Text

Staff Requirements Memo Re SECY-97-143, ACMUI Re-appointment of Members. Informs That Commission Has Approved Reappointments Recommended
	ML20211B038
Person / Time
Issue date:	08/01/1997
From:	Hoyle J; NRC OFFICE OF THE SECRETARY (SECY)
To:	Callan L, Larkins J; Advisory Committee on Reactor Safeguards, NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20211A766	List: ML20211A761; ML20211A800; ML20211A820; ML20211A880; ML20211A887; ML20211A984; ML20211B038;
References
	REF-10CFR9.7 NACMUI, SECY-97-143-C, NUDOCS 9709250046
	Download: ML20211B038 (80)
	v • d • e

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, . Action: Paperiello, NMSS Cys: Callan

/* ** "'%%', UNITED STATES Thadani o NUCLEAR 74EGULATORY COMMISSION jC [

j waswiwovow. o.c. rossa Thompson Norry

'\ Blaha 1,'...**/ August 1, 1997 Larkins. ACRS/ACM

, , , ,c , , , , g , RDd4 MM SECRETARY l

MEMORANDUM TO: L. Joseph Callan Executive Director for Operations

] . John T. Larkins ector, ACRS/ACNW Exe u i D fa _

FROM: Joh . o /' Secretary *

SUBJECT:

ST FF REQUIREMENTS - SECY-97-143 - ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES, RE-APPOIN'INENT OF MEMBERS The Commission has approved the reappointments recommended in the subject paper. In the future, the staff should provide sufficient information in .he form of brief performance evaluations to permit the Commission to make an informed decision O with regard to reappointment requests. Recommendations should be made with enough lead time to allow for selection of a replacement member should the Commission disapprove reappointment.

While the current composition of the Committee is suited to the schedule and continuity necessary to support the pending Part 35 rulemaking, the staff should consider finding room for and recommending the appointment of a Radiation Safety Officer with health physics expertise at the next available opportunity. In the interim, input from this category of individuals should be solicited on the revisions to Part 35. Also, once the rev' sed Part 35 is issued in final form, the staff in consultation with the ACMUI, should re-evaluate the composition of the ACMUI to determine if changes are needed to meet the needs of the agency as it implements a revised rule and medical use regulatory program.

(ESO (SECY Suspense: Hussme) 3/24/2000) 9700233 (NMSS)

SECY NOTE: THIS SRM AND SECY-97-143 CONTAIN SENSITIVE

( O INFORMATION AND WILL BE LIMITED TO NRC UNLESS THE Q COMMISSION DETERMINES OTHERWISE.

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cc: Chairman Jackson Commissioner Dicus Commissioner Dia:

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ATTACHMENT 3

[7590-01 P)

Os NUCLEAR REGULATORY COMMISSION V

RIN 3150 AF74 Medical Use of Byproduct Material:

Issues and Request for Public Comment AGENCY: Nuclear Regulatory Commission ACTION: Notice of Proposed Rulemaking t

SUMMARY

The U. S. Nuclear Regulatory Commission (NRC) is developing a program for revision of 10 CFR Part 35, " Medical Use of Byproduct Material." The decision to revise Part 35 resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction sotting issues and associated options for the future of NRC activities. Specifically, the SA effort included medical use regulation. With this notice, the Commission is initiating a proposed rulemaking action which will culminate in the l developement of a final rule for approvalin late 1999. This notice desenbes issues proposed

) to be included in this rulemaking. The Commission plans to furthe; propose specific rulemaking text for public comment during 1999 (approximately February 1999).

i

) In order to provide the public the most effective opportunity to participate in developing the 3

rule text, the Commission is requesting public comment on the issues identified by the questions in this notice within 90 days of the issuance ofinis notice. Cornments received s after this initial 90 day period will be considered along with the comments received on the proposed text anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments

received after the 90 day period in preparing the detailed proposed rulemaking text.

j DATES: The comment period expires (90 days after the FRN is issued).

ADDRESSES: Send wntten comments and suggestions to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-l 0001, Attention: Docketing and Service Branch. Hand-Deliver comments to 11555 Rockville Pike, Rockville, MD, between 8:00 a.m. and 4:00 p.m. on Federal workdays, Written comments may also be submitted electronically on the Intemat via

- NRC's interactive rulemaking web site, through the NRC home page (http://www.nre. gov). This site provides the ability to upload comments as files (any format), if your web browser suoports this function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415 5905; e mail CAG@nrc. gov.

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/ s FOR FURTHER INFORMATION REGARDING THIS NOTICE CONTACT: '

i Catherine Haney, Office of Nucisar Material Safety and Safeguards, Nuclear l Regulatory Commission, Washington, DC 20555 0001, telephone (301) 415-6825 or Susanne Woods, Office of Nuclear Material Safety and I Safeguards, Nuclear Regulatory Commission, Washington. DC 20555-0001,

< telephone (301) 415 7267.

SUPPLEMENTAL INFORMATION:

Backaround NRC examined the issue of its medical ne program in great detail during the last four years.

, This process started with NRC's 1993 inumal senior management review report; continued with the 1996 independent extemal review report by the National Academy of Sciences, Institute of Medicine; and culminated in NRC's SA process. In particular, medical oversight J

was addressed in the Strategic Assessment Direction Setting issue Paper Number 7 (DSi 7)

(released September 16,1996).

In their " Staff Requirements Memorandum (SRM) COMSECY 96-057, Materials / Medical Oversight (DSI 7)," dated March 20,1997, the Commission directed staff to revise Part 35, associated guidance documents, and, if necessary, tne Commission's 1979 Medical Policy Statement. Further, the SRM stated,'With respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued."

The Commission SRM specifically directed the restructuring of Part 35 into a risk informed, more performance based regulation. Further, during development of the rule and assoc.iated guidance, as well as during review of the Medical Policy Statement, the NRC staff was directed to consider the following issues:

I 1 Focusing Part 35 on those procedures that pose the highest risk.

2. Regulatory oversight attematives, for diagnostie, procedures, that are consistent with the lower overall risk of these procedures.

3. The best way to capture not only relevant safety significant events, but also precursor events.

4. The need in change from the term

misadministration" to " medical event" or other comparable terminology.

5. Redesigning Part 35 so that regulatory requirements for new treatment modalities can be incorporated in a timely manner.

6. Revising the requirement for a quality management program (10 CFR 35.32) to focus on those requirements that are essential for patient safety.

7. The viability of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC needs.

The NRC staff discussed items 17 and solicited preliminary views from the Advisory

'O Committee on the Medical Uses (if isotopes (ACMUI) at the April 1997 Committee meeting.

V [ Transcripts of this meeting are available by contacting the NRC Public Document Room and

s on the Intemet (as specified in the reference information provided).)

The ACMUI discussed their views and recommendations during a briefing of the Commission on May 8,1997. The ACMUI concurred with NRC's position to continue the ongoing medical program with improvements, and to decrease oversight of low risk activities with continued emphasis of high risk activities. The committee supported the use of professional medical organizations and societies in developing a performance based regulation. The ACMUI recommended consideration of a quality improvement approach as an attemative to the present Qua'ity Management Program. Further, the committee recommended, to the Commission, that the 1979 Medical Policy Statement be revised to reflect that NRC will regulate radiatio . .afety of patients only where justified by the risk to the patients and only where voluntary standards or compliance with the standards are inadequate. The ACMUl believed that the assessment of the risks justifying regulations should reference comparable risks and comparable modes of regulation for other types of medical practice. In addition, they believed that the NRC should not intrude into medical judgments affecting patients and into other areas that the ACMUI considered to be traditionally a part of the practice of medinine.

, This notice initiates a proposed rulemaking action which wi'l culminate in the development of a final rule for approval in 1999. In order to provide the public the most effective opportunity to participate in developing the rule text, the Commission is requesting public comment on the issues identified by the questions in this notice and on the ACMUI recommendations within 90 days of the issuance of this notice. Comments received after this initial 90 day

period will be considered along with the comments received on the proposed text that is C anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day penod in preparing the detailed proposed rulemaking text. Further, the sta'f recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented. Rather, the overriding issues are bod the identification of necessary changes (additions and deletions) to Part 35 requiremects and the assessmer.t of risk for a risk-informed, more performance-based

! regulation with sufficient oversight of public health and safety. The NRC staff is interested in idees, proposals, and comments on the structure and content of a revised Part 35, given the Commission guidance and direction as described above. To the extent possible, commentors are asked to provide speciac examples of draft .ule language.

Reguests for Comments on General Considerstions NRC has IV'sntified the following areas of Part 35 for consideration and is seeking comments on these issues, as well as any others, offered for consideration during the revision to Part 35:

]

1. How shuuld the Part 35 requi ements be revised to be risk informed and more performance based? How st suld performance be measured to provide both NRC licensees and NRC with an objective basis for determining regulatory compliance?

s

2. How should risk be assessed for medical uses and the regulation be modified to focus on procedu es posing the highest risk? What quantitative or

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h, qualitative entelia should be considered in determining the " risk" for each V modality?

3. What oversight should exist for diagnostic procedures that is commensurate with the associated risks?

4. What specific events or incidents should be reported to NRC7

[e.g., machine failure, leaking source, software failure, hardware failure) What enteria should be used for determining if the event is reportable (e.g.,

threshold)? Are there modality specific events that should be reported?

Should the term " misadministration" be changed to " medical event" or comparable terminology?

5. How should the regulation be redesigned to incorporate necessary regulatory requirements for new modalities? Should Part 35 be structured such thct requirements for a particular modality are grouped together?

6. Which Quality Management Program provisions should be re-evaluated and revised to focus on requirements that are essential for patient safety? Are different provisions appropriate for each of the different modalities?

7. Which standards and guidance developed by professional societies and other organizations are applicable to NRC-regulated medical uses of radioactive O material and how could they be incorporated within the regulatory framework of Q Part 35 and/or associated guidance?

8. How should the issues of training and experience be addressed? What individuals or groups should be subject to such requirements?

9. Which new issues / modalities should be incorporated into Part 35?

10. Should the 1979 Medical Policy Act Statement (44 FR L242) be modified to increase flexibility for a risk-informed, more performance-based approach to medical regulation?

Reference information 1 Strategic Assessment Direction Setting issues Paper Number 7 is available by witting to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634 3273; fax: (202) 634-3343).

2. The memorandum " Management Review of Existing Medical Uce Regulatory Program (COMIS92-026)" (dated June 16,1993)is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634 3273; fax: (202)

, 634 3343]

U 3. Radiation in Medicine: A Need for Regulatory Reform (1996) is available from

the National Academy Pro. . 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055.

4. Summary minutes and transcripts of the ACMUI April 1997 meeting or transcripts of the May 8,1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634 3273; fax: (202) 634 3343).

Transcriots of the May 8,1997 briefing are also available by Intemet at http://www.nre. gov.

5. The NRC Medical Policy Act Statement of 1979 was published in the Federal Reaister, Volume 44, page 8242, on February 9,1979.

Dated at Rockville, Maryland, this day of May,1997.

l For the U. S. Nuclear Regulatory Commission John C. Hoyle, Secretary of the Commission

l l

Federal Register / Vol. 62. No.153 / Friday August 8,1997 / Proposed Rules 42707 Faperwork Reduction Act AC'lON: Establishment of working group " Medical Policy Statement." The and notice of meeting. Commission SRM specifically directed This proposed rule contains no new isrn mc ng art 3 e dab

, information collection or recordkeeping kmentARY: A working consisting of inf rmed, mon pnfonnanedued requirements under the Paperwork representatives from t S. Nuclear Reduction Act of 1995 (44 U.S.C. 3501 "I '" " '

Regulatory Commiulon, the et seg ). Organlution of Agreement States A June 30,1997, SRM informed the (OAS), and the Conference of Radiation staff of the Commission's approval, with 1.lat of Subjects la 9 CFR Part 92 Control Program Directors (CRCPD) has comments, of the stalTs proposed Animal disease, imports, Livestock, been established in response to Program in SECY-97-131, Poultry and poultry products, Comminion appuval of the stafra SupplementalInformation on SECY-Quarantine, Reporting and proposed plan for revising 10 CFR part 97-115. " Program for Revision of to recordkeeping requirements. 35, associated guidance documents, and CFR Part 35,' Medical Usos of Accordingly,9 CFR part 92 would be the Commission's 1979 " Medical Policy Byproduct Material,' and Anociated amended as follows: Statement,"if necessary, With this Federal Register Nodce," dated June 20, PART 92--#8PORTATION OF CERTAIN a,nproval, the NRC stdu has begun 1097, After this approval, the NRC staff developing draft rule language and inluated development of draft rule ANIMALS, B4RDS, AND POULTRY.

AND CERTAIN ANIMAk, BIRD, AND attemedves, using an enualy modab language, using an entirely modailty.

POUl.TRY PRODUCTS; based approach, to help focus the public based approach. The modality approach REQUIREMENTS FOR MEANS OF input and the discuulons dWe places all requirements for a given type facilitated public mactings. Duru.e, Sir of treatment in.o a single secdon of the CONVEYANCE AND SHIPPfNO regulation, including: (a) Who or what Process, the staff is examining the CONTAINERS or);anir.auon is licensed: (b) what type of applicability of risk. informed, 1, The authority citadon for part 92 performance-based regulations and less license is issued:(c) the 2ccessary would continue to read as follows: prescriptive approaches to reguladon of technical requirements, such as surveys Authorityt 7 U.S C 1622; 19 U.S C 1306; nuclear material used for medical and calibration; (d) the training and 21 U.S C 102-105.111,114a,134a.134b, Purpmes. The working group will meet experience requirements: (e) the event 134c,134d.1341,135,138, and 136a; 31 at NRC Headquarters in Rockville, recording and reporting requirements:

U.S.C 9701; 7 CTR 2.22,2 80, and 3rt.2(d). Maryland, on August 19 and August 20, and (f) the quality improvement and 1997, to review the early draft staff management ob}ectives.

$ E300 (Amended) documents and to discuss the major per NRC Management Directive 6.3,

2. In $ 92.308, paragraph (a)(1) would regulatory issues anociated with the ,,The Rulemakin fYocess, the medical usa i hyproduct material. rulemaking will e nducted using a 9 be amended by removing the reference to "$ 92.317" and adding in its place the Darts: The YxrLing Croup will meet on EmuP approach. A governmental reference to "55 92.317 and 92.324". August 19 and 20,1997, from 9:00 a.m. working group consisting of to 5:00 p.at representadves of NRC, OAS, and 6 92.324 (Amended)

3. Secdon 92.324 would b

amended ADontssts: U.S. Nuclear Regulatory CRCPD has been established to develop Commission. One White Flint North, rule text alternadves, including draft by removing the words ", for . tot less Auditorium,11555 ;tockville Pike, than 7 days and" and by reme ving the guidance documents. State participadon Rockvule MD,20852-2738' in the process will enhance words "ennroved by the Adtcinistrator and constructed so as to prevent the a MTHtn seronenAtxpo cowTAmt development of corresponding rulea in entry of mosquitoes and other Cathy li.ney, U.S. Nuclear Regulatory State regulations, and provide an bematophagous insects". Comminion Office of Nuclear Material opportunity for early State input and Safety and Safeguards, MS T8F5, will allow the Stato staff to assess Ig2 *96 (Amended) Washington, [X: 20555, telephone (301) potential imparts of NRC draft language

4. In $ 92.326, the first sentence 415482d, o. mall cxhenre gov. on the regulation of non Atomic Energy would be amended by removing the a.ppLrssENTARY INFOnn4ATioN: NRC has Act materials used in medical diagnosis, words "92.323, and 92.32$" and adding examined the issues surrounding its tmatment, or research, in the States, in their place the words "and 92.323" medical use program in great detsu At the inidal meeting of the working Done in Washington. DC, this 4th day of during the last four years. This process on August 19-20,1997, the August 1997, started with NRC s 1993 internal senior group'will review the initial draft input Terry 1. Medley, management review report; continued

, deve oped by the NRC staff, focusing its Administrator, Animal and Plant Health with the 1996 independent external dhshab @ @twy inspection Service. - review report by the National Acaderny a ass h MW um of Sciences,lastitute of Medicine; and (FR Doc. 97-20944 Filed 6-7-97; 8:45 aml culminated in NRC's Strategic 0 GYP d 4.d-

'f' m,,, co,, ,,

Assessment and Rebaselining Project Comaanittee Oganiz.atiog and (SA). La particular, medical oversight Operations wac addressed in the SA Direction.

NUCLEAR REGULATORY Sutting issue Paper Number 7 (DSI 7) Cathy llaney, NRC, Office of Nuclear COMMLSSION (released September 16,1996). In its Material Safety and Safeguards, wul

" Staff Requirements Memorandum serve as chairman. Other members are 10 CFR Part 35 (SRM}--COMSECY-96.-oS7, Materials / from the NRC's Office of Nuclear Material Safety and Safeguards: Office 4 [. Medical Use of Byproduct Material'. Medical Oversight (DSI 7),"

March 20,1997, the Commission dated of Nuclear Regulatory Research: Office (v) Wortdng Group for Revision directed staff to revise Part 35, of the Ceneral Counsel, and Office of AGENCY: U.S. Nuclear Regulatory associated guidance documents, and, if St:te Programs; and from OAS and l

Cotamission. necessary, the Commission's 1979 CRCPD.

42706 Fehral Register / Vol. 62, No.153 / Friday, August 8,1997 / Proposed Rul:s Comsnittee Meetings security control room are accessible could choose either to designate one The working group will rneet, as imm the courtyard entrance on 20th omce to hold a single account at one needed, in the Washington, DC, area, or Street tetween Constitution Avenue and Reserve Bank or to continue to have at other locadous agreed upon by the C Street, N.W. Comments may be separate accounts on a same-state /same-warLing group members. Meetings will inspected in Room MP-500 tetween District basis as they do today. The le announced in advance, through the 9.00 a.m. and 5:00 p.m. Iloard is also proposing changes to the NRC Public Meeting Nouce System and, FOR FURTHER INFOfedAT10N CONTACT 3 pass through account rules in with some exceptions, will be opeu for Oliver Ireland, Associate General Reguladon D to accommodate the public observation. Persons attending Counsel, (202/452-3625) or Stephanie single account option and to make other working group meetings will te Martin, Senior Attorney (202/452- changes applicable to all institudons welcome to provide input to the 3198), Legal Division. For the hearing that will simplify and clarify the pass-warLing group for its considerauon, im alred only, contact Diane Jenkins, through rules' either in written form or orally, et times Te ecommunications Device for the Doaf The Board telieves making a single specified by the working gruup chair. (TDD)(202/452-3544), Board of Governors of the Federal Reserve account opuonal rather than required Dated at Rockville. Maryland, this 4th day System,20th and C Streets, N.W., for families of foreign bank branches is Washington, D.C. 20551. reasonable in light of certain o uc eer Regulatory Conuniuion go ,y g,cna, surettaeENTARY pdFOfenAT10N: To operational, legal, and supervisory facilitate interstate bant ing, the Federal differences between U.S. branches and arector, avision oflndustnal and Medical agencies of foreign tents and domestic Nuclear Safery, Office of Nuclear Matenal Reserve Banks will begin to irnple, ment Safety and So/cguards. a new account structure on January 2, %nks.8 For example, certain foreign IFR Doc. 97-20974 Filed 6-7-97; e 45 aml 1998, that will provide a single Federal banks have historically managed their egg, y Reserve account for each domestic U.S. omces as independent enuties that depository institution. This structure do not necenarily coordinate lending will enable the Federal Reserve llanks to and investment decisions fmn a central establish a single debtor-creditor omce. Furthur, each omce of a foreign FEDERAL RESERVE SYSTEM relationship with each chartered entity- bank family must have a seoarate 12 CFR Part 204 thereby providing an effective means for license, either state or federal. The Reserve Banks to carry out their risk " g (Re99tepon D; Docket No. R-0000) management responsibillues, and will at i t e ice d a d no fede a ly Reserve Requirements of Depository insused and are thus would be gement re t tudons.

liquidated separately based on the law institutions To determine the eralFbosi Reserve Bank of each Ilcensing state. In addluon, U.S.

AGENCY: Board of Covernors of the where a bank with interstate branches Federal Reserve System. will hold an account, the Board adopted bank supervisory authorttles treat U.S.

amendments to its Regulation D (12 CFR branches of foreign banks as LCTION: proposed rule, independent units for other purposes, part 204. Reserve Requirements of sunseaARY: The Board is proposing te Depository Institutions) and Reguladon such as asset maintenance requirements.

! (12 CFR part 209, Issue and At a result of these differences, U.S.

cmend its Regulation D Reserve Requirements of Depository Institutions, Cancellation of Capital Stock of Federa) branches of foreign banks may be placed to cllow U.S. branches and agencies of Reserve Banks)(62 FR 34613, lune 27, at a disadvantage if they were required, foreign banks and Edge and Agivement 1997). These amendments define a in the short term, to adopt a single corporations to choose whether to domestic depository institution's account structure, aggregate reserves on a nationwide basis location for purposes of Federal Reserve To ensure stability in account in a single account at one Reserve Bank snembership and reserve account relationships and to move the foreign or to continue to have separate accounte rnaintenance. banks and Edge corporations toward the on a bame : tate /same District basis at U.S. branches and agencies of the n accoun s c ure, d

th:y do today. The amendments would same foreign bank and Edge and Qgong ), ,, 9 ,

clso update and clarif the pass-through Agreement corporations 3 of the same p asi(le, w uld be a one way election.

account rules in Regufstion D for all parent bank were not included in the That is, once an entity selects a single Institutions. These amendments would new single-account structure or in the final amendments to Regulations D and account it would not be permitted to f;cilitate interstate banking and sliminate certain restrictions applicable I, pending further consideradou of legaj switch back to multiple accounts without the lioard's approval. The to pass.thmugh accounts, and operational issues. The Board is DATES: Comments snust be submitted on now Proposing amendments to singte account would be available to Regulation D under which the Federal U.S. branches of foreign banb and Edge or before September 12,1997.

ADORESSES: Com ents, which should Reserve Banks will offer a single corporations effective January 2,1998.

refer to Docket R-0980, may be account to these institutions on an mailed to Mr. William W. Wiles. Optional basis. Under this proposal, a Th distinsuistuns char ctenstica of U.s f reign banks and Edge corporations branch. of tomsa banks do not n.c.naanly apply Secretary, Board of Governors of the to Edg. corporations As a result, the legal.

Faderal Reserve System,20th Street and supem.on and risk man.sement tr.aun.ni of Conslitution Ayenue. N.W., ,y," gl,7,@g]*gu bNb "'P*'f****h*'8'* P ' *

'""ff rs from that of multiple U S ofr' ices of for.ign di wtshington, D C. 20551. Comments and Agreement corporations hav an agrecreent or baras uni.e. otherwi noted.the followins points addressed to Mr. Wiles also may be undertaL2ns with the soard under ciion as of the Federal Reserve Act (12 U S C 601404al For 8rP l y th*2nly to U.S branches of fomgn t anks delivered to the Board's mail room " * ' * " ' ' ' ' b' " ""'*I between 8:45 a rn. and 5:15 P.m. and to P"'P" *' 'h d d ,, ,'h','.ni corpore, on irmiod,,A' "hd co,8' treatmeni of th ',eniii, E*II',I

. how , ','8"I

Y

r. th a'ccouni poret,on, the security control room outside of $imalarly the ierm ' branch" of a for.isn bank structure for U S branches of foreign banks apphes those hours. Both the mail room and the irutudes both branches and agencies io Eds, corporations as weit

42219 Proposed Rules r + ai w Vol. 62, No.161 1]

k Wednesdsy, August 6,1997 TNs secton of the FEDERAL REGISTEH Rockville, MD, between 7:30 a m. and guidance, as well as during review of corna,ns mtices to the putee of the proposed 4:15 p.m. on Federal workdays. the Medical Policy Statement, the NRC essonnce of rules ans regulations. TM Public input may also be submitted staff was directed to consider the j purpose of the notices a to 9've Mterested electronically on the internet via NRC's following issues:

pers ns an mionung m parucepate M the Technical Conference Forum (http:// 1. Focusing part 35 on those 1

M'""*80"D'"*" techconf.llnl gov /coframe.htmll. This site provides the ability to post your prucedures that pose the highest risk

2. Regulatory oversight alternatives.

l

- loput as a menage For informadon for diagnostic procedures, that are NUCLEAR REGULATORY about the Technical Conference Forum consistent with the lower overall risk of COMMISSION contact Mary L. Thomas at (301) 415 these procedures.

6230; Email MLTienic. gov, 3. The best way to capture not only 10 CFR Part 35 FOR FURTHER INFOma4 Aft 0N CONTACT: relevant safoty-significant events, but Catherine lianey, Diane Flack, or also

! 4. gmcunor ie med toevents.

change from the tenn fun St SO-AF74 Susanne Woods Telephone (301) 415- "rnisadrninistradon ' to " medical evnt,,

I 415-5681, or (301) 415-Medical Use of Byproduct Material: 682b, 7267; Emal(301)f CX11eNetc. GOV, -

or other comparable terminology.

lasues and Request for Pubile inpet DSF1taNRC. GOV, or SitWLNRC. GOV; 5. RedesignN pau 35 to that

' Tice of Nuclear Material Safet and mgulatwy reqummmts im ww AGENCV: Nuclear Regulat ary ;afeguards, Nuclear Regulatory treatment modalides can be

- "I "'

Commission, Washington, DC 20$$$- rated in a umely manut.

! ACTION: Request fur public input on rule ooot' & fevisbg 6e mquirement im a development. quality management program (to CFR SUPPLEnfENT ARY INFOResATION: 35.321 to focus on those requirements sunen4AMy: The U.S. Nuclear Regulatory Back I"""d Get am essendal for patient ufety.

Commission (NRC) has developed e 7 The vichtlity of using or referencing l

program for revising the regulations The NRC has examined the issues available industry guidance and l governing the medical use of byproduct surrounding its medical use program in standards, within part 35 and related

,m material. The decision to revise this great detail during the last four years. guidance, to the extent that they meet

, (j\s regulation resulted from the NRC 5trategic Assessment and Rebaselining initiauve (SA), a process involving This process started with NRC's 1993 internal senior managernent review report; continued with the 1996 NRC needs, Pro $ ram for Revision of Part 35 Identificauon of the direction setting independent external review report by The June 30,1997, SRM informed the issues and associated opuons for the the National Academy of Sciences, NRC staff of the Commission's approval, I future of NRC activides. This notice Institute of Medicine; and culminated in with comments, of the NRC staff's describes the NRC's program for NRC's SA process. la particular, proposed program in SECY-97-131, revising the medical use reguladon: medical oversight was addressed in the Supplemental Information on SECY-notifies the pubth. of the availability of SA Direction. Setting lasue Paper 97-115. " Program for Revision of to documents associated with this action Number 7 (DSI 7)(released September CFR part 35,' Medical Uses of on the NRC Technical Conference 16,1996). Ilyproduct Material / and Associated Forum and through the NRC IMlic in its " Staff Requirements Federal Register Notice," dated lune 20, Document Room; and solicits informal Memorandum (SRM)-COMSIE*Y 1997, With this approval, the NRC staff l public input on development cf 057, Materials / Medical Oversight (DSI initiated development of draft language proposed rule language and anociated 7)," dated March 20,1997, the using an entirely modality-based documents. The Commission plans tc, Commission dWeted the NRC staff to approach. The modality approach formally propose s"cific rulemaking t'Vi** Part 35, associated guidance places all requirements for a given type i

text for public com.r.ent during the documents,and,if necouary,the of treatment into a single section of the summer of 1993. Commiazion's 1979 Medical policy regulation, including: Who or what Statement. Further, the SRM stated: organir.ation is licensed; what type of OAtts: Public input is solicued during l development of the reposed rule but. With roepect to the medical program, the license is issued; the necessary to be most helpfults ould be received Commission was not persuaded by the technical requirements, such as surveys by March 1,1998. Comments received National Academy r,I Sciences, Institute of and calibration; the training and g M*dicin8 UOMI t' Port that recommands that experience requirements; the event after this date will be considered if it is NRC should not be the Federal agency Prectical to do so, but the Commission recording and reporting requirements; i involved in the reguisuon of ionizins and the quality improvement and

, only is able to ensure consideration of radiation in medicine. The Commi= ton comments received on or before this man gament objectives. The NRC staff continues to believe that tha conclusions in anticipates that the following modalides e te. the report were not substantiated and that the 3g g,,gg g, AD0 MESSES: Send written input and recommendations should not be pursued.

(1)1Arw dose unsealed materials i suggesuons to Secretary, Nuclear The Co.smission SRM specifically (diahnostic nuclear medicine);

l (,qi Regulatory Commission Washington, directed tLe rostructuring of part 35 into DC 20555-0001, Attention Rulemakings a risk informed, more performance-(2 liigh-dose unsealed (nuclear medicine therapyh materials

' )

\ and Adjudications Sta!!. ILnd-deliver based reguladon. Furthur, during (3) Low-dose scaled source comments to 11555 Rockville Pike, development of the rule and auociated applications;

===.-

42220 jederal Register / Vol. 62, No.151 / Wedn:sday. August 6,1997 / Prop For the Nuclear Regulatory Cotamission.

comment period to facilitate cotoment John C lloyle.

(4) Tcletherapy; submittal.

($)liigh dose rate remote afterloaders: Secretary of the Commission.

Development of the final rule.

(6) Camma stereotactic surgery; and assoclated documents, and final (FR Doc. 97-2% Fded 8-b97 M5 aml (7) Emerging technologies. % ,,,

guidance will be done using a _

This list is not viewed u all- governmental work J g group and inclusive. Additional categories may be steering group. The c iRC staff will d:v: loped, depending on the broadth of continue to make draft documents DEPARTMENT OF THE TREASURY tha areas to be covered, and the avalbbh su the NRC Technical similarity of requirements tri a given Consoren :e Forum, but will not be able 31 CFR Port 27 area. to considar further public input on these C:v:lopment of rule text alternauves, documents, teginning approximately Departmental Offices; Civil Penalty Assessment for Misuse of Department including draft guidance docurnents, four months before the submission of of the Treasury Names, Symbols, Etc.

w:uld be done using a governmental the draft documents for Comminion w:rking group (or groups) and steering 8Pproval(currendy scheduled for May A0Decvs Departmental Offices, Ttrasury, cipants have 1999). The NRC staff plans to discuss b,roup approach.

n identified for State the working and the draft final documentsACTION: with Nodce the of proposed rulemaking by crou reference to Interim steering groups sud will enhance State ACMUI and the Agreement States before regulations.

participation la 'his procou. submitting them t' 'he Commission.

The NRC statt plans to solicit public SutataARY: in the rules and reguladons input on the n. vision to art 35 Reference tafortnation portion of this Federal Resister, the

'"" 1. suatesic Aue sment DEtion Settirig Department of the Treaury is issuing "y*$ [c [tatement on an luvas Paper Number r is aradable by writuig interim reguladons settin forth the ini:rmal and ormal basis during the to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Docament Room, procedures by which civi peaalues will rul: making process. It is expecied that be imposed for violations of the Wuhington, DC 20555-o001. (Telephone:

the first version of the draft rule (202) an-32n; las:(202) 634-n43.1 statutory prohibition against misuse of language will be available to the public 2. The memorandum " Management Review p, *" gg *"

on the NRC Technical Conference Eus M ,al U R latoryI ,y g s,abb e a ns,ini Is, a

Forum and through the NRC public seals, or badges. Section 333(c) of Utle Document Room,in August 1997. , 31, United States Code authorizes the During the development process, the latory Comminion. Attenuon: NRC Secretary of the Treasury to impose NRC staff will make drafts publicly R$ic p Document Room. Washington. DC these civil penalues. The reguladons are avdleble, but will need to cut off 20555 o001, fielephone: (202) 634-3273; being promulgated to ensure that consideration of informal public input fas:(2021634-un) persons assened with a civil penalty

3. " Radiation in Medicine: A Need for at a point approximately two to thae Regulatory Reform"(1996) is available from undet 31 U.S.C. 333(c) are accorded due montas before providing the drah the National Academy Pms at 2101 Process. The interim regulations aise pro ed rule language and associated Constitution Avenue,NW, Box 285, serve as the text of this notice of dra ocuments to the Comndssion for Wuhington. DC 2noss. Proposed rulemaking for final a roval. (Currendy the draft proposed 4. Summary minutes and transcnpts of the reguladons, ru e and associated draft documents are ACMUI April 1997 moeung or transcripts of 997' va db eI'>y e S uc70ar oa or i e u on hy 998 ) blic Input Regulatory Commission, Atter, tion: NRC ing ADORESSES: Send wtatten comments to:

ttcivui after that time would be Public Document Room. Washington, DC Karen Wehner, Senior Advisor, Office of considered as part of the ongoing 20$55-cool, fTelephone: (202) 634-32 n; Enforcement, Room 4414, Department of int:raction process, and as par of the fu (202)634-n43 ITranscripts of the May the Treasury,1500 Pennsylvania comments received duting the formaj a,1997, briefing are also evaliable by laternet

^"""*

public n 13 afte* comment Cr aissionperi" on tl.e approval. Tho proposed $

' "(,#E"j] Policy Act Statement FOR FURTHER WORT 4AT10N CONTACT:

NRC staff plans to interact with of 1979 wu published in the Federal Karen Wehner, Senior Advisor, Office of Register, Volume 44, page 8242, on February Enfortement,202-622-0300 (not a toll-professional socieues on an ongoin8 basis to solicit input. The NRC staff will 9, 6. t e79.

SEC~r-97-115. Program for Revision of free call).

conduct facilitated public meetings in to CR part 35," Medical Uses of Byproduct SUPPt.EWENTARY WOnenAftON:The th] Fall of 1997. These meetings will be Material" and Auociated Federal Register interim regulations in this issue of the used to focus discussion on specific rule Federal Register establish 31 CFR part t;xt pro sals. Discussions would also y, i yl* S,upplit,

,, 'up menal 27, For the text of the interim be held a meetings with the Advisory tdormauon on SECY-97-H5, Program for regulations, see Civil Penalty Committee on the Medical Uses of Revision of to CFR part n,' Medical Uees of Assessment for Misuse of Department of Isotopes (ACMUI) and the Organization Byproduct Material / and Associated Federal the Treasury Names, Symbo Regneeer Notice; and the nuociated SRM cf Agreement States in the Fall of 1997. (dated June 30,1997) are available by writing laterim rule, published to the r After Commission approval of the to the U.S. Nuclear Regulatory Commission, regulations section of this issue of the proposed rule language and auociated Federal Register' documents, the proposed rule and Attention:

Wuhington. DC NRC Public Document 20555-o001, frelephon Room'e.

(2021634-32n; fu (202) 634-n43.1 Executive Order 12866 associated draft documents will be published in the Federal Register for Copies are also available on the NRC It has been determined that this public comment for 75 days. The NRC Technical Conference Forum at http:// proposed rule is not a significant staff will also make these documents techconi.llnl gov /noframe.html. regulatory action as defined in E.D.

available on the NRC rulemaking 12866. Therefore, a regulatory Dated at Rockvslie, MD., this sist day of assessment is not required.

website. The NRC staff plans to bold July,1997, two public meetings during the formal

UNITED STATES NUCLEAR REQUL ATORY COMMISSION

~

RULES cnd RESULATIONS TITLE 10. CHAPitfl 1, C0pt OF MDERAL RIOULATIONS = *.NtROY

=;

4 ( ~

COMMISSION NOTICES POLICY STATEMENTS ME0lCAL USES 3

i a

4 44 FM 8242 Nbl=hed Us/79 ined in the NRC Pubtle Document 11. Itattostus gHech 3fpftp Roorn et Ill? H Street. N.W Wash, tragion. D.C. The NRC and its predecessor the Atomic Energy Commttslon have ress.

l E*pwlefien of time Medisel Weg og lated the toedical uses of radioisotopes Redielsel* Post Statement of G***'* This N!1C polley statement is in! since 1948. AEC tecognised that physk el Pelley tended to bforrn NRC licensees other clans hate the primary responsibilits Federal and state agencies and the for the protection of it'ett patients pubhc of the Commission's generalin- at.d designed its regulations according.

AGENCY: Nuclear RestletorF com' m iention regarding the regulation of the medical uses of radioisotopea

17. ne physicians sete required to be licensed by the Stata, and thett apptl.

AC'f10N; Pinaj Policy StatemenL !!is espected that future NRC actle. cable training and expertence eete itles in the medies) sten, such as pro. etaluated in consultation sith the Ad-8UMMARY: he Nucle *8" "A*fF mutsation of new regulations and de- visory Committee on the Medical Uses Commisalen mRC) baa the fouowtM telopment of cooperathe tel.itionships of Isotopes. Ela regulation has been policy statassent regarding NRCs sith other Federal agencies, s til future tele in regulating the medical follow this statement of NRC pclicy.

Ienersgly oriented tow ard sulsting uses of radioisotopes his NRC policy Based on past espertence and the lified ph) sicians in discharging statement is intended to inforsa NRC comments and adsice of Me public. h",*ir tes$psabilities to pstlents How.

\ Ilcenseen. Other Pederst and State other Federal agencies, the States, and or another encompassed

, agencies and the public of the Com. NRC's Adsttory Committee on the '"' )g'g',f,u stloe f theby AEC/NRC delbery of h sniaaloe's general intenues regarding the regulation of the n>edical uses of Medical tfses of Isot: pes, the Cernmis 41cn has doel; ped the f:lloting state,-

3'jgj,,y,"I md i

" a ser Ices to ps.

radioisotopea. 18 is espected that tients. D broadest regulation oc.

ment of genets! polle{uses to rulde sta res.

of radioiso- red bets en 1962 and 1975, s hen future NRC acuvtues h the smedical ulation of the r stica ye Food and Drug Administrstion trea, such as promulsauce of new reg. topes 3 ulations and development of coopers. 1. The NRC till (9ntinue to regulate t FDA) es'e mpte4 ftorn its req uite-Uve relauenships with other Federsi the medical uses of radiotsotopes as me ts n U * '

ed by ndas ill follow this stateenent of {c(cyaty pg to p c t e ge er AEC Durtng this period AFr teru sta publac, ed the radiation safety or sor).ets nd E77ECT1VE DATE Pebruary 9.1913' the general public p%s the ssfety and

2. The NRC s til regulate the tsdl* efficacy of radicscthe drugs and de-POR PURT1tER INFORMATION stlon safety of patienta a bete justified tleca sith reapest to patienta. AEC CONTACT by the sist to patients and there vol. tegulauon included production of the Mr. Edward Podolak. Oftlee of untary stAndstda, of templiance sitil redlotsotope. manuf acture of the final Standards Development. U.S. Nucle. ese standards, are inahquata, tadioacthe drug product or dedct dia.

at Reguletory Commtssion. Wash. 3. ne NRC will minimite intrualon tributton use and disposalof the pro &

incton. D.C, 30555 (Phnne 301-443 tnto medical judgroenta affecting P6 ucts. In 1915. the FDA termlosted tiae g tients and into other areas traditional. emetoption for radiopharmaceuticata.

ly considered to be a part of the prac" statitig that it sould nos regulate the SUITIEMENTAL IMyCRMATION. Lice of toedicine.

The NRC has developed the follostnf safety and eff6cacy of rad.oacute three att pot 6cy statement regar@ng drugs sith respect to patlenta. ( As NRCs future role in regulattng the noteil later in this statement. FDA

.NRC beennes todtotnotopes in three cate- does t.ot regulate the physician's rou.

snedical uses of rad 6olaotopeA On sortes b3 product. nource and special nuese. ttne use of raa opharmaceuticals.) At March it.1914, the three part pollcy at matertat he NRC does not regulate nat* the same ilmt. NRC sIthdrew iform statement sas oublished La the Funes. urant erruntns or accelerstor produced rr" regulatitag radioacthe drug safety and as Rsctstra t48 FR 113083 for putdae 82*'**'* P** h' t" efficacy. stating that it sould regulata 6"'*8 "8 "

8's"*'

comment. Copies of the polacy state.

ment _a ere anat ta all FRC medical 16

$*MF s$3' y "*

[, 'g$$'$

aiouuse br exposure to the tsdiatico tacs, the radiation safety of the sorkers and the public. The 1918 M ed. cal censees, the States and 25 profetstonal seng go the prae e of prodactor or utustine Dedce Arcendments to the Iood. Drus spesettes. Federal agencies, and indl. special aucJeu matettaL The term sorse and Coucette Act eatended FDA's au.

Oduals De comment period emptred metersal means tu uranium, thonum or ant thority oser medical dettees tinclud:ns May 16.191L Tsecty two commenta combtnauce thereof, in ant physical o' dedces cootalning radioacthe materv sete tecched. NLne commenters it. ta fm tored all three parts of the policy 7,("jgQrm,(t2 pa e t, ids) in a say altnnar to its authority or roote of di ursaluam, att) thorture or cut, oses drugs.

/ \ statement. four commenters opposed are combtnauon therect $ourse snateral NRC's authority to regulate domes-does not tnetude special oucleas materlat ticany the medical uses of byproduct

(\ /) one nine part commenters of the polley statement addressed and specifte .fucial awliar metenal sneans til plutoru- matertal is found to the Atomic issues discuased in the March 11.1913 knL uraniuna 233. urtnlum enriched to the Energy Act of 1954 as amendd For Partau Rtcisica tiollee! The com. Laotope saa or to w tsotope 233 or ::s artt emarnple, section 81 of that Art autho-ments are discussed in Section II mawal an ant enne ed br ant et W titea NRC "to issue general or spectile Copies of the commenta may be exam ^8 - 8***'*** ' * * *

licenses to applicanta seeking to use byproduct matettal fot * *

nedical therapy ' * '." Section el direca hPC

POLICY STATEMENTS ,

' to terulate the manuf acture, produc- rDA's methttles. '.s in harmora sith be a part of the practice of entd!:Ine llork trallfer, rectlpt LD laterstate regulation by the Depaltruent of The Comruissief, -*cegNaes that phy cor.1!Derce, acquisjtlon, otter $ hip. poa' Transportation Soc'.a! Security Ad. sirIsns hate the Hary re.yorts bility seulon, impSrt and esport of b> prod- ministration and the Joint Commis- for the plottesk of their pat!ents uct material. FinaHy. Sectico 81 also ston on Accred!tation of Hospt als; and The Comtnisslor. 'ecifetes that bule' directa that covetails sith Occupational Safety dectstons concerning the diarnos?s and and Health Admlnistration regulation treatment of dinesse are a part of the The Commtanan shall not permit the dh, physictan patient relat!onship and are tilbutton of ans byproduct material to any of the work place for the use of natu-beensee, and shall recall or order the reesa rs!.y occurring and accele.ator pro- traditionaPy considered to be a part of of any distrfbuted matertal from ant beens. duced radloartive materials. the practs.o of med:ctne. NRC regula-et a he is not eculpped to obserse or taca to The second part of NRC's policy tions are p.' decated on the usu.nption etueru such safety standards to protect statement lndicates that NHC stil reg. that proper!r trained 301 and make adequatelf heaJth as mar be estabitshed by the Com. ulate the rad:ation safety of patients informed physiciar.s dec

" where justified by the risk to patter.ts alons to the best interest of their pa-t Ntas a re at of the conun and there voluntary standards, or tients.

or in a mannet oth-r than as dudosed la compilance tith these standards, are The regulations try to find a balance the apolnat;en therefor ce approved br the coauntauceL inadequate. As noted before. NRC has between adequate controls and avold.

the authority to regulate the radiation anee of undue interference in medical Commlulon regulatiou for tM safny of pam judgTnents. A cor sequence of too tuost part set forth in 10 CFR PartJ 30 much regulation could be poorer through 35, tere promu gated to carry The NAS-BEIR ' report discusses health care delivery to patients. A con-out the broad regulatory scheme en. timiting the esposure of the popula-tjon to m..itcal applications of loni:ing acquence of leaving to physicians the vitsged by section St. For eatmple, majority of the dectslons concerning Part 33 estabitshes regulattor a specifle radiatfort That report. a hlch includes au medical uses of lontr.tes rad!ation. their patients is that tht phystelans to human uses of byproduct rosterial. shosi an average dose rate from wul make mistates. The tightest regu-FDA's statutory authority (Federal r3211opharmaceuticals of 1 mrem /ysar lation of physicians

decir. tens by Fed-Food, Drug., and Cosmette Act, as and an averste dose rate from diag- eral. State end professional groups M11 amended, 31 U.S C. 301 et seg.) does nostic radiology of 12 mrem / year in not be able to prestnt future incidents not d!mintsh NRC's authority Where 19'l0. in the med! cal uses of radiotsotopes, NRC's and FDA's authorttles overlap. The folios!ng quotation la frorn the The Cornmiss!on recognl:es that the respective autherttles can be har- N AS*BEIN D II- PDA regulates the manuf acture and monized by lateragency agreement. interstate distribution of drugs,includ-The central question is a question of in the foreseeable future. the scalor con-ing those that are radioactive. FDA policy not aufAortly, namely- tributors to radiatacn espcxme of the poou-To t hat extent should the protec. tation sti continue to be nawral taca* siso regulates the investigational and tion of the patient be consJdered in ground s-tth a.n aserase she's boJr dose of research uses of drugi as well as the t too m / at nd med al app' specific gu! dance on doses and proce-NRC's regulation of the medJeal use of byproduct material. dures found in the product labeling.

posure= to eartous ussees of tr.e body. Medo From the standpoint of su!Aority, it -s! esposures are not under control or syd. Hosever. FDA does not base the au-La clear that NRC can regula'.e the as ce by regulauon or law at prnent. The thority to restrict the routine use of medical itses of byproduct material to w of torcains radiation La sted.ctne is of drugs to procedures (descrCbed Ln the protect the health and safety of users tsemendous estue but it is essentlaJ to product labeling) FDA has approsed of this matettal, for instance, patiects, m% e exposures since tras can be accom- as safe and effecthe. Indeed. NRC ts La licensing the possculon and use of pushed s,thout loss of benefit and at reia- the only Federal Agency thtt is cut.

byproduct material, N'.(C N blishes uvely low cost. The sun la not ordt a rentiy author!ud to regulate the rou-11rnits within which physicians exer, reduce the tsdisttoo exposure to the todo tine use of radioacthe drugs from the eidus2 but also to baee procedures carned ctse professional dtseretion. Ffom the out oth maaunum eff.ctency no that there standpoint of reductng unnecessary ra-standpoint of podey, these !!rg Si be a continmns tneresse tn med. cal distion exposure to patienta.

Q.ftts .act mpaNed tr a alrumum rada- The Cornmission belleses that the nt h rd to t at ent s c. 'm " - &agusuc use of radioacun drugs 13 and safety in the uses of the byptd NRC stil act to help ensure that ra. La most cases, clearly an area of low uct matertal.The greater the potential diatMn exposure to patients is as low rsdiation risk to patients. Therefore, hazard to a patient frorn the byprod, a.s is reuonably achlesable, consistent NRC will not control physician's pre-uct material or its use by a phystelan, s:th sampetent medical care and sith rogatives on patient selection, instru-the me..e NRC may elect to circum. minimal intrusion into medical juds- ment selection, procedure selection, scribe ateu that might otherwise be ments. NRC w!!! not exercise regula* drug selection and dose level for most regarded as within the dtscretion of tory control Ln those areas where, d! agnostic uses of rsdloisotopes. For the physletan, Upo a careful examination, it deter

all therapeutic uses of rsdioacthe The first part of NRC's polley state. mines that there are adequate regula* drugs, and in certain diagnostle uses-

. n ent indicates that NRC will continue tions by other Federal or state agen. for eaample, the use of phosphorus-3:

l to regulate the madleal uses of radfol. ctes or well administer,ed professional for localt:ation of eye tumors-the I actopes as necessary to prostde for the standards. Wherever possible. NRC riat to patients La not los'. The risk of radiation safety of morters and the will work closely with Federal and tissue or organ damage (or even deathn general public.' This la the tisditional State agenetes and professional groups is inherent in the use of therapeutic regulatory function of NRC for all in designing new votuntary guidance uus of b> product, source and special d W W d e NRC g W ,

! nuclear material. It is a regulatory for,practi pa nt loners to 11rnlt unnecassary role that saa not questioned by any of rd p of P s po!!cy state, peutic and certa!n d. agnostic radicac-the commenters but, tsther, it was the drugs to the Ind!cated procedures r

consistently recognized as a necessary ment tndastes that NRC sill mini. that have been approved by FDA. The l

m!:e its intrusion into caed%al judg. NRC sill not cor. trol the physicians' le in the medical uses of radiotso- ments affecting the cat.cr.t and into other areas traditionally co .sidered to prerogathes on patient sdeetloo and C's regulation of the tsdtation I"3 *N*

N E#

safety of workers and the general cedurea, because these procedures a.re public in the medical uses of radioiso" 'Nattorial Aesdemy of SMences Admorr so specla!Lted and patient spectfle.

topes is relinquished by NRC to Agree- committee en the e.oterseat E reets et ton- CongTess recently gave FDA authort.

ment States; does not osertap sith tz:rg Rad.auons tNALEEN re; ort. ne ty to regulate medical dedce1, strnilar sects os Pop.'atno%' of gzvosure to f.aw g gg., gp g nygq gy

'The term seneral pubt:e in this state. ,,fj',,y'# e/ e res but with add tional authority to re-mer.t spectt:cany taclades pattents Coued Washinswn. D C tietn strict the routine use of med: cal de-O l

September 29,1995 PS MtJ-2

s e

POLICY STATEMENTS A vlees as may be Decessary to provide nosed sith radioactive material, as u riotta in *l.e prono:ed policy

( yetsonable usurance of their safety well as the general public who may be sta.4 m.t. NRC la studs tng the tar.

(v) had sufficient time to implement j and effectiveness. FDA has azot yet treatment, areits exposed to radiation as a result of that all members of the tous allied hralth estifiention pro.

gram'. currently in e!!ect or being full authority to regulate medical de. public to be protected by NRC. diaftsd by other Federal. State and Vices contain'ns byproduct, source or Two commenten objected to NRC"s prof essional grotips. If the coterage spec!al nut! ear material Therefore, regulation of patient radiation safety pro'ided by these programs is not ade-WRC stll continue to restrict phal. because they believe that NRC does quale to protect the patient from un-elan's uses of these medkal desicos, not have the authority to regulate pt. necessary radiation exposure, NRC both foe dissnosts and therapy, to tient safety. They note that NRC's en. 3l11 sork sith these g7oups to detelop those procedures that NRC has deter. abling legislation does not specifically a new NRC Droposed rule for the mined (in consultation sith its Addso. mention the radiation safety of pa. training of allied health personnel ry Committee on the Medical Uses of tient4. They believe that patient There sere five comments on the Isotopest to be safe and effective, safety is the responsibility of the phy. specific subject of nuclear pharmacles he Commisalon does not consider stelan, a responsibility that cannot be tradiopharmaclest egulpment calibration, quallfleations shared. They bellene that the Commis- One commenter urged NRC to dis of paramedical personnel or reporting slon is in ersor to equate patients sith tinguish bets een radiopharmacista to NRC missdministrations of radioso. the pubtle and to consider patients as s orking in a hospital setting and those tive material to be esclushelp the u.sers tather than recipients of radio. sorking tn a retall emironment tcom-practice of medictoe or a part of physt- sethe material. mercial nuclear pharmacy). nis -om.

Elan patlent relationships. The Com. As noted in the analysts of the stml. menter also noted the complexity of misalon intends to regulate these areas f ar comment above, the NRC's overrid. the problem of definition then the of patient radiation safety ahere justl. ing congressional roandate la to pro. hospital based radioph"macy pro.

fled by the risk to patients and these tect the health and safety of the tides radlopharmaceuticals to other voluntary standards, or complianc* public. The patient is a member of the hospitals and practitioners in its area, cith these standards, are inadequate. public, notsithstanding the Commis. As noted in the proposed polley ston's recognition of physletans' prima. statement. the NRC atil defer to the III. Discussion or Pvaue Cowworre ry responsibility for protection of Food and Drug Administration (FDA)

A. conottns ON THE roWCY sTaTDEDT their patients. The policy statement regarding a determination of those ac.

and, indeed, all of the Commission's thitles of nuclear pharmacies that sill One commenter opposed the use of be considered manufacture and those the general term "radtotsotupes" in actions in regulatmg the medical uses the first part of the policy statement. of radlotsotopes, acknosledge the sec. meth1tles that will be considered the

' ondary but necessary role of NRC in ordinary practice of pharmacy (com.

This commenter was concerned that, poundmg and dispensingt tf taken out of the context of the foot- regulating the radiation safety of pm.

tients The Commission also considers Four commenters objected to NRC's note,it edd be interpreted to include licensing nuclear pharmaeles to dis.

nat::ralG and accelerator patients to be both users and recipl.

pr. Ant te'N.1rring ents of radioactive material. Rosever, tribute only those products that they 1 msotopea. have prepared from FDA approved Yr't f/ a tion belleges that the the distinction between receipt and O use of radioactive materials is nog radlopharmaceuticals or reagent L!ta.

/ \ get"ran am radioisotopes" is plata Ena"sh ar1 uasily recognised by the meaningful in this case because NRC One commenter cited the practice of

' (

s public. U ' as property footnoted in regulates, among other things. receipt. nuclear pharmacies supplying radio.

A the policy statement to include the possession, use and transfer of byprod, chemicals to researchers aho use more cumbersome but specific terms: uct, source and special nuclear matert, them on humans under their os1m byproduct, source and special nuclear al in protecting the health and safety A Ntcof aim I material and to exclude naturally oc. of the public.

g D [

t One commenter noted that FDA per.

mits nuclear pharmacies to operate in ho#a e atert a. constns on sitetric Isstas the absence of a final deternunation of One commenter, in opposition to There were sia comments on the their status, providing they meet all NRC's regulation of patient radiation question of reporting misadministra- State and local pharmaceutical regula.

safety, suggested that NRC limit its tions of radioactive matertal. Thr e tions. The tuo other commenters role to the radiation safety of the hoe- commenters opposed any misadminis- charactertsed the NRC's restrictions gital staff and the general patient tration reporting and three com' on the distribution of population. He believes that patient menters offered suggestions on how radiopharmaceuticals by nuclear phar.

dostmetry is a responsibility of the in- they should be reported. All of the macies as an unsarranted intrusion Cvidual institution and not NRC. This comments s111 be considered in dealing into the practice of pharmacy se :h is commenter feeis that NRC should with NRC's newly proposed misadmin- regulated by the States.

first require adequate staffing, includ. 1stration reporting requirernent that NRC licenses nuclear pharmacies to ing a board certified phystelan or ts- was published in the FEDERAL REctstra distribute radioactive drugs that hate diopharmacist and a radiation safety for puNie comment on July 7,1978 (43 been approved by FDA. This includes Cfficer, and then essentially leave the FR 29297). radioactive drugs subject to an FDA.

Institution alone regarding dostmetry* There were six comments on the spe- approved "New Drug Application" instrumentation. callbration, drug pro. (NDA) or *Nottee of Claimed Imesti, ettle issue of paramedical training.

curement or any other function con. gational Exemption for a Nea Drug" sidered to be the prsetice of medicine.

Three commenters believe that it is NRC does require the licensee to unnecessary for NRC to become in- (IND). NRC relles on FDA srproval of volved in paramedical training because radioactive drugs because NRC has staff its operation with a radiation several organtrations are already pro. not regulated the safety and effeethe-asfety officer and a physician (not ness of radioactive drugs since 19'l5.

necessarily board certified) trained t riding or developing mtntmum stand-ards, guidelines or certification. One Also, there are not many States that administer rsdioactive material or ts- commenter believed that NRC should are equipped to regulate radioactive diation to patients. Hosever, the Com. drug safety and effeetheness.

mtssion cannot hmit its regulatory role be involved in this area because the

' to protecting the hospital staff and technologist, not the physician, does Dated at' Washington, D.C. this 1st the general pati.at population and at most of the work sith radlotsotopes. day of February 19"9.

the same tLrne fulfill its congTessional Two commenters believe that radiolog-mandate to protect the health and les! phystetsts should be separated out safety of the pubhc as regards source, from other paramedical personnel and typroduct and special nuclear maters. ne of these commenters offered a O al. The patient being treated or ding. definition of radiological phystetst.

\

PS MUS September 29,1995

9/15/97 O

t

V itECOMMENDATION FOR REVISION TO NRC'S 1979 MEDICAL POLICY STATEMENT OPTION 1: Status Quo Current statement of general policy to guide regulation of medical uses of radioisotopes states:

1. - The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.

2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.

3. The NRC will minimize intrusion into medicaljudgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.

P.L92 p 1. Consistent with NRC's authority in the Atomic Energy Act of 1954, as amended, to

('- regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2. Recognizes that physicians have primary responsibility for protection of their patients, by stating that the NRC will minimize intrusion into medical judgments affecting safety.

3. Regulation of the radiation safety of patients is risk-based.

4. For higher risk activities, NRC may elect to circumscribe areas that might otherwise be regarded as within the discretion of the physician.

5. Current statement provides for balance between protection of the patient and avoiding intrusion into the practice of medicine.

C.DllE -

1. Allows for some, although minimal, NRC involvement in medical judgements affecting patients.

.("N d I

- ., .. .-. - . = . . - - .. .. - . .. - - . _ - . - - - . - _ . - -

3 OPTION 2: April 1997 recommendation of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)

ACMUl recommended statement of general policy to guide regulation of medical uses of radioisotopes would be: -

1. [No change.)

2. The NRC will regulate the radiation safety of patients only where justified by the

! risk to the patients, and only where voluntary standards or compliance with these I standards are inadequate. Assessment of the risks justifying such regulations 1

will reference comparable risks and comparable modes of regulation for other types of medical practice.

. 3. The NRC will not intrude into medical judgments affecting patients and into other

{ areas traditionally considered to be a part of the practice of medicine.

F g

1. Regulation of the radiation safety of patients is tisk-based.

2. Acceptable level of risk associated with regulating the medical use of byproduct material may be lower than in other areas of medicine.

O Q 3. Clearly states that NRC will not be involved with the physician-patient interface.

4 4. Recognizes that physicians have primary responsibility for protection of their patients, f

.1

, 1. Requires NRC to assess risks in other types of medical practices, which may be problematic.

2. Implementation of statements #2 and #3 could be in conflict when the level of risk justifies intrusion.

1 d 2

- QP_IlON 3-

\ Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:

1. [No change.)

2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate.

3. The NRC will continually strive to minimize involvement in medical judgments

affecting patients and into other areas traditionally considered to be a part of the

practice of medicine, i

' Plo.s

! 1. Consistent with NRC's authority in thc. Atomic Energy Act of 1954, as amended, to 2

regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2. Regulation of the radiation safety of patients is risk based.

A 3. For higher risk activities, NRC may elect to circumscribe areas that might othenuise be regarded as within the discretion of the physician.

4. Recognizes that physicians have primary responsibility for protectior of their patients.

5. Provides additional emphasis that NRC's policy is not to minimize intrusion into medical practice.

GQDE

1. Acceptable level of risk associated with regulating the medical use of byproduct material may be lower than for other areas of medicine.

2. Allows for some, although minimal, NRC involvement in medicaljudgements affecting patients.

\

v) 3

rh OPTION 4:

Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:

1. [No change.]

2. The NRC will regulate the radiation safety of patients consistent with the risk posed by the radioactive materials. In regulating the radiation safety of patients, NRC's role is to assure that the physician's prescription is accurately delivered to the correct patient.

3. The NRC will not intrude into the medical judgement forming the basis of the physicians' prescription.

ELQS

1. Consistent with NRCs authority in the Atomic Energy Act of 1954, as amended, to regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2. Recognizes that physicians have primary responsibility for protection of their patients, by

(~N statiag that the NRC will not intrude into medical judgements forming the basis of the

!]s physicians' prescription.

3. Regulation of the radiation safety of patients is risk-based.

CQQs

1. NRC's role in regulating the radiation safety of patients is narrowly focused.

4 i

4

9/15/97

) PART 35 - QUALITY MANAGEMENT PROGRAM Summarv of Alternatives

1. Maintain current requirements; S35.32, Sections (a)+(b)+(c)+(d)+(e)+(f).

2. Only require a written quality management program; $35.32, Section (a).

3. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and perform audits; S35.32, Sections (a)+(d)+(b with modifications)) .

4. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events; $35.32, Sections (a)+(d)+(c).

,O NOTE: Section 6 of the SRM dated, March 20,1997, states:

\ f V

[ Staff should consider...]

The Quality Management Program provisions (10 CFR Part 35.32) should be re-evaluated and revised to focus on those requirements that are essential for patient safety, e.g. confirming patient identity, requiring written prescriptions and verifying dose.

To the maximum extent possible, the requirements should be revised to be risk informed. Given this objective, a mixed approach of performance-based rules and otherwise prescriptive regulations should be pursued.

Section 4 of the SRM dated, March 20,1997, states:

[ Staff should consider...)

Changing the nomenclature from " misadministration" to "rnedical event" or comparable terminology.

1

)

y. .~ ~. - ~ . ~_ - ~ - . - - . - . - _ . . - _ - - - - . - . . . - - . - - _ - - _

i

[ - ALTERNATIVE 1 -

Maintain current requirements; $35.32, Sections (a)+(b)+(c)+(d)+(e)+(f)?

? Etat; '

i <

[ 1. No additional regulatory burden to licensees, f 2. No additional NRC resources would be needed for modifications to licensing or inspection procedures.

3. $35.32(a) would continue to require licensee to establish and maintain a written quality

- . management program (QMP) to provide confidence that byproduct material or radiation

[- therefrom will be administered as directed by the authorized user.

1

4. $35.32(b) would continue to require that licensees audit their QMP's to determine the l._ effectiveness of their program and retain records of the audit.

5; . $35.32(c) would continue the concept of " recordable event" to be used to identify.

[.

precursor events.

l! 6. 935.32(d) would continue to require licensees to retain each written directive and record each admir.istered dose or dosage requiring a written directive.

4 e

\ .CSDA

, 1. Does not reduce regulatory burden to licensees.

i i : 2. Does not make the regulation more performance-based.

2 $35.32(e) would continue to require licensees to submit modifications of their QMP's to y . NRC, which continues regulatory burden.

1

. . 4. $35.32(f) would continue to require licensees to submit their'QMP's to the NRC, which

. continues regulatory burden.

5. Rule is inconsistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety e.g., confirming patient identity, requiring written prescriptions, and verifying dose, s

\ 2

1

(

p F- Current Rule Text i

\

Section 35.32 Quality management program.

h (a) Each applicant or licensee under this part, as applicable, shall establish and maintain 5

a written quality management program to provide high confidence that byproduct material or 1 radiation from byproduct material will be administered as directed by the authorized user. The l quality management program must include written policies and procedures to meet the j following' specific objectivesf j_ (1) That, prior to administration, a written directive is prepared for:

(l) Any teletherapy radiation dose;

(ii) Any gamma stereotactic radiosurgery radiation dose; i' (iii) Any brachytherapy radiation dose; j .

. (iv) Any administration of quantities greater than 30 microcuries of either sodium iodide '

- l 125 or I 131; or i_ .

(v) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide

[ l-125 or 1 131;

(2) That, prior to each administration, the patient's or human research subject's identity j is verified by more than one method as the individuai named in the written directive; j- (3) That final plans of treatment and related calculations for brachytherapy, teletherapy, l and gamma stereotactic radiosurgery are in accordance with the respective written directives;

! (4) That each administration is in accordance with the written directive; and i

(5) That any unintended deviation from the written directive is iderntified and evaluated,

, and appropriate action is taken, fI

V (b) The licensee shall

! (1) Develop procedures for and conduct a review of the quality management program

[ including, since the last review, an evaluation of:

-(1) A representative sample of patient and human research subject administrations, i- (ii) All recordable events, and

- (iii) All misadministrations

to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months; (2) Evaluate each of these reviews to determine the effectiveness of the quality

! management program and, if required, make modifications to meet the objectives of paragraph

.(a) of this section; and j (3) Retain records of each review,' including the. evaluations and findings of the review, in an auditable form for three years.

}. - (c) The licensee shall evaluate and respond, within 30 days after discovery of the

{ recordable event, to each recordable event by:

! _(1) Assembling the relevant facts including the cause;

, . (2) Identifying what, if any, corrective action is required to prevent recurrence; and i - (3) Retaining a record, in an auditable form, for three years, of the relevant facts and

what corrective action, if any, was taken.

4 u

l i\ 3 i

4

p\ (d) The licensee shall retain:

6 (1) Each written directive; and i (2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.

(e) The licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. The

licensee shall fumish the modification to the appropriate NRC Regional Office within 30 days after the modification has been made.

i (f)(1) Each applicant for a new license, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the NRC.

(2) Each existing licensee, as applicable, shall submit to the appropriate NRC Regional

Office in accordance with 10 CFR 30.6 by January 27,1992 a written certification that the quality management program has been implemented along with a copy of the program.

' If, because of the patient's condition, a delay in order to provide a written revision to an

existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48

! hours of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior

! to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose,

. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable,

, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of the oral directive, i [56 FR 34121, July 25,1991, as amended at 59 FR 61783, Dec. 2,1994]

l l 4 Y 4

l l

ALTERNATIVE 2 O\ Only require a written quality management program; $35.32, Section (a).*

ELQ1 l

1. Reduces regulatory burden to licensees (no audits or records).

2. Makes the regulation performance-based,

3. $35.32(a) would continue to require licensee to establish and maintain a written quality management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

4. S35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications of their QMPs to the NRC which would decrease regulatory burden.

5. $35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMPs to the NRC which would decrease regulatory burden.

6. Dose based rule.

7. Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.,

i confirming patient identity, requiring written prescriptions, and verifying dose.

Q Cons

1. Additional NRC resources would be needed for modifications to licensing or inspection procedures.

2. May increase on-site inspection time (no audits or records of recordable events are available for inspector review).

3, No requirement ($35.32(b)) for licensees to audit their QMPs to oetermine the effectiveness of their program and retain records of the audit.

4. S35.32(c) would be deleted, discontinuing of the concept of " recordable event" which is used to identify precusor events.

5. No requirement (935.32(d)) for licensees to retain each written directive and record each adm:nistered dose or dosage requiring a written directive, thus these records v - jd not be available for inspection.

6. Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessary V 5

em Draft Rule Text

'v)

I Section 35.32 Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quahty management program must include written policies and procedures to mee' the following specific objectives:

(1) That, prior to administration, a written directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:

(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive; (3) That each administration is in accordance with the written directive; and (4) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

' If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months of the oral revision.

7_.s Also, a written revision to an existing written directive may be made for any diagnostic or

! j therapeutic procedure provided that the revision is dated and signed by an authorized user prior Q' to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.

If, because of the emergent nature of the patient's condition, a delay in order to provide a wntten directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of the oral directive.

I )

V 6

ALTERNATIVEJ J l Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and perform audits; $35.32, Sections (a)+(d)+(b with modifications)) .

i 1. Reduces regulatory burden to licensees.

4- 2. Makes the regulation more performance-based.

, 3. $35.32(a) would continue to require licensee to establish and maintain a written quality

management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

1

4. Retain a requirement ($35.32(b)) for licensees to audit their QMP to determine the effectiveness of their program and retain records of the audit.

I

5. Retains requirements ($35.32(d)) for licensees to retain each written directive and record of each administered dose or dosage requiring a wntten directive, j

6. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit

! / modifications of their QMP to the NRC.

. 'd 7.

$35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their

, QMP's to the NRC.

i j 8. Requirements in draft rule language is consistent with Commission direction (SRM on

DSI 7) to focus on those requirements that are essential for patient safety, e.g.,

confirming patient identity, requiring written prescriptions, and verifying dose, with the exception of the requirement for an audit.

C9.nl

1. Additional NRC resources would be needed for modifications to licensing and hspection procedures.

2. 635.32(c) would be deleted, discontinuing of the concept of " recordable (cet" to be used to identify precursor event.

3. Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessa:/

O 7

7. _ _ _ _ _ _ .. _ _. _ _ _ _ _ . - - _ . _ _ . _ _-

j.'

b a

Draft Rule Text N

, Section 35.32 Quality management program. >

4 1

[ (a) Each applicant or licensee under this part, as applicable, shall establish and maintain j. a written quality management program to provide high confidence that the byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The

. quality management program must include written policies and procedures to meet the

following specific objectives:

} (1) That, prior to administration, a written directive ' is prepared when the dose to any ll organ or tissue exceeds 50 rem:

1 (2) That, prior to each administration, the patient's or human research subject's identity

j. is verified by more than one method as the individual named in the written directive; j_ (3) That each administration is in accordance with the written _ directive; and

! - (4) That any unintended deviation from the written directive is identified and evaluated,

and appropriate action is taken.

l (b) The licensee shall:

i (1) Develop procedures for and conduct a review of the quality management program-l' at intervals no greater than 12 months.;

j and

(2) Retain records of each review, including the evaluations and findings of the review, i 'in an auditable form for three years, i

j_ s (c) The licensee shall retain: t j (1) Each written directive; and

(2) A record of each administered radiation dose or radiopharmaceutical dosage where l a written directive is required in paragraph (a)(1) above, in an auditable form, for three years p after the date of administration.

l ' If, because of the patient's condition, a delay in order to provide a written revision to an -

. . existing written directive would jeopardize the patient's health, an oral revision to an existing

written directive will be acceptable, provided that the oral revision is documented immediately in j the patient's record and a revised written directive is signed by the authorized user within 48 ,

hours of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or

, therapeutic procedure provided that the revision is dated and signed by an authorized user prior-

to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma i l

. stereotactic radiosurgery dose, the teletherapy oose, or the next teletherapy fractional dose.

i _

If, because of the emergent nature .of the patient's condition, a delay in order to provide -

. a written directive would jeopardize the patient's health, an oral directive will be acceptable, ,

( provided that the information contained in the oral directive is documented immediately in the .

[ patient's record and a written directive is prepared within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of the oral directive.

i

[- 8 i

, , - -m--- ,-,

I i

p ALTERNATIVE 4 Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events; $35.32, Sections (a)+(d)+(c).

i P.LQA 1

1. Reduces regulatory burden to licensees (no required audits).

2. Makes the regulation more performance-based.

i a

3. S35.32(a) would continue to require licensee to establish and maintain a written quality 1

management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

! 4. $35.32(c) would continue the concept of " recordable event" to be used to identify i precursor events

5. Retains requirements ($35.32(d)) for licensees to retain each written directive and records of each administered dose or dosage requiring a written directive.

4

6. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications of their QMP to the NRC.

j 7. 635.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMP's to the NRC.

8. Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.,

confirming patient identity, requiring written prescriptions, and verifying dose.

Cons

1. Additional NRC resources would be needed for modifications to licensing and inspection i procedures.

2. May increase on-site incpection time.

. 3. $35.32(b) would be deleted, thus there would be no requirements for licensees to audit their QMP to determine the effectiveness of their program and retain records of the i audit.

4. Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessary.

O

i i

Draft Rule Text

- ( . . .

L Section 36.32 Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain 7 '

a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the j following specific objectives: i (1) That, prior to administration, a written directivei is prepared when the dose to any '

organ or tissuc exceeds 50 rem:

(2) That, prior to each administration, the patient's or human research subject's identity ,

is verified by more than one method as the individual named in_ the written directive; (3) That each administration is in accordance with the written directiva; and (4) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(b) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

(1) Assembling the relevant facts including the cause; *

(2) Identifying what, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.

(c) The licensee shall retain:

. (1) Each written directive; and (2) A_ record of each administered radiation dose or radiopharmaceutical dosage where -

a written directive is required in paragraph (a)(1) above, ln an auditable form, for three years

- after the date of administration.

' If, because of the patient's condition, a delay in order to provide a written revision to an -

existing written directive would jeopardize the patient's health, an oral revision to an existing

_ written directive will be acceptable, provided that the oral revision is documented immediately in

_. the patient's record and a revised written directive is signed by the authorized user within 48

. hours of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure pruvided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the bracnytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.

If, becausa of the emergent nature of the patient's condition, a delay in order to provide -

a written clirective would jeopardize the patient's health, an oral directive will be acceptable, .

provided that iiie !. formation contained in the oral directive is documented immediately in the patient's recor-J ar d a written directive is prepared within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of the oral directive.

10

a. . _ _ - _ _ . . ._ - --.. _ _ _ . -. - . . . - . -. -- . _ . -

)

QUAll1Y MANAGEMENT OVERVIEWS i ,

i 1

ALTERNATIVES KEY ITEMS FOR CONSIDERA50N 1 2 3 4 Licensee establish and maintain QMP X X X X

[ objectives identified in regulation)

Licensee required to perform audits X X and record results Licensee required to retain written X X X directives and records of administered doses Licensee required to submit QMP X modifications to NRC Licensee required to maintain X X recordable events

\

l l

1 a

9/15/97

( PART 36 - RADIATION SAFETY COMMITTEE

]

)

Summarv of_ Alternatives

)

1

1. Status quo A Radiation Safety Committee (RSC) is required for all modalities in a

medicalinstitution.

2. A RSC is required for a medical institution and all modalities, with the exception of l diagnostic low dose sealed and unsealed byproduct material uses,

3. A RSC will not be required for any medical licensee.

. 4. A RSC will not be required, but medical licensees will be required to establish and implement a program for administrative and technical oversight of radiation safety.

i j

r k

1 L________ -.

i l

l

&lJERNATIVE 1 !

Status quo: A Radiation Safety Committee (RSC) is required for all modalities in a medicalinstitution.

ECDA

1. Licensee familiarity and continuation of established radiation safety programs.

2. Provision for communication between disciplines & departments in a singl6 committee, with a radiation safety focus. '

3. Requirements for approvals via multidisciplinary view points in a team approach. *

4. Radioactive material use and users are under licensee personnel / peer review and accountability.

5. Provisions for direct involvement of executive management (resource allocation, corporate policy, and interdepartmental coordination).

6. A (.ommittee of varied representation is granted significant latitude and authority to develop & implement an appropriate radiation safety program & direct personnel. !

v c.

1. Need for RSC is not based on risk of modality.

2, May not be necessacy for effective radiation safety management at small medical institutions.

3, Radiation safety is not directed solely by an individual (s) (e.g., Radiation Safety Officer) whose role is independent of the authorized user role and interests. .

Current Rule Text Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.

(a) Esoh Committee must meet the following administrative requirements:

(1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.

(2) The Committee must meet at least quarterly.

2

o (3) To establish a quorum and to conduct business, at least one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's (V) representative.

(4) The minutes of each Radiation Safety Committee meeting must include:

(i) The date of the meeting; (ii) Members present; (iii) Members absent; (iv) Summary of deliberations and discussions; (v) Recommended actions and the numerical results of all ballots; and (vi) Al. ARA program reviews described in Section 35.20(c).

(5) The Committee must promptly provide each member with a copy of the meeting minutes, and retain one copy for the duration of the license.

(b) To oversee the use of licensed material, the Committee must:

(1) Review recommendations on ways to maintain individual and collective doses Al. ARA:

(2)(i) Review, on the basis of safety and with regard to the training and experience standards in subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety C"icer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to Section 35.13 (b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear

( ) pharmacist;

(/ (3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part; (4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material; (5) Review quarterly, with the assistance of the Radiation Safety Officer, allincidents involving byproduct material with respect to cause and subsequent actions taken; and (6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.

[51 FR 36951, Oct.16,1986, as amended at 59 FR 61782, Dec. 2,1994)

( ,/ 3

ALTERNATIVE 2 1

O A RSC is required for a medicalinstitution and all modalities, with the exception of diagnostic low dose sealed and unsealed byproduct material uses.

J

1. Risk based.

2. Licensee familiarity and some continuation of established radiation safety programs.

4

3. Provisions for communication between disciplines & departments in a single 4 cornmittee, with e adiation safety focus.

I

4. Requirements for approvals via multidisciplinary view points in a team approach.

i i 5. Radioactive material use and users are under licensee personnel / peer review and accountability.

! 6. Provide for direct involvement of executive management (resource allocation, corporate

policy, and interdepartmental coordination).

I i 7. A wmmittee of varied representation is granted significant latitude and authority to

. O cevelop & implement an appropriate radiation safety program & direct personnel.

i

Cons Fo' institutions with an RSC

1

1. An RSC may not be necessary for effective radiation safety management at small i medicalinstitutions, j 2. Radiation safety is not solely directed by an individual (s) (e.g., Radiation Safety Officer) 3 whose role is independent of the authorized user role and interests.

l For diagnostic low-dose sealed and unsealed byproduct material uses:

1. No provisions for licensee to establish interdepartmental / interdisciplinary communication

& lor a committee with ernphasis on radiation safety,

2. No collegial consensus assisting / representing executive management in oversight of radiation safety issues.

3. Radiation safety is dependent upon only the RSO and executive management oversight.

O 4

i

4. ~ Current broad scope licensees & regulatory provisions for use & approvals (facilities &

use) will undergo significant change.

- 5. Decreased potential for executive management involvement in the radiation safety program.

l Draft Rule Text

. Section 35.XX Radiation Safety Committee j Each medical institution licensee shall establish a Radiation Safety Committee to oversee the j- use of byproduct material, with the exception of diagnostic low-dose sealed and unsealed _

byproduct material use, i

l ~ (a) Each Committee must meet the following administrative !oquirements:

l (1) Membership must consist of at least four individuals and must include an authorized j user of each type of use permitted by the license (s), appropriste modality specific physicist (s)

! (if applicable), the Radiation Safety Officer, a representative of the nursing service, and a ,

e representative of management who is neither an authorized user nor a Radiation Safety Officer.

Other members may be included as the licensee deems appropriate.

(2) To establish a quorum and to conduct business, at least one-half of the Committee's

- membership must be present, including the Radiation Safety Officer and the management's representative.

(3) The committee must meet at least quarterly.

(4) The liansee shall prepare and maintain records of the Committee meetings in accordance with 935.2022.

(b) To oversee the use of licensed material, the Committee must:

(1) Review, on the basis of safety and with regard to the training and experience, and approve or disapprove any individual who is to be listed as an authorized user, authorized nuclear pharmacist, the Radiation Safety Officer, or an authorized modality-specific physicist, before submitting a license application or request for amendment or renewal; or (2) Review, pursuant to Section 35.13, on the basis of the board certification, the license, or the permit identifying an individual, additional training and experience requirements,

- as applicable, to approve or disapprove any individual prior to allowing that individual to work as an authorized user, nuclear pharmacist, or physicist; (3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures, provided the changes do not affect the standard of safety established in applicable NRC regulations;

- (4) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents

- involving byproduct material with respect to cause and subsequent actions taken; and

- (5) Review the radiation safety program at least annually, with the assistance of the

-Radiation Safety Officer.

q 5

I ALTERNATIVE 3 O A RSC will not be required for any medical licensee.

Eros

1. Supports a performance-based approach and acknowledges the low risk of sealed and unsealed low-dose byproduct material uses.

2. Licensee directs the structure and management of their own radiation safety program Cuna

1. Not risk based.

2. No provisions for licensee to establish interdepartmental / interdisciplinary communication

& lor a committee with ernphasis on radiation safety.

3. No collegial consensus assisting / representing executive managemant in oversight of radiation safety issues.

4. Radiation safety is dependent upon only the RSO and executive management oversight.

5. Current broad scope licensees & regulatory provisions for use & approvals (facilities &

use) will undergo significant change.

6. Decreased potential for executive management involvement in the radiation safety program.

6

l j

ALTERNATIVE 4 -

ID A RSC will not be required, but medical licensees will be required to establish and implement a

[ program for administrative and technical oversight of radiation safety.

1 Erns = ,

! 1. Consistent with a risk-informed, performance based approach to regulations.

2. Provisions for direct involvement of executive management (e.g., resource allocation, corporate policy, and interdepartmental coordination.

3, Licensee is granted significant latitude and cuthority to develop & implement an

[ appropriate radiation safety program.

i

[ 'CQtl4

1. '

Radiation safety is dependent only upon executive management oversight.

[ 2. Resources devoted to management oversight of the radiation safety program may, at j times, be impacted by the need to devote management resources to other program t

areas within the facility, s-Draft rule text To oversee the use of licensed material, the licensee must establish a program that will do the following:

(a)(1) Approve or disapprove any individual who is to be listed as an authorized user, an

- authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (2) Approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist; -

(b) Approve or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part; (c) Review all incidents involving byproduct material viith respect to cause and subsequent actions taken; and (d) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program, (e) Provide a mechanism for interdepartmental / interdisciplinary communication.

7

_ --_ m --

Radiation Safety Committee Overview Alternative 1 Altemative 2 Attemative 3 Attemative 4 Key items for Consideration with RSC/ without RSC Risk basis x/x x Ucensee famil;arity and continuation of x x/_

established radiation safety programs with minimal or no impact on corresponding regulatory oversight Provisions for communication between x x/_

disciplines & departments in a single committee with a radiation safety focus Approvals via multidisciplinary view points in x x/_

a team approach Radioactive material use and users are x x/_

ur der licensee personnel /peei review and accountability Provisions for direct involvement of x x/_ x executive management (resource allocation, corporate policy, and interdepartmental coordination)

A committee of varied representation is x x/_

granted significant latitude and authority to develop & implement an appropriate radiation safety program & direct personnel May not be necessary for effective radiation x x/_

safety management at small medical institutions Collegial consensus representing executive x x/_

management in oversight of radiation safety issues Radiation safety and initial autnorized user x x/_

approval directed by Radiation Safety

Committee Radiation Safety is dependent upon only the x _/x x RSO and executive management (Aersight Licensee directs the structure of their own _/x x x radiation safety program 8

1

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

l i

f 9/15/97

6 PART 35-TRAINING AND EXPERIENCE

\

i Summarv of Alternatives - Authorized User

1. Status quo (i.e., M.D. + Board certification or tpecified number of hours of training and

, experience).

2. M.D. + Board certification or specified number of hours of training and experience (with a change in the number of hours to focus on radiation safety, with minimal requirements ror clinical experience). Note, the specific board certifications will not be listw in the rule, but instead will be a certification that is approved by the NRC.

3. M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

4. M.D. only.

5. M.D. + exam.

6. M.D. + exam + clinical experience.

NOTES i

The Altematives represent various combinations of training and experience criteria that could i be used to demonstrate that an authonzed user can receive, possess, use, and transfer

, radioactive material consistent with radiation safety practices and in accordance with the regulations.

These key elements are listed below with a reference to the Altemative that incorporates the element.

1. Is it necessary to state the need for clinical experience in the training and experience requirement? If yes, see Attematives 1,2,3, and 6.

2. How should a potential authorized user demonstrate that they have obtained knowledge about1he safe handling of radioactive material?

a. If by industry certification (e.g., American Board of Nuclear Medicine, American Board of Radiology, etc.), see Altematives 1,2, and 3.

b. If by radiation safety exem, set Attematives 3,5, and 6.

1

ALTERNATIVES AVAILABLE FOR EACH MODALITY -

Ahemative 1 Altemative 2 Altemat've 3 Attemative 4 - Attemative 5 Memative 6 Low Dosa - / / '

/ ./ /

Unsealed Diagnostic High Dose / / / No / /

Unsealed Low Dose - / / / No / /

Sealed Brachy-therapy Low Dose / / ~/ / / /

Sealed Diagnostic Teletherapy / / / No / /

HDR / / / No / /

Gamma-Knife / / / No / /

r

( Emerging Technology

/ / / / / /

L 2 W - +

ALTERNATIVE 1: Status quo (i.e., M.D. + Board certification or specified number of hours of training and experience).

d P.Los

1. More than one means to meet authorized user criteria,

2. Modality specific.

3. Easy to use if board certifi3d by a board listed or if have completed a training program.

4. Assures that user has radiation safety training if training hour option is pursued.

S. Has a clinical experience component.

4 I U i

1. Reference to a training program that is not in existence [e.g.,35.910(c)- six month training program).

s i 2. Limits approval to boards specifically listed and must amend regulations to add or delete a i board, t

O 3. Training hours required may not accurately reflact the risk of the modality (i.e., not risk based).

4. No process developed for periodic review and assurance of certifying board standing.

5. NRC must review / accept any certifying boards not listed.

6. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Current Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) Is certified by:

(1) The American Board of Nuclear Medicine; (2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; (3) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (4) The American Osteopathic Board of Radiology after 1984; or

( 3

- - .-_.._ . - = -

1 I i

i 1

j (b) Has had classroom and laboratory training in basic radioisotope handling techniques

j applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as j follows: i j (1) 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroom and laboratory training that includes: !

(1) Radiation physics and instrumentation; l

! (ii) Radiation protection; '

(ill) Mathematics pertaining to the use and measurement of radioactivity; and -

! (iv) Radiation biology; and (2) Supervised clinical experience under the supervision of an authorized user at a medical i Institution that includes;

! (l) Use of lodine 131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and j (ii) Use of iodine 131 for treatment of thyroid carcinoma in 3 individuals. '

b I

O 4

l j

ALTERNATIVE 2: M.D, + Board certification or specified numter of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

ELDE

1. More than one means to meet authorized user criteria.

2. Modality specific.

3. Easy to use if board certified or if have completed a training program.

4. Empnasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).

5. Board changes do not require rulemaking.

6. Assures that user has radiation safety training if training hour option is pursued.

7. Clinical experience component is included.

CDus 1 NRC must review / accept certifying board.

2. A mechanism must be developed to notify the public of the NRC accepted boards.

3. No process developed for periodic review and assurance of certifying board standing.

4. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by a medical specialty board whose certification process includes all nf the training and experience requirements in Section 35.930(b) and whose certification has been accepted by the NRC; or-(b) Has completed hours of training (e.g.,120 hours0.00139 days 0.0333 hours 1.984127e-4 weeks 4.566e-5 months ) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals; and has had supervised radiopharmaceutica!

administration experience.

(1) The classroom and laboratory training shall include:

5

i i

(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology.

(2) The supervised work exp3rience under the supervision of an authorized user shall include:

(l) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (lil) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadministration of byproduct material; ;

and (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures.

(3) The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medical institution shall include:

(l) Oral administration in 10 individuals of lodine 131 or diagnostic studies (involving dosages of sodium lodide I 131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 Individuals of: phosphorus-32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium 89 or samarium 153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of lodine 131 for treatment of thyroid carcinoma.

O .

p ALTERNATIVE 3: M.D. + Board certification or specified number of hours of training (with a

( change in the number of hours to focus on radiation safety, with minimal requirements for

\ clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, !

but instead will be a certification that is approved by the NRC.

P_rns

1. More than one means to meet authorized user criteric,

2. Modality specific.

3. Easy to use if board certified.

l

4. Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).

S. Board changes do not require rulemaking.

6. Standardized method for testing a baseline of awareness / knowledge.

7. Added assurance that tested individualls aware of radiation safety issues (i.e., baseline).

, 8. Clinical experience component is included.

h

1. NRC most review / accept certifying board.

2. A mechanism must be developed to notify the publ.3 of the NRC accepted boards.

3. Process required for periodic review and assurance of certifying board requirements.

4. Resource intensive to develop and administer exam and maintain testing program.

1

5. Added expense to person taking exam (e.g., cost to travel to exam location).

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by examination by a medical specialty board whose certification process includes all of the training and experience requirements in Section 35.930(b) and whose certification has been accepted by the NRC; or J

(b) Has completed hours of training (e g.,120 hours0.00139 days 0.0333 hours 1.984127e-4 weeks 4.566e-5 months ) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable

! \

V 7

i to the use of therapeutic radiopharmaceuticals; has had supervised radiopharmaceutical O administration experience; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

(1) The classroom and laboratory training shall include:

(1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology.

(2) The supervised work experience under the supervision of an authorized user shall include:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey mStors; (iii) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadministration of byproduct material; and (v) Using procedures to contain spilled byproduct material safely and using proper decontaminat2on procedures.

(3) The supervised radiop%rmaceutical administration experience under the supervision of an authorized user et a medical institution shall include:

(1) Oral administration in 10 individuals of lodine 131 or diagnostic studies (involving dossges of sodium iodide 1 131 in quantities greater than 30 microcuries) or for treatment of hypa rthyroidism or cardiac dysfunction; or I (ii) Parenteral administration in 3 individuals of: phosphorus 32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium 89 or samarium 153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of lodine 131 for treatment of thyrold carcinomn i

9 0 .

Y f

ALTERNATIVE 4: M.D. only.

P.L91

1. No NRC specified training required to practice medicine using radioactive material.

2. Easier to apprcve authorized users.

3. Licensee is given complete latitude to review and determine the radiation safety and modality specific qualifications of a practitioner.

4. Supports a highly performance basW sonroach.

CQM

1. May not accurately reflect risk of modality (i.e., not risk based).

2. No assurance that user has received radiation safety training.

3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk-based).

Draft Rule Text:

1 The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician.

O ,

ALTERNATIVE 5: M.D. + exam.

ELDA

1. Modality specific if tailor test to each modality.

2. Standardized method for testing a baseline of awareness / knowledge.

3. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline).

4. No NRC specified training required to practice medicine using radioactive materie.

C201

1. Resource intensive to develop and administer exam and maintain testing program.

2. Added expense to person taking exam (e g., cost to travel to exam location).

3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk based).

4. Relies on exam results to show that individual has received appropriate radiation safety training.

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician and has demonstrated sufficient knowled0e in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

O 4.

3 ALTERNATIVE 6: M.D, + exam + clinical experience.

. U

1. Modality specific if tailor test and experience to each modality.

2. Standardized method for testing a baseline of awareness / knowledge.

1

3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

4. Clinical experience component is included.

CQDA

1. Resource intensive to develop and administer exam and maintain testing program.

2. Added expense to person taking exam (e.g., cost to travel to exam location).

l

3. Relies on exam results to show that individual has received appropriate radiation safety training.

. Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) Has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission; and (b) Has had supervised radiopharmaceutical administration experience. The supervised

radiopharmaceutical administration experience under the supervision of an authorized user at a medicalinstitution shallinclude

, (1) Oral administration in 10 individuals of lodine-131 or diagnostic studies (involving dosages of sodium iodide 1-131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (2) Parenteral administration in 3 individuals of: phosphorus-32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium-89 or samarium-153 for treatment of bone metastasis; and (3) Oral administration in 3 individuals of lodine-131 for treatment of thyroid carcinoma.

4 1

O 11

AUTHORIZED USER OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 6 More than one means to meet training and experience X X X criteria.

Modality specific. X X X X X l Easy to use if board certified. X X X l Emphasis on radiation safety training when training and X X i expenence required. (i.e., risk based) l Board changes do not require rulemaking. X X '

Standardized method for testing a baseline of training and X X X experience.

Licensee given complete latitude to review and approve X users.

Resource intensive to develop and administer exam. X X X Added expense to person taking exam. X X X Added assurance that tested individualis aware of radiation X X X safety issues.

Clinical experience component included. X X X X l

I 12

summarv of Alternatives . Radiation Safety Officer

1. Status quo (i.e., Board certification or specified number of training hours along with one year of training under an RSO or identified as an authorized user on a license).

2. Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used at the facility.

Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

3. Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used at the facility

+ exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

4. Exam only.

5. One year of full time experience at a medicalinstitution under the supervision of a radiation safety officer + exam.

I i

13

ALTERNATIVE 1: Status quo (i.e., Board certification or specified number of training hours p\

along with one year of training under an RSO or identified as an authorized user on a license).

(' d ems t

1. More than one means to meet RSO criteria.

2. Easy to use if board certified by a board listed or if named as an authorized user on a license.

1

3. Assures that RSO has radiation safety training if training hour option is pursued.

Cann

1. Not risk-based. Same training requirement regardless of level of use.

2. Assumes that an authorized user has sufficient radiation safety training.

3. Limits to specific boards listed in the rule and must amend regulations to add or delete boards.

4. Number of hours specified may not accurately reflect the risk of each modality.

5. NRC must review / accept any certifying boards not listed.

O v 6. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Current Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a) Is certified by:

(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine;

(/) American Board of Science in Nuclear Medicine;

(5) Boardtf Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or A

b 14

1 (b) Has had classroom and laboratory training and experience as follows:

O (1) 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and laboratory training that includes:

(1) Radiation physics and instrumentation; (ii) Radiation protection; l

l l

(iii) Mathernatics pertaining to the use and measurement of radioactivity; ,

(iv) Radiation biology; and I (v) Radiopharmaceutical chemistry; and (2) One year of full tirne experience as a radiation safety technologist at a medicalinstitution

under the supervision of the individual identified as the Radiation Safety Officer on a l

Commission or Agreement State license that authorizes the medical use of byproduct material; or (c) Be an authorized user identified on the licensee's license.

b

)

al 1

C/ 1s

7m ALTERNATIVE 2: Board certification by a board approved by the NRC or specified number of I

training hours to include experience with the types and forms of radioactive material to be used C at the facility. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

EfAS

1. More than one means to meet RSO criteria.

2. Modality specific if experience and training hours are tailored for each modality.

3. Easy to use if board certified.

4. Board changes do not require rulemaking.

5. Assurer that RSO has radiation safety training it training hour option is pursued.

Cons

1. NRC must review / accept certify'ng board.

2. A mechanism must be developed for notifying the public of NRC accepted boards.

3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.

( \

() 4. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Draft Rul1 I. ext The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a) is certified by a specialty board whose certification process includes all of the training and experience requirements in Section 35.000(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months ) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be used.

(1) The classroom and laboratory training shall include:

(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; (v) Radiopharmaceutical chemistry.

\v/ 16

(2) The supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:

(1) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of radioactive material; (iii) Storing radioactive material; (iv) Keeping an inventory record of radioactive material; (v) Using radioactive material safely; (vi) Taking emergency action if control of radioactive material is lost;

' (vil) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of radioactive material; and

~

(x) Training personnel who work in or frequent areas where radioactive material is used or stored.

I e

17

,m ALTERNATIVE 3: Board certification by a board approved by the NRC or specified number of (d ) training hours to include experience with the types and forms of radioactive material to be used at the tacility + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

P_ms

1. More than one means to meet RSO criteria.

2. Modality specific if experience and training hours are tailored for each modality.

3. Easy to use if board certified.

4. Board changes do not require rulemaking.

5. Standardized method for testing a baseline of awareness / knowledge.

6. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

CRat

1. NRC must review / accept certifying board.

2. A mechanism must be developed for notifying the public of NRC accepted boards.

O V 3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.

4. Resource intensive to develop and administer exam and maintain testing program.

5. Added expense to person taking exam (e.g., cost to travel to exam location).

Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:

(a) is certified by examination by a specialty board whose certification process includes all of the training and experience requirements in Section 35.900(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months ) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be used; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

(1) The classroom and laboratory training shall include:

l'% '

18

8 (l) Radiation physics and Instrumentation;

(ii) Radiation protection; i (iii) Mathematics pertaining to the use and measurement of radioactivity; i (iv) Radiation biology; i

(v) Radiopharmaceutical chemistry.

i (2) The supervised work experience, under the supervision of a Radiation Sr fety Officer on i a Commission or Agreement State license that authorizes the use of byproduct material similar I to the use requested shallinclude:

j (i) Authorizing the purchase of radioactive material:

, (ii) Receiving and opening packages of radioactive material; I (iii) Storing radioactive material;

(iv) Keeping an inventory record of radioactive material; i (v) Using radioactive material safely; (vi) Taking emergency action if control of radioactive materialis lost; I (vii) Performing periodic radiation surveys; I '(viii) Performing checks of survey instruments and other safety equipment; ,

(ix) Disposing of radioactive material; and

(x) Training personnel who work in or frequent areas where radioactive material is used or

stored.

4 i

d 9

J 1

l O 4.

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

ALTERNATIVE 4: Exam only.

s Erga !

1. Modality specific if tailor test to each modality. :

2. Standardized method for testing a baseline of awareness / knowledge.

3, Added assurance that tested individual is aware of radiation safety issues (i.e., baseline). '

CQnt

1. Resource intensive to develop and administer exam and maintain testing program.

2. . Added expense to person taking exam (e.g., cost to travel to exam location).

3. Relies on exam results to show that individual has received appropriate radiation safety training.

4. To approve an authorized user to be RSO, the AU must meet the specified RSO criterb.

Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

r S

k 20

A)

(V ALTERNATIVE 5. One year of full-time experience at a medicalinstitution under the supervision of a radiation safety officer + exam. 1 ELO.1

1. Assures that RSO has radiation safety training at a medicalinstitution.

2. Standardized method for testing a baseline of awareness / knowledge.

3. Added assurance that tested individualis aware of radiation safety issues.

CDDR

1. Not risk based. Same training requirement regardless of level of use.

2. Amount of time specified may not accurately reflect the risk of each modality.

3. Rs source intensive to develop and administer exam and maintain testing program.

4, Added expense to person taking the exam.

Drrsft Rule Text The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:

(a) Has completed one year of full time experience at a medicalinstitution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material and, (b) Has demonstrated sufficierit knowledge in the radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

k i

U 21

Rummarv of Alternatives . Authorized Physicist and Authorized Nuclear Pharmacist Attornatives for training and experience are similar to the alternatives provided for the radiation safety officer, except for the text discuss lng an authorized user requesting to be listed as a radiation safety officer. However, care must be taken to ensure that the training and experience for physicists is commensurate with the type of physics performed.

i i '

i t

1 1

l i

i

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22 4

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g/15/g7 PART 36 PATIENT NOTIFICATION OF REPORTABLE EVENT Summary.of Alternatives

1. Status Quo : Licensee to notify NRC, referring physician, and patient or responsible relative, unless referring physician personally informs the licensee that he or she will inform the patient or that, based on medicaljudgment that telling the patient or a responsible relative would be harmful.

2. Licensee to notify NRC only but not referring physician or patient.

3. Licensee to notify NRC and referring physician but not patlant.

4. Licensee would always notify NRC, referring physician, and patient or guardian.

5. Licensee would notify NRC and referring physician, and patient or guardian if ba' 3d on medicaljudgment, there are or would be detrimental effects on patient due to tlw reportable event.

O NOTE: Item 4 of the SRM, March 20,19g7, states:

[ Staff should consider...]

Changing the nomenclature from ' misadministration" to

medical event' or comparable terminology.

Use of term " guardian' in Alternative 4 & 5 is intended to encompass guardian, individual having ' medical power of attorney" or 'next of kin' but not all individuals who have been considered to be " responsible relative.'

i i

('

ALTERNATIVE 1 : Status Quo : Licensee to notify NRC, referring physician, and patient or responsible relative, unless referring physician personally informs the licensee that he or she will inform the patient or that, based on medical judgment that telling the patient or a responsible relative would be harmful.

ELQ1

1. Is consistent with other NRC requirements (e.g.,10 CFR 9919.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when !

i licensees are required to report such exposure to NRC.

2. Is consistent with other Federallegislation (e.g., Privacy Act) recognizing !

the right of individuals to know information about themselves which is contained in '

records both inside and outside the Federal sector. See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35-SC-10) and 55 Fed. Reg.1439, at i 1444 (January 16,1990),

i

3. Enables patients, in consultation with their personal physicians, to make timely decisions regarding remedial and prospective medical care 56 Fed. Reg. 23360.

4. Enables NRC to identify the causes of misadministrations and help identify precursor

, events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents 7) l (V can reveal a generic problem when compared nationally) RDd preserves patients right to know.

, 5. Enables NRC to fulfill its statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report Abnormal Occurrences (*ANO's') to Congress.

6. Is consistent with present NRC guidance regarding medical events (e.g., Management Directive 8.10 Handbook regarding medical event reporting).

CQas

1. Current rule language lacks definition of

responsible relativa," which may not be well understood by the medical community. Also, there appears to be multiple and sometimes conflicting interpretations of the extent to which and circumstances in which the " responsible relative' must be notified.

2. Patient notification requirement could be viewed as an unnecessary intrusion into the practice of medicine.

Current Rule Text (a) For a misadministration:

C (1) The licensee shall notify by telephone the NRC Operations Center 1 ) no later than

( the next calendar day after discovery of the misadministration.

2

4 i

(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration. The written report

must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual who received the misadministration; 5

what improvements are needed to prevent recurrence; actions taken to prevent recurrence; ,

j whether the licensee notified the individual (or the individual's responsible relative or guardian),

and if not, why not; and if there was notification, what information was provided. The report

! must not contain the individual's name or any other information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual

receiving the misadministration may be made instead to that Individual's responsible relative or

! guardian, when appropriate.

(3) The licensee shall notify the referring physician and also notify the individual

{ receiving the misadministration of the misadministration no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after its j discovery, unless the referring physician personally informs the licensee either that he will

, inform the individual or that, based on medical judgement, telling the individual woulo be harmful. The licensee is not required to notify the individual without first consulting the referring j- - physician, if the referring physiclan or the individual receiving the misadministration cannot be

reached within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , the licensee shall notify the individual as soon es possible thereafter.

The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in

notification.

(4) If the individual was notified, the licensee shall also furnish, within 15 days after

\ discovery of the misadministration, a written report to the individual by sending either:

(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be

obtained from the licensee,

(b) Each licensee shall retain a record of each misadministration for 5 years. The record

! must contain the names of all individuals involved (including the prescribing physician, allied j health personnel, the individual who received the misadministration, and that individual's i referring physician, if applicable), the individual's social security number or other identifit"ition l number if one has been assigned, a brief description of the misadministration, whv it necurred, j the effect on the individual, improvements needed to prevent recurrence, and tho actions takn

to prevent recurrence.

(c) Aside from the notification requirement, nothing in this section affects any rights or j duties of licensees and physicians in relation to each other, to individuals receiving misadministrations, or to that individual's responsible relatives or guardians.

i 1/ The commercial telephone number of the NRC Operations Center is

, (301) 816-5100.

t 3

t

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ALTERNATIVE 2 : Licensee to notify NRC only but not referring physician or patient.

O ems

1. Would not directly result in what some view as NRC intrusion in the practice of medicine.

2. Enables NRC to identify the causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic pro 0lem when compared nationally) and preserves patient's right to know.

3. Continues to enable NRC to fulfill statutory obligation to report *ANO's* to Congress.

4. Relies on ethical standard of care to present medical facts to patients. (SRM DSI 7)

5. May support more consistent compliance with the rule.

C_QDa

1. Is not consistent with other NRC requirements in Parts 19 and 20 regarding reporting radiation exposures to individuals when such reports are made to NRC.

n 2. NRC and licensee potentially aware of patient information (e g., potential consequences to patient health) when referring physician and patient are not aware for future informed (V) decisions and medical histories by other physicians.

3. Does not effectuate specific Commission determinaen that patients have a right to know when they have been involved in a misadministration. 55 Fed. Reg.1444 (January 16,1990).

4. Recognizes inconsistent application of ethical standard of care.

5. If patients are not notified and need follow-up care, NRC may have, at minimum, an ethical obligation to either notify patients itself or find another entity (such as a state) to do so.

6. In order for NRC to comply with Section 208 of Energy Reorganization Act requirement to include " nature and probable consequences

in ANO reports, NRC action to obtain such information may inject NRC into patient physician relationship and result in patient notification without explicit notification requirement in regulations.

Draft Rule Text (a) For a reportable event :

(1) The licensee shall notify by telephone the NRC Operations Center2 no later than Cs the next calendar day after discovery of the reportable event.

( )

v 4

i (2) The licensee shall submit a written report to the appro ariate NRC Regional Office l listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report

) must include the licensee's name; the prescribing physician's name; a brief description of the i event; why the event occurred; the effect on the individual ; what improvements are needed to prevent recurrence; actions taken to prevent recurrence. The report must not contain the individual's name or any other information that could lead to identification of the individual.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the individual's social secu.-ity number or other identification number if one has been assigned, a brief description of the reportable event , why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevt.nt recurrence.

(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event, or to that individual's responsible relatives or guardians.

2) The commercial telephone number of the NRC Operations Center is (301) 816 5100.

5

I ALTERNATIVE 3 : Licensee to notify NRC and referring physic'an.

ELDS

1. Does not involve NRC in what some view as intrusion in the practice of medicine.

2. Enables NRC to identify the causes of reportable evente and help identify precursor events (S".$ 1 DSl 7) in order to correct them and prevent recurrence (iso!;..,J incidents can reveal

generic problem when compared nationally) and preserves patient's r!ght to know.

3. Continues to enable NRC to fulfill statutory obligation to report 'ANO's* to Congress.

4. Less prescriptive than current rule by relying on ethical standard of care to present medical facts to patients.

5. May support more consistent compilance with the rule.

6. Relies on ethical standard of care to present medical facts to patients. (SRM DSI 7)

CQDE

1. Is not consistent with other NRC requirements in Perts ig and 20 regarding reporting O radiation exposures to individuals when such reports are made to NRC.

U 2. Unless referring physician fo! lows ethical standard to inform patients of medical facts, does not effectuate specific Commission deterr.sination that patients have a right to know when they have been involved in a misadntinistratiun. 55 Fed. Reg.1444 (January 16,1990).

3. NRC actions to obtain information to comply with Section 208 of Energy Reorganization ct of 1974, requirement to include

nature and probable consequences" in ANO reports, could result in patient notification without explicit notification requirement in regulations.

4. Recognizes inconsistent application of ethical standard of care.

5. If patients are not notified and need follow-up care, NRC may .1 ave, at minimum, an ethical obligation to either notify patients itself or find anothe. entity (such as a state) to j do so.

Draft Rule Text (a) For a reportable event:

(1) The licensee shall notify by telephone the NRC Operations Conter8 no later than the

next calendar day after discovery of the reportable event.

6

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~f (2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence. The report must not contain the individuars name or any other information that could lead to identification of the individual.

(3) The licensee shall notify the referring physician of the reportable event no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after its discovery. If the referring physician cannot be reached within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , the licensee shall notify the referring physician as soon as possible thereafter. The licenseo may not delay any. appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.

(4) If the referdng physician was notified, the licensee shall also fumish, within 15 days after discovery of the reportable event, a written report to the referring physician by sending either:

(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of all individuals hivolvad (including the prescribing physician, allied health personnel, the individual, and that individuars referring physician, if applicable), the individuars social security number or other identification number if one has been assigned, a brief description of the reportable event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

(c) Aside from the notification requirernent, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event, or to that individual's responsible relatives or guardians.

2) The commercial telephone number of the NRC Operations Center is (301) 81G-5100.

7

T

- ALTERNATIVE __4 : Same as status quo but licensee must always notify patient or guardian (does not provide for licensee reliance on referring physician to do so, or no notification based on medicaljudgmwat).

1 i j Elot i

1. Is consistent with other NRC requirements (e.g.,10 CFR $$ 19.13(d) and 20.2205) i requiring licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to NRC.

2. Is consistent with other Federal legislation (e.g., Privacy Act) recognizing the right of

! Individuals to know information about themselves which is contained in records both i inside an outside the Federal sector. See Statements of Consideration for

misadministration rule at 45 Fed. Reg. 31701 (35 SC 10) and 55 Fed. Reg.1439, at ;

{ 1444 (January 16,1990).

3. Enables patients or guardian in consultation with their personal physician, to make

timely decisions regarding remedial and prospective medical care. 56 Fed, Reg.

4 23360.

}

4. Enables NRC to identify the causes of reportable event and help identify precursor l events (SRM DSI.7) in order to correct them and prevent recurrence (isolated incidents l

! can reveal a generic problem when compared nationally) . !

I 4

5. Enables NRC to fulfill its statutory obligation (in Section 208 of The Energy j s Reorganization Act of 1974) to repori Abnormal Occurrences ('ANO's") to Congress.

6. Patient or guardian would always be required to be notified because there is no

! provision for referring physician to inform patient in lieu of licensee doing so or for l withholding notification based on medicaljudgment of harm to patient.

[ CODA l 1. Determining who is

guardian

may be difficult without a definition.

1 i 2. Not consistent with ' therapeutic privilege

of physician to withhold certain information

) from the patient which could adversely affect the patient's condition.

3. Not consistent with Medical Policy Statement to minimize intrusion in the practice of j medicine.

l 4. May not require notification of individual (responsible relative) who under current rule would have been notified.

4 4

i 8

[? raft Rule Text

' (a) For a reportable event:

(1) The licensee shall notify by telephone the NRC Operations Center 2 ] no later than the next calendar day after discovery of the reportable event.

(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 9 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or guardian), and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could lead to identification of the Individual. To meet the requirements of this section, the notification of the individual may be made instead to that individual's guardian, when appropriate.

(3) The licensee shall notify the referring physician and also notify the individual (or guardian)of the reportable event no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after its discovery. If the referring physician or the individual cannot be reached within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.

, b V

(4) The licensee shall fumish, within 15 days after discovery of the reportable event , a written report to the individual by sending either.

(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of ear.5 reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a ,

brief description of the reportable event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence, (c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event , or to that individual's guardian.

2) The commercial telephone number of the NRC Operations Center is (301) 816-5100.

(A G

l 9

n ALTERNATIVE 5 : Licensee to notify NRC, referring physician, but not patient or guardian (or

( :ssponsible relative) unless based on medical judgement, there would be detrimental effects on

't patient due to a reportable event.

t PLos

1. Enables NRC to identify the causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared national:y) .

2. Continues to enable NRC to fulfill statutory obligation to report 'ANO's' to Congress.

3. Is consistent with Medical Policy statement to minimize intrusion into the practice of medicine.

4. Is consistent with SRM direction to revise Part 35 to be risk-based.

5. Is consistent with SRM direction to rely on industry standard [here, ethical standard of care), except for required notification of reportable events causing " detrimental" effects.

CADA

1. Not consistent with Parts 19 and 20 regarding reporting to individuals radiation exposure information fumished to NRC, which do not require threshold of " detrimental" effects.

/ n\

V 2. Determining what is " detrimental' may be difficult without definition of this term (e.g.,

some effects may be delayed in time).

3. NRC has previously rejected threshold of " clinically detectable adverse effect" ( for reporting misadministrations) as not well understood by the medical community and a

' moving target' for patient notification of misadministration. 45 Fed. Reg. 31701,

4. NRC and referring physic! may possess information regarding patient's medical treatment and consequences of misadministration without patient being aware of that information, which is not consistent with patient's "right to know" (55 Fed. Reg.1444, January 16,1990).

5. Recognizes inconsistent application of ethical standard of care for reportable events not having detrimental effects.

6. May not require notification of al! patient's (or guardians) who under current rule would have been notified.

7. Determining who is " guardian" may be difficult without a definition.

n

,. j x.s 10

- r i

Draft Rule Text -

I -

(a) For's reportable event:-

p

. (1) The licensee shall notify by telephone the NRC Operations Center L, no later than the next calendar day after discovery of the reportable event. ,

3 _

_ (2) The licensee shall submit a written report to the appropriate NRC Regional Office p listed in 10 CFR 30.6_ within 15 days after discovery of the reportable event.The written report L must include the licensee's name; the prescribing physician's name; a brief description of the

! event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the

individual (or guardian), and if not, why not; and if thare was notification, what information was provided. The report must not contain the individuars name or any other information that could

! lead to identification of the individual. To meet the requbaments of this section, the notification

[ of the individual may be made instead to that individuars guardian, when appropriate.

l (3) The licensee shall notify the referring physician and also notify the individual (or p - guardian) of the reportable event no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after its discovery if, based on medical l ludgment, there are or would be detrimental effects on the individual due to the reportable

_ event. The licensee is not required to notify the individual without first consulting the referring _

l physician, if the referring physician or the individual (s) cannot be reached within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , the

licensee shall notify the individual as soon as possible thereafter. The licensee may not delay

any appropriate medical care for the individual, incluoing any necessary remedial care as a -

result of the reportable event, because of any delay in notification, i ' (4) If the individual was notified, the licensee shall also fumish, within 15 days after lO discovery of the reportable event, a written report to the individual by sending either:

(i) A copy of the report that was st.bmitted to the NRC; or l (ii) A brief description of both the event and the consequences as they may affect the l- individual, provided a statement is included that the report submitted to the NRC can be lJ obtained from the licensee.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record i must contain the names of all individuals involved (including the prescribing physician, allied "

p health personnel, the individual, and that individuars referring physician, if applicable), the individuars social security number or other identification number if one has been assigned, a l brief description of the, why it occurred, the effect on the individual, improvements needed to j prevent recurrence, and the actions taken to prevent recurrence.

l (c) Aside from the notification requirement, nothing in this section afit.:ts any rights or t duties of licensees and physicians in relation to each other, to individuals involved in the l

reportable event, or to that individuars guardian.

6 l~ 2) -The commercial telephone number of the NRC Operations Center is (301) 816-5100.

i O

11

PATIENT NOTIFICATION OVERVIEW ALTERNATIVES t

p) KEY ITEMS FOR CONSIDERATION 1 2 3 4 5_

C/ Consistent with other NRC requirements (e.g.,10 CFR 59 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are X X required to report such exposure to NRC.

Consistent with other Federal legislation (e.g., Privacy Act) recognizing the right of individuals to know information about themselves which is containea in records both inside X X and outside the Federal sector. See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35-SC-10) and 55 Fed. Reg.1439, at 1444 (1/16/90).

Rule clearly defines who must be informed X X X Requirement minimizes intrusion into medical juJgements X X X X affecting patientc.

Notification requirement enables patients, ir, consultation with their personal physicians, to make timely oecisions regarding X X X remedial and prospective medical care. 56 Fed. Reg. 23360.

,O Enables NRC to identify the causes of reportable events and V' help identify precursor events (SRM DSI-7) in order to correct X X X X X them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).

Enables NRC to fulfill its statutory obligation (in Section 208 of X X X X X The Energy Reorganization Act of 1974) to report Abnormal

_ Occurrences ("ANO's') to Congress.

Consistent with present NRC guidance regarding medical events (e.g., Management Directive 8.10 Handbook regarding X medical event reporting).

Relies solely on physician ethical standard of care to present X medical facts to patients. X Consistent with Commission SRM directive to rely on X X voluntary standards if such meets NRC needs.

Requires definition of " detrimental" effects. X Allows physician discretion, based on medicaljudgement, in X X X X deciding whether to inform patient of medical event.

Preserves patient right to know X X

'V Requires definition of ' guardian" or " responsible relative" X X X 12

ML20211B038

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SUBJECT:

SUMMARY

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