ML20050A627

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Forwards Fr Notice Re Proposed Revisions to Training & Experience Criteria for Physician Requesting Authorization to Use reactor-produced Radioactive Isotopes for Nuclear Medicine Procedures
ML20050A627
Person / Time
Issue date: 01/19/1982
From: Miller V
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
AFFILIATION NOT ASSIGNED
Shared Package
ML20050A621 List:
References
RTR-REGGD-10.008 NUDOCS 8204010509
Download: ML20050A627 (11)
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.J -:. _. 4,'. - no UNITED STATES [ C /' NUCLEAR REGULATORY COMMISSION

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Enclosed is the text of a Federal Register notice that is scheduled.to'.

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-? . M. - - be published on January 21, 1982. > ;, - s ~ -. m9.:.9;,.y n. This notice concerns proposed revisions to NRC's training an'd e'xperience-l iB.y > criteria-for physicians who request authorization to uw reactor produced fA:";CUS ' '2 . radioactive isotopes for nuclear medicine procedures, including nuclear ^ 'T@#Ns%; cardiology. Comments from interested parties must be received within'45' ' J C. @. days of the date of publication. v. Q : ", iff.J;;*W. ~ 3 -,j p Please circulate this notice to the cardiology and nuclear medicineMadiology)& - 1 4.; 3J;1.t,.' .ph sicians on your staff. gf g, 3. %,,1, g.@ - 5 r.

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Enclosure:

Federal Register , c. fit::$ Notice 7.l]p? ...-4 q ',$s ,,5.N,. 2 - ?" ~ 3. p. p., n-r: .:.y., . - 4..y.;. a .Tj U s

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t-[ ' '~ ,s A p o Q .C ,4 g 7. g Q ql,M ,bhV - [ }G"[ NUCLEAR REGilLATORY COMMISSION 4 g/j y. ^ Revised Training and Experience Criteria for Nuclear Medicine Physicians I*# gy. :gy .r

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~ # ~ i AGENCY: Nuclear Regulatory Comission. a M..t._ ,.s d

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(.[,*" N.3 {4 -h['. ' ACTION: Notice of' proposed training and experience criteria..for. nuclear [; Mym. ~ ,5

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medicine physicians, including' nuclear cardiologists. +. M..s.~.n..#.e W~ m.....T w The~ Nuclear Regulatory Comission is publishing.. fo_r: public,jmyw;;;n. ? Jgr. 1.D StMMARY: comment @,*," ' N al .a draft revision of its training and experience criteria for, physicians 1who@t@;iy" request authorization to use reactor produced radioactive ~ isotopes (byprodus W J,c material) for nuclear medicine procedures, including nuclear cardiology. (Thist. revision increases the minimum time appropriate for a physician to.obtainh 4 y;

d. 'sacceptable training and experience fo
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~ nuclear medicine studies, including nuclear cardiology; studies.y j ; ^ gjja,. c _.n; .m y - ~, ~, EFFECTIVE DATE: Coment period expires 11 1 , 1982.<, Commeniis. "! 6 difb S E.c i 'E% ,,M ...cc. received after this date will be considered if it is practical (toido(so,%WM s but assurance of consideration cannot be given except as;to coments receive,d/;,;.*. a on or before this date.

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1. ADDRESSES: Interested persons are invited to submit. written comments and1:Q:h tm'

. suggestions on this notice to the Secretary of the CommissionnU.S.cNuclearw&;/; ./ 1 . Regulatory Commission, Washington, D.C., 20555, Attention:. Docketing.andM;M Service branch.. Copies of coments received by the Comission-may betexaminedC: - ^ ' at the Comission's Public Docunent room at 1717 H Street, N.W., Wash'ington,; 7,Q .k 0.C. i.s

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. e z f !,x j 4 Joseph De1 Medico, Division of Fuel. CycleE FOR FURTHER INFORMATION CONTACT: and Material Safety, Office of Nuclear Material Safety and Safeguards, C.. ; l' U.S. Nuclear Regulatory Comission, Washington, D.C., 20555, 301-427-4E32.' -.?m

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Copies of the criteria currently in use may also be obtained ~at this address.,. I ~ t y ,?, .w .r3 SUPPLEMENTARY INFORMATION: NRC i s publishing in draft form, forLpublic, J.. '.. g-0- comment, a proposed revision to Appendix A of Regu' tory Guidei10.81 LAppendix A concerns training and experience criteria for physicians who> apply for.Q. ' a authorization to use byproduct material in medical diagnosis an'd therapy. ', Z.. By way of background, NRC's. objective is to ensure that atkhorized 7

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' physician'-users have sufficient training and experience to handle safely - i the byproduct material used. in nuclear medicine. The current criteria are y. y l 7 stated in Appendix A of~ Regulatory Guide 10.8. ~ ~ , o,. l l .w 'z... _, 4 ? l ' Insert date 45 days after publication of notice in Federal Register.. e e l l 'l

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L. The proposed revision to Appendix A has been recommended by the NRC'sya w '
Advisory Comriittee on the Medical Uses of Isotopes ( ACMUI), and:by various 9P B 3:f, N. h WDMQ "pr' fessional groups including the Federated Council of Nuclear Medicine'. 'Q(M$P o

10rganizations. The ACMUI discussed this topic at public meetings held. on /*p y.EGd.kgh.lf-] i L IJanuary 18 - 1980, August 18, 1980 and August 31,.1981. Information con - ?f y l.pF. ctrning:these meetings is available in 44 FR 73170, 45 FR 42904 and :46'FR1 32354; - Copies of the meeting transcripts are available from NRC's Public, Mc 'lr Document Room. - ?.E 5*A;.. ;h.+ :,., ;"d .Esseritially, the revised criteria indicate that physicians'who' apply'for@ Y.... #W $ e":*Mk@?s Y Ms 1 - - O. e V

' authorization to use byproduct material for diagnostic nuclear medicine PP ' 'dtyJpW
1 astudies, including nuclear cardiology. studies, should nonnally have a minimum, E

_ QFl.Vy ; 'of six' months of special education,.. training and. experience 'The present~ criteria is three months training. . %.68.4. gpag.?, 92.g 4;)gg',c,tgl' :j ~'m The proposed revised criteria would not affect physicians who are.- e-fp3 e:.8 . presently authorized to perform these studies, but would apply tof. physicians;. 7 O d M W who.. seek to enter the field for the first time. At the time that' the-TrevisionW Jthpt physicians-who are currently enrolled in nuclear medicine Q J.is; published in final form, an effective date will be established 1tofensureiJM, Efih s M$h%

programs; will-not be affected and to allow the various tra sufficient time to restructure their curricula. Written coments or suggesW tions from~ tne public may address an appropriate effective date as well as~ the:

~ 5l@j. 8. N proposed revision itself.

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n The proposed Appendix-A is printed in its entirety below:

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y,y, '[ U b'p -g, y , v' . p.a ,;9, ',.: q::= ; WO V APPENDIX A '.~W: R'( ~v.> % sy@r '~ ACCEPTABLE TRAINING AND EXPERIENCE FOR. ~ 3;,*

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~ MEDICAL USES OF BYPRODUCT MATERIAL

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.X-r ' ?Any human' use* of byproduct material must be carried out by' cr 'ujide'rf e.WTESGW th 7 supervision of a physician.* This appendix outlines training' and experienke%M .%D../ ~ '; criteria that the Commission, with the assistance of the physician and healt t -physics specialist of NRC's Advisory Committee on the Medica 1UUses ofiIsotope579, V ( ACMUI), has found acceptable for physicians who wish to use byproduct materialE ~' ~ for human use. We recommend that this training and experience-be, obtained ;incadD i? g, ' .foma1, accredited training program for resident physicians.

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..(_ f-Physician training and experience can be examined on a case-by-c.ase.JA'physiciatt?/ n Ewishing to use radioactive materials but not having the training ~'and ~ experience 4: i idescribed, may submit an appliation listing specific qualifications;Fand7thesel ?, : .. will be reviewed by the Commission with the assistance of. the ACMUI.. k.\\, J:, m.. ~ II. ACCEPTANCE OF MEDICAL SPECIALTY BOARD CERTIFICATION A;p.a: 92 ~ a. Certification by the medical specialty boards listed in Tabl,e l' :will be. f ^ accepted as evidence that a physician has had adequate training and experience for the corresponding procedures listed in the tabh. 4q. .; n < T,

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~ > III. DOCUMENTING TRAINING AND EXPERIENCE V-N 4,77 . L, - ~3 Supplements A and B of Fom NRC 313M are used to document trainingfand expeiience. Physicians who wish to qualify on the basis of board certification need'only;,, 1 complete Items 1.. 2. and 3. on Supplement A. Other applicants should ~ submit ,c 3 upplements A and B with all items completed. A separate Sup'plement BfformP,;N S n ;. v i should be completed and signed by each preceptor who provided training.or-- supervised experience. The remaining sections. of this appendix 'specify;.traininghc'. . and experiece criteria for specific procedures or groups. of procedures'. i,[ .}. .y IV.; TIME LIMITATION ON ACCEPTABLE TRAINING AND EXPERIENCE ' m W N d j .h '. T ' Q. Q'l ' NJp ' ' MTraining and experience must have been obtained within fiveh . i'. 7 'date of the application, or else the applicant must demonstrate' continuing.;.w. Einvolvenent in.the procedures since the time of training'. 5 V A@ [C g$[ Q n 71:a, - .F ff JV. TRAI'NING FO'R ROUTINE DIAGNOSTIC PROCEDURES'(GROUPS I-III, INCLUDING NUCLEAli $ .E CARDIOLOGY PROCEDURES) .. J .t.C. ' ~ ,.a i To qualify as adequately trained to use or directly supervise the~use:of. .. 4 i sy ". ~ byproduct material listed in Groups I, II, and III in section 35'100'of 10 CFR. A Part 35, a physician should have the training and experience li.sted,in :TabTe,2.- ~; 4 Y W "As, defined in 10 GFR 35.3 ? g 8 g. .mme.-w -an.-ww e w,.e w4,. , - eu.mme.e_.e.u N

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,.w... ,... ar., ',>. ; r G We ,,: s t.y*', a - Q ' 4.d)k',["N.. t.,, 7 'I VI E TRAINING FOR SPECIFIC DIAGNOSTIC PROCEDURES dai 6A' physician who ' wishes to be authorized for only one or two specific diagnostic;1 %.. w' .': :,? f. _ procedures should have training in basic radioisotope handling techniques,;, eg.a.f:gf;J,fj 'i.i and clinical experience commensurate with the quantities and uses of by-1 ? r y'fN. S,53Q product material being requested.. Such requests will be examined cas8by-> =, ; ~ y qC cc; M(case by-the Commission with th,e assistance of the ACMUI. ".'g- , ',9: N J .s.. ~ er / VII; TRAINING FOR THERAPY PROCEDURES INVOLVING RADI0 PHARMACEUTICALS (GROUPS- .c., f, e-i IV AND V) 4 . <l. 'J " y,.... .r

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,4 ' 1 i (a) I-131 for treatment of hyperthyroidism and/or cardiac condition's':. Olh? - Clinical experience in the diagnosis of thyroid function _ and ,1, ?f zW e '. '.QLb.. 1r,

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, active participation in the treatment of ten patients, w.a: .(b) Soluble P-32 for treatment of polycythemia vera, f eu'ksmia,[' y ;;? TEU ' n p: ~ ' l $ - WMP ei and/or bone metastases:

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Active participation in the treatment of three patients. 'y,' (c) Colloidal P-32 for intracavitary treatment: .i sn.s. ,-. w., r For Group V ?:'r, ' 2..

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WW. 7 thyroidism and/or ca,rdiac. dysfunction, and active partici-7 ..... O c5 1 pation in the treatment of three patients with thyroid - 2 f ff.T;. can:inoma. 1 f;, d W a.- .x m. (b) Colloidal Au-198 for intracavitary treatment: "'mNJ ^

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Active participation in the treatment of three patients. rc meet the criteria for Groups I-III must obtain the specific clinical ' experien ,, B. -To perfom only Group IV and V therapy procedures, physicians who do not. y c:

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Radiation biology 'N20hobI'((.t em b (....: y. c, 3 3. y - 7 1 YIII". TRAINING: FOR THERAPY <ROCEDURES INVOLVING SEALED SOURCES:.(Group VI)" n3 ,.y When a physician is not board certified in one of the radiation therapy My e-: z specialties listed.in Table 1., his or her training.will.be.reviewedtwith,g

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,4V the assistance of.the ACMUI. In addition to Supplements' A and B as 'r JM ' ' <

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described in Section III. above, the applicant should submit l'ettorstofo.@, @[: ,j , evaluation from each physician who served as preceptor. iThese letterstof2M evaluation should. describe the scope and extent of the. applicant's' training}fd ;.7 .g

and experience and should state whether, in the opinion of the preceptor /pd';v the applicant is fully qualified to independently perfonn Group-VI therapy.]J'ai procedures.

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q, .e** .f To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Group VI of Section 35.100,10 CF.R ~ : Part 35, a physician should have the training and experience listed. a.~ - b 'y?+ g; - - in Table 3. e' " S ' s s

; f IX.. TRAINING'FOR PHYSICIANS WISHING TO USE SR-90 EYE APPLICATORS ONLY'..

1 /1 'To qualify as adequately trained to use or supervise the use of a-_ gj n; '1 , y c i N1 Sr-90 eye. applicator only, a physician should submit: . R' I ,

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Radiology or Theraputic Radiology, or .w g-: l t.- B. Evidence of: ~ b #N w -a. i[

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Active practice in therapeutic radiology or y ^. ophthalmology, and . C 7 e. X e-s. -**m ~ ',rgy _- c g., ,a,_

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Mathematics pertairting to the use and (4 hours) T measurement of radioactivity i

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d... Radiation biology ,(8~ hours). m,.c.n..g' ]$ .r,.... *n. m,,,, y e e. This information shoulo be submitted on Supplement A of.Fom-NRC-313M. jlpq 3 -] The hours listed next to each of the four subjects are suggested . f.h 4" minimum: values and should not be interpreted as specific requirements.. e.. a;p. s. i, ~ y .g ~ 3.- Evidence of active participation in the treatment of five patients . p , Q.L 1 (to be submitted on Preceptor Statement, Fom NRC 313H, Supplement' B)'. % C. .. q..s ;; t.M, -,.o &; 4 a .r.

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' M W d.! - " Active participation" should include supervised examination of ~ 4 2 patients; collaboration and calculations concerning the: dose. to:be ; - J n;* administered, administration ~ of the dose to the patient, fo110wup4 i li;l ;"XQ.%b:j and study of patient case histories'. ~ - V.'

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TABLE 1. pl-. The following medical specialty boards will be accepted as evidence thi'tla 1 4 ACCEPTANCE OF MEDICAL SPECIALTY BOARD CERTIFICATION J ^=6 .. ~... ~. ~ A. n; physician has had adequate training and experience for the procedures listedh h,.n {4 below: 3., ,. Procedures: Board Specialty i. . ' ~ 5 ~ American Board of Nuclear Medicine Nuclear Medicine Groups I Yf American Board of Radiology Diagnostic Radiology with Special Competence in Nuclear Radiology Groups IyIII t ,. c.. Radiology Group VI.? bI Therapeutic Radiology Group VI:

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+ . l ~ American Osteopathic Board i of Radiology Radiation Oncology Groups.Y s VI j British Faculty of c Group VI .p Radiology

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Canadian Royal College of Physicians and Surgeons Therapeutic Radiology Group VI 3 ]1 .B. The following Medical Specialty Boards will be accepted as evidence that al. physician has had adequate training and experience for the corresponding-list i_ of procedures; however, the board easmination must have been passed within-l', five years prior to the date of the application, or else the physician mustu ~ I demonstrate continuing involvement in the procedures since the time.of ~the ~ board certification: b. Board Specialty Procedures American Osteopathic Buard of ( j Radiology Diagnostic Radiology Groups I.-III Groups.hIII $, * /.1 Radiology I

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' Concurrent Training in Six Month Programs 7 m. c. %:W# e fi Y, - '.., 4 W., ?,N:..::.. - 2.Th'e criteria specified below may be satisfied concurrently Jin alformal,: e,f 7p x, ~ -integrated six month training program for resident physicians in,an..:g,., J., ' - ' -accredited nuclear medicine (cr nuclear cardiology) curriculum. Note, q:JL: 3:9-5

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. however, that all of the requirements in Sections A., B., 'and C.'must be ? ?1 w@'. fully' integrated into the program. Physicians who do not receive their-3 ff training in such a program should obtain the specified number of'. hours in f 4 each area: ~ { '-u o ....3

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c A. Training in the basic radioisotope handling ,,(200l hours) ,y,7 3' g a: techniques specifically applicable to the use of .,.4 t ', _' unsealed sources. This training should consist of and supervised experience in a nuclear medicine .,. 4,~ Q @S;,

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1ectures, laboratory sessions, discussion groups,

- J s, 7._. g-4 j laboratory in the following areas: 47; .? 1. Radiation physics and instrumentation (100 hours)-' lg:. f h' I,. ~ 2.; Radiation protection '(30 hours) l T' i 3. Mathematics pertaining to the use and . [.. 'C measurement of radioactivity .'(20 hours) ...,..~. a,R, 4. Radiation biology '(20 hours)' "? r S. Radiopharmaceutical chemistry .'(30 'hdurs) o . (The hours listed next to each of the five subjects ab'ove are; suggested!,. [ values and should not be interpreted as specific requirements.) c' {.. _ 2:j B. Experience handling unwalad r=dinactive materials under the' supervision .a.f a qualified instru.ct.or (500 hour _R. inis expeVWnce should cover the - .c, types and quantities of byproduct material requested in the application 1 ? l p; .and should include: ~ .f; u. :.1. f A,, !.? :.. 1.. ' Ordering, receiving, and unpackaging radioactive material _s safely,' ' ' 'x -' J3:8 . including perfomance of the related radiation surveys. e i ),,..~ 2. Calibration of dose calibrators and diagnostic instrumentation, and; i perfomance of operational checks on survey meters. (( + . @,N 3. Calculation, preparation and calibration of patient doses, including ~ l - f' - radiation safety considerations. (continuedonnextpage) e e B e - w g .m -e w..

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j l . f'Q.,'* ^ r " /, 4. Administration of doses to patients, including proper use of syringe'.' shields. m.[ '.)g ' a. p ;.7 ' 5., Appropriate. internal control procedures to prevent the misadministr' tioni ?IYii?.'i a W_a /W%' ~ f materials to patients. ' t. o r.Lc:.3p a ' i." ' \\~ 6. Emergsncy procedures to handle and contain sp111ed materials safel);%[ %8 ' including related decontamination procedures.. C ^> K.. =R..., p x;;. .,e. 7.:.Elution of Tc-99m f' rom generator systems, assay and testf rig of; the b, 'Q.7 . luate for Mo-99 and alumina contamination, and processing the e ?- . eluate with. reagent kits to prepare Tc-99m labeled radiopharma-14 .ceutical s. (Required when physicians apply for Group III authori-3 1lp" '% s > %v zation. Group III includes generators and reagent kits.). s p<.n w 9, ; C. Supervised clinical traininhan_ institutional nuclear medicine (' r"nuclearT'.'05 ".. o S ?"@,T ~ ~ cardio1Wrogram79xI-}iours-). The clihtrafili~ng should cover all. ~ appropriate types of diagnostic procedures and should includef a. W l *, j 1. Supervised examination of patients to determine the suitability' for. .N ; radioisotope diagnosis and recommendation on dosage to be;~ prescribed.m ' ~ 'PU *

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./w f %W. 2. Selection of the proper radipharmaceutical and dosage,' calculation of thei NW ' y .related radiation dose and collaboration in the interpretation'o'f the k t M em i F .'1.%w.:y:, i ~ '1" c _. radioisotope test results'. q.x w. 1;h M. 3. Followup of patients when required. -.. ;n. - 4. Study and discussion with preceptor of case histories to establish.the, most appropriate diagnostic procedures, limitations, contraindic.ations, ' W 1 etc. 9.' e ya, - j .N p;.gQ i ,e .n t.;, l, l.-- ,, ':p y?. N: - p = . f.. ,:f g J,- s m, y.j 4 e g O f 3 f. e.

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y g 4 = s+ t en ' O S' 't g b

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,.;p c Ek Table 3. TRAINING FOR THERAPY PROCEDURES INVOLVING SEALED SOURCES (GROUP VI) _ $s T~.Y .x.. 9.y To qualify as adequately trained to use or directly supervise the use of - - E q.',. byprcduct material listed in Group VI of Section 35.100, 10 CFR Part 35,, a. ' ' h W , T + a, physician should have: . $ 'A D. i,'g _.; - (200 hours) J Training in basic radioisotope handling %,'M A. techniques specifically applicable to the use of ^ '%.'; ssaled sources far therapy procedures, consisting' of lectures, laboratory sessions, discussion groups, and supervised experience in the following areas: W". (110Iours): 1. Radiation physics and instrumentation (40 hours)i .g ~ 2. Radiation protection (25 hours); i[ gf 3. Mathematics pertaining to the use and 9, - measurement of radioactivity (25 hours); 4. Radiation biology ~ Y

n...

(The hours listed next to each of the four subjects above are suggestedf. :, values and should not be interpreted as specific requirements.) 'f,47.i : Experience handling sealed radionuclide therapy sources under the super @ ',f vision of a qualified instructor (500 hours). This experience should. 8. cover the types and quantities of byproduct material requested in the y,' M 4 ' Jf. application and should include: Ordering, receiving, and unpackaging sealed sources safely, including.,M 1. performance of the related radiation surveys. Performance of operationa? checks on ion chambers and survey meters'.. 2. Safe handling of sealed sources d?ving preparation, insertion and. [fp-3. renoval. 4. Quality control and emergency procedures. ,. y; ',, s.. g' s si' O. m Clinical training in Group VI procedures: . Active practice in therapeutic radiology with a minimia of 3' years. . f- .M C.

  • i's experience of which at least 1 year should have been in a formal training.

program approved by the Residency Review Committee for Radiology of the' Accreditation Council for Graduate Medical Education. t ( l l p 4 0 4}}

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