ML20247G920

Requests That Encl IP 87119 for Use by Regions Be Issued. Summary of Comments & Resolutions on IP Also Encl

ML20247G920
Person / Time
Issue date:	05/06/1998
From:	Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Gillespie F NRC (Affiliation Not Assigned)
References
NUDOCS 9805210012
Download: ML20247G920 (65)

Text

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MEMORANDUM TO: Frank P. Gillespia, Dir:ctor Divisi n ofIn:pection cnd May 6, 1998 l Support Progr ms, NRR FROM: Dona!d A. Cool, Director (orig. signed by)  !

Division of Industrial and i Medical Nuclear Safety, NMSS

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 1 87119, MEDICAL BROAD-SCOPE PROGRAMS l

t. We request that you issue the attached Inspection Procedure (IP) 87119 for use by the l

regions. It was distributed to the regions in draft form for review and comment. A summary of comments and resolutions is also attached.

This is another 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 medical broad-scope programs contained in IP 87100.

i Attachments: As stated.

cc: R. Blough, RI D. Collins, Ril C. Pederson, Rlli R. Scarano, RIV J. Ricci, TTC CONTACT: Ronald E. Zelac, NMSS/lMNS l ( '"'" 'S gg RF CEFB COPY DISTRIBUTION:

NRC Central File : S. Baggett IMNS r/f S. Merchant NMSS r/f R. Borchardt /

G. Klingler /

DOCUMENT NAME: Glucy/87119.iss cAf

( SY PDR: _X_YES__NO -

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- ' #- IMNS/SEC.

/ /98 To receive a copy of this document, indicate in the box: j "C"= Copy w/o att/enci "E" = Copy w/att/enci"N" = No copy Mj N O/ N b OFC RGB' O RGB, IMNS/ 4 ,

NAME helac/II (cone / [

DATE M/98 [d98 N /98 g/ OFFICIAL RECORD COPY (7[ f l [g [ ggpp vi ( Y 9805210012 POR I&E 990506 l M PDR L i

MEMORANDUM TO: Frank P. Gillsspis, Director Division ofInspection and May 6, 1998 Support Programs, NRR 1

FROM: Donald A. Cool, Director (orig. signed by)

Division of Industrial and Medical Nuclear Safety, NMSS

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 87119, MEDICAL BROAD-SCOPE PROGRAMS We request that you issue the attached Inspection Procedure (IP) 87119 for use by the regions. It was distributed to the regions in draft form for review and comment. A summary of comments and resolutions is also attached.

This is another 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 medical broad-scope programs contained in IP 87100.

Attachments: As stated.

cc: R. Blough, RI D. Collins, Rll C. Pederson, Rill R. Scarano, RIV J. Ricci TTC CONTACT: Ronald E. Zelac, NMSS/IMNS (301) 415-6316 DISTRIBUTION:

NRC Central File S. Baggett l

lMNS r/f S. Merchant NMSS r/f R. Borchardt G. Klingler i

DOCUMENT NAME: Glucy/87119.iss PDR: _X_YES_NO IMNS/SEc. i

/ /98 To receive a copy of this document, indicate in the bor '

j "C"= Copy w/o att/end. "E" = Copy w/att/end."N" = No copy kj O/ b OFC RGB C RGB, IMNS/ ,f NAME helac/II bone M[

DATE MA2/98 [d98 N /98 t OFFICIAL RECORD COPY Jui[j q1,f ,

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4. ,* .*,+ / May 6, 1998 l

MEMORANDUM TO: Frank P. Gillespie, Director Division ofInspection and Support Programs, NRR FROM: Donald A. Cool, Director

~

Division ofIndustrial and Medical Nuclear Safety, NMSS -

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 87119, MEDICAL BROAD-SCOPE PROGRAMS We request that you issue the attached Inspection Procedure (IP) 87119 for use by the regions. It was distributed to the regions in draft form for review and comment. A summary of comments and resolutions is also attached.

This is another 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 medical broad-scope programs contained in IP 87100.

i Attachments: As stated.

cc: R. Blough, RI D. Collins, Ril C. Pederson, Rill R. Scarano, RIV J. Ricci, TTC CONTACT: Ronald E. Zelac, NMSS/IMNS (301) 415-6316 1

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l DOCUMENT ISSUlNG FORM i

! To: NRR. DISP. Director From: Donald A. Cool. Director. Division of Industdal and Medical Nuclear Safety. NMSS (Originating Director)

1. Number and title of document l

87119. Medical Broad-Scone Proarams

2. Type of document 3. Type of action

_ Manual Chapter (MC) linspection Procedure (IP) 1New document (number)

__ Appendix __ Temporary instruction (TI) .1 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 category it applies to, the direct inspection 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: .1Yes_.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 medical broad-scone licensee oroarams. -It reflects a performance ba=ed insoection anoroach. Comoared to IP 87100. it chanaes 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  !

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d. If new training requirements or the revision of current training requirements are needed as

l 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 1No Revision to existing training course? l Yes _No Lead Branch for establishing training:

Training to be given by:

I Brief description of proposed training: Add discussion on the revised format of the orocedure.

5. Attach a WP6.1 floppy disk with a hard copy of the document.

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

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

l _Yes 1No _N/A l .

'7. Attach a summary of cornments and resolutions. State comment, its source, and if not adopted why. Is summary attached? lyes __No _.N/A

8. All approval signatures must be obtained in the order listed below: Check items 1-7 above and ensure all domments (floppy disk with file in Wordperfect & hard copy, special exhibits,

comment summary and resolution, and any background information) are attached to this

! form bef e outi it for ovals.

a. Ron A 7alac 4 d.

O Iato /' PIPB, Manual Coord./Date

'/L : Aq

b. oseohine . Piccone A/S/ik e.

Originator Brar)ch Chief /6 ate PIPB, Branch Chief /Date

c. 'Do OY 1hlf f.

IMNS' Division Director /Date DISP, NRR, Director /Date 1

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

' END

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INSPECTION PROCEDURE 87119 MEDICAL BROAD-SCOPE PROGRAMS COMMENT RESOLUTION Reaion 1:

1. Comment:

Add the following wording to the last paragraph of 87119-02. " Inspectors are also l expected to exercise judgement in emphasizing or de-emphasizing areas to inspect based on information obtained in preparation for the inspection, and from conditions observed during the inspection. Not all areas specified in this procedure will necessarily l be inspected during each inspection."

2. Resolution:

The suggested wording has been added. It should be noted that the inspector is l

prominently reminded in the inspection report (boxed guidance at the beginning of Part Il-Inspection Documentation) that not all areas specified in the procedure will necessarily be inspected during each inspection.

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2. c.omment:

l Add the following wording to Section 02.05, " Facilities." "The inspector must ensure that they inspect changes pursuant to subsequent amendments as well as the license l application." l

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2. Resolution:

The wording of the section was modified to include the indicated requirement. This requirement is also reflected in the guidance provided in Section 03.05, " Facilities" l 3. Comment:

(Section 02.06.b, " Equipment and instrumentation)

Since we inspect these facilities on at least an annual basis, why do we need to verify l that these procedures have been established and implemented during each inspection?

This may be better covered in licensing rather than inspection. Consider deleting this l item.

3. Resolution:

1 Through Comment / Response No.1, above, the " Inspection Requirements" part of the  !

inspection procedure specifically indicates that not all areas must be addressed during  !

each inspection. This guidance is repeated in the " inspection Documentation" part of l l

r the inspection report. No changes were made.

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4. Comment:

(Section 02.08.a. " General Training")

! Modify the wording to the following, adding the thought appearing in italics.

! " Verify that appropriate training, both initial and refresher as required, [is] being accomplished...."

4. Resolution:

The suggested wording states the requirement more clearly than did the original {

l wording. Wording similar to that suggested has been incorporated.  !

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5. Comment:

(Section 02.12.a, " Waste Storage and Disposal")

Modify the wording in paragraphs 2 and 3 to the following, adding the thought appearing in italics.

• Review the licensees procedures and a spresentative sample of the licensee's records l to verify...."

5. Resolution:

The suggested wording has been added.

l 6. Comment:

l l (Section 02.12.e," Financial Assurance and Decommissioning")

Modify the wording in paragraph 2 to the following, adding the words appearing in italics.  !

" Examples of changes are significant radiological incidents such as major spills...."

i l 6. Resolution: '

The suggested wording has been added.

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7. Comment:

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(Section 02.12.f, " Decommissioning Timeliness")

Could not find Attachment B to Appendix A. However, this review could require significant inspector effort.

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l l 7. Resolution:

l l The designation of the attachment to Appendix A was incorrect. It has been changed to

" Attachment A to Appendix A" both in Section 02.12.f. and the corresponding Inspection l Guidance, Section 03.12.f.

Also, Attachment A to Appendix A apparently was not included in the copy of the draft procedure provided to the regions for comment. It should be, however, familiar to the regions as it is identical to that appearing in two inspection procedures issued in 1997, IP 87110, " Industrial / Academic Research Programs," and IP 87120, " Industrial -

Radiography Programs."' With respect to the particular concem expressed, an expectation of significant inspector effort for review, Attachment A provides a relatively short and straight-forward procedure to use for collection and documentation of the required information. This item, considered an essential element of every inspection, must remain in the inspection procedure.

8. Comment:

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(Section 02.14, " Posting and Labeling")

j in order to verify that containers of licensed material are properly labeled, the containers -

may have to be handled in such a way that could require protective gloves for inspectors.

8. Resolution:

The inspection guidance portion.of the inspection procedure was changed as follows. Section 03.01, " Preparation," advises the inspector to consider including protective gloves when gathering equipment for the inspection. Section 03.14. " Posting and Labeling," reminds the inspector to use protective gloves when handling potentially radioactively-contaminated objects. Section 02.14, listing inspection requirements, was left unchanged.

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9. Comment: i (Appendix A Part I, item 1, " Amendments and Program Changes")

Modify the wording in parentheses, adding the thought appearing in italics. l

" License amendments..., or program changes..., ormajor changes in facilities, activities, '

procedures, orpersonnel."

9. Resolution:

The parenthetical prompt in item i has been expanded to include the suggested  !

wording.

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. 10, Comment:

L l (Appendix A, Part II, item 1, " Organization and Scope of Program")

l Modify the wording in parentheses by adding the following. '

"..., administrative controls, procedures, and management policies."

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10. Resolution: i L The recommended wording was added.

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11. Comment:

l (Appendix A, Part II, item 9, " Training and instructions to Workers")

l Modify the wording in parentheses by adding the following.  !

" Training and instruction should be commensurate with the potential radiological  !'

hazards involved."

- 11. Resolution:

The expressed thought, which is inspection guidance, was added to the inspection guidance portion of the inspection procedure, in Section 03.08.a., " General Training," at the end of paragraph 1. Item 9 of Part 11 of the inspection documentation (Appendix A) was augmented by adding the words " adequacy of training and instruction."

12. Comment: 1 (Appendix A, Part II, item 10, " Radiation Protection")  !

Modify the wording in parentheses by adding the thought appearing in italics.  !

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• Radiation protection program for control and minimization of radiation exposure to workers and the generalpublic consistent with ALARA provisions." l

12. Resolution: I l

Using the wording as suggested would inappropriately limit the intent of the inspector L prompt by excluding ALARA for effluents. Clarifying wording, covering both exposure control for workere and the public, as well as effluent control, has been added. l i13. Comment: .

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'(Appendix A, Part II, item 10, " Radiation Protection")

Separate "Extemal and Internal Dosimetry Program" as a separate item.

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13. Resolution:

L Extemal and internal exposure control for ALARA objectives should be l

discussed / reviewed under item 10. Since the item also includes exposure evaluations and dose records and reports, it is appropriate for the item to continue to include extemal and internal dosimetry. Accordingly, no change was made except to add the word " program" after " dosimetry."

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14. Comment:

(Appendix A, Part II, item 12, " Decommissioning")

This item is not inspected on a routine basis for the majority of licensees. Perhaps we should delete this and develop a separate set of field notes for the few licensees which require this.

14. Resolution:

It should be noted that the inspector is prominently reminded in the inspection report (boxed guidance at the beginning of Part Il-Inspection Documentation) that not all areas specified in the procedure will necessarily be inspected during each inspection.

However, certain elements of this area, relating to decommissioning of sites, separate buildings, and/or outdoor areas, and review of decommissioning records, are required for allinspections. For these reasons and for uniformity of the IP 87100 series of procedures, no change was made in response to this comment.

Reaion Ill:

1. Comment: l The guidance is very strong on the need to complete the decommissioning section each time. (a) Management should be aware of this and the time constraints. (b) Wording allowing the inspector to bring some of this back for Decommissioning Branch review and resolution would be rnore efficient in some cases.

1. Resolution:

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(a) Certain elements of this area, relating to decommissioning of sites, separate  !

buildings, and/or outdoor areas, and review of decommissioning records, are required for all inspections; others elements are considered discretionary, based on 4 circumstances, Including the previous inspection record. (b) The inspector is, in several portions of the inspection procedure requirements and guidance sections, directed to contact regional management when potentially complicated issues become apparent.

Accordingly, no changes have been made in response to this comment.

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r l 2. Comment:

Pages 18-19, Decommissioning, state " Inspectors should identify the rooms that have l been released since the last inspection and perform confirmatory measurements to

! verify that radiation and contamination levels are below release limits." This should be clarified. The inspector should have better guidance on accomplishing this time consuming task, Confirmatory grids and confirmatory surveys of sewer lines, etc. may be out of the scope of the inspection and best brought back for the Decommissioning Branch for resolution.

2. Resolution:

l It should be noted that the referenced guidance applies to individual rooms or areas within a building, not entire buildings The intent was that the inspector would perform spot checks, including questionable areas, not repeat the final surveys. The objective would be to confirm, by measurements, that radiation and contamination levels in the l

rooms or areas appear to be below release limits. The adequacy of the licensee's decontamination verification measurements is a separate issue. The guidance has been modified to provide this clarification. The sentence now reads as follows.

Inspectors should identify the rooms that have been released since the last ,

inspection and perform measurements (on a spot-check sampling basis, including questionable areas) to confirm that radiation and contamination levels in the rooms or areas appear to be below release limits.

3. Comment: I (Section 03.03.c.2', " Management Oversight-RSO")

Evaluation of staffing sufficiency as described is bordering on assessments made by licensee management. It has been Region 111 policy that inspectors do not assess licensee management decisions. This should be clarified to indicate that any perceived deficiencies should be forwarded to the inspector's management.

3. Resolution:

The requested clarification has been incorporated.

4. Comment: I I

The IP and Appendix are disorgariized and do not complement each other. The  !

procedure headings should match the headings in the Appendix (Inspection Record).

j- This is a matter of editing, not substance.

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4. Resolution:

Section 02, " Inspection Requirements," and Section 03, " Inspection Guidance," of the .

Inspection procedure, used together, are intemally consistent regarding the order of subsections. Additionally, Appendix A, Part 11, " Inspection Documentation," and Appendix B, " Medical Broad-Scope Inspection References," used together, are internally consistent regarding numbering of subsections.

Various elements of the inspection procedure were combined for the inspection receni, reflecting desired emphasis during inspections. Similarly, various subsection elements b

of the inspection procedure were elevated to section status in the inspection report, for the same reason. _ With this approach, it was not possible to have numbering (or order) consistency between the inspection procedure and the inspection report. Accordingly, no change was made.

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5. Comment:

. (Section 03.19, "Research involving Human Subjects")

It is not clear if the guidance are the only acceptable methods to assure that the RSC and Human Research or RDRC have made ethical and scientific merit considerations, as required in Section 03.03.c.1, " Management Oversight-RSC."

5. Resolution:

Section 03.19 lists minimum requirements. The text was modified to reflect this. Also, the guidance in Section 03.1g was supplemented by referring the inspector to Section 03.03.c.1 for additional guidance on required associated inspection elements.

6. Comment:

Appendix A does not flow in the order of the inspection procedure.  :

6.' Resolution:

See Region lil, Comment and Resolution No. 4, above. No change was made.

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7. Comment:

i There is no IP section or guidance on Therapy or reference to another procedure. This  !

should be developed and placed in the IP 87119.

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7. Resolution: '

There are three inspection procedures being issued approximately concurrently with this 7

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one, all of which deal with therapy: IP 87115, " Nuclear Medicine Programs"; IP 87116,

" Medical Teletherapy Programs'; and IP 87118, " Brachytherapy Programs."

Accordingly, therapy is not an appropriate topic for this inspection procedure. Also, Section 04, " References," of this inspection procedure directs the inspector to Section 2800-11 in IMC 2800 for a listing of inspection manual chapters and inspection procedures applicable to the inspection program for materials licensees. Accordingly, no change was made regarding the suggested addition of therapy references.

8. Comment:

There is no section in Appendix A for Year 2000 issues.

8. Resolution:

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! An additional section, No. 20, "Special Conditions or issues," was added to the Inspection Record (Appendix A). It specifically prompts the inspector to consideration of ]

year-2000 effects of computer software.

9. Comment:

(Appendix A, Part II, Section 2, " Management Oversight")

Remove the ASCll cheracters under MANAGEMENT OVERSIGHT.

9. Resolution:

The noted characters must have been associated with the transmission to Region 111:

they were not seen on copies viewed and printed at Headquarters. Accordingly, no action was taken.

10. Comment:

(Appendix A, Part il, Section 14, " Notifications and Reports")

Overexposure is misspelled and a space is needed between " incidents" and "over."

10. Resolution:

The indicated corrections were made.

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NRC INSPECTION MANUAL IM0B INSPECTION PROCEDURE 87119 MEDICAL BROAD-SCOPE PROGRAMS PROGRAM APPLICABILITY: 2800 87119-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers and the general public.

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

87119-02 INSPECTION REQUIREMENTS A review of the licensed activities will be commensurate with the scope of the licensee's program. A determination regarding safety and compliance with NRC requirements will be based on direct observation of work activities, interviews with workers, demonstrations by workers performing tasks regulated by MRC, and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.

In reviewing the licensee's performance, the inspector should cover the period from the last to the current inspections. However, older issues preceding the last inspection should be reviewed, if warranted by' circumstances such as incidents, noncompliance, or high radiation exposures.

Some of the following areas may not be applicable to all medical broad-scope licensees. Inspectors are also expected to exercise judgment in emphasizing or de-emphasizing areas to inspect based on information obtained in preparation of the inspection, and from conditions observed during the inspection. Not all areas specified in this procedure will necessarily be inspected during each inspection.

02.01 Preparation. The inspector should allow adequate time to prepare for the inspection. Preparation will include reviewing documents, making travel arrangements coordinating with appropriate staff, notifying appropriate State agencies, and selecting necessary equipment. In particular the inspector shall identify whether any license amendments have been issued since the last

. inspection, or whether the licensee has informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event Issue Date: XX/XX/XX 87119

E legs and files to determine if the licensee had any incidents or events since the last inspection.

02.02 Entrance Briefing. When the inspector arrives at the licensee's facility. I he/she will inform an available senior management representative of the purpose  !

and scope of the inspection. '

02.03 General Overview

a. Organization. Interview cognizant licensee representatives about the current organization of the program. Examine the licensee's organizatim with respect to changes that have occurred in personnel, functions.  ;

responsibilities, and authorities since the previous inspection. Identify '

l the reporting relationship and management structure between the licensee's executive management, the Radiation Safety Officer (RS0) the Chairpersm of the Radiation Safety Committee (RSC), and the other members of the RSC.

b. Scoce of Proaram. Interview the cognizant personnel to determine the

! types, quantities, and use of licensed material, frequency of use, staff I

sizei etc.

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c. Manaaement Oversicht. In the course of interviewing cognizant personnel, L

determine if management oversight is sufficient to provide the licensee  !

staff with adequate resources and authority to administer the 1 licensed program.  :

1. RSC - Review the committee meeting minutes for topics of discussion, membership frequency, and attendance. Inspector should interview .

some RSC members to determine their involvement in the radiation J safety program.

2. RSO - Determine whether tte RSO has been appointed

is named on the I

license: has sufficient authority, adequate assistance and support of the RSC and management to ensure that radiation safety activities are performed in accordance with ap'3 roved policies, procedures, and regulatory requirements: and fu fills the appropriate duties commensurate with the size and scope of licensed activities.

3. Audits - Verify that audits are performed as required and are of sufficient detail and scope to cover all major facets of the broad-scope program. Verify that the results of the audits are reviewed  !

and addressed.

4. Human Research Subcommittees - If licensed material is being used for human research studies, determine whether the licensee has estab-lished the appropriate committees in accordance with the U.S. Food and Drug Administration (FDA) criteria. [e.g. . Radioactive Drug Research Committee (s) (RDRCs) or Institutional Review Boards (IRBs)]

to evaluate research requests. Verify that the appropriate comittee

.has reviewed current protocols.

l d. Authorized Users. Cetermine that only authorized individuals perform i and/or supervise licensed activities. Verify that these users are qualified. Also verify that authorized users perform an appro of supervision, as required by the license or regulations. priate level 87119 Issue Date: XX/XX/XX

l 02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed facility to make general observations of the condition of the facility and the l licensed activities being performed.

l 02.05 Facilities. Verify that the facility conforms to that described in the license application, reflecting changes authorized by subsequent license amendments; that material receipt, use, and storag 3reas are secured; and that the licensee uses processes or other engineering controls to maintain doses as low as is reasonably achievable (ALARA). Verify that a maintenance program is being implemented for engineering controls (e.g. flow rates, filter changes, etc.).

02.06 Eauioment and Instrumentation

a. Verify that equipment and instrumentation are appropriate, operable, calibrated, adequately maintained, and conform to that described in the license.

b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 CFR Part 21.

02.07 Materials

a. Receiot and,Ransfer of Licensed Material . Verify that the licensee is receiving packages and making transfers of licensed material in accordance I with NRC and applicable U.S. Department of Transportation (DOT) regula-tions and license conditions. Verify that the licensee has a system to {

account for all materials received, possessed, stored, and used, to ensure  :

compliance with possession limits.

b. Authorized Uses. Determine from observing the use of licensed material.

discussing the activities with licensee personnel, and reviewing records, that the type, quantity, and use of licensed material at the licensee's facility is authorized by the license. To the extent practical, ensure by physical confirmation that the licensee's inventory is complete and accurate,

c. Material Security and Control Verify that the licensee has e~stablished 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 i unrestricted areas, is secure from unauthorized removal or access. Verify that licensed material, not in storage, in controlled or unrestricted areas, is controlled and under ct;nstant surveillance. Verify that access to restricted areas is limited by the licensee. l 02.08 Trainina

a. General Trainina. Verify that appropriate training, both initial and refresher, as s]ecified in the license and/or regulations, is  !

being accomplis 1ed.

b. Doeratina and Emeroency Procedures. Verify that operational procedures are being followed by observing licensee personnel perform tasks at selected work stations and by comparing their activities with estabhshed procedures. Also examine the licensee's emergency procedures to determine Issue Date: XX/XX/XX 87119 i

that these procedures are as approved by NRC. Through discussions with workers, verify that licensee personnel understand and implement the established procedures and are aware of procedural revisions. Document in the inspection record what activities the inspector observed.

When applicable, discuss with the licensee's representatives, or observe.

the conduct of periodic tests and drills, especially Yor scenarios involving fires and large releases of radioactive materi:.l.

c. Specialized Trafnina. Specialized, duty-specific training is generally required for individuals involved in such activities as radioactive waste handling and processing, incinerator operations, animal research, and individuals attending patients receiving therapeutic quantities of radioactive material . Verify through discussion, observation, and record review, that these individuals receive the appropriate training.

d. Theraov Trainina. Verify that the licensee provides radiation safety instruction for all ]ersonnel caring for patients receiving therapy. in accordance with 10 C R 35.310 and 10 CFR 35.410. The instructions must describe the licensee's procedures for control of patients, visitors.

contamination, and waste, and for notification of the RSO in case of the patient's death or medical emergency.

02.09 Area Radiation and Contamination Control

a. Area Surveys. Verify, during observations and by direct measurements, that the radiation levels are within the limits of 10 CFR Part 20. and that these areas are properly posted. Confirm that area surveys are performed in accordance with 10 CFR 35.70, where applicable, and procedures described in the license documents.

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

c. Contamination Control . Verify that the licensee performs s'u rveys for removable contamination at the required frequencies (e.g., weekly surveys), for contamination control must be made in all areas where radiopharmaceuticals are routinely prepared, administered, or stored. If the licensee has had spills or other incidents of contamination exceeding the licensee's action levels, verify that the licensee has taken appropriate actions.

d. Protective Clothina. Verify that radiation workers are provided with, and wear. the appropriate protective clothing, gloves, shields, etc..

commensurate with activities being performed.

l 02.10 Radiation Protection

a. Radiation Protection Proaram. Verify that the licensee has develo)ed and l

implemented a written radiation protection, program commensurate w'th the licensee's activities, that the program includes ALARA provisions, and that the program is reviewed at least annually, both for content and implementation, j 87119 Issue Date: XX/XX/XX

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

c. Instruments and Ecuioment. Verify that radiation protection instruments and equipment are operable, have the 3 roper alarm settings (if applica-ble), and- are calibrated and checced for appropriate res accordance with license requirements and licensee procedures. ponte in

d. External Dosimetry. Verify that personnel dosimetry devices are worn by appropriate licensee personnel. Dosimetry devices appropriate to the type, energy. or emitted radiation, and the anticipated radiation fields should have been issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program-approved and-accredited processor.

Verify that. pursuant to 10 CFR 19.13(b), the licensee advises each worker annually of the worker's dose, as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106, " Records of individual monitoring results."

i e, Internal Dosimetrv. Verify that measurements for internal deposition of licensed materials are performed and evaluated in accordance with license and regulatory requ rements.

02.11 Oualitv Manaaement Procram (OMP)

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 the applicable modalities on the license and all the applicable objectives set fcrth 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 the QMP 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.

d. Misadministration and Recordable Events. Through review of the licensee's records, determine if the licensee is in compliance with the requirements for identification, notification, reports. and l records for misadministration and recordable events in 10 CFR 35.33.

02.12 Waste Manaaement

a. Waste Storace and Disoosal. Verify that the waste is stored and controlled in a secure and safe manner, and that radiation levels in )

unrestricted areas surrounding the storage area do not exceed the limits )

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

Verify that disposal of decay-in-storage waste is performed in accordance with 10 CFR 35.92 and license conditions (medical licensees are specifi-cally authorized to dispose of waste by decay-in-storage for waste with J

1ssue Date: XX/XX/XX 87119

_ _ - _ _ _ _ _ _ _ _ _ _ _ - _ a

a half life of less than 65 days). Verify that the licensee is conducting appropriate surveys and defacing radioactive material labels before disposing of the waste.

Review the licensee's procedures and a representative sample of the licensee's records to verify that each shipment of radwaste intended for offsite disposal is accompanied by a shipment manifest that includes all the required information.

Review the licensee's procedures and a representative sample of the licensee's records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is labeled, as appropriate, to identify it as Class A. B or C waste, in accordance with the classification criteria of 10 CFR 61.55 [ Subsection III.A.2 of Appendix F to 10 CFR 20.1001-20.2401].

Verify. through review of records and procedures, that releases into a public sanitary sewerage system, if any, are consistent with the form and 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 releases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003, respectively, and that treatment or disposal of waste by incineration is according to 10 CFR 20.2004.

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

Determine the quality of the relevant procedures and the degree to which ALARA techniques are incorporated into them. Determine the extent to which process and engineering controls are used to minimize effluents.

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 o)erated in accordance with manufacturer's recommendations and good health p1ysics practices.

Determine if all significant release pathways are monitored, all un-monitored pathways have been characterized, and all surveillance procedures for effluents are being implemented.

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.

d. Records. Verify that records of waste storage transfer, and disposal are maintained in accordance with the requirements of Part 20 and the license.

87119 Issue Date: XX/XX/XX

l e. Financial Assurance and Decommissioning. For all licensees, including

)

l sealed source licensees, review the licensee's records of information <

important to the safe and effective decommissioning of the facility.

. Verify that the records are complete, updated, and assembled appropriately, in accordance with the requirements in 10 CFR 30.35(g).

l Review the licensee's' list of restricted areas required under 16 CFR 30.35(g)(3) and determine whether laboratories or other rooms have been released since the last inspection. If areas have been released verify that the licensee has adequately decontaminated each room and documented the basis for releasing each room. Document the location of the released rooms in the inspection report and document adequacy of the licensee's decontamination. your findings regarding the Verify whether radiological conditions at the facility have changed since the financial assurance instrument and/or decommissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are significant radiological incidents such as major spills or process upsets. Unauthorized changes by the licensee to processes, types of licensed materials, possession limits, or chemical or physical forms of licensed materials may also prompt a reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect the financial assuiance instrument or decommis-sioning plan, he/she should immediately notify regional management. 1 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. Decommissioning Timeliness. Review com'liance a with the Decommissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the inspection report that should be completed on all inspections.

If the license to conduct principal activities has expired or been revoked: if the licensee has made a decision to permanently cease  !

3rincipal activities at the site or in any separate building: or if there ~

1as been a 24-month duration when no principal activities were conducted at the site or in any separate building, then the decommissioning timeliness requirements in 10 CFR 30.36, 40.42. 70.38. or Part'72 apply. 1 If this is the case, complete in full the " Decommissioning Timeliness l Inspection Inspection Attachment." Attachment A to Appendix A.  !

02.13 Transportation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with 10 CFR Part 71 and DOT regulations for transportation of  !

radioactive materials.

02.14 Postino and Labelina. Verify that the licensee has posted the appropriate documents, notices. forms, and caution signs. as required. Also verify that containers of licensed material are labeled appropriately. )

i 02.15 Generic communications of Information. Confirm that the licensee is

. receiving the applicable bulletins. information notices. NMSS Licensee l Newsletter, etc. Verify that the licensee has taken appropriate action in l l response to these notices.

Issue Date: XX/XX/XX 87119

02.16 Notifications and Reoorts. Determine compliance with the regulations and license requirements regarding notification and reports to NRC and individuals.

Verify that the licensee is in compliance with the requirements, in 10 CFR 35.14, l for medical licensees to notify the Commission about changes in the authorized

[ user, authorized nuclear pharmacist, or RSO.

02.17 Soecial License Conditions. If applicable, review the licensee's compliance with any special license conditions.

02.18 Independent and Confirmatory Measurements. Compare and verify, on a sampling basis, survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this inspection procedure, unless warranted by special circumstances. If independent i

' measurements were not made, provide a justification in the inspection report explaining why independent measurements were not performed. The inspector shall use radiation detection instruments that are calibrated, at a minimum, on an annual basis.

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

02.20 Year-2000 Issues. Verify that the licensee has reviewed its computer software to ensure that any potential year-2000 problems have been identified and corrected.

02.21 Exit Meetina. The inspector will conduct an exit meeting with senior licensee management and the RSO to discuss the preliminary inspection findings.

These will include any apparent violations, safety-related concerns. and any unresolved items identified during the inspection. Discuss any negative Performance Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of concern, For further guidance, refer to IP 87101, " Performance Evaluation Factors."

02.22 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.

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 give feedback on how the licensee has addressed recent licensing actions. This  !

meeting shall be documented in the inspection report. l Additionally, in some instences, inspection findings will warrant communication I with enforcement staff Office of Investigations staff, State liaison staff, or l Federal agencies with whom NRC has Memoranda of Understanding (MOUs). Similarly, i if information related to year-2000 problems and solutions is obtained, it is to l be conveyed to the NMSS Year-2000 Coordinator.

The inspector will ensure that inspection findings are clearly documented, and l reported to the licensee as appropriate. The inspector shall also follow the  :

l requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and l l Records," regarding notifying the licensee that retained information is subject 87119 Issue Date: XX/XX/XX

to public disclosure and giving the licensee the opportunity to request withholding it (see IMC 0620 Section 04.06.b.).

87119-03 INSPECTION GUIDANCE General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather, observations of activities in progress, equipment, facilities and use areas, etc., will be a better indicator of the licensee's overall radiation safety program than a review of records alone.

Some of the requirement and guidance sections of this procedure instruct the inspector to " verify" the adequacy of certain aspects of che licensee's program.

Whenever possible, verification should be accomplished through discussions, observations, and demonstrations.

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

" Basis for Findings" section(s) of the inspection inspection report.

Retain a copy of each pertinent record that is needed to substantiate an 1 inspection finding, such as a violation. Those copies shall be attached to the  !

inspection inspection report or, when applicable, to a written inspection report. l When an inspector identifies an apparent violation. he/she should gather copies I from the licensee while onsite, of all records that are needed to support the  !

apparent violation. In general, inspectors should use caution before retaining  !

copies of licensee documents, unless they are needed to support apparent violations. expedite the inspection (e.g. , licensee materials invento ies), or l make the licensing file more complete. In all cases where licensee documents are l 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 should kee NRC management informed of significant findings (e.g., safety hazards, pwillful violations, and other potential escalated enforcement issues) identified during the course of the inspection.

, 03.01 Preparation. Before the inspection, the inspector should do the l following:

l

• Review the licensee's previous inspection history (at a minimum review the past two inspections): the license; and the status of any allegations or incidents. Note the licensee's commitments in response to previous violations, for followup during the inspection:

r Issue Date: XX/XX/XX 87119

o Review regional event / incident logs event / incident files, and the docket file to determine whether the licensee was involved in any incidents, recordable events, or misadministration. If NRC did receive notification l of an incident, review that incident during the inspection and document I the licensee's followup in the inspection report:

l l

e In the inspection report, complete the administrative information, the inspection compliance history, the listing of any license amendments or program changes since the last inspection, and descriptions of any incidents or events that have occurred since the last inspection:

I e

Determine the dates that the licensee submitted the most recent financial assurance instrument and decommissioning plan (if applicable):

e Discuss the licensee's program with previous inspector (s) and/or license reviewer (s), as necessary:

• Prepare an inspection plan:

e Notify the appropriate State radiation control program personnel:

i e Review pending licensing actions:

e Obtain a map of the area and/or directions; e Make travel arrangements and prepare itinerary:

• Select calibrated instruments and perform source check; e Select appropriate documents: and o' Select appropriate equipment to take.

In selecting the appropriate documents, the inspector should consider taking the applicable regulations, inspection report, generic communications, license, NRC forms. etc.

In selecting the appropriate equipment the inspector should consider the type of facility to be inspected. The ecuipment may include safety glasses, protective gloves, sample vials, wipes, poccet dosimeters, alarming rate meters, etc.

During the inspection, focus (among other areas) on whether the licensee is in compliance with any license amendments issued since the last inspection or with any program changes described by the licensee since the last inspection. This requires review of documentation submitted in support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.

03.02 Entrance Briefino After arriving on site, the inspector should contact the RSO or radiation safety staff to arrange an entrance briefing with licensee management. This notification should be made as soon as practical after arriving on site. However, in certain instances (e.g., unannounced inspections at hospitals, which may begin at early hours before management arrives on site) the

. inspector may choose to inform the licensee of his/her presence on site after

- initial observations of the licensed activities currently in progress.

' 87119 Issue Date: XX/XX/XX 0

The purpose of the entrance briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for discussing or reviewing selected inspection items with various licensee staff personnel. However, in some instances, the inspector may only need to inform management of NRC's presence on site, and apprise management that an exit briefing will be conducted, at the end of the inspection, which will detail the inspection findings,

, This is often an o tune time for the inspector to identify i

interviewed. Scheduling interviews will enhance inspector effibersonnel to be iency and give the licensee the opportunity to have the most knowledgeable individuals present l to respond in the areas being inspected, i

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

03.03 General overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.

a, Organization. The licensee's organizational structure will usually be found in the license documents. Determine the reporting structure among executive management, the RS0, the Chairperson of the RSC, and the other members of the RSC, Determine whether the RSO has sufficient access to licensee management. Through. discussions with licensee staff, the inspector should determine if changes in ownership or staffing have occurred. If individuals named in the license have changed, determine whether the licensee has sub'nitted appropriate notification to NRC. Ask licensee management if changes have occurred, or are anticipated, and ask i

)ersonnel to confirm (to the inspector's satisfaction) that no changes lave taken place. If there have been no changes in the organization since i

the previous inspection, there is no need to pursue this element in further detail The inspector should review any organizational change in the RSO position, authorities, responsibilities, and reporting chains. The inspector should be sensitive to changes that reduce the ability of the RSO to resolve concerns or issues related to the safe conduct of the radiation protection program. The inspector should ask licensee management and the RS0 about the RSO's authority and about any changes that may impact on the RS0's duties, responsibilities, or effectiveness.

b. Scone of Proaram. Through discussions with licensee personnel, the inspector can obtain useful information about the types and quantities of material, frequency of use, incidents, etc., which can not always be gained by reviewing records alone. This is also an opportunity for the inspector to discern the actual size and scope of the licensee's program, and to determine if significant changes in activities have occurred since the arevious inspection. To determine program scope, the information obta ned should include the numbers of laboratories, permit holders, lab personnel, and locations of use: human research and medical use activities: mobile nuclear medicine services: distribution of pharmaceuticals under 10 CFR Part 35 license: and principal types and quantities of licensed materials used.

Issue Date: XX/XX/XX 87119

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I

c. Manaaement Oversiaht. The inspection is a verification of the licensee's L .im lamentation of the required program, In the review to verify l -1 lamentation, the inspector should pay particular attention to the scope o the program: frequency of licensee audits and the use of qualified

! auditors; procedures for recording and reporting deficiencies to management: and methods and completion of followup actions by management.

1. RSC - Topics of discussion should include ALARA reviews, incidents, generic communications, authorized users and uses, waste issues, audits. re)ortable events, misadministration and recordable events, j

as definec in 10 CFR 35.2, etc. The committee should be made up of a representative from each type of program area, the RSO, and a

l. representative from management. The inspector should review meeting minutes (and interview selected committee members when practical) to determine the committee's effectiveness. The RSC must meet at least

quarterly.

l Determine if the RSC has been aggressive in seeking out areas needing )

improvement, rather than just responding to events and information from outside sources. Determine whether the committee has recommended any specific actions and assess the implementation of those recommendations. The inspector's review should be of l sufficient depth and detail to provide an overall assessment of the committee's ability to identify, assess, and resolve issues. The l

o inspector should also consider the effectiveness of the RSC to l communicate the results of audits and trending analyses to j appropriate personnel performing licensed activities.

Broad-scope medical programs may be authorized to conduct research involving the use of radioactive drugs or radiation-emitting devices L in humans. Such research may require U.S. Food and Drug i Administration (FDA) approval. In addition, a research studies also re an RDRC, or other f

appropriate committee (s)RSC.

, includ ng the quires input should The inspector from an IRB confirm that the licensee has received FDA approval, if required, and L that' studies involving the use of radioactivity in humans have been

, reviewed by the appropriate committee (s). The inspector should l

' review the interaction between the RSC and the IRB and/or RDRC to assure that patient safety, ethical considerations, and ' scientific ,

l- merit are examined. '

2. RSO - The RSO is the individual, appointed by licensee management and identified on the license, who is responsible for implementing the l radiation safety. program. The inspector should verify that this L

individual is knowledgeable about the program, and ensures that activities are being performed in accordance with approved arocedures

! and the regulations. The inspector should verify tlat, when deficiencies are identified, the RSO has sufficient authority.

1 l l without prior approval of the RSC, to implement corrective actions, including termination of operations that pose a threat to health q and safety.

The RSO should be supported by a staff of health physics  !

professionals who assist in the maintenance and control of the licensed program. The number and qualifications of these professionals will vary with the size of the program. The inspector should through observation and interviews with staff, evaluate 87119 Issue Date: XX/XX/XX

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l whether staffing appears sufficient to adequately administer the program. Any perceived deficiencies in this element should be {j forwarded to the inspector's management.

, 3. Audits - The frequency and scope of audits of the licensed program l

will vary. However, note that at a minimum, medical institution licensees are required by 10 CFR 20.1101(c) and 10 CFR 35.32(b)(1)

to review the r viation safety program content, implementation, and i

OMP at least annually. The results of audits should be documented.

Examine these records with particular attention to deficiencies I identified by the auditors, and note any corrective actions taken as a result of deficiencies found. If no corrective actions were taken, determine why the licensee disregarded deficiencies identified during audits, and whether the lack of corrective actions caused the l licensee to be in non-compliance with regulatory requirements. {

d. Authorized Users. Authorized users of licensed material for non-human use are generally designated by the RSC. The inspector should review the process of approving users through interviews with users, RSC members, and the RSO. The 3rocedure for designating users can be found in the license documents. Au;horized users of licensed material for medical purposes and human research may either be named in the license or designated by the RSC. For those designated by the RSC verify that the authorized user received training in accordance with approved criteria and/or Part 35, and has knowledge commensurate with operational duties.

The regulations in 10 CFR 35.11(b) allow an individual to receive, possess, use, or transfer byproduct material for medical use "under the supervision of" the authorized user. unless prohibited by 1icense conditi on. These regulations do not specifically require that the authorized user be present at all times during the use of such materials.

The authorized user / supervisor is responsible for assuring that personnel under his/her supervision have been properly trained and instructed.

pursuant to 10 CFR 35.25(a), and is responsible for the supervision of operations involving the use of radioactive materials whether he/she is present or absent.

03.04 Walk-Throuah Orientation Tour. The inspector should make initial observations of licensed activities to determine that materials are being safely handled and that good health physics practices are followed. The inspector should look at areas of receipt use, storage, and disposal to make an initial  !

assessment of the licensee's ALARA program with regard to facility design, engineering controls, house-keeping practices, etc.

During the course of the inspection, the inspector should randomly visit a number  ;

of research laboratories to observe workers using all types and quantities of '

licensed material. This is an excellent time to ask workers to demonstrate certain procedures or to observe activities in an effort to evaluate the j effectiveness of the licensee's training program. The inspector should ensure '

that observations of activities are documented in the inspection record.

03.05 Facilities. Descriptions of the facilities are generally found in the

. application for a license and subsequent amendments that are usually tied down i

to a license condition. The actual or as-built facility should be configured to provide safe working areas separated from unrestricted areas and sufficient l l access controls to preclude unauthorized entry. Describe any self-contained dry-l storage or instrument calibrators. The inspector should also be aware of l I Issue Date: XX/XX/XX 87119

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a

)otential industrial safety hazards, for referral to the U.S. Department of

. abor's Occupational Safety and Health Administration.

03.06 Eouioment and Instrumentation

a. Equipment and instrumentation should be appropriate to the scope of the -4 licensed program. The inspector should verify that survey instrumentation I has the appropriate range of use. The inspector should also verify that the survey instruments are calibrated at the appropriate frequency and checked for o)erability before use. All survey, sampling, and monitoring instruments s1ould have current calibrations appropriate to the types and energies of radiation to be detected. The technical adequacy of 1 calibration procedures at facilities that perform their own cal 13 rations j should be examined. Processing equipment, fume hoods, ventilation, and  !

exhaust systems should be sufficient to provide safe use, handling, and storage of the materials in use.

b. The inspector should determine if dose calibrators for )hoton-emitting radionuclides and equipment used to assay alpha- anc beta-emitting radionuclides are possessed, used, and tested at the appropriate intervals, in accordance with 10 CFR 35.50 and 35.52, respectively, and the licensee's procedures; and if appropriate actions are taken when errors are identified. Tests to be conducted are linearity, geometric dependence, accuracy, and constancy. If generators are used, determine that each eluate / extract used for radiopharmacy is tested for molybdenum-99 breakthrough in accordance with 10 CFR 35.204. Also determine that vials and syringes are properly labeled and shielded per 10 CFR 35.60 and 35.61, respectively

c. Inspectors should verify that licensees have procedures for reporting defects in accordance with 10 CFR 'Part 21. The complexity of the procedures will vary.

03.07 Materials

a. Receiot and Transfer of Licensed Materials. Depending on the size of the licensed program, the package receipt and transfer procedures (a few or many) will be found in the license application. These procedures should be carefully reviewed before an inspection is conducted. By discussions with the licensee, determine. if the procedures have been changed or modified. Some changes may require a license amendment, whereas other minor changes (updating telephone numbers, editing procedures for clarity. ,

, etc.) may not require NRC approval. Randomly examine procedures used by i the licensee to determine if they are in accordance with those identified in the license application, or if they warrant a license amendment. If

! procedural changes have occurred, verify that they were approved by

! the RSC.

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

actions are to be taken if surveys reveal Jackages that are contaminated  !

in excess of s than expected.Ifpecified packageslimits, arriveand/or during raciation the courselevels that are higher of an inspection, the 87119 Issue Date: XX/XX/XX j

inspector should observe, when practical, personnel perform the package receipt surveys.

The inspector should randomly examine records of package surveys and also determine if inventories for each radionuclides 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 the materials possessed.

The licensee should have an accounting system that suits the type of licensed program. For example, a relatively small facility will generally need to maintain recei)t records, disposal records, and records of any transfers of materia'. However, a large facility will need a sophisticated accounting system for all licensed material that provides accurate information on the receipt, location, the quantity used and disposed of, the amount transferred to other laboratories oaerating under the same license, and the amount remaining after decay. "he accounting systems should also consider licensed 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.

b. Authorized Uses. Authorized uses of radioactive material will be found in the license and referenced license documents. Licenses list the isotopes, physical form, and the maximum possession limit. The inspector should physically examine the inventory of radioactive material on hand or examine records of receipt and transfer to determine that possession limits have not been exceeded. Additionally, the inspector should verify that the licensee's use of licensed material (i .e. . cell labeling.

iodinations, animal research) is limited to that which is authorized in the license, and in accordance with current procedures.

c. Material Security and Control. Examine areas where licensed materials are used and stored. Storage areas should be locked and have limited and controlled access. Licensed material use areas should be under constant surveillance or physically secured. The licensee should have procedures for access controls. Controls may include a utilization log to indicate when licensed material is taken from and returned to storage areas. The ins)ector should verify that adequate controls are in place and worcing effectively.

d. Use of Pharmaceuticals: Examine the licensee's procedures for assay and use of radiopharmaceuticals, including photon , alpha , and beta-emitting radionuclides. Examine the methods used by the licensee to ensure the administration of the correct dosages of radiopharmaceuticals. Ensure that radioisotopes are used in research in accordance with current procedures.

03.08 Trainina L

' a. EgneralTrainina. Certain kinds of training and instruction are found in the regulations; how they are implemented will be found in the license. l Discuss with the licensee how, and by whom, training is conducted and the content of the training provided to workers (generally found in the Issue Date: XX/XX/XX 87119 4

l l .-

l

license application). Training and instruction should be commensurate with the potential radiological hazards involved.

, Verify, pursuant to 10 CFR 19.12, that initial instructions have been given to individuals who in the course of employment are likely to receive in 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 equipment to be used. The workers should also be informed of the pertinent provisions of NRC regulations and the license, and the requirement to notify management of conditions observed that may, if not corrected, result in a violation of NRC requirements. Also verify that authorized users and workers understand the mechanism for raising safety concerns.

Of the training program elements in the license application, training given to authorized users, and those individuals under the supervision of autho~rized users, is of primary importance. One or more users of radioactive materials should be interviewed to determine that they have-received the required training, both in the basic instructions and in that specified in the license application. For some licensees, this includes specific training needed to perform infrequent procedures and prepare and use radioactive material in research studies or in production. Note that the training should be (and in most cases is required to be) provided to workers before the individual's performance of licensed activities.

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

Where examinations are required, read a few of the examination cuestions to ascertain that they are indicative of what the worker shoult know to carry out his/her responsibilities.

The inspector should also observe related activities and discuss the radiation safety training received by selected individuals to ensure that appropriate training ' was actually received by these individuals.

Authorized users and supervised individuals should understand the radiation protection re associated with their ~ assigned activities. The licensee'quirements s radiation safety training may include, but is not limited to, demonstrations by cognizant facility personnel, formal lectures, testing, films, and " dry runs" for more complex or hazardous operations.

b. Doeratino and Emeraency Procedures. Operating and emergency procedures-will be found in license applications and may vary from step-by-step procedures to more generalized procedures for lower-ins)ection-priority licenses. The emergency procedures will be approved by 4RC and reviewed and updated by the licensee.

Some licensees may have agreements with other agencies'(e.g., fire, law enforcement, and medical organizations) regarding response to emergencies.

Discuss with the licensee's representatives what has been done to ensure that agencies (involved in such agreements) understand their roles in emergency responses.

87119 Issue Date: XX/XX/XX l

l L ___

t l c. S w ialized Trainino. Authorized users and research laboratory personnel

~

l slould receive periodic radiation safety training commensurate with their f

' use of licensed materials. For example, these individuals should know how and when to use radiation survey instrumentation, fume hoods, and protective gear. They should know procedures concerning waste disposal, bioassays, surveys, inventories, etc. Also, if the licensee uses licensed material _ for therapeutic purposes, training specific to the types of i

therapy performed should be provided to the nursing staff and others caring for these patients. This training should include personnel who do not directly deal with patients, such as housekeeping, maintenance,

! security. etc. The training should also include such topics as contamination control, ALARA. emergency procedures, and sealed source L identification. The inspector should determine that personnel are appropriately trained through interviews, demonstration, and observation of licensed activities.

I

d. Iheraov Trainina. Licensees that provide radiation therapy must provide radiation safety instructions for all personnel caring for such therapy i patients and retain records of such training for 3 years. ,

l 03.09 Area Radiation and Contamination Control

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

l

' However, the inspector must use NRC's instruments for independent verification of the licensee's measurements. (The inspector's instruments shall be calibrated and source-checked before he/she leaves the

regional office.)

l If practical, observe how licensees conduct surveys to determine the adequacy of surveys. ' Also, note the types of instruments used, and whether they are designed and calibrated for the type of radiation L being measured.

The inspector. should determine if workers take smears or instrument readings in areas that are readily accessible to facility personnel. l Particular attention should be given to released patients rooms, bench tops, sinks used for disposal, and storage areas. The survey activities should be performed in accordance with 10 CFR 35.70, where applicable.

l The inspector should also perform independent measurements, as needed to verify licensee assumptions or measurements.

l b. Leak Tests and Inventories. Through discussions with licensee personnel' I l and/or by demonstration of leak test procedures, the inspector should  !

verify that leak tests are performed in accordance with the manufacturer's l

l recommendations and/or license. Verify that inventories of sealed sources  ;

are performed at the required frequency.

c. Contamination Control. The-inspector should verify that the licensee's  ;

survey procedures and counting equipment are adequate to detect and  !

control radionuclides contamination. The inspector may choose to examine i the instrument calibration records (efficiency checks, lower limit of detection calculations, geometry, linearity, etc.): physical location of counting instruments, methods of detection; and wipe-sample locations.

Additionally, when .ap3ropriate, the inspector should consider taking confirmatory wipe samp' es. Verify that eating, drinking, and smoking are Issue Date: XX/XX/XX 87119

not permitted in contaminated or potentially contaminated areas. Also verify that mouth pipetting'is not practiced. Verify that personnel check for contamination on leaving these areas.

l

'd.

Protective Clothina. If practical, the observation of the protective clothing that research lab personnel or other applicable staff wear during >

l their work activities should provide the inspector with an acceptable l means of reviewing this requirement. Requirements for protective clothing p may be found in the licensee's procedures or on precautions posted at the l entrance to controlled areas.

03.10 Radiation Protection. Specific guidance for this element is set forth in IP 83822. " Radiation Protection." Additional guidance is as follows.

The inspection of the patient release criteria is to be performance-based. The inspector should be familiar with the content of Regulatory Guide 8.39. " Release of Patients Administered Radioactive Materials." Four distinct objectives should be addressed in establishing compliance with 10 CFR 35.75, i~ (1) The patient release criteria permit licensees to release individuals from control if the total effective dose equivalent (TEDE) to any other individual is not likely to exceed 5 mSv (0.5 rem). The quantities of radio) pharmaceuticals (dosage) administered to patients for most, if not al , diagnostic studies will deliver less than 5 mSv (0.5 rem) to other individuals. The licensee should be familiar with Regulatory Guide 8.39. The inspector should bring this Regulatory Guide to the attention of appropriate individuals if the licensee is not familiar with the Guide. In particular, the 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 in 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 CFR 35.75(b) to provide instructions to released individuals if the dose to any other individual is likely to exceed 1 mSv (0.1 rem). In general, the licensee is required to give instructions, including written instructions, on how to maintain doses to other individuals ALARA. The inspector may determine how the licensee is demonstrating liance with this requirement by reviewing sample instructions comp and /or discussing the content of the instructions with applicable staff. If the licensee is required by the rule to provide instruc-tions to breast-feeding women, the instructions should include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance.

(3) Licensees are required to maintain, for 3 years, a record of the release if the patient's TEDE has been calculated: (1) using the retained activity rather than the activity administered: (2) using an occupancy factor less than 0.25 at 1 meter (39.4 inches): (3) using the biological or effective half-life: or (4) considering the L 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 (0.5 rem)

' if the breast-feeding were continued, licensees are required to document-that instructions are being provided per 10 CFR 35.75(d).

87119 Issue Date: XX/r !XX

Section 19.13(b) requires that each licensee shall advise each worker annually of the worker's dose- as shown in dose records maintained by the licensee.

Verify.- that proper dosimetry is worn as required by license or regulations.

Verify. through discussions with workers and management, and through . records review,. that the licensee has advised. workers of their doses annually. The licensee must advise all workers for whom monitoring is required (and, therefore, dose records are required). The licensee must advise these workers of internal and external doses from routine operations, and doses received during planned l special exposures, accidents, and emergencies. The report to the individual must be in writing and must contain all the information required in 10 CFR 19.13(a).

J 03.11 ME

a. OMP Directives. Ins]ectors should observe and interview individuals i as they perform appl' cable duties to determine if the licensee's QMP. '

as implemented, effectively ensures that byproduct material, or radiation from byproduct material, will be administered as directed j by the authorized user. The review should include consideration of j the licensee's implementation of a continuous improvement in the following processes: monitoring, identification, evaluation, ,

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 OMP be performed'at intervals of no greater than 12 months. The annual review of the licensee's OMP should include: (1) a representative sample of patient and human research subject administrations: (2) all recordable events; and (3) J all misadministration.

c. Recor_ds. Records of OMP annual reviews should demonstrate that each review included: (1) a representative sample of oatient and human research subject administrations: (2) all recordable events: and (3) all misadministration since the last review. The licensee should also have available for audit: (1) each written directive and a record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required (for three years after the date of administration): and (2) for each recordable event in the previous three years, the relevant facts and what corrective actions, if any, were taken

d. Misadministration and Recordable Events. If, during the inspection, a previously unidentified misadministration is identified by the inspector: (1) remind the licensee of the need to comply with the reporting requirements described in 10 CFR 35.33. " Notifications, reports, and records of misadministration": and (2) follow the 3rocedure for reactive ianagement Directive 8.10,insp'NRC Medical Event Assessment Program."

For recordable events, verify that an evaluation was performed within 30. days after discovery of a self-identified (identified by j the licensee) event, and note the corrective actions that were taken.

If no or inadequate, corrective actions were taken, determine whether the lack of corrective action caused the license to be in noncompliance with regulatory requirements. If a recordable event is identified by the inspector, bring the event to the attention of l

Issue Date: XX/XX/XX 87119

[ - - _ _ _ _ _ _ _ _ _ _ ___ _ _

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

03.12 Waste Manaaement

a. Waste Storaae and Disoosal. 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.

Inspection effort should be directed at verifying that written procedures have been established in a manner approved by management. The procedures should be readily available to any persons having responsibility for low-level waste classification and preparation for transfer of such wastes to land disposal facilities.

For further inspection guidance, refer to IP 84850, " Radio!.ctive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61": and Information Notice (IN) 94-0/, " Solubility Criteria for Liquid Effluent Releases to sanitary Sewerage Under the Revised 10 CFR Part 20."

b. Effluents. Examine the waste release records generated since the last inspection, all annual or semiannual re] orts, all pertinent nonroutine event reports, and a random selection of 'iquid and airborne waste release records. Randomly select procedures for both liquid and airborne systems and verify that the licensee's procedures are being followed. The verification can be made by observations of an operation, a review of selected records, interviews with workers, etc.

For liquid wastes, determine if the licensee has identified all sources of liquid waste: evaluated treatment methods to minimize concentrations (such as the use of retention tanks); and complies with the regulatory requirements for disposal into sanitary sewerage.

For airborne radioactivity, determine if the license has identified all routes of airborne releases to the environment and complies with the regulations and all applicable license restrictions. For those licensees authorized to dispose of radioactive material by incineration, determine compliance with 10 CFR 20.2004 and license requirements.

Review the licensee's ALARA goals, and determine if they are sufficiently challenging yet realistic. Determine if the licensee understands and implements these goals. Determine if the licensee has calculated annual

-doses resulting from air effluents and if the doses: (1) are within the licensee's ALARA goals (as described in its radiation protection program):

(2) exceed the licensee's ALARA goals or (3) are uncertain because there is insufficient information or basis for determination. Review the licensee's history in meeting ALARA goals, and its corrective actions when l

the goals were not met.

I For further inspection guidance, refer to IP 87102.

c. Transfer. Ascertain if the licensee has an adequate method of determining that recipients of radioactive wastes are licensed to receive such waste 87119 - 20 Issue Date: XX/XX/XX 1

(i.e., licensee obtains a copy of the waste recipient's current license before the transfer).

j

d. Records. Each licensee is required to maintain records of the disposal of licensed material made under 10 CFR 20.2002-2005 and 10 CFR Part 61.

and by disposal by burial in soil. These records must be retained until the. Commission terminates each pertinent license requiring the record.

The inspector should review these records to verify that disposals are made in accordance with the a)plicable regulations, and that records are complete and accurate for eac1 type of disposal. For medical 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.

e. Financial Assurance and Decommissioning. The decommissioning record-keeping requirements are applicable to all materials licensees, including licensees with only sealed sources, and are specified in 10 CFR 30.35(g).

These records should contain, among other information: (1) records of

! spills or other unusual occurrences involving the spread of contaminatial in and around the facility, equipment, or site (when contamination remains after cleanup, or when contaminants may have spread to inaccessible areas--e.g., seepage into concrete): (2) as-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and locations of possible inaccessible contamination (e.g., buried pipes): (3) except for areas with

, only non-leaking sealed sources or byproduct materials with half-lives of less than 65 days, a single document detailing restricted areas and formerly restricted areas, buried waste, areas, requiring decontamination, that are outside of restricted areas, and areas outside of restricted areas which if the license expired, would have to be decontaminated or approved for disposal: and (4) records of the cost estimate performed for

a decommissioning funding plan or the amount certified for decommissioning. This list is not all inclusive of the information and requirements given in 10 CFR 30.35(g). On all inspections, including inspections of sealed source licensees. the inspector should ensure that the licensee has such decommissioning records, that the records are complete, that they are updated as required, and that the decommissioning records are assembled or referenced in an identified location.

Some licensees may release laboratories or other rooms within a building, or entire buildings, 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 or in other buildings on the i site. Inspectors should identify the rooms that have been released since the -last inspection and perform measurements (on a spot-check sampling  !

l basis, including questionable areas) to confirm that radiation and contamination levels in the rooms or areas appear to be 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.

l l

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 Issue Date: XX/XX/XX 87119 l

J

[ assurance instrument and/or decommissioning plan, especially where the radiological conditions deteriorate and the financial assurance instrument r

or decommissioning plan may no longer be sufficient. In preparation for t

the inspection, the inspector should determine the dates that the financial assurance instrument and decommissioning plan (if applicable) were submitted to NRC. Then during the inspection, through observations, discussions with licensee Jersonnel, and records review, the inspector l should determine whether t1e radiological conditions at the licensee's facility have changed since the documents were submitted to NRC. If conditions have changed and the adequacy of the' financial assurance instrument and/or decommissioning plan is in doubt, the inspector should immediately contact regional management from the licensee's site to discuss the situation.

Additionally, some licensees are required to maintain decommissioning cost estimates and funding methods on file. If the licensee uses a parent company guarantee or a self-guarantee as a funding method, the inspector should verify that the licensee has a certified public accountant certify each year that the licensee passes a financial test. The financial test ratios for parent company guarantees and self-guarantees are specified in Section II, Appendix A and Appendix C, respectively, to Part 30.

f. Decommissioning Timeliness. Determine whether the license to conduct a l

principal activity has expired or been revoked. If the license remains in effect. determine if the licensee has made a decision to cease l principal activities at the site or in any separate building. Finally, determine if there has been a 24-month duration in which no principal activities have been conducted in such areas. A principal activity is one that is essential to the purpose for which a license was issued or amended, and does not include storage incidental to decontamination or

decommissioning. If the licensee meets any of the above conditions, AND.

I the separate building (s) or outdoor area (s) contains residual radioactivity such that the building or outdoor areas is unsuitable for release in accordance with NRC requirements, then the decommissioning l

timeliness requirements apply, and the inspector must complete in full the

" Decommissioning Timeliness Inspection Attachment." Attachment A to Appendix A.

The requirements of 10 CFR 30.36, 40.42, and 70.38 do not apply to released rooms within a building where princiaal activities are still on-going in other parts of the same building. Fowever, in those cases, the L

inspector should follow the guidance in 03.12.e. regarding confirmatory measurements of the released area. Once principal activities have ceased in the entire building. then the decommissioning timeliness requirements will take effect IF the building contains residual radioactivity such that it is unsuitable for release in accordance with NRC requirements.

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

l In completing Appendix A. Attachment A of the inspection report, specific l

guidance is needed regarding the timing of the notification requirements.

j If the license has expired or been revoked, or if the licensee has made l

a decision to permanently cease principal activities, and the licensee orovided NRC notification before Auaust 15. 1994, then August 15, 1994, is considered to be the cate for initiating the decommissioning calendar (i .e. , date of notification). If there has been a 24-month duration in which no principal activities have been conducted at the location before the effective date of the rule, but the licensee did not notify NRC, then 87119 Issue Date: XX/XX/XX x

the 24-month time period 'of inactivity is considered to be initiated on August 15. 1994, l

either 30 or 60 days andofthe August licensee mustdepending

15. 1996 p(rovide on notification whether theto licensee NRC within requests a delay).

-NRC has a stringent enforcement policy with respect to violations of the decommissioning timeliness requirements. Failure to comply with the Decommissioning Timeliness Rule (failures to: (a) notify NRC: (b) meet decommissioning standards: (c) complete decommissioning activities, in l accordance with regulation or license condition: or (d) meet required decommissioning schedules without adequate justification) may be classified as a Severity Level III violation and may result in l

consideration of monetary civil penalties or other enforcement actions.

as appropriate.

Decommissioning timeliness issues can be complex. For situations where l .an inspector has questions'about the licensee's status and whether the decommissioning timeliness standards apply, he/she should immediately L contact regional management.

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

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

l 03.13 Transportation. The inspector should review: the licensee's hazardous material training: packages and associated documentation: vehicles (including

. placarding. cargo alocking, and bracing, etc.): shipping papers: and any l incidents reported to DOT. This is an ideal area for the inspector to make observations of licensee practices, DOT and NRC regulations for transportation of radioactive materials were recently revised, and the revisions generally became effective' April 1. 1996.

I For further inspection guidance, refer to IP 86740, " Inspection of Transportation Activities." Inspectors should also refer closely to " Hazard Communications for L Class 7 (Radioactive) Materials," the NRC field reference charts on hazard communications for transportation of radioactive materials, whicih contain l'

references to the new transportation requirements, and are useful field references for determining compliance with the transportation rules on labeling.

_ placarding, shipping papers, and package markings.

03.14 Postina and Labelina. The inspector should determine whether proper

! caution signs are being used at access points to areas containing licensed materials, radiation areas, and those areas containing airborne radioactive materials. Section 20.1903 provides exceptions to posting caution signs. When

. applicable. the inspector should also randomly examine signals and alarms to determine operability. The inspector should also randomly observe labeling on packages or other containers to determine that pro i quantity, and date of measurement) is recorded.perIf information handling of(e.g., isotope, potentially L radioactively-contaminated objects is required to carry out this task.

l protective gloves should be worn.

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

rope, or structural barriers to prevent access. If volatile licensed materials L Issue Date: XX/XX/XX 87119 l

are used in an area, such an area should be controlled for airborne contamination. b Nh radiation areas should be strictly controlled to prevent unauthorized or 1 odvertent access. Such controls may include, but are not limited to, direct surveillance, locking the high radiation area, warning lights, and audible alarms. Areas occupied by radiation workers for long periods of time and common-use areas should be controlled in accordance with licensa orocedures and be consistent with the licensee's ALARA program.

The inspector should also examine locations where notices to workers are posted.

Applicable documents, notices, or forms should be posted in a sufficient number of places to permit individuals engaged in licensed activities to observe them on the way to or from any particular licensed activity location to which the postings would apply.

03.15 Generic Communications of Information. Through discussions with license management and the RSO. the inspector should verify that the licensee is receiving the applicable bulletins , information notices. NMSS Licensee Newsletter, etc., and that the information contained in these documents is l

disseminated to appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC communications, when a response is required. 1 03.16 Notifications and Reoorts. The inspector should determine the licensee's compliance for notifications and reports to the Commission. The licensee may be required to make notifications after loss or theft of material, overexposure.

incidents. high radiation levels, safety-related equipment failure, etc.

Additionally, some licensees are required to make annual reports to NRC.

Verify. that notifications and/or reports were appropriately submitted to NRC.

Through observations and discussions with licensee personnel, the inspector should gather information concerning events that were reported to NRC. The depth of onsite followup should be proportional to the severity of the event.

03.17 Soecial License conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of equipment used by the licensee. In these instances, the inspector should verify that the licensee understands the additional requirements, and maintains compliance with the special license conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC requirement.

03.18 Independent and Confirmatory Measurements. The inspector should perform independent and confirmatory measurements in restricted, controlled, and unrestricted areas of the licensee's facility. Independent measurements should be performed on all inspections, unless exceptional circumstances make it impossible to perform the measurements (e.g.. inspector's detection equipment l .

Measurements of dose rates at the malfunctions boundaries of the during an inspection restricted areas shoutrip)ld be performed at the surfaces of the most accessible planes. Examples of measurements that may be performed include area radiation surveys, wipe samples, soil samples, leak tests, air flow measurements, etc. These measurements should be taken in licensed material use areas, storage areas, effluent release points, etc. Confirmatory measurements are those whereby the inspector compares his/her measurements with those of the licensee's. Independent measurements are those performed by the inspector

. independently of the licensee's measurements. To perform the independent or confirmatory measurement, use NRC radiation detection instruments that are calibrated, at a minimum, on an annual basis.

i 87119 Issue Date: XX/XX/XX 1

03.19 Research Involvina Human Subiects: This type of research must satisfy the

. following minimum conditions: (1) All research is conducted, supported, or regulated by 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 research; (2) the licensee obtains informed consent from the subjects, as defined and described in the afore-mentioned Federal Policy; and (3) the licensee obtains prior review and approval from an IRB, as defined and described in the Federal Policy. For additional guidance on required associated inspection elements, see Section 03.03.c.1, " Management Oversight-RSC."

- 03.20 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 any identified problems and solutions:

(c) determine whether the licensee has identified any sotential problems, and if so, taken corrective action. (Note that if informa; ion 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.)

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

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

However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO, if not present at the preliminary exit meeting) as soon as practical after the inspection. This meeting will usually be held by telephone conference call.

During the exit meeting, the licensee re)resentatives should be told the preliminary inspection findings -- inclucing any negative PEFs, apparent violations of regulatory requirements, safety-related concerns, or unresolved items identified during the inspection -- and the status of any previously  !

identified violations. The licensee niust immediately address any significant j safety concerns, j If the inspector identifies safety concerns or violations of significant I regulatory requirements that affect safe operation of a licensee facility, the ,

licensee must initiate prompt corrective action. The inspector should not leave i the site until the licensee fully understands the concern and has initiated l corrective action. If the inspector and the licensee disagree over how ,

significantly the concern impacts continued safe operation of the facility, i regional management should be notified immediately. Although deficiencies identified in some areas (e.g., workers' knowledge of the Part 20 requirements)  ;

are not always violations, the inspector should bring such deficiencies to the l attention of licensee management at the exit meeting and also in the cover letter transmitting the inspection record or Notice of Violation.

03.22 Post-Insoection Actions. Regional office policy will dictate with whom the inspector will review his or her inspection findings (e.g., the inspector's  !

. supervisor). following the guidance in IMC 2800 " Materials Inspection Program."  !

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

Issue Date: XX/XX/XX 87119 l

i negative PEFs): and unresolved items should be discussed in sufficient depth for management to make appropriate decisions regarding enforcement actions, referral to other State and Federal agencies, and decisions on the scheduling of future inspections of the licensee's facility.

The inspector should also discuss inspecticn findings with licensing staff. This l information exchange can be particularly useful if the licensee is having its license renewed or has recently submitted a license amendment request. The inspector should inform licensing staff about how the licensee has addressed (or failed to address) special license amendments or recent licensing actions.

Licensing information requested by the licensee should also be discussed with the licensing staff.

Inspectors should be aware that NRC has entered into several MOUs. with other i Federal agencies, that outline agreements on items such as exchange of l information and evidence in criminal proceedings. The inspector should ensure l that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.

The inspector may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following the guidance in IMC 2800. The inspector must also ensure that the findings are documented in the inspection record, in sufficient detail for the reader to determine what requirement was violated, how it was violated, who violated the requirement, and w1en it was violated. Copies of all licensee documents needed to support the violation should be attached to the inspection record. The inspection record should not be used as merely a checklist to note areas reviewed. It should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the ins)ection, 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.

If the inspector is documenting the inspection record in electronic format, the sub-items under major sections that are not applicable or not reviewed may be deleted. However, the heading itself (e.g. , " Radioactive Waste Management." or l " Transportation") should remain in the inspection record, and the inspector should enter appropriate remarks about why the section is not applicable or not reviewed.

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

87119-04 REFERENCES A listing of IMCs and IPs applicable to the inspection program for materials licensees can be found in Section 2800-11 of IMC 2800. Inspectors are to use these documents as guidelines in determining the inspection requirements for operational and radiological safety aspects of various types of licensee activities.

Specific references to regulatory requirements can be found in the " Medical Broad-Scope Inspection References" appendix. following this IP, END i

87119 Issue Date: XX/XX/XX l

L._____.___. _ _ _ _ _ . _ . _

APPENDIX A MEDICAL BROAD-SCOPE 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:

4 Summary of Findings and Actions:

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

( ) Non-cited violations

( ) Violation (s), Form 591 issued

( ) Violation (s), regional letter issued

( ) Followup on previous violations l

l Inspector (s) Date (Sign Name) l (Print Name)

Approved Date (Sign Name)

(Print Name)

Issue Date: XX/XX/XX A-1 87119, Appendix A l

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

1. ' AMENDMENTS AND PROGRAM CHANGES:

[ License amendments issued since last inspection; program changes (including major changes in facilities, activities, procedures, or personnel) noted in the license)

AMENDMENT # DATE SUBJECT

2. INSPECTION AND ENFORCEMENT HISTORY:

(Unresolved issues; previous and repeat violations; Confirmatory Action Letters; and orders) 1 l

3. INCIDENT / EVENT HISTORY:

! (List any incidents, recordable events, or misadministration reported to NRC since the last inspection. Citing "None" indicates that regional event logs, event files, and the 1 l licensing file have no evidence of any incidents or events since the last inspection.) l l

l

! i l

i i

87119, Appendix A A-2 issue Date: XX/XX/XX L__________________________________________ _ _ _ . _ . _ _ _ _ _ _ _ _ __ _ . _ _ _ _ _ _ _ _ _ _ _ _ . . _ . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . . .

f l

PART 11-INSPECTION DOCUMENTATION l Refercnces th*t corrcspond to cach inspection docum:ntition topic era in inspection )

Procedure 87119, Appendix B, " Medic:l Brord-Scope inspection R:f:rcnces."

i i

The inspection documentation part is to be used by the inspector to assist with the performance of the inspection. Note that all areas indicatedin this part are not required to be addressed during RaCh inspection. However, for those areas not covered during the inspection, a notation ("Not Reviewed" or "Not Applicable") should be made in each section l where applicable.

AII areas covered during the inspection should be documented in sufficient detail to describe what activities andprocedures 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 with measurements and some records review, should substantiate yourinspection findings.

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

1. ORGANIZATION AND SCOPE OF PROGP (Managementorganization;authoritiesandi , .ibilities; Radiation Safety Officer (RSO),

Radiation Safety Committee (RSC) chairman and members; administrative controls, procedures, and management policies; authorized locations of use; 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

1 1

l

2. MANAGEMENT OVERSIGHT:

(Management support to radiation safety; RSC, RSO; and program audits, including as l low as is reat,onably achievable (ALARA) reviews]

i l

l Issue Date: XX/XX/XX A-3 87119, Appendix A j

3. FACILITIES:

[Faciliths cs d; scribed; uses; control of access; cnginesring controls,( o.g., vsntilition, hoods, filt:rs, ctc); irradiators end survsy instrum:nt calibrators; maint ntnce by authorized persons]

4. EQUIPMENT AND INSTRUMENTATION-(Dose calibrator;instrumentatial for assaying alpha- and beta- radionuclides; generators; syringes and vials; survey instruments; 10 CFR Part 21 procedures; and special equipmert and instrumentation)

5. MATERIAL RECEIPT. USE. CONTROL. AND TRANSFER:

(Materials and uses authorized; use of Iadiopharmaceuticals; security and control of licensed materials; and procedures for receipt and transfer of licensed material) i 87119, Appendix A A-4 issue Date: XX/XX/XX

. _ - _ _ _ l

, __ _-_ . _ - - _ . - _ _ _ - - - - - - - - - - - - - ~ - - _ - - - - - - - - - - -

6. IldEBAPES'

. (Safety precautions; postings; contamination control; st:y tim:s; survsys; rchase crit:ria of pati:nts end rooms) l I i

l' i

lasue Date: g A-5 87119, Appendix A

- ' ' - ^ - ~ ~ - - - - - ~ _ _ _ _ _ _ _ _ _ - - . . _ _

7. QUALITY MANAGEMENT PROGRAM (GMP) AND MISADMINISTRATION:

, (QMP - writt:n dirIctives, impi;mIntation, rsviews, and r: cords; misidministrations -

identification, notifications, reports, and records) i

8. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL:

I (Radiation and contamination surveys; air sampling; leak tests; inventories; handling of radioactive materials; protective clothing; dosimetry; records; and public doses) l l

l b

87119, Appendix A A-6 issue Date: XX/XX/XX

g. TRAINING AND INSTRUCTIONS TO WORKERS:

(Interviews and observations of routine work; staff knowledge of all routine activities; 10 l CFR Part 20 requirements; therapy training and postulated emergency situations; supervision by authorized users; retraining and periodic training programs; training of ancillary personnel such as housekeeping, security, and maintenance; adequacy of training and instruction)

10. RADIATION PROTECTION:

[ Radiation protection program with ALARA provisions (worker and general public external and internal exposure control; effluent control); external and internal dosimetry program; exposure evaluations; dose records and reports; and patient release]

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11. RADIOACTIVE WASTE MANAGEMENT:

(Disposal; effluent pathways and control; storage areas; transfer; packaging, control, and tracking procedures; equipment incinerabrs, hoods, vents, and compactors; and records) ,

l I

l l

l lasue Date: XX/XX/XX -

A-7 87119, Appendix A i

\

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12. DECOMMISSIONING-(Records of radiological conditions; decommissioning plan / schedule; notification requirements; cost estimates; funding methods; financial assurance; and Timeliness l Rule requirements) l l l

I

13. TRANSPORTATION:

! (Quantities and types of licensed material shipped; packaging design requirements; HAZMAT communication procedures; unit dose return; return of sources; procedures for

monitoring radiation and contamination !evels of packages; HAZMAT training; and

, records and reports) l l

l i-l l

14. NOTIFICATIONS AND REPORTS:

(Theft; loss; incidents; overexposure; change in RSO, authorized user, or nuclear pharmacist; and radiation exposure reports to individuals) 87119, Appendix A A-8 Issue Date: XX/XX/XX 9

15. POSTING AND LABELING:

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

l I

l

)

16. INDEPENDENT AND CONFIRMATORY MEASUREMENTS:

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

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17. VIOLATIONS. NON-CITED V.0LATIONS (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 all licensee documents needed to support violations.)

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Issue Date: XX/XX/XX A-9 87119, Appendix A

18. PERSONNEL CONTACT D:

[ldI:ntify licensee personnel contact:d during ths inspection (including thoss individuals contacted by telephone).]

l l

t Use the following identification symbols:

1. individual (s) present at entrance meeting

• Individual (s) present at exit meeting

19. PERFORMANCE EVALUATION FACTORS (PEFsk A. Lack of senior management involvement with tha I

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

i

21. Soecial Conditions or issues: 4 (Special license conditions; year-2000 effects of computer software) i f

1 f 87119, Appendix A A - 10 issue Date: XX/XX/XX

PART lli - POST-INSPECTION ACTIVITIES

1. REGIONAL FOLLOWUP ON PEFs:

2. DEBRIEF WITH REGIONAL STAFF:

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

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/XX A - 11 87119, Appendix A

l-APPENDIX A- ATTACHMENT A DECOMMISSIONING TIMELINESS INSPECTION ATTACHMENT Licensee:

l Date of Inspection:

1. COMPLIANCE WITH DECOMMISSIONING TIMELINESS RULE (NOTE: Repeat the answers given in Section 12 of the main body of the inspection

- record. The issues in subsequent sections are dependent on the answers to these questions.)

l A. License to conduct a principal activity ban .

expired or been revoked. ()Y()N L B. Licensee has made a decision to permanently

[ cease principal activities, at the entire site, or any separate buildings, or any outdoor areas, -

including inactive burial grounds; ()Y()N

- C. A 24-month duration has passed in which no principal activities have been conducted under the license at the site, or at any separate buildings, or any outdoor areas, including j inactive burial grounds. ()Y()N

, D. If"Yes" to either A or 8 or C above:

(1) Identify Site /Bidg/ Area:

(2) Date of occurrence of A, B, or C:

' 2. NOTIFICATION REQUIREMENTS l~

A. Licensee has provided written notification; to U.S. Nuclear Regulatory, Commission (NRC) within 60 days of the occurrence of 1.A.,1.B., or  ;

1.C.,above. ()Y()N '

If"Yes," date of notification:

B. If the licensee is requesting to delay initiation  ;

l. of the decommissioning process, the licensee

• has provided written notification to NRC within 30 days of occurrence of 1.A.,1.B.,

. or 1.C.,above ( ) N/A ( ) Y ( ) N If "Yes," date of notification:

. Basis for Findings:

• Issue Date: XX/XX/XX AA-1 Appendix A, Att. A l=

l-

3. DECOMMISSIONING PLAN / SCHEDULE REQUIREMENTS A. Licensee is required to submit a d: commissioning plan per 10 CFR 30.36(g),40.42(g),70.38(g), or 10 CFR Part 727 ()Y()N 1

i If "No" to 3.A., answer the following items B. - F.:

l B. The decommissioning work scope is covered by current license conditions. ()Y()N l C. Decommissbning has been initiated within 60 days

! of notification to NRC, or NRC has granted a delay. ()Y()N D. If licensee has initiated decommissioning, give date the decommissioning was initiated:

Initiation date:

E. If decommissioning has been completed, it was completed within 24 months of notification l of NRC. ( ) N/A ( ) Y ( ) N F. If decommissioning is still scheduled to be completed, it is on schedule to be completed within 24 months of notification of NRC. ( ) N/A ( ) Y ( ) N Basis for Findings:

i l

l l l l

87117, Appendix A Att. A AA-2 Issue Date: XX/XX/XX

If "Yes" to 3.A., cnsw::r tha following it:ms G. - J.: ,

G. The decommissioning plan has been submitted to NRC within 12 months of notification ()Y()N If"Yes," date of submittal:

- If NRC approved, date of NRC approval:

H. Has the licensee submitted an altemative schedule request?. ()Y()N if"Yes," date of submittal:

l .i l l. If decommissioning has been completed, it was {

completed within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N J. If deconimissioning is still scheduled to be completed, it is on schedule to be completed within 24 months after approval of the decommissioning plan. ( ) N/A ( ) Y ( ) N Basis for Findings:

l Violations identified, if any:

l i

Issue Date: XX/XX/XX AA-3 Appendix A, Att. A

APPENDIX B MEDICAL CROAD-SCOPE INSPECTION REFERENCES *

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

10 CFR 35.29 Administrative requirements - mobile nuclear medicine service.

10 CFR 35.80 Technical requirements - mobile nuclear medicine service.

License application and applicable license conditions.

2. MANAGEMENT OVERSIGHT A. Radiation Safety Committee 10 CFR 33.13 Requirements for issuance of a Type A specific license of broad scope 10 CFR 35.22 Radiation safety committee.

10 CFR 35.23 Statements of authority and responsibilities.

10 CFR 35.31 Radiation safety program changes.

Applicable license conditions.

B. Radiation Safety Officer ,

)

10 CFR 35.21 Radiation safety officer.

10 CFR 35.23 Statements of authority and responsibilities.

10 CFR 35.900 Radiation safety officer.

C. Audits, Reviews, or Inspections 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. I D. ALARA 10 CFR 35.20 Radiation protection programs.

E. Authorized Users ,

10 CFR 35.11 License required.

10 CFR 35.13 License amendments.

10 CFR 35.25 Supervision.

Applicable license conditions.

These references correspond to the sections of IP 87119, Part ll of Appendix A, the

' Medical Broad-Scope inspection Record ."

j issue Date: XX/XX/XX B-1 87119, Appendix B

_ _ _ ._. _ . _ . --._...-._.__._.--_________.___.__________-________.-_n

l

3. FACILITIES -

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

L 10 CFR 20.1602 Control of access to very high-radiation areas.

l Applicable license conditions.

B. Engineering Controls 10 CFR 20.1701 Use of process or other engineering controls.

10 CFR 20.1702 Use of other controls 10 CFR 35.90 Storage of volatile gases. I 10 CFR 35.205 Control of aerosols and gases.

Applicable license conditions.

4. EQUIPMENT AND INSTRUMENTATION A. Dose Calibrators - Photon-emitting radionuclides i 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 l measure dosages of alpha- or beta-emitting radionuclides. l Applicable licer.se conditions.  :

C. Generators 10 CFR 35.204 Permissible molybdenum-99 concentrations, i D. Syringes and Vials 10 CFR 35.60 Syringe shields and labels.  !

10 CFR 35.61 ' Vial shields and labels. i E. Survey Instruments  !

1. Possession 10 CFR 35.120 Posession of survey instrument.

10 CFR 35.220 Possesion of survey instruments.

10 CFR 35.320 Possession of survey instruments.  ;

10 CFR 35.520 Availability of survey instrument. '

' Applicable license conditions.-

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.

l l 871.19, Appendix B B-2 Issue Date: XX/XX/XX

r. _ __ _ _ _ _ . _ - _ __ _________

5.' MATERIAL USE. CONTROL. AND TRANSFER A. AuthorizGd Uses l I:

L ~ 10 CFR 31.11 General license for use of byproduct material for certain in-vitro clinical or laboratory testing.

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

10 CFR 35.100 - Use of unsealed byproduct material for uptake, dilution, ,

and excretion studies.

10 CFR 35.200 ~ Use of unsealed byproduct material for imaging and localization studies.

- 10 CFR 35.204 Permissible molybdenum-99 concentrations.

10 CFR 35.300 Use of unsealed byproduct material for therapeutic administration.

10 CFR 35.400 Use of sources for brachytherapy.

l 10 CFR 35.500 Use of sealed sources for diagnosis.

B ~ Security and Control

! 10 CFR 20.1003 Definitions (restricted area and unrestricted area).

L 10 CFR 20.1801 Security of stored material.

10 CFR 20.1802 Control of material not in storage.

C. Receipt and Transfer of Licensed Material 10 CFR 20.1906 Procedures for 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. THERAPIES 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 MISADMINISTRATION 10 CFR 35.2 ' Definitions (misadministration and recordable events).

10 CFR 35.32 Quality management program.

L 10 CFR 35.33 Notifications, reports, and records of misadministration.

I l j 8. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL i

' A. Area Surveys 10 CFR 2.01301 Dose limits for individual members of the public.

10 CFR 20.1302 Compliance with dose limits for individual members of the public.-

10 CFR 20.1501 General. .I 10 CFR 20.2103 Records of surveys.

10 CFR 20.2107 Records of dose to individual members of the public. ,

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

Applicable license conditions.

o Issue Date: XX/XX/XX -

B-3 87119, Appendix B l

B. Lcik Tests and Inv:ntosi.n 10 CFR 35.59 RIquirtments for posstssion of sul:d sources and brachytherapy sources.

Applicable license conditions.

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

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

B. Specific 10 CFR 35.900 Radiation Safety Officer.

10 CFR 35.901 Training for experienced Radiation Safety Officer.

10 CFR 35.910 Training for uptake, dilution, and excretion studies.

10 CFR 35.920 Training for imaging and localization studies.

10 CFR 35.930 Training for therapeutic use of unsealed byproduct material.

10 CFR 35.932 Training for treatment of hyperthyroidism.

10 CFR 35.934 Training for treatment of thyroid carcinoma.

10 CFR 35.950 Training for use of sealed sources for diagnosis.

10 CFR 35.970 Training for experienced authorized users.

10 CFR 35.971 PhysicQn training in a three month program. j 10 CFR 35.972 Rec',ntness of training. )

10 CFR 35.980 -Training for an authorized nuclear pharmacist.

10 CFR 35.981 Training for experienced nuclear pharmacists.

C. Therapy Training 10 CFR 35.310 Safety instruction.

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

D. Supervision 10 CFR 35.25 Supervision.

10. RADIATION PROTECTION A. General IP 83822 Radiation Protection.

B. Radiation Protection Program l

1. Exposure evaluation i 10 CFR 20.1501 - General.

2. Programs l 10 CFR 20.1101 Radiation protection programs.

10 CFR 35.20 AI. ARA program. ,

87119, Appendix B B-4 Issue Date: XX/XX/XX

l C. Dosimetry

1. Dose Limits t

10 CFR 20.1201 Occupational dose limits for adults.

10 CFR 20.1202 Compliance with requirements for summation of extemal and internal doses.

10 CFR 20.1207 Occupational dose limits for minors.

10 CFR 20.1208 Doses to an embryo / fetus.

2. Extemal 10 CFR 20.1203 Determination of extemal dose from airbome radioactive material.

10 CFR 20.1501 Dosimetry processing.

10 CFR 20.1502 Conditions requiring individual monitoring of extemal and intemal occupational dose. l Applicable license conditions.

3. Intemal 10 CFR 20.1204 Determination of intemal exposure.

10 CFR 20.1502 Conditions requiring individual monitoring of extemal and intamal occupational dose.

10 CFR 20, Respiratory protection and controls to restrict Subpart H intemal exposure in restricted areas.

10 CFR 35.205 Control of aerosols and gases.

10 CFR 35.315 Safety precautions - radiopharmaceutical therapy.

D. 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 E. Patient Release 10 CFR 35.75 Release of patients or human research subject's containing radiopharmaceuticals or permanent implants.

11. RADIOACTIVE WASTE MANAGEMENT l

l A. Disposal i 4

10 CFR 35.92 Decay in storage. l 10 CFR 20.1904 Labeling containers. l 10 CFR 20.2001 General waste disposal requirements.

10 CFR 20.2005 Disposal of specific waste 10 CFR 20.2103 Records of surveys.

10 CFR 20.2108 Records of waste disposal.

B. Effluents l I' 1. General I

j_ lasue Date: XX/XX/XX B-5 87119, Appendix B

IP 87102 Maintaining Effluents from Materials Facilities As Low As is Reasonably Achievable (ALARA)

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

Applicable license conditions.

3. Release to septic tanks 10 CFR 20.1003 Definitions (sanitary sewerage).

10 CFR Part 20, Limits.

App. B, Table 2

4. Incineration of waste 10 CFR 20.2004 Treatment or disposa. 5y 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 and 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.

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

10 CFR 20.1902 Posting requirements.

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.

10 CFR 61.55 Waste classification.

10 CFR 61.56 Waste characterization.

5. Transfer 87119, Appendix B B-6 issue Date: XX/XX/XX

10 CFR Part 20, Requir: mints for low-1;v:1 wista transfir for Appendix F disposil at IInd disposil faciliti:s end manif:sts.

10 CFR 20.2001 General r:quirements.

10 CFR 20.2006 Transfer for disposal and manifests.

10 CFR 30.41 Transfer of byproduct material

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 record-keeping for decommissioning.

10 CFR 30.36 Expiration and termination oflicenses and decommissioning 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 Decommissioning 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.

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

B. Shippers - Requirements for Shipments and Packaging

1. General Requirements 49 CFR Part 173, Class 7, radioactive material.

Subpart i 49 CFR 173.24 General requirements for packagings and packages.

49 CFR 173.448 General transportation requirements.

49 CFR 173.435 Table of A, and A2 values for radionuclides.

2. Transport Quantities 10 CFR 71.4 Definitions of quantities.

a. All quantities 10 CFR 71.4 Definitions of quantities.

49 CFR 173.410 General design requirements.

49 CFR 173.441 Radiation levellimitations.

49 CFR 173.443 Contamination control.

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

f lasue Date: XX/XX/XX B-7 87119, Appendix B '

I

49 CFR 173.476 Approval of special form Cirss 7 (radio:ctiva) mat rills.

l

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

i 49 CFR 173.422 Additional requirements for excepted packages containing Class 7 (radioactive)

! materials.

c. Type A quantities 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 I IP 86740, Section 2 Inspection of transportation activities.

e. LSA material and SCO 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).

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

49 CFR 172.300-338 Marking packages.

49 CFR 172.400-450 Labeling packages.

49 CFR 172.500-560 Placarding vehicles.

49 CFR 172.600-604 Emergency response information and

guidance.

C. HAZMAT Training l

49 CFR 172.702 Applicability and responsibility for training and testing. i 49 CFR 172.704 Training requirements.

l D. Transportation by Public Highway t-49 CFR 171.15 Immediate notice of certain hazardous materials incidents.

49 CFR 171.16 Detailed hazardous materials incident reports.

49 CFR 177.800 Responsibility for compliance and training.

t 49 CFR 177.816 Driver training.

49 CFR 177.842 Loading and unloading: Class 7 (radioactive) material.

I 87119, Appendix B B-8 issue Date: XX%X/XX l

. l

)

14. NOTIFICATIONS AND REPORTS 10 CFR 19.13 Notifications cnd r; ports to individuals.

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

10 CFR 20.2202 Notification ofincidents.

10 CFR 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits.

10 CFR 30.50 Reporting requirements.

10 CFR 35.14 Notifications (RSO, authorized users, and nuclear pharmacists).

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

10 CFR 20.1902 Posting requirements.

10 CFR 20.1903 Exemptions to posting requirements.

10 CFR 20.1904 Labeling containers.

10 CFR 20.1905 Exemptions to labeling requirements.

10 CFR 21.6 Posting requirements.

16. INDEPENDENT AND CONFIRMATORY MEASUREMENTS No references.

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

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

18. PERSONNEL CONTACTED No references.

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

END l

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l l Issue Date: XX/XX/XX B-9 67119, Appendix B l

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