description of proposed training: Add discussion on the

. tgylted format of the orocedure

5. Provide a floppy disk with the file in the current version of Wordperfect and attach a hard I copy of the document.

a. Has document been reviewed by the technical editor? _X_Yes _No if not, state why

6. Special exhibits (anything that cannot be put in Wordperfect such as drawings, reductions, or block diagrams) are attached?

_Yes _No XN/A

.7. Attach a summary of comments and resolutions. State comment, its source, and if not adopted why. Is summary attached? XYes _No __N/A

8. All approval signatures must be obtained in the order listed below: Check items 1-7 above <

and ensure all documents (floppy disk with file in Wordperfect & hard copy, special exhibits, comment summary and resolution, and any background information) are attached to this provals.

form be eg ti . it

a. Ronhld E. Zelac f//f/ff d.

Origi ator/ tg ' '

e PIPB, Manual Coord./Date da MbO '/b /f e.

b.( ))(doseohine M. Piccone Originator Branch Chief /dat PIPB, Branch Chief /Date

c. f- Asohl ntr f.

l IMNS Division Director /Date DISP, NRR, Director /Date

9. Date received by PIPB 10. Change notice number and issue Manual Coordinator date:

b INSPECTION PROCEDURE 87115 '

COMMENT RESOLUTION Office of State Proarams: i Comment:

No coraments. Concur without comment.

Office of Enforcement: ,

1. Comment:

No major comments. Paragraph 02.21, Post inspection Actions, should be modified as follows:

Additionally, in some instances, inspection findings will warrant communication with NRC enforcement staff, Office of Investigations staff, State Liaison staff, or other Federal agencies with whom NRC has memoranda of understanding 3 (MOUs). In the latter case, ensure that the exchange of information is made in accordance with the appropriate MOU.

1. Resolution:

The suggested changes have been made.

Medical. Academic. & Commercial Use Safety Branch:

1. Comment:

In item 03.03,b,3rd bullet, add an asterisk and the note: r

• As defined or described in the Federal Policy for the Protection of Human Subjects.

The licensee may affirm the use of this policy.

1. Resolution:

The suggested changes have been made.

Reaion 1:

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1. Comment: [

The old Nuclear Medicine Inspection field notes were used to document the inspection of alllimited scope medical programs, not just nuclear medicine programs. The only i .

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other field note options available to medicalinspectors were the broad scope medical and teletherapy field notes. Because of this, the old field notes included a section for brachytherapy. The new " Nuclear Medicine inspection Record" does not include a l section for brachytherapy, nor does the IP discuss brachytherapy. These sections should be addedL We may want to rename the IP " Limited Scope Medical Programs"

1. Resolution: .,

The revised IP 87100 procedures include five in the medical area: Nuclear Medicine, L Medical Teletherapy, Radiopharmacy, Brachytherapy, and Medical Broad-Scope. Since there is specific procedure that addresses brachytherapy, no changes were made.

2. Comment: 1 i

Appendix B can be deleted. If inspector prompts are believed to be necessary, incorporate the regulatory references in Appendix B into the appropriate sections of the  ;

inspection Record. If an inspector wants more information, she/he can always refer to the IP.

2. Resolution:

l Appendix B is a list of applicable regulatory documents for use in preparing for inspections. This purpose and this format are common to each inspection procedure in the new series. From these perspectives, we believe Appendix B should remain as it ,s.

3. Comment:

i l Page 7 of the IP, Section 02.12e, discusses the need to " verify that' radiation and <

l contamination levels are below release limits.". With new release criteria being issued, guidance being generated by RES should be incorporated.

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! 3. Resolution.'

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l The new release criteria being developed by RES, although established in terms of dose, have not yet been converted into quantities that are measurable in the field. Work is ongoing to develop models that would permit such conversion, but it is not yet  ;

complete. The procedures will be updated when such criteria become available. i

4. Comment: '  !

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On Page B-7 of Appendix B, and on Page 23 of the draft IP, the Decommissioning j' Handbook should be referenced as NUREG/BR-0241.

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7. Resolution:

Item 19, Performance Evaluation Factors, is useful because, although the subject matter in the item is indeed covered in items 1 and 2, they are covered in Item 19 in an explicit ,

' manner to ensure that they are highlighted for review. We believe it is beneficial to

' retain this item,

8. Comment:

}' It has been suggested that Part til of the Inspection Record (Post inspection Activities)

' be deleted. Follow up is evidenced by the inspection Record approval.

8. Resolution:  ;

a Part lll includes Regional Follow-Up on PEFs and Debrief with Regional Staff, which j includes post-inspection communication with supervisors, regional licensing staff, Agreement State Officer, and/or State Liaison Officer. We believe this section may be  ;

useful in planning subsequent inspections of the facility, because it indicates what i actW were taken in response to certsin identified performance factors and who was informed o.'aspection findings, as well as any follow-up actions with other organizations.

Reaion ll:

1. Comment:

Should delete the note that requires the inspector to attach copies of alllicensee documents and records to support violations. The inspector should review these documents and provide sufficient information to identify the documents: however, there is no justification to keep these documents as a part of the officialinspection record.

1. . Resolution:

Information provided by the inspector, based on document review, is not sufficient for regional and Headquarters management review of the violation and consideration of various possible enforcement options, as well as resolution of uncertain or controversial points related to the violation. In addition, this is a requirement specified in NRC

. inspection Manual Chapter 620. No changes were made to the procedure.

2. Comment:

A section should be added to the inspection Record to document the exit meeting with

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the licensee (i.e, what was discussed and who in the licensee management did the inspector meet with).

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' 4. Resolution!

Made sugges' ted change.

5.; Comment:

L ltem 6 of the Inspection Record (Material Use, Control, and Transfer) should be l amended to include transportation of licensed material. This would allow elimination of item 13 (Transportation) which, for limited scope medical licensees wh.o normally receive only short-lived radioactive materials from commercial radiopharmacies, is not a major concern.

l '5. Resolution: j p Although it is true that limited scope licensees are not normally involved in complex l transportation situations, there may be occasions when the material in this section may be needed. ' Inspectors may use as much of the material in that section as is needed and ignore the rest. In addition, t_ransportation is, from a regulatory point of view, a complex activity,'and including it with other functional program areas may not be appropriate.: All the IP 87100 series procedures were designed with a separate section on transportation, and this section is nearly identical in all the procedures. We believe we should not deviate from this pattem in this case. Therefore,- no change was made.

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6. Comment:

Item 12 (Decommissioning) (should] be deleted from the inspection Record as this has ,

l little applicability to limited scope medical programs and any concern in this area would be more than adequately addressed in item 5 (Material Use, Control, and Transfer) and item 8 (Area Radiation Surveys and Contamination Control). j

6. Resolution: ,

No change was made in response to this comment for the same reasons noted in item 5 above, namely, complexity of the subject matter, uniformity of the IP 87100 series of

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procedures, and selective use of the material by the inspector as appropriate for the -

specific situation.

L l ' 7. Comment:

Item 19 could be deleted as these inspector assessments would be covered in item 1

_( Organization and Scope of Program) and item 2 (Management Oversight).

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• 2.: Resolution:

Item 18'in the inspection Re' cord, " Personnel Contac'.ed," provides a neans to record -

the names of licensee personnel with whom the inspector had conta(t during the

. inspection. Those licensee' personnel who attend the exit meeting are usually indicted lon the list by adding an asterisk (*) opposite their names. The footnote points out that -

the indicated individuals attended the exit meeting. The entrance _ briefing is handled similarly, with~ a pound sign (#) and a footnote explanation. No changes were made in the procedure

3. Comment:

Should consider including those parts of the field notes which can be addressed without a narrative but with a simple yes/no answer (i.e. was the dose calibrator calibrated at the required frequency?) in the appropriate section of the Inspection Record.

3. Resolution:

We believe that adding such sections would ): eld an inspection procedure that is a .

hybrid between the current straft and the old field notes approach.- This was not the intent of the' revision of the 87100 procedures, and therefore such a change cannot be made at this tims.' How< ve., if experience with the'use of the procedures indicates that .,

such a hybrid woulo h ine optimum approach, then the matter will be reconsidered.

Reaion Ill:

1. Comment:

We recommend that in the next revision you add a heading for " brachytherapy and/or HDR", and possibly add a heading for $35.500 devices (sealed sources for diagnosis),

i.e. STEP and VANTAGE units, bone mineral analysis (BMAs), Lixi devices, etc. We L many times see these types of devices in large nuclear medicine programs.-

1. Resolution:

0 A separate inspection procedure has been provided for brachytherapy activities, and

- therefore there is no need to add a heading in the nuclear medicine procedure. We believe that the devices rnentioned in the comment can be inspected within the framework of the overall nuclear medicine procedure, which is general enough to encompass all safety aspects of use, such as' oversight of use, location of use, training,

' maintenance, contamination control, security, etc. No changes were made in the procedure.

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-2. Comment:

Part 1, item 1 of the new field notes (Appendix A," Nuclear Medicine inspection Record"]:

requires time and effort to document the licensee's amendment history since the last inspection, and I don't believe the result is worth the effort. If the intent is to highlight program changes since the last inspection, why not just request the inspector to' -

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! document significant (emphasis added) program changes? Is it really necessary to document all of the program changes since the last inspection? i

2. Resolution:

This item requires documentation of license amendments issued since the last -

~ inspection, or program changes noted in the license. For most licensees, these changes will likely be few or none. It was felt that this section may be useful in drawing 4 attention to those items that should be reviewed to ensure proper implementation of the changes in license requirements. No change was made at this time.

-3. Comment:

- Part 1, Item 11, of the new field notes [ Appendix 'A, " Nuclear Medicine Inspection Record"] refers to EPA referral forms, yet we no longer use them.

3. Resolution:

The section in question has been deleted.

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~4. Comment:

Appendix B of the new field notes is simply an outline of the regulations.- l think it would ,

be better to have a more detailed outline to serve as a checklist for inspectors to: (1) ensure key program areas have not been overlooked during the inspection; and (2) provide some specific information regarding certain program areas (e.g., shipping paper a l

. contents,' package labeling elements, etc.). In fact, I plan to use the old field notes as .

my on-site checklist because it is more helpful to me in the field. 1

' 4.~ Resolution:

. The consensus that prompted revision of the 87100 series procedures was that it was

. desirable to discontinue the checklist approach to inspection of materials facilities.- The" idecision to use the present format was jointly reached by regional and headquarters management at the January,1997 Division Directors Counterpart Meeting. Appendix B is intended to be simply a list of references that may prove helpful to the inspector in preparing for an inspection.-- Therefore, no changes were made.

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Reaion IV:

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1. Comment: 3 3

The only recommendation I have is that A'p pendix B include the detailed regulatory references that appear in the checklist type field notes.' This checklist is helpful in finding the specific requirements in the regulations.

- 1. Resolution:

'" See comment and resolution (4), Region ill, above. No changes were made.

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NRC INSPECTION MANUAL ium INSPECTION PROCEDURE 87115 h . NUCLEAR. MEDICINE PROGRAMS r ,'

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PROGRAM APPLICABILITY: 2800

87115-01 . INSPECTION OBJECTIVES =

01.01 . To determine if licensed activities ~are being conducted in a manner-that will protect;the health and safety of workers and the general pubiic.

01.02 To. determine if. licensed programs are being conducted in accordance with U.S. Nuclear Regulatory Commission (NRC) requirements.

87115 INSPECTION REQUIREMENTS A review of th'e licensed activities should be commensurate with the scope of thel

. licensee's program. Verification of the licensee's compliance with NRC's health and safety requirements, including -the adequacy of specific aspects of the.

licensee's program, should be' based on direct observation of work' activities:

interviews and discussions with workers and management: demonstration's by workers performing tasks regulated by NRC: independent and confirmatory measuremen_ts of radiation conditions"at the facility: and a review of.some licensee records.

"Some of the. requirement and guidance sections of this ' 3rocedure instruct the.

inspector to " verify" the adequacy of certain aspects of :he licensee's program.

.Whenever possible, verification should be accomplished through discussions,-

observations, and demonstrations.

In ' reviewing the licensee's performance, thefinspector. should cover the period since the last inspection, However. issues preceding the last inspection should-

'be' reviewed, if warranted by circumstances, such as incidents.' noncompliance, or

.high radiation exposures.

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Specibcinspectionrequirementsfollow: however,'some of the areas may not be applicable to-all nuclear medicine licensees. ,

- 02.01 Preoaration. .Before(the inspection, the inspector shall do the following:

Review the licensee's licensing history, including identifying any amendments 1 issued since the last inspection, pending licensing actions, and whether the licensee has informed NRC of any major program changes since the last inspection.

Review the licensee's previo'us inspection history (at a' minimum, review the past i two. inspections): the license; and the status of any allegations or incidents.

.~ i "' Note the licensee's commitments in response to previous violations for followup during the.' inspection.

Issue Date: XX/XX/XX 87115

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' Review regional event / incident' logs, event / incident files, and the docket file  !

' c to . determine whether the licensee was involved in any incidents, recordable  !

' events; or misadministrations. If NRC did receive notification of an incident,  !

review that incident during the inspection and document the licensee's' followup l in the inspection record. 1 1

Preparation should also include determining the dates that the licensee submitted the most recent financial assurance instrument -and decommissioning plan (if applicable); notifying the appropriate State radiation control program aersonnel:

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and selecting-appropriate documents and equipment to take. In add' tion, the appropriate calibrated instruments should be selected and source checks performed on them before the inspection.

02.02 Entrance Briefing. After arriving on site, the inspector should inform the licensee's management representative of the purpose and scope of the inspection -to be performed. This notification saould be made as soon as

. practical after arriving on site.

02.03 General Overview l

a. -Oraanization. Interview cognizant licensee representatives about the current organization of the program. Examine the licensee's organizatici with' respect to changes that have occurred in personnel, functions, responsibilities, and authorities' since the previous inspection.

Identify the reporting relationship cod management structure between the licensee's executive management: the Radiation Safety Officer (RS0):- the Chairperson of the Radiation Safety Committee (RSC): and the other members of the RSC. Determine whether the RSO has sufficient access to licensee management. Through discussions with licensee s'taff and management, the inspector should determine if changes in ownership or staffing have occurred' or are anticipated.to occur. Confirm (to the inspector's satisfaction) with personnel that no changes have taken place. If the owner or individuals named in the license have changed, I

determine whether the licensee has submitted appro3riate notification to  !

NRC. This information must be provided whenever c1anges in ownership or  !

personnel are made.

b. Scoce of Proaram. Interview cognizant personnel to determine the locations of use, types and quantities of licensed byproduct material used for medical uses, frequency of use, staff size, and any other factors, as necessary, to determine the scope of the licensee's operations.

If a mobile nuclear medicine program is being inspected. Information concerning letters of contract with the licensee's client management g should be discussed and reviewed.

Determine if the licensee conducts research involving human subjects using - byproduct material . If so, verify that the licensee obtains i informed consent from the human subjects and that the licensee has obtained prior review and approval of the research activities by an

" Institutional Review Board

c. Management Oversicht. In the course of interviewing cognizant personnel, determine if management oversight is sufficient to provide the licensee staff with adequate resources and authority to administer the licensed program. In particular, the inspector should verify that, when 1

87115 Issue Date: XX/XX/XX

~ deficiencies are-identified, the RSO has sufficient authority without

< 1 . prior approval- of the- RSC, to implement corrective actions, including

.. . termination of operations that pose a threat to health and safety.

1. RSC - Review the r.ommittee meeting minutes for topics of discussion, membership. freruency, and attendance. Determine whether the RSC 4

has recommended any s)ecific actions and assess the implementation 1 of those reccamendations. The ins)ector should' also review the meetirg minutes (and interview 'se'ected committee members when l practical) to determine the committee's effectiveness. '

The inspector should interview some RSC members to determine.the '4 depth of their involvement in the radiation safety program.  !

2. RS0 - Determine whether the RS0'has been appointed. is named on the license, has sufficient' authority and fulfills the appropriate L duties commensurate with the size and ~ scope of licensed activities.

t The inspector should verify that this individual is knowledgeable j aoout'the program, and ensures that activities are being performed '

in accordance with approved procedures'and the regulations. i

.3. Audits - At a minimum, medical institution licensees are. required.  ;

by 10 CFR 35.22(b)(6). to review the radiation safety program i content and implementation.at least annually. Verify that' audits j are performed as required. Verify that the results of the audits i are documented, reviewed, and addressed. If no corrective actions were taken, determine why the licensee disregarded deficiencies identified durino audits, and whether the lack of corrective actions '

caused the licemee to be in noncompliance with '

regulatory requirements.

4. ALARA (As Low As Is Reasonably Achievable) - Verify that the l licensee's radiation protection program includes provisions for keeping doses ALARA and that ALARA reviews are conducted, as

, ' required by 10 CFR 35.20.

d. . Authorized Individuals. Determine that only authorized individuals l (users and nuclear. pharmacists) perform and/or supervise licensed i

< activities. Verify that authorized individuals perform an appropriate level of supervision, as required by 10 CFR 35.25.

02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed facility'to make general cbservations of the condition of the facility and the licensed activities to determine that materials are being safely handled and-that good health physics practices are followed. .

02.05 Eacilities. . Verify that the facility conforms to that described in the

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license . application and that material receipt, use and storage areas are secured. Verify that the licensee uses process or other engineering controls to maintain doses : ALARA and has implemented a maintenance program for the l engineering controls.

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' Issue Date: XX/XX/XX 87115

02.06 Ecuioment and instrumentation-

) a. ' Verify that equipment and instrumentation are ap opriate operable.

properly calibrated adequately maintained, and conform to the scope of the licensed program.

b. Verify that. if molybdenum-99/ technetium-99mgenerators are utilized the

~ licensee measures the molybdenum-99 concentration of each eluate / extract used for preparing a technetium-99m radiopharmaceutical and limits usage to = those eluates / extracts with <0.15 microcuries of- molybdemum-99 per millicurie of technetium-99m.

c. Verify:that vials and syringes are properly labeled and shielded.

d. Verify that the licensee has established and implemented procedures to identi fy. evaluate. and report safety component defects per the requirements of 10 CFR Part 21.

~02.07 Naterial Use. Control . and' Transfer

a. Authorized Uses. Determine, from-observing the use of licensed material, discussing the activities with licensee personnel, and reviewing records of receipt and transfer, that the type, quantity, and use of-licerised material at the licensee's facility are authorized by the license . To the ' extent practical, physict.lly examine the licensee's- inventory of radioactive material to determine if-it is complete and accurate, and-review the licensee *s receipt and transfer records.

b. Material Security' and Control. Verify that the licensee has established procedures for maintaining security and control of licensed material, and that these , procedures are understood and implemented by appropriate personnel'. Verify that licensed material, in storage, in controlled or unrestricted areas, is secure from unauthorized. removal- or access.

Veri fy that ' licensed material, not in storage, in controlled or unrestricted areas. is controlled and under constant surveillance.

Verify that access to restricted areas is limited.by the licensee,

c. Receiot and Transfer of Licensed Material. Verify that the licensee is receiving packages and making transfers of licensed material in accordance with NRC and applicable U.S. Department of Transportation (DOT) regulations and license conditions.

02.08 Trainina

a. General Trainina. ' Verify that appropriate' training and initial instructions are being accomplished as specified in the license and/or regulations.

Verify that authorized users and workers understand the mechanism for raising' safety concerns.

Randomly examine records of training and periodic retraining of personnel '

and attendant examinations or tests (if applicable) to the extent that the inspector is satisfied that the training program is being implemented as required.

87115 Issue Date: XX/XX/XX

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b. Operatino and Emergency Procedures. Verify that operational procedures

. are being followed by observing licensee personnel perform tasks at

l. selected work stations and by a comparison of their activities with ]

established procedures. j Examine the licensee's emergency I procedures are as approved by NRC. procedures, to determine that these Examine revised procedures. Through discussions with workers, verify )

that licensee personnel understand and implement the established l operational and emergency procedures and are aware of l procedural revisions,

c. Radiocharmaceutical Theraov Trainina. Verify that the licensee provides radiation safety instruction for all personnel caring for patients receiving radiopharmaceutical therapy, in accordance with 10 CFR 35.310.

02.09 Ate Radiation and Contamination Control

a. Area Survevs. Verify, during observations and by direct measurements, that the radiation levels are within the limits of 10 CFR Part 20. and l that surveys are performed, as required by 10 CFR 35.70. Verify that the licensee has established trigger levels and that the licensee decontami. ates at the appropriate trigger levels.

b. Leak Tests. Verify that the procedures for and frequency of leak tests of sealed sources are in accordance with 10 CFR 35.59. Also verify that l the leak test is analyzed in accordance with the license. If records of l leak test results show contamination in excess of the regulatory requirements, verify that the licensee made appropriate notifications and removed the source from service.

c. Contamination Control. Verify that the licensee's survey procedures and counting equipment are adequate to detect and control radionuclide contamination. Verify that the licensee performs weekly surveys for removable contamination in all areas where radio)harmaceuticals are routinely prepared administered, or stored. If t1e licensee has had spils or other incidents of contamination exceeding the . licensee's trigger levels, verify that the licensee has taken appropriate actions.

d. Protective Clothina. Verify that radiation workers are provided with, and wear, the appropriate pr;tective clothing commensurate with activities being performed.

02.10 Radiation Protection

a. Radiation Protection Procrau). Verify that the licensee has developed and implemented a written radiation protection program commensurate with the licensee's activities, that the program includes ALARA provisions, and that the program is reviewed at least annually, both for content and implementation.

b. Radiation Protection Procedures. Ver'ify that changes in the radiological protection procedures made since the last inspection are consistent with regulations and license requirements. Determine whether the licensee was required by 10 CFR 35.13 to apply for license amendments for any of f these changes.

l Issue Date: XX/XX/XX 87115

c. Personnel Dosimeters. Verify that personal dosimetry devices are worn by i .-

• appropriate licensee personnel. Verify.that dosimeters are processed'by

. a National' Voluntary Laboratory Accreditation Program (NVLAP)-approved

-and accredited processor.

.d. Exoosure Records. Verify that, pursuant to 10 CFR 20.2106, the licensee maintains- records of doses received by all individuals for whom monitoring is required.

e. Patient Rele n . Determine by observing, and discussing with the {

'l.icensee,'that a process exists to establish that a patient administered i radioactive material is releasable from control under 10 CFR 35.75. i

' Determine that written instructions are provided to released individuals )

l on -actions recommended to maintain doses ALARA. if doses to other 1

' individuals are 'l.ikely to exceed 1 mSv (100 mrem). Verify that the licensee is recording: (a) the basis for ' release of patients, when necessary; and (b) that instructions are provided to breast-feeding women when required.

'02.11 Quality Manaaement Proaram (OMP) and Misadministrations

a. Written OMP. . Verify that a written OMP, commensurate with .the '

licensee's activities, has been established and implemented.. - Also.

verify that the OMP procedures address all of the applicable i modalities on the license and ail of. the applicable objectises set l forth in 10 CFR 35.32.

b. Review. Verify that the licensee has reviewed the OMP at least ,

annually. If the reviews indicated that changes should be made in i

! the OMP program, verify that such modifications were made and implemented.

c. Records. Verify that records of each review are maintained in an auditable form for 3 years.

L d. Misadministrations and Recordable Events. Through review of the i

licensee's records, determine if the licensee is in compliance with the requirements for identification, notif.ication, reports, and records for misadministrations and rec.ordable events in 10 CFR 35.33.

02.12 Waste Manaaement L a. Waste Storaae and Disoosal. Verify that written procedures for waste l storage and disposal have been established in a manner approved by management and are readily available to any persons having responsibility for low-level waste classification and preparation for transfer of such wastes to land disposal facilities. Verify that the waste is stored and controlled in a secure and safe manner, and that radiation levels in i unrestricted areas surrounding the storage area do not exceed the limits l of 10 CFR 20.1301, " Dose limits for individual members of the public."

l Verify that disposal of decay-in-storage waste is performed in accordance with 10 CFR 35.92 and license conditions. Verify that the licensee is conducting appropriate surveys and defacing radioactive mterial labels before disposing of the waste.

l L 87115 Issue'Date: XX/XX/XX

' Verify 'that the waste is protected from fire and the elements, that package integrity is adequately maintained < that the storage area is'

. properly ventilated, and that adequate controls are in effect to minimize the risk from other hazardous materials. Verify that the licensee has appropriate methods to track the items in storage.

Review the licensee's procedures and' records to verify that each shipment l of radioactive waste intended for offsite disposal is accompanied by a l shipment manifest that includes all the information required by Section I of Appendix F to Part 20.

Review the licensee's procedures and records to verify that each package of radioactive waste intended for' shipment to a licensed land disposal

. facility.is labeled, as appropriate, to identify it' as Class A. B, or C waste in accordance with the. classification criteria of 10 CFR 61.55

[ Subsection III. A.2 of Appendix F to 10 CFR. 20].

! Verify, through review of records and procedures, that releases into a

, public sanitary sewerage system, if any, are consistent with the form and l quantity restrictions of 10 CFR 20.2003. Pay particular attention to the licensee's documentation for demonstrating that.the material is readily_

soluble (or readily dispersible biological material) in water.

b. Effluents. Verify that effluent rekases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003, respectively, and that treatment or disposal of waste by incineration is according to 10 CFR 20.2004.

L Review the licensee's ALARA goals, and determine if they are sufficiently l challenging yet realistic. Determine if the licensee understands and

implements these goals. Determine if the licensee has calculated annual l doses resulting from air effluents and if the doses

(1) are within the licensee's ALARA goals -(as ' described in its radiation. protection 3rogram): (2) exceed the. licensee's- ALARA goals; or (3) are uncertain 3ecause there is insufficient .information or basis for determination.

Review the licensee's history in meeting ALARA goals, and'its corrective

. actions when the goals.were not met.

Review and. verify that waste-handling equipment, monitoring ecuipment, and/ori administrative controls are adequate to maintain racioactive effluents within the limits established by the license and other regulatory requirements and are ALARA.

Randomly select 3rocedures for both liquid and airborne systems and determine the qua'ity of the relevant procedure.s determine the degree to which ALARA techniques are incorporated into them, and verify that the L licensee's procedures are being followed. Determine the xtent to which process and engineering controls are used to minimize effluents.

Determine whether effluent monitoring systems and the associated analytical equipment are adequate to detect and quantify effluents with sufficient sensitivity, and whether they are maintained, calibrated, and operated in accordance with manufacturer's recommendations and good L health physics practices.

i Issue Date: XX/XX/XX 87115 I i

G.

Determine if all significant release pathways are monitored, all l . -

unmonitored pathways have been characterized, and all surveillance

'4 procedures for ~ effluents are being implemented.

l Additional . inspection requirements are specified in Inspection Procedure

! (IP) 87102, " Maintaining Effluents from Materials Facilities As low As Is Reasonably Achievable (ALARA)."

c. Transfer. Verify that wastes are transferred to an authorized recipient specifically licensed to receive radioactive waste i d. Records. Review the records of waste storage, transfer, and disposal to verify that disposals are made in accordance with the requirements of Part 20 and the license, and that the records are complete and accurate l for each type of disposal.

e. Financial Assurance and Deconmissionina. Review the licensee's records of information important to the safe and effective decommissioning of the facility. Vorify that the records are complete, updated, and assembled j l appropriately, in accordance with the requirements in 10 CFR 30.35(g).  ;

Review the licensee's list of restricted areas required under 10 CFR 30.35(g)(3) and determine whether laboratories or other rocms have been released since the last inspection. If areas have been released.

verify that the licensee has adequately decontaminated each room and documented the basis for re; easing each room. Perform conf.irmatory measurements to verify that radiation and contamination levels are below release limits. Document the location of the released rooms in the inspection record, and document your findings regarding the adequacy of the licensee's decontamination.

Through ~ observations, discussions with licensee personnel, and records review, verify whether radiological . conditions at the facility have changed since the financial assurance instrument and/or decommissioning l plan was submitted such that either document needs to be changed to l address the new radiological conditions. If changes that may affect the financial assurance instrument or decommissioning plan are identified. l immediately contact regional management from the licensee's site, to  ;

discuss the situation.

If a parent company guarantee or a self-guarantee is used to ensure decommissioning financial assurance, review the licensee's financial assurance file to ensure that 10 CFR Part 30 Appendix A or Appendix C requirements are met,

f. Decommissionina Timeliness. On all inspections, review compliance with the Decommissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h).

02.13 Transoortation. Verify that the licensee's procedures and documentation i are sufficient to ensure that licensed material is transported in accordance

!. - with 10 CFR Part 71 and D0T regulations for transportation of l~ radioactive materials.

02",14 Postina and Labelina. Verify that the licensee has posted the appropriate license documents, regulations, notices, procedures, and forms. Examine locations where notices to workers are posted. Determine whether proper caution signs are posted at access points to areas containing radioactive materials, n

! 87115 - 8.- Issue Date: XX/XX/XX

1 radiation areas, and areas containing airborne radioactive materials. Verify

, , .. -that containers of licensed material are labeled appropriately.  !

I i 02.15 Year-2000 Issues. Verify that licensees are aware of and are addressing the effect of the Year 2000 on computer systems and software programs that are

, used to meet licensing requirements or those that have safety significance.

02.16 Generic Communications of Information. Verify that the licensee is receiving the applicable bulletins, information notices, NMSS Newsletter, etc. ,

and disseminating the information to appropriate staff. Verify that the licensee has taken appropriate action in response to these notices.

~

02.17 Notifications and Reoorts. Determine compliance with the regulations and license requirements for notification and reports to NRC and individudls. Verify that the licensee is in compliance with the requirements in 10 CFR 35.14, for o medical licensees, to notify the Commission about changes in the authorized user, authorized nuclear pharmacist, or RSO.

Verify, through discussions with workers and management, and through records review, that the licensee has advised workers of their doses annuall,,. ' l 02.18 Soecial License Conditions. If applicable, verify that the licensee is 4 in compliance with any special license conditions and that the licensee understands any additional requirements they impose.

02.19 Research Involvina Human Subiects, Verify that research involving human subjects is conducted in conformity with the provisions of 10 CFR 35.6.

02.20' Indeoendent and confirmatory Measurements. Conduct independent and confirmatory measurements in restricted, controlled, and unrestricted areas of the licensee's facility. Compare and verify, on a sampling basis, survey results  ;

or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this IP, unless warranted by special circumstances. If independent measurements were not made, provide a justification in the inspection record explaining why independent measurements were not performed. The inspector shall use radiation detection instruments that are calibrated, at a minimum, on an annual basis.

02.21 Exit Meetina. Conduct an exit meeting with senior licensee management and-the RSO to discuss the preliminary inspection findings, including any apparent violations, safety-related concerns, or any unresolved items identified during the inspection: the status of any previously identified violations; and any ,

negative Performance Evaluation Factors (PEFs). Ensure that the licensee l understands any safety significant concerns identified during the inspection and l initiates prompt corrective actions. j 02.22 Post Insoection Actions. After an inspection, the inspector shall summarize the findings with his/her appropriate NRC supervisor. This is especially important if there are, or are expected to be, controversial issues ,

arising from the findings.

t Inspectors shall also meet with regional licensing staff when any pertinent  !

licensing issues are raised during the inspection, when inspection findings impact on any licensing actions, to discuss the licensee's PEF results, or to l Issue Date: XX/XX/XX 87115

a

=

g) .

giVe feedback on how the licensee has addressed special license amendments or

. recent licensing actions. This meeting shall be documented in the

.. inspection record.

Additionally.-in some instances'. , inspection findings will warrant communication with NRC Enforcement staff, Office of Investigations staff. State liaison staff, or other Federal' agencies with whom NRC has Memoranda of Understanding (MOUs).

In the.latter case, ensure that the. exchange of information is made in accordance with the appropriate M00. . If information related to year-2000 problems and solutions is obtained, it is to be conveyed to the NMSS Year-2000 Coordinator.

The inspector will ensure.that inspection findings are clearly documented and reported'to the licensee as appropriate. The inspector shall also follow the requirements of Inspection Manual Chapter (IMC) 0620, "Inspetion Documents and Records," regarding notifying'the licensee that retained information is subject to public disclosure and giving the licensee the opportunity to request withholding it (see IMC 0620, Section 04.06.b.).

87115-03 INSPECTION GUIDANCE

-General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather. observations of activities in progress. equipment, facilities and use areas will be a better indicator of the licensee's overall; radiation safety program than a review of records alone.

-When records are reviewed, look for trends such as increasing doses or. effluent releases. Records such as surveys, waste disposal, effluent releases, receipt ano transfer of radioactive materials, training, utilization logs, and air sampling should be examined randomly until the inspector is satisfied that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel dose-monitoring records and incident reports) should be examined in more detail. The type of records that were reviewed and the time periods covered by these records should be noted in the inspection record.

Retain a copy of each pertinent record that is needed to substantiate an

~

inspection finding, such as a violation. Those copies should be attached to the inspection record. When an inspector identifies an apparent violation, he/she.

should obtain copies from the licensee, while on site, of all records that are needed to support the apparent violatico. In general, use caution before retaining copies of licensee documents, unless they are needed to support apparent violations, expedite the inspection (e.g., licensee materials inventories), or make the licensing file more complete. In all cases where licensee documents are retained beyond the inspection, follow the requirements of IMC 0620. Especially ensure that the licensee understands that the retained record will become publicly available, and give the licensee the opportunity to request withholding the information pursuant to the requirements of 10 CFR 2.790(b)(1).

The inspector should keep the licensee apprised of the inspection findings throughout the course of the inspection and not wait until the exit meeting.

Whenever possible the inspector shculd kee informed of significant findings (e.g. , safety hazards, p NRC managementwillful violations, and other potential escalated enforcement issues) identified during the course of the inspection.

87115 Issue Date: XX/XX/XX

l:

l 10IE In the guidance which follows, additional items' that should be considered i for. review, but are - not specifically mentioned in the text, are

'< identified, where appropriate.

03.01 Preoaration. Before the inspection, the inspector should discuss the-licenseets program with previous inspector (s) and/or license reviewer (s),

as necessary.

In selecting the appropriate documents to take on the inspection the inspector should consider taking the applicable regulations, inspection record. generic )

communications.-license copy. NRC forms, etc.

]

In selecting the appropriate instrumentation and equipment, the inspector should {'

consider the licensed activities 'to be inspected. The equipment may include l

sample vials, wipes, pocket dosimeters survey meters, etc.

.During the inspection.. focus (among other areas) on whether the licensee is in -

compliance with any license amendments issued since the last inspection or with J

, any program changes described by the licensee since the last inspection. This

! = requires review of documentation submitted in support of the licensing action.

L before the inspection. The inspection represents NRC's first opportunity to i- verify whether the licensee has enacted the most recent changes to.the license.

i. 03.02 Entrance Briefing. It is not always possible to meet with licensee

! management, on arrival, because of the ear'y hours that the inspection may be conducted. In those instances, the inspector may need to inform the licensee's management of his/her presence on site after initial observations of the licensed activities have begun. Personnel involved in the entrance briefing are to be identified in the Inspection Record.

.The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for i

. discussing or reviewing selected inspection items with various licensee. staff

personnel.. However.~ in some instances, the inspector may only need to inform ,

management of NRC's presence on site, -and apprise management that an exit briefing will be conducted, at the end of the inspection, which will detail the inspection findings.

This is often'an opportune time for the inspector to identify personnel to be interviewed. Scheduling interviews will enhance inspector efficiency and give the licensee the opportunity to have the most knowledgeable individuals present to respond in the areas being nspected.

Certain inspection items involving visual observations and/or records review are better performed unannounced; therefore, these types of items need not be addressed during the entrance briefing.

l 03.03 General Overview. Interviews of cognizant licensee representatives can provide-information about the organization, scope, and management oversight of th? radiation safety program.

l -a. Oraanization. The licensee's organizational structure'will usually be l found in the license application and may involve one or more individuals.

The ins]ector should be sensitive to changes in the organization that reduce ;he ability of the RSO to resolve concerns or issues related to the safe conduct .of the radiation protection program. The inspector l

L Issue Date: XX/XX/XX 87115 L

.should ask licensee management and the RSO about the RS0's authority and

. .~ ' about any changes that may impact on the RS0's duties, responsibilities.

.; or effectiveness.

.b. Scoce ' of Proaram. If the licensee distributes radiopharmaceuticals-to several facilities the inspector should consider the need to complete IP 87100. Appendix H. " Radiopharmacy Inspection: record."

Additional Items:

+ Mobile. Nuclear Medicine Service (1) Administrative requirements [10 CFR 35.29)

(2) Technical requirements [10 CFR 35.80)

(3) Compliance with 10 CFR 20.1301 dose limits (4) -Records of surveys L

! . Limited distribution of pharmaceuticals under 10 CFR Part 35 license (1) Type of operation (a) Registered or licensed with U.S. Food and Drug Administration as a drug manufacturer

. (b) Registered or licensed with State agency as a drug

! manufacturer (c) Licensed as a pharmacy by State Board of Pharmacy (d) Operating as a nuclear pharmacy within a Federal medical institution (2) Licensee distributes

, (a) Sealed sources l (b) Alpha and beta emitters

! (c) Generators (d) Photon emitters

. Research involving human subjects (1) Research is conducted. funded, supported, or regulated by l another Federal agency that has implemented " Federal Policy for Protection of Human Subjects" (as defined or described in the

" Federal Policy for the Protection of Human Subjects." The licensee may affirm the use of this policy).

OR

! Licensee has license amendment authorizing human research.

(2) Informed consent from human subjects .

(3) Approval of research activities from an Institutional Review L Board or Radioactive Drug Research Committee

c. Manaaement Oversicht. The degree of management oversight can be determined by the frequency of licensee audits and the use of qualified auditors; procedures for recording and reporting deficiencies to management: and methods and completion of follow-up actions by management.

87115 Issue Date: XX/XX/XX

l'. RSC [10 CFR 35.22.'35.23, 35.31. license conditio'n'(L/C)] - If an v 4 RSC is applicable to this licensee, topics of discussion at RSC

. meetings should ~ include ALARA reviews, incidents. generic communications. authorized users and uses, waste issues, audits. and misadministrations and recordable events, as defined in 10:CFR 35.2.

The RSC should be aggressive in seeking out areas needing improvement, rather than just responding to events and information from outside sources. The inspector's review should be of ,

sufficient depth and detail to provide an overall assessment of the committee's ability to identify, assess, and resolve issues. Also consider the effectiveness of.the RSC to communicate the results of audits and trending _ analyses to appropriate personnel performing licensed activities. .

Additional Items:

. Membershi) as specified

. Meetings 1 eld quarterly Quorums established

. Records of meetings maintained

. Has sufficient authority .

.- A3 prove / disapprove credentials of individuals before allowing t1em to work as an authorized user or authorized '

nuclear pharmacist

2. RSO [10 CFR 35.21, 35.23, 35.900) - The RSO is the individual, appointed by licensee management and identified on the license, who is responsible for implementing the radiation safety program.

3. Audits [10 CFR 25.22. 20.1101, 20.2102: L/C] - Records should be reviewed with particular attention to deficiencies identified by the auditors and any corrective actions taken as a result of these deficiencies.

4. ALARA [10 CFR 35.20] - Medical' licensees most conduct reviews to ensure that- efforts are made to maintain in'ividual J and collective-doses ALARA.

For additional guidance, refer to IP 87102. '" Maintaining Effluents From Materials Facilities As Low As Is Reasonably Achievable (ALARA)."

d. Authorized Users. ' Authorized users may either be named in the license application or be appointed by the-licensee, depending on the type of license issued and/or the wording in the license. For those appointed by the licensee, verify that the authorized user is trained in accordance with the approved criteria and has knowledge commensurate with

. operational duties.

.The . regulations in 10 CFR 35.11(b) allow an individual .to receive, possess, use, or transfer byproduct material for medical use "under the

supervision of" the authorized user, unless prohibited by license condition. The' regulations in-10 CFR 35.11(c) allow an individual to prepare unsealed byproduct material for medical use "under the supervision of" an authorized nuclear pharmacist or authorized user..

These regulations do not specifically require that the authorizer user / nuclear pharmacist be present at all times during the use of such Issue Date: XX/XX/XX 87115

materials. The authorized user / supervisori 's responsible for assuring

.- . that personnel under his/her supervision have been properly trained and

.- instructed.' pursuant to 10 CFR 35.25(a and b), and is responsible for the

-supervision of operations involving the preparation /use of radioactive materials whether he/she is present or absent.

LAdditional items:

. Radiopharmacy Rule [10 CFR 35.13]

(1) Compliance is established by meeting at least one criterion under each category.

(a) Authorized user Certified by organization in 10 CFR 35.910, 920, 930, 940, 950. 960 Identified on NRC or Agreement State license Identified on permit issued by broad-scope licensee Listed on facility license (b) Authorized nuclear pharmacist l

Does not apply to facilities that are registered / licensed by FDA/ State Agency as a drug manufacturer and distribution is regulated under Part 32.

Certified by organization in 35.980 ,

Identified on NRC or Agreement State license i Identified on permit issued by broad-scope licensee  !

Listed on facility license (c) Radiation Safety Officer Listed on. facility license 03.04 Walk-Throuah Orientation Tour. The inspector should observe areas of use, storage, and disposal to make- an initial assessment of the licensee's ALARA program with regard to facility design, engineering controls, housekeeping -

practices, etc.  ;

03.05 Facilities. Descriptions of the facilities are generally found in the application for a license and subsequent amendments that are usually tied down to a license condition. The actual or as-built facility should be configured to provide safe worki.ng areas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry.

' High radiation areas should be strictly controlled to prevent unauthorized or inadvertent access. Such controls may include, but are not limited to, direct surveillance, locking the high radiation area, warning lights, and audible alarms. When applicable, the inspector should also randomly examine signals and alarms to determine operability.

Areas occupied by radiation workers for long periods of time and common-use areas should be controlled in accordance with licensee procedures and be consistent with the licensee's ALARA program. The inspector should also be aware of 87115 Issue Datei XX/XX/XX

~

Jotential industrial safety hazards for ~ referral' to the U.S'. Department of

. . abor's Occupational Safety and Health Administration (OSHA).

Processing equipment. ventilation, and exhaust systems should be sufficient to provide safe use, handling, and storage of the materials-in use. Examination of periodic flow rate checks of ventilation and exhaust systems should be performed.

I 03.06 Eauioment and Instrumentation.

i a. Dose calibrators for photon emitting radionuclides and equipment used to I

assay alpha .and beta-emitting radionuclides should be possessed, used, and tested at the appropriate intervals, in accordance with 10 CFR 35.50 and 35.52, respectively, and the licensee's procedures:'and appropriate actions . should be taken when errors are identified. Tests to be  ;

conducted by the licensee are constancy, accuracy, linearity, and  !

geometric dependence.

1 Operable survey instrumentation should be possessed and readily accessible, per 10 CFR 35.120. 35.220, 35.320 or 35.520, or available, per license conditions, to show compliance with Part 35. Survey instruments are required to be calibrated before first use, annually, and after repairs, and checked for response with a dedicated check source each day of use. All survey, sampling, and monitoring instruments should have current calibrations appropriate to the types and energies of radiatio.i to be detected. The t?chnical adequacy of calibration procedures at facilities that perform their own calibrations should be examined.

L b. Licensees that use molybdenum-99/ technetium-99m generators are required to measure and record the molybdenum-99 concentration in each eluate or extract, to ensure that humans are not administered a pharmaceutical containir.g more than 0.15 microcuries of molybdenun-99 per millicurie of technetium-99m.

c. No i c ection guidance.

l

d. No inspection guidance.

l Additional Items:

. Dose calibrator - Photon-emitting radionuclides [10 CFR 35.50, L/C]

(1) Performed appropriate checks and tests after adjustment or repair of the dose calibrator [10 CFR 35.50(c)].

(2) Dosage readings over 10 pCi mathematically corrected for geometry or linearity errors greater than 10 percent

[10 CFR 35.50(d)].

(3). Repaired or replaced when constancy or accuracy errors exceeded i10 percent.[10 CFR 35.50(d)].

(4) Approved procedures followed [10 CFR 35.21, 35.25: L/C]

(5.) . Records maintained and include identity of individual i

performing test [10 CFR 35.50(e)].

. Instrumentation - Alpha- or beta-emitting radionuclides Issue Date: .XX/XX/XX 87115

E (1) Procedures for use of instrumentation [10 CFR 35.52(b)]

l...

(2) Appropriate action taken when calibration errors in excess of  !

i limits are identified [L/C]- '

(3) Records maintained [L/C]

. Survey. instruments ]

(1) Calibrated per [10 CFR 35.'il. L/C]

(a) Within 20 percent in each scale or decade of interest [10 CFR 35.51(b) L/C]

(b). Records' maintained-[10 CFR 35.51(d)] l 03.07 Material . Use. Control 1 and Transfer  !

I l l a. . Authorized Uses. Authorized uses of licensed material are in the licenses and license aaplications. Licenses list the isotopes, physical-or chemical forms, anc the maximum possession limits. ,

LAdditional Items: I

. Licensee uses unit ~ doses. .

Use of radiopharmaceuticals [L/C]

(1) Licensee measures activity of each dosage of photon-emitting radionuclide before use [10 CFR 35.53(a)].

(2) Licensee administers alpha- or beta- emitting radionuclides.

(a) Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organizaticr1

[10-CFR 35.53(b)]

AND/0R (b) -Licensee measures..by direct measurements or combination of measurement and calculation, each dosage 'of alpha- or beta-emitting radionuclide, before medicai use

[10 CFR 35.53(b).t/C]

(3) Unsealed material used under 10 CFR 35.100, 200 or 300:

[10 CFR 35.100(b). 35.200(b). 35.300(b)]

(a) Obtained from manufacturer- or properly licensed organization AND/0R (b) Prepared by authorized nuclear pharmacist or physician

, user or individual under the supervision of an authorized l nuclear pharmacist or physician user [35.920]

b. Material Security and Control. Examine areas where radioactive materials are used and stored. Storage areas should be locked and have limited and r

controlled ~ access. Radioactive material use areas should be under L constant surveillance or viysically secured. Controls may include a utilization log to inc iate when, in What amount, and by whom, radioactive material-is taken from and returned to storage areas.

87115 Issue Date: XX/XX/XX

! l

!. \

c. Receiot and Transfer of Licensed Materials. Depending on the size of the licensed program. the package receipt and transfer procedures (a few or

. , many) will be found in the license application. These procedures should be carefully reviewed before an inspection is conducted. Procedures for l transfer and shipment should include surveying all sources before I shipment or transfer transferring among the licensee's authorized users i or locations, and maintaining survey and receipt /t ansfer records. l Through discussions with the licensee determine if the procedures are l followed or have been changed or modified. Some changes will require a license amendment, whereas other minor changes (updating telephone numbers, editing procedures for clarity, etc.) may not require NRC ,

l approval. Randomly examine procedures used by the licensee to determine '

if they are in accordance with those identi fied in the license application, and determine whether these changes warrant a license amendment.

l The procedures for picking up, receiving, and opening packages should I include how and when packages will be picked up, radiation surveys and wipe tests of packages to be done on receipt, and procedura for opening packages (such as the location in the facility where packages are received, surveyed, and opened). The procedures also should include what actions are to be taken if surveys reveal that packages are contaminated ,

in excess of specified limits, and/or radiation levels that are higher '

than expected. If packages arrive during the course of an inspet , ion, the inspector should observe, when practical, personnel performing the package receipt surveys.

The inspector should randomly examine records of package surveys and also determine if inventories for each radionuclide are within the license limits. In this regard, records of inventories after receipt and transfer should indicate / demonstrate that the materials on hand at any one time are within the licensee's possession limit. When practical, the records examined should be compared with a physical inventory of materials possessed.

l The inspector should also examine the licensed materials accounting system. A relatively small facility will generally need to maintain receipt records, disposal records, and records of any transfers of l material. However, a large facility will need a sophisticated accounting system that provides accurate information on the receipt of material, its i location, the quantity used and disposed of, the amount transferred to other laboratories operating under the same license, and the amount remaining after decay. The accounting systems should also consider radioactive material held for decay-in-storage, near-term disposal, or transfer to other licensees. In both types of accounting systems, the licensee should perform routine physical audits to ensure the accuracy of the system.

Additional Items:

• Arrangements made for packages containing quantities of radioactive r material in excess of Type A quantity [10 CFR 20.1906(a)]

. Package receipt / distribution activities evaluated for compliance with 10 CFR 20.1301. " Dose limits for individual members of the public." [10 CFR 20.1302]

Issue Date: XX/XX/XX 87115

l 03.08 Training

.[ a. General Trainino, Certain kinds of training and instruction are found in the regulationsi how they are implemented will be found in the license.

. Discuss with the licensee how, and by whom, training is conducted and the.

. content of the training provided to workers (generally. found in the-license application).

Pursuant to 10 CFR 19.12, instructions must be provided to individuals:

who _in the course of employment are likely to receive in a year an occupational dose in excess of 1 mSv (100 mrem). Under the basic instructions.:it is management's responsibility to inform the workers of.

precautions to take when entering a restricted area, kinds and uses of radioactive materials in that area, exposure levels, and the types of protective ecuipment to be used. The workers should also be informed of the 3ertinen; provisions of NRC regulations and the license, and the requorement to notify management of conditions observed .that may, if not corrected, result in a violation of NRC requirements.

, Of the training program elements in the license application, training l- given to authorized users, and those individuals under the supervision of authorized users, is of primary imoortance. One or more users of radioactive materials should be observed while using licensed material or interviewed to determine that they have received the required training.

l both in the basic instructions and in that specified in the-license l

application. For some. licensees, this includes specific training needed-to perform infrecuent procedures and prepare and use radioactive material in research studies. Training should be (and in most cases is required to be) provided to workers before the individual's performance of licensed activities. Where examinations are required. read a few of the examination questions to ascertain that they are indicative of what the  :

worker should know to carry out his/her responsibilities.

l The inspector should also observe related activities and discuss the-radiation safety training received by selected individuals to assure that ,

, . appropriate.. training was actually received by these individuals.

b Authorized users and supervised individuals should understand the l radiation re associated with their assigned activitier protectionThe licensee'quirements s radiation safety training may include, but is not limited to, demonstrations by cognizant facility personnel, formal lectures, testing, films, and'"dri runs" for more complex or haza(dous operations.

Additional Items:

. Individual's understanding of procedures. regulations, and instructions.

(1) Use of survey instrumentation (2) Manufacturer's instructions available and followed for sealed sources [10 CFR 35.59(a)]

. Supervision of individuals by authorized user in accordance with

[10 CFR 35.25]

~

87115- Issue Date: XX/XX/XX 2

(1)- Supervised. individuals! are instructed in preparation' of

,' .- material, principles, and procedures.for radiation safety and

. quality management (QM) program, as appropriate.

-(2) Licensee periodically reviews supervised individuals' uses of byproduct material and records.kept to reflect these uses.

(3) . Authorized nuclear pharmacist or user ]eriodically reviews work and records of _ work of supervised incividual, as then pertain to preparing byproduct material. )

. Workers cognizant of Part 20 requirements for:

(1). Radiation safety program [10 CFR'20.1101]

(2) Annual dose limits [10 CFR 20.1301, 20.1302]

(3)- NRC Forms 4 and,5 (4) 10 percent monitoring threshold [10 CFR 20.1502] l (5) Declared pregnant worker provisions and dose limits' to '

embryo / fetus [10-CFR 20.1208]

(6) Procedures for opening nackages [10 CFR 20.1906]

l -(7) Sewer disposal limits [10-CFR 20.2003]

b. Operatina and Emeraency Procedures. Operating and emergency p_rocedures step will be found procedures to in license more applications generalized and mayThe prcredores. varyprocedures from step-byl wil be approved by NRC and reviewed and updar.ed by the licensee. Minor changes in radiation safety procedures may be made in accordance with 10 CFR 35.21(b)(6) . 35.22. and 35.31. Any major revisions require an ,

amendment to the license, in accordance with 10 CFR 35.13.

[ Some licensees may have agreements with other agencies (e.g. , fire, law l . enforcement, and medical organizations) regarding response to l emergencies. Discuss with the licensee's representatives what has been done to ensure that agencies (involvea in such agreements) understand their roles in emergency responses.

c. 'Radiooharmaceutical Theraov Trainina [10 CFR 35.310. L/C). Licensees that l

, administer radiopharmaceutical therapy must provide ~ radiation safety  !

instructions for all personnel caring for such therapy patients and retain records of such training for 3 years. The instructions must describe.the licensce's procedures for centrol of patients. Visitors, contamination, and waste and for notification of the RSO in case of the L patient's death or medical emergency.

03.09 Area Radiation and Contamination Control L a. Area Survevs. The' inspector may ask the licensee to spot-check radiation levels in selected areas, using the licensee's own instrumentation.

However, the inspector must use NRC's ' instruments for independent verification of the licensee's measurements. j 1

i Applies to individuals that receive, possess, use, transfer, or prepare byproduct material for medical use under supervision of authorized user or nuclear ph3rmacist.

-Issue Date: XX/XX/XX 87115

L* If, practical observe how licensees conduct surveys to determine the ,

... . adequacy 'of surveys; Also note the types of instruments used, and .

L .: whether they are designed and calibrated for the type of radiation l

being. measured.

The' inspector 'should ' determine if workers : take smears or instrument ' i readings in areas that are readily accessible to facility personnel. )

Particular ' attention should'be given to released patient rooms hot lab bench . tops. sinks used -for disposal, and storage areas. The survey-

-acti vities should be performed -in accordance with 10 CFR 35.70.

Independent measurements should be performed, as needed. to verify licensee assumptions or measurements.

Additional Items:

. Surveys performed as required [10.CFR 20.1501(a). 35.70: L/C]

(1) Daily with survey instruments in all areas where

! radiopharmaceuticals are prepared or administered]

(2) Weekly with. survey instruments in. all areas where radiopharmaceuticals or radiopharmacy waste are stored (3) Survey techniques can detect 0.001 mSv/hr (0.1 mrem /hr):

H 2000 dpm (4) -Trigger ievels.

(a) Exceeded (b) Corrective action taken

-(5) Records maintained [10 CFR 35.70(h). 20.2103: L/C]-

.- Protection of members of the public

(1) Licensee made adequate surveys .to demonstrate.either~

(1) that the total effective dose equivalent (TEDE) to the individual likely to receive the highest dose does not exceed 1 mSv (100 mrem) in a year: or (2) that if an individual were continuously -

i present in an unrestricted area. the external dose-would not exceed 0.02 mSv (2 mrem)~16 any hour and 0.5 mSv (50 mrem) in l a year [10 CFR 20.1301(a)(1). 1302(b)].

(2) . Unrestricted area radiation levels do not exceed 0.02mSv.-

(2 mrem) in any-one hour [10 CFR'20.1301(a)(2)].

-(3) Records maintained [10 CFR 20.2103. 2107]

b. Leak Tests [10 CFR 35.59). Through a random review of the records the-inspector should determine if records of leak' tests are maintained and signed by the RSO and if an inventory of the sealed sources is performed quarterly.

, c. . Contamination Control . The inspector may choose to examine .he instrument calibration records (efficiency checks, lower limit of

. detection calculationsc geometry. linearity, etc.). physical location of L counting instruments.. methods of detection. and wipe sample locations.

Additionally when appropriate, the inspector should consider taking

. confirmatory wipe samples.

Additional Items:

Handling and use of radioactive materials for contamination control [L/C]

l

~

87115 Issue Date: XX/XX/XX

[

(1) Personnel routinely monitor themselves after procedures or

. . before leaving.

. (2) No eating / drinking / smoking in use/ storage areas (3) No food, drink. or personal effects kept in use/ storage areas (4) Radioactive waste disposed of in proper containers i (5) Use of shielding / distance while using/ storing material l d. Protective Clothina. Observation of the protective clothing worn by nuclear medicine personnel or other applicable staff during work activities should provide the inspector with an acceptable means of reviewing this requirement. Recuirements for protective clothing may be found in the licensee's procecures. Typical protective clothing may include disposable gloves, laboratory coats, eye / face shields, and l shoe covers.

03.10 Radiation Protection, a.-d. Specific guidance is set forth in IP 83822. " Radiation Protection."

c. Personnel Dosimeters. Dosimetry devices appropriate to the type, energy, or emitted radiation, and the anticipated radiation fields, should have been issued to facility personnel.

Additional Items:

. Licensee performed exposure evaluation [10 CFR 20.1501]. I

. External dosimetry (1) Monitoring of workers [10 CFR 20.1502(a). L/C]

(2) External exposures account for contributions from airborne activity [10 CFR 20.1203]

(3) Dosimeters uchanged at required frequency [L/C]

. Internal dosimetry (1) Monitoring of workers [10 CFR 20.1502(b), L/C]

(2) Air sampling [L/C, 10 CFR 20.1204]

(3) Monitoring / controlling program implemented [10 CFR 35.205, 35.315(a)]

(4) Respiratory protection equipment [10 CFR 20.1703, L/C]

. Records (1) Prior dose determined for individuals likely to receive doses

[10 CFR 20.2104]

(2) Maximum exposures TEDE (3) Maximum committed dose equivalent (CDE)

(4) Maximum committed effective dose equivalent (CEDE)

(5) Licensee sums internal and external [10 CFR 20.1202]

(6) TEDEs and total organ dose equivalents (TODEs) within limits

[10 CFR 20.1201]

(7) NRC forms or equivalent [10 CFR 20.2104(d), 20.2106(c)]

• If licensee had a declared pregnant woman during inspection i period, then declaration was made in writing (review records).

Issue Date: XX/XX/XX 87115 1

(1). Licensee in compliance with dose to~ embryo / fetus [10 CFR 20,1208].and records maintained [10 CFR 20.2106(e)]

l e. Patient Release. The inspection of the patient release criteria is to be

} performance-based. The inspector should be familiar with the contents of Regulatory Guide 8.39, ~ " Release of Patients Administered Radioactive Materials." Four distinct objectives should be addressed in establishing ,

compliance.with 10 CFR 35.75.

(1) . The patient release criteria permit licensees to release individuals l from control if the TEDE to any other individual is not likely to L exceed 5 mSv (500 mrem). The quantities of radiopharmaceuticals l

(dosage) administered to patients for most, if not all. diagnostic l studies will deliver less than 5 mSv-(500 mrem to'other-individuals.  :

l The li'censee should be familiar with Regulatory Guide 8.39 The i

[

inspector should bring this Regulatory Guide to the attentfon of 1 i appropriate individuals if the licensee is not -familiar with the l

!. : . Guide. In particular,. the licensee should be familiar with the

!- table of activities and dose rates for authorizing patient release and giving instructions. If the licensee is not using the tables ;n the Regulatory Guides as the basis for releasing the patient, the

licensee's practices should be reviewed.

(2) The licensee should be familiar with the requirements in 10 l CFR 35.75(b) to 3rovide instructions to released individuals if the dose to any otler individual is likely to exceed 1 mSv (0.1 rem).

In general, the licensee is required to give instructions, including j written instructions on how to maintain doses to other individuals '

as low as is reasonably achic"able. The inspector may determine how l l the licensee is demonstratw compliance with this requirement by  !

reviewing sample instructions and/or discussing the content 'of the

! instructions with applicable staff; If the licensee is required by L s the rule to provide instructions to breast-feeding women, the

! instructions should include guidance on -the interruption or l discontinuation of breast-feeding and information on. the ,

consequences of. failure to follow the guidance.

L (3) Licensees are required to maintain, for 3 years, a record of the l

' release if- the patient's TEDE has been calculated: (1) using the L

retained activity rather than the activity administered. (2) using j L an occupancy factor less than i meter 0.25 at 1 meter (39.4 incnes): 4 (3) using the biological or effective half-life, or (4) considering l the shielding 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 5 mSv (500 mrem) if the breast-feeding were continued, licensees are required to document that instructions are being provided per 10 CFR 35,75(d).

03.11 OMP and Misadministrations [10 CFR 35.32]. This guidance applies to nuclear medicine licensees who are authorized to possess and use: (1)

. quantities greater than 30 microcuries of either sodium iodide I-125 or I-131: and/or (2) therapeutic quantities of.radiopharmaceuticals, other than sodium iodide I-125 or I-131.

a. OMP Directives. Inspectors should observe and interview individuals as they perform applicable duties, to determine if- the licensee's L

I 87115 Issue Date: XX/XX/XX

OMP as implemented, effectively ensures that byproduct material, or

• radiation from byproduct material will be administered as directed

. by the authorized user. The review should include consideration of the licensee's implementation of a continuous improvement in the .

following processes: monitoring. identification, evaluation. l corrective action. and preventative measures.

b. Review. The frequency of the OMP review may vary. However. 10 CFR 35.32 requires that a review of the QMP be performed at '

intervals of no greater than 12 months. The annual review of the <

licensee's QMP should include: (1) a representative sample of patient (and humamresearch) administrations: (2) all recordable events: and (3) all misadministrations.

, a

c. Records. Records of the OMP annual review should include each written directive, a record of each administered dose or dosage ,and the evaluations and findings.

e s

d. Misadministrations and Recordable Events. If, during the i inspection, a previously unidentified misadministration is )

identified by the inspector: (1) remind the licensee of the need to '

comply with the reporting recuirements described in 10 CFR 35.33, i " Notifications, reports, anc records of misadministrations"; and '

(2) follow the procedure for reactive inspections and the guidance i pr(iided in Management Directive 8.10. "NRC Medical Event Assessment l Program. " l For recordable events, verify that an evaluation was performed within 30 days after discovery of a self-identified (identified by ,

the licensee) event, and note the corrective actions that were i taken. If no, or inadequate, corrective actions were taken.  !

determine whether the lack of corrective acticn caused the license j to be in noncompliance with regulatory requirements. If a  :

recordable event is identified by the inspector, bring the event to  !

the attention of the licensee. The licensee has 30 days in which to l l evaluate the event and take any necessary corrective action.

03.12 Waste Manaaement  ;

l

a. Waste Storace and Discosal . Generally, radionuclides used in nuclear medicine facilities have half-lives of 65 days or less and caa be decayed in storage for 10 half-lives, surveyed and, when indistinguishable from '

background can be disposed of in ordinary trash.

For further inspection guidance, refer to IP 84850, " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part .61" and Information Notice (IN) 94-07, " Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20."

Additional Items:

. Disposal records maintained [10 CFR 20.2103(a) 20.2108: L/C]

. Waste compacted [L/C)

. Waste storage area (s)

Issue Date: XX/XX/XX 87115 1

(1) Containers properly labeled and area properly posted  ;

. [10 CFR 20.1902. 20.1904] l

. (2) Package integrity maintained [L/C] '

. Packaging. Control and Tracking [ App. F.III] [10 CFR 20.2006(d)]:

Note: The licensee's waste is likely to be Class A.

(1) Not packaged for disposal in cardboard or fiberboard boxes [10 CFR 61.56(a)] 1 (2) Liquid wastes solidi fied (i.e.. less than 1 percent freestanding liquid), and void spaces minimized [10 CFR 61.56(a),(b)]

(3) Does not generate harmful vapors [10 CFR 61.56].

(4) Structurally stable (will maintain its physical dimensions and form ur. der expected disposal conditions) [10 CFR 61.56(b)].

(5) Packages oroperly labeled [10 CFR 20, App. F.III.A.2]

(6) Licensee conducts a quality control (OC) program to ensure compliance with [10 CFR 61.55. 56] and includes management evaluation of audits [10 CFR 20 App. F.III.A.3].

(7) Shipments not acknowledged within 20 days after transfer are investigated and reported [10 CFR 20. App. F.III.A.8].

b. Effilents. The verification o" the licensee's compliance with the requirements for effluent releases and the treatment or disposal of waste l can be made through observations of an operation, a review of selected '

records, interviews with workers, etc. The review of records should include the waste release records generated since the last inspection, annual or semiannual reports, pertinent nonroutine event reports, and a random selection of liquid and airborne waste release records.

For further inspection guidance, refer to IP 87102.

Additional Items:

. Release into sanitary sewer [10 CFR 20.2003]

(1) Material is readily soluble or readily dispersible

[10 CFR 20.2003(a)(1)].

(2) Monthly average release concentrations do not exceed Appendix B values [10 CFR 20.2003(a)(2), 20.2003(a)(3)].

(3) No more than 5 Ci of hydrogen-3 (H-3): 1 Ci of carbon-14 (C-14); and 1 Ci of all other radionuclides combined released in a year [10 CFR 20.2003(a)(4)]

(4) Procedures to ensure representative sampling and analysis properly implemented [10 CRF 20.1501 L/C]

• Release to septic tanks [10 CFR 20.1003)

(1) Within unrestricted limits [10 CFR App B. Table 2]

Waste incinerated [10 CFR 20.2004]

l

! (1) License authorizes [10 CFR 20.2004(a)(3)]

(2) Licensee directly monitors exhaust.

f (3)- Airborne releases evaluated and controlled

}

87115 Issue Date: XX/XX/XX l

[10 CFR 20.1501, 20.1701]

• Control of air effluents and ashes [10 CFR 20.1201. 20.1301.

l 20.1501. 20.2001: L/C]{$eealsoIP87102,RegulatoryGuide l

l (RG)8.37}

(1) Canis for determination of compliance with air emission requirements i in Part 20-I (a) Measured concentrations of radionuclides in air effluents

, are below Appendix B. Table 2. concentrations [and

! external dose <0.5 mSv/yr (50 mrem /yr)].

(b) Bounding calculations show that air effluents could not i' exceed Appendix B. Table 2. concentrations [(and external dose < 0.5 mSv/yr (50 mrem /yr)]. l l (c) Dose modeling shows that the TEDE to the individual member of the public likely to receive the highest dose will not exceed 0.1 mSv/yr (10 mrem /yr) from these emissions.

(d) Licensee does not possess sufficient radioactive material to exceed Part 20 requirements.

, c. Transfer [10 CFR 20.2001. 20.2006]. Licensees must have an adequate l method of determining that recipients of radioactive wastes are licensed l to receive such waste (i .e. , licensee obtains a copy of the waste recipient's current license before tle transfer).

Additional Items:

. Transfers to land disposal facilities (1) Each shipment accompanied by a manifest prepared as l specified in Section I of Appendix F [10 CFR 20,2006(b),

10 CFR 20 App. F.III.A.4]

(2) Manifests certified as specified in Section II of Appendix l F [10 CFR 20.2006(c)]

I d. Records. Each licensee is required to maintain records of the disposal of licensed material made under 10 CFR 20.2002-2005. Part 61, and disposal by burial in soil. These records must be retained until the Commission terminates each pertinent license requiring the record. For nuclear medicine waste that is decayed in storage for 10 half-lives, surveyed, and disposed of in the normal waste stream, records are required to be retained for 3 years from the date of disposal.

Additional Items

l

. Records of surveys and material accountability [10 CFR 20.2103.

2108]

e. Financial Assurance and Decommissionina. The decommissioning record-keeping requirements are applicable to all materials licensees, including

, licensees with only sealed sources, and are specified in 10 CFR 30.35(g).

l These records should contain, among other information: (1) records of spills or other unusual occurrences involving the spread of contaminatim in and around the facility, equipment, or site (when contamination remains after cleanup, or when contaminants may have spread to

. inaccessible areas): (2) as-built drawings and modi fications of l

Issue Date: XX/XX/XX 87115 l

l

structures and equipment in restricted areas where radioactive materials

?. t .are used and/or stored. and locations of possible inaccessible

. contamination: (3) except for areas with only nonleaking sealed sources '

or byproduct materials with half lives of less than 65-days, a single document detailing restricted areas and formerly restricted areas, buried waste, areas requiring decontamination that are outside of restricted areas - and areas outside- of restricted areas that, if the license

. expired, would have to be decontaminated or approved for disposal: and (4T records.of the cost estimate performed for a decommissioning funding plan or the amount certified for decommissioning. This list is not all-inclusive of the information and requirements given in 10 CFR 30.35(g).

Some licensees, but not all, may release-laboratories or other rooms within a building for unrestricted use, without a license amendment. The release of these areas may fall outside of the reporting requirements in the Decommissioning Timeliness Rule if the licensee continues to conduct other' activities in the same building. Inspectors should identify the rooms that 'have been released since the last inspection and perform confirmatory measurements to verify that radiation and contamination levels are below release limits. Licensee survey' records and other documentation should be reviewed to verify that the basis for releasing each room is adequately documented in the licensee's decommissioning records.

Licensees submit financial assurance instruments and/or decommissioning plans for a specific set of conditions. Occasionally, those conditions may change over time and the licensee may not notify NRC. The inspector should be aware of changes, in radiological conditions, while inspecting a licensee's facility, that would necessitate a change in the financial assurance instrument and/or decommissioning plan, especially where the radiological conditions deteriorate and the financial assurance instrument or decommissioning plan may no longer be sufficient. Examples of changes are radiological. incidents such as spills or process upsets.

-Unauthorized changes by the licensee to processes, types of licensed materials, possession limits, or chemical or physical forms of licensed materials, may also prompt a reevaluation of whether the financial assurance instrument.and/or decommissioning plan remains sufficient.

Some licensees are required to maintain decommissioning cost estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as ; funding method, a Certified Phlic Accountant should certify each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in Section II, Appendix A and Appendix C.

respectively, to 10 CFR Part 30.

f. Decommissionina Timeliness. If the license to conduct principal activities has expired or been revoked: if the licensee has made a decision to permanently cease principal activities at the site or in any separate building; or if there has been a 24-month duration when no 3rincipal activities were conducted at the site or in any separate

)uilding, then the decommissioning timeliness requirements in 10 CFR 30.36, 40.42. 70.38, or Part 72 apply. A principal activity is one that is essential to the purpose for which a license was issued or amended, and does not include storage incidental to decontamination or decommissioning.

87115 Issue Date: XX/XX/XX

'The requirements of 10 CFR 30.36, 40.42. and 70.38 do not apply to

. i released rooms within a building where principal activities are still on-t going in other parts of the same building. However, in those cases, the inspector should follow the guidance in Section 03.12.e. above, regarding

- confirmatory measurements of the released area. Once principal

-activities have ceased.in the entire building, then the decommissioning timeliness requirements will take effect.

The Decommissioning Timeliness Rule became effective on August 15. 1994.

Specific guidance.regarding the timing.of the notification requirements is as follows: (1) If the license has expired or been revoked, or if the licensee has made a decision to permanently cease principal activities.

and the licensee orovided NRC notification before Auaust 15. 1994.-then l_ August 15 1994, is considered . to be the date for initiating the l decommissioning calendar (i.e., date of notification):~ or (2) If there has been a'24-month duration in which no principal activities have been conducted at the location before the effective date of the rule. but the

' licensee did not notify NRC then the 24-month time period of inactivity is considered to be initiated on August 15. 1994, and the licensee must provide notification to NRC within either 30 or 60 days of August 15.

1996 (depending on whether the licensee requests a delay).

L Decommissioning timsiness issues can be complex. For situations where

an inspector has questions about the licensee's status and whether-the decommirsioning timeliness standardr apply. he/she should immediately contact regional management.

For planning and conducting inspections of licensees undergoing decommissioning. refer-to IMC 2602. " Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees"; IP 87104

" Decommissioning Inspection Procedure for Materials Licensees": and the Decommissioning Manual Chapter and Handbook.

03.13 Transoortation. The inspection should include a review of the licensee's compliance with transportation requirements for the quantities and types. of licensed material shipped: the mode. of transportation used for licensee shipments the licensee,s hazardous material training: packages and associated documentation (marking and. labeling) procedures for monitoring radiation levels

'and contamination levels' of packages: package design requirements: vehicles-(including placarding, cargo blocking, and bracing. etc.): shipping papers:

HAZMAT training and commur,ication procedures: records and reports: and any incidents reported to DOT. This is an ideal' area for inspector observations of licensee practices. The DOT and NRC regulations ' for transportation of radioactive material: we:e recently revised, and the revisions generally became

. effective April 1, 1996.

For further inspection guidance, refer to IP 86740. " Inspection of Transportatim Activities," and Temporary Instruction (TI) 2515/133. " Implementation of Revised 40 CFR Parts 100-179 and 10 CFR Part 71." Inspectors should also refer closely

< 'to " Hazard Communications for Class 7 (Radioactive) Materials," the NRC field reference charts on hazard communications for transportation of radioactive materials, which contain references to the new transportation requirements and l

are usefulL field references for determining compliance with the transportation l rules ~on labeling, placarding, shipping papers, and package markings.

f ,

! 1 Issue Date: XX/XX/XX 87115 l

LAdditional Items:

, Licensee' returns radiopharmacy doses-(1) - Licensee assumes shipping responsibility.

-(2) . Describe arrangements. made between licensee and radiopharmacy 'for shipping = responsibilities. -if licensee does not assume shipping L responsibility.  ;

q

. Miscellaneous Requirements.

L

.(1) No labeled packages carried in passenger compartments

[10 CFR 173.448(c)] .

-(2) .Overpack recuirements observed, if packages are offered in overpack l (3) Expanded anc changed A1/A2 values' from the April- 1,1996, rule changes - i have been implemented [10.CFR 173.435] (verify only once per licensee). I 03.14. -Postino and Labelina; . Applicable documents, notices, or forms should be-posted in a sufficient number of places to permit individuals engaged in licensed activities to' observe them on the way to or from any particular licensed activity location to which the. posting would apply.

' Areas with radiation hazards should be conspicuously posted. as required by 10 l CFR'20.1902. Depending on the associated hazard', controls may include. tape.  !

rope, or ' structural barriers, to prevant access. If volatile radioactive ,

. materials are used'in an area, such an area should be controlled for airborne contamination. Exceptions to posting caution signs can be found in 10 CFR .

-20.1903. The inspector should randomly observe labeling on packages or other- 1 containers. .to determine that proper information (e.g. , radionuclide, quantity..

and date of-measurement) is recorded.  :

03.15- Year-2000 Issues. Verifying that the licensee has reviewed its computer software to ensure that any potential year-2000 problems have been identified and corrected can be accomplished, in part, by covering the following points: (a) confirm that the licensee received Information Notice 96-70, " Year 2000 Effect

-on Computer System Software," and Information Notice 97-61, "U. S. Department of Health and Human Services Letter to Medical Device Manufacturers, on the Year

-2000 Problem": (b) inform the licensee of the NRC list. server on the. year-2000 problem, and encourage its use in sharing a'ny identified problems and solutions:

(c) determine whether the licensee has identified any potential problems, and if'-

. so, taken corrective action. (Note that if information related to year-2000 ,

licensee-identified problems and associated. corrections is. obtained during the inspection, the inspector is to convey. it to the NMSS Year-2000 Coordinator.)

03.16 Generic Communications of Information. NRC generic communications often alert licensees to potential health and safety issues as a result of or the potential for an event / incident. -

03.17 Notifications and Reoorts. -The licensee may be recuired to make notifications after loss or theft of material, overexposures. ncidents, high radiation levels, etc, TheLinspector should use discussions with licensee personnel and reviews of representative records to verify that notifications and/or reports were appropriately submitted to NRC.

! :The' regulations in 10 CFR 19.13(b) require that each licensee shall advise each

. worker annually of the worker's dose, as shown in dose records maintained by the licensee. The licensee.must advise all workers for whom moni>toring is required 87115 Issue Date: XX/XX/XX 1

E (and. therefore, dose records are required). The licensee must advise these.

.

• workers - of ' internal and: external doses from routine operations and doses

'> received during planned special exposures. accidents, and emergencies. The report to the individual must be in writing and must contain all the informaticn required in 10 CFR 19.13(a). .

! 03.18 Soecial License Conditions. Some licenses will contain special license

! conditions that are unique to a _particular practice, procedure, or piece of

equipment used by the licensee. Tt;e inspector should also note that some special license conditions will state an exemption to a particular NRC requirement.

i 03.19. Research Involvina Human Subiects: This_ type of research must satisfy the 4 following conditions: (1) All research is conducted. supported or regulated by i another Federal Agency that has implemented " Federal Policy for Protection of  !

! Human Subjects". [10.CFR 35.6] or the licensee is authorized to conduct such l l

research: (2) the licensee obtains informed consent from the subjects, as defined l; and described in the Federal Policy; and (3) the licensee obtains prior review and ap royal from an Institutional Review Board, as defined and described in the. ]

Feder Policy.

> 03.20 Indeoendent and Confirmatory Measurements. Confirmatory measurements are l l

those whereby the . inspector compares his/her measurements with those of the l L licensee's. Independent measurements are those performed by the inspector, l independently of the licensee's measurements. Independent measurements should be performed en all inspections, unless exceptional circumstances make it impossible to perform the measurements (e.g. , inspector's detection equipment L malfunctions during an inspection trip). Measurements of dose -rates at the boundary of the restricted areas should be performed at the surface of the most accessible plane. Examples of measurements that may be performed include area radiation surveys, wi 3e samples, leak tests, air flow measurements, etc. These measurements should )e taken in licensed material use areas, storage areas.

effluent' release points, etc. To perform the independent or confirmatory measurement, use NRC radiation detection instruments that are calibrated at least as frequently as required for the nuclear medicine licensee being inspected.

03.21 Exit Meetina. When the inspection is -over. 'there should be an exit meeting with the most senior licensee representative present at the facility.

L .If a senior management representative is-unavailable for the exit meeting. the i l inspector may hold a preliminary exit meeting with appropriate staff on site.

However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO, if not present at the L

i meeting) as soon as practical after the inspection. This exit formalpreliminary meeting may ex

-be performed by telephone conference call. Personnel involved in the exit meeting are to be identified in the Inspection Record.

The-licensee should be encouraged to respond to the PEFs of concern. For further

! guidance, refer to IP ,87101. " Performance Evaluation Factors."

If the inspector identifies safety concerns- or violations of s gnificant regulatory requirements that affect safe operation of a licensee's facility, the licensee must immediately ' address any significant safety concerns and initiate prompt corrective action. The inspector should not leave the site until the concern is fully understood by the licensee and corrective action has been

-initiated. If the inspector and the licensee disagree over how significantly the concern impacts continued safe oshould be notified immediately. peration of th Issue Date: XX/XX/XX 29 - 87115

e Although deficiencies identified in some ' areas. (e.g. , workers' knowledge of the

. Part 20 requirements) are not always violations, the inspector should bring such '

le deficiencies to the attention of licensee management at the exit meeting and also

! in the cover letter transmitting the inspection record or Notice of

! Violation (NOV).

l 03.22_ Post Insoection Actions, Regional office policy indicates with whom the inspector will review his or her inspection findings (e.g. , the inspector's supervisor). following the guidance in IMC 2800 " Materials Inspection Program."

The inspector should discuss the findings in detail, commensurate with the scope of..the licensee's program. Violations, items of concern (e.g. , negative PEFs) .

and unresolved. items should be discussed in sufficient depth for management to l-make appropriate decisions regarding enforcement actions, referral to other State and Federal agencies, and decisions on the scheduling of future inspections of i I

l the licensee's facility, Discussion of the inspection findings with licensing staff can be particularly

useful if the licensee is having its license renewed or has recently submitted L a license amendment request. Licensing information requested by the licensee ,

should also be discussed with the licensing staff. j l

Inspectors should be aware that NRC has entered into several MOUs, with other Federal agencies, that outline agreements on items such as exchange of l information and eviche in criminal proceedings.

t the results of inspections to the licensee either by The inspector issuing may rk91 or a cegional office letter to the licensee, following an NRC Form )

the guidance in IMC 2800 and flRC's Enforcement' Manual. The findings'should be  !

documented in the inspection record, in sufficient detail for the reader to determine what recuirement was violated, how it was violated, who violated the requirement, and w1en it was violated. Copies of all licensee documents needed l to support the violation should be attached to the inspection record. The l inspection record should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the inspection and any items of concern identified that were not cited as a violation of regulatory requirements.

Inspectors may complete the inspection record either by hand or electronically.

When the inspection did not include a major section on the inspection record I form, the record should include remarks about why the section was not applicable

or was not reviewed.

For further inspection guidance, refer to Section 07.04 of IMC 2800.

l 87115-04 REFERENCES l

Specific references to regulatory and license requirements for nuclear medicine licensees are listed in Appendix B. 1 A listing of IMCs and IPs, applicable to the inspection program for materials licensees, can be found in Section 2800-11 of IMC 2800. These documents are to be used as guidelines for inspectors in determining the inspection requirements for operational and radiological safety asr~ ts of various types of licensee activities.

END 87115 Issue Date: XX/XX/XX

j

• Appendices:

A. " Nuclear Medicine Inspection Record" I B. " Nuclear Medicine Inspection References" l i

l l

l l

i 1

1

[ ..

Issue Date: XX/XX/XX 87115

c y

.- ;APPENDlX A NUCLEAR MEDICINE INSPECTION RECORD Region _

Inspection record No.  : License No.

Licensee'(Name and Address): Docket No.

- Licensee

Contact:

Telephone No.

Priority: Program Code:

Date of Last inspection:

Date of This inspection:

Type of Inspection:' ( ) Announced - ( ) Unannounced ~

( ) Routine ( ) Special

( ) Initial Next inspection Date ( ) Normal ( ) Reduced ( ) Extended Justification for change in normal inspection frequency:

Summary of Findings and Actions:

( ) No violations cited, clear U.S. Nuclear Regulatory Commission (NRC) Form 591 or.

regionalletter issued

( ) Non-cited violations

( -) Violation (s), Form 591 issued

( - ) Victation(s), regional letter issued

-( ) Followup on previous violations inspector (s)'

Date (Sign Name)

_ .c (Print Name)

Approved .

Date (Sign Name)

(Print Name)

' Issue date: XX/XX/XX A-1 87115, Appendix A I

i

l PART l-LICENSE, INSPECTION, INCIDENT / EVENT, AND ENFORCEMENT HISTORY

,- 1. AMENDMENTS AND PROGRAM CHANGES:

} (License amendments issued since last inspection, or program changes noted in the license)

AMENDMENT # DATE SUBJECT

2. INSPECTION AND ENFORCEMENT HISTORY:

(Unresolved issues; previous and repeat violations; Confirmatory Action Lette.3; and l orders) 1

3. INCIDENT / EVENT HISTORY:

(List any incidents, recordable events, or misadministrations reported to NRC since the l last inspection. Citing "None" indicates that regional event logs, event files, and the licensing file have no evidence of any incidents or events since the last inspection.) i i

87115, Appendix A A-2 Issue Date: XX/XX/XX

i l I

j .

l

' PART ll-INSPECTION DOCUMENTATION

, References that correspond to each inspection documentation topic are in inspection Procedure (IP) 87115, Appendix B, " Nuclear Medicine Inspection References."

l The inspection documentation part is to be used by the inspector to assist with the

! performance of the inspection. Note that all areas indicated in this part are not required to i be addressed during each inspection. However, for those areas not covered during the l inspection, a notation ("Not Reviewed" or "Not Applicable") should be made in each section, where applicable.

All areas covered during the inspection should be documented in sufficient detail to describe wha: activities and procedures were observed and/or demonstrated. In addition, the types of records that were reviewed and the time periods covered by those records should be noted. If the licensee demonstrated any practices at your request, describe those

demonstrations. The observations and demonstrations you describe in this report, along l

with measurements and some records review, should substantiate yourinspection findings.

Attach copies of alllicensee documents and records needed to support violations.

l 1. . ORGANIZATION AND SCOPE OF PROGRAM: 1 (Management organization; authnrities and responsibilities; authorized locations of use; I type, quantity, and frequency of byproduct material use; staff size; mobile nuclear medicine )

service; limited distribution of pharmaceuticals; and research involving human subjects) l l

l

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2. MANAGEMENT OVERSIGHT:

(Management support to radiation safety; Radiation Safety Committee; Radiation Safety Officer; and program audits, including as low as is reasonably achievable (ALARA) reviews) 1 i

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Issue date: XX/XX/XX A-3 87115, Appendix A 1

1

i i.

i

.- 3. FACILITIES:

- (Facilities as described; uses; control of access; and engineering controls) l

(

)

l

(

k

)

4. EQUIPMENT AND INSTRUMENTATION:

- (Dose calibrator; instrumentation for assaying alpha- emitting and beta-emitting radionuclides; generators; syringes and vials; survey instruments; 10 CFR Part 21 procedures; and special equipment and instrumentation.)

l

5. MATERIAL USE. CONTROL. AND TRANSFER:

(Materials and uses authorized; use of radiopharmaceuticals; security and control of licensed materials; and p ocedures for receipt and transfer of licensed m:terial)

\

87115, Appendix A A-4 Issue Date: XX/XX/XX

~~

l l . .

l .. J* 6. RADIOPHARMACEUTICAL THERAPY:

l:+ (Safety precautions; surveys; and release criteria of patients and rooms) 4 L

i t

i i

1 l:

7. - QUALITY MANAGEMENT PROGRAM (QMP) AND MISADMINISTRATIONS:

(QMP - written directives, implementation, reviews, and records; misadministrations -

l identification,- notifications, reports, and records) t 8 . AREA RADIATION SURVEYS AND CONTAMINATION CONTROL:

(Radiological surveys; air sampling; leak tests; inventories; handling of radioactive materials; records; and public doses) i i

i-l l:

Issue date: XX/XX/XX A-5 87115, Appendix A l

9. TRAINING AND INSTRUCTIONS TO WORKERS:

,- .- (intarvirws and observations of routine work; staff knowledge of all routine activities;

.. 10 CFR Part 20 requirements; therapy training and postulated emergency situations; supervision by. authorized users)

P 1

l

10. ' fMDIATION PROTECTION:

(Radiation protection program with ALARA provisions; external and internal'dosimetry; exposure evaluations; dose records; and patient release)

11. RADIOACTIVE WASTE MANAGEMENT:

(Disposal; effluent pathways and control; storage areas; transfer; packaging, control, and ~

tracking procedures; equipment incinerators, hoods, vents and compactors; and records)

I i

i 87115, Appendix A A-6 issuo Date: XX/XX/XX )

l i

12. DECOMMISSIONING:

.. -a

(Records of radiological conditions; d: commissioning plan /schedulo; notification

- 1. = requirements; cost estimates; funding methods; financial assurance; and Timeliness -

Rule requirements)

13. ' TRANSPORTATIONi (Quantities and types of licensed material shipped; packaging design requirements; hazardous materials (HAZMAT) communication procedures; unit dose return; return of sources; procedures for monitoring radiation and contamination levels of packages; HAZMAT training; and records and reports) -

Issue date: XX/XX/XX A-7 87115, Appendix A

• *14. NOTIFICATIONS AND REPORTS: -

• ' (Theft; loss; incidents; overexposures; change in Radiation Sately Cificer (RSO), ,

authorized user, or nuclear pharmacist; and radiation exposure reports to individuals) l l

F l

l L

15. POSTING AND LABELING:

(Notices; license documents; regulations; bulletins and generic information; posting of l radiation areas; and labeling of containers of licensed material) .

J l

l

16. INDEPENDENT AND CON;lRMATORY MEASUREMENTS:

l (Areas surveyed; comparison of data with licensee's results and regulations; and r instrument type and calibration date) l l

l l

87115, Appendix A A-8 lssue Date: XX/XX/XX

• l 4

17. VIOLATIONS. NON-CITED VIOLATIONS (NCVs) AND OTHER SAFETY ISSUES:

(State requirement and how and when licensee violated the requirement. For NCVs, indicate why the violation was not cited. Attach copies of alllicensee documents needed to support violations.)

18. PERSONNEL CONTACTED:

(Identify licensee personnel contacted during the inspection (including those individuals contacted by telephone).)

Use the following identification symbols:

1. Individual (s) present at entrance meeting

• Individual (s) present at exit meeting

19. PERFORMANCE EVALUATION FACTORS:

'A. Lack of senior management involvement with the radiation safety program and/or RSO oversight ()Y()N B. RSO too busy with other assignments ( ) Y ( ) N C. Insufficient staffing ()Y()N D. Radiation Safety Committee (RSC) fails to meet or functions inadequately () N/A ()Y()N E. Inadequate consulting services or inadequate audits conducted () N/A ()Y()N Remarks (consider the above assessment and/or other pertinent performance evaluation factors (PEFs) with regard to the licensee's oversight of the radiation safety program):

Issue date: XX/XX/XX A-9 87115, Appendix A

4 s.

20.1 'Soecial Conditions or issues: . ..

.(Speciallicense conditions; year-2000 effects of computer software) u I

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. 87115, Appendix A' A-10 lasue Date: XX/XX/XX

l. ' -

1

~ PART lli - POST-INSPECTION ACTIVITIES 3 1. . REGIONAL FOLLOWUP ON PEFs:

2. DEBRIEF WITH REGIONAL STAFF:

(Post-inspection communication with supervisor, regionallicensing staff, Agreement State Officer; and/or State Liaison Officer) 1

- 3. YEAR-2000 ISSUES:

(Convey, to the NMSS Year-2000 Coordinator, all year-2000 licensee-identified problems and corrective actions taken.) -

END Issue date: XX/XX/X A-11 87115, Appendix A I

i

(.

-r APPE'NDIX B -

. NUCLEAR MEDICINE INSPECTION REFERENCES ,

1 .-

1. ORGANIZATION AND SCOPE OF PROGRAM 10 CFR 35.6 '-  : Provisions for research involving human subjects.

.10 CFR 35.29 - Administrative requirements that apply to the provision of mobile nuclear medicine service.

10 CFR 35.80 Technical requirements that apply to the provision of mobile nuclear medicine service.

-License application and applicable license conditions.

(

2. MANAGEMENT OVERSIGHT A.- Radiation Safety Committee

.'10 CFR 35.22 Radiation Safety Committee.

10 CFR 35.23 Statements of authority and responsibilities.

l 10 CFR 35.31 Radiation safety program changes.

t Applicable license conditions.

B. Radiation Safety Officer 10 CFR 35.21 ' Radiation Safety Officer.

10 CFR 35.23 Statements of authority and responsibilities. ,

l 10 CFR 35.900 Radiation Safety Officer, i

C. Audits, Reviews, o-Inspections l

l 10 CFR 35.22 Radiation Safety Committee.

10 CFR 20.1101 Radiation protection programs.

10 CFR 20.2102 Records of radiation protection programs.

Applicable license conditions.

l- D. As low as is reasonably achievable (ALARA)

L' 10 CFR 35.20 ALARA program.

E. Authorized Users

- 10 CFR 35.11 License required.

- 10 CFR 35.13 License amendments. 1 10 CFR 35.25 Supervisio'n. l Applicable license conditions.

' 3. FACILITIES

~

A.- Access Control 10 CFR 20.1601 Control of access to high radiation areas.

Applicable license conditions.

- issue Date: -XX/XX/XX B 87115, Appendix B

B. Engin:sring Controls 10 CFR 20.1701 Use of process or other engineering controls.

l 10 CFR 35.90 Storage of volatiles and gases.

10 CFR 35.205 Control of aerosols and gases.

Applicable license conditions.

l 4. EQUlPMENT AND INSTRUMENTATION A. Dose Calibrators - Photon-emitting radionuclides 10 CFR 35.50 Possession, use, calibration, and check of dose

- calibrators.

Applicable license conditions.

B. Instrumentation- Alpha- or beta-emitting radionuclides 10 CFR 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.

Applicable license conditions.

C. Generators 10 CFR 35.204 Dermissible molybdenutn-99 concentration.

D. Syringes and Vials 10 CFR 35.60 Syringe shields and labels.

10 CFR 35.61 Vial shields and labels.

E. Survey Instruments

1. Possession j 10 CFR 35.120 Possession of survey instrument.

10 CFR 35.220 Posession of survey instruments.

10 CFR 35.320 Possession of survey instruments.

10 CFR 35.520 Availability of survey instrument.

Applicable license conditions. j

2. Calibration 10 CFR 35.51 Calibration and check of survey instruments.

F. Safety Component Defects 10 CFR 21.21 Notification of failure to comply or existence of a defect and its evaluation.

5. MATERIAL USE. CONTROL. AND TRANSFER A. Authorized Uses 10 CFR 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.

i 87115, Appendix B B-2 issue Date: XX/XX/XX

10 CFR 35.100 Use of unsealtd byproduct material for imaging and

, . localization studies.

. 10 CFR 35.200 Use of unsealed byproduct material for uptake, dilution, and excretion studies. I 10 CFR 35.300 Use of unsealed byproduct material for therapeutic l administration. 1 10 CFR 35.500 Use of sealed sources for diagnosis.

10 CFR 35.53 Measurement of dosages of unsealed byproduct material l for medical use. {

10 CFR 35.204 Permissible molybdenum-99 concentration. l License and applicable license conditions. q B. Security and Control

\

10 CFR 20.1003 Definitions (restricted area and unres"icted area). )

10 CFR 20.1801 Security of stored material.

10 CFR 20.1802 Control of material not in storage.

l C. Receipt and Transfer of Licensed Material 1 10 CFR 20.1302 Compliance with dose limits for individual members of the public.

10 CFR 20.1906 Procedures fr c receiving and opening packages.

10 CFR 20.1501 General.

10 CFR 20.2103 Records of surveys.

10 CFR 30.41 Transfer of byproduct material.

10 CFR 30.51 Records.

6. RADIOPHARMACEUTICAL THERAPY 10 CFR 35.75 Release of patients or human research subjects containing radiopharmaceuticals or permanent implants.

10 CFR 35.315 Safety precautions.

Applicable license conditions.

7. QUALITY MANAGEMENT PROGRAM AND MISADMINISTRATIONS 10 CFR 35.2 Definitions (misadministration and recordable events).

10 CFR 35.32 Quality management program.

10 CFR 35.33 Notifications, reports, and records of misadministrations.

8. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL A. Area Surveys 10 CFR 20.1302 Compliance with dose limits for individual members of the public.

10 CFR 20.1501 General.

10 CFR 20.2103 Records of surveys.

10 CFR 35.70 Surveys for cortamination and ambient radiation exposure rate.

Applicable license conditions.

Issue Date: XX/XX/XX B-3 87115, Appendix B

e B. Leak Tcsts and Inventori:s e 10 CFR 35.59 ~ Requirements for possession of sealed sources and ,

brachytherapy sources. I Applicable license conditions.

9. TRAINING AND INSTRUCTIONS TO WORKERS A. General i 10 CFR 19.12 Instruction to workers.

Knowledge of 10 CFR Part 20 radiation protection procedures and requirements. 4 1

B. Specific 10 CFR 35.900 Radiation Safety Officer.

10 CFR 35.901 Training for experienced Radiation Safety Officer. I 10 CFR 35.910 Training for uptake, dilution, and excre' tion studies.

10 CFR 35.920 Training for imaging and localization studies. 1 10 CFR 35.930 Training for therapeutic use of unsealed byproduct I material.  !

10 CFR 35.932 Training for treatment of hyperthyroidism. i' 10 CFR 35.934 Training for tre.atment of thyroid carcinoma.

10 CFR 35.950 Training for use of sealed sources for diagnosis. i 10 CFR 35.970 Training for experienced authorized users. l 10 CFR 35.971 Physician training in a three month program. i 10 CFR 35.972 Recentness of training.

10 CFR 35.980 Training for an authorized nuclear pharmacist.

10 CFR 35.981 Training for experienced nuclear pharmacists.

C. Therapy Training i 10 CFR 35.310 Safety instruction.

10 CFR 35.59 Requirements for possession of sealed sources and 1 brachytherapy sources.

D. Supervision 10 CFR 35.25 Supervision.

• l

10. RADIATION PROTECTION A. Radiation Protection Program ,

1. Exposure evaluation 10 CFR 20.1501 General. l

2. Programs l 10 CFR 20.1101 Radiation protection programs.

10 CFR 35.20 ALARA program.

87115, Appendix B B-4 issue Date: XX/XX/XX l

)

1

. I l

<- ** B. Dosimstry

=

1. Dose Limit 10 CFR 20.1201 Occupational dose limits for adults.

10 CFR 20.1202 Compliance with requirements for summation of l external and internal doses. I 10 CFR 20.1207 Occupational dose limits for minors.

10 CFR 20.1208 Doses to an embryolfetus.

2. External 10 CFR 20.1203 Determination of external dose from airborne radioactive material.

10 CFR 20.1501 General 10 CFR 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Applicable license conditions.

3. Internal 10 CFR 20.1204 Determinatica of internal exposure.

10 CFR 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

10 CFR 20, Respiratory protection and controls to restrict I lbpart H internal exposure in restricted areas.

10 JFR 35.205 Control of aerosols and gases.

10 CFR 35.315 Safety precautions.

C. Records 10 CFR 20.2102 Records of radiation protection programs.

10 CFR 20.2103 Records of surveys.

10 CFR 20.2104 Determination of prior occupational dose.

10 CFR 20.2106 Records of individual monitoring results. l D. Patient Release 10 CFR 35.75 Release of patients or human research subjects containing radiopharmaceuticals or permanent implants.

11. RADIOACTIVE WASTE MANAGEMENT A. Disposal 10 CFR 35.92 Decay-in-storage.

10 CFR 20.1904 Labeling containers.

10 CFR 20.2001 General requirements.

10 CFR 20.2103 Records of surveys.

10 CFR 20.2108 Records of waste disposal. '

. IN 94-07 Solubility Criteria for Liquid Effluent Releases to Sanitary ,

Sewerage Under the Revised 10 CFR Part 20 issue Date: XX/XX/XX B-5 87115, Appendix B

ef ps-

4 Bc Effluents ' ,

I

\

1: General '

~lP 87102 ' - Maintaining Effluents from Materials Facilities'As

- Low As is Reasonably Achievable ALARA

2. Release into sanitary sewer I 10 CFR 20.2003 Disposal by release into sanitary sewerage.-

Applicable license conditions.'

3. - Release to septic tanks

'10 CFR 20.1003.- Definitions.

10 CFR Part 20, Effluent Concentrations.

App. B,. Table 2 4.- Incineration of waste 110 CFR 20.2004 - Treatment or disposal by incineration.

5. . Control of air effluents and ashes 10 CFR 20.1201 Occupational dose limits for adults.

10 CFR 20.1301 Dose limits for individual members of the public.

-10 CFR 20.1501 General.

10 CFR 20.1701- Use of process or other engineering controls.

Applicable license conditions.

C. Waste Management

'1. General 10 CFR 20.2001 General requirements.

IP 84850 . Radioactive Waste Management - Inspection of Waste Generator Requirements of 10 CFR Part 20

. and 10 CFR Part 61

2. Waste compacted Applicable license conditions.

.s.

3. Waste storage areas 10 CFR 20.1801 Security of stored material.

10 CFR 20.1902 Posting requirements. .

t 10 CFR 20.1904 . Labeling containers:

Applicable license conditions.

4. Packaging, Control, and Tracking 10 CFR Part 20, Requirements for low-level waste transfer for Appendix F disposal at land disposal facilities and manifests.

10 CFR 20.2006  : Transfer for disposal and manifests.

87115, Appendix B B-6 issue Date: XX/XX/XX

') ,

10 CFR 61.55 Waste classification.  !

<a 10 CFR 61.56 Waste characterization. l c

5. Transfer j 1

l 10 CFR Part 20, Requirements for low-level waste transfer for i Appendix F disposal at land disposal facilities and manifests.  !

10 CFR 20.2001 General requirements. l 10 CFR 20.2006 Transfer for disposal and manifests. )

6. Records 10 CFR 20.2103 Records of surveys.

10 CFR 20.2108 Records of waste disposal.

12. DECOMMISSIONING 10 CFR 30.35 Financial assurance and recordkeeping for decommissioning.

10 CFR 30.36 Expiration and termination of licenses and decommissio-ing of sites and separate buildings or outdoor areas.

IMC 2602 Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees.

IP 87104 Decommissioning Inspection Procedure for Materials Licensees.

IMC 2605 Decommissioning Procedures for Fuel Cycle and Materials Licensees.

NUREG/BR-0241 NMSS Handbook for Decommissionirig Fuel Cycle and Materials Licensees.

13. TRANSPORTATION A. General NRC Charts Hazard Communication for Class 7 (Radioactive)

Materials.

10 CFR 71.5 Transportation of licensed material.

Tl 2515/133 Implementation of Revised 49 CFR Parts 100-179 and 10 CFR Part 71.

j B. Shippers - Requirements for Shipments and Packaging

1. General Requirements 49 CFR Part 173, Class 7 (radioactive) materials.

l Subpart I 49 CFR 173.24 General requirements for packagings and l packages.

l 49 CFR 173.448 General transportation requirements.

l 49 CFR 173.435 Table of A, and A2values for radionuclides.

l

2. Transport Quantities 10 CFR 71.4 Definitions,

a. All quantities issue Date: XX/XX/XX B-7 87115, Appendix B

4 l-10 CFR 714, Dsfinitions.

. is: *C .

$ ~49 CFR 173.410 ' General dnsign requirements.

t#' i 49 CFR 173.441 Radiation levellimitations.

49 CFR'173.443 Contamination control.

f 49 CFR 173.475 Quality control requirements prior to each shipment of Class 7 (radioactive) materials.

49 CFR 173.476 - Approval of special form Class 7 'f' l

(radioactive) materials.

b. Limited quantities 49 CFR 173.421 Excepted packages for limited quantities of Class 7 (radioactive) materials.

! 49 CFR 173.422 Additional requirements for excepted L l packages containing Class 7 (radioactive)

L, materials.

c. Type A quantiths i

49 CFR 173.412 Additional design requirements for Type A packages.

49 CFR 173.415 Authorized Type A packages.

49 CFR 178.350 Specification 7A; general packaging, _

' Type A.

d. Type B quantities IP 86740, Section 2 Inspection of Transportation Activities.

L

e. LSA material and SCO F

L 49 CFR 173.403 Definitions.

49 CFR 173.427 Transport requirements for low specific activity (LSA) Class 7 (radioactive) materials and surface contaminated objects (SCO).'

3. HAZMAT Communication Requirements 49 CFR 172.200-205 Shipping papers.

49 CFR 172.300-338 Niarking.

49 CFR 172.400-450 Labeling.

-49 CFR 172.500-560 Placarding. R 49 CFR 172.600-604 Emergency response information. i

' C. HAZMAT Training

,i L 49 CFR 172.702 Applicability and responsibility for training and testing.  !

49 CFR 172.704 Training requirements.

t D. Transportation by Public Highway i

49 CFR 171.15 Immediate notice of certain hazardous materials incidents.

' 49 CFR 171.16 Detailed hazardous materials incident reports.

49 CFR 177.800 Purpose and scope of this part and responsibility for compliance and training.

87115, Appendix B- B-8 issue Date: XX/XX/XX l i

i

• • 49 CFR 177.816 Driver training.

," . 49 CFR 177.842 Class 7 (radioactive) material.

14. NOTIFICATIONS AND REPORTS 10 CFR 19.13 Notifications and reports to individuals.

10 CFR 20.2201 Reports of theft or loss of licensed material.

10 CFR 20.2202 Notification of incidents.

10 CFR 20.2203 Reports of exposures, radiati.on levels, and concentrations of  ;

radioactive material exceeding the constraints or limits. i 10 CFR 30.50 Reporting requirements.

10 CFR 35.14 Notifications. ,

15. POSTING AND LABELING 10 CFR 19.11 Posting of notices to workers.

10 CFR 21.6 Posting requirements.

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 requirements. j

16. INDEPENDENT AND CONFIRMATORY MEASUREMENTS l No references. .

l l

17. y10LA rlONS. NON-CITED VIOLATIONS AND OTHER SAFETY ISSUES l NUREG/BR-0195, Rev.1 NRC Enforcement Manual.

NUREG-1600 General Statement of Policy and Procedures for NRC Enforcement Actions.

18. PERSONNEL CONTACTED l No references.

19. PERFORMANCE EVALUATION FACTORS IP 87101 Performance Evaluation Factors.  ;

END l

l Issue Date: XX/XX/XX B-9 87115, Appendix B