ML20213F765

Discusses 851231 Memo Requesting Guidance on Permissible Delegation of Responsibilities by Physician Users to Supervised Physicians.Responses to Questions in 851231 Memo Listed

ML20213F765
Person / Time
Issue date:	04/30/1986
From:	Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Joyner J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20213F749	List: IA-86-759, Requests Guidance on Permissible Delegation of Responsibilities by Physician Users to Supervised Physicians.Issues Where Clarification Needed Listed ML20213F748 ML20213F757 ML20213F765
References
FOIA-86-759 NUDOCS 8611170147
Download: ML20213F765 (13)

Text

- -

UNITED STATES 2, ** * * % '.

NUCLEAR REGULATORY cOMMlsSION i fYC 1 o W ASHINGToN. D. C. 20555

%....'/ i..:. ;g t1EH0 RAND i FOR: James H. Joyner, Chief Nuclear Mate rials Safety and Safeguards Branch, R I FROM: Vandy L. Miller, Chief Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS

SUBJECT:

REQUEST FOR GUIDANCE ON PERMISSIBLE DELEGATION OF RESPONSIBILITIES BY PHYSICIAN USERS TO SUPERVISED PHYSICIANS This is in reference to your December 31, 1985 memorandum on the same subject.

You have raised some complex issues related to the practice of medicine and to the Nuclear Regulatory Commission's (NRC's) medical policy statement, espe- -

. cially part 3; see Enclosure 1. We have discussed your memorandum and our responses as given below with appropriate staff in the Offices of the Execu-tive Legal Director (ELD) and Inspection and Enforcement (IE); ELD and IE concur in this memorandum. ,

Please note that our letter to Christian Hospital considered the limited case of an authorized physician-usea delegating only image interpretation duties to l a nonauthorized physician. Your memorandum describes a case that apparently involves more extensive delegation of duties to nonauthorized physicians.

We will repeat each of the questions listed in your memorandum, provide an answer to the specific question and, as appropriate, discuss broader, general principles or give you some additional pertinent information.

l QUESTION 1: Can duties restricted to physicians (clinical management of radioisotope patients) be delegated to physicians not in a formal training program at an institution? For example, can physicians who never intend to become authorized users perform this function under appropriate supervision?

ANSWER 1: Yes " clinical management of radioisotope patients" (as defined in your memorandum) may be delegated to physicians who are not in a training program and who may never intend to become authorized users.

BROADER, GENERAL PRINCIPLES 1: Although an authorized physician-user may -

delegate such duties to other physicians, the authorized physician-user

retains responsibility, from NRC's regulatory standpoint, for the actions of l those to whom duties have been delegated, including clinical duties such as l selection of patients, prescription of the radiopharmaceutical (including determinatior, of the dosage and route of administration), and interpretation of the test results (including preparation of a written report for the i 8611170147 861112 k l PDR FOIA CHEREWIB6-759 PDR

.. ,.,. . m .. w . ,. , , , ,

.~

James H. Joyner patient's referring physician). Ideally, the authorized physician-user would not delegate these clinical duties and e do not believe that such delegation should be encouraged. However, if the authorized physician-user does delegate clinical or nonclinical duties, or both, he or she must exercise appropriate supervision over these individuals (whether physicians, technologists, or other personnel).

A key question then is what constitutes adequate supervision. The dictionary defines " supervise" as follows: " ...to coordinate, direct and inspect continuously and at first hand the accomplishment of; oversee with the powers of direction and decision the implementation of one's own or another's intentions." In accordance with 10 CFR 19.12, NRC expects that: (1) before the person supervised (supervisee) begins performing delegated work, the supervisor provides specific instructions, both orally and in writing, about what the supervisee can and cannot do, what the supervisee may do, and how the delegated tasks are to be done; (2) the supervisor must ensure that the supervisee has adequate training and experience to perform delegated tasks safely; (3) the supervisor should also have defined unusual or abnormal situations and provided instructions about what the supervisee should do in such situations. Finally, the supervisor needs to audit all activities, including reviewing the supervisee's work (e.g., pointing out errors) and providing. additional guidance as needed.

(*

Although Section 35.38 of the proposed revision of 10 CFR Part 35 provided medical licensees with a draft operating definition of adequate supervision, it did not eliminate all questions. Note that it did not require licensees to maintain written records of delegations of tasks or instructions from the supervisor regarding which tasks must be performed and how, which may be performed, and which may not be performed. Note also that it did not specify how often a supervisor must review or audit the supervisee's activities.

(Note also that the final revision of 10 CFR Part 35 recently circulated to l Headquarters' and Regional Offices for concurrence does not require immediate availability by telephone and physical availability within one hour. The purpose of deleting the definition of supervision was keep NRC away from regulating the delivery of medical care.)

The regulations cannot cover all of the circumstances faced by medical licensees, so the NRC staff must exercise judgment in reviewing individual situations. On most medical licenses we use Standard Conditions 6 or 7 (as shown in Policy and Guidance Directive FC 83-20, Revision 1) and understand that the authorized physician-user's involvement need not be 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per day and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week. Accordingly, it may be helpful to set some outer boundaries of acceptable involvement for guidance in individual cases; see Enclosure 2 for our evaluation based on licensing experience and actual l

enforcement cases. (If we want an authorized user to be physically present

' whenever licensed material is used, we use Standard Condition 8 that includes l

the phrase, "...by, or under the supervision of and in the physical presence o f . . .")

James H. Joyner f. . . . .

w From an inspection standpoint, the adequacy of supervision might be more easily judged by the number and type of items of noMompliance noted in the areas or activities supervised by an authorized physician-user. Many items of noncomplitnce may be indicative of inadequate training (violation of 10 CFR 19.12), or inadequate supervision, or both.

QUESTION 2: If the answer to question 1 is yes, can the same delegation be made under a private practice license?

, ANSWER 2: Yes, the same delegation can be made under a private practice license, provided that the authorized physician-user retains responsibility and adequately supervises all individuals .(e.g., technologists, nonauthorized physicians) to whom various duties are delegated.

QUESTION 3: If the answer te question 2 is yes, do you recommend that our citation against Dr. Reddy be withdrawn?

ANSWER 3:"We do not believe that we can provide a definitive answer to question 3 because we do not have all the facts at hand. We recommend that -

j t

you reevaluate Dr. Reddy's case in light of the information provided above.

We believe that the key issue is whether Dr. Reddy exercised adequate supervi-sion over the other physicians and other staff (e.g., technologists). It is not clear to us that Dr. Reddy did exercise adequate supervision, but our impressions of the case cannot substitute for your and your staff's first-hand information and observations.

QUESTION 4: If the answer to question 2 is no, we plan to use strodg language -

to put Dr. Reddy on notice that the continuation of this practice will result in a significant enforcement action. Do you agree that such a violation is serious and merits strong enforcement action?

ANSWER 4: Because the answer to question 2 is yes, no response to question 4 is needed.

QUESTION 5: Is our understanding correct that acceptable clinical experience cannot be obtained under a private practice license?

ANSWER 5: Your understanding is correct that our current policy is that, for i

clinical experience to be acceptable for licensing purposes, it must be obtained in an institutional nuclear medicine (or nuclear cardiology) program.

See Section 2.c of Enclosure 3 and Table 2, Section C of Enclosure 4.

ADDITONAL PERTINENT INFORMATION: From telephone conversations between our .

staff, both Dr. Glenn and Mr. Kinneman of your staff are aware that this policy may change. The revision of 10 CFR Part 35 that was circulated recently for concurrence (to both Headquarters' and Regional Offices) does not restrict acceptable clinical experience for diagnostic uses to that obtained in an institutional nuclear medicine (or nuclear cardiology) program. We understand from discussions with Dr. Glenn that in Dr. Reddy's case this point may be moot because the cardiologist in question is obtaining clinical experience in an institutional program.

l L.-.-.__-_----_-_________-________.

James H. Joyner We agree that the same user conditions are used on medical and industrial licenses and have different meanings. This issue has been discussed on several tccasions, most recently at the December 1985 Regional Licensing Workshop. Note that we have provided written guidance to some medical licensees in the recently published draft teletherapy guide (FC 414-4, dated December 1985). Finally, as agreed in the December 1985 meeting, we will try to resolve this matter in connection with the complete revision of 10 CFR Part 35.

If you have any questions on this matter, please contact me at FTS 427-4002.

e h*f Vandy L. Miller, Chief

., .NMaterial Licensing Branch Division of Fuel Cycle and Material Safety

Enclosures:

1. 44 FR 8242 l 2. Additional discussion of " adequate supervision"

3. Appendix A. Regulatory Guide 10.8 (Revision 1), October 1980

! 4. 47 FR 54376 cc w/ copy of R I's 12/31/85 memorandum:

J. Glenn, R I K. Barr, R II J. Potter, R II W. Axelson, R III B. Mallett, R III R. Hall, R IV R. Everett, R IV J. Montgomery, R V l R. Thomas, R V D. Nussbaumer, SP N. McElroy, NMSS l

I 1

l

UNITED STATES NUCLEAR REGULATORY COMMISSION

(, RULES and REGULATIONS TffLE 10. CHAPTER 1. CODE OF FEDERAL REQULATIONS-ENEROf T COMMISSION NOTICES POLICY STATEMENTS Medical Uses a4Fm02e2 pmp g afgfyg ined in the NRC PJblac Docuritat gg,g ,ygg ,ggg gneeuw 3/9/79 Roorn at 1117 H 5treet. N W W:.sh- The NRC and Ita predeceasor the Insten. D C. Atomic Energy Cornmtasion hate resv-lated the ruedical uses of radictsotopes Segufetten of the Ste$cel Uses of ms NRC poucy statant is in. - since IM AEC recogrused that ph)a.

Red'eIsetepes; Seelement of Gener. tended ta inforte NRC laceraees, other clans have the primary resportsability M.*Y Federal and State agencias and the for the protectjon .of their patienta -

pub!ac of the Co:nt-isston's generalin- and destsned lu regulattorts accordj.ng.

AOENCY: Nuclear ResWatory Com. tention regard.ng the regafatica of ly.The physicians sete required to be antanen the rnedical uses of rad-oisotopen-licertsed by the State, and their sphD.

esbte tratning and emperience were ACTION. Final Pol!cy Statament. It is euected that future NRC sette.

- ltfes in the med!cs.1 area. such as pro- esaluated in consultation s1th trie Ad-ggy,mgy. The Nuclear R'8d"E84 mu?satiers of new regu!stions and de* stsory Comtnittee on the Medacal Uses Cctruniaslon (NRCI bas the foucsing of isotopes. This regulatica has been

(..

po!!cy statarnest regsiding NRCs future role in regu!stu'is the medical ge:e;rrent of cocper:tige relationships sith other Tederst agencies. s til fo!!os this staternent of NRC p:! Icy.

generally oriented toward a.ssistans qualified pha sicians in dischargirst

, uses of radiotsotopes. Tbl.: NRC po!!cy Based on past expertence and the their ru nonsibilattes to patients How-statement is intended to trtform NRC cc:ntr.enta and adece of the pu%c- eser, regulation by AEC/NRC has at licensees, other Federtl and state other Federal agencies.the states. and one time or another encompmed agencies and the pubtle of the Com. NRC's Abtsory Csratnittee on the tirarly esery aspect of the delisery of annalen s ger.e 33 Intentlos regarding Medren! Usea of Isot:;es, the C:r rr.fa. redtoisotope medical serslees to pa.

the regulattos of the mesica.1 uses of sien has one!: ped the f:1!ostr. state- tients. The broadest regulatiori oc-rsolo:.sotopes. It is espected that spent of genera) psticy la guide its reg- curred betsees 1962 and 1915. shes future NBC acahttles bt the stadacal u!ation of the med cal uses of race 6so. the Food and Drug Ads!nistrstlos area auch as profoulsallon of new reg. tcpes:' 47"D A) esempted frorn Ita require-ulations and deselopment of coopera. 1. The NRC 3111 centinue to regulate g gg the relationahlps with other Federst the medical uses of rad ol M radiophar uscauttra.13 regulated by e e a to stil isUon this asatement of s

ar,y W pg ,,t trs and the general AEC. During this period AEC regulat-8'I- ed the radiation safety of sorkers and pub!!c. the generst public and the safety and EFFECmVE DATT. February 9, Ipfg. 3. The NRC till regulate the rad!- efficacy of radiesetise drugs med de-FCR FCRTRER DrTORMATIOlg atton safety of patients abere justified tiecs sith respect to patients. AEC COff7ACT by the r6sk to patienta and there vol. regulattoo included productiors of the untan standa'da, or c:mpuance e radJotsotope, manufacture of the final Mr. Eds ard Podolak. Offlee of thne standards, are inadequata. radlonctise drug product or desics, dis-standards Developreent. U.S. Nucle. tributton, use and disposal of the prod-at Regulatory Commisaton. Wash. 3. The NRC sti2 anintrnise intrustoa Ersto medical judgments affect!r.: paa ucts In 1973, the TVA termiosted the Ington. D.C. 2CSSS (Phone 301 443 emernption for redlopharmaceuticata, gggg 3, tienta and into other areas traditional-ly cortsidered to be a part of the prac- statir.g that it sou3d now regulate the 3CPP1.EMCrTAI. INTORMAT10N. tier of eedictrne- safety and efficacy of rad.oactive The NRC has developed the fot!catnf d. ags sith respect to patients. (As three part policy statement retarding note.1 later to this statement. FDA NRC s future role in regolating the .NnC tecenses radiotnotepas in three cate- does r.ot regulate the phasician's rou.

medical unas of radio 4sotopes. On eeries taproduct nouru aria special nucle- tt.se kne of roo;opha.rmaceuticalsJ At Marcts 17. 1914. the three part poucy at matettaL The IcRC dees not recata's naa- the manae time. NRC sithdrew from atstement a na pubitahed to the Fusca, uraus eaurms or nu. ele nuit prodwced es. regulatisag rsdacactise drug safety and aa Razurcs (43 FR 183001 for putdae a:etnesapen The ime h, oduce marines ef t.cacy, stating that I. sould regu.ata the radiattoo safety of the sorkers coarment Coples of the po:acy state.

ment .nere seit ta all)fRC medacal Ib Q

,. '"",$',,U',yu e.,an, ey.re ala U .e$

,,,,,,,e to use rad:st'.es 6 ass.

and the putille. The 1974 Med: cal censees. the States and :S professional seat se the procas et sroductr.a er ususae Desire Assendssents to the 7 ood. Drug societies. Federal agencies. and Inda- sowins sucJent matenaL The term s*=see and Conrnetic Act e.stended FDA's au-sidusta. The corrJrent perfod emptred mesmal means its urarJum, taenum et nar thority eser medical devices stac2ud:sg May 18.191L Tseety.two corarnents sessir.ause thervor. to aar pm:s.t.a4 e' deuces contnJning radicactise maters-slan la a say sarnalat to its authority sete recened. Nine comtnenters fa-sored all three parts of the policy

'hd*y,I'["E]'d',h

, , $" e

,, ,,,, ,g gg, ,,sarum, sul thortum er stu,s cier drusa.

statement, four comunenters opposed any eemMnauen the vot soure ca*enag NRC s authority to regulate domes-l does not include sportaa euclear eat.eMal. (!caRy the snedecal uses of b3 product ene part of the policy state:riest and

[

rune cornmenters addressed specirle special amelne, mesen J menas til DNtan6- sratertal is found la the Atomic l

urn uransure 23s. utstuva eartcaed la toe Energy Act of 1954 as arnended. For haues dtscuated in the March it,1973 example, sect!on el of that Act authe-3**' 888 in the tuimpe rss se a:s anF Fisca.a.a Recastra notice: The com. " *" 'I '^ '0 'E# '""' h 'd * * *^' 'h' rtzes NRC to tasue deneral or specific ment.s are d.seussed la Section IL " "' **' 8' lacertsaa to apphessiu seeking to use Coples of the commenta enay be nare. lproduct snatertal for * *

• med!cm3 theraer * * *.* Secttert 81 directs NRC

l POLICY STATEMENTS to regulate the manJfacture, produc.

Efon. transfer, rece pt to Interstate IVA s methtt.es.11 in harw y E.th be a psrt of the ~2* ** of re;d w .

e==merce, actu*att.cc car.ership, pos- re:ulat!cn by th e Depar:nwnt of I seulon tr. port and esport of b> prod. Transpcrtatten. Sotfal Ser r;ty Ad- sraarts hate the pr.rd es The Co riiss.on rech"b'k that e:por.s.%t uet rnatcrial Tir.aDr. Sectsoo 81 also Etnistrat!cn afd the Joint Con:rn!s. for the protec::en of their pat'ents

• Crects mat- sten on Accred::a: on of Hosa.!sts, and dosetatta sith Occupational Safety The Cornmtssion be!! eses that haste .

The Corn.ni.sJoe shas ser pertr.!: tr.e 4: and Health Administratica regu!ation deetsior.: conceming the d:sg osis and tr'aution et 4Ar byprodwet sister.nJ te may of the work place for the use of natu. treatment of dues.te are a part of the t.renaee and are.;J reca.U er ordar the rees;g physician patient re!st!ct:.sh!D and are rsUy-occurring ard acce!erator pro. traditionally coe.s:dered to be a part of e.f ans d:str%Les raaieriaJ frors aar beens- duced radicartise t=attria!s.

es s he is not eevioswr to obsene er f ara e,e the practice of med: cine. NRC regula-

"the second part of NRC's pot:cy 44cns are pred,cated on the nas:.:enstion a th as r be a ed er he g'et staternent tnd '*1:es that NRC m:11 reg. that proper!y tra' ..ed and adequately

. won er the ases such rester ma to ne[ u! ate the radia*!on safety of pa!!er.ta inferrted physic.ar:.s s:;l malte dect.

Leo er tas er rerutation or tae Ceests;as.ca where justaf.ed by the rist to patfe .ts afor.s in the best interest of their ps.

me in a sw.nar other tea.n as a;acleted to and there voluntary standard.s. or 14en t.s.

t%e sos cat:oa therefor et appre.ed ey t.h, cor ip!!ance eith the:e sta. rSrds. are Csanmias'ea, inadequate. As noted before. NRC has The rerJIallotts try to far:d a balance

( the authority to regulate the rad.stion betseen adequate contra!s and avold.

Cornmiasfon re tsf ations. for the safety of pat:ents. ance of undue Interference in medfeat a= cst part set forth in 10 CML Par.s 30 Judgments. A corJequence of too t?.routh 35, a ere premu*3ated to carry The NAS.BEIR e report d'.scusses much regulation could be poorer l ar it the broad res.Catcry scherne en. I! mat:ng the espesure of the popula. health cate delhery to patients. A con.

nsaged by section St. F4r exa.mple, tJcn to med cal app!! cations of lor.:::r.g negaence of leavit:g to physfcfarts the Part 33 estabhshes regvfations spectfle rad!atforu That report. t hJc! includes

' snaforf ty of the decisier:.s concerning to human uses of bsproduct rester al. a!! meccal we of lonfr.tre racation. their patients is that the phystefans F DA's statutory authority (Tederal shots an temge dose rate from W33 make mistates. The t!ghtest rega.

, Tood. Drug, and Costnelle Act, a.s racopharmaceuticats of I s rem / year tation of physicians

• deetions by Ted.

a. . ended. 31 U $ C. 301 et seg i does and an averste dose rate frorn d.ag- eral. State and profess: oral gro.:ps till

r. t dlm!nish NRC's authority. Where mostic rad 4 ology of 'l2 mie:n/) ear in not be able to present fu:ure tr'eidents NRC's and TDA's authori!!es oserlap. Wo. In the sned cs! uses of rad:otsotopes.

t.he respeethe author: ties can be hat. The fotom:rg quotat!on !s frorn the i

m:ni.ted by loteragericy ag ee:nent. NA3-E EIN E'fL The Corntn;sa!cn recor-ti:es that The central question la a que.stion of TDA regulates the sia .ufacture ar.d

{ In the foreseest'e future. tre zater een. Interstre datribut!or. of drugs. inc!ud-t pc.t:cy not sisthonry. nac:ely- tr buars to raca:.on esposare er the ooou- &ng those that are rad.cacthe. TDA l To that eatent should the protec. lat.o.i s;;3 continue to te aa: ral tact.

s'so regu!stes the investigational and tien of the patient be co .sidered in evound at:.h an a.erage e r.oie toJr dose of researc!s uses of drugs as se!! as the NRC's regsf atton of the med; cal use of ecoat too an emrear. and niecrst ses sea.

byproduct mater:al? cons er.Jch nos eer::r.bue entrra-se.e es. spec;,fic gu! dance on doses and proce.

dures fourid in the product labe!:rg.

T' rom the standpofnt of sisthority. It Is clear that NRC can res;! ate the UQ',',,(T,,N'g,*,$7 74r '

Moseser. FDA does not base the au.

me:Jeal uses of byproduct triaterial to ,,,, g, ,,,y; g:en ,, 33.  : ,,,,,. t. The

. thority to restrict the routirle use of pr: Lect the health and safety of users use er noru rg ra. cat:oo to steda:.ne ts of drssa to procedures fdescribed in the of tJia mater.al. for instance. patfects, tremerdoas eau.e but it is asser:t:aJ to product labetical TDA has approsed red.re esposures stace tras can be steom-In !cenalrig the poneuron and use of pt.smed e,tnout tous of gener:t are as reis- as safe and effecthe. Irideed. NRC la bsproduct material. NRC estabt.shes u.etr now east. The a::n is nos erJr to the only rederal Agency that is eur.

1:._Jts s1 thin t htch phisiefans eser, reduce the roara.:so espesure to tae indt- rently author: sed to reralate the rou.

cise professional discretion. From the 8 t:rie hse of radioacthe drugs from the s andpotnt of pofiev. these Droits jyuj,8, [,,f,y,$G,,y,j star.dpoint of reduc!ng u riecessary ra.

can 3. a cons:ca.rg incren.se in sed.cs2 diation exposure to patients, t Ih a d to th pat ent s esft$ tena amed by a wo The Cwe.nuan Wu that the ar d~ safety in the uses of the b) prod. * " "## d**I~ ' "*' #" "# "

• uct material. The t eater the potentta! NRC sil! act to help ensure that ra. to most esses, clearly an area of low ha.:ard to a patient from the byprod. diatton esposure to pat;ent.s is as lom- rad.ation risk to patients. Therefore, uct snaterial or Its use by a phss: clan, as is reasonably achatt able consister.t NRC till not control ph) sic:aNs pre.

the more NRC may elect to circum. sith competent med.l cal care and alth rotatsses on pat;ent selection. Instru.

act;be areas that might otherstee be minimal intrusion trito sned:ca.! Judg- scent selectiorL procedare selection, regarded as within the dlscretton of snents. NRC si!! cot exercise regtfa- drug selection at.d dose less! for most the physician. Lory control in those areas where, gag.nostic u.ses of radlei.notopea. Toe The first part of NRC's pot:cy state, upon careful exarninat!cn. It deter. all therapeutic uses of rs&oacthe ment indicates that NRC ud3 continue mines that there are adequate regula. g,.ugs and to cirtain d:agnost!c uses.

to reguiste the medical uses of radiot. tions by other Feders! or State agen. for taample, the use of phosphorus.32 actopes as esecessary to proude for the cles or sett adrniruster rad.ation atlety of sorters and the standards. Whereser ,ed proftulonal pou;ble. NRC for localt:stion of eye tumora-the gere's! pub!!c.' Thas is the tra&tional sdl work c!asely with Tederal and rtst to patients is put lot.The risk of res alatory functice of NRC foe all Rau armeks W p@WoM gmM tissue or organ damage for even deaths sses of bsproduct, source at:d special in design 1 rig nes voluntary guidance is takherent to the use of therapeutte auc ear siatenal. It is a regu: story for pracWonus to ht unmuary lesels of radaoactive drugs NRC till continue to restrtet t.he uses of thers.

role that sas not questioned by any of the commenters but, rather, it sas pa i' h aj '

t ct **P s po"cy state, peutic arid certain d. age.catic rad!cac.

son.aistertly recog u:ed as a nectuary snent trdnates that NRC sd2 m:n! the drugs to the Ind.ca:ed procedures to:e in the medical uses of radaotso- Hs mWon Wo medaal Judg. Lt.at base been approsed by TDA. The I'C anents affecting the pat.ent a.-d into NRC si2! not coctrol the physicians

• NR C' s regulation of the tsdiation other area.s trad:!: ens!!y cor.sidered to prerogathes on patierit selection and safety of sorters and the general tr.strutnen) selectics for the spy pro-put!.c in the medical uses of rad:o6so- cedures, because these proceduras are Lopes is re!!nquished by N*e'.C to Agree .pregi3n,3 3,3g,.y er Se'reres Adu: ort so speela!!.:ed and patlent speettic.

l

' co,.umttee en the e res cal g :eets of fan. Corgress recently gste FDA authert-a: erst States, does not oserlap sith ta.r Ras.a .ons steat.sti.m eesort, fae i

Eder:s es Pop. :s .ees of 2;rosmre te law ty to regulate medda! dev.cet, strn!!ar to TDKs authority to reg *.Cate dr%gs.

l 'The term ereerst pubi e La this state.

eena spectrica!!r eac!. cts pa::ents. Nn[Wf ',,[,f[,7,,,

WiasNtran.D ht Oth amor.al aun.orHy to m C.41:[g f,8,[,,$

g 721 strict the routtre use of sied: cal de-Decernber 31,1985 (eeset) PS MU 2

POLICY STATEMENTS

(* Tices as may be necessa.=y to preside noted tith rad!cacthe material, as set! as the general public t-ho may be As noted in it.e reass:cd pol,cy statement. NRC is stud;:rg the sar-reuorable suura te of the'.t safety sad effectise. t eu. FDA h.u tros yet exposed to rad.ation as a result of that tous albed health ecrtif.e.t!sa pro.

kad s.;fflC!ent t1rne to tr pierner.t fu treatment, are all members of the grama currently in effect er be;ng fu 3 authority to reg.;!ste med.fcal de- pubile to be protected by NRC. drafted by other Federal. S:ste and .

efces cor'taln'ng byprodR* acurce or Tso corr.menters otjected to NRC's profeufona! groups. If the coserage

• spec:13 mucl ear a"aterlal. Therefore, regulat!on of patlent radlat!cn safety pros'aded by these progra' J !s not ade.

NRC t"! cor.t!..ue no res'.flet phnt. because they bellese that NRC does quate to protect the pat!ent from un-e%n's uses of these medl:a! desicas, not have the authority to regulate pa- riecessary rad:atfon capon.re. NRC both for diar asts and therapy. to tient safety.They note that NRC's en- stil eork m:th these groups to desetop those procedures that NRC has deter, ab!: rig legislation does not specittcal!F a near NRC proposed rute for the mention the radiation safety of pa* training of allied health personnel.

snined tin consultation eith its Ads'tse- tienta. They believe that patient There s ere the tor'irnenu on the ry Ccmmittee on the Medical Uses of spec!fse subject of nucfrar ph:tt. .actes Isotopest to be safe and effective. safety is the responsibillty of the phy-sfctan, a respor.stbility that cannot be trassopharmaciesl.

The Commtwon does not consider shared. They bellege that the Comrnts- One commenter urged NRC to dis equ!sment cal!bratter, qualificatform (fnguish betteen rad.opharmacisu of pa?amedical persortnel or reporting ston la in error to equate patienu tith the pub!!c and to cons der patienu as e orktr:g Ln a herpatal settar.g a9d those to NRC missdentnistration.: of radioac- torking In a retad enutorur.ent (ccm tise traterial to be exclu.stsely the users rather than ree!pients of radle-rnerclaj nue: ear pharmacyL Tha corn.

practice of medic!ce er a part of physt. acth e materf aL menter stso noted the cc:nstealty of clan pallernt relationahlps. The Com* A.s noted Ln the analysts of the stmi-m!u.cn intends to regu! ate these atens far com. ment above. the NRC's overrid-the proble'n of defmJtlen then the trig contreufonal reandate is to pro- hospita.1 based rad!c;harmacy pro-of patient rad.ation safety t here justi- tides radio;harmaceuticals to other fied by the risk to pattents and where tect the heaJth and safety of the volunt ary standards, or comp!!ance pubtle. The patient ts a member of the hospita!s and practitione's in its area, tith these standards. are tnadequate. Public. oottithstanding the Cortm13 A.s noted in the pre;csed po!!cy ston's recognition of phplcians' prima. statement, the NRC alU defer to the 111. Discossion or Pusuc Comroers ry responsibility for protection of Food and Drug Administration tFDA) their patlents. The policy statement regard:ng a dete m! nation of those ac.

4. consMEarfs om TME POLICY stattMI3ee tauties of nuclear pharmae.as that sul and. Lndeed. a!! of the Commission's be cortsidered manufacture and those One commenter odosed the use of actions in regulating the snedical uses the genert! terta "radfotsotopas" la of radfo!soto;es, ackncaledge the see- actMties that 31.!! be cens.dered the the first part cf the po!!cy statement. ondary but necesaary role of NRC la ordinary practice of pharmacy (com.

This commenter sas concerned that. regulating the rad!ation safety of pa- pounding and d3pensingt If taken out of the context of the foot- Four commenters objected to NRC's note,it could be interpreted to include tients. The Commlaston also considers licensing nuclear pharmacies to das.

naturally occurring and accelerator patients to be both users and recipl. tribute only those products that they prod.ced radiotsotopes, ents of radioactive material Roseser. have prepared from FVA sparosed the distinction betteen receipt and radiopharmaceuticals or reagent DJta.

The Commiuton be!! eses that the use of rsdloactive materlats is nog generst terrn ' radioisotopes" is plata One cootmenter etted the p settte of C.' Enghah and easily recognized by the publec. It tas properly footnoted in mean!ngful in thts case because NRC regulates. stnong ether things. rTceipt.

nuclear pharmacles supplying radio-chemicals to researchers the use the pobey statement to Lnclude the pouession. use end transfer of bprod, Ih on hur .ans under their osts I uct, source and specla! nuclear materl-more cumbenorne but specific terras: A l ' dI st n.

bsproduct, source arid special nuclear al in protecting the health and safety t on fo e D e,

' material and to exclude naturally co- of the public. One corr.menter poted that TDA pet.

mita nuclear pharmeCies to operate IA

4. conoscers on srsetr:C lsstrE3 d ca e aten 1 the absence of a final determination of One corrunenter, in opposition to There sere sta comments on the thett status, presid&ng they meet all NRC's regulation of pattent radiation question of reporting misadmin!strs- State and local pharmarrutica.! regula-safety, suggested that NRC liralt its tfona of rsdjonctive material Three tions. The tuo other cornmenters role Le the radiation safety of the hos- commenters opposed any mtsadminia- characterized the NRC's restrictions pita.1 staff and the general pattent trstlos reporting and three com* en the distnbution of popu!sttorL Ne belleses that patient menters offered suggestions on how rsdlopharmaceuticals by nut! ear phar.

dostrnetry is a responsibility of the in. they should be reported. A.tl of the macles as an unmarranted tntrusion dividualinstitution and not h*RC. This commenta stil be considered in dealing into the practtee of phartnacy s hsch as comrnenter feels that NRC should tith NRC's newly proposed entsadmLn. regulated by ti;r States.

first requLre adequate staffing. Includ. 1stration reporting requirement that NRC licenses nuclent pharmacles to trig a betrit certified phystefan or ts. g.as published ta the FEDERAL RsC1 ster distribute radioaCthe drugs that hate diopharmacist and a rad!ation safety for public comment en July 1.1974 (43 been approsed by TDA. This includes officer. and then essenttally teste the FR 29297L radioactne drugs subject to an FVA.

Institution alone regarding dostmetry* There mere s!s comrnents on the spe- appresed "New Drut App!ication" trutrurnentation, calibrattort, drug pro- cific tasue of paramedical traintrns. (NDA). or " Notice of C*a;med Insesti.

curement or any other function coa. Three commenters belJeve that it is sational Esemption for a Net D ru g" t!ND). NRC telles on TDA arpros at of sidered to be the practlee of medicine. unnecessary for NRC to becorne in-s require the Ucensa h volved in paramed! cal tratning because radioactive drugs because h AC has staff it.s operstlos tith a radiatles severs) orga tzattons are already pro- not regulated the safety and effectise-safety officer and a physictaa (not neas of rad;oactise drugs since 3973.

tiding or developf at utntrnum stand. Alao. there are not many 3:stes that necessartly board certified tratned to ards. gulde!!nes or certificatloa. One administer radioacttse material or ra- are equipped to regulate radioactsve diation to patienta. Noteser. the Com. comtnenter believed that NRC should drug safety and effectlieness.

be In,#hed in this area because the i

misalon cannot 11mit its regulatory role technologist. not the physiclaa. does Dated at' Washing *on D C. this 1st to protecting the hospital staff arug most of the 3ork sith radictsotopes. day of February 19"S.

the general patient population and at Tso comrnenters be!! eve that redlolog.

- the same tirse fulfiti its congresstonal tr%3 physicists should be separated out mandate to protect the health and frorn other paraJnedjcal personnel and safety of the public as regards source, boroduct and special nuclear materf. 3r c of these corrutenters offered a m2. 'ITie patient being treated or d!ag. definitle.: of rsdlological ph)sfetst.

/ "

\

PS MU 3 December 31.1985 (reset)

- -- - , , - , - - - - - - _ . , . _ -,--,-,,,--,-,---v - - - - - - - - - - - - - - - - _ - - - - - - . _ _ - - - -

{ ENCLOSURE 2 ADDITIONAL DISCUSSION OF " ADEQUATE SUPERVISION"

1. The authorized user must be able to provide supervision. Obviously, those who are deceased or are no longer employed by (or associated with) the licensee are not able to provide supervision.

2.

The authorized physician-user must be located within reasonable proximity of the licensed activities. Accessibility by telephone alone is not acceptable. Several escalated enforcement actions in 1985 (i.e., EA 85-45, 85-58, and 85-132) touch on this issue and are discussed briefly below.

0 EA 85-45: St. Thomas Hospital, St. Thomas, Virgin Islands (License No.

55-17986-01)

This license authorizes the licensee to possess and use the materials listed in Groups I-VI, inclusive, Schedule A,10 CFR 35.100. Three physfcians (Dr. A, Dr. B, and Dr. C) are specifically named in Condition 12 as authorized users; all three are authorized for Group VI procedures. -

However, only one physician (Dr. A) is at the licensee's facility on a routine basis. The other two (Dr. B and Dr. C) are usually located in Washington, D. C.

On three occasions in 1984, Group VI sources were used for brachytherapy by an unauthorized physician, Dr. D. Dr. A was not present on these occasions and was not consulted about, nor involved with, these three cases. Dr. B was consulted by telephone, but was not physically present for these procedures. Dr. B also did not visit the licensee's facility either shortly before these procedures to provide training to Dr. D or shortly after the procedures to review Dr. D's activities.

This licensee was cited, among other things, for violation of Condition 12, i.e., use of licensed materials by an unsupervised individual. This case points to the need for the supervisor to be located sufficiently r

l close to the licensed activities to oversee or audit the operations. It also indicates that telephone contact alone is insufficient for adequate supervi sion.

EA 85-45 is closed.

l 0 EA 85-58: Frances Mahon Deaconess Hospital, Glasgow, Montana (License

No. 25-16906-01)

This license authorizes the licensee to possess and use the materials listed in Groups I-III, inclusive, Schedule A,10 CFR 35.100, and a sealed source of iodine-125 in a lixiscope for diagnostic purposes. At the time of the inspection, two physicians (Dr. E and Dr. F) were i

I

(

specifically named in Condition 12 as authorized users for all of the materials authorized by the license. However, one of these two physfcians, Dr. E, was no longer associated with the licensee, and the licensee had not asked for her name to be deleted from the license. The other physician (Dr. F) moved to North Carolina in June 1984 and remained on the hospital's staff until mid-November 1984. From June 1984 through mid-April 1985 when NRC conducted an inspection, a third physician, Dr. G, conducted diagnostic nuclear medicine studies at the hospital.

The licensee was cited, among other things, for violation of Condition 12, i.e., use of licensed material by, or under the supervision of, a i

physician not named on the license. During the more than five months that Dr. F remained on the hospital's staff after moving to North Carolina, it does not appear the Dr. F ever returned to the hospital to

! review or audit Dr. G's activities; the extent of telephone contact or consultation, if any, between Dr. F and Dr. G is not clear.

This case makes the same points as EA 85-45, namely, the need for the

supervisor to be located sufficiently close to the licensed activities to oversee the operations and telephone contact alone is insufficient for j adequate supervision.

s EA 85-58 is open as of the date of this memorandum.  ;

O EA 85-132: Presbyterian-University of Pennsylvania Medical Center.

Philadelphia, Pennsylvania (License No. 37-00168-06)

This license authorizes the licensee to possess and use the materials listed in Groups I-V, inclusive, Schedule A,10 CFR 35.100 and a variety of radionuclides for in vitro studies, laboratory research, and animal studies. Five individuals are specifically named in Condition 12 as authorized users. Of these five, two (Dr. H and Dr. I) are authorized for human use. Dr. H is authorized to use all of the materials ,

authorized by the license, while Dr. I is limited to the use of technetium-99m radiopharmaceuticals for cardiac studies.

On the day of the inspection, Dr. H was in Chicago for several days and various nuclear medicine studies (i.e., studies other than cardiac studies) were being conducted. Dr. H is in charge of both nuclear ,

medicine and clinical laboratories at the hospital and he designated another physician (Dr. J) to act for him in his absence. However. Dr. J .

is not an authorized user and, to the best of our knowledge, has little or no training and experience in the safe use of radioactive materials in humans.

The licensee was cited, among other things, for violation of Condition 12, i.e., use of licensed material by individuals who were neither named on the license nor were adequately supervised by the authorized user who was in Chicago. This case makes one of the same points as EA 85-45 and 1

I 85-58, namely, a supervisor must be in reasonably close proximity to the supervised activities. The issue of telephone availability does'not seem to bTve arisen in this case. This case also suggests that an authorized physician-user who plans to be absent should delegate supervisory responsibilities to a physician well-qualified by training and experience to use radioactive materials safely in humans, preferably another authorized physician-user.

EA 85-132 is open as of the date of this memorandum.

3. The delegation of duties must be clear and understood by both the supervisor and supervisees. Delegated duties will not be performed properly and supervision will be inadequate if the supervisor and supervisee do not agree on: what duties have been delegated, how the delegated duties are to be performed, what duties have not been delegated, what constitutes an abnormal or unusual situation, and what is to be'done in such situations.

4. The supervisor must ensure that supervisees have adequate training and experience to perform delegated duties safely.

5. The supervisor must periodically audit or oversee the activities of those supervised. The complete lack of oversight or audit is clearly unaccep-table. Usually, daily to weekly review by the supervisor should be acceptable, but each case must judged individually.

O e

. . b APPENDlX A ACCEPTABLE TRAINING AND EXPERIENCE FOR

• MEDICAL USES OF BYPRODUCT MATERIAL *

1. General Criterf[ a Trainmg m hasic radioisotope s 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> P handhns techniques appheable Any human use of hyproduct material (i.e., the internal to Ihe use of unsealed sources.

or esternal administration of byproduct matenal, or This training should consist of the radiation therefrom. to human bemssi must he lectures, laboratory sessions, carried out by or under the supervition of a physician. discussion smurs, or supervise d As defined in paragraph 35 3(b)of 10 CFR Part 35.a esperien:e in a nuclear medicme p8 pricaan means an individual licensed by a State or laboratory ( i.e., on the Job temtory of the United States, the District of Columbia, trainmg m a formahzed traming or the Commonwealth of Puerto Rico to dispense drugs program)in the followire areas:

m the practice of medicine.

(I) Radiation physics and (100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />)

Paragraph 35.II(d)of 10CFR Part 35 provides that the instrumentation Commission wdl approve a heense application by an institution for medical use of byproduct materialif it (2) Radiation protection (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />) determines, ame'ng other thirigs, that the physician designated as the individual user is adequately trained (3) Mathematics pertaining to (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) -

and experienced m (a) basic radioisotope handling the usc and rrussurement techniques and (b) the clinical management of of radioactivity patients to whom radiopharmaceuticals have been l administered. Similar criteria are estabbshed in para- f4) Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)

! graph 35.12(a)(4) of 10 CFR Part 35 for the approval of heenses for medical use of radiopharmaceuticals by (5) Radiopharmaceutical chemistry (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />) individual physicians. Outlined below are training and

- enperience criteria that the Commission, with the (The hours listed next to each of the five subjects assistance of its Advisory Committee on the Medical above are suggested values and should not be Uses of Isotopes I ACMUI) has found acceptable for interpreted as specific requirements )

physicians who use radiopharmaceuticals.

b. F perience with the types and quantities of This training and experience must have been obtained byproduct material for which the application is withm a 5 year period precedmgthe date of thebeense being made, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). For author-application or must be supplemented by continuing ization for Croup !Il(generators and reagent kits),

education or empenence. Also, the original traming and this esperience should mclude personal partici-emperience should have been received in a formal resi- pation in five procedures to elute Tc 99m, including l dency program in an accredited medical institution. testing of eluate, and five procedures to prepare Fach physie:an's training and experience are examined radiopharmaceuticals from Group Ill reagent kits.

i on a case by-case basis. If a physicianwishes to use radio.

pharmaceuticals but does not have the training and c. Supervised clinical training in an institutional enperience described. he may submit an apphcation nuclear medicine prograni(500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).The chne-listing his specific qualifications and these will he cal training should cover all apprnpriate typesof reviewed by the Commission with the assistance of diagnostic procedures and should include:

the ACMUI.

(I) Supervised examination of patients to deter-

2. Training for Routine Diagnostic Procedures (Croups mine the suitahihty for radioisotope diag-lIII) nosis and recommendation on dosage to be

, prescribed.

To qualify as adequately trained to use or directly su rse rvise the use of byproduct material listed in f2) Collaboration in calibration of the dose and l Groups 1. II, anJ/or Ill in R 35.100 of 10 CFR Part 35, the actualadministration of the dose to the a physician should have: patient, m.:!uding calculation of the radia-g tion dose. related measurement, and plot-Q , .

rhennes in thew reewirements are salicerated en the near rurure ..

ting data.

(arier puw.earia at thr* su.Jes and wili ne puhe.shed sa a re is on The nnues are in seems or hours or etaas, taharatory.ar etia. eat i3 this geeJe. es pertence rather than semester hnues.

10.8-15

t3# I ollowup of patients when te,4uired., (!! Radiation physics and 4M hours) mstrumentation

1. 4# Study and discussmn with preceptor of tase histories to estabiash most apprornate diag- (2) Radiation protection nottic procedures, hmita tion. contraindica- (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) tion, ete (3) Mathematics pertaining (10 hou rs) to the use and measure.

ment of radioactivity (4) Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)

The requirements specif ed m Sections 2a b. and c may be satisfied concurrently in a 3 month training protram (These requirements are in lieu of, not in addition IF all three areas are integrated into the program, to, those specified m Section 2a above.)

b. Clinical training in specific therapy procedures:

Note 5-For Group lY

, For each physician named m item 4 of Form NRC 313M,

[ complete Supplements A (Traming and Expenence) (1) 1131 for treatment of hyperthyroidism j and B (Preceptor Statement) of Form NRC 313M. For and/or cardiac conditions :

rach subject covered in basic trainmg, state where the j trainms mas obtained, the dates, total number of hours. Clinical experience in the diagnosis of i

and type of traming Hours of traimng should be broken thyroid function and active participation down mio lecture or laboratory hours or on the job in the treatment of sta paratats.

trainmg (OJU OJT must have been obtamed in a l formahaed training program. Be sure that individual (2) Soluble P 32 for treatment of polycythe-hours of training can be traced to ,the institution mia vera, leukemia. and/or bone rnetsstases; where the trainmg was received. Each hour of trainmg should be hsted under only one subject category (i e., Active participation in the treatment.of the most applicable subject category). three paratnts with any combination of these three conditions.

Alternatives (3) Colloidal P 32forintracavitary treatment :

Certification by(a)the Arnetican Board of Nuclear Med.

icine, or (b) the American Board of Radiology in Diag- Active participation in the treatment of nostic Radiology with Special Competence in Nuclear thirt paratars.

Raociogy will be accepted as evidence that a physician has had adequate training and expenence to use Groups for Croup V I,11 and Ill.

(1) 1131 for treatment of thyroid carcinoma :

3. Trelning for Specific Diagnostic Proced ares Chnical experience in diagnosis of thyroid A physician who wishes to be authorized for only one function, personal participation in the treat-cr two specific diagnostic procedures should have train- rnent of ten paratnis with hyperthyroidism ing in basic radioisotope handling techniques and clini- and/or cardiac dysfunction, and active par-cal procedures commensurate with the procedures and ticipation in the treatment of thite pars'ents quantities of byproduct material being requested. Such with thyroid carcinoma.

regiasts wdl be examined on a case by-case basis by the Comm.ssion with the assistance of the ACMUI. (2) Colloidal Au-198 for intracavitary treat.

ment:

! 4 Training for Therapy Procedures involving Aadio-pharmaceuticals Active participation in the treatment of threr parstnts.

To qualify as adequately trained to use or directly supervise the use of byproduct material listed m 5. Training for Therapy Procedures Involving Scaled Groups IV and/or V in $ 35.100 of 10 CFR Part 35, a Sources .

physician should have:

To qualify as afequat ely trained to use or directly super-

a. Training in basic radioisotope (80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) vise the use of byproduct matenallistedin Croup Vim harndling techniques applicable 635.100 of 10 CFR Part 35, a physician should have

• to the use of unsealed sources for thera py procedures, includ- a. Training in basic radioisotope (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) mg handling techniques applicable 10816 -.

to the use of sesled sources for above Physicianscertihed by the FFR or FRCR must therap) procedures, consisting also submit evidence of specialpation in radiotherapy,

, oflectures, laboratory sessions, Evidence of previous approval by the NRCor an Agree-g discussion groups, or supervised ment State may also be submitted m lieu of the infor

• experience in the following mation requested above. In this case, the appheant arets : should specify the number of the NRClicense or submit a copy of the Agreement State license on which the (1) IbeEation physics and (110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br />) applicant physician was specifically listed as an author-instrumentation ized user.

(2) Radiation protection (40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> t

6. Training for Physicians Wishing to Use St 90 Ophthal.

(3) Mathematics pertaming (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) mic Eye Applicators Only to the use and measure-ment of radioactivity To qualify as adequately trained to use or supervise the use of an St 90 cye appheator only a physician (4) Radiation biology (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) ' should submit :

(The hourihsted neat to each of the four subjects a. Evidence of certification by the American Board above are suggested values and should not be of Radiology m radiology or therapeutic radiol-interpreted as specific requirements.) ogy,or

b. Experienc'e'with the types and quantities of radio. b. Evidence of:

active material for which the application is made. -

or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). (1) Active practice m therapeutic radiology or ophthalmology and

c. Clinical training in Group VI procedures :

(2) Training in basic radio- f 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Active practice in therapeutic radiology with a isotope handlms tech-minimurriof 3 years experience of which at least niques. includmg 1 year should have been spent in a formal traming W program accredited by the Residency Review (a) Radiation physics and (6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />)

Committee of Radiology and the Liaison Com- instrumentation l mittee on Graduate Medical Education.

(b) Radiation protection (6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />)

As evidenceof the foregoing training and enperi-ence, the applicant should complete Supple- (c) Mathematics pertain- (4 hourt) ments A and B of Form NRC 313M. Supple- ing to the use and ment B should be completed and signed by each measurement of preceptor physician under whom the applicant- radioactivity physician gained experience or training. Submis-sion ofletters of evaluation from esch preceptor- (d) Radiation biology (s hoursi physician on behalf of the applicant physician should be included with the application. These This information may be submitted on i letters of evaluation should describe the scope Supplement A of Form NRC 313M. The l and extent of the applicant physician's traming hours listed next to each of the four sub-and experience and should include an appraisal jects are suggested minimum values and of the appheant physician's competency to use should not be interpreted at specific Group VI sources independently for therapy requirements.

proce dures.

(3) Fvidence of active garlicipation in the treat.

Note : , ment of fire paticars (to be tuhmitted on Suppicment B (Preweptor Statement) or Evidence of certification by the American Board of Form NRC 313M).

l Radiology in Radiology or Therapeutic Radiology, I

certification as a British " Fellow of the Faculty of "Actne rurticipation" shnuid inchide super-Radiology"(FFR) or " Fellow of the Royal College of vised e sammation of retients, collaboration Radiology" (FRCR) or Canadian certification from and calculations concerning the dose to be (e '

the Royal College of Physicians and Surgeons (RCPS) in therapeutic radiology may be submitted in lieu of used admmistration of the dose to the patient, and followup and studyof patient the information requested in Sections 5a through c case histories.

(*

g o

• U% UNITED STATES fi '

. NUCLEAR REGULATORY COMMisslON .

WASMNGToN. D. C. 20555 .

%, ,e

, DEC 071982 TO ALL MEDICAL LICENSEES AND CCMMENTERS Enclosed is a Federal Register notice that concerns revised training and experience criteria for pnysicians who request authorization to use reactor produced radioactive isotopes (byproduct material) in nuclear medicine procedures, including cardiovascular nuclear medicine.

This notice is of primary interest to cardiology and nuclear medicine (radiology) physicians, especially those involved.with physician training programs. .

The effective date of the revision is July 1,1984. This revision does not affect physicians who are currently authorized to perform nuclear medicine procedures, nor those who begin their training prior to the effective date.

, J, _

n y L. 11 r, Chi teria Licensing Branch Division of Fuel Cycle and .

Material Safety

Enclosure:

Federal Register No tice Nc

543'8 F*deral Register / Vol. 47. No. 232 / Thursday. December 2.1982 / Notices

.a

• Revised Training and Expertence Criteria for Nuclear Medicine Physicians Actwcv: Nuclear Regulatory Commission.

AcTioec Notice of revised training and experience enteria for physicians who apply for authorization to perform nuclear medicine procedures.

suumaav:The Nuclear Regulatory Corr. mission is publishing revised training and experience criteria for physicians who request authorization to i

i use reactor. produced radioactive isotopes (byproduct material)in nue! ear medicine procedures. This revision increases the minimum tame appropriate for a physician to obtain acceptable training and experience for authonsation to perform diagnostic l

nucleer med2 cine studies.

l sirscTive patt: July 1.1984. This revision does not affect physicians who begin their nuclear medicine training pner to the effect2ve date.

l Poa rusTwan snroamarem contact:

Joseph DelMedico. Division of Fuel Cycle and Material Safety. Office of Nuc!est Materia! 5afety and Safeguards.

(

Federal Regieter / Vol. 47. No. 232 / Thursday. December 2.1982 / Notices 5077

=

U S. Nuc!aar Regulatory Corumission evpressed opposition. Most of abe Wa shmston. D C 20555,3a1-427-4082. C Coarments Co!!/rpferMore Stringe.-f opposing czuzuneete ett.ber suppor1ed or Cnteria s meisterfasry twonesarioso:NRCis actuaBy endosed a copy of the position .

rev.s:ng Appen6m A of Regulatory takaa joindy by the Americas Co!! age of Over SC commeme s stated that six Cade 10.3. Appegdix A concema Cardmiogy (ACC) and the Amancan months of training was minimum or not training and experience entene fbr enougL Some recorr. mended that only Heart Aseecianon (AHA). AD comments board.certtfled physicians should be ph3sicians who apply fer authenzstion w ere carefully considered and, to one byproduct matenal in medical authorized.Many of the commenters wherever possible. the new criteria were d.agnosis and therapy. Reg :! story Culde changed to take them into account. noted that six months of specific study to s desenbes the type and extent of In rme!est medicine may not allow Copies of the comrnentletters arv enough time to sansfy the radiation ir.fsnm.aoon nuded by the Nuclear avatlebte for inspection at NRCs Pub!!c Regn!atory Comtrussion (NRC) stasto safety training as wvU as the c!mical

- Document Room. requirerents of that specialty.The esa!uste an applicauen for a spectSc license for the possession of byproduct Discussion af Pubus Commams' incresains complexity of the Held.

material and its use in or on human especiaDy as related to equipment and be.ngs. This type of heense is provided A Commeors ofon Editorio/Natur, clinical procedures. was cited by se veral t

fer under to Ca Part 35. " Human Uses commenters. In determining that the A!! comtnents of an editorial nature of Bgroduct Matanal" The reviaina of published criteria are jushfied. the staff were secommodated la the new critaria.

! Ap;endix Ais based upon the nese changes incladed- (a) Revision of took into account the facts that these i rec:=mendation of NRC's Advisory Section YU.A to erun.tnate confusion criteria received strong support during Com=uttee on the Medical Usee of the puh!!c meetings and that no conceming colloida! gold 19e. which is algnincant new information has been Isetepes (ACMUI).

currently not in use-(b} mod:fication of l Essentia!!y. the revised criteria presented to support a period of training ind.cate that physicians who apply far Section IX to include su of the radiation thersyy cernfiestion boards !!sted in icnger than six months. Comrnenters are -

i authonzation to use byproduct matenal therefore referred to the meecng i for diagnostic nuclear med: cine stu&as, Table 1:(c) mention of the accrediting transcripts.

l authorrty for osteopathic training la j ine!uding cardiovascular nuclear D. Comments Concerning Tah!e 3;(d)inc!saion of xenon T33 me6 cine stu6es. should have a rmn. mum of six months of special studies in the training criteria: (e) use of Documentation of Troimas and Experience education. traming. and esperience in the term "carecesscular nuclear these uses.The previous enteria medicine"in place of & Ins Commene A number of comroents 1

inicated a minimum of three enorsths. descriptive "nuc!aar cardiologr."(f) concerned the nethod for documenting l

The revison does not sifact physiciana mo6fications to emphasize that the new training and experience. One commenter who are presently authonzed to perform criteria reprennt the minimum that NRC suggested t! at NRC issue cernficate.

nuc! ear me& cine procedures, not g gg g tne credentials to all qualined ph3sicians who begin their nuclear Federal Register notice to stress that the physicians.The commenter stated that meisine training prior to the effective new criteria will not affect phyn,ciana the certificate would be convenient for date. The effective date was chosen so who are curnatly authorized to perform physiciana changing jobs. The premise as to allow the various training nuc! ear medidne studies orphyalcians was that a physician. once licensed, pres ams suf5cient tur.a to restructur, who besta their training prior in the could thervetter show a new employer their entricula, efective does. or radiation safety committee the sackgemand certi$cate as evidence that NRC B. Comments Concerning Table 1 acjep endenns s.

The revised Appendix A evolved from ,, , ,g A number of commentare questioned current Supplements A and 5 of Torm preposals initiated by the medical why ce:1ala medical specialty cornmunity to reflect the training . NRC 313M are adrquate for believed necessary for a physician to certificados boards were or were not documenting training and experience.

use licensed materials ufely and to includad io Table t and whether certain Physicians authorized as users on NRC procedures should or shouldnotbe licenses may make copies of b IIcense protect workers. patients. and the public from unnecessary rediation exposura. authorized on the basis of varions board to pressuut to a new employer as This topic was discussed at pub!!c certincadone. Each individual board . evideoca of such approvst initfates ection to become acceymd b E Comments Concerning the Medico /

C?2f.'J"a'n'n'uio'sh?"h. g,ar,dLaf,','2' 3gd n'",e",'F ' a' d, comiaacamr*e-v-=

Information concerning these muttngs was published in the Federal Registar the Cornmissian evidence of eligibility Cannane Several commenters asked prior o each meetmg (44 FR 73170. 45 fR requirements, accreditadon proy ass. NBC to anyth physican and hospital 4:904. and 46 FR 32354). Transcripts of * ' dure Inch

• Ilcertaees that NRC authorisation relates these meetings are available from NRC's "bP R s be mA only to radiation safsty and not to Public Document Room at 1717 H Street. Additional boarda may beincludedat medicalecespetence.

NE Washington, D.C. any time provided that they approach AasponseIn ters, the NEC publiebed A rederal Registar notice that the new NRC and presect this information. These *Rasulation of the Medical Ussa of enteria were under consideration and submissions aan examined by the staf Radiotastepes Statsment of General that public comments were invited was and by appropnata members of the Policy"(44 FR a242).ne third and Anal pubbshed on January 22.19a2 (47 FR specise ama la the policy stated. "Da ACMUL A recoms:endetionis made to 22:8), ne Cornmiuma received 232 the full ACMUI at an open public NRC will =Wa intrusion lato comment letsera. of which 150 supported meeting. no boards listed taTable 1 needical judgements affecting pa tients the new cnterie.36 expressed support met the requirements speciBed above. and irne other anos traditionally but suasested spectic changes, and 33 considesed to be a part of the pracoca of medicina." He stas has and will

.gne Federal Resister / Vol. 47. No. 232 / Thursday. December 2,1932 / Notices

~

continue to interpret this to mean NRC The concept of concurrent training in have tra6tions!!y been addressed by -

approval of a physician to use three month programs orig.nated the State medicallicensing authonties .

byproduct materials in humans for because such programs were offered as and by peer review groups and treatment and diagnosis relates to part of the residency training leading to professional societies withm the r .e& cal radiation safety and to yaf! Ling . certificauon by the American Scard of profession. As stated previously, dRC sufficient to avoid unwarrented Radiology (ABR).The ABR and AOBR published its decision to mimmize rad auen exposure to the physician, pg ams have recognized the need for a intrusion into areas trs&uone!1y medical workers and the pubhc. miramum of six months of training and considered to be a part of the practice of in!cu6ng patents. Such authorization expenence med have voluntarily taken me& cine in 1979 ( +4 FR 8242).

does not imply a standard for action to restructure their programs Comment !f the training and professional chnical achievement as accordmgly.The new pregrams will be experience enteria are increased to six .

would be evidenced by a medical in place by July 1.1984. NRC's action months. the only aspe-t that would be specialty board certification. Further will maintain its enteria equal to the augmented for card r!v;ists would be in cJanfication of NRC's position la being minimum standards set by the the area ofinterpretation of scans.

censidered in connection with a profession. Aesponse

NRC believes that actual separate revision to part 35 of Title 10.

Comment Technetium 99m is the on!y experience handling unsealed Code of Federal Regulations.This NRC licensed matena! used la revision la under way at the present radioactive materials (!!em B of Table 2.

cardiovascular nuclear medicine studies Appendix Al should be augmented.

time. and its properties make it uniqua!y safe Presently there is httle incentive for a E. Comments Opposing the New Criterio for handling and use; therefore. en physleien.In. training to acquin such increase in the trainia.g and expenence experience. It is the physician. however.

The concerns of those whg object to criteria la unwarranted.

the criteria (as persphissed by the NRC who is listed on the NRClicense as the Aesponse:The enteria in Section V of authorized user and who may be listed staff) and the staff response are Appendix A apply to physicians who as the radiation safety officer.The -

. aummarized below: use or supervise the use of molybdenum physician la responsible for the use of Comment The current criteria have 99/ technetium 99m generators and the material.To fulfill this been more than adequate in protecting ressent hits to prepare Tc.99m lebeled nsponsibility the physician must have the public: therefore, there is no basis radiopharmaceuticals. nese materials ha d adequate " hands.on" expenence

'er an increase. do present serious safety hazards if they during the training period.

Response:The current criteria have are misused or improperly supervised. Comment: Additional requirements

.nen adequate because they have been Tc-99m radiopharmaceuticals are a!ao wi!! serve to discourage persons well revised wheneser necessary to keep as ailable in prepared. unit dose fann.

pace with developments in nuclear trained in cardio!cgy from participating

! ready for patient injection. lf a physician in cardiovascular nuclear medicine and l medicitie. a rapidly expanding. wishes to use this form for one or two will thenfore deprive the public of the technology based c!inical specialty. In tpes of diagnostic studies and accepts expertise that cardiologists lend to these 1972. the Atomic Energy Commission, a limited possession limit, he or she may studies.

MtC's predecessor agency, had apply under the provisions of Appendix physician training enteria that involved A.Section VI. Aesponse:The NRC licensing process only 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of training in basic Comment:Through their training and does not prohibit cardiologists or any radioisotope handhng techniques. Since experience with cardiac catherization other physicians from being present.

that time.the criteria have been revised and angiocardiography. cardiologists are providing patient care. and participating arid increased three separate times, in the diagnosis during cardiovascular already famihar with the pnnciples of n2 clear medicine procedures.The Transenpts of NRC's ACMUlmeetings radiation exposure.

show that each change was made m license specifies only what physician (or Kasponse: Any hours of training that physiciana) may use or supervise the use respense to the increasing complexity of are specifically applicable to basic the field. not in response to accidents or of the radioactive material that la handling techniques using unsealed needed to perform the procedure.In incidents. radioisotopes may be included in the many hospitala. these procedures are

- The transenpts of the public meetings physician's application to NRC.

merformed as a coordinated effort conceming the present changes indicate Comment There are important risks if 5etween the nuclear medicine physician that there has been an incressa in the cardiovascular nuclest medicine studies and the cardiologist.

complexity of the diagnostic are performed by physicians who la:k interpretation of nucleat medicine formal training in cardiovascular The revision to Appendix A of stud es and that this has resulted in a hemodynamics, coronary artery dinese y,,yy,,,,y cy;g, yy ;,,,,,,,4;, y,,

concamitant increase in the portion of physiology, exercise tes and

,,gj,,fy 3,f,,,

the time that is allotted to thia aspect of exercise physiology, arrh a Appendia A-Acceptable Tretning and traming dunna the three month detection, and cardiopulmonary Experience for Medical Uses of programs. It is apparent from the resuscitation. Byproduct Material transcripts that in order to stay within Aesponser ne Implication here is that y g,,,,,jgfjg,,j, the three month limit many programa NRC should not allow physicians with have made proportiona'e decreases in little or no training in cardiovascu!ar Paragraphs 35.11 and 35.12 of to CF1t e aspects of training involving basic disesse to perform cardiovascular Part 35 provide that the Commission will

.dioisotope handling techniques and nuclear medicine studies. Trafning and approve a license application for actual expenence handhng unsealed experience criteria set by NRC relate medical use if it determines, among rad:oactive matenals. In order to specifica!!y to safe handling of the other things that the physic!an maintain the previous levelof training in reactor produced radioisotopes that are designated as the individual user has these last two areas. the inenase to used during the medical procedure. NRC adequate experience in the proposed pregram of stx months duranon la does not regulate the qua!ity of medical use, the handhng and administration of justified. practice. Matters of med ca! competence isotopes. and where applicable. the

l

, 8'ederal Resister / Vc!. 47. No. 232 / Thursday. December 2.1982 / Notices 54373 chnical management of radioactive  !. !!. and E of l 35.100.10 CFR Part 35 a ,,,,

patients. In ad6 tion 8 30.33 of to CFR physician should have the training and Part 30 requires that applicants be expenence listed in Table 2.

is=-__ __ ._ .n quahned by trauung and expenence to j 7 1** 4== g . as use licensed matenal for the purpose VI Tmini *"'*'*****'**

• requested m the application.

pyg,j,&Spfic Diagnostic * *=*a= ===se as 1

This appendiz shthnes training and A physician who wishes to be i

experience critirris that the Comminion. authorized for only one or two specinc V//L Tminingfor TherapyPmeedures with the assistance ofits Addsory d4 agnostic procedures should have i Involving SealedSources(Croup VI)

Committee on the Medical Uses of training in basic radioisotope handHag Isotopes (ACMLT). has found acceptable techniques and clinical experience To qualify as adequately trained to I for physiciana ' who wish to use comtnensurate with the types, quantitles use byproduct matenellisted in Group

. byproduct material for human use.' We and uses of byproduct matenal bein8 VI of l 35.100.10 CFR Part 35. a recomtnend that this training and requested. Such requests will be physician should have she training and experience be obtained in a fortnaf examined case by. case b the experience listed la Table 3.

acemhted training program for resident Co sion wnh advice from the M*n a pbys' 'a is a t 4

phys ciana. ,g, , ,

Physician training and experience can ~

specialtin listed la Table m &

be examined on a case.by<ase basis. A VIL TrainIW Therspy Procedures training wiH be aviM e h Invo/ ring Aadiopharmaceuticals (Croups IVand V) assistance of the ACMlll.la addition to ma er' fb a the t nir and Supplements A and 8 as desenbed in experience described. may submit an A. Physicians who meet the criteria Section M. above, the applicant should appheation !isting specine for Groups ! ~Il may qualify to perform submit letters of evaluation from each quahfications: and these will be spectfic therapy ph)sician who served as preceptor.

reviewed by the Commission with the following clinicafrocedures experienca: with the These let ers of evaluauon should assistance of the ACMUI. 1.!-131 for treatment of desenbe the scope and extent of the .

hyperthyroidism ar.d/or cardiac applicant a training and experience and II Acceptones e/ Medico / Specialty conditions should state whether. In the opinion of Board Certification Clinical experience in the diagnosis of the puceptar, the appheant is My .

Certification by the rnedical spec:alty thy oid function asd active parucipation qualified to independently perform beards listed in Table 1 will be accepted in the treatment of ten patients. Croup VI therapy procedures.

as evidence that a physician has had 2. Soluble P-32 for treatment of adequate training and experience for the polycythecus vera. leukemia, and/or IX. Trainingforphysicians Wishing To corresponding procedures listed in the Use SA-80 Eye Applicators Only bone netastases:

table. .

Aethe participation in the treatment To quahfy as adequately trained to ,

//I Documenting Ticining and of three patients with any' combination use a St-go eye appli:stor only, e ,

Esperience of these three conditions. physician should outmit evidence of

3. Co!!oidal P-32 for intracavitary certi$ cation by one of the radiation r

Supplements A and B of Form NRC - treatment: therapy specialty hoarda listed in Table 313M are used to document training and Actis e participation la the 1 or, as a minimum, asidence of; experience. Physicians who wish to intracame treatment of three patients A. Actise practice in thera qualify on the basis of board using co!!oi7al forms of either p-J2 or radiology or opthalmology. peutic certificauon need only complete Items 1. Au-19s 2.and 3 on Supplement A Other 4.1-131 for treatment of thyroid apphesnts should submit Suppfements.A carcinoma: ,.,,

and B with allitems completed. A a,,,, , i,.

Clinical experience in diagnosis of separate Supplement B form should be ae m e.

thyroid function. personal psiticipation completed and signed by each preceptor in the treatment of ten re t: .sts with

• ,,*,,7," "" = - - -

l. no l s=ho provided training or supervised e s e e. ..

hyperthyroidism andM ca. disc a'e' * **="'"t --

• experience. dyefunction. and atha pa 'cipation in *""'"*""

• IV. Time f. imitation on Acceptoble 'h * 'M * '** *' M " ' P * * '* "I'h Training andExperience thyroid carci>am t This infonnation should be submitted Training and experience must have 5.Colloidalu-198 W.rscavitary on Supplement A cf Form NRC-312M.

treatment:

been obtained within Ave years of the The hours listed next to each of the tsur Active participatina in the subjects are ruggested minimum values date of the application. or else the appheant must demonstrate continuing intracavitary treatment of three patients and should not be interpreted as specific Ins olvement in the procedures since the using co!!oidal forms of either Au-les or requirements.

p42.

time of training.

C. Active participation la the B.To perform only Croup IV and V treatment of Ave patiente (to be V. Trainingfor Routine Diesnostic therapy procedures. physicians who do submitted on Preceptor Statement. Form Procedures (Groups 1-flL

• lac!uding not meet the criter's for Croups 1-1B NEC 313M. Supplement B).

CordiaroscularNuclearMedicine) neea to obtalz.the specine chnical

. experience listed in VD. A. above and. " Active participation" should include To qualify as adequately trai.ned to supervised examinadon of patients.

as a minimum:

use byproduct matenallisted in Groups co!!aboration and calculations

• • • concerning the dose to be administered.

,g adeninistration of the dose to the patient.

,",",.n,<,,

P followup and study of patient case er re xc'.. ins.sas avoienud 8se C=, u , m eer w ,, new as histories.

l l

d 54380 rederal Register / Vol. 47. No. 232 / Thursday. Decembee 2.1982 / Notices -

Tasta 1.--Accorrance or haeo cat Sasciatty Soamo Convicaricus e-. I s== , m -.m .T _ _.

a ,. a

=, e.* e == ene -

ev et a a= e w,

am e e am w - o.v=a s c . a, =

y 6 .e e w n. s. ,

a o

. . , . .e. .. a -

su.e nm e, a.., _ e, . an _ __s - . .

s w.e e=..e

. i as a, cm a e or=a .o,. wwa a .u.~

n e, m.

-*.-e as s, e , e n ..

A-a

. o m.sy o,

Q,

.a v a vt a *.ma.a , - as e

,. m n == = , s m.

e , a.,., c .n a o, .

vi.

.w=,=,,=,,= .ma = = = = . .

-. =

cm aa c eav. Ti==.a. a m , en a e-. B. Experience handling sealed e.U T @ [ "" Y.*=", E

, - O".17 * "" " "" u tv s a o a qualifie iratructor hours). Thia expenence should cover the types and quenuties of bypt. duct Table 2.-Mitateuen Acceptable Training misadministration of materials to material requested in the application br Routine Diagneetic Procedures patients. and should include:

(Orontpe IE) 3. Emergency procedures to bandle 1. Ordering. mceiving. and Concurrent Trainingla Six month and centein epilled materials safely. '" P * *k

• fE *S ** *I* d ***'*** **I*IY Progroters. De criteria specifiedbe/oir including rt!sted decontaminetion rmance of the related may be satisfiedca.,currectly a o I",C "

di procedures. e .

)brmo!intergroted sinmanth I.roming pigram. None. Aowever, that c/lof the 7.Elution of Tc49m from genetetor ' "I*""" " N ****0*"* **

eystems, ausy and testing of the eluste en k' n d em and sumy mm requirements in Sections A B. and C. 3. Safe handhng d naled wurcu must be fully InterTreted into the for Mo-09 and alumina contamination.

and processing the eluate with reagent during paperseon. Insertion and program. Physicians who do not recieve "'"""I' hits to pmpan Tc-eem labeled their training in auch a program should 4' Ebtain the specified number of hours in radiopharmaceuticals. (Required when "" 'I ""'#*' ** *"'I"#I t

ph. ysicians spply for Croup III procedures.

cach u m C. Chnical training la Group VI authorization.)

C. Superused c!!nical training in an procadures: Active practice in

• • = therspeutic radiology with a minimum of Institutional nuclear medicine (or

• y a *== 3,*; cardiovascular nuclear medicine) 3 years experience of which at least 1 year should have been in a formal r ewe , program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). The clinical trsining program opproved by the wt ===, ,a4= =g training should cover s!! appropriate Residency Review Committee for

.L.am a , , , , , , ,,, types of diagncstic procedures and ia *

• Pv=. ,=:- 'so Rad: ology of the Accreditation Council s 7 0 "." ".". ,. " shou!d include: for Graduste Medical Education or the 6a'* * =.====r

3. Supervind examination of paUents Committee on Postdoctoral Training of so to determine the suitability for the American Osteopathic Associauon.

s I***" ***" ~J.;;7.,

E redioisotope diagnosis and Deted e Silur Spring. Md thia 37th day of

,,, , , , , , , , , , recommendation on douge to be 54pteinbu tes2.

-. .,,. proscribed. yor the NucJur Regulatory Consuasion.

2. Selection of the proper stidard L cunninsham.

B Experience handling unsealed radiopharmaceutical and dense. Director. rinsion e/rve/ Cycle andMoserrel redioactive meterials under the calculation of the related radiation dose Se/ery. O$ce e/NucleerNereria/Sofety and supervision of a quahfied Instructor (500 and co!!aboration in the interpretation 3C/'F8'1/8-hIurs). This experience should cover the of the radioisotope test resulta. In om es.s:mara.e u.i.e am :

types and quenUUes of byproduct 3. yellow.up of patients when 85'******"'**'*

material requested in the application tequind.

end should include: _

i i ii

1. OrMng. meining and 4. Study and discussion of cau en schafn3 radioactive materials histories with preceptor to establish the sa ly. Including perfo mance of the mod app priate disgusde pmudures, n!sted radiation surveys. limita tions. contraindications, etc.

' 2. Calibration of dose calibrators and Table 3.-Muurnum Acceptable Training diagnostic instrumentation. and for Therepy Procedures !avolving performance of operaUonal checks on errvey metere. Suled Sources (Group VI)

3. Calculation preparation and To qualify as adequately treined to r.alibrauon of patient doses. Including use byproduct materiallisted in Croup todistion safety considerations. . Y! of l 35100.10 CTR Part 35, a

4. Administretion of doses to patients, physician should have:

Including proper use of syn'nge shields.

5. Appropnete laternal control procedures to prevent the 1

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