Regulatory Guide 10.8

Guide for the Preparation of Applications for Medical Programs
	ML13350A208
Person / Time
Issue date:	01/31/1979
From:	; NRC/OSD
To:	;
References
	RG-10.008
	Download: ML13350A208 (51)
	v • d • e

d, U.S. NUCLEAR REGULATORY COMMISSION January 1979 eM..

, ."

REGULATORY GUIDE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 10.8

>ii"'

GUIDE FOR THE P REPARATI ON

OF APPLICATIONS FOR NtEDICAL PROGRAMS

1. INTRODUCTION Byproduct Material;" andd-, 10 CFR,, Part 170,

"Fees for Facilites and.b1aterL"Is Licenscs."

!;.6 1.1 Purpose of'Guwt This..gu.ide.describes the type and extent of 1.3 Iterns'Requirin

.'. ~ . n parac/p*icaiions ip.=l.*.**t*' tm .

information-, needed -by the Nuclear Regulatory Commission '(NRC) staffto -tevaluate anv appli- A separaL;' pliba iýapp i should be submitted cation for Specific. license for the .posSesion for kilocur'.s ifs"sed .in teletherapy facil-

"rc

,.of-6by0roduct material.(reactor-produced radio- ities. %-spe'.tfilicensing guide for teletherapy

ýnuclides) and its use, in!x or on human beings. applicUýý4s.j* aiilhable uponireques! from the This type of license is provided for under L.ense * naniment Branch, Division of Fuel

10 CFR Part 35, "Human Uses of Byproduct Cyaw and'ý,M.Vlaterial Safety, Office of Nuclear Material." Me'leppul*t*6ry

, I Safety and Safeguards, U.S. Nuclear Commission, Washington. 1). C.

The NRC will usually issue a single bypro- ,20555.

duct material license to covert an institution's,,.,

entire radioisotope program other than te~e- V' -y.

therapy. Separ.ate licenses, except for .tele V. Source and Special NuclearM aterials. Exccpt therapy.. are. not normally issued to,,dife~iat for-d&epeted uranium*used or' shielding in

.W.departments of a medical institutii, 'nor am;.,! linear accelerators or teletherapy devices.

they, issued to individuals associat d rwith', the separate applications should ;be submitted for

-hospital. ... . . .... r these. materials in .. accordance with 10 CFII

..... ...............................

.. Part 40, "Domestic Licensing: of Source Mate- The applicant, should carefully. study the rial'," and Part 70, "Dorihestic Licensing, of regulations (see Sectio*-1.2 of this guide) and Special- Nuclear Material. "., Source material is

- this guide and should bibmit all information defined** in paragraph. 40l-4(h) of 10 CFRl

.

requested,.. The. NgC;wi~-irequest additional Part 40 as,(1) uranium or thorium, of- any

.infOrmation when. nec.ssry to" provide reason- combination' thereof. in any physical or chem- able assurancefkýiat tlii<,applicant has estab- ical form or (2) ores that contain by weight lished an .adeuatr'radia ion safety program. 1/20 of one percent. (0.05'P .or more of (a)

Such-. requestAWill delay final action on the uranium,. (b)) thorium. or (c). any combination thereof. Source material does not incile special nuclear, material.

" I

In addltion to 10 CFR Part 35, other regula.- Special nuclear material is defined in para-

.tions pertaining to this type. of license are graph 70.4(m) of 10 CFR Part 70 and includes found in 10 CFR Part 19, "Notices, Instruc- (1) plutonium, ;uranium-233, 'uranium enriched tions, and Reports to Workers; Inspections;" in the isotope 233 or in th6 isotope 2:35 or (2)

10 CFR Part 20, "Standards for Protection any material. artificially enriched by any one of Against Radiation;" 10 CFR Part 30, "Rules of the foregoing but does not include source General Applicability to Domestic Licensing of material.

USNRC REGULATORY GUIDES Comments staould be sent to the Secretary o0 the commission. U.S. Nuckwo Reguatory Comm-ison. Wsl*vton. D.C. 205%. Attention: Docketmg and Regulatony Guldes wte aued to descrbe and make avoilable to the public Service Banch,.

efthod acceptable to the NRC staff of Inplemengln Specific: parts of 010

Conmvml*sn't tegulatiofn to delieatseci Ied s by ft ff In eval,- The guides ae issued In the fonowing tan broad divisions:

stiog specific problems or. postult td accidenta. as to provide guidance to

= = RWnt

=e "at Guido$ ae not fht .ftor teguelaoal, annd o- 1,Power Reactors -& Prodýucz

~41 pku'm he bn1ot toeqwed. Mefthds VWd Solutions diftsteal from t1os 2.Research and Tiet Reactors

3. Fuels and Mlateria Facites

7, $am>0rttion

8. Occurational Health set an in&Aguides wil be acceopWe H they provide a bees for ft findinps 9. An=tlrit and F~nwss fl vw"

iqMi'to to the Issuance or conrwance of a p-rmit. o kere by the 4. Enviontnanal and Sifng

5, Materials*nd Plam Po-ect-on tO. GenIM * *.

co-ents end suggetin . for p.o.emen In ,ee guides -a. encouaged Requesm foe sW,* opes ofissued gulde which may .be repeduceda o tat at *llltk¶he ~ardgewk be appropriate. to accommodate cor- ae~nset,, ~mcmn list for u nan automsafic dictuibuOtion sirgie copies of fautue guides moIrf omd onat experience. However. comments an dKsions etould be made In w*l*ing to the U.S. Nuce A&Weplory

&a gquis, Ofreceivd -w Nn about two mantdt aftr Ito isuance. wll be Commision. Wangton. O.C. 206. Attention: O O:vrion of mect1r.

pertlfAtfy unafl in emkstng the need fo, an early rdsots. TecvkAf Infortrmation end Doument Contio.

II I

1.4: As LowAs,U Is Rasnaby Achemablc IALARA) . rcceive:"a. registration number-.prior to receiv-

0 *..in vitro for

"....ing or using:

'testing. ,:. .i. .i:* , material the...byprzdudt .,.* . ..

Paragraph:-20'.1(c) :of 10 -CFR. Part'-20 states t:!

-hat.:,... .. , ,.*,persons engaged in activities under licenses...issued..i byý-. the ,Nuclear Regulatory SLicenses issued to physicians for private

-- !-- nCommissionpursuant to. t e Atomic Energy Act practice' specify. the radioisotopes and the

0o 19.54;-.. a's . amended land.' the Energy:: Reor- clinical uses !that may be. performed by the K- . ganizatidoni. Act.. of- 1974.. should, in addition: to physician to whom the license is issued, Such licenses are issued to physicians who are lo- complyingk -.with'ý ,the?.reqiirfmentS: set 'forth in this part.. make 'every '-reasonable. .effort.. to cated, in private offices and not on hospital maintain. radiation.- exposures, .and releases of premises. It is not. required iha

t. a medical

.. radioactive&materials

" sin':effluents to'unrestrict- Isotopes. committee :be formed. The private ed" iaasa' as low, as "is' reasonably. achievable.". 'practice license. does" not: permit' other physi-

.cins" to obtain' clinical "radioisotop' training

. Regulitory'o Guide 8.10, "Operating Philosophy.

for,- Maintaining., occupational: Radiation .Expo- .:and experience "under it. ,Section 35.12 of sures AsLow As Is ýReasonably Achievable," 0' "CFR :Part 35: outlines. specific requirements provides the NRC staff position on this impor- for this typet.of license.' ' .

tant subject. Regulatory..-Guide 8.18. "Infor-,

mation; Relevant to. Ensuring Thai Occupational Specific licenses of limited scope issued to 0

Radiation Exposures at Medical Institutions Will institutions specify the radioisotopes and the Be As. Low As ..Reasonably Achievable." clinical uses that may be performed by physi- provides ways of applying the ALARA philos-. cians named on the institution's license. The ophy.in medical -institutions. License applicants regulations in paragraph 35.11(b) of 10 CFII

should give consideration. to the ALARA Part 35 .require an institutional li.censee to have philosophy, as . described in Regulatory a medical isotopes committee (see Appendix B

',"Guides .I and 8.18. in the, development of to this guide) to evaluate all'proposals for

'clinical. research, diagnostic, and therapeutic plans .. for work with radioactive, materials.

NUREG-0267, "!Principles" and:. Practices for uses of radioisotopes within the institution.

Keeping Occupational. Radiation: Exposures. at'

. ledical I.Institutions" As. Low. As Reasonably The. physicians named on the institution's.,

Achievaible,.",'contalns., information and' refer- License" conduct ' their prrigrams with the ences useful .'in" establishing radiation safety, approval of -the medical is topes. committee.

programs to maintain, exposures ALARA in Institutional licenses provide i means whereby medical institutions. nonapproved physicians under *.ie supervision of physicians named on the licei:se may obtain

1.5 Types of Materials Licenses basic. and clinical 'radioisotope; training and experience that may enable them to qualify as The general license provided in §35.31 of individual users. Training and experience

10 CFR. Part 35 authorizes the physician to criteria for physicians are outlined in Appen- possess and. use. limited quantities of prepack- dix A 'to this guide.

aged. individual doses of iodine-131 for mea- surement of. thyroid . uptake, iodine-125 and Specific licenses, of broad scooe for medical

" iodine'131 for6`blood and' plasma volume dete:- use, i.e.,'Iicenses. authorizing multiple quanti- minations,.. balt-58 and cobalt-60 for intestinal. ties and 'types of byproduct. 'material. for Un- absorption: of -cyanocobalamin, and chromium-5i, specified 'uses, are issuedlto"institutions. that"

for. red ."blood% cell volume and' survival.time (1) have had previous 'experience-operating, determinations'." 'Section.35.31 explains the under a specific institutional license ofilimited general license" requirements and requires, the scope .and (2) are engaged~in medical'research,.

physician to register with the Commission and as well as routine diagnosis and' therapy using.

receive a registration number prior to radioisotopes. Such programs operate under receiving or using the diagnostic radiophact-a- the supervision of a medical isotopes committee.

ceuticals covered by the general license.

Individual users are not named on the license Section 31,11 of 10 CFR Part 31, "General nor are radioisotopes limited to specified uses.

Domestic Licenses for Byproduct Material," Individual users and procedures are approved establishes a general license authorizing physi- by the institution's medical isotopes committee.

cians, flinical laboratories, and hospitals to Physicians may obtain basic and clinical possess certain small quantities of byproduct radioisotope training and experience in the use material (iodine-125, iodine-131, carbor1 -14, of radiopharmaceuticals in such programs. This hydrogen-3,. iron-59, selenium-75, and mock type of license is not appropriate for most iodine-125 reference sources), for in vitro clin- institutions using byproduct material in medical ical or laboratory tests 'not involving the in- programs.

ternal or external administration of byproduct material, or the radiation therefrom, to human beings or animals. Section 31.11 explains the general license' requirements and -requires the Alternative titles are "radioisotope"' or "radiaUoa safety, applicant to register with the Commission and Cammitte".

10.8-2

07 L2.'iCENSE FEES Item 3 .ndicate wh-ther this it an applica-w ...

Lion for:"a - new license., an amendment. or. a An application fee is required for.-most types renewal.-

.. of licenses. The applicant should refer *to

§170.12, "Payment of Fees,". and §170.31,. Item 4. List the full names of all physicians

"Schedule of Fees for Materials' Licenses," of who wl use or directly supervise the use of

1

0. CFRPart

. 170to..determine .the amount-of fec' byproduct material. These are the physicians that must accompany-the application. Review -or who'-use the byproduct material directly or whe the -application will =not begin until the-:.:proper . are direct supervisors: of physicians, techni- fec is received by. the NRC. cians,. technologists, : or 'othei- paramedical

% pcrsonnel -to '-whom specific. activities. - are

- delegated.. .

3. FILING AN APPLICATION

Physicians under direct supervisinn of the A license application for specific licenses for .named users may. be d.legated the following human use should be submitted on Form NRC-

responsibilities:

313M, "Application for Materials License--

Medical" (see Exhibit A). The applicant 5hould complete all items on the application form in a. The approval of prdcedures involving the administration to patients of radiophaTrma- sufficient detail for the NRC staff to determine ceuticais or the application to patients of rIad-

that, the applicant's equipment, facilities, and iation from radioisotope sources radiation protection program are adequate to

protec-t health and minimize danger to life and property. b. The prescription of the radiopharmaceu- tical or source of radiation and the dose or Since the space provided on Form NRC-313M * exposure to be administered.

is limited, the applicant should append sepa- rate sheets of. paper. for Items 7-2

3. listed in

- c. The determination of the route of admin- istration.

the form or may indicate by checking the ap-.

propriate box that specific procedures will be

- d. The interpretation of the results of diag- followed. E.--h separate sheet should contain *nostic procedures 'in which radiopharmaceu-

. the. item nu. jer and the application date in'the ticals are administered..

lower right, corner..

technologists,.

Properly trained. technicians,.

'.One copy of the application, with. all attach-. or. other paramedical personnel under a user's.

ments; should be -retained by the applicant, supervision may be delegated the following since> the 'license will require as a condition *activities:

that ' 'the licensee follow the statements and representations set forth in the application and

a. Preparation and quality control testing of any supplement to it. The original and one radiopharmaceuticals and sources of radiation.

copy should be mailed to the License Man-

. affement

. Branch, Division of Fuel Cycle and b. Measurement of radiopharmaceutical doses Material Safety, Office of Nuclear 'Material prior to administration.

Safety and Safeguards, U.S. Nuclear Regula- tory Commission, Washington, D.C. 20555. c. Use of appropriate instrumentation for the collection of-data to be used by the physician.

4. CONTENTS OF AN APPLICATION.

d. Administration of radiopharmaceuticals and The following paragraphs explain the infor- radiation from radioisotope -sources to patients, mation' requested on Form NRC-313,. within limits otherwise permitted under

- applicable Federal, State, or local laws.

Item l.a. -Enter the name, mailing address, and-telephone number. of the applicant. If the Item S. State. the name and title of the per- request is for a private license, enter tie name son--ignated by, and responsible to., the of the, physician or partnership:. institution's management for the coordination of the institution's radiation: safety program.

Item 1.b.. List the addresses and locations where r.wioactive material will be used 'or For routine human use, the.appli-

6.a.check Itemmay cant the group numbers of Sched- stored if . other than the address stated in Item - I.a. If multiple addresses are to be used, ule A in §35.100 of 10 CFR Part 35 for which explain the extent of use at each address and the license is, requested.' Groups 1, It, and III

the facilities and.. equipment located at. each consist of the more. commonly used diagnostic place of use. .procedures that involve radiopharmaceuticals;

Groups IV and V consist -or routine therapeutic Item 2. Enter the name and telephone num- procedures .that involve ' radiopharmaceuticals;

" . ber_(including area code) of the individual to and Group VI consists of sealed sources used be contacted. primarily for therapeutic procedures.

10.8-3

0

i..(..For,* Groups:,.1I,. 11I,: IV.,. and ..V . .posses ion! Submit. the followiing information:

HO: :are/hot listed on -thelicense ..-

.:'.lits {,-.." .7 a. The responsibility and"duties of the com- Fo .,Gou 'h:* possession' lim~it willbe mittee.

"un.Wo", Cu ries ess.a larger. limit radioactive f*each in the 'listed:

is requestedmaterial appli=

b. The meeting frequency of ithe committee cation;. State .theanyrequested radioactive materiallimit possession for listed (at least quarterly).

f:..i*,d" roup VL,. and

1,.separately., from. : Groups I

7:*:=: through. V. The.

c. The name and specialty of each member of possession: limit:. for each radionuclide includes the committee.

material held as radioactive. waste'.

i teih 6."b*. For routine human use not listed Appendix B to this guide contains an exam-

'in ups L'through VI and for nonhuman use, ple of typical responsibilities and duties for a list, each'-radionuclide to be used, the chemical medical isotopes committee. Indicate, by check-

and.. physical form:, and the maximum quantity ing the appropriate box in Item 7, that the re-

*nd.miti*es) . . sponsibilities, duties, and meeting frequency will be as described in Appendix B, or propose List ,the' manufacturer's name, model number, alternatives. If the responsibilities, duties, or and, activity. (in'. millicuries) for all sealed meeting frequency will be different from those sources. (Sealed .. ources up to 3 mCi used for ..described, submit a complete description.

calibration. and, reference standards are autho- rized .'under 'paragraph 35.14(d) of 10 CFR Item 8 Training and Experience Part 35 and should not be listed.) a. Authorized User(s). If the physician has A specific: :authorization must -be obtained been pýreviously authorized to usc the radio- from the. NRC to perform studies involving'the active material requested in this application, it use of radioactive material in animals. is necessary to submit only - the previous.

license number (if issued by the AEC or NRC)

or a copy .of .the -license (if issued by an Describe the. intended use for each radio- Agreement State). *

nuclide and form listed in Item 6.b.. If. the radioactive material is for human use and has If the. physician has not been previously I! '-*';'

not been:approved for routine human use by the

"m'.

a... *_.-and Drug Food.

.

eviufnce .wa L..I_ Administration (FDA), sub- procurementI,. preparation, and use of the ,material will be in accordance authorized to use the radioactive material being requested, state where he is licensed to prac- tice medicine, .and submit ' a complete description of his training and experience. Use with the. Federal Food,. Drug, and Cosmetic Act Supplements A and. B to Form NRC-313M (see and the Public Health Service Act. If the study Exhibit A). for the " description of the

is conducted : under a, "Notice of Claimed physician's training and experience. Criteria Investigational Exemption .for a New Drug for acceptable training 'and experience are (IND) sponsored: by the physician or institu- contained in Appendix A.

tion. state the radionuclir%2 chemical form,

" possession limit, and use, aaid submit a copy of *b. Radiation Safety Officer. If the radiation the'IND acceptance letter from the FDA. safety.. officer is not one of the physicians named in Item. 4, submit a-complete description Item 7 Medical Isotopes Committee. In accord- of. his training and. experienc

e. Supplement A

ance with paragraph 35.11(b) of 10 CFR to Form NRC-313M. may be used for the de- Part 35. an institution applying for a bypro- scription of the'radiation safety officer's train- d

duct material license: for .human use is required ing and experience.

to e-tablish a.medical"Isotopes committee' of at Item 9-.instrumentation. Instruments required least three members. This -committee evaluates all proposals for research,. diagnosis, and in a typical 'nuclearmaedicine laboratory. are:

therapeutic. use ofradioisotopes. Membership of V

the committee should:include: a'. Survey Instrument's

() A; low-level .'survey meter capable of

.. Atleastone pysician specializing in nu- a.

clear medicine, internal medicine, ,hematology, detecting 0.1' milliroentgen per hour.to therapeutic radiology, diagnostic radiology, or perform contamination su'rveys.

pathology, who will use or directly supervise the use of radioactive materials in humans. (2) A high-level survey meter such as an ionization type capable of. reading up b. A person with special competence in ra- to I roentgen per hour to measure diation safety. radiation exposure rates that may exist in the vicinity of MO-99/Tc-99m gen- c. A representative of the institution's man- erators and therapeutic quantities of agement. radioactive material.

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-b. Dose -calibrators and other instruments to If a consultant, or outside: firm will perform

" assay radiopharmaceuticals... the. 'alibration .of your. radiation survey and monitoring instruments, specify his'name, ad-.

c. Diagnostic instruments for all procedures dress, and :the license number. Contact the.

gamma cumera, .well counter, thyroid

-.:. (e.6g.,

Probe.).!. " " "" .. .. ./" "' firm or consultant .that will provide the call-

'bration to determine if information concerning calibration services and procedures has been d.. Other pertinent instrumentation (e. g. , filed With the Commission. If this information liquid. scintillation counter, area monitor). has not been filed, submit it with your applica- tion.'

Appendix C to this guide, contains a form that. maybe used -to describe the instruments. Section. 1 of Appendix D to this guide con- Complete this -form 'by listing the instruments tains an acceptable procedure for. calibrating to be used. If this form is not used, attach survey instruments and *a form that may be equivalent information. Check :the appropriate used to supply .the information required in box in Item 9.of Form NRC-313M. Item 10 of the application ýform.. Indicate, by checking the Ppprtpriate box ,in Item 10 of Item 10 Calibration of Instruments ... Form ,NRC-313M, if. the procedure. described.in AppendixiD will b-fowed. If the procedure a. Survey Instruments.. An adequate calibra- 4in. Appendix 1I ,,'? not followed. submit tion of with survey instruments cannot be performed built-in equivalent proceaures.

check. source.s. Electronic calibra- tions that do not involve a source -of radiation b. Dose Calibrator. AU radiopharmaceuticals are also not adequate to determine the proper should, be assayeJ or activity to an accuracy functioning and response of all components of of 10% prior to being administered to patients.

an instrument. The usual method for performing assays is with a dose calibrator. Upon installation and Daily constancy checks of survey instru- periodically thereafter, dose calibrators should ments should be supplemented at least every 12 be tested for accuracy of response for the months with b. battery check and two-point energies commonly used, for geometr'cal calibration on each scale of the instrument. 'variation, for linearity of response over the

.One point should be in each half of the scale, entire :range of activities'to be used, and for and the two points should be separated by 35- day-to-day constancy of operation.

.50% of full scale. Survey instruments should also be calibrated after repair'"and after Submit a description:of 'your calibration pro- battery replacement. cedures. :These should include as a minimum:

A survey instrument may be considered (1) The manufacturer's name and model properly calibrated at one point when the ex- number of any sealed sources to be posure rate measured by the instrument differs used (unless authorized by para- from, the.true exposure rate by less than 10%of- graph 35.14(d) of 10 CFR Part 35).

full scale.

(2) .The nuclide and activity (in millicu- If you propose to calibrate your own radia- ries) of radioactive material in the tion survey -and monitoring instruments, submit standards.

aadetailed description of, you r planned calibra-

tion procedures.include in, the description: (3) The accuracy of the standard.

MI) The manuficturer's name and :,model (4) The. step-by-step procedures used for number of the source(s) to be used. calibration.

(2) The nuclide and activity (in milli- If an instrument other than a dose calibrator curies) of radioactive material con- is used to assay patient doses, submit a tained in the source. complete description of:

(3) The accuracy* of the source(s). (1) The assay methodJ

(4),The step-by-step procedures, includ- (2) The method of calibration.

ing associated radiation safety proce- dures. These procedures . should (3) The frequency of calibration.

include a two-point calibration of each scale of each instrument, with the (4) The standards to be used for calibra- points separated -by 35-50% of. full tion (radionuclide, activity, accuracy).

scale.

Section 2 of Appendix D contains a descrip- b *Th "uazm deviation or the omi-al value of the source from the true value. Ths information .a normally prnoftded by tion of an acceptable procedure for calibrating dose calibrators and a form that may be used to

10.8-5

supply the informa on required in Item 10 of g. 'Their obligation to report unsafe condi-.

-this ýapplication,-- form. indicate, by -'checking tions.

,he.appropriate...box in. Item .10 of' Form NRC-:

313M , if the procedure'in Appendix D for, cali- h. Appropriate response to emergencies or brating* dose calibrators will be followed. If unsafe conditions.

Appendix DI is." not followed, submit equivalent procedures- .. T i. Their right to be informed of their radiii- C..:Diao Instruments. The manufactur- Lion exposure and bioassay results.'

for calibra- er's :directions shouIld., be followed instrumenta- j. Locations where the licensee has posted or tion and maintenance of diagnostic made available, notices, copies of pertinent

-'tion .. regulations,, and- copies of pertinent licenses and license conditions (including applications I:item II:Facilities and Equipment. Describe.the and applicable correspondence), 'as required

-araible,facilities -:and equipmen t (e. g., remote - by 10 CFR'Part 19. , '-

..

handling! equipment, :s.torage',..: containers, Sshieding, fume bhoods) ,,at each. location where Verify - that personnel will be properly in- radioactive, material will. be used. Include a structed; ; . I

description of the area(s) assigned for the receipt, storage. (including Waste), prepara- a. Before assuming duties with or in the vi- tion, and measurement of radioactive material. cinity of radioactive materials. 0

Submit a diagram showing the locations of b. During annual refresher training.

shielding, the proximity of radiation sources to unrestricted areas, and.other items related to c. Whenever there is a significant change in radiation safety. Indicate any wall shielding, duties, regulations, or the terms of tht!

special storage area shielding, or movable license..

shielding around storage areas, generators, kit preparation areas, etc. Item 13 ýProcedures for Ordering and Receiv- ing'Radioactive Material. Describe procedures For facilities-in which radioactive material for ordering radioactive materials, for receiv- may, become airborne, , include schlimatic de- ing materials during off-duty hours, and for scriptions of the :ventilation system in the dia- notifying responslble persons upon receipt of grams with. pertinent airflow rates, pressures,, radioactive ,materials. These. procedures should filtration equipment, and, monitoring instru- be adequate to ensure that possession limits ments. Draw' diagrams to a specified scale, or are not exceeded,' that radioactive materials are indicate dimensions. secured at all. times against , unauthorized removal, and that radiation levels in unre- Figures 1. and 2 contain examptes of accept- stricted areas do not exceed the limits specified able facility and equipment descriptions. in §20.105 of l0 CFR.Part 20.,

Item 12 PersonnelTraining Program. Describe Security personnel, nursing personnel, or

..the training required for all. personnel who anyone. else who' receives packages during off- work with or in "the vicinity of radioactive duty hours should be issued written' instruc- materials. Include the form of training (e.g., tions as to procedures to be followed.for re- formal course work, lectures), frequency of ceiving, examining, and' securing, the package;

training, duration of .training, and subject for notification procedures if the 'package is matter. The training program should be of suf- found or suspected to be leaking; and the im- ficient scope to ensure that all personnel, mediate steps to be taken. to prevent. spread of including technical, clerical, nursing, house- contamination.

keeping, and security personnel, receive prop- er instruction in the Items specified in §19.12 Appendix E to this guide contains sample of, 10 CFR Part 19, including: procedures and instructions for ordering and receiving packages containing radioactive mate- a. Areas where radioactive material is used rial. Attach a copy of your procedures.

or.:stored.*

Item 14 Procedures for Safely Opening Pack- b. Potential hazards. associated with radio- ages Containing Radioactive Materials. Describe active material. your procedures for examining incoming packages for leakage, contamination, or c. Radiological safety procedures appropriate damagei and for safely opening- packages in to their respective duties. accordance with §20.205 of 10 CFR'Part 2P,

Perform the monitoring as soon as practicat e d. Pertinent NRC regulations. after 'receipt of the package of', radioactive material. The procedures may vary depending e6. Rules and regulations of the licensee. on the quantity of radioactive material received but should, at a minimum, include instructions f, Pertinent terms of the license. for surveying packages, wearing gloves while

10.8-6

SUPPLY VENT

HALLWAY 0 EXHAUST VENT

BUILDING EXTERIOR

'HALLWAY

SCALE 1 4'

FIGURE 1.

EXAMPLE OF AN:ACCEPTABLE TYPE OF LAYOUT DIAGRAM FOR

A FACILITY DESCRIPTION INCLUDING VENTILATION FLOW RATES'

10.8-7

HALLWAY

REST REST

GAMAROM ROOM BUILDING EXTERIOR

CAMERA

-oLEAD BRICK

HOT LAB

-STOR AGE

LEAD

CAMERA ROOMSHEDN

HALLWAY

GENERATOR

'L SHIELD

DRESSING

ROOM DOSE

r--CALIBRATOR

HOTSINK

DRESSING LEAD BRICK

ROOM

WASTE AREA.

HALWYFUME HOOD SCALE I--4'

FIGURE 2.

EXAMPLE OF AN ACCEPTABLE TYPE OF LAYOUT DIAGRAM FOR

A FACILITY DESCRIPTION INCLUDING SHIELDING PROVISIONS

10.8-8

ýopening packages, and checking packing j. Describe contamination control proce- material for contamination after opening. Even dures, including prohibitions against smoking.

though §20.205:exempts certain packages from eating, drinking, or applying cosmetics in re- immediate monitoring, it is necessary that pro- stricted areas and instructions for individuals cedures be established for. safely opening, all who prepare doses and radiopharmaceuticals to packages containing radioactive. material. monitor their hands after, each procedure and at the end of the :day.

Appendix F to this guide contains a descrip- tion of an acceptable .procedure for safely For smaller programs, Appendix G to this opening packages. Indicate, by chedking the guide contains an acceptable set of laboratory

appropriate box in.Item 14 of Form NRC-313M,, rules for the safe use of' radioactive material.

that the procedure in Appendix F will be fol-. Indicate,' by checking the appropriate box in lowed, or attach equivalent procedures. Item 15. of Form NRC-313M, if Appendix G

rules will be followed, or attach equivalent Item 15 General Rules for the Safe Use of Ra- procedures.

dioactive Material. Describe the general in- structions to be followed hy physicians and Item 16 Emergency Procedures. Describe the technologists while working with radioactive emergency instructions to be posted in all labo- materials. The instructions should: ratory areas where radio.CaiV- materials are used. These instructions should (a) describe a.. Outline control procedures for obtaining immediate action to be taken in order to pre- permission to use radioactive material at the vent contaminatiotn of personnel and work areas institution. (e.g., turning off the ventilation, evacuation of the area, containment of the spill), (b) state b -. Explain what laboratory apparel to wear the names and telephone numbers of the and what equipment to use, e.g., wearing of responsible persons to be notified in case of an laboratory coats and use of disposable gloves emergency, and (c) instruct personnel on ap- and trays. propriate methods for re-entering, decon- taminating, and recovering facilities that may c. Prescribe limitations and conditions for have been accidentally contaminated.

handling liquid or loose radioactive -materials and the laboratory equipment to use in working An acceptable set of emergency procedures is with them. For example, specify which contained in Appendix H to this guide. Indi- materials and operations should be confined to cate, by checking the appropriate box in radiochemical fume hoods or gloveboxes. Item 16 .of Form NRC-313M, that you will follow the emergency procedures in Appendix 11, or d. Specify the shielding or remote handling. submit a copy of equivalent procedures.

equipment to be used when hard beta- and/or, gamma-emitting materials are handled.' Prepa- Item 17 Area Survey 'Procedures. Describe ration. of radiopharmaceuticals from :reagent the routine iýsurvey program, including :'the.

kits should be done behind shielding." Syringe. areas to be'surveyed, the level-: of contamina-

.shields should be used for the preparation and tion, considered -to be acceptable, and provi- administration of patient doses. sions for maintaining records of surveys.' (A

regulatory guide on radiation safety surveys at e. Give instructions for preparation and medical institutions is now-under development.)

assay of patient doses.

If the application is to cover multiple users f. Give instructions concerning movement of and areas of use, the individual user should P

material between rooms, in halls, or in corri- perform surveys of his own work areas in addi- dors, if applicable. tion to those performed by the radiation safety staff. Acceptable procedures and frequencies g. Explain requirements for storage of mate- for routine surveys are described in Appen- rials, labeling of containers, and identification dix I to this guide. Indicate, by checking the of areas where radioactive materials are used. appropriate box in Item 17 of Form NRC-313M,

Describe the shielding used for areas where that you will follow survey procedures. in Ap- large amounts of byproduct material are pendix I. or submit equivalent procedures.

stored.,

Item' 18 Waste Disposal. Describe specific h. Specify personnel monitoring devices to methods used for disposal of waste byproduct be used, where to obtain them, and instruc- material. A licensee may dispose of waste by:

tions for recording exposure results or prop- erly turning in per.;onnel monitoring devices a. Transfer to a person properly licensed to for processing at appropriate intervals. receive such waste, e.g., commercial waste disposal firms. (See §20.301 of 10 CFR

i. Describe waste disposal procedures to be Part 20.) Submit the name and the NRC or followed for each type of waste (e.g., liquids, Agreement State license number of the com- gases,: solids, long-lived, short-lived). mercial firm selected.

10.8-9

.

N . .,

.=".:!*..:"*'

E :.*i'*!,. -i*i.':*

L~

b. Release into a sanitary sewer in conform-;: "Licensees should also perform. surveys ance with §20.303 of 10 CFR Part 20. Describe :(e.g., measurement of iodine-131 :in air; mea- your sals, methods

. oo.p for .controlling .the .sewage dis- surement of iodine-131 in the thyroid gland of of radioactive wastes-iin order to ensure laboratory personnel; contamination surveys of

..that disposals do,not exceed the-limits specified personnel,. .equipment, and faciliiies) to deter- in §20.303 of. 10 CFR Part1.20. mine compliance with §§20.103 and 20.100 of

10 CFR Part 20..]

c. Bu rial in soil in conformance with §20.304 of 10 CFR Part 20. d. Instructions to nursing staff.

e. Procedures for disposal of waste.

d. Release into the air in conformance with

§20.106 of 10 CFR Part 20. (I) Patient excreta.

e. Other. methods' specifically approved by (2) Surgical dressings.

..the Commission pursuant to §20,302 of 10 CFR

Part 20. (3) Disposable items.

Note': No licensee. may dispose .of byproduct f. Procedures to:be. followed in case- of emer- material . waste by incineration. unless gency~surgery or death.

specifically approved by the Commission.

(See §20.30S of 10 CFR Part 20.) g. Procedures for release of patients.

Appendix J to this guide contains a form that (1) Criteria for release of patients.

may. be used to supply the information (2) Instructions to patients and families.

requested in *Item 18 of the application form.

.- indicate, by checking the appropriate box in item 18. of,, Form NRC-313M, that you will h. Procedures for bioassay cf' personnel.

dispose of wastes as. specified on the form in Significant thyroid uptakes have been detected Appendix J, or.attach equivalent information.* in .individuals who open .and prepare. oral solutions of iodine-131 for therapeutic doses.

Item 19 Therapeutic. Use of Radiopharmaceu- Guidance on situations requiring bioassay for

.ticals. Describe.. special. precautions for. pa- iodine-131 and. appropriate action levels -may be

" ents treated with byproduct material listed in found -in Regulatory Guide .20' ."Applications Groups. IV..and V, Schedule A. §35.100 of of lBioassay.for 1-125 and[-131."

l0.CFR Part 35: Although Group IV proce- dures are often, performed on an outpatient Guidance for the management of therapy

basis. hospitalization is sometimes required.

patients can be found in the National Council Establish appropriate procedures for all pa- on Radiation Protection and Measurements tients treated with byproduct material and (NCRP) Report No. 37, "Precautions in the include: Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."* Other a. Method for. preparation and administration pertinent references are given, in Regulatory i of therapeutic., doses of iodine-131. Instruct Guide 8.18 and NUREG-0267.

personnel to wear gloves and to open con- tainers -of. iodine-131 in a fume hood with Appendix K to this guide contains a descrip- adequate airflow .or to. take other precautionary tion of precautions to be. followed 'for patients measures to prevent :contamination of them- treated with iodine-131, . gold-I98, and selves and. surrounding areas.. phosphorus-32. Indicate, by checking. the appropriate box in Item 19 of Form:NRC-313M,

b. Methods for contamination control that you will follow Appendix K procedures, or submit equivalent procedures. In either case',

(1) Assignment to private room. attach a separate description of. facilities and detailed procedures for preparation and

(2) Use of disposable items (e.g., dishes, administration of therapeutic doses of iodine- utensils). 131, phosphorus-32, and gold-198, c. Procedures for surveys of Item 20 Therapeutic Use of Sealed Sources.

(1) Unrestricted areas. Describe special , procedures for patients treated with byproduct materials listed in S .(2) Linens and other items removed from Group VI on Schedule A, §35.100 of 10 CFR

patient's room.

UI

(3) Patient's room before it is reassigned NCRP reports are avarlable fr=m KCRP Publiatons, P.O.

to another patient. Box 30175, Washington. D.C. 2D014.

10.8-10

I I

II

IPart- 35-,. These. procedures* should-in'claide de- lions. .for. submitting an 'application' to. rue- a Appendix M: this guide contains inst scripiLion's -of: use xenon-133Y` The information requested in Ap- a. The. areas. where sealed sources will he pendix M shoold.be submitted.

stored," including (1) placement and thickness of shielding and (2) proximity of the storage Item 22 Procedures and Precautions for Usf area to unres'tricted areas. of Radioactive Material in Animals. Describe procedures to be followed if radioisotopes will b. Special orecautions. to be used while be used in animals including (a) a description handling sealed sources. of the animal housing facilities. (b) a copy of instructions provided to animal caretakers for c. Special instructions for nursing care of the handling of animals, animal waste, and car- patients who are treated with sealed sources. casses. (c) instructions for cleaning and de- (Appendix. L to this guide contains a descrip- contaminating animal cages, and (d) procc- tion of procedures to be followed for patients dures for ensuring that 'animal rooms will be treated with scaled sources.) locked or otherwise secured unless attended by authorized users of radioactive material.

d. Your method for determining the.radiation doses to the extremities of personnel handling Item 23 Procedures and Precautions for Use sealed sources. of :Radioactive Materials Specified in Item 6.b.

Clearly state any additional radiat ion safety e. The equipment and shielding availaLule for procedures to be followed while individuals are transporting sourcefs from storage sites to the using the materials listed in Item 6.b, e.g., air place of use. sampling, other special surveys. bioassays.

f. Your method for maintaining source ac- Bioassays may be required when individuals countability at all times.. This should include a work .with millicurie quantities of hydrogen-3, description of sign-in and sign-out proce- iodine-125, or iodine-131 (depending on the

%dures, periodic inventory, and the method for .chemical and physical. form, the procedures determining that all sources are accounted for followed, and the equipment used). Bioassays and returned.to storage following treatment,. may also be required for other radionuclides if the chemical or physical form or procedures g. Surveys to be performed during the and equipment. used make it likely that the course of .treatment and at the conclusion of radioactive material will be ingested, inhaled, treatment. The patient and room should be or absorbed into the body. Show in the appli- surveyed with a radiation survey instrument cation that the need for bioassays has been

-after the end of treatment and before thoroughly considered and that the 'proposed dismissal. Your dismissal survey should include bioassay program is appropriate for the in- a source count and should be adequate to tended use of radioactive material. Guidance on determine that all temporary implant. sources bioassay. programs for. iodine-125 and iodine- have been removed from the patient and.from 131 is provided in Regulatory Guide 8.20.

all areas that the patient occupied. Guidance for bioassay programs for tritium and other radionuclides is available as staff criteria Submit detailed responses to Item Nos. .20.a, from the License Management Branc

h. Division

.20 .b, 20.d, 20.e, 20.f, and 20.g. In response of Fuel Cycle and Material Safety, -Office of

to Item .20.c, indicate that the procedures Nuclear Material Safety find Safeguards, U.S.

'described in Appendix L will be followed, or Nuclear Regulatory Commission, Washington,

.submit equivalent procedures. D.C. 20555.

Item .24 Personnel Monitoring Devices. State I tem 21 Procedures and Preceutions for Use. the name of the organization furnishing film

.of Radioactive Gases (e.g., Xenon-133). The' badge or, thermoluminescent dosimeter (TLD).

use of radioactive gases (e.g., xenon-133 gas service. Specify the frequency with which :the or gas ih. saline) requires attention not:only to badges are changed and evaluated, and give a the standard radiation safety considerations description of the type, e.g., whole-body, but also to an evaluation of expected air con- wrist, or finger badge. Where wrist badges are centrations of the radioactive gas in restricted *.worn to monitor extremity exposures and and .unrestricted areas. T'he NRC requires that exposures to fingertips are likely to be greater each applicant make such determinations for his than the wrist exposures. describe how own unique situation and submit sufficient fingertip exposures will'be estimated from the evidence to the Commission in support of his wrist badge data in lieulof fingertip monitors, request. and provide any backup data used to perform or verify these estimates.

Guidance on faeilities, equipment, and procedures is avail- able in NUREG-0257, *Principles and Practices for Keeping Item 25 (For Private Practice I Applicants Only).

Oecu stional Rnsdon Exposures at Medical Institutions -As Low A.s T Reasonably Achievable," Office or Standard. Devel- Item 25.a. State the name and address of oplent. U.S. Nuclear Regulatory Coammusion. Washingtan.

D.C. ZM55. De*ember I977. Guldsnce on bra'chyterapy pro- the hospital that has agreed to admit patients cedure-is give,,, on pp. 3-16 to 3-19 of this report. containing radioactive material.

10.8-I1

Item 25. b. Submit a copy of the letter of 6.: RENEWAL OF . A LICENSE

authorizatiýon, Msgiied by the administrator, An application for renewal of a license should from.. the' hospital -that .has agreed to admiit patients, containing, radioactive material. be riled at least 30 days prior to the expiration date. This wilensure that the license does not Item: 25.c. If -patients -.treated with thera- expire until final action on the, application has.

Speutii--iiquantities. under this license are been taken by the NRC as provided for in

-admitted: to the: hospital, (1) describe the ra. paragraph 30.37(b) of 10 CFR Part, 30.

diation detection instruments, available at thb hospital. and (2) 'submit a copy oi. radiation Renewal applications should be filed on Form safety procedures:to be followed, NRC- 313M appropriately supplemented, should contain complete and up-to-date information Item 26.a'. Licensee Fee Category and Licensee about the applicant's current program, and

'Fee: Enclosed may, be.. selected from information should meet all licensing and regulatory pertaining .to edical institutions in §170.31.of requirements' in effect. at the time of renewal.

.*: .l10 CFR ,Part*.170.,.! :." '." ... : " .. Renewal applications should also include the user physicians' trainingr and experience Items 26.b and c. Provide the.signature of (Supplements A and B of Exhibit A) or make a an. individual, authorized by management to clear and specific reference to previous represent iaan.*. applicant.: institution or the applications on which individual users received sigiature .. of.an individual physician, in the approval.

case. of Category 7C. of §170:31," with the date, of signature.. In order to facilitate the review process, the application for renewal should be submitted without reference to previously submitted doc-

SAMEND.MENTS

. TO LICENSES uments and information (except for previously approved users). If such references cannot be Licensees are. required to conduct their pro- avoided, they are acceptable provided:

grams in accordance with statements, repre- sentations, and procedures contained in the a. The reference is made in response to a license application and supporting documents. particular item of required information (e.g.,

The license:must therefore be amended if the bioassay procedures).

licensee-plans to make'any changes in the facil- ities,' equipment (including types of monitoring b. The reference is clear and specific ',e.g.,

and survey:. instruments), procedures, autho- title of document, date of submission, page, rized users or radiation safety officer, or and paragraph).

byproduct'material to be used.

c. The referenced document contains all in- Applications for license amendments may be formation required for a particular item at the filed either on the application form or in letter time of renewal.

form. The application should identify the license by: number and should clearly describe Prepare an' original and two copies of the the exact natureaof the changes, 'additions, or application. Retain one copy of the application-,

deletions. References to previously submitted with all attachments, because the license 'will information:and documents should be clear and require, -as a condition, that the institution specific and should identify the pertinent follow the :statements and representations set information 'by: date, page, and paragraph. A .forth :in the-application and any-sutpplement.to fee must -accompany amendment applications as it.' Mail the original and one -copy to the indicated, in Item 26.a. An original and two License Managementa Branch, Division of Fuel copies of the application for amendment should Cycle and Material Safety, Office of Nuclear be prepared, the original-andone copy should Material Safety and Safeguards, U.S. Nuclear be submitted, as in the cases for new or Regulatory Commission, Washington, D.C.

renewal applications. See Appendix N for 20555. A fee must also accompany renewal commonly requested amendments. applications, as indicated in Item 26.a.

10.8-12

LIST OF APPENDICES

Item No.

on Form Appendix NRC-313N

A Acceptable Training and Experience for Medical Uses of 8 Byproduct Material B Medical Isotopes Committee 7 C Instrumentation 9

D Calibration of Instruments 10

Section I - Methods -for Calibration of Survey Meters, Including Procedures, Standards', and Frequency Section 2 - Methods for Calibration for Dose Calibrator E Procedures for Ordering and Receiving Radioactive Material 13 F Procedures for Safely Opening Packages Containing Radioactive 14 Materials G * General. Rules for the Safe Use. of Radioactive Material

-

I 15- H Emergency Procedures 16 I Area Survey Procedures 17 J Waste Disposal 18 K Therapeutic Use of Radiopharmaceuticals 19 L Therapeutic Use of Sealed Sources 20

M Procedures and Precautions for Use of Radioactive Gases 21 (e.g., Xenon-133)

N Guidance on Requests for-License Amendments and License Terminations

10.8-13

APPENDIX A

ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES

OF BYPRODUCT MATERIAL

I'ar:igraih 35+11(d) of 10 ('FR Part 35 pWV- (The hour!, listed Iiext to v.:0l1 of tihe

idtes that the Conimissin will appro,'e a five sutbjecls :tbovc aVrc sggmsted

!1C. se application IV 'n1 in..,:itution fori l-hical Values and should not be interpreteL:d u.e of byro,duLt i11itCrLal if it dItvl ntlnc.a, as Nip'cifiC rieqUirflcl ttlis )

Saing 'other thigs. I hat the ph.y'sic;an de(signated is the ic-dvidual usectr is adcquately l.. I.xpurieunet: with. the I ,v.s :w1id qual.liliv..i trained and experi-nced in (1) basic radio- 1.,f. I.ypr:,duel matu-;'ial for wh ich .liht.

isotope handling techniql*es and (2) the clinical application is being tnadt:r. w uquivahlnt use of blyproduct materi:il poposed in the i.500 h,101'!- ).

application. Similar criteria aire enitablishcd in C. 8tuperv\il.,d clinical t,'ainiiný in an in.,tilu- paragraph 35.12(c) of if) CFH Part 33 for the I ion;,l lwvlvl( irtl" mvd~icint., prIo,1"'fra1 (."5()0

approval of licerses for medical use of r,,.lio- pharmaceuticals by individual physici;:ns. Out-w hi.,ur.s; The clinieAl t raining sh,'.1iII

. . lined below are training and exprience criteria covz:r all :i l.,"'wp itv vyf .' . ,liagtl(n,:. ic thait the Commission. with the assiltance; of its " l;','udu res :and should inrclutiu:

Advisory. -Committee on the Medical Uses.of io0-

topes (ACMHI).. has. found acceptable- for ph:.'- "*, ! "Ssupei\-is\td exa.minat ion uof ptifel i

s. o

.icians., who u.5e radiophaxnaceut-cals. Fach S d ,ciletmin. the suitahility for radio-

[physician's . training and e.Npurivnce are *.. ;J.tovp d.iignc'sin i ant nl 'eo.mnltenda'latinn x .

examined on a case-by-case basis. If a physi- on, thosige to hv prIscribetd.

c6an wishes to use rcaiophamaceuticals bitt does not. have the training and experience de- (2.) Ccdlabora tion in calibration of the scribed, he may submi: an application listing dose, and the actuual administration of hi,ý specific quilifications and these will be the dose to the patient, including reviewed by tht- Commission with the assistance calculation of the radiativn duse.

of th,.- A\Ck-11 . rlAat.vd mleasurlinent , and phItting data.

3)Followup of patients when rcquitred.

. '1. General T'raining

(4.) Study and discussion with preceptor To qualifyv -as. adequately, trained. to .use or .f W case histories to establish most- directly" supervise . the use of byproduct appropriate diagnostic procedures.

.material. listed in. Groups I. 1I1 and/or Ill in limit:ition, conttraindication, et(:.

35..100'of 10 CFR. Part 35. a physician should have:" Note A:.

S, . . Training

-... in basic radio- (200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months ) 'The requirements specified in Sections 1.a, isotope handling tech- b, and c may be satisfied concurrently in a 3- niques consisting of month training, program IF all three areas are lectures, laboratory integrated into the program.

sessions. discussion p groups, Ur.. supervised Notu l..:

experience in a nuclear medicine laboratory in For each physician named in Item '4 or Form tthe following areas: NRC-313M. complete. Supplements A and 13 of Form NRC-3131% (Preceptor Statement and the

.(I) Radiation -physics and statement. of training in basic.'radioisotope

(100 hours0.00116 days 0.0278 hours 1.653439e-4 weeks 3.805e-5 months )

instrumentation handling techniques).. For each subject :overed in basic, training, state where the training was

(2) Radiation protection (30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months ) obtained. the dates, total number of hours, and type of training (e.g.. lectures, labora-

(3) Mathematics pertaining (20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months ) tory Sessions.).

to the usc and measure- ment of radioactivit:y Alternatives:

(4) Radiation biology (20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months ) Certification by the American Board of Nu- clear Medicine will be accepted as evidence that

(5) lRadiopharmaccutical (30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months ) a physician has had adequate training and chemistry experience to use Groups 1, I1, and Ill.

' Certification by the American Board of Radi- Treatment of three patients with any

' ology in Diagnostic Radiology with Special Com- combination oVT"teUier-th-e condi- petence in Nuclear Radiology will be accepted tions.

as evidence that a physician has had adequaie training, in basic radioisotope handling tech- i3) Cilhoidal phosphorus-32 intracavitary niques and 'has had . adequate clinical treatment:

experience to use Groups 11 and 1ll..

Active participation in the trcatme:nt

2. Training Requirements for Specific Diagnostic of three patients.

Pmcedures For GrouL" \_

A. physician who wishes to be authorized for

only one or two specific diagnostic procedures (I) Iodine-131 for treatment of thyroid should have training in basic radioisotope carcinoma:

handling techniques and clinical procedures commensurate with the procedures and cluanti- Clinical experience in diagnosis of ties of byproduct material being requested. thyroid function and treatment of Such requests will be examined on a case-by- hyperthyroidism and/or cardiac dys- case basis by the Commission with the function and active participation in assistance.of the ACMIUI. the treatment of three patients with thyroid carcinoma.

.3. Training Requirements for Therapy Procedures Involving Radiopharmaceuticals (2) Colloidal gold-19R for intracavitary treatment:

To qualify as adequately trained to use or directly supervise the use of byproduct, mate- Active participation in the treatment rial listed in Groups IV and/or V in §3S. 100 of of three patients.

10 CFR Part 35. a physician should have:

4. Training Requirements for Therapy Procedurem a. Training in basic radioisotope handling Involving Sealed Sources techniques (80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months ) including:

To qualify as adequately trained to use or (I) Radiation, physics and .(25 hours2.893519e-4 days 0.00694 hours 4.133598e-5 weeks 9.5125e-6 months ) directly supervise the use of byproduct mate- instrumentation rial listed in Group VI in §35.100 of 10 CFR

Part 35, a physician should have:

(2) Radiation protection (25 hours2.893519e-4 days 0.00694 hours 4.133598e-5 weeks 9.5125e-6 months )

a. Training in basic radioisotope handling

(3) Mathematics pertaining (10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months ) techniques (200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months ) consisting of to. the use and measure- lectures, laboratory sessions, discussion ment of radioactivity groups, or supervised experience in the following areas:

(4) Radiation biology (20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months )

(1) Radiation physics and (110 hours0.00127 days 0.0306 hours 1.818783e-4 weeks 4.1855e-5 months )

(These requirements are in lieu of. not instrumentation in addition to, those specified in Section

la, above.) (2) Radiation protection (40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months )

b. CLinical training in specific therapy pro-

(3) Mathematics pertaining (25 hours2.893519e-4 days 0.00694 hours 4.133598e-5 weeks 9.5125e-6 months )

cedures: to the use and measure- ment of radioactivity For Group IV

(4) Radiation biology (25 hour2.893519e-4 days 0.00694 hours 4.133598e-5 weeks 9.5125e-6 months 's)

(1) Iodine-131 for treatment of hyper- thyroidism and/or cardiac condi- (The hours listed next to each of the

tions: four subjects above are suggested valu.s and should not.be interprett'd as specific Clinical experience in the diagnosis requirements.)

of thyroid function and active par-

:Licipation in the treatment of ten b. Clinical training in specific therapy pro- Spatients. cedures:

(2) Phosphorus-32 for treatment of poly- (1) Radiation sources for interstitial.

cythemia vera, leukemia, and/or intracavitary. or surface treatment bone metastases: of cancer:

10.8-16

Active practice in therapeutic radiol- Note:

ogy with a minimum of 3 years experience. Evidence of certification by the American Board of Radiology in Radiology or Therapeutic

(2) Beta ray applicators for the treat- Radiology, certification as a British "Fellow of.

ment of superficial eye disease: the Faculty of Radiology" (FFR) or "Fellow of the Royal College of Radiology" (FRCR), or a Active practice in therapeutic radiol- Canadian certification from the Royal College of ogy or ophthalmology and experience Physicians and Surgeons (RCPS) may be sub- in the therapeutic use of beta rays mitted in lieu of the. information requested in or soft X-rays. Sections 4.a and b above.

0.

10.8-17

APPENDIX B

MEDICAL ISOTOPES* COMMITTEE

Responsibility (e.g., nursing, security, and housekeep- ing personnel) are properly instructed as The committee is responsible for required. by §19.12 of 10 CFR Part 19.

1. Ensuring that all individuals who work with. 4. Review and approve all requests for use of or in the vicinity of radioactive material radioactive material within the institution.

have sufficient .training and experience to enable them, to perform their duties safely S. Prescribe special conditions that will be and in accordance with .NRC regulations required during a proposed use of radio- and the conditions of the license. active material such as requirements for bioassays, physical examinations of users.

2.. Ensuring that all use of radioactive mate- andspecial monitoring procedures.

rial is conducted in a safe manner and in accordance with NRC regulations and the 6. Review the entire radiation safety program conditions of the license. at least annually to determine that all ac- tivities are being conducted safely and in accordance with NRC regulations and the

'Duties conditions of the license. The review shall include an examination of all records.

The committee shall reports from the radiation safety officer.

results of NRC inspection, written safety I.. Be familiar with all pertinent NRC regula- procedures, and management control tions, the terms of the license, and infor- system.

mation submitted in support of the request for the license and its amendments. 7. Recommend remedial action to correct any deficiencies identified in the radiation safe-

2. Review the training and experience of any ty program.

individual who uses radioactive material (including physicians,. technologists, physi- 8. Maintain written records or all committee cists, and pharmacists) and determine that meetings, actions, recommendations, and the qualifications are sufficient to enable decisions.

them to perform their duties safely and in accordance :with NRC regulations and the 9. Ensure that the byproduct material license conditions of the license. is amended, when necessary, prior to any changes in facilities, equipment, policies.

3. .Establish a program to ensure that all indi- procedures, and personnel.

viduals whose duties may require them to

.work in the vicinity of radioactive material .Meeting Frequency The .medical isotopes committee shall meet as Alternative titles are "radioisotope" or "radiation safet-"

often as necessary to conduct its business but committee. not less than once in each calendar quarter.

10.8-19

. . . . .. . . . . . *

APPENDIX' C

INSTRUMENTATION

Survey meters a. Manufacturer's name:

Manufacturer's model number:

Number of instruments available:

Minimum range: rmr/hr to amr/hr Maximum range: mr/hr to rmr/hr b. Manufacturer's name:

Manufacturer's model number:

Number of instruments available:

Minimum range _mr/hr to mr/hr Maximum range mr/hr to mr/hr

2. Dose calibrator Manufacturer's name:

Manufacturer's model number:

Number of instruments available:

3. Diagnostic instruments Manufacturer's Type of Instrument Name Model No.

a

4. Other

10.8-21

APPENDIX D

CALIBRATION OF INSTRUMENTS"

Section I

METHODS FOR CALIBRATION OF (X- AND GAMMA-RAY) SURVEY METERS.

INCLUDING PROCEDURES. STANDARDS. AND FREQUENCY

A. Calibration of survey meters shall be I. Before each use and also after each performed with radionuclide sources. survey to ensure that the instrument was operational during the survey.

I. The sources shall be approximate point .2. After each maintenance and/or battery sources.

a change.

2. The source activities shall be traceable within 5% accuracy to the U.S. National 3'. At least quarterly.

Bureau of Standards (NBS) calibra- S

tions. If any reading with the same geometry is not within +/-20% of the reading

3. The frequency shall be at least annual- measured immediately after calibration, ly and after servicing. the instrument should be recalibrated (see item A).

4. Each scale of the instrument shall be calibrated at least at two points such that (a) one point is in each half of the C. The instrument must be calibrated at lower scale and (b) the two points are energies if its response is energy separated by 35-50% of full scale. dependent-and it is to be used to measure in the Xe-133 or Tc-99m energy ranges.

5. The exposure rate measured by the in- strument shall differ from the true This calibration may be done either exposure rate by less than 10% of full scale (read appropriate section of the I. As in item A above with calibrated instrument manual to determine how to standards of radionuclides at or near make necessary adjustments to bring the desired energies or instrument into calibration). Readings

'within +/-20% will be considered accept- 2. As a relative intercomparison with an

'able if a calibration chart or, graph is energy-independent, instrument and prepared and attached to the uncalibrated radionucides.

instrument.

Note:

D. Records of the above items A, B-2, B-3, Sources ,of"Cs-137, Ra-226, or.Co-60 are ap- ..and C:must be maintained.

propriate for use in calibrations. The activity of the, calibration standard should be sufficient to callbrate-the survey meters on all ranges, or at least up to I R/hr on the higher-range E. Use of Inverse Square Law and Radioactive instruments. If there are higher ranges, they Decay Law should at least be checked for operation and approximately correct response to radiation. 1. A calibrated source will have a calibra- tion certificate giving its output at a given distance measured on a specified B. A reference check source of long half-life, date by the manufacturer or NBS.

e.g., Cs-137 or Ra D and E, shall also be read.at the time of the above calibration. a'. The Inverse Square Law may be The readings shall be taken with the check used with any point source to source placed in specific geometry relative calculate the exposure rate at to the detector, A reading of this refer- other -distances.

ence check source should be taken:

b. The Radioactive Decay Law may be

'See ANSI N42.1.3. "Calbration and Usnle ofrDose Calibrator used to calculate the output at ionization Chambers for the Assay of Radionuclides.'Copite may other times after the specified be obtained from the A-yrltin National Standards Institute. date.

Inc.. 1430 Broadway, New York. New York 10018.

10.8-23

t units of

2. Inverse Squ.Lre Law Rt time. later. rate is:exposure S (Rl) (R 2 )

T and t are in the same: units (years, months, days, etc.)

P2 -T/ 2 is radionuclide half-life Expcsure rate at P2: t is number of units of time elapsed between calibration and present time

2 R 2 - (P 1 ) 2 (R 1) 4. Exaple: Source output is given by calibration certificate as 100 mR/hr at where 1 foot on March 10, 1975. Radionuclide half-life is 5.27 years.

S is the point source ft.

Question: What is the output at 3 feet on R, and R 2 are in the same units (mR/hr March YO, 1977 (2.0 years)?

or R/hr) a. Output at I foot, 2.0 years after P1 and P2 are in -the same units (cen- calibration date:

timeters, meters, feet, etc.)

(0.693 x 2.0)

R = 100 mR/hr x e.

3. Radioactive Decay Law

= 100 x 0.77 77 mR/hr at I foot Exposure rate t units of time after specified calibration date on March 10, 1977.

0.693 b. Output at 3 feet, 2.0 years after cal- R R 0 .xe Xt1 ibration date:

where foot) 2 (I feeet )2 x 77 R~ee~ -,~~(3.feet)2

' .. R : mR/hr

.. :

R. andR are in the units mR/hr or R/hr .x77 = 8.6 mR/hr at

0

is exposure rate on specified 3 feet, 2.0 years after calibration date calibration.

10.8-24

CALIBRATION OF SURVEY INSTRUMENTS

Check appropriate items.

1. Survey instruments will be calibrated at least annualy and following repair.

2. Calibration will be performed at two points on each scale.

The two points will be approximately 1/3 and 2/3 of full scale.

A survey instrument may be considered properly calibrated when the instrument readings are within +/-109 of the calculated or known values. for each point checke

d. Readings

Jwithin +/-20% are considered acceptable if a calibration chart or graph is prepared and attached to the ir strument,

3. Survey instruments will be calibrated a. By the manufacturer b. At the licensee's facility

(1) Calibration source Manufacturer's name Model no.

Activity in millicuries Accuracy Traceability to primary standard

, .__.(2) The calibration procedures in Section I of Appendix D

w be used or

(3) The step-by-step procedures, including radiation safety procedures, are attached.

c. By a consultant or, outside firm

(1) Name ,_"__

(2) Location

(3) Procedures and sourcon have been approved by NRC and are on file in License No.

are attached

10.8-25

APPENDIX D (Continued)

Section 2 METHODS FOR CALIBRATION OF DOSE CAUBRATOR

All radiopharmaceuticals must be assayed for I. Assay the Tc-99m vial in the dose cali- activity': to an -accuracy of 10%. The most brator and subtract background level common instrument for accomplishing this is an .. to obtain net activity in millicuries.

ionization-type dose calibrator., The instrument t, be checked. for accurate operation' at the must 2. Repeat. step I at time intervals of 6, time of installation and periodically thereafter. 24, 30, and 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months after the initial assay.

A. Test, for the following:

3. Using the. 30-hour activity measure-

1. Instrument linearity (at installation and ment:as a. starting point, calculate the quiprterly thereafter) predicted activities at 0, 6, 24, and 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months using the following table:

2. Geometrical variation (at installation)

Assay Time (hr) Correction Factor

3. Instrument accuracy (at installation and annually thereafter). 0 32

6 16

B. After repair or adjustment of the dose 24 2 calibrator, repeat all the.appropriate tests 30 1 listed above (dependent upon the nature of 48 0.125 the repairs)..

Exaple: If the net activity measured C. Daily or:-before each use of the instrument: at 0 ours was 15.625 mCi, the pre- dicted activity for 6 and 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months

1. Measure and record the activity of. at would be 15.625 mCi x 16 = 250 mCi least one reference source (e~g., 1-2 and 15.625 mCi x 0.125 = 1.95 mCi, mCi of Co-57). This check should be respectively.

repeated during the day whenever sample readings are not within 10% of 4. Plot the measured net activity for each the anticipated assay Variation time interval versus the predicted greater than 5% in this test will indi- activity on log-log graph paper.

cate the need for instrument repair, adjustment, or recalibration. 5. t5% activities The plotted should be within of the. predicted curve if the

2. Measure and record the apparent ac- 'instrument. is linear and.. functioning tivity. of. a long-lived standard radio- :, properly. .Errors greater than +/-5%

nuclide 'such- as Cs-137. or Ra-226 at all indicate the need for repair or adjust- the commonly used radionuclide, set- mentof the instrument.

tings (when the-unit was first, calibrat- ed against NBS-traceable standards). 6. If instrument linearity. cannot be cor- Choose a source with activity in the rected, it will be necessary in routine

100 VCi range. assays to either assay an aliquot of the a eluate that can be accurately measured D. Inspect the instrument on a quarterly basis or to use the graph constructed in to ascertain that the measurement chamber step 4 to relate measured activities to liner is in place and that instrument zero is true activities.

properly set (see manufacturer's instruc- tions). F. Test for Geometrical Variation E. Test of Instrument Linearity There may be significant geometrical varia- tion in activity measured as a function of The .linearity of a dose calibrator should be sample volume or configuration, depending ascertained over the entire rangc of activ- on the volume and size of the ionization ities employed. This test Will utilize a vial chamber used in the dose calibrator. The of Tc-99m whose activity is equivalent to extent of geometrical variation should be the. maximum anticipated activity to be ascertained for commonly used radionu- assayed (e.g., the first elution from a new clides and appropriate correction factors generator). computed if variations are significant,

10.8-26

i.e., greater, than +/-2% (even though An alternate to providing syringe cali- correction factors may be provided by the ;bration factors is to simply assay the manufacturer, the accuracy of these should stock vial before and after filling the be checked). syringe. The activity in the syringe is then the difference in the two readings To me.sure variation with volume of liquid., (with a volume correction if signif- a 30-cc vial containing 2 mCit.of Co-57 or icant).

other appropriate radionuclide in a volume of I ml will be used.

G. Test For Instrument Accuracy

1. Assay vial at the appropriate instru- ment setting and subtract background Check the accuracy of the dose calibrator level to obtain net activity. for several radionuclides such as Cs-137, Co-57, and Ba-133 using appropriate

2. Increase the volume of liquid in the reference standards whose activity is vial in steps to 2, 4, 8, 10, 20i and 25 traceable to NBS. The activity levels of the ml by adding the appropriate amount of reference sources used should approximate water or saline. After each addition, those levels normally encountered, giving gently shake vial to mix contents and .adequate, attention to source configuration.

assay as in step I. The lower-energy reference standards (Te-99m, .Xe-133, 1-125) must be in vials.

3. Select one volume as a standard (such with the same thickness- of glass as the as the volume of reference standard actual samples to be measured for best used in performing the test for instru- accuracy.

ment accuracy), and calculate the ratio of measured activities for each volume 1. Assay.. the reference standard in the to the reference volume activity. This dose calibrator at the appropriate represents the volume correction factor setting and subtract the background (CF). level to obtain the net activity.

Exam e: If activities of 2.04, 2.02, 2.' Repeat step I for a total of 3 determi- and 2.O mCi are measured for 4, 8, nations, and average results.

and 10 ml. volumes and 10 ml is the reference volume selected,9 . 3. The average activity determined in

~ ..step 2 should agree with the certified

'~~~ " """""""200 activity of the. reference source within

4 ml Volume CF = 0.98 +/-5% after decay corrections.

4. Plot the correction factors against the 4. Repeat the above steps for other volume on linear graph paper. Use this commonly used radionuclides for which graph to select the proper volume adequate reference standards are correction factors for routine assay of available.

that radionuclide.

5. Keep a log of these calibration checks.

S. The true activity of a sample is calcu- lated as follows: 6. Calibration checks that do nut agree within +/-5% indicate that the instrument True Activity = Measured Activity x should be repaired or adjusted. If this Correction Factor is not possible, a calibration factor should be calculated for use during

where the correction factor used is for routine assays of radionuclides.

the., same volume and geometrical con- figuration as the sample measured. 7. At. the same time the instrument is being initially calibrated vdiLh the NBS-

.4 6. Similarly, the same activity of Co-57 in traceable standards, place a long-lived a syringe may be compared .ith that of source in the calibrator, set the

10 .ml in a 30-cc vial and a correction instrument, in turn, at the various factor may be calculated. radionuclide. settings .used .(Cs-137, I-

131, Tc-99m, 1-125, etc.), and record

7. It should, be noted that differences of the readings. These values may later

200% in dose calibrator readings be used to check instrument calibration between glass and plastic syringes at each setting (after correcting for have been observed for lower-energy decay of the long-lived source) without radionuclides such as 1-125. -Hence, requiring more NBS-traceabl t stand- adequate correction factors must be ards. Keep a log of these initial and established for this type of syringe. subsequent readings.

10.8-27

H. Test for Instrument.Constancy S. Log the background levels.

Assay two reference sources such as Cs- 6. Indicate the predicted activity of each

137 -and Co-57 using a reproducible source based on decay calculations and geometry before each daily use of the the :t5% limits on the graph as illus- instrument trated.

1 Assay. each reference source using the 7. Repeat the procedure used for the Cs- appropriate instrument setting (i.e., 137 source for all the commonly used Cs-137 setting for Cs-137). radionuclide settings.

2.' Measure background level at same in- *8. Variations greater than .5% from the strument setting. predicted activity indicate the need for instrument repair or adjustment.

3. Calculate net activity of each source subtracting out background level.

9. Investigate higher than normal back- a

4. For each source, plot net activity ground levels to determine their origin versus the day of.the year on semi-log and to. eliminate them if possible by graph paper. decontamination, relocation, etc.

0

10.8'28

CALIBRATION OF DOSE CALIBRATOR

A. Sources Used for Linearity Test (Check as appropriate)

First elution from new Mo-S9/Tc-99m generator or

___ Other* (specify)

B. Sources Used for instrument Accuracy and Constancy Tests Activity Radionuclide (MCi) Accuracy a

Co-57 Ba-133 Cs-137 C. The procedures described in Section 2 of Appendix D will be used for calibration of the dose calibrator'

or Equivalent procedures are attached.

Must be equivalent to the highest activity used.

a

10.8-29

APPENDIX E

PROCEDURES FOR ORDERING AND RECEIVING RADIOACTIVE MATERIAL

1. The Chief Nuclear Medicine Technologist .packages directly to the Nuclear Medicine must place all orders for radioactive mate- Department.

rial and must ensure that the requested maierials and quantities are authorized by

the license and that possession limits are not exceeded. 3. During off-duty hours, security personnel must accept delivery of radioactive pack-

2.

During normal working hours, carriers ages in accordance with the procedures must be instructed to deliver radioactive outlined in the sample memorandum below.

SAMPLE MEMORANDUM

MEMORANDUM FOR: Security Personnel FROM: John Jones, Administrator SUBJECT: RECEIPT OF PACKAGES CONTAINING RADIOACTIVE

MATERIAL

Any packages containing radioactive material that arrive between 4:30 p.m.

and 7 a. m. oraon Sundays shall be signed for by the Security guard on duty and taken immediately to the Nuclear Medicine Department. Unlock the door, place the package on. top of the counter immediately to the right of the door, and relock the door.

If the package is wet or appears to be damaged, immediately contact the hospital Radiation Safety Officer. Ask the carrier to remain at the hospital until It can be determined that neither he nor the delivery vehicle. is con- taminated.

RADIATION SAFETY OFFICER:

OFFICE PHONE:

HOME PHONE:

10.8-31

RADIOACTIVE SHIPMENT RECEIPT REPORT

1. P.O. # Survey Date Time Surveyor

2. CONDITION OF PACKAGE:

O.K. _, Punctured _ _Status ___

et Crushed Other

3. RADIATION UNITS OF LABEL: Units (mRem/hr)

4. MEASURED RADIATION LEVELS:

a. Package surface mRem/hr b. 3 feet or I meter from surface mRem/hr

5. DO PACKING SLIP AND VIAL CONTENTS AGREE?

a.' Radionuclide yes _ no, difference b. Amount yes _ no,. 'difference c. Chem Form _ yes no, difference

6. WIPE RESULTS FROM:

a. Outer CPM DPM:

" eff=( )

b. Final source container CPM __= DPM

erff ( )

8. SURVEY RESULTS OF PACKING MATERIAL AND CARTONS mRem/hr, CPM

9. DISPOSITION OF PACKAGE AFTEi" INSPECTION

10. IF NRC/CARRIER NOTIFICATION REQUIRED, GIVE TIME, DATE, AND PERSONS

NOTIFIED.

Signature Date

10.8-32

: ....

"" ;-,;,i' ',.'"3

4:r"u/

.p{ APPENDIX- iF;

PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING

RADIOACTIVE MATERIAL

F:.

., S J.. ..Visually. inspect package for any, sign of damage. (e.g.:, wetness, crushed). :If damage is noted,.stop procedure and notify Radiation Safety Officer..

loss of liquid,, discoloration of packaging material). Check also that shipment does not exceed possession limits.

6. Wipe external surface of final source

2.":isure:'

. exposure rate at 3- feet '.'from' container with moistened cotton swab or package surface and .record. If >10 mR/hr. filter paper held with forceps- assay and

--"-. Ostop

!,: .".. procedure fficer.. .. ..and notify

... "Radiation

....; v . Safety

- :. .. . record.

Mo.onitor the packing material and packages

3. Measure surface exposure rate and record. for..contamination before discarding.

If'i>200 mR/hr,. stop proeedure and notify

.Radiation Safety Officer:*. a. If contaminated., treat as radioactive waste.

.. Put on.gloves-. b. If not. contaminated, obliterate radia- tion labels before discarding in regular

5.. - Open.,the outer, package - (following manu-. trash.

facturer's directions,. if supplied). and remove packing slip. Open inner package. In all the above procedures, take wipe to verify contents (compare requisition.' tests with a paper towel, check wipes with a packing. slip, and label ,on bottle), and thin-end-window G-M survey meter, and take check integrity of final source container precaution against the spread of contamination

.. : (inspecting for breakage of seals or vials., as necessary..

10.8-33

APPENDIX G

.GENERAL RULES FOR THE SAFE USE OF RADIOACTIVE MATERIAL

.7; Weir , personnel monitoring devices (film

1.'Wear laboratory coats or other protective clothing at all. Limesin areas where radio- badgec or.-TLDI .! all times while in areas active materials are used.'. where radioacive materials are used or stored. These devices should be worn at

2; Wear disposable gloves at all times while chest or waist level.

handling radioactive materials.

8. Wear TLD finger badges during elution of

3. Monitor hands and clothing for contamina- generator and preparation, assay, and tion after each procedure or before leaving injection of radiopharmaceuticals.

the area. 9. Dispose of radioactive waste only in specially designated receptacles.

4. Use syringe shields for preparation of patient doses and administration to patients 10. Never pipette by mouth.

except in circumstances such as pediatric cases when their use would compromise the 11. Survey, generator, kit preparation. and patient's well-being. injection areas for contamination after each procedure or at the end of the day.

Decontaminate if necessary.

5. Do not eat, cosmetics drink, smoke, or apply in any area where radioactive 12. Confine radioactive solutions in covered material is stored or used. containers plainly identified and labeled with name of compound, radionuclide, date, activity, and radiation level, if

6. Assay each. patient' dose in the dose cali- applicable.

brator prior :to administration. Do not use any doses that .differ from the prescribed .13. Always transport radioactive material in

. doseby, more"thn 10%. shielding containers.

10.8-35

. . . . ,.

APPENDIX H

.EMERGENCY PROCEDURES

M:inor Spills personnel potentially contaminated to

prevent the spread.

1. NOTIFY: Notify persons in the area that a spill has occurred. 3. SHIELD THE SOURCE: if possible, the spill should be shielded, but only if it can

2. PREVENT THE SPREAD: Cover the spill be done without further contamination or with absorbent paper. without significantly increasing your radiation exposure.

3. CLEAN UP: Use disposable gloves and remote handling tongs. Carefully fold the 4. CLOSE THE ROOM: Leave the room and absorbent- paper and pad. Insert into a lock. the door(s) to prevent entry.

plastic bag and dispose of in the

radioactive waste container, Also insert 5. CALL FOR HELP: Notify the Radiation into the plastic~bag all other contaminated .Safety Officer immediately.

materials such as disposable gloves.

6. PERSONNEL DECONTAMI NATION: Contam-

4. SURVEY: With .a low-range, thin-window inated -Clothing ,should be. removed -and G-M- survey meter, check the area around stored for further evaluation by the the spill, hands, and clothing for contami- Radiation Safety Officer. If the spill is on nation. the skin, flush thoroughly and then wash with mild soap and lukewarm water.

5. REPORT: Report incident to the Radiation Safety Officer. RADIATION SAFETY OFFICER:

OFFICE PHONE:

Major Spills HOME PHONE:

1. CLEAR THE AREA: Notify all persons not involved in the spill to vacate the room. ALTERNATE NAMES AND TELEPHONE

NUMBERS DESIGNATED BY RSO.

2. PREVENT THE SPREAD: Cover the spill with absorbent pads, but do not attempt to clean it up. Confine the movement of all

10.8-37

APPENDIX 4 AREA SURVEY PROCEDURES.

1. All elution, preparation, and injection a. Location, date. and type or equipment areas will be surveyed daily with a low- used.

range thin-window G-M survey meter and decontaminated if necessary. b. Name of person conducting the survey.

2. Laboratory areas where only small quanti- c. Drawing of area surveyed, identifying ties of radioactive material are used (less relevant features such as active than 100 pCi) will be surveyed monthly. storage areas, active-waste areas. etc.

4 3. All other laboratory areas will be surveyed d. Measured exposure rates, keyed to weekly. location on the drawing (point out rates that require corrective action).

4. The weekly and monthly survey will consist of: e. Detected contamination levels, keyed to locations on drawing.

a. A measurement of radiation levels with f. Corrective action taken in the case of a survey meter sufficiently sensitive to contamination or excessive exposure detect 0.1 rRecm/hr. rates, reduced contamination levels or exposure rates after corrective action, and any appropriate comments.

b. A series of wipe tests to measure con- 6. Area will be cleaned if the contamination tamination levels. The method for performing wipe tests will be suffi- level exceeds 100 dpm/100 cm2 .

ciently sensitive to detect 100 dpm per

100 cm2 for the contaminant involved. Note:

For daily surveys where no abnormal expo-

5. A permanent record will be kept of all sures are found, only the date, the identifica- survey results, including negative results. tion of the person performing the survey, and The record will include: the survey reports will be recorded.

10.8-39.

APPENDIX J

WASTE DISPOSAL

I. Liquid waste will be disposed of (check as Disposed of by commercial waste dis- appropriate) posal service (see also item 4 below).

By commercial waste disposal service Other (specify): "

(see also item 4 below).

In the sanitary sewer system in 3. Other solid waste will be (check as appro- accordance with §20.303 of 10 CFR priate)

Part 20.

teld for decay until radiation levels, Other (specify): as measured with a low-level survey meter and with all shielding removed, have reached background levels. AUl radiation labels will be removed or

2. Mo-99/Tc-99m generators will be (check as obliterated and the waste will be appropriate) disposed of in normal trash.

Returned to the manufacturLr for Disposed of by commercial waste dis- disposal. posal service (see also item 4 below).

Held for decay until radiation levels, Other (specify):

as: measured :with a low-level survey meter and with all shielding removed, have reached background levels. AU 4. The commercial waste disposal service used radiation labels will be removed or ob- will be literated and the generators disposed of as normal trash. (Note: This method of disposal may not be practical for (Name) (City, State)

generators containing long-lived radioactive contaminants. ) NRC/Agreement State License No.

10.8-41"

APPENDIX K

THERAPEUTIC USE OF RADIOPHARMACEUTICALS

I. All patients treated with iodine-131 or designee. Items may be returned for gold-198 wil -be placed in a private room normal use, held for decay. or decon- with a toilet. The room and toilet areas taminated, as appropriate.

more likely to be contaminated will be covered with protective material as appro- 9. Urine and vom-itus from iodine-131 therapy priate to the amounts of contamination to patients will be stored ror decay in the ra- be expected. Particular attention should be dioactive waste storage area. When it has given to objects likely to be touched by the reached background levels, as measured patient, e.g., telephones, doorknobs, and with a low-level survey meter. it may be other items that would be difficult to released to the sanitary sewer system.

decontaminate.

10, Before a therapy patient's room is re-

2. The patient's room will be properly posted assigned to another patient, the room will in accordance with §20.203 of 10 CFR be surveyed for contamination and decon- Part 20. taminated if necessary, and all radioactive waste and waste containers will be

3. Surveys of the patient's room and sur- removed.

rounding areas will be conducted as soon as practicable after administration of the 11. Nursing Instructions treatment dose. Exposure rates will- be measured at the patient's bedside, 3 feet a. Nurses should spend only that amount (or. I meter) away, and at the entrance to of time near the patient required for the room. The Radiation Safety Officer or ordinary nursing care. Special restric- his designee will then determine how long a tions may be noted on the precaution person may remain at these positions and sheet on the patient's chart., Nurses will post these times on the patient's chart should read these restrictions before and on his door. The results of daily administering to the patients. Call the surveys will be used to recalculate Nuclear Medicine Department with any permitted times, which will be posted on questions about the care of these the patient's chart and on his door. patients.

.4. The form, Nursing Instructions for Pa- b. Visitors will be limited to those 18 tients Treated with Phosphorus-32, Gold- years of age or over unless other in-

198, or Iodine-131, will be completed imme- structions are noted on the precaution diately after, administration of the treat- sheet on the patient's chart.

r'ent. dose. A copy will be posted on the patient's chart. c. Patients must remain in bed while visitors are in the room and visitors S. Radiation levels in unrestricted areas will should remain at least 3 feet from the be maintained .less than the limits specified patient.

inparagraph 20.105(b) of 10 CFR Part 20.

d. Patients containing radioactive mate-

.6. AIl linens, will be surveyed for contamina- rials are to be confined to their rooms tion before being removed from the except for special medical or nursing patient's room and, if necessary, will be purposes approved by the Nuclear held for decay. Medicine Department.

7. Disposable plates, cups, eating utensils, e. No nurse, visitor, or attendant who is

tissue, surgical dressings, and other pregnant should be permitted in the similar waste"items, will be placed in a room of a patient who has received a Specially designated -container. The mate- therapeutic amount of radioactivity rial will Sbe collected daily by the Radiation until the patient no longer presents a Safety Officer or his designee, checked:for radiation hazard. Female visitors eontamination', and:'disposed of as normal should be asked whether they are or radioactive waste, as appropriate. pregnant.

B. Nondisposable Items used for these patients f. Attending personnel should wear will be held in plastic bags in the patient's rubber or disposable plastic gloves room and will be checked for contamination when handling urinals, bedpans, A_ ,

_ by the Radiation Safety Officer or his enesis basins, or other containers

10.8-43

having any material obtained from the container for disposal by the body .of the patient. Wash gloves Radiation Safety Officer or his before removing and then wash hands.. . designee.

The gjoves should. be' left in the patient's' room' in the designatedwaste (3) Disposable plates, cups, and container.;. These gloves need not be eating. utensils will be used by pa- L."...: sterile:or surgical in type. tients who are treated with iodine-

131, . . .

g. Disposable Items should be used in the care 'of these patients, whenever (4) Vomiting within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after oral possible.. These 'items should be placed administration. urinary inconti- in the designated waste container. nence, or excessive sweating with-.

Contact the Radiation Safety Officer or in the first 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months may result in his designee for proper disposal of the contamination of linen and floor. In contents. of the .designated waste any such situations or .if radio- container. active urine and/or feces is spilled during collection, call the Radia- h. All clothes and bed -linens used by the *tion Safety 'Officer or his desig- patient should be placed in the laundry nee, Ext. Meanwhile, M.

bag provided and should" be left in the handle all contaminated material patient's, room to be checked by the with.. disposable gloves and avoid Radiation -Safety . officer: or his spreading contamination.

designee.

(5) AU. vomitus must .also. be kept in i. 'All'. nondisposable items should be the patient's room for disposal by

placed in a plastic .bag and should be the Radiation Safety Officer or his left in the patient's room to be checked designee. Feces need, not be S" by the Radiation Safety Officer or his :routinely saved, unless ordered on S" designee.. the chart. The same toilet should be used by the patient at all times j. Surgical dressings should be changed and it should be well flushed (3 only as directed by the physician. times).

Gold-198 lbaking from a puncture wound will. stain the dressings dark I, Utmost precautions must be taken to red: or purple. Such dressings should. .see that no urine or vomitus is spilled not. be discarded ,but should be on the floor or the bed. If any part of collected in plastic bags and turned the patient's room is suspected to be over to the"Radiation Safety Officer or contaminated, notify the Radiation his designee. Handle these. dressings. Safety Officer or his designee.

only with tongs or.. tweezers. Wear disposable gloves.. i. :If a nursei. attendant, or anyone else knows or. suspects. that his or her skin.

k For iodine-131 patients.. o...Or

.clothingiincluding shoes, is con-.

taminated.,, notify the Radiation Safety

.() Urine from iodlne-131 patients will. -Officer- or his designee immediately.

be collected in special containers This. person.: should remain in an area provided by the Radlation. Safety adjacent to .the patient's room and Officer or his designee. The pa- should not walk about the hospital. If tient should be encouraged to the hands become contaminated, wash collect his own urine in the con- them immediately with soap and water.

tainer. If the patient is bedridden, a separate urinal or bed pan should be provided. The urinal or n. If a therapy patient should need emer- bed..pan should be flushed several gency surgery or should die, notify times .with hot soapy water after the Radiation Safety 'Officer or the Nu- use. clear Medicine Department immediately.

(2).-If. the nurse helps to collect the.

excreta, disposable :gloves should: o.. When the patient is -discharged, call

"be worn. Afterwards, hands should the :Radiation 'Safet

y. Officer or his

'be washed with the gloves on and designee or the Nuclear Medicine again after the gloves are Department, and request that the room removed. The gloves should be' be surveyed for contamination before placed in the designated waste remaking the room.

10.8-44

Date.:

NURSING INSTRUCTIONS FOR PATIENTS TREATED WITH

PHOSPHORUS-32, GOLD.198, OR IODINE-131 Patient's Name:

Room No.: Physician's Name:

Radioisotope Administered:

Date and Time of Administration:

Dose Received: Method of Administration:

Exposure Rates in mRem/hr Date 3 feet from bed 10 feet from bed (Comply with all checked items.)

I. Visiting time permitted:

2. Visitors must remain from patient.

3. Patient may not leave room.

4. Visitors under 18 are not permitted.

5. Pregnant visitors are not permitted.

6. Film badges must be worn.

7. Tag the following objects and fill out the Lag:

door bed chart wrist

8. Gloves must be worn while attending patient.

9. Patient must use disposable utensils.

10. All items must remain in room until approved by the Radiation Safety Officer or his designee.

II. Smoking is not permitted.

12. Room is not to be released -to Admitting Office until approved by the Radiation

.0.Safety. Officer, or his designee.

13. Other instructions.

In case of an emergency contact:

RSO

Name On-duty/Off-duty Telephone Nos.

10.8-45

APPENDIX L

THERAPEUTIC USE OR SEALED SOURCES

1. All patients treated with brachythcrapy .. Nurses should spend only the minimum sources will be placed in a private room time netessary near a patient for with toilet. routine nursing care. Obtain and wear a filmbadge.

2. The patient's room will be properly pusted in accordance with §20.203 of 10 CFR c. When :a nurse 'eceives an assignment Part .20. to a therapy patient. a film or TIy)

badge should be obtained immediately

3. Surveys of the paticnt's room and from the Radiation safety Officer or surrounding areas will be conducted as his designee. Tht badge shall be worn soon as practicable after sources are only by th,. nurse to whom it is issued implanted. Exposure rate measurements will and sha;ll not be exci2* nged between be taken at the patient's bedside. 3 feet (or 1 meter) from the patient. 3 feet (or I

meter) from the bed. and at the entrance d. l'regnant nurses should not be as- to the room. The Radiation Safety Officer signed to the personal care of these or his designee will then determine how patients.

long a person may remain at these positions and will post these times and the exposure e. Never touch needles. capsules. or con- rate at 3 feet (or 1 meter) from the patient tainers. holding brachytherapy sources.

on the patient's chart. If a source becomes dislodged, use long forceps and put it in the corner

.1. Immediately after sources are implanted. of the room or in the shielded coat- the form "Nursing Instructions for Patients tainer . provided: contact Radiation Treated with Brachytherapy Sources" will Therapy, the Radiation Safety Officer.

be completed and placed on the patient's or the Nuclear Medicine Department at chart. once.

5. Radiation levels in unrestricted areas will f. [ed bath given by the nurse should be be maintained less than the limits specified omitted while the sources are in place.

in paragraph 20.105(b) of 10 CFR Part 20.

g. Perineal care is not given during

6. Nurses caring for brachytherapy patients gynecologic treatment; the perineal will be assigned film badges. TLD finger pad may be changed when necessary badges will also be assigned to nurses who unless orders to the contrary have must provide extended personal care to the been written.

patient.

h. Surgical dressings and bandages used

7. At the conclusion of treatment, a survey to cover the area of needle insertion will be performed to ensure that all source: may be changed only by the attending have been removed from the patient and physician or radiologist, and MAY NOT

that no sources remain in the patient's BE DISCARDED until directed by the room or any other area occupied' by the radiologist. Dressings should be kept patient. At the same time, all radiation in a basin until checked by the Radia- signs will be removed and all film and TLD tion Safety Officer or his designee.

badges assigned to nurses will be collected. Special orders will be written for oral hygiene for patients with oral implants.

8. Instructions to Nurses i. No special precautions are needed for sputum, urine, vomitus, stools, dishes, a. Special restrictions may be noted on instruments, or. utensils unless specifi- the precaution sheet on the patient's cally ordered, but these items should chart. Nurses should read these in- be saved for a check with a radiation structions before administering to the survey meter to ensure that no sources patient. Call the Radiation Safety have been inadvertently displaced into Office or his designee with any ques- these items.

tions about the care of these patients in regard to radiation safety j. All bed linens must be checked with a precautions. radiation survey meter before being

10.8-47

removed from the patient's room. to of a patient while brachytherapy sources ensure that no dislodged sources are are implanted in the patient. Female inadvertently removed. visitors should be asked whether they are pregnant.

k. These patients must stay in bed unless o. Emergency Procedures orders to the contrary are written. In any event, patients will remain in their (I) If an implanted source become.;

assigned rooms during the treatment loose or separated from the pia- period. tient, or

1. Visitors will be limited to those 18 (2) If the patient dies, or years of age or over, unless other in- structions are noted on the precaution (3) If the patient requires emergeney sheet on the patient's chart. surgery, immediately: call m. Visitors should sit at least 3 feet (or I Telephone No. (days)

meter) from the patient and should (nights)

remain no longer than the time specified on the form posted on the p. At the conclusion of treatment. call the patient's door and on his chart. Radiation Safety Officer to (1) survey the patient and room ind (L) count thl:

radiation, sources to be sure that all n. No nurse, visitor, or attendant who is temporary implants have been removed pregnant should be permitted in the room prior to discharging the patienL.

10.8-48

. . . .

NURSING INSTRUCTIONS FOR PATIENTS TREATED

WITH BRACHYTHERAPY SOURCES

Patient's Name:

Room Number: Physician's Name:

IF, Isotope Activity:

Date and Time of Administration:

Date and Time Sources Are To Be Removed: Isotope:

Exposure Rates in mR/hr Bedside 3 feet from bed 10 feet from bed (Comply with all checked items.)

Wear film badge.

2.

Wear rubber gloves.

Place laundry in linen bag and save.

4. Housekeeping may not enter the room.

___5. Patient may not have visitors.

8. Patient may not have pregnant visitors.

7. Patient may not have visitors under 18 years of age.

8. A dismissal survey must be performed before patient is discharged.

Patient must have a private room.

10. Other instructions.

0

RSO

Name On-duty/Off-duty/Telephone Numbers

10.8-49

APPENDIX M

PROCEDURES AND PRECAUTIONS FOR USE OF RADIOACTIVE GASES

(e.g., XENON-133) .1.

The following information should be submitted 4. Emergency Procedures in support of requests to use xenon-133:

Describe the emergenicy procedures to be

1. Quantities to be used used in case of an accidental release of xenon-133. This should include such con- a. Patient information siderations as tempormry evacuation of the area *,r increasing the ventilation of the

(1) Number of studies expected per area.

week

5. Air Concentrations of Xenon-133 in Re-

(2) Average activity per patient stricted Areas b. State the desired.possession limit. This No licensee shall permit any individual in a should be sufficient to provide for restricted area to inhale a quantity of shipments whose calibration dates are radioactive material in any period of one several days after receipt. calendar quarter greater than the quantity that would result from inhalation for 40

2. Use and Storage Areas hours per week for 13 weeks at uniform concentrations of radioactive material of a. Describe the area(s) in which you plan I x i0-5 pCi/ml.

to use and store xenon-133. Include a diagram indicating the availability of You may evaluate your situation by making shielding materials and the proximity actual measurements of xenon-133 concen- to unrestricted areas. trations or by means of calculations. If you choose the .latter approach, you may make b. Describe the ventilation in all areas simplifying assumptions, PROVIDING they where xenon-133 is used and stored. are reasonable, conservative, and stated The location of supply and exhaust explicitly in your request.

vents, the measured airflow rates for each vent, and the fraction of air that In actual use and storage, some xenon-.133 is recirculated by the system should be will be released into the room from the indicated. storage and administration devices. ire- breathing apparatus, collection systems.

c. All areas where xenon is used should and escape from the patient. All sources of be under negative pressure. State how loss must be considered when esthnating you will ensure that all airflow rates the fraction of xenon-133 that is lost.

are maintained as specified in this iapplication. The following procedures may be used to calculate the air concentration of xenon-133

3, Procedures for Routine Use in restricted areas:

. '

a. Describe the procedures to be followed a. Estimate the maximum amount of activ- for routine use of xenon-133, giving ity to be used -per week (A).

particular. attention to radiological safety factors. b. Estimate the fraction of xenon-133 that a is lost during use and storage (f).

b. If you plan to use a special apparatus This fractional loss must include ALL

for administration and collection of sources of loss, e.g., during patient xenon-133, specify the manufacturer's administration, storage, and disposal.

name and model number and include a description of its design 'character- c. Determine the measured airflow rate in istics. (Inclusion of a brochure:would the area(s) of interest, and calculale be helpful.) the volume of air available per week for dilution of the xenon-.133 (V).

d. For restricted areas, §20.103 of c. Describe any special procedures that i0 CFR Part 20 requires that you plan to temploy .to reduce leakage, e.g., use or nose clamps or special A xf < I x I0'ý pCi/ml.

enclosure

s. V

10.8-51

I _______________________

e.:,Sample Problem" Maximum Xenon- 133 A nuclear medicine laboratory plans to Ventilation Released per use 10 mCi xenon-133 per patient and Rate 40-Hour Week will perform a maximum of 10 studies (ft 3 /min) .(mCi)

per week. What ventilation rate is required to ensure compliance with 100 67.9

§20.103 of 10 CFR Part 20? 500 339.7

1,000 679.4 Maximum activity used per week 6. Methods of Xenon-133 Disposal A 10 mCi 10 patients a. Dilution through Exhaust Systems (less pAti= en week -

desirable).

m ii One method for disposal of xenon-133 is by release to the atmosphere

1,=x. 105s ~I through an air exhaust system. Li- censees are required to perform sur- veys (measurements or calculations) to Assume a loss rate of 20% (M) ensure that they are in compliance with paragraph 20.1(c) and §20.106 of Ax f 10 CFR Part 20. Paragraph 20.1(c)

V. requires that the concentrations of I x 105 pCi/ml xenon-133 in effluents to unrestricted areas be as low as is reasonably L .x .105 pCi/week x 0.20 achievable by the current state of lx 10-5 pCi/ml technology, and §20.106 -requires that the concentrations, averaged over a

2.0Ox r09 ml/week. period of I year, shall not exceed 3 x

107 lCi/ml, The required ventilation rate is Many facilities do not have sufficient

2.0 x I10 ml/week airflow to achieve the necessary

40 hr/week dilution. The following procedure may be used to estimate the concentrations

1.7 x 106 ml/hr of xenon-133 in effluents to unrestrict- ftimin 30 fta/min ed areas.

The answer shows that, in order to M()Estimate the maximum amount of meet the requirements of §20.103 of xenon-133 to be released per year

10 CFR Part 20, the imaging room (A). This should include all antic- (RESTRICTED AREA) must have a ipated losses during administra- ventilation rate of at least 30 frt3 /min tion, storage, and disposal.

with no recirculati-'n *F air. Where practical, the ventilation rate should (2) Determine the flow rate of the be greater than that shown necessary exhaust system, and describe. the by the calculations. Consider every methods and equipment used for alternative in order to maintain the air measuring the airflow rates.

concentration of xenon-133 as low as reasonably achievable in accordance (3) Calculate the airflow per year (V).

with, paragraph 20.1(c) of 10 CFR

Part 20. (4) Calculate the average concentra- tions for unrestricted areas. Sec- If the ventilation rate is inadequate to tion 20.106 of 10 CFR Part 20

meet the requirements of §20.103 of requires that

10 CFR Part 20, consider methods of increasing ventilation or reducing the C =A < 3 x 10-7 pCi/ml.

patient load. .V L-

The following table gives the amount of (5) Sample Problem xenon-133 that can be released per week without exceeding the permissible A nuclear medicine laboratory levels for xenon- 133 in restricted areas. plans to use 10 mCi per patient

10.8-52

and will perform a maximum of 10 that xenon-133 is tral !'.-. .nto charcoal studies per week. A fume hood is or other adsorbing w- Filters con- available for disposal of xenon-133 taining xenon-133 are Uwen stored for and has a measured airflow of 168 decay.

ft/min with an opening of 8 ft 2 .

What is the average concentration One difficulty with this approach is that of xenon-133 at the point of re- charcoal is not 100'1 efficient for trapping lease from the fume hood exhaust? xenon-l33. If this is your method of dis- (NOTE: All xenon that has been posal, you should consider the following released, e.g., collection bags, points.

filters, must be considered.)

(l) Describe how you will handle the

.x problem of leakage from such trap- A = 10 patients 10 mCi 103 C*

ping devices. If the exhaust is week x iaE1int m6_31 1 vented to the outdoors (UNRE-

52 weeks STRICTED AREA). show that air yr concentrations of xenon-133, aver- aged over I year, do not exceed 3 x A = 5.2 x 10G pCi/yr 10-7 pCi/ml. (See example in item

6.a.)

V = 168 Q x 8 ft 2 x 1.49 min (2) Describe how you will ensure that x I010 1-t-lmin collection and trapping devices are performing according to specifica- tions, both initially and on a con- V = 13,14f x 1.49 x 10 10 mI/yr tinuing basis. Include in your min (7-/min description how you will monitor traps to determine when saturation V = 2.01 x I013 ml/yr occurs and filter must be replaced.

5.2 x 106 1iiU

2.01 x I0 m/yr (3) Describe your procedures for handling saturated filters. Your dis- C = 2.6 x I0-7 pCi/ml cussion should include a description of the area (a diagram would be useful), available shielding, proxim- The following table gives the amount of ity to restricted areas, ventilation, xenon-133 that can be released .per week and an evaluation of average concen- without exceeding an average concentra- trations of xenon-133 in air. (See tion of 3 x I0-7 pCi/ml. example in item 5.c.)

Average Release of Exhaust rate Xenon-133 per Week (ft 3 /min) (mCi) USEFUL CONVERSIONS

100 8.6 = I03 pCi

500 42.8 1 mCi

1,000 85.6 I ft0 = 2.832 x 10-2 m3 = 2.832 x 104 ml

1,500 128.4

1 ft 3 /min = 1.699 x 100 mlfhr

.0

If the exhaust is released to a restricted area, e.g., a roof to which access is = 6.797 x I01 ml/40-hr week controlled, or from a tall stack, Sutton's equation (Refs. 1 and 2) may be used to = 1.484 x 1010 mi/yr calculate the concentrations at the nearest unrestricted area. If this ap- 1 week = 168 hr proach is used, describe the location of the exhaust system outlet, including proximity to unrestricted areas, air intakes, and open windows. Methods for REFERENCES

controlling access to the area where the exhaust is located should also be described. I. Blatz, Hanson, Radiation Hygiene Hand- book, McGraw-Hil (NiewYork, 1959), pp.

b. Adsorption onto Charcoal Traps

2. Cember, Herman, Introduction to Health This is the disposal method of choice. Ph s', Pergamon Press (NeW or

1969) Wp. 334-9.

The advantage of this disposalmethod is

10.8-53

l APPENDIX N'

GUIDANCE ON REQUESTS FOR LICENSE

AMENDMENTS AND LICENSE TERMINATIONS

1. License Amendment Requests dix A to this guide, and year of certification; or

a. To add a new user

(3) Give information requested in Sec- (I) Give NRC license number (with tion :3 of Appendix A to this guide specific references as' indicated in (i.e., 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months training in basic Item 6 of :this guide) under which radioisotope handling techniques the person was previously listed as and clinical experience as de- a user, if applicable: or scribed in Section 3 of Appen- dix A).

(2) Give.Agreement State license num- ber (.preferahly including a copy d. To add a user for Group VI*

of the license.), if applicable; or

(1) Give NIBC license number (with

(3) Send letter of. request. attaching specific references as indicated in Supplements A and/or. B. (see Item G of this guide) under which

-Item8 of this guide) if new user the person was previously listed as has.not been previously approved a user, if applicable; or fo r;this type of license.

(2) Give evidence of certification by b. To add a user for Groups 1-111* the American, Board of Radiology in Radiology. or Therapeutic Radiolo-

(1) Give NRC license, number (with gy. or other applicable certifica- specific references as indicated in tions in radiation oncology as Item 6 of this guide.) under which specified in Section '1 of Appen- the person was previously listed as dix A to this guide; or

.a user, if applicable. or

(3) Give evidence of three years active

(2) Give evidence of certification by experience in therapeutic radiology the American Board of Nuclear (see Section 4 of Appendix A to Medicine, or other certifications as this guide).

specified in Section 4 of Appen- dix A :to this guide, and year of, -e. To'add Group Ill certification; or The following specific informationshould

(3) Give information requested in See-: be referenced to the previous applica- tion 1 of Appendix A (i.e., 200 .tion or should be given specialatten- hours training in basic radio- tion if it has not been previously sub- isotope handling techniques. mitted:

500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months tiPzining and cxperience in handling the types and (I) Calibration frequency, procedures,

.quantities of material requested; and standards for high-level sur- and 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months clinical experience). vey meter capable of reading up to I R/hr.

c. 'F,,. add a user for Groups IV-V*

(2) Room diagram showing location of

0() Give NRC license number (with generator, kit preparation, patient specific references as indicated in dose.preparation areas, etc., with Item. 6 of this guide) under. which special attention paid to shielding.

the person was previously listed as a user, if appLicable; or (3) Use of syringe shields.

(2) Give evidence of certification by (4) Method for assaying patient doses the American Board of Nuclear prior to administration.

Medicine, or other certifications as specified in Section 4 of Appen- (5) Use of ring badges for personnel who elute generators, prepare ra- diopharmaceuticals from reagent

@See 35. 100 of t0 CFR Part 35. kits, and prepare patient doses.

10.8-55

(6) Daily survey of areas used* for (2) Procedures for handling scaled

-generator elution, preparation of sources.

radiopharmaceutlcals from reagent kits', and preparation of patient (3) Instructions for nurses.

doses,

(4) Use of ring badges by personnel

(7) Rules. for personnel who elute gen- handling sealed saurces.

erators or prepare radjopharma- ceuticals from reagent kits to (5) Procedures for transporting sourc&es monitor hands and clothing after from storage area to are;, of use each procedure or before leaving and return.

these areas.

(6) Inventory procedures to enbure f; To add Groups IV and V* that all sources are accounted for after treatment.

The following specific information should be referenced to the previous applica- (7) Survey procedures. Dismissal sur- Lion or should be given special attea- vey, including radiation survey of Lion if it has not been previously sub- patient and room after removal of mitted:. sources, must ensure that all permanent sources are removud

(1) Itoom assignment. from patient and from those areas the patient occupied.

(2) Instructions to nurses.

h. To add xenon-133

(3) Procedures for handling contami- nated linen and other contaminated (I) Follow xenon-133 licensing guid- items. ance carefully (see:t ApJpendix . to this guido).

(4) Use of disposable items, primarily for iodine-131 patients. (2) Other concerns not. expresst:d sp- cifically in guidance.

(5) Survey procedures, including dis- nmissal survey. (a) Area in which xenon-133 is used and stored should In-

(6) Procedures for preparing oral under negative pressure.

iodine-131 doses, including proce- dures for controlling and monitor- (b) Air in these areas should not ing airborne iodine-131 and thy- be recirculated.

roid uptake by personnel.**

(W) All losses of xenon-133 to g. To add Group Vl*** restricted area should also be aassumed to go to unrestricted The following specific information should areas. Concentrations in unre- be referenced to the previous applica- stricted areas must not exceed Lion or should be'given special atten- levels specified in q20. 106.

tion':lf it has not been previously sub- mitted: i. To move Nuclear Medicine Department

(1).Diagramn of storage area with spe- (1) Provide diagram of new areas (see Cial attcntion paid to shielding and Item 11.of this guide).

security.

(2) Provide survey showing all pre- viously occupied areas are free of contamination and all sources have been remove

d. A decontamination

Addliaorjl guidance on planning an acceptable radiation guide is available from the License safety prmgram for.tese uses is provided in NCRP Report 37. Management Branch. t

'Precautions in theMansagement of Patients %Ut Mave Received Therapeutic Amounts or Radlionuclides;" Regulatory Guide 8.18.

"Information Relevant to EnsuringThat Occupational Radiation j. To terminate a License Exposures at Hedlcal'Institutions WLZI Be As low As Reasonebly Achievableo. and NUREG-0267, "Principles and Practices for

.Keeping ,Occupational ftadiation . Exposures at MedicAl a.. Submit a signed Form NRC-314 Institutions As Low A, Reasonably Achievable." indicating the disposition of the

S. eg.

Reguatwry Guide 8.20. "Applications of Bioassay for I- radioactive material.

125 and 1-131.*

G u=ldance on facility, equipment, and procedures for tA regulatory guide on radiation safety surmeys at medical

0

breebythenpy is provided in Reguhtwry Guide 8.18 and in

UREG-02S7. lnastltutians is now under development.

10.8-56

b. 8ubmit survey, showing. ll: pre- turer-sponsored IND. This use is viously occupied areas are !rte of already covered in §35. 100 of 10 CFIl contamination and all sources .havte Part 35, ptrovided thu licensee obtains been removed. ithe radio~pharmnaccutical frum a corn- pany authorized by NRC or an Agree- ment State to distribute the radioactive

2. Actions Nor Requiring Amendnntis drgti to NRC's group medical licenseces.

a. To add naturaUy occurring or accel- c. To add scaled sourctes of less than crator-produced radionuclides (e.g., 3 mCi for calibration or reference pur- radium-226, cobalt-57, gallium-67, poses. These sources arc authorieud thallium-201). NRC has no authority by 435.14(d) provided the licensee over these materials. obtains them from a company autlo- rized by NRC or -n Agreement' Slate to b. To add use of particular radiophanma- distribute them to NRC's group medical coutical for participation in manufac- licensees.

10.8-57

EXHIBIT A

FORM NRC-313M U.S. NUCLEAR REGULATORY COMMISSION

(0-..) APPLICATION FOR MATERIALS LICENSE - MEDICAL GAO Rossi

1OCFR 35 INSTRUCTIONS - Conwier trsI frqm2 i f this Ofi iugitiaaPplocation o almolc~aua~n.1foe ,nr.w1o ar kranwUse,. w(irw i-1Oe wheremcgury. Ite mC muin w cconf,,ktnd an at/*ifoonz s9ged wd R*t anionecoy. S.jr,? or*u1 and rn,- copy OFe.nt,,"

ao*plkraion ." Dinrcto,. Office alNuctear Mareuai a,rj ely and .*Selads, U.S. tducd, Reutro.* C mnini,*on.WP,',zhngion. D C.

20555. Upon app'ov41of ehis arWliwion'tha icantwill nt¢. a Mau~vialsLwamie An NRC Marwa Li~aw'g :uued arme with the geneal requirwnemts conrrj in Titl 10. Code of Fetdral Rp~urioz. Piri 30. araI the L canlu a sj&imtf to T, Or 10.

Code of Federal Rl*fionh, Patti 19, 0 ani 35 andthe f, Jkz fer plrowma oa Tirke 10. Code of FrWIcf iRtlmani.Parr I/0 Tnt liccnse fee care~tv Ohoukd be stated in Irrm 26 wrlAJ *e awmpviare fee enclosed.

1.o. NAME AND MAILING ADDRESS OF APPLICANT linifirotion, 1.b. STREET ADDRESStESI AT WHICH RADIOACTIVE MATERIAL

firfm cllnic.physiciajn,etcJ INCLUDE ZiP CODE WILL BE USED I/I df0,int from 7..

x. INCLUDE ZIP CODE

0

TELEPHONE NO.: AREA CODEI I-

2. PERSON T

O. CONTACT

REGARDING THIS APPLICATION 3. THIS IS AN APPLICATION FOR: ICheck .ppfrevta oevm)

&.5 NEW LICENSE

U0 AMENDMENT TO LICENSE NO.

c- 0 RENEWAL OF LICENSE NO.

TELEPHONE NOD; AREA CODE I I -

4. INDIVIDUAL USERS (NMamr individuals who wi/uls of dijrctfy 5. RADIATION SAFETY OFFICER IRSO) INamo of person &mugnated SuPervise use of radioactivemateria1. Cowepltk Supplements A and B at radiationjafety officer. f oriw Pun iJduri urn tnh.frrr's.

for each individua. I mneet fra.mng andramrfinwea.m enST*uWkn r A.f

6.a. RADIOACTIVE MATERIAL FOR MEDICAL USE

MAXIMUM. MARK MAXIMUM

ITEMS POSSESSION ITEMS POSSESSION

RADI1OACTIVE MATERIAL [DESIE IMT ADDITIONAL ITEMS: [D;ES IRED LMT

LISTED IN: " fin millicuriesj .X'* tin meflhcuueij

10 CFR 31.11 FOR IN VITRO STUDIES IoDINE131 AS IODIDE FOR TREATMENT

OF HYPERTHYROIDISM

10 CFR 35.100, SCHEDULE A, GROUP I AS NEEDED PHOSPHORUS-32 AS SOLUBLE PHOSPHATE

FOR TREATMENT OFPOLYCYTHEMIA

VERA,.LEUKEMIA AND DONE METASTASES

AS NEEDED VERAP..RUKEMI ASD C OIDAL TARES

10 CFR 35.100. SCHEDULE A, GROUP II PHOSPHORUS-32 AS COLLOIDAL CHROMIC

- iPHOSPHATE FOR INTRACAVITARY TREAT-

10 CFR 35.100, SCHEDULE A, GROUP IlI MENT OF MALIGNANT EFFUSIONS.

- GOLD-1BB AS COLLOID FOR INTRA.

CAVITARY TREATMENT OF MALIGNANT

10CFR 35.100,SCHEOULE A. GROUP IV AS NEEDED EFFUSIONS.

IODINE-131 AS IODIDE FOR TREATMENT

10 CFR 35.100. SCHEDULE A, GROUP V AS NEEDED OF THYROID CARCINOMA

.. XENON-133 ASGASOR GAS INSALINE FOR

10 CFR 35.10

0. SCHEDULE

10_____35.100 GROUP VI

A. GROUPV__

__SCHEDULEA.__ BLOOD

FUNCTION

FLOW STUDIES AND PULMONARY

STUDIES.

6.b. RADIOACTIVE MATERIAL FOR USES NOTLISTED IN ITEM 6.a. ri",'mewrres tjin3mCiusedfol Calibration andl reference giandords are authorized under Sect'n 35.14(d)o 10 CFR Pan 35. end NEED NOTr6EL1STEDJ

CHEMICAL MAXIMUM NUMBER

ELEMENT AND MASS NUMBER ANDIOR OF MILLICURIES DESCRIB

E. PURPOSE

OF USE

PHYSICAL FORM OF EACH FORM

r ,

7 ORM Nnc.1Imm

. .INFORMATION REQUIRED FOR ITEMS?7 THROUGH 23 For Items 7 through 23, check the appropriate boxies) and submit a detailed desription of all the requested information. Begin each item on a separata sheet. Identify the item number and the date of the application In the lower right corner of each page. If you Indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the revision number and date of the referenced guide: Regulatory Guide 10.8 , Rev. Date:

GENERAL RULES FOR THE SAFE USE OF

7. MEDICAL ISOTOPES COMMITTEE RADIOACTIVE MATERIAL (Check One)

Names and Specialties Attached; and Appendix G Rules Followed; or I!

Duties:as in Appendix B; or Equivalent Rules Attached

[Check One)

Equivalent Duties Attached 16. EMERGENCY PROCEDURES (Check One)

B. TRAINING AND EXPERIENCE Appendix H Procedures Followed; or Supplements A & B Attached for Each Individual User; Equivalent Procedures Attached and Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check One)

9. INSTRUMENTATION (Check One) Appendix I Procedures Followed;or Appendix C Form Attached; or Equivalent Procedures Attached List by Nameand Model Number 18. WASTE DISPOSAL (Check One)

-j ~-r ~

10. CALIBRATION OF INSTRUMENTS

Appendix J Form Attached; or Appendix D Procedures Instruments; or Followed

- for Survey CekOe Equivalentlnformation Attached EIrumalents; oedres (CheckndOneTHERAPEUTIC USE OF RADIOPHARMACEUTICALS

Equivalent Procedures Attached; and (Check One)

Appendix D Procedures Followed for Dose Calibrator; or ICheck One) Appendix K Procedures Followed:or

,

Equivalent Procedures Attached Equivalent Procedures Attached

11. FACILITIES AND EQUIPMENT 20. THERAPEUTIC USE OF SEALED SOURCES

Description and Diagram Attached Detailed Information Attached; and

12. PERSONNEL TRAINING PROGRAM Appendix L'Procedures Followed, or (Check One)

Description of Training Attached Equivalent Procedures Attached

13. PROCEDURES FOR ORDERING AND RECEIVING PROCEDURES;AND PRECAUTIONS FOR USE OF

RADIOACTIVE MATERIAL 21. RADIOACTIVE GASES (e.g., Xenon - 133)

Detailed Information Attached Detailed Information Attached PROCEDURES AND PRECAUTIONS FOR USE OF

PROCEDURES FOR SAFELY OPENING PACKAGES 22. RADIOACTIVE MATERIAL IN ANIMALS

14. CONTAINING RADIOACTIVE MATERIALS

(Check One) _jDetailed Information Attached PROCEDURES AND PRECAUTIONS FOR USE

Appendix F Procedures Followed; or OF

23. RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6,b Equivalent Procedures Attached I-Detailed Information Attached"

FORM NRC-313M

19-79) Page 2

-7

24. PERSONNEL MONITORING DEVICES

-,

24. PERSONNEL MONITORING DEVICES r -7 TYPE

SUPPLIER EXCHIANGE FREQUENCY

d. OTH ER ISpecily)

25. FOR PRIVATE PRACTICE APPLICANTS ONLY

a. HOSPITAL AGREEING TO ACCEPT PATIENTS CONTAINING RADIOACTIVE MATERIAL

NAME OF HOSPITAL b. ATTACH A COPY OF THE AGREEMENT LETTER

SIGNED BY THE HOSPITAL ADMINISTRATOR.

MAILING ADDRESS c- WHEN REQUESTING THERAPY PROCEDURES.

.0 ATTACH A COPY OF RADIATION SAFETYPRECAY.

CITY STATE ZIP CODE TIONSTO BE TAKEN AND LIST AVAILABLE

I I IRADIATION DETECTION INSTRUMENTS.

2

6. CERTIFICATE

(This item must be completed by applicant]

The applicant and any official executing this mrlificate on behall uf the applicant namw in Item la certily that this applhcation is preporrd in conformity with Title 10. Code of Federal Regulations, Patts 30 and 35, "ndthat all information contained herein, including any %upplements attached hereto, it true anid correct to the best of our knowyledge and belief. .

b. APPLICANT OR CERTIFYING OFFICIAL tS~gna.ti!PJ

a. LICENSE FEE REQUIRED

MeffSdcriorn 170.31. 1OCFR 170, 11 "NAME ITYp eof Print.

(1) LICENSE FEE CATEGORY: .92) TITLE

c- DATE

12) LICENSE FEE ENCLOSED: S

FORM NRC-,313M 18-78)

Page 3

PRIVACY ACT STATEMENT

S.. Pursuant to 5 U.S.C, 552a(e)(3). enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93,579). the following

statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on Form NRC.313M.

This information is maintained in a system of records designated as NRC-3 and described at 40 Federal Register 45334 (October 1. 1975).

11. AUTHORITY. Sections 81 and 161(b) of the Atomic Energy Act of 1954. as amended (42 U.S.C. 2111 and 2201(b)).

2. PRINCIPA

L. PURPOSE

(S) The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFR

Parts 30-36 to determine whether the application meets the requirements of the Atomic Energy Act of 1954,as amended.

and the Commission's regulations, for the issuance of a radioactive material license or amendment thereof.

3. ROUTINE USES The intormation may be used: (a) to provide records to State health departments for their information and use; and (b) to provide information to Federal. State. and local health officials and other persons in the event of inci- I

dent or exposure, for their information, investigation, and protection of the public health and safety. The information may also be disclosed to appropriate Federal, State, and local agencies in the event that the information indicates a violation or potential violation of law and in the course of an administrative or judicial proceeding. In addition, this in- formation may be transferred to an appropriate Federal;State. or local-agency to the extent relevant and. necessary for a NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you. A copy of the license issued will routinely be placed in the NRC's Public Document Room, 1717 H Street, N.W.,

Washington, D.C.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECTON INDIVIDUAL OF NOT PROVIDING

INFORMATION Disclosure of the requested information is voluntary. If the requested information is not furnished, however, the application for radioactive material license, or amendment thereof, will not be processed.

5. SYSTEM MANAGER(S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety. Office of Nuclear Mate- rial Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington. D.C. 20555.

4%

FORM NRC-313M

(8-78)

Page 4

FORM NRC-313MSUPPLEMENT A U.. NUCLEAR REGULATORY"COMMISSION

(e-78I TRAINING AND EXPERIENCE

AUTHORIZED USER OR RADIATION :SAFETY OFFICER

1. NAME OF AUTHORtZEU USER OR RADIATION SAFETY OFFICER 2. STATE OR TERRITORY IN

WHICH LICENSED TO

PRAcTIcE MEDICINE

3. CERTIFICATION

SPECIALTY BOARD CATEGORY MONTH AND YEAR CERTIFIED

A B C

4. TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

TYPE AND LENGTH OF TRAINING

LECTURE/ SUPERVISED

FIELD OF TRAINING LOCATION AND DATE(S) OF TRAINING LABORATORY LABORATORY

A B COURSES EXPERIENCE

(Hours) ,Houru)

C 0

a. RADIATION PHYSICS AND

INSTRUMENTATION

b. RADIATION PROTECTION

C. MATHEMATICS PERTAINING TO

THE USE AND MEASUREMENT

OF RADIOACTIVITY

d. RADIATION BIOLOGY

e. RADIOPHARMACEUTICAL

CHEMISTRY

a

5. EXPERIENCE WITH RADIATION. (Actual usw of RadioiSotopes or Equivalent Experienre)

.ISOTOPE MAXIMUM AMOUNT WHERE EXPERIENCE WAS GAINED DURATION OF EXPERIENCE TYPE OF LSE

FORM NRC-313M Supolement A

Is-P} Page 5

FORM NRC-313M-SUPPLEMENT B U. S. NUCLEAR REGULATORY COMMISSION

EB-38)

PRECEPTOR STATEMENT

Supplement B must be cmrpletedby the 4pplicanr physician'spreceptor. If moae than one preceptoris necessary to document experience. obtoin a separatestatement from each.

1. APPLICANT PHYSICIAN'S NAME AND ADDRESS KEY TO COLUMN C

FULL NAME PS RSONALPARTICIPATION SHOULD CONSIST OF:

1-Supervited examination of patients io determine the suItability for radiolsotope diagnosis and/or treatment and recommendation for

_ __ __prescribed dosage.

STREET ADDRESS 2o~;llaboratlon in dose calibration and aLtuat administration ol dose to the patient Including calatlation of the radiation dose. related m"asurements.gind plotting of data.

CITY STATE I ZIP CODE 3-Ad.Quateperiodo d erainingto enable physician to manage radioactive patients and follow Patients through diagnosis andlor course of treatment.

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN

NUMBER OF

CASES INVOLVING COMMENTS

ISOTOPE CONDITIONS DIAGNOSED OR TREATED PERSONAL lAdditional information or cornmeniJ may PARTICIPATION be submitted in duplicate on separate Shee 1.)

A B C D

DIAGNOSIS OF THYROID FUNCTION

DETERMINATION OF BLOOD AND

BLOOD PLASMA VOLUME

1-131 LIVER FUNCTION STUDIES

or

1-125 FAT ABSORPTION STUDIES

KIDNEY FUNCTION STUDIES

IN VITRO STUDIES

OTHER

1-125 DETECTION OF THROMBOSIS

1-131 THYROID IMAGING

P-32 EYE TUMOR LOCALIZATION

Se,75 PANCREAS IMAGING

Yb-169 C3STERNOGRAPHY

BLOOD FLOW STUDIES AND.

Xe-133 PULMONARY FUNCTION STUDIES

OTHER

BRAIN IMAGING

CARDIAC IMAGING

THYROID IMAGING

SALIVARY GLAND IMAGING

Tc.B9m BLOOD POOL IMAGING

PLACENTA LOCALIZATION

UVER AND SPLEEN IMAGING

LUNG IMAGING

BONE IMAGING

OTHER

FORM NRC-313M-SUPPLEMENT B Pae.18-781 page 6

PRECEPTOR STATEMENT (Continued)

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Cofninued)

NUM8ER OI

CASES INVOLVING COMMENTS

ISOTOPE Or7iTIONS DIAGNOSED OR TREATED PERSONAL ,Additionalinlomnuti or camirna may be PARTICIPATION wbhmialdin dup/icua on sc,&raze LhfttLL

A 9 c o P.3* TREATMENT OF POLYCYTHEMIA VERA,

(UbJe) LEUKEMIA, AND BONE METASTASES

P-32 ,""RAVTR

fCoLtoidali )INTACAVITARY

__________________ TREATMENT _______

TREATMENT OF THYROID CARCINOMA

1-131 TREATMENT OF HYPE RTHYROIDISM

Au-198 INTRACAVITARY TREATMENT

Co-60 INTERSTITIAL TREATMENT

or Cs-137 INTRACAVITARY TREATMENT

1.125 or INTERSTITIAL TREATMENT

0t-192

Co.60

Or TELETHERAPY TREATMENT

CS-137 Sr.90 TREATMENT OF EYE DISEASE

RADIOPHARMACEUTICAL PREPARATION

Tc-99m GENERATOR

S*n..13' GENERATOR

In,! 13m ___________________ _____ ___

To-99m REAGENT KITS

Other

3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CLINICAL RADIOISOTOPE TRAINING

4. THE TRAINING AND EXPERIENCE INDICATED ABOVE U. FPRECEPTOR'S SIGNATURE

WAS OBTAINED UNDER THE SUPERVISION OF:

L. NAME OF SUPERVISOR

b. NAME OF INSTITUTION 7. PRECEPTOR'S NAME IPlease type atpnntJ

C. MAILING ADDRESS

4 CITY'

8. DATE

5. MATERIALS LICENSE NUMBERIS)

FORM NIRC-~313kSUPPLEMENT 9 Page 7

Regulatory Guide 10.8

Contents

t. a medical

0. CFRPart

3. listed in

e. Supplement A

h. Division

s. o

4. Other

d. Readings

y. Officer or his

s. V

a. To add a new user

d. A decontamination

x. INCLUDE ZIP CODE

2. PERSON T

O. CONTACT

0. SCHEDULE

E. PURPOSE

6. CERTIFICATE

a. LICENSE FEE REQUIRED

2. PRINCIPA

L. PURPOSE

3. CERTIFICATION

b. RADIATION PROTECTION

d. RADIATION BIOLOGY

e. RADIOPHARMACEUTICAL

8. DATE

Navigation menu

Regulatory Guide 10.8

t. a medical

0. CFRPart

3. listed in

e. Supplement A

h. Division

s. o

4. Other

d. Readings

y. Officer or his

s. V

a. To add a new user

d. A decontamination

x. INCLUDE ZIP CODE

2. PERSON T

O. CONTACT

0. SCHEDULE

E. PURPOSE

6. CERTIFICATE

a. LICENSE FEE REQUIRED

2. PRINCIPA

L. PURPOSE

3. CERTIFICATION

b. RADIATION PROTECTION

d. RADIATION BIOLOGY

e. RADIOPHARMACEUTICAL

8. DATE

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