ML20136D909

Reg Guide 10.8,Revision 1, Guide for Preparation of Applications for Medical Programs

ML20136D909
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Issue date:	10/31/1980
From:	NRC OFFICE OF STANDARDS DEVELOPMENT
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References
FRN-50FR30616, RULE-PR-35, TASK-OH-723-4, TASK-OS AA73-1, REGGD-10.008, NUDOCS 8011060064
Download: ML20136D909 (60)

Text

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M 73-/

PDA R2 vision 1*

October 1980

[" U.S. NUCLEAR REGULATORY COMMISSION O'

v @v, REGULATORY GUIDE

\ .*.. Q. #OFFICE OF STANDARDS DEVELOPMENT REGULATORY GUIDE 10.8 GUIDE FOR THE PREPARATION OF APPLICATIONS FOR MEDICAL PROGRAMS 1, INTGODUCTION safety program. Such requests will delay final action on the application.

I,I Purpose of Guide I.2 Applicable Regulations This guide describes tlie type and extent of information needed by the Nuclear Regulatory Commission (NRC) staff in addition to 10 CFR Part 35, other regulations pertam-to evaluate an apphcation for a specific license for the mg to this type of license are found in 10 CFR Part 19, possession of byproduct material (reactor-produced radio- " Notices. Instructions. and Reports to O .kers, inspections",

nuchdes) and its use in or on human beings. This type of 10 CFR Part 20. " Standards for Protection Agamst Radia-license is rrovided for under 10 CFR Part 3 5,"Iluman Uses tion";10 CFR Part 21, " Reporting of Defects and Noncom-of Byproduct Material." This guide does not cover require- phance",10 CFR Part 30. " Rules of General Applicabihty ments for naturally occurring or accelerator-produced to Domestic L.cc . sing of Byproduct Material", and 10 CFR radioactive materials that may be subject to hcensing by Part 170, " Fees for Facihties and Materials Licenses and mdividual States This guide is also not appheable to academ. Other Regulatory Services Under the Atomic Energy Act of ic programs, including medical, on campuses that do not 1954, As Amended.'

include hospitals or clinies where byproduct materialis used m or on humans. Guidance for medical teaching programs 1.1 Items Requiring Separate Applications n that do not involve human use is provided in Regulatory

) Guide 10 2," Guidance to Academic Institutions Applymg for Teletherapy. A separate apphcation should be submitted q'j Specific Byproduct Material Licenses of Limited Scope," or in Regulatory Guide 10 5, " Guide for the Preparation of for kilocurse sources used in teletherapy facilities. A specific heensmg guide for tele therapy apphcatmns is available Applecations for Type A Licenses of Broad Scope for By- upon request from the Material Licensing Branch, Division product Material." of Fuel Cycle and Material Safety, Office of Nuclear Mate-rial Safety and Safeguards, U.S. Nuclear Regulatory Com-The NRC will usually issue a single byproduct material mission, Washmgton, D.C. 205 5 5.

hcense to cover an mstitution's entire radioisotope program other than teletherapy. Separate licenses, except for tele- Source and Spectat Nuclear 3farerrah. F xcept for dep;eted therapy, are not normally issued to different departments uranium used for shielding m haear auclerators or tele-af a medical mstitution, nor are they issued to individuals therapy deuces, separate apphcations should be submitted associated with the hospital. for t hese materials in accordance with 10 CF R Part 40,

" Domestic licensing of Source Material / and Part 70.

The apphcant should carefully study the regulations (see " Domestic Licensing of Special Nuclear Material." Source Section 1.2 of this guide) and this guide and should submit material is defmed m paragraph 40.4(h) of 10 CFR Part 40 all mformation requested. The N RC will request additional as (1) uranium or thorium. or any combmation thereof, m mformation when necessary to provide reasonable assurance any phy sical or chemical torm or t 2) ores that contam by that the applicant has established an adequate radiation weight I/ 20 of one percent q 0.05H or more of (a) uranium.

(b) thorium, or (c) any combination thereof. Source mate-rial does not mclude special nuclear material.

T he substantial number nr Changes en this restuun he ni3Je er NO *I ernt rattnal to en daate the Changes with tones en the rnargen of 10( F R l'arI 70 and includes 1 I ) plutonmm, uramum-233.

USNRC Nf GULATORY GuiOF5 Comments shnuid be sent to the secretary of the commesseon, U.$- NuCleat N egulat or y Commission, Washengt on, O C. 20555, Regulatory Guides are issued to describe and matie available to the A t t en t io n Doc keting and Servite Branch.

Du bleC fnet h ods aC C eDiable 10 the NRC sta r f of emplementeng sD eC a f *C Darts of the Commeslaon't regulations, to delsneate teC n. Tne quedes are essued en the f ouowing ten eroad d v.sions neQues used by the Staf f en evalualmg speCafeC Droblems or Dostu-lated Accidents, of to Drovide 9usdante to aDDieCants. Regulatory i . Po wer N eac t or s (, . Pr oduc t s O Guides are not luLstetuf en f or F#9ulations, and Cornphance wa t h 2. ResearCM and r est Heat tors

3. F uels and Materials F atehteel

?, t r an sDor t et son

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y s

tnem os not requevec Methods and solutions dif ferent from tnose set Out en the quedes will be ACCeDf able af they Drovede a basel fOr tne 4, r nvernnmental and Setsng P. Occupational Health Q Antstrust and r enancial Neveen Imdengs F#Quasete to the sssuante or Continuance or a farmet or- 5. Matereell and Plant ptnteCteon 10. r.ener al

\ isCense by the Commission v/

C ODeel Of sssued Quedel ma y be Purc hased at the tuf rent Government Comments and suggestions for emprovements en these guides are printing Of fiCe peace. A substreDtson servere f or f uture guedes en sDe-encouraged at all temes, and guides well be revised, as aDDroprea,e. C ef st devisions is ava.lable tnrough the Government Pe mt mg Of fit e.

to ACCorntnodate Comn.ents and to re flec t ne w e n f orm a t son or latormateG9 on the sdDs(repteon ServsCe and C uf f ent CePO Drices may esDerlente. Tnes guide was revised as a result rif suDstantive C om- he obtained by me eting t he U.5 Nuclear Hegulator y c ommessson, ments re< * =** -

d4 'm at staf f review, Wash anot on, O c. 20$55, Attenteon Puritst ations sales Manager.

4 ur:nium enriched m the isotope 233 or in the isotope 235 heense authorizing physicians, veterinarians, clinicallabora-or (2) any material artificially enriched by any one of the tories, and hospitals to possess certain small quantities of foregoing but not including source material. by product material (1-125,1 131, C-14, H-3, Fe-59, Se-75, and mock 1-125 reference scurces) forin vitro chnical or laboratory 1.G As Low As Is Reasonably Achievable ( AL AR A) tests not involving the internal or external administration of byproduct matenal, or the radiation therefrom, to human Ptragraph 20. l(c) of 10 CFR Part 20 states that " .. persons beings or animals. Section 31.11 explains the generallicense engaged m activities under licenses issued by the Nuclear requirements and requires the applicant to register with the Regulatory Commission pursuant to the Atomic Energy Commission and receive a registration number prior to Act of 1954, as amended, and the Energy Reorganization receivmg or using the byproduct material for in vitro testing.

Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable 1.5.2 Specific Licenses Limited Scope effort to maintam radiation exposures, and releases of radioactive matenals in effluents to unrestricted areas, as Licenses issued to physicians for private practice specify low as is reasonably achievable." Regulatory Guide 8.10, the radioisotopes and the clinicaluses that may be performed

" Operating Philosophy for Maintaining Occupational Radia- by the physician to whom the license is issued. Such tion Exposures As Low As is Reasonably Achievable," pro- licenses are issued to physicians who are located in pnvate vides the N RC stafl position on this important subject. Regu- offices and not on hospital premises. It is not required that latory Guide 8.18, "Information Relevant to Ensunng That a medical isotopes committee be formed. The private 8

Occupational Radiation Exposures at Medical Institutions practice license does not permit other physicians to obtain Will Be As Low As Reasonably Achievable," provides ways clinical radioisotope training and experience ander it.

of applying the ALARA philosophy in medicalinstitutions. Section 35.12 of 10 CFR Part 35 outhnes specific require-License applicants should give consideration to the ALARA ments for this type of license.

philosophy, as described in Regulatory Guides 8.10 and 8.18, m the development of plans for work with radioactive mate- Specific hcenses of hmited scope issued to mstitutions tills. NOREG-0267, " Principles and Practices for Keeping specify the radioisotopes and the clinical uses that may be Occupational Radiation Exposures at Medical Institutions performed by physicians named on the institution's license.

As 8.ow As Reasonably Achievable," contains information The regulations in paragraph 35.ll(b) of 10 CFR Part 35 and references useful in estabbshmg radiation safety pro- require an institutional hcensee to have a medical isotopes grams to maintain exposures ALAR A in medicalinstitutions. committee (see Appendix B to this guide) to evaluate all proposals for chmcal research, diagnostic, and therapeutic Effective August 15,1980, applicatmns for new hcenses, uses of radioisotopes within the institution, renewal requests, and requests for significant license amend-ments (i.e., to broaden programs; to increase possession limits) The physicians named on the institution'slicense conduct should be accompanied by a description of the applicant's/ their programs with the approval of the medical isotopes hcensee's ALARA program. Apphcants/hcensees may adopt committee. Institutional licenses provide a means whereby the model program described in Appendix 0 to this guide nonapproved physicians under the supervision of physicians or may develop and submit for NRC review an equivalent named on the license may obtain basic and clmical radio-alternative program. If the model program in Appendix 0 is isotope training and experience that may enable them to adopted, Appendix 0 should be removed from this guide, quahfy as individual users. Trammg and experience criteria should be dated and signed by an individual authorized to for physicians are outhned in Appendix A to this guide.

mrke commitments for the applicant / licensee, and should be attached to the request for hcensmg action. 1.5.3 Specific Licenses - Broad Scope 1.5 Types of Materials Licenses Specific hcenses of broad scope for medical use, i.e.,

hcenses authorizing multiple quantities and types of bypro-duct material for unspecified uses, are issued to mstitutions L5.1 General Licenses that (1) have had previous experience operatmg under a The generallicense provided m 35.31 of 10CFR Part 35 specific institutional hcense of hmited scope and (2) are authorizes the physician to possess and use bmited quantitles engaged in medical research as well as routine diagnosis and of prepackaged mdividual doses of I-131 for measurement of therapy usmg radioisotopet Such programs operate under thyroid uptake,1 125 and I-131 for blood and plasma volume the supervision of a medical isotopes committee.

determinations, Co-58 and Co-60 for intestmal absorption of cy anocobalamm, and Cr-51 for red blood cell volume and Individual users are not named on the hcense nor are survival time determinationt Section 35.31 explains the radioisotopes hmited to specified uses. Indnidual users and general hcense requirements and requires the physician to procedures are approved by the institutmn's medicalisotopes register with the Commission and receive a registration number prior to recening or using the diagnostic radio-pharmaceuticah covered by the general hcense I Alternative titles are "radimsntope" or "raJiation safeiy" com

"'itee. A rule change n es pected an luo to ihange the riame or this Section 31.1 I of 10 CFR Part 31, " General Domestic committee to the radiation safer, commiitee ar.a in revne ihe cnm 1.icenses for By prod uct Materialf estabbshes a general poutinn and scope nf the commitiee.

10 8-2

committee. Physicians may obtain basic and clinical radio- licensee will reach persons responsible for the radiation isotope training and experience in the use of radiopharma- safety program.

l ceuticals in such programs. This type of license is not appro-

[

priate for most institutions using byproduct material in medical programs, Item Ib. List the addresses and locations where radio-active material will be used or stored if other than the 4

address stated in item la. If multiple addresses are to be i

2. LICENSE FEkS used, explain the extent of use at each address and the facilities and equipment located at each place of use. The An application fee is required for most types oflicenses. actuallocations of use should be listed, whether or not they The applicant should refer to Q 170.12," Payment of Fees," are the same as the mailing address in item la; e.g., a P.O.

and Q 170.31, " Schedule of Fees for Materials Licenses," of box may be most suitable for item la in some cases, but 10 CFR Part 170 to determine the amount of the fee that this address does not adequately describe the location of must accompany the application. Review of the application use, will not begin until the proper fee is received by the NRC.

Item 2. Enter the nalne and telephone number (including

3. FILING AN APPLICATION area code) of the individual to be contacted.

A license application for specific licenses for human use Item 3. Indicate whether this is an application for a new should be submitted on Form NRC-313M,2 " Appl eation license, an amendment. or a renewal.

for Materials License-Medical"(see Exhibit A).The appliant should complete all items on the application form in item 4. List the names of all persons who will use, sufficient detail for the NRC staff to determine that the supervise, or direct the use of byproduct material. This list applicant's equipment, facilities, personnel training and should include the physicians who supervise other physicians qualifications, and radiation protection program are adequate in training and/or who direct technologists or other para-to protect health and minimize danger to life and property, medical personnel who use byproduct material for human or nonhuman use. Nonphysicians may be authorized to use Since the spact rovided on Form NRC-313M is limited, byproduct material for nonhuman use (e.g., instrument

the applicant shoW append separate sheets of paper for calibration).

Items 7-23 listed in the form or may indicate by checking l the appropriate box that specific procedures will be followed. Authorized physician-users have the following respon-Each separate sheet should contain the item number and sibilities:

the application date in the lower right corner. When com-( pletely filled out, Form NRC-313M should be signed and a. The approval of procedures involving the administra-dated on item 26b by a representative of the institution's tion to patients of radiopharmaceuticals or the application management. The fee required by @ 170.31 of 10 CFR to patients of radiation from radioisotope sources.

Part 170 must accompany the application as indicated in Item 26a. b. The prescription of the radiopharmaceutical or source of radiation and the amount or dose to be admin-One copy of the application, with all attachments, istered.

should be retained by the applicant, since the license will require as a condition that the licensee follow the statements c. The determination of the route of administration.

and representations set forth in the application and any supplement to it. The original and one copy should be d. The interpretation of the results of diagnostic proce-mailed to the Material Licensing Branch, Division of Fuel dures in which radiopharmaceutiole t.e administered.

Cycle and Material Safety Office of Nuclear Material

, Safety and Safeguards, U.S. Nuclear Regulatory Commission, items a through d may be delegated to physicians who Washington, D.C. 2055 5. are in training under the supervision3 of authorized physician-users.

4. CONTENTS OF AN APPLICATION Properly trained technicians, technologists, or other The following paragraphs explain the information paramedical personnel under an authorized user's direction requested on Form NRC-313M. may be delegated the following activities:

Item la. Enter the name, mading address, and telephone a. The preparation and quality control testing of radio-number of the applicant. If the request is for a private pharmaceuticals and sources of radiation.

license, enter the name of the physician or partnership. It is particularly important that the mailing address be suffi- 3 superv4shm means that the physician.ser has adequaiesy in.

ciently complete that all NRC correspondence to the structed the physicien(s) in trainins in the specific human use and has escortsened that they are receiving trainms in 'he safe use of these meteriale in humans. It also means that the physnioneeer 2 periodically reviews the work of those su tvised and esaures himself A newly revised Form NRC.313M and changes in requirements that proper med:Cel records are mede o och use. it does not mean d for radiation safety committee and physician education and training that the physiciengeer se necenserHy present for each radiopharmaceu-are under review. Puhhcetion of these charges is expected in late 198o. tKel adminestra tion.

10A3

b. The measurement of radiopharmaceutical doses pnor the Pubhc Ilealth Service Act. If the study is conducted to administration, under a " Notice of Claimed Investigational 1 xemption for a New l) rug"(IND) sponsored by the physician or institution,

c. The use of appropriate instrumentation for the state the radionuclide, chemical form, possession limit, and collection of data to be used by the physician. use, and submit a copy of the IND acceptance letter from the FDA. If a study is to be conducted under a protoco

d. The administration of radiopharmaceuticals and approved by an FDA-approved Radioactive Drug Research radiation from radioisotope sources to patients,if permitted Committee, submit a copy of the FDA letter granting under applicable Federal, State, or local laws. approval; state the radionuchde, chemical form, possession himt, and use; and submit a copy of the protocol. I Item .5. State the name and title of the person designated by, and responsible to, the institution's n$anagement for the item 7 Medical /sotopes Committee." In accordance with coordination of the institution's radiation safety program paragraph 35.Ilfb) of 10 CFR Part 35,an institution applying if the radiation safety officer is assisted by a consultant or for a byproduct materiallicense for human useis required to p:rt-time employee, state the consultant's name and establish a medical isotopes committee of at least three mem-desenbe his/her duties, responsibilities, and the amount of bers. This committee evaluates all proposals for research, time to be devoted to the radiation safety program. Also diagnosis, and therapeutic use of radioisotopes. Membership su bmit the name and desenption of the training and of the committee should include :

expenence of the person responsible for the radiztion program oa a day-to-day basis. a. Physicians speciahzing in nuclear medicine, internal medicine, and either hematology or pathology, at least one

/ tem 6a. For routine human use, the applicant may of whom will use or directly supervise the use of radioactive check the group numbers of Schedule A in 35.100 of matenals for diagnosis or treatment of humans.

10 CFR Part 35 for which the license is requested. Groups I,11, and lit consist of the more commonly used diagnos- b. A person with special competence in radiation safety.

tic procedures that involve radiopharmaceuticals, Groups IV and V consist of routine therapeutic procedures that c. A representative of the institution's management.

mvolve radiopharmaceuticals; and Group VI consists of sealed sources used primanly for therapeutic procedures. Submit the followmg information:

For Groups I,11 IV, and V, possession limits are not a. The responsibility and duties of the committee listed on the license.

b. The meeting frequency of the committee (at least For Group til, the possession limit will be two cunes of quarterly).

each radioactive material listed unless a larger limit is requested in the application. State the requested possession c. The name and specialty of each member of the limit for Group VI. The possession limit for each radionuclide committee.

should be sufficient to include matenal held as radioactive w:ste, Appendix B to this guide contains an example of typical responsibilities and duties for a medicalisotopes committee.

Irem 6b. For routine human use not listed in Groups i Indicate, by checking the apprornate box in item 7, that through VI and for nonhuman use, hst each radionuchde to the responsibihties. duties, and meeting frequency will be as be used, the chemical and physical form, and the maximum described in Appendix B, or propose alternatives. If the quantity (in millicunes). responsibihties, duties, or meeting frequency will be different from those described, submit a complete description.

Iist the manufacturer's name, model nu m ber, and activity (in millicunes) for all sealed sources. (Sealed Item 8 Trainmg and Experience sources up to 3 mci used for cabbration and reference standards are authorized under paragraph 35.14(d) of a. riurhorized User /s). If the physician has been previotsly 10 CFR Part 35 and should not be hsted ) authonzed to use the radioactive material requested in this apphcation, it is necessary to submit only the previous Describe the intended use for each radionuclide and license number (if issued by the AFC or NRC)or a copy of the form hsted in item 6b. A specific authorization must be license (if issued by an Agreement State).

obtained from the NRC to perform studies involving the use of radioactive matenal in animals. The information if the physician has not been previously authonzed to required is specified in item 22. use the radioactive material bemg requested, state where he is licensed to practice medicine, and subrnit a complete If the radioactive matenal is for human .ase and has not been approved for routme liuman use by the Food and #

Drug Admmistration (FDA), submit evidence that procure- A rule thange is under renew to revise the name of this com

"" '" 'h' d" ' **'Itee and change its runttsons e,o mint, Ereparation, and use of the material will be in accord- emphastre its role m" estab 58'"'hsh"ing and revie wing the institu taan a ence with the Federal Food, Drug, and Cosmetic Act and radiation sorely program.

10. M-4

description of his training and experience. Use Supple- at least every 12 months with a battery check and two-point ments A and B to Form NRC-313M (see Exhibit A) to calibration (at about 1/3 and 2/3 of full scale)on each scale of

[ ,h describe the physician's training and experience. Criteria for the instrument to be used for radiation protection surveys.s

~j acceptable training and experience are contained in Appen-dix A to this guide, Survey instruments should also be calibrated after repair or maintenance that may affect the calibraticm of the instrument.

b. Radiation Safety Officer. If the radiation safety officer A survey instrument may be considered properly calibrated is not one of the physicians named in item 4, submit a at one point when the exposure rate measured by the instru-complete description of his training and experience. Supple- ment differs from the true exposure rate by less than 10 ment A to Form NRC-313M may be used to describe the percent.

radiation safety officer's training and experience. Where a consultant is employed to assist the radiation safety officer, If you propose to calibrate your own radiation survey the institution will still be responsible for the proper and monitoring instruments, submit a detailed description performance of the radiation safety program as required by of your planned calibration procedures, include in the the license, and the institution's radiation safety officer will description:

be expected to review the consultant's work and sign the required reports and records. (1) The manufacturer's name and model number of the source (s) to be used. The source should be Item 9 Instrumentation. Instruments generally required of sufficient strength to give at least a 2/3-scale in a typical nuclear medicine laboratory are : reading on the highest scale to be calibrated when the source is 20 cm faom the effective

a. Survey Instruments '

center of the detector.

(1) A low-level survey meter, with a thin window of (2) The nuclide and either (a) activity (in millicuries about 2 mg/cm2, capable of detecting 0.1 milli- or equivalent SI units) of radioactive material roentgen per hout to perform contamination contained in the source or (b) exposure rates at surveys. fixed distances from the source as certified by measurements involving direct comparisons (2) A high-level survey meter such as an ionization with sources or dosimeters calibrated at the type capable of reading up to 1 Roentgen per National Bureau of Standards.

( )

hour to measure radiation exposure rates that 6

/ may exist in the vicinity of Mo-99/Tc-99m (3) The accuracy of the source (s).

generators and therapeutic quantities of radio-active material such as I-131 or Ir-192. (4) The st' p-by-step ; socedures, including associated radiatt

• safety procedures. For each instrument,

b. Dose calibrators and other instruments to assay these p: >cedures should include a two-point radiopharmaceuticals. calibration (at about'l/3 and 2/3 of full scale) oh each scale used for radiation protection

c. Instruments used for diagnostic procedures in nuclear survey s.5 medicine (e.g., gamma camera, thyroid probe, well counter,

cintillation counter for in vitro studies). If a consultant or outside firm will perform the cahbra-tion of your radiation survey and monitoring instruments,

d. Other pertinent instrumentation (e.g., liquid scintilla- specify his name, address, and the license number. Contact tion counter, area monitor). the firm or consultant that will provide the calibration to determine whether information concerning calibration Appendix C to this guide contains a form that may be services and procedures has been filed with the Commission, used to describe the instruments. Complete this form by If this information has not been filed, submit it with your listing the instruments to be used. If this form is not used, application, including details of the information the outside attach equivalent information. Check the appropriate firm will supply you about the results of the calibration.

box in item 9 of Form NRC-313M.

Section 1 of Appendix D to this guide contains an accept-Item 10 Calibration ofInstruments able procedure for calibrating sorvey instruments and a form that r,iay be used to supply the information required in

a. Survey Instruments. An adequate calibration of survey instruments cannot be performed with - built-in check s scales up to a R/hr should be calibrated but. in order to keep sources. Electronic calibrations that do not involve a source personnel ex posures ALARA, high-range scales above I R/hr need of radiation are also not adequate to determine the proper "io',beSca**$'a*NeYNr'[h re c" ba P

h chec "U functioning and response of all components of an instru- for operation when possible. The resulta should be noted on the

/m i ment.

instrument. The user should be alerted to scales not cahbrated or checked.

\

Daily constancy checks of survey instruments should be ,,,[6h rnasjm d et o of t n a ut of h ur made before and after each use and should be supplemented manu fac turer.

10.8-5

7 It:m 10 of the apphcation form. A sample " Certificate of in- Item 11 Facilities and Equipment Describe the available strum:nt Cahbration"is also provided in Appendix D for use facilities and equipment (e.g., remote handling equipment, by a consultant in reporting calibration results. Indicate, by storage containers, shielding, fume hoods) at each location checking the appropriate boxesin item 10 of Form NRC-31N, where radioetive material will be used. Include a description of if th3 procedures described in Appendix D will be followed. the area (s) assigned for the receipt, storage (including waste),

if the procedures in Appendix D are not followed, submit preparation, and measurement of radioactive material.

equivalent procedures. -

Submit a detailed diagram of the facility, indicating the

b. Dose Calibrator. All radiopharmaceuticals should be type, dimensions, position, and thickness of shielding that assayed for activity to an accuracy of110 percent of the true will be used for:

value prior to being administered to patients. The usual m;thod for performing assays is with a dose calibrator. a. Use and storage of Tc-99m generators.

Upon installation and periodically thereafter, dose calibrators sh uld be tested for accuracy of response for the energies b. Storage of radiopharmaceuticals (refrigerated and c:mmonly used, for geometrical variation, for linearity of nontefrigerated).

response over the entire range of activities to be used, and for day to-day constancy of operation. c. Storage of radioactive waste,includingdecay-in-storage prior to disposal as nonradioactive waste. (This area should Submit a description of your cahbration procedures. be large enough to handle an accumulation of used Tc-99m Th;se should include as a minimum; generators as well as other solid waste. If this area is located outside your department, describe how the material will be secured. Cmfirm that this area will be surveyed at least weekly.)

(1) The manufacturer's name and model number of any scaled sources to be used (unless autho-rized by paragraph 35.14(d)of 10 CFR Part 35). J. Preparation and dispensing of Group Ill kit radio-pharmaceuticals (e.g., lead glass leblock).

(2) The nuclide and activity (in millicuries or equiva- Identify adjacent areas across the walls from use and lent SI units) of radioactive materials in the storage locations, and show that adequate steps have been standards, taken to ensure that radiation levels in unrestricted areas do not exceed the limits specified in paragraph 20.105(b) of 10 CFR Part 20 (see Figure 1).

(3) The accuracy of the standard.

Shielding requirements for the walls, floor, and ceiling should be evaluated for each nuclear medicine room based (4) The step-by-step procedures used for calibration. on total workload (in mci / week), the energy of radiation, and the presence of patients with activity in the room.

Adequate distances should be allowed between technologists If an instrument other than a dose calibrator is used to assay patient doses, submit a complete description of: and patients being scanned or imaged.

If Xe-133 is to be used, submit a version of your facdity (1) The assay method.

diagrari that specifies the location and the measured airflow rate of each air exhaust vent and each air supply (2) The method of calibration.

vent in areas where Xe-133 will be used or stored. This (3) The frequency of calibration. information is necessary in order to determine that the vents are properly located and that use and storage areas are under negative pressure. (See Figure M 1 of Appendix M for

14) The standards to be used for calibration (radio- an example of the type of diagram to be submitted.)

nuclide, activity, accuracy).

For other facihn v 'ich radioactive material may Section 2 of Appendix D contains a description of an .

become airborne, inen._ ..nematic desenptions of the ven-acceptable procedure for calibrating dose calibrators and a form that may be used to supply the information required tilation system in the diagrams with pertment airflow rates, in item 10 of this apphcation form. Indicate, by checking pressures, filtration equipment, and monitonng instruments.

Draw diagrams to a specified scale, or indicate dimensions the appropriate box in item 10 of Form NRC 313M,if the procedure in Appendix D for cabbrating dose cahbrators frem 12. Personnel Training Program. Radiation workers will be followed. If Appendix D is net followed, submit (e.g , technologists) must receive instruction as specified m equivalent procedures.

s 1912 of 10 CFR P,irt 19. Note that many of these items

c. Instruments Usedfor Diagnostic Purposes. Calibration, pertain to circumstances at a particularinstitution;therefore, quahty control, and maintenance of instrumentation used 7 Su als Regulatory Guide 8.18 and NUREG o267 for checkhsts for diagnostic procedures should be performed routinely in of f acdstics, equipment. and procedures to consider in designing hospitals for rnedical uses or tsyproduct material.

accordance with the manufacturer's recommendations.

10 8-6

- a

O O HALLWAY Y Y REST REST GAMMA ROOM ROOM BUILDING EXTE RIOR I

CAMERA

+LE AD BRICK

- -STOR AGE CAMER A ROOM rSHIELD NG HALLWAY

' GENERATOR

= L" SHIE LD DRESSING ROOM DOSE g -CALIBRATOR q V

DRESSING +LE AD BRICK ROOM [ I

-WASTE ARE A wwa^ f/77/*A

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HALLWAY FUME HOOD SCALE T* = 4' FIGURE 1 EXAMPLE OF AN ACCEPTABLE TYPE OF LAYOUT DIAGRAM FOR

{

A FACILITY DESCRIPTION INCLUDING SHIELDING PROVISIONS j

it may not be awamed that thn instinction has been ade- ensure that possewion hmits are not esteeded, that radio-

,piatel) (overed by prior occupational traming, Board actisc materials ordered for human u se are adequately ces tifica tion, cre. Outhne and submit the program for veril'ied upon reteipt and thecked before use. that radio-pros edmg the necessary instrucinon. at tive matettals are setured at all times agamst unauthors/cd removal. and that radiation levels in unrestricted areas do

\neillar) personnel t e g , clerical, nursmg, housekeeping, not escoed ihe hmits specified m paragraph 20105t M of wcurity personnel) whose duties may require them to work 10 CFR part 20 m the vicmity of radioactive material ( whether escorted or not) need to be mformed about radiation hazards and Security personnel, nursing personnel, or anyone else appropriate precautions. wha receives packages durmg off-duty hours shou d be issued written instructions as to procedures to be followed Describe the training that will be provided to all personnel tor (a) receiving, examinmg, and securing packages and who work with, or in the vicimty of, radioactive materials th) notifying specific personnel (mcludmg names and IntluJe the form of training (e g., formal course work. telephone numbers of persons to be contacted) if the lectures), frequency of training, duration of traming, and package is found or suspected to be teaking and the immediate subject matter. steps to be taken to prevent spread of contamination-Venfy that personnel will be properly instructed: Appendix E to this guide contams sample procedures and mstructions for ordermg and rece;ving packages containing

a. Before assummg duties with, or m the vicinity of, radioactive material. Attach a copy of your procedures radioactive materials.

Item 14 Proceduresfor Safely Opening thekages Contain-

b. During annual refresher training. ing Ralioactive.thterials. Although @20.205 of 10 CFR Part 20 exempts certain packages from immediate monitoring, para-

c. Whenever there is a significant change m duties, graph 20.205(d) requires that each hcensee estabhsh proce-regulations, or the terms of the license. dures for safely opemng all packages contammg hcensed material.

Instruction as required by 10 CFR Part 19 should include :

Describe your procedures for examming incoming

a. All terms of the license pertinent to radiation safety. packages for leakage, contamination, or damage, and for comphance with 20.205 of 10 CFR Part 20. Momtormg

b. Areas where radioactive material is used or stored. should be performed as soon as practicable after receipt of the package of radioactive material. The procedures may

c. Potential hazards associated with radioactive rnaterial. vary depending on the quantity of radioactive material received but should, at a mmimum, include instruct.ons for

d. Radiological safety procedures appropriate to their (a) surveymg packages, (b) wearmg gloves while opening respective duties. packages, (c) checking packmg material for contammation after opening, and (d) verifying package contents.

e. Pertinent NRC regulations.

Appendix F to this guide contains a description of an

f. Rules and regulations of the licensee. acceptable procedure for safely opening packages Indicate.

by checking the appropriate box m item 14 of Form

g. Obhgation to report unsafe conditions to the radiation NRC-313M, that the procedure in Appendix F will be fol-safety officer. Iowed, or attach equivalent procedures.

h. Appropriate response to emergencies or unsafe item 13 General Rules for the Safe Use of Radioactive conditions. Material. Describe the general instructions to be followed by physicians, radiopharmacists, and technologists while

i. Right to be informed of their radiation exposure and workmg with radioactive materials. The instructions should bioassay results.

a. Outhne control procedures for obtaining permission

j. Locations where the licensee has posted or made to use radioactive material at the institution.

available notices, copies of pertinent regulations, and copies of pertinent licenses and license conditions (including b Explam what laboratory apparel to wear and what applications and applicable correspondence), as required equipment to use, e g , wear laboratory coats and disposable by 10 CFR Part 19. gloves and use trays item 13 Procedures for ordering and Receiving Radioac- c. Prescribe hmitations and conditions for handhng tire M;terial. Describe procedures for ordering radioactive hquid or loose radioactive materials and the laboratory materi ls, for receiving materials during off duty hours, and equipment to be used in workmg with them. I or example, for notifying responsible persons upon receipt of radio- specify which materials and operations should be conf ned active materials. These procedures should be adequate to to radiochemical fume hoods or gloveboxes 10.8 8

- r- ,

d. Specify the shielding or remote handling equipment and (c) instruct personnel on appropriate methods for to be used when hard beta- and/orgamma-emitting materials re-entering, decentaminating, and recovering facilities that are handled. Preparation of radiopharmaceuticals from may have been accidentally contaminated.

p

j reagent kits should always be done bchind shielding and (g' within appropriate hoods or enclosures. Syringe shields An acceptable set of emergency procedures is contained should be used W the routine preparation and administra- in Appendix H to this guide. Indicate, by checking the tion of patient doses, except on the rare occasions where appropriate box in Item 16 of Form NRC-313M, that you difficulties in properly administering the dose to the patient will follow the emergency procedures in Appendix 11, would warrant expedited use of lighter syringes. Even in or submit a copy of equivalent procedures.

these cases, syringes with the best possible finger protection or remote delivery of the dose (e.g., through use of a / tem 17 Arc Surrey [rocedures. Describe the routine butterfly valve) should be used. survey program, including the areas to be surveyed, the levels of contamination considered to be acceptable, and

e. Give instructions for preparation and assay of patient provisions for maintaining records of surveys.s doses, including instructions to check each therapy dcse against the ordering physician's written request. If the application is to cover multiple users and areas of use, the individual user should perform surveys of his own

f. Give instructions concerning movement of material work areas in addition to those performed by the radiation between rooms, iri halls, or in cbtridors, if applicable. safety staff. Acceptable procedures and frequencies for routinc surveys are described in Appendix I to this, guide.

g. Explain requirements for storage of materials, labeling Indicate, by checking the appropriate box in item 17 of of containers, and identification of areas where radioactive Form NRC-313M, that you will follow survey procedures in materials are used. Describe the shielding used for areas Appendix 1, or submit equivalent procedures.

where large amounts of byproduct material are stored.

frem 18 Waste Disposal. Describe specific methods used

h. Specify personnel monitoring devices to be used, for disposal of waste byproduct material. A licensee may where to obtain them, procedures for properly turning in dispose of waste by:

personnel monitoring devices for processing at appropriate intervals, and instructions for recording exposure results. a. Carefut segregation of nonradioactive waste from radio-Also describe where personnel monitoring devices and active waste, decay of radioactive waste in storage, moni-f control dosimeters will be stored to ensure accuracy in toring, and release to normal trash. Wastes may be held for

( ) monitoring employee occupational exposures and to avoid decay until radiation levels. as measured in a low background

(,I inadvertent exposure of the devices when they are not area with a low-level survey meter and with all shielding being worn. removed, have reached background levels. Then, after radia-tion labels have been removed or obliterated, the waste may

i. Describe waste disposal procedures to be followed be disposed of in normal trash.

for each type of waste (e.g., liquids, gases. solids, long-lived, short-lived). Properly shielded waste receptacles should be b. Release into a sanitary sewer in conformance with employed for used syringes 'and other radioactive wastes. Q20.303 of 10 Cl-R Part 20. Describe the methods for controlling the sewage disposals of radioactive wastes in

j. Describe contamination control procedures. including order to ensure that disposals do not exceed the hmits (1) prohibitions against smoking, eating, drinking, or specified in @ 20 303 of 10 CFR Part 20.

applying cosmetics in restricted areas, (2) prohibition against storing food, beverages, and personaleffects with radioactive c. Burialin soilin conformance with Q20.304 of 10 CFR materials, and (3) instmetions for individuals who prepare Part 20.'

and administer doses of radiopharmaceuticals to monitor their hands after each procedure and at the end of the day. d. Release into the air in conformance with 20106 of 10 CFR Part 20.

For smaller programs, Appendix G to this guide contains an acceptable set of laboratory rules for the safe use of e. Other methods specifically approved by the Commis-radioactive material. Indicate, by checkmg the appropriate sion in accordance with @20.302 of 10 CFR Part 20. Amend-box in item 15 of Fo'rm NRC-313M, if Appendix G rules ments to licenses will be considered to allow the addition of will be f ollowed, or attach equivalent procedures. volatile laboratory wastes to fuel oil or the dispoul of very low activity laboratory wastes containing C-14 or 11-3 in the item 16 Emergency Procedures. Describe the emergency pathology department incinerators.

mstructions to be posted in all laboratory areas where 8 radioactive materials are used These instructions should (a) Regulatory Guide 8.23. "Itadiation Safety Surveys at Mednal institu tions.' provides further inforrnation on acceptable surtev describe immediate action to be taken in order to prevent procedures.

A

[ \ contamination off the ventilationofevacuation personnel andarea, of the work areas (e.g.,

containment of turning h rule change is pending to delete the provmon for burial of

(/ the spill),(b) state the names and telephone numbers of the (**,','p', ," ",d db * ' o is n h a requYre pec r'ic sir a I ce se responsible persons to be notified m case of an emergency, amendment eor burial.

10.8-9 L

Note: No licensee may dispose of byproduct material waste (d) Linens and other items removed from the by incineration unless specifically approved by the patient's room, and Commission. (See Q20.305 of 10 CFR Part 20.)

(e) The patient's room before it is reassigned to

f. Transfer to a person or firm properly licensed to receive another patient.

such waste, e.g., commercial waste disposal firms. (See 20.301 of 10CFR Part 20.) Submit the name and the NRror Agree- (4) Records of surveys to be recorded on patient's ment State license number of the commercial firm (s) selected.

chart arid in radiation safety office records.

In view of the recent problems with the shallow-land (5) Instructions to nursing staff (see Appendix K).

burial sites used by commercial waste disposal firms, the NRC is encouraging its licensees to reduce the volume of (6) Personnel monitormg procedures for medical wast;s sent to these facilities. Important steps in volume and nursing staff.

reduction are to segregate radioactive from nonradioactive waste, to hold short lived radioactive waste for decay in (7) Procedures for disposal of wastes, including:

storage, and to release certain materials into the sanitary sewer (paragraphs a and b above). (a) Patient excreta, (b) Surgical dressings, and Appendix J to this guide contains a form that may be (c) Other disposable items.

used to supply the information requested in Item 18 of the application form. Indicate, by checking the appropriate box (8) Procedures to be followed in case of emergency in Ittm 18 of Form NRC-313M that you will dispose of surgery or death (see NCRP Report Nos. 37 and wastes as specified on the form in Appendix J, or attach 48).

(quivalent information.

(9) Procedures for release of patients, including:

Item 19 Therapeutic Use of Radiopharmaceutscals. De-scribe special precautions" for patients treated with by- (a) Criteria for release of patients and product matenal listed in Groups IV and V, Schedule A, 35.100 of 10 CFR Part 35. Although Group IV procedures (b) Instructions to patients and families (see

.are often performed on an outpatient basis, appropriate NCRP Report Nos. 37 and 48).

procedures should be established because hospitahzation is som; times required. b Describe radiation safety procedures involved with all other aspects of therapy procedures, including.

a. Describe radiation safety procedures directly involved with care of therapy patients, mcluding: (1) Criteria for determinmg when it is appropriate to use protective facilities, equipment,or sipphes (1) Procedures for assignmg patients to rooms. (e g., hoods, shielding blocks, tongs, disposable Private rooms should be designated for 1131 gloves) and procedures for their use. Personnel therapy patients or any other patientsthat may should always wear glovesand work within fume constitute an internal or external exposure hoods or special enclosures whenever opening hazard for roommates. vials containing therapeutic quantities of volatile radiopharmaceuticals such as 1 131. These hoods (2) Paocedures for contamination control m the should have adequate airflow, and operating patient's room (e.g., protective covering for procedures should be designed to prevent con-areas of likely contact, use of disposable taminatnn of personnel and surrounding areas.

dishes and utensils, and procedures for posting and controlhng radiation areas or potentially (2) Criteria and procedures for bioassay of person-contaminatcJ areas (see NUREG-0267)). nel. Significant thyroid uptakes hase been detected in individuals who open and prepare (3) Procedures for surveys of' , oral solutions of I-131 for therapeutic doses.

Bioassays should also be considered for person-t a) Areas, equipment, personnel involved in nel (e.g , radiation safety, nursing) who are admmistration of radiopharmaceuticals, mvohed m other aspects of therapy procedures.

t iuidance on situations requiring bioassay for (b) t he patient's room on a daily basis. 1 131 and appropriate action levels may be f ound in Regulatory Guide B.20. ' Appihations of Bio-tc) Unrestricted areas ti e., areas adjacent to the assay f or l-l 3 and 1-1.4 l.

patient s roomt i3) Sursrys to h mit the spread of contamination "See Regulatory Guide 8 2 3 and NURf G 0267. and procedures f or decontamination Surveys 10 blU

(e g., measurement of I-131 in air, measurement Appendix L will be followed, or submit equivalent proce-of I-131 in the thyroid glands of laboratory d u res.

personnel; contamination surveys of personnel.

fm equipment, and facilities) should also be per-()) formed to determine compliance with and 20.I06 of 10 CFR Part 20.

20.103 Item 21 Proceduresand Precautionsfor Use of Radioac-tive Gases fr.g., Xc-133/and Aerosols. The use of radioactive gases (e.g., Xe-133 gas or gas in saline) and aerosols requires attention not only to the standard radiation safety considera-Submit detailed responses to items 19a and 19b. In heu tions but also to an evaluation of expected air concentrations of submitting a detailed response to item l9a. you may of the radioactive gas or aerosolin restricted and unrestncted state that you will follow Ihe procedures in Appendix K. areas. The NRC requires that each applicant make such deter-minations for his own unique situation and submit sufficient item 20 77:erapeutic Use of Sealed Sources. Desenbe spe- evidence to the Commission m support of his request.

cial procedures for patients treated with byproduct materials listed in GroupVI on Schedule A, @35.100 of 10 CFR Part 35. Appendix M to this guide contains instructions for submit-These procedures should include descriptions of: ting an application to use Xe-133 or aerosol. The information requested m Appendix M should be submitted.

a. Tl:e areas where sealed sources will be stored, includ-ing (I) placement and thickness of shieldmg,(2) proximity / tem 22 Procedures arki Precautionsfor Use of Radaoactive of the storage area to unrestricted areas, and (3) a,ny Matenalin Animals. Describe procedures to be followed if calculations or measurement data used to check the adequacy radioisotopes will be used an animals, including (a) a descrip-of the shielding and other facility protection specifications. tion of the animal housing facilities, (b) a copy of instruc-Radiation levels in unrestricted areas must be less than tions provided to animal caretakers for the handhng of 2 millirems in any I hour and less than 100 millirems in any animals, animal waste, and carcasses, (c) instructions for 7 consecutive days (see paragraphs 20.105(b)(I) and (b)(2) cleaning and decontaminating animal cages, and (d) proce-of 10 CFR Part 20). dures for ensuring that animal rooms will be locked or otherwise secured unless attended by authorized users of

b. Special precautions to be used while handling sealed radioactive material. Instructions to animal caretakers sources. should reflect the types of studies done at the institution,

c. Your method for determining the radiation doses to / tem 23 Procedures and Precautions for Use of Radioac-the extremities of personnel handling scaled sources. tive Materials Specifiedin / tem 6b. Clearly state any addi-(O) tional radiation safety procedures to be followed while indi-C/ d. The equipment and shielding available for transporting viduals are using the materials listed in item 6b, e.g., air sources from storage sites to the place of use. sampimg, other special surveys, bioassays, leak testmg scaled sources. including radiation safety precautions.

e. Your method for maintaining source accountability at all times. This should include a description of sign-in and Bioassays may be required when individuals work with sign-out procedures, periodic inventory, and the method for millicune quantities of H-3, I-125, or I 131 (depending on determining that all sairces are accounted forand returned to the chemical and physical form, the procedures followed, storage immediately following the conclusion of treatment. and the equipment used). Bioassays may also be required for other radionuclides if the chemical or physical form or

f. Surveys to be performed during the course of treatment procedures and equipment used make it likely that the and at the conclusion of treatment. The patient and room radioactive material will be mgested, inhaled, or absorbed should be surveyed with a radiation survey instrument imme- into the body. Show in the application that the need for diately following the conclusion of treatment and before the bioassays has been thoroughly considered and that the pro-patient is discharged. This survey should melude a source posed bioassay program is appropriate for the intended use count and should be adequate to determine that all tempo- of radioactive material. Guidance on bioassay programs for rary implant sources have been removed from the patient I-125 and 1131 is provided in Regulatory Guide 8. 20 Guid-and from all areas that the patient occupied. ance for bioassay programs for tritium and other radionu-clides is available as staff criteria from the Matenal Licensing

g. Special instructions for nursing care of patients who Branch, Division of Fuel Cycle and Material Safety Office are treated with sealed sources. ( Appendix L to this guide of Nuclear Material Safety and Safeguards, U.S. Nuclear contains a description of procedures to be followed for Regulatory Commission, Washington, D.C. 20555.

patients treated with sealed sourcesl

/ tem 24 PersonnelMonitoring Dences. Provide the name Submit detailed responses to item Nos 20a through 20f. of the organization furnishing film badge or thermolumines-In response to item 20g, indicate, by checkmg the appro- cent dosimeter (TLD) service. Specify the frequency with priate box in Item 20. that the procedures described in which the badges are changed and evaluated, and give a

/ O description of the type, e.g., whole body, wnst, or finger

( ) badge Where wrist badges are worn to monitor extremity mN F, 6 u e'on h th'e p pt cc ure ss exposures and exposures to Imgertips are likely to be greater pp. 3.i6 through 314 of then report, than the wrist exposures, describe how fmgertip exposures 10 &li L

I l

will be estimated from the wrist badge data m heu of using Amendment apphcations should be signed and dated by

finger monitors, and provide any backup data used to a representative of the hcenseeN admmntrative management perfirm or verify these estimates Wrist or rmg badges (e.g., the hospital adnunistrator) A tce must accompany

'should be worn toward the palm side of the hand f or mea- amendment appheations as mdwatcJ m item ha. An

suring hand exposures. Where feasible, rmg badges should onginal and two copies of the apphcation for amendment be w:rn on the index (mger facing toward the palm side of should be prepared, and the onginal and one copy should be th? h:nd. When pocket ionization chambers (pocket dosim- submitted, as m the cases for new or renewal applications.

eters) are to be used for personnel monitoring,give the manu- See Appendix N lor commonly requested amendments f:ctur r's name, model number, range of scale readmgs, cahbration and check procedures, frequency of cabbration, and frequency of reading and recording exposures. 6. RENEWAL OF A LICENSE

/ tem 23 /For Private Pracoce Apphcants Only) An application for renewal of a hcense should be tiled at least 30 days prior to the espiration date. T his will ensure Item 25a. State the name and address of the hospital that the license does not expire untd fmal action on the that has rgreed to admit patients containmg radioactive application has been taken by the NRC as provided for in material, paragraph 30.371b) of 10 CFR Part 30.

Item 25b. Submit a copy of theletterof authorization, Renewal applications should be filed on Form NRC-313M signed by the administrator, from the hospital that has agreed appropriately supplemented, should contam complete and to admit patients containing radioactive material. u p-to-da te information about the applicant's current program, should meet all licensmg and regulatory require-Item 25c. If patients treated with therapeutic quanti- ments m effect at the time of renewal, and should be signed ties under this license are admitted to the hospital,(1) de- and dated by a representatne of the ticensee's admmistrative scribe the radiation detection instruments available at the management (e.g., hospital administrator). Renewal apphca-hospital and (2) submit a copy of radiation safety proce- tions should also mclude the physician-users' traming and dures to be followed. experience (Supplements A and B of Exhibit A) or make a clear and specific reference to previous applications on which item 26a. Ucense fee category and license fee may be deter- individual users received approval.

mined from information pertaining to medical licenses in In order to facihtate the review process, the apphcation

@ l70.31 of 10 CFR Part 170.

for renewal should be submitted without reference to

/tems 2db and c. Provide the signature of an mdividual previously submitted documents and information (except authonzed by management to represent an applicant institu- for previously approved users) If such ref erences cannot he tion or the signature of an individual physician,in the case

~

avoided. they are acceptable provided .

of Category 7C of Q 170.31, with the date of signature

a. The reference is made in response to a particular item

5. AMENDMENTS TO LICENSES of required information (e g., bioassay procedures).

Licensees are required to conduct their programs m b. The reference is clear and specific (e g, title of dotu.

accordance with statements, representations,and procedures ment, date of submission. page, and paragraph L and contained m the hcense apphcation and supporting docu-ments. The license must therefore be amended if the c. The referenced document contains all information hcensee plans to make any changes m the facihties, equip- required for a particular item at the time of renewal mint (includmg types of monitoring and survey instruments).

procedures, authorized users or radiation safety officer, or Prepare an ongmal and two topies of the application byproduct material to be used. Retain one copy of the application, with all attachments.

because the beense will require, as a condition. that the institution follow the statements and representations Applications for hcense amendments may be fded either on the application form or in letter form The application set forth in the apphcation and any supplement to it. Mail should identify the license by number and should clearly the onginal and one copy to the Matenal Licensing Branch.

describe the exact nature of the changes, additions, or Division of Fuel Cycle and Matenal Safety Offwe of d;tetions. References to previously submitted information Nuclear Matenal Safety and Safeguards, U S. Nuclear and documents should be clear and specific and should Regulatory Commission. Washington. D C. 205 5 5 A fee identify the pertinent information by date, page, and must also accompany renewal apphtations, as indicated m paragraph. Item 264 O

10.412

)

LIST OF APPENDICES

\

Item No.

on Form Appendix NRC 313M A Acceptable Training and Experience for Medical Uses of Byproduct Material 8 B Medical Isotopes Committee 7 C Instrumentation 9 D Calibration of instruments 10 Section 1 - Methods for Calibration,of Survey Meters,includmg Procedures, Standards, and Frequency Sectie t 2 - Methods for Calibration of Dose Calibr.stor l E Procedu.v ,r Ordering and Accepting Delivery of Radioactive Material 13 F Procedures for Sa:('v C peni. g Packages Containing Radioactive Material 14 G General Rules for Safe s e of k 'dioactive Material 15 H Emergency Procedures 16

% I Area Survey Procedures 17 J Waste Disposal 18 K Radiation Safety Procedures for Thera. euti Use of Radiopharmaceuticals 19 L Radiation Safety Procedures for Therapeu c is .* of Scaled Sources 20 M Procedures and Precautions for Use of Radio..-tive ' eses (e.g., Xe-133) 21 N Guidance on Requests for License Amendmen'*

• _. ense Terminations O Model Program for Maintaining Occupationai stadiation hposures at MedicalInstitutions ALAR A P Bibliography

)

10.8-13 l L

F~

APPENDIX A

! ]I f

'V' ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES OF BYPRODUCT MATERIAL

• General Criteria a. Training m basic radioisotope ( 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />)"

1.

handling techniques apphcable Any human use of byproduct material (i.e., the internal to the use of unsealed sources.

or external administration of byproduct material, or This training should consist of .

the radiation therefrom, to human beings) must be lectures, laboratory sessions, carried out by or under the supervision of a physician, discussion gmups, or supervised As defined in paragraph 35.3(b) of 10 CFR Part 35 a experience in a nuclear medicme physician means an individual licensed by a State or laboratory ( i.e., on-the job territory of the United States, the District of Columbia. trainirig in a formalizal traming or the Commonwealth of Puerto Rico to dispense drugs program) in the followire areas in the practice of medicme.

f!! R:Liion physics and (100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />)

Paragraph 35.ll(d) of 10CFR Part 35 provides that the mstrumentation Commission will approve a license application by an institution for medical use of byproduct materialif it (2) Radiation protection (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />) determines, among other things, that the physician designated as the individual user is adequately trained (3) Mathematics pertaining to (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) and experienced in (a) basic radioisotope handling the usc and rneasurement techniques and (b) the clinical management of of radioactivity patients to whom radiopharmaceuticals have been administered. Similar criteria are established in para- (4) Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) graph 35.12(a)(4) of 10 CFR Part 35 for the approval of g licenses for medical use of radiopharmaceuticals by (5) Ra!iopharmaceutical chemistry (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)

I mdividual physicians. Outlined below are training and g

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

physicians who use radiopharmaceuticals.

b. Fxperience with the types and quantities of This training and experience must have been obtained byproduct material for which the application is within a 5-year period preceding the date of theIt:ense being rnate, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). For author-application or must be supplemented by continuing ization for Group ill(generators and reagent kits),

education or experience. Also, the original training and this experience should include personal partici-experience should have been received in a formal resi- pation in five procedures to clute Tc-99m including dency program in an accredited medical institution. testing of cluate, and five procedures to prepare Each physician's training and experience are examined radiopharmaceuticals from Group til reagent kits.

on a case-by-case basis. If a physician wishes to use radio-pharmaceuticals but does not have the training and c. Supervised clinical trainmg in an institutional experience described, he may submit an application nuclear medicine program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). The clini-listing his specific qualifications and these will be cal training should cover all appropriate types of reviewed by the Commission with the assistance of diagnostic procedures and should include:

the ACMUI.

(l} Supervised examination of putients to deter-

2. Training for Routine Diagnostic Procedures (Groups mine the suitabihty for radioisotope diag-nosis and recommendation on dosage to be I-III) prescribed.

To, qualify as adequately trained to use or directly supervise the use of byproduct material listed in (2) Collaborati sn .n calibration of the ese and Groups I,11, and/or tilin Q35.100 of 10 CFR Part 35, the actual administration of the dose to the a physician should have. patient, including calculation of the radia-O 3

Changes in these requirements are antacerated in the near future ..

tion dose, related measurement, and plot-ting data.

The hours are in terms of hours of class, laboratory, or cimscal (arter publicatson of thn guide) and wiH be published in a revision es perience rather than semester hours.

to this guide.

10.8-15 t _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -

(3) Followup of patients when required. (1) Radiation physics and (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) mstru mentation (4) Study and discussion with preceptor of case histories to establish most appropriate diag- (2) Radiation protection (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) nostic procedu res, limitation, contraindica-tion, et c (3) Mathematics pertaining (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />) to the use and measure-ment of radioactivity Note A; (4) Radiation bielogy (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)

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

b. Clinical training in specific therapy procedures:

N:te B:

For Group IV Fct each physician named in item 4 of Form NRC-313M, c:mplete Supplements A (Training and Experience) (1) 1-131 for treatment of hyperthyroidism and B (Preceptor Statement) of Form NRC-313M. For and/or cardiac conditions :

each subject covered in basic trainmg, state where the tr:ining was obtained, the dates, total number of hours, Clinical experience in the diagnosis of and type of training. Hours of training should be broken thyroid function and active participation d:wn into lecture or laboratory hours or on-the-job in the treatment of ten parients.

training (OJT). OJT must have been obtained in a firmalized training program. Be sure that individual (2) Soluble P-32 for treatment of polycythe-hours of training can be traced to the institution mia vera, leukemia.and/or bone rnetastases:

where the training was received. Each hour of training should be listed under only one subject category (i.e., Active participation in the treatment of the most applicable subject category). three patients with any combination of these three conditions.

Alternatives (3) Colloidal P-32 forintracavitary treatment :

Certification by(a)the American Board of Nuclear Med-icine, or (b) the American Board of Radiology in Diag- Active participation in the treatment of nostic Radiology with Special Competence in Nuclear three patients.

Radiology will be accepted as evidence that a physician h s had adequate training and experience to use Groups For Group V 1, II, and Ill.

(1) 1-131 for treatment of thyroid carcinoma :

3. Training for Specific Diagnostic Proced ires Clinical experience in diagnosis of thyroid A physician who wishes to be authorized for only one function, persnnal participation in the treat-or two specific diagnostic procedures should have train- ment of ten patients with hyperthyroidism ing in basic radioisotope handling techniques and clini- and/or cardiac dysfunction, and active par-cal procedures commensurate with the procedures and ticipation in the treatment of three patients quantities of byproduct material being requested. Such with thyroid carcmoma.

requests will be examined on a case-by-case basis by the Commission with the assistance of the ACMUI. (2) Colloidal Au-198 for intracavitary treat-ment:

4 Training for Therapy Procedures involving R adio-pharmaceuticals Active participation in the treatment of three patients Ta qualify as adequately trained to use or directly supervise the use of byproduct material listed in 5. Training for Therapy Procedures involving Scaled Groups IV and/or V in Q35.100 of 10 CFR Part 35, a Sources ,

physician should have:

To qualify as adequately trained to use or directly super-

a. Training in basic radioisotope (80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) vise the use of byproduct materiallisted in Group Viin handling techniques applicable Q35.100 of 10 CFR Part 35, a physician should have to the use of unsealed sources for therapy procedures, includ- a. Training in basic radioisotope (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) ing handling techniques appbcable 10.8-16

p ._

to the use of sealed sources for above. Physicianscertified by the FFR or FRCR must therapy procedures, c'onsisting also submit evidence of specialpation in radiotherapy.

[m\ oflectures, laboratory sessions, Evidence of previous approval by the NRC or an Agree-(  ! discussion groups, or supervised experience in the following ment State may also be submitted in lieu of the infor-mation requested above In this case, the applicant areas: should specify the number of the NRClicense or submit a copy of the Agreement State license on which the (1) Radiation physics and (110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br />) applicant-physician was specifically listed as an author-instrumentation ized user.

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

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

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

b. Experience with the types and quantities of radio- b. Evidence of:

active material for which the application is made, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). (1) Active practice m therapeutic radiology or ophthalmology, and

c. Clinical training in Group Vi procedures :

(2) Training in basic radio- 124 hour0.00144 days <br />0.0344 hours <br />2.050265e-4 weeks <br />4.7182e-5 months <br />st Active practice in therapeutic radiology with a isotope handling tech-

[]

(

minimum of 3 years experience of which at least l year should have been spent in a formal training niques, including bj program accredited by the Residency Review (a) Radiation physics and (6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />)

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

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

As evidence of the foregoing training and experi-ence, Ihe applicant should complete Supple. (c) Mathematies pertain- (4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />) ments A and B of Form NRC-313M. Supple- ing to the use and ment B should be completed and signed by each measurement of preceptor physician under whom the applicant- radioactivity physician gained experience or training. Submis-sion oflettersof evaluation from each preceptor- (d) Radiation biology (M hoursi physician on behalf of the applicant-physician should be included with the application. These This information may be submitted on letters of evaluation should describe the scope Supplement A of Form NRC-313M. The and extent of the applicant-physician's training hours listed next to each of the four sub-and experience and should include an appraisal jects are suggested minimum values and of the appheant-physician's competency to use should not be interpreted as specific Group VI sources independently for therapy requirements.

procedures.

(3) Evidence of active participation in the treat-Note: ment of /be parients (to be submitted on Supplement B (Preceptor Statement) of Evidence of certification by the American Board of Form NRC-313M).

Radiology in Radiology or Therapeutic Radiology, certification as a Bntish " Fellow of the Faculty of " Active retticipation"should mchufe super-Radiology"(FFR) or " Fellow of the Royal College of vised examination of patients, collaboration

[m (y} Radiology" (FRCR) or Canadian certification from the Royal College of Physicians and Surgeons (RCPS) and calculations concernmg the dose to be used administration of the dose to the in therapeutic radiology may be submitted in heu of patient, and followup and studyof patient the information requested in Sections 5a through c case histories.

10.8 17

l APPENDIX B O

( MEDICAL ISOTOPES COMMITTEE

• N Responsibility keeping personnel) are properly instructed as required by 19.12 of 10 CFR Part 19.

The committee is responsible for :

4. Review and approve all requests for use of radioactive l

l. Ensuring that all individuals who work with or in the material within the institution.

vicinity of radioactive material have sufficient training and experience to enable them to perform their duties 5. Prescribe special conditions that will be required dur-safely and in accordance with NRC regulations and ing a proposed use of radioactive material such as the conditions of the license. requirements for bioassays, physical examinations of users, and special monitoring procedures.

I 2. Ensuring that all use of radioactive material is con-ducted in a safe manner and in accordance with NRC 6. Review the entire radiatiun safety program at least regulations and the conditions of the license. annually to determine that all activities are being con-ducted safely and in accordance with NRC regulations Duties and the conditions of the license. The review shall include an examination of alt records reports from the The committee shall: radiation safety officer, results of NRC inspection, written safety procedures, and the adequacy of the

1. Be familiar with all pertinent NRC regulations, the institution's management control system.

terms of the license, and information submitted in sup-port of the request for thelicense anditsamendments. 7. Recommend remedial action to correct any deficiencies identified in the radiation safety program.

2. Review the training and experience of all individuals who use radioactive material (including physicians, 8. Maintain written records of all committee meetings, technologists, physicists, and pharmacists) and deter- actions, recommendations, and decisions.

mine that their qualifications are sufficient to enable N'") them to perform their duties safely and in accordance 9. Ensure that the byproduct materiallicenseis amended, with NRC regulations and the conditionsof the hcense. when necessary, prior to any changes in facilities, equipment, policies, procedures, and personnel, as

3. Establish a program to ensure that allindividuals whose specified in the license.

duties may require them to work in the vicinity of radioactive material (e.g., nursing, security, and house- Meeting Frequency The medical isotopes committee shall meet as often as neces-A rule as espected in 1961 that would thange the name.composi-sary to conduct its business but not less than once in each tion, and functions or this committee. calendar quarter.

(

10.8 19 L

APPENDlX C INSTRUMENTATION 1.- Survey meters

a. Manufacturer's name:

Manufacturer's model number t Number of instruments available:

Minimum range: mR/hr to mR/hr Maximum range: mR/hr to mR/hr

b. . Manufacturer's name :

l 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. Instr aments used for diagnostic procedures Manufacturer's Type of instrument Name Model No.

4 Other (e g., liquid scintillation counter, area monitos, velometer) 10.8-21 s ..

} APPENDlX D

\"/ CALIBRATION OF INSTRUMENTS Section 1 METHODS FOR CALIBRATION OF (X. AND G AMMA RAY) SUI 1VEY METERS, INCLUDING PROCEDURES, STANDARDS, AND FREQUENCY A. Calibration of survey meters shall be performed with wise, a cautionary note that they have not been checked

! radionuclide sources. should be placed on the instrument.

1. The sources shall be approximate point sources. B. A reference check source of long half ! fe, e.g.. Cs-137 l

or Ra D and E, shall also be read at the time of the above

2. The source activities or exposure rates at given calibration or as soon as the instrument is received distances shall be traceable bydocumented mea- from a calibration laboratory. The readings shall be surements to a standard source certified within taken with the check source placed in specific geometry 5 percent accuracy to the U.S. National Bureau relative to the detector. A reading of this reference of Standards (NBS) calibrations. check source should be taken:

3. The frequency shall be at least annually and af ter 1. Before each use and also after each survey to en-servicing. sure that the instrument was operational during

?e survey.

4. Each scale of the instrument shall be calibrated at least at two points located at approximately 2. After each maintenance and/or battery change.

gS 1/3 and 2/3 of full scale.

i 3. At least quarterly.

(

(,,/ 5. The exposure rate measured by the instrument shall differ from the true exposure rate by less if any reading with the same geometry is not than 10 percent at the two points on each scale within 120 percent of the reading measured (read appropriate section of the instrument imrsediately after calibration, the instrument manual to determine how to make necessary should be recalibrated (see item A).

adjustments to bring instrument into calibra-tion). Readings within 120 percent will be con- C. The instrument must be calibrated at lower energies if sidered acceptable if a calibration chart, graph, its response is energy dependent and if the instrument is or response factor is prepared, attached to the to be use $ forquantitative measurementsin the Xe 133 instrument, and used to interpret meter readings or Tc 99m energy ranges.

to within 10 percent for radiation protection purposes. The calibration may be done either:

Note: 1. As in item A above with calibrated standards of radionuclides at or near the desired energies, or Sources of Cs-137, Ra 226, or Co-60* are appropriate for use in calibrations. Since these sources emit rather 2. As a relative intercomparison with an energy-high-energy photons, they are not suitable for low- independent instrument and uncalibrated radio-energy calibrations that may be required under special nuclides circumstances (see item C below). The activity of the calibration standard should be sufficient to calibrate Alternatively, the manufacturer's energy response the survey meters on each scale to be used for radia- curve (s) may be used to correct instrument readings tion protection purposes. Scales up to i R/hr should appropriately when lower energy radiation is monitored.

be calibrated, but higher range scales above i R/hr need not be calibrated when they will not be needed for D. Records of the above items A, B-2. B 3, and C must be radiation protection surveys. If there are higher ranges, maintained Og they should at least be checked for operation and approximately correct response to radiation. Other. E. Use of Inverse Squsrc Law and Radioactive Decay Law

(%_d /

mnimum activism of typicet sources are es mci or Cs.137, I. A calibrated sourec will have a calibration certifi-2

,,1 gc6 c_o co40, and 34 mci nt Re 226 (na sive et least 700 mR/hr cate giving its eitpostire rate at a given distance.

10.8-23 I

or its activity, measured on a specified date by where the manufacturer or NBS.

Roand R t are in the same units (e.g.,

a. The inverse Square Law may be used with mR/hr or R/hr).

any point source to calculate the exposure rate at other distances. Ro is exposure rate on the speci-fled calibration date.

b. The Radioactive Decay Law may be used to calo21 ate the exposure rates or source activi- R, is exposure rate t units of time ties at times other than the caliteration aate. later.

2. Inverse Square Law Tg and t are in the same units (years, months, days, etc.).

Consider a" point"* source d radiation at position S, as shown in Figure D-1. Then, the relationship Tg is radionuclide half-life.

between exposure rates R, and R, at detector positions P, and P 2,which are at distancesD, and t is number of units of time D2fr m S respectively,is given by the following elapsed between calibration equation !

• and present time.

2 D

R=A 2 D xR 8

4. Example: Source output is given.by calibration 2

certificate as 100 mR/hr at I foot on March 10, 1975. Radionuclide half-life is 5.27 years.

where R, and R are 2 exposure rates in the same units (e.g., mR/hr, R/hr), and D, and D2 are the Question: What is the output at 3 feet on distances in Figure D-1 in the same units (c.r.,

March 10.1977 (2.0 years)?

m,em,ft).

P, P 2 a. Om at I foot,10 years afmalihah

_S _

date :

Dj =

(0.693 x 2.0)

D2 R = 100 mR/hr x e' 5.3

= 100 x 0.77 = 77,mR/hr at Figure D 1 I foot on March 10,1977.

3. Radioactive Decay Law b. Output at 3 feet,2.0 years after calibration date :

Exposure rate t unitsof time after specified cali-(I foot)2 bration date feet = x 77 mR/hr 3

0 (3 feet):

1T693 x tl Rt = R, x e g

= 1 x 77 = 8.6 mR/hr at A source rney be considered a " point" source when the source and the radiation detector are small,in any dimension, compared to 3 feet,2.0 years after the distances at which radiation is to he measured. The center of th, detector should be at distances D, or D2 as shown in bgure D-l. cahbration.

O'

10. A-24

p....

CALIBRATION OF SURVEY INSTRUMENTS A

\

( Check appropriate items.

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

, 2. Calibration will be performed at two points on each scale used for radiation protection purposes, i.e. at least up to 1 R/hr.

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 t 10 percent of the calculated or known values for each point checked. Readings within 120 percent are considered acceptable if a calibration chart, graph, or response factor is prepared, attached to the instrument, and used to interpret readings to within i10 percent. Also, when higher scales ase not checked or calibrated, an appropriate precautionary note will be posted on the instrument.

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 or Exposure rate at a specified distance Accuracy i Traceability to primary standard

%)

(2) The calibration proceduresin Section I of Appendix D will 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 sources have been approved by NRC and are on file in 1.icente No.

have been approved by an Agreement State.a copy of the Agreement State license, the procedures, and a description of the sources are attached, and the consultant's report will contam the information on the attached " Certificate of Instrument Calibration."

the consultani's reportmg form as attached.

are described n the attachment, and the consultant's report will wnf ain the information on the attached " Certificate of Instrument Cahbration."

the consultant's reporting form as attached.

10425

CERTIFICATE OF INSTRUMENT CAllBR ATION For:

O Instrument:

Manufacturer l

Type l

Model No.

Serial No.

Calibration Data:

Exposure Instrument E x posu re Instrument Ex posure Instrument rate reading rate readmg rate reading Scale (mR/hr) (mR/hr) (mR/hr) (mR/hr) (mR/hr) (mR/hr) . . .

O Cc mments:

Activit y or Calibration Nuclide Exposure Rate at Specified Distance Accuracy Calibration Source -

Calibrated by - - -- - - Date O

10.8 26

APPENDIX D (Continued) g

\

'j Sect on 2 METHODS FOR CALIBR ATION OF DOSE CAllBRATOR*

All radiopharmaceuticals must he assayed for activity to 3. Calculate net activity of each source subtracting an accuracy of 10 percent. The most common instrument for out background level.

accomplishing this is an ionization-type dose calibrator. The instrument must be checked for accurate operation at the time of installation and periodically thereafter. 4. Fo' each source, plot net activity versus the day of the year on semilog graph paper.

( A. Test for the following:

l S. Log the background levels.

f I. Instrument constancy (daily) i

2. Instrument accuracy (at installation and annually 6. Indicate the predicted activity of each source thereafter) based on decay calculations and the 15 percent limits on the graph.

3. Instrument lmearity (at installation and quarterly thereafter)

7. Repeat the procedure used for the Cs-137 source 4 Geometncal variation (at installatien) for all the commonly used radionuclide settings.

l B. Af ter repair or adjustment of the dose calibrator, repeat 8. Variations greater than 15 percent from the pre-all the appropriate tests listed above (dependent upon dicted activity indicate the need for instrument l n the nature of the repairs). repair or adjustment.

' I \

l ( ,/ C. Test for Instrument Constancy 9 Investigate higher than normal background levels to determine their origin and to eliminate them Instrument constancy means that there is reproduci- if possible by decontamination, relocation, etc.

bility, within a stated acceptable degree of precision, in measuring a constant activity over time. Assay at least one relatively long-lived reference source such as D. Inspect the instrument on a quarterly basis to ascertain Cs-137, Co-57,** or Ra-226** using a reproducible that the measurement chamber liner is in place and geometry before each day's use of the instrument. that instrument zero is properly set (see manufacturer's Preferably, at least two reference sources (for example, instructions).

3-5 mci of Co-57 and 100-200 pCi of Cs-137 or 1-2 mg Ra-226 (with appropriate decay corrections) will be alternated each day of use to test the instrument's E. Test of Instrument Linearity performance over a range of photon energies and source activities. The linearity of a dose calibrato should be ascertained over the entire range of activities employed. This test

1. Assay each reference source using the appropriate will use a vialof Tc-99m whose activity is equivalent to instrument setting (i.e., Cs-137 setting for Cs.137). the maximum anticipated activity to be assayed (e.g.,

the first clution from a new generator).

l 2. Measure background level at same instrument set-ting, or check that automatic background sub- 1. Assay the Tc-99m vial in the dose calibrator and traction is operating properly when blanks arc subtract background level to obtain net activity inserted in the calibrator. in millicuries.

'See ANSI N42.13-197s." Calibration and Usese of Dase Calibrator 2. Repeat step I at time intervals of 6,24,30, and tonisation Chambers ror the Assay of Radsonuclides" (American 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> af ter the initial assay.

National Standards Institute, Inc.,1430 Broadway, New York, N.Y.

loo t a).

/G ,, 3. Using the 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> activity measurement as a start-

! i Cn-s7 and Ra 226 are not subject to NRC tscensins; the respective j *M M,'g"'di, '" ,$ ,d U.* """" ' d""""'"'"""'"**"''

ing point, calculate the predicted activities at 0.

6, 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> using the following table:

10.8 27

Assay Time'(hr/ Correction Frctor as in step i. (Fo; low good radiation safety prac-tices to avoid contaminatica and to minimize 0 31.633 radiation exposure )

6 15.853 24 1.995 3. Select one volume as a standard (such as the 30 I volume of reference standard used in performing 48 0.126 the test for instrument accuracy), and calculate the ratio of measured activities for each volume Example : If the net activity meawiaxi at 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> to the reference volume activity. This represents was 15.625 mci, the calculated actmties for 6 and the volume correction factor (CF).

48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci 4 b 853 = 247.7 mci and 15.625 mci x 0.126 = 197 mGi, respec- Emmple: If activities of 2.04, 2.02. and 2.00 mci tively. are measured for 4, 8. and 10 mi volumes and 10 mi is the reference volume selected.

4. On log-log coordinate paper, plot the measured net activity (for each time interval) versus the 2 calculated activity (for the same time interval). 4 ml Volume CF == 0.98 g.00

5. The activities plotted should be within + 5 percent of the calculated activity if the instrument is 4. M a the correction factors against the volume on l linear and functioning properly. Errors greater haear graph paper. Use this graph to select the than 15 percent indicate the need for repair or proper volume correction factors for routine adjustment of the instrument. assay of that radionuclide.

6. If instrument linearity cannot be corrected,it will 5. The true activity of a sample is calculated as be necessary in routine assays to use either(a)an follows :

aliquot of the cluate that can be accurately mea-sured or (b) the graph constructed m step 4 to True Activity = Measured Activity x relate measured activities to calculated activities Correction Factor F. T;st for Geometrical Variation where the correction factor used is for the same volume and geometrical configuration as the There may be significant geometrical variation in activi- sample measured.

ty measured as a function of sample volume or configu-ration, depending on the volume and size of the ioniza- 6. Simdarly, the same activity of Co-57 in a syrmge tion chamber used in the dose calibrator. The extent may be compared with that of 10 miin a 30-cc of geometrical variation should be ascertained for vial, and a correction factor may be calculated.

commonly used radionuclides and appropriate correc-tion factors computed if variations are significant, i.e., 7. It should be noted that differences of 200 percent greater than 12 percent. (Even though correction fac- in dose calibrator readings between glass and tirs may be provided by the manufacturer, the accu- plastic syringes have been observed for lower-racy of these should be checked.)When available from energy radionuclides such as 1125, which should th] manufacturer, certified data on geometrical varia- be assayed in a dose calibrator only if the relia-tions may be used in lieu of these measurements. bility of such an assay can be established. Glass tubes and syringes may also vary enough in thick-To measure variation with volume of liquid, a 30 cc ness to cause sigmficant errors in assaying 1125.

vial containing 2 mci of Co-57 or other appropriate Hence, adequate correction factors must be radionuclide in a volume of I ml will be used. established.

Assay vial at the appropriate instrument setting, An alternative to providing syrmge calibration 1.

and subtract background level to obtain net factors is to simply assay the stock vial before activity. and af ter filling the syringe. The activity in the syringe is then the difference in the two readings Increase the volume of itquid in the vial in steps (with a volume correction if sigmficant)

• 2.

to 2,4,8,10,20, and 25 ml by adding the appro-priate amount of wster or saline. After each addi- G. Test for Instrument Accuracy tion, gently shake vial to mix contents and assay Check the accuracy of the dose calibrat 3r for several radionuchdes, including Cs-137, Co-57. and Ha !33.

Assay times should be measured in whole hours and entrectmn using appropriate reference standards whose a6tivities factors should be used to the third decimal place as indgated. The have been calibrated by comparisons with standard more recent half 4fe of T = 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> has been used en calculahng sources that have been assayed by NBS and documented.

thue correction factors. I/2 10.8-28

i i

The activity levels of the reference sources used should 4. Repeat the above steps for other commonly used approximate those levels normally encountered in clin- radionuclides for which adequate reference stand-

/ ical use (e.g., Co-57,3 5 millicuries) giving adequate ards are available.

. Q} attention to source configuration. Identify in your application the three sources that you will use. State 5. Keep a log of these calibration checks.

nuclide, activity, and calibration accuracy. The lower-energy reference standards (Tc-99m, Xe-133,1-125) 6. Calibration checks that do not agree within must be in vials with the same thickness of glass as the 15 percent indicate that the instrument should actualsamples to be measured for best accuracy. be repaired or adjusted. If this is not possible, a calibration factor should be calculated for use during routine assays of radionuclides.

1. Assay the reference standard in the dose calibra-tot at the appropnate setting, and subtract the 7. At the same time theinstrumentis beinginitially background level to obtain the net activity. calibrated at thelicensee's facility with the refer-ence standards, place a long lived source in the calibrator, set the instrument, in turn, at the vari-

2. Repeat step i for a totalof 3 determinations, and ous radionuclide settings used (Cs-137,1-131, average results. Tc-99m,1-125, etc.), and record the readings.

These values may later be used to check instru-ment calibration at each setting (after correcting

3. The average activity determined in step 2 should for decay of the long-lived source) without re-agree with the certified activity of the reference quiring more reference standards. Keep a los of source within 15 percent af ter decay corrections. these initial and subsequent readings.

s 10.8-29

CAllBRATION OF DOSE CAllBRATOR A. Sources Used for Line'anty Test (Check as appropriate)

First elution from new Mo-99/Tc-99m generator or Other* (specify)

B. Sources Used for Instrument Accuracy and Constancy Tests Suggested Activity ( mci) Activity (mci) Accuracy Radionuclide Co-57 3-5 Ba-133 0.1-0.5 Cs l37 0.1-0.2 Ra-226 l2 C. The procedures desenbed in Section 2 of Appendix D will be used for calibration of the dose calibrator or

_ Equivalent procedures are attached.

'For licensees who are not authorized for Mo.99/Tc.99m generators activity must be equivalent to the highest activity used.

@t 10 430

APPENDIX E b/ PROCEDURES FOR ORDERING AND ACCEPTING DELIVERY OF RADIOACTIVE MATERIAL

1. The Supervisory Nuclear Medicine Technologist will (I) A written request

• will be obtained from the place all orders for radioactive materials and will ensure physician who will perform the procedure.

that the requested materials and quantities are auth-orized by the license and that possession limits are not (2) Persons ordering the materials will refer-exceeded. ence the physician's written request when placing the order. The physician's request will indicate isotope, compound, activity

2. A system for ordering and receiving radioactive mate- level,etc.

rials will be established and maintained. The system will consist minimally of the following. (3) The physician's written request will be ref-erenced when receiving, opening, or storing the radioactive material.

a. Ordering of routinely used materials

c. It is essential that written records

• be maintained for all ordering and receipt procedures.

(1) Written records that identify the isotope, compound, activity levels, and supplier, 3. During normal working hours, carriers will be instructed j etc., will be used. to deliver radioactive packages directly to the Nuclear '

Medicine Department.

(2) The written records will be referenced when 4. During off-duty hours, security personnel or other opening or storing radioactive shipment. designated individuals will accept delivery of radioac-tive packages in accordance with the procedures out-(O

%d

)

• Ordering of specially used materials (e.g., thera-lined in the sample memorandum below.

In the case of spectat orders, the physician's written request and b.

peutic uses) appropriate shippins/ receipt records will be referenced and the dose

assayed prior to sts administration.

SAMPLE" MEMOR ANDUM MEMORANDUM FOR: Security Personnel

, FROM: John Jones, Administrator SUBJECT; RECEIPT OF PACK AGES CONTAININ ADI MATERIAL Any packages containing radioactive material that arriv m. or on Sundays shall be signed for by the Security guard on duty ar I taken immediatc! e artment. Unlock the door, place the package on ton of the counter immediately to the ri of , ockt oor, if the package is wet or appears to .e da tact the hospital Radiation Safety Officer. Ask the carrier to i remain at the hospital unt; lit ca er he nor the delivery vehicle is contaminated.

RADI ATION SAFF 0 E OFFICE PilONE : - M llOME PilONE:

\

Submit a copy of your own institution's memorendum 10.8-31

p APPENDIX F kj)

/

PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING RADIOACTIVE MATERIA 1.

1. Special requirements will be followed for packages con- (2) Open inner package and verify that con-taining quantities of radioactive material in excess of tents agree with those on packing slip.

the Type A quantity limits as specified in paragraphs Compare requisition.* packing slip, and 2Q205(aXI) and (c)(1) of 10CFR Part 20 (more than label on bottic.

20 Ci for Mo-99 and Tc-99m). They will be monitored for surface contamination and external radiation levels (3) Check integrity of final source container within 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt if received during working (i.e., inspect for breakage of seals or vials, hours or within 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> if received after working loss of liquid. and discoloration of pack-hours, in accordance with the requirements of para- aging material).

graphs 2Q205(a) through (c). All shipments ofliquids greater than exempt quantities will be tested forleak- (4) Check also that shipment does not exceed age. The NRC Regional Office will be notified in accord- possession limits.

ance with the regulationsif removable contamination exceeds 0.01 pCi/100 cm' or if external radiation levels exceed 200mR/hr at the package surface or f. Wipe external surface of final source container 10 mR/hr at 3 feet (or I m). and remove wipe to low background area. Assay the wipe and record amount of removable radio .

2. For all packages, the following additional procedures activity (e.g., pCi/100 cm2, etc.). Check wipes for opening packages will be carried out; with a thin-end-window G-M survey meter, and take precautions against the spread of contamina- :

a. Put on gloves to prevent hand contamination. tion as necessary.

p b. Visually inspect package for any sign of damage (e g., wetness, crushed). If damage is noted, stop g. Monitor the packing material and packages for t

\ procedure and notify Radiation Safety Officer. contamination before discarding.

c. Measure exporure rate at 3 feet (or I m) from (1) If contaminated, treat as radioactive waste.

package surface and record. If >10 mR/hr stop procedure and notify Radiation Safety Officer. (2) If not contaminated, obliterate radiation labels before discarding in regular trash.

d. Measure surface exposure rate and record. If

>200 mR/hr, stop procedure and notify Radiation Safety Officer. 3. Maintain records of the results of checking each guckage, using " Radioactive Shipment Receipt Record"(see next

e. Open the package with the following precau- page) or a form containing the same information.

tionary steps; (1) Open the outer package (following manu-facturer's directions, if supplied) and 'In the case of special orders (e.s . therspr doses). also compere remove packing slip. with physacian's written request.

10.8-33

1 RADIOACTIVE SHIPMENT RECEIPT REPORT

l. P.O. No. : Survey Date Time O

Surveyor

3. CONDITION OF PACK AGE :

O.K. Punctured Status Wet Crushed Other

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

4. MEASURED RADI ATION LEVELS :

a. Package surface mR/hr

b. 3 feet or i meter from surface mR/hr

5. DO PACKING SLIP AND VIAL CONTENTS AGREE?

a. Radionuclide yes no. difference

. b. Amount yes no. difference

c. Chem Form yes no. difterence .

6. CIPE RESULTS FROM:

a. Outer CPM = DPM eff = ( )

b. Finai source container CPM = DPM eff = ( )

8. SURVEY RESULTS OF PACKING M ATERI AL AND CARTONS m R/hr. CPM

9. DISPOSITION OF PACKAGE AFTER INSPECTION ___

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

Signature Date O

10.8 34

I APPENOlX G (j GENERAL RULES FOR SAFE USE OF RADIOACTIVE MATERIAL

1. Wear laboratory coats or other protective clothing at ity vs. the order written by the physician who will all times in areas where radioactive materials are used. perform the procedure.

2. Wear disposable gloves at all times while handling 7 Wear personnel monitoring devices (film badge or TLD) radioactive materials. at all times while in areas where radioactive materials are used or stored. These devices should be worn at

3. Monitor hands and clothing for contamination after chest or waist level. Personnel monitoring devices when each procedure or before leaving the area. not being worn to monitor occupational exposures should be stored in a designated low background area.

4. Always use syringe shields for routine preparation of patient doses and administration to patients.except in 8. Wear TLD finger badges during elution of generator and circumstances such as pediatric cases when their use preparation, assay, and injection of radiopharmaceuti-would compromise the patient's well-being. In these cats.

caceptional cases, use other protective methods such as remote delivery of the dose (e g.. through use of a 9. Dispose of radioactive waste only in specially designated butterfly valve). and properly shielded receptacles.

5. a. Do not eat, drink, smoke, or apply cosmetics in any 10. Never pipette by mouth.

area where radioactive material is stored or used.

II. Survey generator, kit preparation, and injection areas

b. Do not store food, drink, or personal effects with for contamination after each procedure or at the end radioactive material, of the day. Decontaminate if necessary.

6. a. Assay each patient dose in the dose calibrator prior 12. Confine radioactive solutions in covered containers to administration. Do not use any doses that differ plainly identified and labeled with name of compound.

( from the prescribed dose by more than 10 percent. radionuclide, date, activity, and radiation level. if applicable.

h. For therapeutic doses.also check the patient's name, 13. Always transport radio.ictive material in shielded the radionuclide, the chemical form, and the activ- containers

(

10.8 35

t APPENDIX H s

EMERGENCY PROCEDURES Minor Spills 3. SHIELD THE SOURCE: If possible, the spill should be shielded, but only if it can be done without further

1. NOTIFY: Notify persons in the area that a spill has contarnination or without significantly increasing occurred. your radiation enposure.

2. PREVENT THE SPREAD;tover the spill with absorb- 4 CLOSE THE ROOM: Leave the room and lock the ent paper. door (s) to prevent entry.

3. CLEAN UP; Use disposable gloves and rernote handling 5. CALL FOR llELP; Notify the Radiation Safety Offs-tongs. Carefully fold the absorbent paper and pad. in- cet immediately, sert into a plastic bag and dispose of in the radioactive waste container. Also insert into the plastic bag allother 6 PERSONNEL DECONTAMINATION: Contaminated l

contaminated materials such as disposable gloves. clothmg should be removed and stored for further evalu-ation by the Radiation Safety Officer. If the spillison 4 SURVEY: With a low range, thin window G M survey the skin, flush thoroughly and then wash with mild meter, check the area around the spill, hands, and soap and lukewarm water.

clothing for contamination.

l RADIATION SAFETY OFFICER- *

$. REPORT: Report incident to the Radiation Safety OFFICE PHONE:

Officer, llOME PHONEi Major Spdis ALTERNATE NAMES AND TELEPilONE NUMBERS DESIGNATED BY R ADIATION SAFLTY OFFICER.

1. CLEAR THE AREA

• Notify all persons not involved in the spill to vacate the room.

l

2. PREVENT Tile SPRE AD: Cover the spill with absorb-ent pads, but do not attempt to clean it up. Confine ,

the movement of all personnel potentially contami- supp eJ

,, gaQt najl; tut aponp r ya ut facility shou J nated to prevent the spread. wiin ene .ppiccation.

b 4

\

10.8 37

,q APPENDlX 1

\

(V) AREA SURVEY PROCEDURES 1

1. All clution, preparation, and injection areas will be $. A permanent record will be kept of all survey results, surveyed daily with an appropriately low-range survey including negative results. The record will include :

meter and decontaminated if necessary.*

a. Location. date, and identification of equipment

2. Laboratory areas where only small quantities of radio- used including the senal number and pertinent active material are used (lew than 200 pCl) will be counting efficiencies.

surveyed monthly.

b. Name of person conducting the survey.

3. Waste storage areas and all other laboratory areas will be surveyed weekly, c. Drawing of area surveyed, identifying relevant I features such as active storage areas, active waste

4. The weekly ahd monthly surveys will consist of: areas,etc.

d. Measured exposure rates, keyed to location on the l

a. A measurement of radiation levels with a survey drawing (pc, int out rates that require corrective meter sufficiently sensitive to detect 0.1 mR/hr. action).

b. A series of wipe tests to measure contamination e. Detected contamination levels, keyed to loca-levels. The method for performing wipe tests will tions on drawing.

be sufficiently sensitive to detect 200 dpm per 100 cm3 for the contaminant involved. Wipes of f. Corrective action taken in the case of contamina-flution and preparation areas or other "high tion or excessive exposure rates, reduced con-background" areas will be removed to s low back- tamination levels or exposure rates after correc-f ground area for measurement, tive action, and any appropriate comments.

\\ .

g,,[,"',,d'l'J,'",$',Fj"j','[,",*,*y"g',,},Q,N",,",d',7,8j

, , $l 6. Area will be cleaned if the contaminationlevelexceeds survey results wm tw recorded. 200 dpm/l00 cm .

v 10.8 39

"N O

O W

w O

O

APPENDIX J WASTE DISPOSAL Note : In view of the recent problems with shallow land burial sites used by commercial wash dispoul firms, NRC is encouraging its licensees to reduce the volume of wastes sent to these facilitics important steps in volume reduction are to segregate radioactive frc m nonradioactive waste, to hold short lived radioactive waste for decay in storage, and to release certain materials in the sanitary sewer in accordance with 20.303 of 10 Cf R Part 20.

1. Liquid waste will be disposed of(check as appropriate) Disposed of by commercial waste disposal serv-ice (see also item 4 below!

In the sanitary sewer system in accordance with

{ 20 303 of 10 CFR Part 20. Other (specify):

By commercial waste disposal service (see also ---

Item 4 helow).

• 3. Other solid waste will be (check as appropriate)

Other (specify ).

lleld for decay

• until radiation levels, as mea-sured in a low background area with a low level survey nrter and with all shielding renxwed, have

2. Mo-99/Tc 99m generators will be(check as appropriate) reached background levels. All radiation labels will be removed or obliterated. and the waste Returned to the manufacturer for disposal. will be disposed of in normal trash lleld for decay

• until radiation levels, as mea- Disposed of by commercial waste disposal serv-sured in a low background area with a low level ice t see also item 4 below).

survey nrter and with all shielding renv>ved. have reached background levels. All radiation labels . Other (specify) will be removed or obliterated, and the generators will be dispowd of as normal trash.* * - - - - - -

4. The commercial waste dnposal serwe used will be tie sure that waste storage areas were described in item ti and that they are surveyed perhidgeity (ltem 17).

These generatoft may (Ontaan long hved radioisotoptC Contame. (Name) trity, Statel nanta. Therefore, the generatot columns will be segregaied in that they may tse monitored separately to ensure decay to background levels pnor to darnest. NRC/ Agreement State License No _

t 10 M-41

1 l APPENDIX J WASTE DISPOSAL Note : In view of the recent problems with shallow-land burial sites used by commercial waste disposal firms, NRC is encouraging its licensees to reduce the volume of wastes sent to these facilitics, important steps in volume reduction are to segregate radioactive from nonradioactive waste, to hold short lived radioactive waste for decay in storage, and to release certain materials in the sanitary sewer in accordance with 20.303 of 10 CI~R Part 20.

l. l_iquid waste will be disposed of(check as appropriate) Disposed of by commercial waste disposal serv-ace (see also item 4 below).

In the sanitary sewer system in accordance with Q 20.303 of 10 CFR Part 20. Other (specify):

By commercial waste disposal service (see also --

item 4 below).

• 3. Other solid waste will be (check as appropriate)

Other (specify ).

lleid for decay

• until radiation levels, as mea-sured in a low background area with a low-level survey nrter and with all shielding removed, have

2. Mo-WTTc Wm generators will be(check as appropriateI reached background levels. All radiation labels will be removed or obliterated, and the waste Returned to the manufacturer for disposal, will be disposed of in normal trash lleid for decay

• until radiation levels, as mea- Disposed of by commercial waste disposal serv-sured in a low background area with a low level ice tsee also item 4 below).

survey meter and with all shielding removed.have reached background levels. All radiation labels Other(specify) will be removed or obliterated, and the generators

• will be disposed of as normal trash.** - - - -

4. The commercial waste dnposal wrvice uwd will be Be sure that waste storage areas were described in liem ti and that they are surveyed periodwelly (Item 17).

These senerators may contain long hved raJioisotopic contami. (Name) (City. State) nants. Thererove, the senerstne columns will be segressted so that they may tie monitored separately to ensure decay to background levels pnot to d6sposal. NRC/ Agreement State license No ,_

b 10 M 41

APPENDIX K RADIATION SAFETY PROCEDURES FOR THERAPEUTIC USE OF RADIOPHARMACEUTICAl.S*

1. All putients treatal with I.131 or Au 198 will be placed 8. Nondisposable items used for these patients will be held in a private room that has a todet. f he large surfaces in plastic bags in the patient's room and will be checked in the rooin and toilet areas that are more hkely to be for contamination by the Radiation Safety Officer or contaminated wdl be sovered with absorbent pads or his designec, items may be returned for normal toe.

protective material as appropriate to the amounts of held for decay, or decontaminated, as appropriate.

contamination to be expected. Attention should be given to objects I kely to be touched by the patient. 9. If utme and vomitus from I 131 therapy patients are e g , telephones, doorknobs, and other items that would tollected, they wdl be stored for decay in the radioac-be diffisult to decontaminate. Plastic bags or wrappings tive waste storage area Such stored wastes will be re-that are waterproof and easdy disposable should be tained untu they have reached background levels, as used on the smaller items measured with a low levelsurvey meter.They will then be released to the sanitary sewer system, 1 f he patient's room wdi be properly posted or attended m accordante with 20.203 or 20.204 of 10 CF R 10. Before a therapy patient's room is reassignal .o another Part 20 patient, the room wdl be surveyed for coritammation and decontammated of necessary, and all radioat tive 3 Surveys of the patient's room and surroundmg areas waste and waste containers wdl be removed.

wdl be conducted as soon as practiable af ter admmis-tration of the treatment Jose. liposure rates will be 11. Nursing instructions measured at the patient's bedside and 3 feet (or 1 mi from the pitient after administration and at the entrante a Narses should spend only that amount of time to the room. The Radiation Safety Officer or his desig- near the patient required for ordinary nursing nee wdi then determme how long a person may remain care. Special restrictions nsay be noted on the pre-al these positions and wdl post these times on the caution sheet on the patient's chart. Nurses should patient's chart and on his door. The results of daily read these restrictions before administermg to surveys wdl be used to recalculate permitted times. the patients. Call the Noclear Medicine Depart-whnh wdl be posted on the patient's chart and on hn ment or the Radiation Safety Officer with any door, questions about the care of these patients Nursmg personnel who attend the patient will 4 'T he form. Nursing Instructions for Patients Treated wear personnel monitoring devices as advised by with Phosphoruv32, Gold 198, or lodine 131 (or a the Radiation Safety Office.

somlar form contammg all the requested information L wdi he (ompleted immediately af ter adminntration of b %sitors will be hmited to those 18 years of age or the treatment dose A copy wdl be posted on the over unless other instructions are noted on the pa tie n t's (h a r t. presaution sheet on the patient's chart.

t Radiation levels m unrestricted areas will be maintained c. Patients must remain in bed whde viutors are m less than the hmits specified in paragraph 20.105(h) of the room and visitors should remain at least J feet 10(l R Part 20 (or i m) from the patient.

6 All knens wdl he suricyed for ointammation tefore bemn d. Patientsinntaining radioactive materials are to le removed from the patient *s room and. if necessary, wdi confined to their rooms except for special mede be held for decay cal or nursing pitposes agyroved by the Nu(lear Medicine Department.

7 D6 potable plates, tups, eating utensdt insue, surgical drenings, and other sondar waste items will be plased c. No nurse. visitor, or attendant who is pregnant m a specially deugnated tontamer Ihr material adi be should be permitled in the room of a patient who s olla ted dady by the Radiation Sately tillner or hn tus racived a theragrutic amount of rejeoactivity deugnce thet ked for sontamination, and dnposed of untd the patient no longer presents a radiation as normal or r adioat tiv e wastc. as appropriate. hatard, l'emale viutort should be asked whether they are pregnant.

N sure in sursme e oimpiece rewonie to leem i +h in 4JJirnia in A *O* M*"d b "" #

rererenting pros eJure* in AppenJin >,. posable plastic gloves when handl6AA urmals, 10.8 43

o halpans, emesis basins, or other containers having (3) Disposable plates, cups, and cating uternals any materialobtained from tir body of the pistient, will be uwd by patients who are treated Wash gloves before removing and then wash with l 131.

hands. The gloves should be left in the patient's room in the designated waste container These (4) Vomiting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> af ter oral admin-gloves need not be sterile or surgical in type istra tion. unnary inwnt mence. or e xcessive sweating withm the first 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> may result

g. Disposable items should be used)t: the care of m contamination of hnen and floor. in any these patients, whenever possible. These items situation where the patient's room may be should be placal in the designated waste contain- contaminated or if radioactive urine and/or er. Contact the Radiation Safety Officer or his Icses is spilled during collection, call the designee for proper disposal of the contents of Radiation Safety Officer or his designee.

the designated waste container. Est. Meanwhile, handle all con-taminated material with disposable gloves

h. All clothes and bed linens used by the patient and avoid spreading contamination.

should be placed in the laundry bag provaled and should be lef t in the patient's room to be checked i5) Keep all contaminated wastes and vomitus by the Radiation Safety Officer or his designee. m plastic bags in the patient's room for disposal by the Radiation Safety Officer or

i. ,.11 nondisposable items should be placed m a his desiFnce. l'cces need not he routinely plastic bag and should be left in the patient's saved innless ordered on the t hart. The same room to be checked by the Radiation Safety toilet should be used by the patient at all Officer or his designee. tmrs and it siv>uld be well flushed l3 timest The Radiation Safety Officer will estabinh J. Surzical dressings should be changed only as procedures for disposal of wastes (sce directed by the physician. Au 198 leaking from a item I: tselow) tuncture wound may stain the dressmgs dark red or purple. Such dressings should not be discarded I. If a nurse, attendant, or anyone else knows or but should be collected m plastic bags and turned suspects that hn or her skm or slothmg. meludinp over to the Radiation Safety Officer or his desig- shoes, is contaminated notify the Radiation nee. llandle these dressings only with tongs or Safety Officer or his designee immediately. Ihn tweeters Wear disposable gloves. person should remain in an area aducent to the patient's room and should not walk about the

k. For I 131 patients' hospital. If the hands become contaminatal, wash them immediately with soap and water.

(1) lo the degree possible with cooperative pattents, urine will be collected in special m, if a therapy patient should need emergency sur-containers provided by the Raliation Safety gery or should die, notify the Radiation Safety Officer or hin designer The patient should Offiser or the Nuclear Medicine Department be encouraged to collect hn own urine m immediately.

the container, if the patient is bedndden. 4 separate urinal or bed pan should be pro- n. When the patient n dacharged tall the Radiation vided. The urinal or bed ran should be Safety Of fiser or ha designee or the Nuclear Medi-flushed several times with hot soapy water sine lk uttment i and request tiut the rmm te sur-af ter use, veyed for contarnination tefore renukmg tir nm (2) If the nurse helps to collect the escreta, 12 Waste Dnpoul dnposable gloves should be worn. Af ter.

ward, hands should be washed with the W!rn tontaminatal wutes arc transported to the Waste gloves on and again af ter the gloves are te Storage / Disposal area. precautmns will t e taken to moved. The gloves should be placed in the mmimite esternal irradiation of personnel Stored designated waste container for disposal by wastes wul be shielded to maintam esposure to per-

. the Kahation Safety Of ficer or ha tk signee sonnelin restristed and unrestristed areas Al AR A O

10 M 44

Date NURSING INSTRUCTIONS FOR PATIENTS TRE ATED V/ITH PHOSPHORUS-32 GOLD 198, OR lODifJE 131 P.s t ie n t 's N a m e _ ___

Room No . , _ __._ _ Ph y uua n's N ame ' __

Radionotope Administered:

Date and Time of Administration I)ow Received. Method of Administration:

Esposure Rates in mR/hr Date 3 feel from bed 10 feel from bed Komply with all checked itemd

___ I Viuling time permitted

.' Viutors must remain f rom patient.

1 Patient may not leave room

.4 Vautors under 18 are not pernutt. I 5 Pregnant viutors are not permitted ti lilm or TLD liadges must be worn 7 Po(Let chambers will be worn for supplementary personnel monitoring of individual tasks M IJg the following obiects and fill out the tag

. door chart bed w rist 9 linrosable gloves must be worn while attending patient

,10 Patient must use ilispcsable utensils 1I Allitems inust remain in room until approved for removal by the Radiation Safety Officer or his designee.

1 .' %moking n not permitteil

13. Room is not to lic released to Admitting Office until approved by the Radiation Safety Officer or his designee 14 Other instrus tions in case of an emergency contact:

R50 Name On duty /Off duty Telephone Numtwrs 10 8 4$

APPENDtX L O RADI ATION SAFETY PROCEDURES FOR k THERAPEUTIC USE OF SEALED SOURCES *

1. All patients treated with brachytherapy sources will be be contacted to answer any questions about the placed in a private room that has a toilet. care of these patientsin regard to radiation safety

> precautions.

2. The petient's toom will be prorefly posted or attended in accordancewith QQ 20 203 or 20.204 of 10 CFR Part 20. b. Nurses should spend only the minimum time necessary near a patient for routine nursing care.

3. Surveys of the patient's room and surrounding areas Obtain and wear a film or TLD badge or a pocket will be conducted as soon as practicable after sources chamber as instructed by the Radiation Safety are implanted. Exposure rate measurements will be Officer.

taken at 3 feet (or 1 m) from the patient with sources implanted, at the patient's bedside, at 3 feet (or i m) c. When a nurse is assigned to a therapy patient, a from the bed, and at the entrance to the room. The film or TLD badge should be obtained immedi-Radiation Safety Of ficer or his designee wdi then deter. ately from the Radiation Safety Officer or his mine how long a person may remain at these positions designee. The badge shall be worn only by the and will post these times and the en posure rate at 3 feet nurse to whom it is issued and shall not be ex.

(or I m) from the patient on the patient's chart. changed among nurses.

4. Immediately after sources are implanted, the form d. Pregnant nurses should not be assigned to the

" Nursing instructions for Patients Treated with tirachy. personal care of these patients.

therapy Sources" will be completed and attached to the patient's char 1. e. Never touch needles, capsules, or containers hold-ing brachytherapy sources. If a source becomes

5. Radiation levels in unrest ricted aress will be maintamed dislodged, use long forceps and put it in the less than the limits specified m paragraphs 20.10$t bW1) corner of the room or in the shieldedcontainer and (hW 2) of 10 CFR Part 20. provided; contact Radiation Therapy, the Radia-tior Ssfety Officer, or the Nuclear Medicine 6, Nurses canng for brach>1herapy patients will be assigned Department at once.

film or TLD badges ILD imger badges will also be asugned to nurses who must provide en tended personal f. Red bath given by the nurse should be omitted care to the patient Pocket dos! meters may be assigned while the sources are in place.

in addition to a film or ILD badge

g. Perineal care is not given during gynecologic 7 At the contiusion of treatment, a survey will be per- treatment, the perineal ped may be changed when formed in accordance with paragraph 35.141hX$Xvu) necessary unless orders to the contrary have been of 10CFR Pari 35 to enwre that all soure:s other than written, permaient implantsluve been removest from the patient and that no sourses remain m the patient's room or in h. Surgical dressmas and bandages used to cover the any other area occupied by the patient. At the same area of nsedle insertion may be changed only by time all radiation signs will be removed and all fdm the attending physician or radiologist and MAY and ILD badges amaned to nurws will be collected if NOT BE DISCARDED untildirected by the rade the patient is to be distharged, the final survey will ologist. Dressings should be kept in a haun until

' also instude a notation on the patient's chart that the checked by the Radiation Safety Offner or hn activity remaining in the patient meets conditmns for designee, release from the hospital.

- Special orders will be written for oral hyriene for M. Instructions to Nurws patients with oralimplants, a Special restrictions may be noted on the precau. i. No special precautions are needed for sputum, tion sheet on the patient's shaf t. Nurses shoul.t urine, vomitus, stools, dishes, instruments, or read these instructions before administering to utensils unless specifically ordsted, but these the patient. The Hadiation safety Offnet should items should be saved for a check with a radia-lion survey meter to ensure Ihat no sources have

' tie iure in s >m.: omelete eeironies en teem 204 shenush tot en eaJ.non so vereren. s, penudurei .a Arrendia L. been inadvertently displaced into them.

10.M-4 7

J. All bed line s must be checked with a radiation o. I mergency Procedures survey meter before being removed from the patient's room to ensure that no dislodged sources (l) 11 an implanted sourte becomes loose or are inadvertently removed. wpar.ited from the patient, or t2) If the patient dies. or

k. These patients must stay in bed unless orders to the contrary are written. In any event, patients (3) If the patient requires emergency surgery, wdl remaan in their assigned rooms during the immediately call treatment period. .

Telephone No. (days)

1. Visitors will be limited to those 18 years of age or oser unless other instructions are noted on the (nights) precaution sheet on the patient's chart.

p. At the conclusion of treatment, call the Raliation yi m Visitors should sit at least 3 feet (or i m) from Safety Officer to(l) survey the patient and room.

, the patient and should remain nolonger than the (2) count the radiation sources to be sure that all time specifim! on the form posted on the patient's temporary implants have been removed prior to door and on his chart, discharging the patient, and (3) record a summary of the final survey results on the patient's chart.

rt No nurse, visitor, or attendant who is pregnant if any permancnl implants are to remam in the should bepermitled in the room of a pstient while patient, the Radiation Safety Offiser will brief brashytherapy sources are implanted in the pa- the patient on precautions for minimuing radia-tient. Female visitors .hould be asked whether tion cu posure to others af ter discharge from the they are pregnant, hospit al.

O A

4 O

10 M 4R

I NURSING INSTRUCTIONS FOR PATIENTS TRE ATED WITH BRACHYTHERAPY SOURCES Patient's Name' _

Room Number Physician's Name' _

lwtore and Activity' Date and Time of Adminatration _

Date and Time Sources Are To lie Removed ^ isotope En posure Rates in mR/hr Bedside 3 feet from bed 10 feet from bed f('oinply with all checked items.)

_ l Wear film or TLD badge

2. Wear posket chambers for supplementary personnel monitoring of individual tasks.

z_.

3 Wear rubber gloves.

4 lag the following objects and fill out the tag

,_. _ door __ s hart

, bed w rist

_ . . 5. I' late laundry in linen bag and save.

_ 6 llousekeeping may not enter the room, 7 Visiting time permilted R Vnitort must remain from patient.

9 Patient may not leave the foom.

10 Patient may not havs' visitors 11 Patient may not have pregnant visitors.

12 Patient rnay not have vnitort under IR years of age.

1.1 Patient must have a private room.

_ _ 14 A dismitut survey must be performed before the patient is dikharged.

10849 i

, _15. All items must remain in the room until approved for disposal by the Radiation Safety Officer or his designee.

16. Contact the Radiation Safety Office when temporary sources (nonpermanent implants) are re:noved to perform a survey to be sure all sources are removed from the patient, to do a physical source count, and to be sure no sources remain in the room.

, 17. Contact the Radiation Safety Office when the patient is discharged to survey the room pnot to its assign-ment to another patient

_ l 8. Other instructions.

RSO Name On duty /Off duty Telephone Numbers O

O 10.850

APPENDIX M e

PROCEDURES AND PRECAUTIONS FOR USE OF RADIOACTIVE GASES

[ (e.g., Xe 133)

\v/

4. Fmergency Procedures l The following information should be submitted in support of requests to use Xc 133 : l Describe the emergency procedures to be followed m ,

l. Quantities to be used case of an accidental release of Xe 133. This should include such considerations as temporary evacuation

a. Patient informatior. of the area or intreasing the ventilation of the area (I) Number of studies capected per week 5. Air Concentrations of Xe 133 in Restricted Areas (2) Average activity per patient No hcensee shall permit any individualin a restricted area to inhale a quantity of radioattive materialin .ny

b. State the desired possessionlimit. T his should be period of one calendar quarter greater than the quantity sufficient to provide for shipments whose cah- that would result from inhalation for 40 houts per week bration dates are several days af ter receipt, for 13 weeks at uniform concentrations of radioactive material of I a 10'5 pCi/ml.

2. Use and Storage Areas You may evaluate your situation by making actual mea-a Describe the area (s) m which you plan to use and surements of Xe 133 concentrations or by means of store Xe 133. A diagram such as that in Figure M l calculations. If you choose the latter approach, you is acceptable include in the ihagram the availa- truy nuke simplifying assumptions. PROVIDING they bility of shieldmg nuterials and the proximity to are reasonable. conservative, and stated ciphcitly in unrestricted areas. your requsst.

- b. Describe the ventilation in all areas where Xe 133 in actualuse and storage, some Xe 133 wdl be released

[m\

( ,) is used and stored. (Ventdation features should also be indicated on a diagram such at that in into the room from the storage and administration devices, rebreathing apparatus, collection systemt_ and I agure M l.) The location of supply and exhaust escape from the patient. All sources of loss must be vents, the measured attflow rates for each vent, considered when estimating the fraction ol Xe I33 and the fraction of air that is recirculated by the that is lost.

system should be mdicated Describe any changes in flow rates that nuy entst between heating and The following procedures may be used to (alsulate the cooling seasons air concentration of Xe 133 in restrnted areas c All areas where zenon is used should be under a. I stimate the nusimum aniount of .ictivity to be negative pressurc State the type and frequency used per week ( Al (at lesst semiannually)of periodic measurements that yc,u wdi make to determine that airflow b lstimate the fraction of Xe 133 that islost during rates are maintained 45 described m item 2b. use and storage (fl. This f ractionallots must in-clude ALL sourcci of loss. e.g., during p.itient 3 Procedures for Routine Use adminntration, storage, and disposal t a. Describe the procalutes to be followed for routine 6 Descrmine the twasured airflow rate m the arcat s) use of Xc 133, givmg particular attention to of mterest, and talculate the volume of air avail-rathological safsty factors. able per week for dilution of the Xc Ill iVI b 1 you plan to use a special apparatus for admm. d. For restricted areas. $ 20103 of 10 CFR l' art 20 istration and collection of Xc 133, specify the requires that manuf acturer's name and model number and include a description of its design characteris- A , y . g a gogri/ml.

tics. (Intlution of a brochure would he helpful i V A \

l

\Q ,/l 10N.51

SUPPLY VENT HALLWAY EXH AUST VENT v v REST REST 125 FT3/ MIN

~ ~

ROOM ROOM BUILDING EXTERIOR I

kV ISOTOPE

^ FT / MIN B

4 o CAMERA ROOM g ) f g HALLWAY 100 3 g

FT3/ MIN DRESSING O 3 ROOM FT3/ MIN O

1 I l U a DRESSING /

150 ROOM  % /

J FT 3/ MIN , \ V/////11

/ f/

_ /00 FT /3 MIN \

HALLWAY SCALE 1" = 4" FIGURE M-1 EXAMPLE OF AN ACCEPTABLE TYPE OF LAYOUT DIAGRAM FOR A FACILITY DESCRIPTION INCLUDING VENTILATION FLOW RATES 9 . .

9 .

e

e. Sample Problem .sfaximum Xc /JJ Ventstarson Released per (p) A nuclear medicine laboratory plans to use 10 mCs Xe 133 per patient and will perform a maximum Rare

//t #/mm/

40 //our Week (m Cs)

\ / of 10 studies per week. What ventilation rate is required to ensure compliance with Q 20.103 of 100 67.9 10 CFR Part 20? $00 339.7 1.000 679.4 Maximum activity used per week

6. Air Concentrations of Xc-133 in Unrestncted Areas A = 10 mci ,10 patients patient week a Disposal of Xe 133 by Dilution through Exhaust Systems (less desirable).

x I x 10 340

• C' One method for disposal of Xe-133 is by release' to the atinosphere through an air exhaust system.

= l x 10 8 FC' Licensees are required to perform surveys (mea-wuk surements or calculations) to ensure that they are in comphance with paragraph 20 l(c) and Assume a loss rate of 20 percent (f) Q 20.106 of 10 CFR Part 20. Paragraph 20 l(c) requires that the concentrations of Xe-133 in V= ^"I effluents to unrestricted areas be as low as a 1 x 10'8 pCi/ml reasonably achievable by the current state of technology, and @ 20.106 requires that the con-centrations, averaged over a period of I year, 1 x 10 pri/ week x 0 20 8

4 pri/ml.

shall not exceed 3 x 10 I x 10'8pCi/ml Many facilities do not have sufficient airflow to a achieve the necessary dilution. The following pro-2.0 x 10' ml/ week.

cedure may be used to estimate the concentrations s

]/

The required ventilation rate is of Xe 133 in effluents to unrestricted areas V 2.0 x 10' ml/ week (1) Estimate the maximum amount of Xe 133 40 hr/ weck to be released per year (A). This shoofd in-clude allanticipated losses during adminis-t 1.7 x 10* ml/hr = 30 ft /3 min tration, storage, and disposal.

3 ft / min i2) Determine the tiow rate of the exhaust sys-The answer shows that, in order to meet the tem, and describe the methods and equip-requirements of Q 20.103 of 10 CFR Part 20. the ment used for measuring the airflow rates imaging room (RESTRICTFD ARFAlmust have a ventilation rate of at least 30 ft / min with no (3) Calculate the airflow per year (V).

recirculation of air. Where practical, the ventila-tion rate should be greater than that shown (4) Calculate the average cmicentrations for un-necessary by the calculations. Consider every restricted areas. Section 20.106 of 10 CFR alternative in order to maintain the air con- Part 20 requires that centration of Xe 133 as low as reasonably achievable in accordance with paragraph 20.l(c) c.A 33,;0 pCi/ml.

4 of 10 CFR Part 20. V If the vexilation rate 65 inadequate to meet the ($) Sample Problem requirements of 6 20.103 of 10 CFR Part 20. con-sader methods of increasing ventilation or reduc-l- A nuclear medicine laboratory plans to use ing the patient load.

10 mci per patient and will perform a ma n-imum of 10 studies per week. A fume hood The following table gives the amount of Xe 133 is available for disposal of Xe 113 and has that can be released per week without exceeding a measured airflow of 168 ft/ min with an

[]

i /

the permissible levels for Xe 133 in restricted areas.

opening of 8 ft .2 What is the average con-centration of Xe 133 at the point of release v

10.8 $3

from th2 fume hood exhaust'? (NOTE: AJl till perform in accordance with 20.201 of menon that has been released, e g , collec- 10 CFR Part 20.

tion bags, filters, must be considered.)

b. Adsorotion of Xe 133 onto Charcoal Traps 3

A= 10 patients , 10 mci ,

10 pCi This is the disposal method of choice.The advan-week patient mci tage of this disposal method is that Xe-133 is trapped onto charcoal or other adsorbing medium.

x 52*"" Filters containing Xe 133 are then stored for Y' decay.

A = 5.2 x 10' pCi/yr One difficulty with this approach is that charcoal is not 100 percent efficient for trapping Xe 133.

V = 1681 x 8 ft 2x 1.49 If this is your method of disposal, you should

• • consider the followmg points:

x 10' O *IIY' (1) Describe how you will handle the problem

• 3 ft / min of leakage from such trapping devices. Ex-haust from trapping devices and from areas V = 1344 I' 3 x 1.49x 10'O *IIY' of use ad storage may be vented to the out-mm 3 ft / min doors or other unrestricted areas. Submit calculations to show that air concentrations V = 2.01 x 10' 3 ml/yr of Xe 133, averaged over 1 year, do not exceed 3 x 10 pCi/m!. (See example in 6

p . 5.2 x 10 pCi/yr 2.01 x 10' 3 ml/yr (2) Desenbe how you will ensure that collec-tion and trapping devices are performing C = 2.6 x 10 pCi/ml according to specifications, both initiady and on a continuing basis Include in your The following table gives the amount of Xe 133 description how you will monitor traps to that can be released per week without exceeding determine when saturation occurs and filter an average concentration of 3 x 10 pCi/ml. must be replaced. Where adequate, manu-facturer's instructions relevant to trap test-A verage Release of ing may be incorporated in the application.

Exhaust Rate Xe 1331'er Week

//t / min / /mCl/ (3) Describe your procedu res for handling satu-rated filters. Your discussion should include 100 8.6 a description of the area (a diagram would 500 42.8 be useful), available shieldmg, proximity to 1,000 85.6 restricted areas, ventdation, and an evalua-1,500 128.4 tionof average concentrationsof Xe 133in air. (See example in item Se.)

If the exhaust is released to s testricted area,e s., USEFUL CONVERSIONS a roof to which access is controlled, you t.hould also describe the physical contrels you use to I mci = 103 pCi restrict access to the restricted area, the number, 3

wording, size, and location of warning signs Ift = 2.8 3 2 x 10 2 m3 = 2. 83 2 x 104 mi placed in the vicinity of the restricted area;your 3 =

program Inr ensuring that personnelentering the I ft / min 1.699 x 10* ml/hr restricted area receive proper instruction in 7 accordance with @l9.12 of 10CFR Part 19;yous = 6.797 x 10 ml/40 hr week program for ensuring that personnel entering the

= 1.484x 1080ml/yr restricted area are monitored in accordance with 9 20 202 of 10 CFR Part 20;and the surveys you I week = 168 hr O

10.8-54

l i

j l

l APPENDIX N I

l fQ GUIDANCE ON REQUESTS FOR LICENSE AMENOMENTS AND LICENSE TERMINATIONS l

V)

l. License Amendment Requests c. To add a user for Groups IV-V*

License amendment requests should be prepared in Provide the information in la(1) through (3) three copies, one to be retained by the applicant and above (specific training and experience criteria two to be submitted to the NRC. They should be filled are found in Section 4 of Appendix A).

out on Form NRC 313M, should be signed by an auth-orized representative of management (e.g.,the hospital d. To add a user for Group VI*

administrator), and should be dated. The appropriate fee (see 10 CFR Part 170, " Fees for Facilities and Mate- (1) Provide the information in la(l) through rials Licenses and Other Regulatory Services Under the (3) above (specific training and experience Atomic Energy Act of 1954, As Amended") must also be criteria are found in Section 5 of Appen-enclosed with the amendment request. Review of an dix A), or amendment request will not begin untilthe appropriate fee has been paid. (2) Submit evidence of licensure (see paragraph 35.3(b) of 10 CFR Part 35) and evidence of certification by one of the nedicalsrecialty

a. To add a new user (see items 4 and 8 of Form boards hsted in the Note in Section $ of NRC 313M and Appendix A to this guide) Appendix A.

(1) Provide detailed information requested in e. To add a user for Sr 90 eye applicator items 4 and 8 to show that (a) the new phy sician-user is licensed to dispense drugs (l} Provide the information in la(l) through in the practice of medicine (see paragraph (3) above (specific training and experience 35.3(b) of 10 CFR Part 35), and (b) his/her criteria are found in Section 6 of Appen-training and experience meet or exceed the dix A), or g

criteria in Appendix A,or

(/ (2) Submit evidence oflicensure(see paragraph 35.3(b)of 10 CFR Part 35)and evidence of (2) State the AEC/NRC license number on certification by the American Board of which the new user was specifically named Radiology in Radiology or Therapeutic as an authorized user, or Radiology and the year of certification.

f. To add Group lil' (3) Submit a copy of the Agreement State li-cense on which the new user was specifi- The following specific information should be cally named as an authonted user. referenced in a previous application or should be given special attention if it has not been pre-viously submitted.

b To add a us:r for Groups I lll*

(1) Ihgh-level survey meter capable of read-(1) Pr9 vide the information in la(l) through mg up to i R/hr.

(3) above (specific trainips and experience criteria are found in Section 2 of Appen- (a) Manufacturer's name and model dix A), or number.

0 (2) Submit evitLnce of ficensure(see pararraph (b) The frequency, procedures, and 35.3(b) of 10CFR Part 35) and evidence of standards used to calibrate the high-certification by (a) the American Board of level survey meter (see Itent 10 and Nuclear Medicine,or(b)the American Board Appendis D, Section 1).

of Radiology,ln Diagnostic Radiology with Special Competence in Nuclear Radiology 42) Room diagram showing location of gener-and year of certification. ator, kit preparation, patient dose prepara- ,

tion areas, etc., with special attention paid

! ('

• see section Js.soo nt to CF R Pers 3s. to shielding isee item Il).

10.8 $5 l

l l

(3) Use of syringe shields. (2) If you are currently authorized to use Xe-133 and you wish to continue, include (4) Method for assaying patient doses prior to the information in item 21 and in Appen-administration. dix M to describe the new facilities and equipment, the trw location ard ventilation, (5) Use of ring hadges for personnel who elute and calculations pertaining to air concen-generators, prepare radiopharmaceuticals trations in restricted and unrestricted from reagent kits,and prepare ptient doses. areas.

(6) Daily survey of areas used for generator (3) Provide survey showing that all previously clution, preparation of radiopharma- occupied areas are free of contamination I ceuticals from reagent kits, and prepara- and all sources have been removed. A de-tion of patient doses. contamination guide is available from the Material Licensing Branch.

(7) Rulea for pcrsonnel who elute generators or prepare radiophatmaceuticals from reagent 2. License Termination Requests kits to monitor hands and clothing af ter och procedure or before leaving these areas. a. Submit a signed Form NRC-314 indicating the disposition of the radioactive material. Form

g. To add Groups IV and V*t fGroup V may be NRC 314 is available from the Material Licensing added to institutionallicenses only) Branch, Provide detailed responses to items 19a and 19h b. Submit survey showing that all previously occu-of Form NRC-313M. In lieu of submitting a pied areas are free of contamination and all detailed response to item 19a, you may state that sources of radioactive material have been removed.

you will follow the procedures in Appendix K. A decontamination guide is available from the Material Licensing Branch.

h. To add Group VI*tt to an institutionallicense

3. Actions Not Requiring Amendments Provide detailed responses to items 20a through 20g of this guide. In lieu of submitting a detailed a. To add naturally occurring or accelerator-response to item 20g, you may state that you produced radionuclides (e.g., Ra 226, Co 57, wdl follow the procedures in Appendix L. Ga-67. TI-201). NRC has no authority over these materials. However, most States do regulate the

i. To add Xe 133 possession and use of these materials. The radia-tion control prograrr, of the State (and locality, Provide the information requested in item 21, as where applicable) should be contacted regarding described in detailin Appendix M. its requirements.

). To move Nuclear Medicine Department b. To add use of particular radiopharmaceutical(s) for participation in a manufacturer sponsored (1) Provide diagram of new areas (see item Il IND. This use is already covered in {35.100 of of this guide) 10 CFR Part 35, provided the licensee obtains the radiopharmaceutical(s) from a company see sect 6on 3s.soo nt 10 ct R t' art 35. authorized by NRC or by an Agreement State to distribute the radioactive drug to NRC's tAdduinnat suidance nn plannias an ecceptable redist6on safety ostam fne these uses is prnvaded in NCRP Repnet 37,"Precautione group medicallicensees. '

Fn the Manesement of Patients Who Have Received Therapeutec AmnuQ of Rad 6onuclides;" Regutetney Gu6de a.t 8, "Information Relevant to Fnsuring That Occ ,9stlonal Radiation F.sposures et c. To add sealed sources of less than 3 mCifor cali-Med&c1 lastitutinns *611 Ele .s s Low As Reasonably Ach6eveble f' and bration or reference purposes. These sources are NURFG4267, "Prtactples and Practices for Keeping Occupellonal '

Radiation Es authorired by paragraph 35.14(d), provided the Achiev:ble." posures et Med& cal Inst 6tutions As Low As ReasonablySee sisa licensee Repletory obtains Guide them from 8.10. "autMrized a company Appl. cations of Bin-naasy far I ils and 1131 U ;6 G dance nn rec 61ay, equipenent, and procedures for brachy.

b W m h an Asmment Mau M Mrhe therspy O provided 6n Regulatory Gv6de a.18 and in NUREG 0267 them to NRC's group medicallicensees.

O 10 8-56

l l

APPENDIX O MODEL PROGRAM FOR MAINTAINING OCCUPATIONAL RADIATION EXPOSURES l

AT MEDICAL INSTITUTIONS ALARA (Licensee's Namel (Date)

1. Mtnagement Commitment 2. Radiatien Safety Committee (RSC)2

a. We, the managenient of this (medical taality, a. Review of Proposed Users and Uses hospital, cle.), are committed to the program described in this paper for keeping exposures (1) The RSC will thoroughly review the (mdividual and collective) aslow asis reasonably qualifications of each applicant with achievable ( ALAR A). In accord with this com- respect to the types and quantities of mitment, we hereby describe an administrative materials and uses for wheeh hc has organization for radiation safety and will develop applied to ensure that the apphcant will the necessary wntten policy, procedures, and be able in take appropriate measures to '

instructions to foster the ALAR A concept with- maintain exposure ALAR A.

in our institution. The organization wil; include a Radiation Safety Committee (RSC)' and a (2) When considermg a new use of byproduct Radiation Safety Officer (RSO). material. the RSC will review the efforts of the applicant 'o maintain exposure

h. We will perform a formal annual review of the ALARA. The user should have systematized radiation safety program, including ALAR A procedures to ensure ALARA and shall considerations. This shall include reviews of have incorporated the use of special operating procedures and past exposure records, equipment such as syrmge shields. rubber l

inspections, etc., and consultations with the gloves, etc., in his proposed use.

radiation protection stJIIor outside consalt ants.

(3) The RSC will ensure that the user justifies

c. Modification to operating and maintenance pro- his procedures and that dosc will be ALARA cedures and to equipment and facahties will be (mdividual and collective).

made where locy wdl reduce exposures unlew the cost, in our judgment, is considered to be b. Delegation of Authority unjustified. We will be able to demonstrate, if necessary,that improvements have been sought, (The judicious delegation of RSC authority is that modifications have tren considered and that essential to the enforcement of in ALARA they have been implemented where reasonable. program.)

Where modifications have been recommended but not implemented, we will be prepared to (lp The RSC wdl delegate authonty to the describe the reasons for not implementing them. RSO for enforcement of the ALARA concept

d. In addition to mamtaimng dows to individuals as far below the hmits as as reawnably achievable, (2) The RSC will support the RSO m those the sum of the doses received by all esposed instances where it is necessary for the RSO individuals will alw be mamtamed at the lowest to assert his/her authority, Where the practicable level. It would not be desirable, for RSO has been overruled, the Committee example, to hold the highest doses to mdividuals will record the basis for its action in the to some traction of the apphtahic htmt if this minutes of the Committee's quarterly involved cuposing additional people and signit- meetmg icantly incressmg the sum of radiation doses received by allinvolveJ individuals.

I The RSO on private pesctke h y sises thennes will assume the g

Pr6uis practke phnk6an hcennes do not include an 1450. responsihitii6,s or the MSC under $ etion 2 10.16 57

e

c. Review of AL AR A Program (2) ~Ihe RSO willensure that authorized users, workers, and ancillary personnel who may (I) The RSC will encourage all users to revsew be exposed to radiation wdl be instructed current procedures and develop new pro- m the AL AR A philosophy and informed cedures as appropriate to implement the that management, the RSC, and the RSO AL AR A concept. are committed to implementing the AIARA concept.

( 2) The RSC wd! perform a quarterly review of occupational radiation exposure with c. Cooperative Efforts for Development of AL AR A particular attention to instances where Procedures investigational Levels m Table 0-1 below are exceeded The principal purpose of Radiation workers wul be given opportunities thn review is to assess trends in occupa- to participate in formulation of the procedures tional exposure as an index of the ALARA that they will be required to follow.

program quality and to decide if action is warranted when Investigational Levels are (1) The RSO wul be in close contact with all exceeded (see Section 6).3 users and workers in order to develop ALARA procedures for working .with (3) The RSC will evaluate our institution's radioactive matenals.

overall efforts for maintaming exposures ALAR A on an annual basis. This review (2) The RSO will establish procedures for will indude the ef forts of the RSO, autho- receiving and evaluating the suggestions of rated users. and workers as wc!! as those individual workers for improving health of management. physics practices and will encourage the use of those procedures.

3. Radiation Safety Officer (RSO)

d. Reviewing instances of Deviation from Good

a. Annual and Quarterly Review ALAR A Practices

(!) Annual review of the radiation safety pro- The RSO will investigate all known instances gram. The RSO wdl ps tform an annual re- of deviation from good ALAR A practices and, view of the radiation safety program for if possible, will determine the causes. When the adherence to AL AR A concents Reviews cause is known, the RSO will require changes of specific procedures may be conducted in the program to mamtain exposures ALAR A.

on a more frequent basis.

4 Authorized Users (2) Quarterly review of occupational expo-sures. The RSO will review at least quar- a. New Procedures involving Potential Radiation terly the external radiation exposures of Ex posures authornied users and workers to determine that their exposures are Al ARA in accord- (I) The authorized user will consult with, and ance with the provisions of Section 6 of receive the approval of, the RSO and/or ihn program RSC during the planning stage before using radioactive materials for a new procedure.

(1) Quarterly review of records of radiation level surveys. The RSO will review radia- (2) The authorized user willevaluate all proce-tion levels in unrestrict d and restricted dures before using radioactive materials areas to determine that they were at to ensure that exposures will be kept A L A R A levels during the previous qmrter. ALAR A. Tha may be enhanced through the application of tnal runs.

b Education Responsibihties for Al.AR A Program

b. Responsibihty of Authorized User to Persons (ii The RSO will schedule bricfings and educa- Under liis/Iler Supervision tional seuions to inform workers of A L AR A program efforts. (1) T he authorized user will explain the AL AR A concept and his/her commitment to maintain exposures AIARA to all per-3 the NRC has emphasired that the investisational Levels in this prosram are n.it ne w dose limits but, as noted in ICRP Report 26. l

" Recommendations of the internatannal Commksion on Radiological (2) The authorized user will ensure that per-Pr oth e son , serve as sheck points atsove which the results are con uJmd suinoently important to susury rurther investisanons. sons under his/her superinion who are 10.8-58

subject to occupational radiation expo- a. Quarterly exposure of individuals to less than sure are trained and educated in good investigational Level I.

health physics practices and in maintaining exposures ALARA. Except when deemed appropriate by the RSO, no further action will be taken in those cases where an individual's exposure is less than

5. hreons Who Receive Occupational Radiation Exposure Table 0-1 values for the investigational Level I.

a. The worker wdl be instructed in the ALARA b. Personnel exposures equal to or greater than concept and its relationship to working proce- Investigational Level I, but less than Investiga-dures and work conditions. tional Level II.

b. The worker will know what recourses are avail- The RSO wdl review the exposure of each mdi-able if he/she feels that ALARA is not being vidual whose quarterly ex posures equal or exceed promoted on the job. Investigational Levell and wdl report the results of the reviews at the first RSC meeting following

6. Est:blishment of Investigational Levels in Order to the quarter when the exposure was recorded if Monitor Individual Occupational l'xternal Radiation the exposure does not equal or exceed Investiga-Exposures tional Level II, no action related specifically to the exposure is required unless deemed appro-This institution (or private practice) hereby establishes priate by the Committee. The Committee will, Investigational Levels for occupational external radia- however, consider each such exposure in com-tion exposure which, when exceeded, wdl initiate parison with those of others performing similar review or investigation by the RSC and/or the RSO. tasks as an index of ALARA program quality The Investigational Levels that we have adopted arc and will record the review m the Committee l listed in Table 01 below, These levels apply to the minu tes.

i exposure of individual workers.

c. Exposure equal to or greater than Investiga-tional Level 11.

Table 0-1 The RSO willinvestigate in a timely manner the Investigational Levels cause(s) of all personnel ex posures equaling or ex

/merms per calendar quarter) ceeding Investigational Level 11 and,if warranted, will take action. A report of the investigation. ac-f.erel l Lereill tions taken,tf any,and a copy of the individual's l Form NRC 5 or its equivalent will be presented l 1. Whole body; head and 125 375 to the RSC at the first RSC meeting following trunk ; active blood forming completion of the investigation. The details of organs; lens of eyes; or these reports will be recorded in the P.SC minutes.

gonads Committee minutes wdl be sent to the manage-ment of this institution for review. The minutes,

2. llands and forearms; feet 1875 5625 containing details of the investigation, will be and ankles made available to NRC inspectors for review at j the time of the next inspection.

l

3. Skin of whole body

• 750 2250 l d. Reestablishment of an individual occupational worker's investigational Leveill to a levelabove

• I' Not normally applicable to nuclear medicine operations except

those using signancant quantities or tieta<mitting isotopes.

In cases where a worker's or a group of workers' ex posures need to exceed Investigational Level lt a new, higher investigational Level 11 may be The Radiation Safety Officer wdl review and record estabhshed on the basis that it is consistent with l on Form NRC-5, " Current Occupational External good ALARA practices for that individual or

! Radiation Fxposures," or an equivalent form (e g., group. Justification for a new investigationa!

dosimeter processor's report), results of personnel Level 11 will be documented monitoring not less than once in any calendar quarter as required by 20 401 of 10 CFR Part 20. The follow- The RSC will review the sustification for. and *ill ing actions will be taken at the Investigational Levels approve. all revisions of Investigational Level 11.

as stated in Table 0-1 in such cases. when the emosure equals oresceeds l

l 10.8 59

the newly established Investigational Leveill, thow actions listed in paragraph 6.c above will Signature be followed.

7. Signature of Certifying Official d Name (print or type)

I hereby certify that t'his institution (or private prac-tace) has implemented the ALAR A Program set forth Title above.

Institutica (or Private Practice) Name and Address

• The person who is authorized to make commstments for the dministration of the institution (e s., hospital administrator) or, n the case of a private practice, the licensed physician.

1 i

10.8-60

i APPENDIX P BIBLIOGRAPHY Titir 10. Code of Federal Regulations' Regulatory Guide 10.5. " Guide for the Preparation of Apph-cations for Type A Licenses of Broad Scope for Byproduct Part 19 - Notices, Instructions, and Reports to Workers. Material."

Inspections Part 20 - Standards for Protection Against Radiation Other NRC Publications Part21 - Reporting of lefects and Noncomphance Part 30 - Ru!es of General Applicabihty to Domestic NUR EG-0267, " Principles and Practices for Keeping Occupa-Lices. sing of Byproduct Material tional Radiation Exposures at Medicat institutions As low As Part 31 - General Domestic Licenses for By product is Reasonably Achievable." Office of Standards Development.

Material USN RC. Washington, D C. 20555.

Part 3 2 - Specific Domestic Licenses to Manufacture or Transfer Certain items Containing Hyproduct NUREG-0339. " Draft Licensing Guide for Teletherapy Pro-Material grams." Office of Nuclear Material Safety and Safeguards.

Part 33 Specific Domestic Licenses of Broad Scope for USNRC Washington, D C. 20555.

Byrroduct Material Part 35 - Human Uses of Byproduct Material Technical Reports Part 40 - Domestic Licensing of Source Material Pa r t 70 - Domestic Licensmg of Special Nuclear Material International Atomic' Energy Agency (IAEA)2 Technical Part 71 - Packaging of Radioactive Material for Transport Report Series No.120. " Monitoring of Radioactive Contam-and Transportation of Radioactive Material ination on Surfaces." '1970.

Under Certain Conditions Part 170 - Fen for Facihties and Materials Licenses and I AEA Technical Report Series No.133," Handbook on Cali-Other Regulatory Services Under the Atomic bration of Radiation Protection Monitoring Instruments."

Fnergy Act of 1954. As Amended 1971.

Rrgulatory Guides International Commission on Radiological Protection (ICRP)3 Report No.12. " General Principles of Monitoring Regulatory Guide 8 4. " Direct Reading and Indirect Reading for Radiation Protection of Workers," Pergamon Press,1969.

Pocket Dosimeters."

Internation.nl Commission on Radiation Units and Measure-Regulatory Guide M.lo,"Oper.iting Philosophy for Mamiain- ments (ICRU)* Report No.12. " Certification of Standardized ing Oscupational Radiation Esposures As Low As is Reason- Radioactive Sources." September 12.1968.

ably Achievable."

National Council on Radiation Protection and Measurements Regulatory Guide M.13. " Instruction Concerning Prenatal (NCRP/ Report No. 37 " Precautions m the Managernent Radiation I sposure

• of Patients Who llave Received Therapeutic Amounts of Radionuchdes." 1970.

Regulatory Guide 8.1M. "Information Relevant to Fnsuring That Occupational Radiation F sposures at Medical Institu- NCRP Report No.48. "Radiatiori .'rotection for Medical .md tions Will He As low As Reasonably Achievable." Albed IIcalth Personnel." issued August 1.1976.

Regulatory Guide 8 20. "Apphcations of Bioassay for 1125 NCRP Report No. 57. " Instrumentation and Monitoring and 1 111." Methods for Radiation Protection." 1978.

Regulatory Guide M.23. " Radiation Safety Surveys at Medi. 2 ing gi,,,,,,,,onal Atom c Enersy Agency) reports mJ) I'e cal Institutiont o obtaineJ from UNIPUB. Inc., P O. Bos 433, New York, N.Y. fool 6.

ICRP (Internahonal Commission on Radiologica Protre tion)

RegulJtory Cuide 10 2. " Guidance to Atademie trutitutions reports may be obtained rrom Pergamun Press. Masweft flouse.

Applymg for Specit~ic B) product MaterialIitensesof Limited ''""' P8'" E8**f 'd. N .Y .10 s 2 3 bN P' lCRU (internahonal Commission un Radiation Units and Mea-surements) reports may be obtained from ICRU Publicahons. P O.

l the 30165. Washington, D C. 20014.

I Tatte to of the Code of leJeral Regulations as avadable trom the 'NCRP (National Counul on Radsatson Protection an : Measure.

Naperintendent nr Dnsuments. U.S. Government Prinhng Orrice, menis) reports may be obtained trom NCRP PubHsations. P O. D.n Washenston, D C. 20402, 4 867. Washington. D.C. 20014 10.8 6i

NCRP Report No. 58, "A flandbook of Radioactivity Mea. ANSI N44.3-1973, " Thyroid Radiciodine liptake Measure-surcei.ent Procedures " 1978. ments Using a Neck Phantom."

Standards ANSI N3231978, " Radiation Protection Instrumentation i Test and Calibration.'

6 ANSl N13.21969. "Admmistrative Practices in Radiation Monitoring ( A Guide for Management)." ANSI N449-1974, "Guidelmes for Maintainmg Cobalt-60 and Cesium-137 Teletherapy Fquipment

• ANSI N 13.4-1971, " Specification of Portable X- or Gamma Radiation Survey Instruments." ANSI N449.1-1978, " Procedures for Periodic inspection of Cobalt 60 and Cesium-137 Teletherapy Equipment.'

ANSI N13.5-1972, " Performance and Specifications for Direct Reading and Indirect Reading Pocket Dosimeters for X and Gamma Radiation." Other Resources ANSI N13 6-1966 ( R1972), " Practice for Occurational Radia. Blatz, llanson, " Radiation flygiene flandbook ' M cG ra w-tion Exposure Records Systems." 11:11, New York.1959, pp 22-7 ANSI N14.5-1977, " Leakage Tests on Packages for Shipment of Radioactive Matenals." Cember, lierman. " Introduction to llealth Physics."Ittgamon Press, New York,1969, pp 334-9 ANSI N42.f 31978, " Calibration and Usage of Dose Cali-brator lontration Chambers for the Assay of Radionuclides." Steere, Norman V ,(ditor, //andbook of /.aboratory Safety.

chapter on " Determining industrial flygier.e Requirements ANSI N44.1-1973, " Integrity and Test Specifications for in Installations Usmg Radioactive Materials." pp 482-502; Selected Brachytherapy Sources." also " Basic Units of Radiation Measurement," pp 391 426, CRC Press, Inc., 2000 N.W. 24th Street, Boca Raton, ANSI N44.2-1979, " Leak Testing Radioactive Brachytherapy Florida 33431,1970.

Sou rces.'

Wang. Yen, Editor, Handbook of Radioacture Nuclides, 6

Part Vill " Radiation Protection and Regulation," pp 573-ANsl ( American National standards Institute) standards mar 831, CRC Press, Inc., 2000 N.W. 24th Street. Boca Raton, be utitained from the American National Standards Institute, Inc.,

talo Broadway, New York, N.Y. loon s. Florida 33431,1969 l

10.8-62

EXHIBIT A

)

FORu NRC-313M U.S$ NUCLE AR REGULATORY COMMISSION Approwd

• • APPLICATION FOR MATERIALS LICENSE - MEDICAL G AO H0557 to CF R 35 INSTR UCTIONS - Comoore trams I eroup n or e s a w m.t a wo nernon o or an w. cat. ors ror renews or a r ce >se use n,oo r emente sheers where neceamary item 26 must be comoMted on an wolsarens armi noped Retam one coor Submot ongenal and one coor of entere wotwaton to Deret nov. Ofhte of Nucnar Matersan Safety ed Safegnoardn. Li S Nuctear Reputatory Commossoon. Washmyton. O C 20$$5 Upon approvst 09 thus apphcaten. ee apolwet an*H receove a Matends L ocense An NRC Mater **Is L oewse os assued m accord-me anon the generar renvoremmes contemed e Torne 10. Code of federat Reputatens. Part 30. and the L acwere os subiect to Torne to Code of fodered Rreutetens. Parta 99. 20 arm 9 35 ed ee tocener rae provnaen of Totte t0. Code of f ederal Regulatoons Part t70 The Jocense 900 category shoukt be stated m Itwo 26 armi the appropreste fee enclosed 1.a. NAME AND M AILING ADDRESS OF APPLIC ANT (insotucon, 1.tx STREET ADDRESS (ES) AT WHICH R ADIOACTIVE MATEHI AL f,rm, clonoc, phys.c.an, etc) INC LUDE ZIP CODE WILL BE USED (if dsfArrent from 1.4) INCLUDE ZIP CODE TE LEPHONE NO.- ARE A CODEI )

2. PERSON TO CONTACT REGARDING THIS APPLICATIOfe 3. THIS IS AN APPLICATION FOR : (Chech @propnate seem) a O NEW LICENSE ts O AME NDME NT TO LICE NSE NO.

c. O aENEw At Os LiCEssE NO.

TE LE PHONE NO. - ARE A CODE ( )

4. INDIVIDU AL USERS (Name indriduals wwho well use or erectly 5.R ADI ATION SAFETY OF FICER (RSO) (Name of person desorated suoervose use of redooactove manonat. Comosete Supplements A and B as rad. sten serty artcer or other the .nd,andus user. comosete resu-for each ondsvodual.) me of trannmg and empertence as m Suppbement A 1 64 RADIOACTIVE MATERIAL FOR MEDICAL USE MAXIMUM MARK MAXIMUM ITEMS POSSE SSION ITEMS POSSESSION RADIOACTIVE MATERIAL DESIRED LIMITS ADDITION AL ITEMS- DE SIRE D LIMITS LISTED 1N

~x * (in millocurnsi "X (In mollocut esi IOOiNE 131 AS IODIDE FOR TREA TMENT 10 CFR 31.11 FOR IN VITRO STUDIES OF HYPERTHYROIDISM 10 CFR 35.100. SCHEDULE A, GROUP I AS NE E DE D PHOSPHORUS-32 AS SOLUBLE PHOSPH ATE FOR TREATMENT OF POLYCYTHEMI A VER A. LEUKEMI A AND BONE METASTASES 10 CF R 35.100. SCHEDU LE A. GROUP ll AS NEE DE D PHOSPHORUS 32 AS col;LOIDAL CHROMIC PHOSPH ATE FOR INTRACAVITARY TRE AT-10 CF R 35.100. SCHE DU LE A GR OUP lil MENT OF MALIGN ANT E FFUSIONS.

GOLD.198 AS COLLOID FOR INTRA-CAVITARY TRE ATMENT OF MALIGNANT 10 CFR 35.100. SCHEDULE A, GRGUP IV AS NEEDED E F FUSIONS.

IODINE 131 AS lODIDE FOR TRE ATMENT 10 CFR 3.100 SCHEDULE A, GROUP V AS NEEDED OF THYRulD CARCtNOMA XENON 133 AS GASOR G AS IN S ALINE FOR 1C CER 3.100. SCHEDULE A. GROUP VI BLOOD F LOW STUDIES AND PULMONARY FUNCTION STUDIES __

6.b. RADIOACTIVE MATERI AL FOR USES NOT LISTED IN ITEM 6.a. r$aee d ames up to J mCo used for calabret on and reference standards are author

• sed under SecDon 35.14fdl.10 CFR Part 35. and NEED NO T BE LISTEDJ CH E MIC A L M AXIMUM NUMBE R E LEMENT AND MASS NUM8ER AND/OR OF MILLICURIES DESCRIBE PURPOSE OF USE PHYSICAL FORM OF E ACH FORM i l I i l l I I l l l 1  ! l I I I I II I I I i l l I I I t i t i _

FOmu NaC staw f lL. *m

P_s l

l

. _ _ _ . l M;h.f _f-L I !

hf .1$

INFORMATION REQUIRED FOR ITEMS 7 THROUGH 23 4 /

For items 7 through 23, deck the appropriate box (es) and submit a deta! led desalption of all the requested information. Begin each item on a separate sheet. Identify the item number and the date of the application in the lower right corner of each page. If r60 md2'

~

you indicate that an appendix to the medical IL ensing guide will be followed, do not submit the pages, but specify the revision number and date of the referenced guide: Reguletory Guide 10.8 , R ev. Date.

7. MEDICAL ISOTOPES COMMITTEE 15. GENER AL RULES FOR THE SAFE USE OF RADIOACTIVE MATERIAL (Check Onel Names and Spectattles Attached; and Appendix G Rules Followed;or Duties as in Appendix B;or Equivalent Rules Attached

(@eck One)

Equivalent Duties Attached 16. EMERGENCY PROCEDURES (Check One)

8. TRAINING AND EXPERIENCE Appendix H Procedures Followed; or Supplements A & B Attached for Each Individual User; and EWim W a h M 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 Name and Model Number 18. WASTE DISPOSAL (Check One)

10. CALIBRATION OF INSTRUMENTS Appendix J Form Attached;or Appendix D Procedures Followed for Survey Instruments; or EWW WMim AW Equivalent Procedures Attached;and

" ^' ^

19.

(Check One)

Appendix 0 Proadures Followed for Dose Calitrstor; or Appendix K Procedures Followed;or (Check One)

Equivalent Procedures Attached Equivalent Procedures Attached

11. FACILITIES AND EQUIPMENT 20. THERAPEUTIC USE OF SEALED SOURCES Desaiption and Diagram Attamed Detailed Information Attached;and

12. PERSONNEL TR AINING PROGRAM Appendix L Procedures Followed;or (Check One)

Desaiption of Training Attached Equivalent Procedures Attached PROCEDURES AND PRECAUTIONS FOR USE OF

'

• PROCEDURES FOR ORDERING AND RECElVING 21. R ADIOACTIVE GASES (e.g., Xenon - 133)

RADIOACTIVE MATERI AL Detailed information Attached Detailed Information Attached PROCEDURES FOR SAFELY OPENING PACKAGES

14. CONTAINING RADIOACTIVE MATERIALS

22. RADIOACTIVE MATERIAL IN ANIMALS (Check One) Detailed Information Attached PROCEDURES AND PRECAUTIONS FOR USE OF Appendix F Procedures Followed;or 23 RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.b Equ'rvalent Procedures Attached Detailed information Attached 4

FORM NRC.313M m Page 2 # # '

j % Q'i U

% w.-

24. PERSONNEL MONITORING DEVICES TYPE IChec.* noprocroare bow 1 SUPP LIE R EXCHANGE FREQUENCY FILM a WHOLE BODY I'U OTHE R (Specrfy]

F s LM

b. FINGER yto OTHE R (Speedyt FILM

c. WRIST TLO OTHE R (Specify)

d. OTHER ISpecifyl

25. FOR PRIVATE PRACTICE APPLICANTS ONLY a

HOSPs TAL AGRE EING TO ACCEPT P ATIEN TS CONT AINING RADIOACTavE M ATE RI AL N Auf OF HOSPIT AL ts ATTACH A COPY OF THE AGREEMENT LETTER SIGNED BY THE HOSPITAL ADMINISTRATOR.

c. WHEN REQUESTING THER APY PROCEDURES.

Ct T V STATE ATTACH A COPY OF RAOIATION SAFETY PRECAU-ZIP CODE TIONS TO BE TAKEN ANO LIST AVAILABLE RAOIATION DETECTION INSTRUMENTS.

26. CERTIFICATE (This imm must be completed by applicant)

The aposicant and any othcial esecuting this certificate on benalf of the soolicant named in Item la certify trat tNs sootication is prepared sa conformity mth Title 10. Code of Federal Requistions. Parts 30 and 35. and that allinformation contained herein, including any svootements attac%ed hereto,is true arid correct to the best of our knowledge and belief.

tx APPLICANT OR CERTIFYING OF FICI AL (Strahr WJ e

a. LICENSE FEE REQUIRED (See Secrow 910 31.10 CFR 110)

(1) N AME (Type of Pront)

(1) LICENSE FEE CATEGORY (2) M LE

c. DA TE (2) LICENSE FEE ENCLOSED $

FORM NRC-313M 18 78)

Page 3

1 PRIVACY ACT STATEMENT i ut .uant to 5 U.S C. 552 ate)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the f ollowing stancment is furnished to individuals who supply information to the Nuclear Regulatory Commission on Form NRC 313M.

This information is maintained m a system of records designated as NRC-3 and described at 40 Federal Register 45334 (Octotter 1,1975) 1 AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U S.C. 2111 and 22011bi).

2 PRINCIPAL PURPOSE (S) The infurmat on 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 materiallicense or amendment thereof.

3 ROUTINE USES The information 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 inct.

dont 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 violaticn 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 rout'inely 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 EFFECT ON INDIVIDUAL OF NOT PROVIDING INFORMATION Disclosure of the requested information is voluntary. If the requested information is not furnished, however, the application f or 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-real Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C 20555.

FORM NRC-313M (8 - 78)

Page 4

Fonns NRC 313M-SUPPLEMENT A U.S. NUCLE AR REGULATORY COMMISSION TRAINING AND EXF2RIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER

1. NAME OF AUTHORIZED USER OR RADIATION SAFETY OFFICER 2. STATE OR TE RRITORY IN WHICH LICENSED TO PRACTICE MEDICINE

3. CERTIFICATION SPECI ALTY 80ARD CATE GO RY MONTH AND YEAR CERTIFIED A B C

4. TRAINING RECElVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TRAINING LECTURE / SUPE RVISED FIE LD OF TRAINING LOCATION AND DATEIS)OF TRAINING LABORATORY LABORATORY A B COU RSE S E XPE RIE NCE (Hours) (Hours)

C D

a. RADI ATION PHYSICS AND -

INSTRUMENTATION

b. R ADI ATION PROTECTION

c. MATHEMATICS PERTAINING TO THE USE AND MEASUREMENT OF RADIOACTIVITY

d. R ADI ATION 8tOLOGY

e. R ADIOPH ARMACE UTICAL CHE MISTRY

5. EXPERIENCE WITH R AD1ATION. (Actualuse of Radioisotopes or Equivalent Expenence)

ISOTOPE MAXIMUM AMOUNT WHERE EXPERIENCE WAS GAINED DUR ATION OF EXPERIENCE TYPE OF USE rORM NRC-J13M Supolameat A IS-78) Page 5

PRECEPTOR STATEMENT (Continued)

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Ccritinued/

NUMBER OF CASE S INVOLVING COMMENTS ISOTOPE CONDITIONS DI AGNOSED OR TRE ATED PE RSON AL (Adfsrsmalsoformarim a comnwns may be PARTICIPATION submared en Asphcam on separeer sheet 1 A 8 C D P 32 TRE ATMENT OF POLYCYTHEMIA VERA.

GaAs&#1 LEUKEMtA. AND BONE METASTASES

[ j INT R ACAVITA RY TRE ATMENT TRE ATMENT OF THYROID CARCINOMA 1131 TRE ATMENT OF HYPERTHYROIDISM A+ 198 INTRACAVITARY TREATMENT Co60 INTE RSTITI AL TR E ATMENT or C>l37 INTRACAVITARY TREATMENT INTE RSTITI AL TRE ATME NT Ir 192 Ca60 or TE LETHE RAPY TRE ATMENT C&137 So90 TRE ATMENT OF EYE DISE ASE R ADIOPH ARMACE UTICAL PRE PARATION Tc GE NE R ATOR GE NE R ATOR Tc.99rn RE AGENT KITS O ther 1 DATES AND TOTAL NUMBER OF HOURS RECElVED IN CLINICAL RADIOlSOTOPE TRAINING

4. THE TRAINING AND EXPERIENCE INDICATED ABOVE ti PRECEPTOR 3 SIGNATURE WAS OBTAINED UNDER THE SUPERVISION OF:

a NAME OF SUPE RVISOR th NAME OP INSTITUTION 7. PRECEPTOR'S NAME Pwan type oranar)

C. M AILING ADDRESS cL CIT Y 8. DATE lb. MATE Ri ALS LICENSE NUMBE RIS)

_. FORM NGJ134$UPPLEMENT e (b 701 e u s GOVERNMENT PRINTING OFFICE 1981 - 341 742 1160

RA73-/

_.y' S0$

l~

' W.10 NUREG-0338, Rey, 1 DRAFT A Guide For Preparation Of Applications for Medical Programs Nuclear Regulatory Commission Radioisotopes Licensing Branch Division of Fuel Cycle and Materials Safety s

4 4

e d

Date: NOV 011977 DRAFT Collation of information upon uhich Regulatory Guide 10 n vill be based. t i n e

?

a M b I^ ^ OM f

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i .."

I 1.0 Introduction 1.1 Purpose of Guide -

This Guide describes the type and extent of information needed by the Nuclear Regulatory Commission (NRC) Licensing staff to evaluate an application for a specific license for the posses-sion and use of byproduct material (reactor produced radio-nuclides), in or on human beings. This type of license is provided for under Title 10, Code of Federal Regulations, Part 35, " Human Uses of Byproduct Material," (10 CFR Part 35).

The NRC will usually issue a single byproduct material license to cover the institution's entire radioisotope program, other than teletherapy. Separate licenses, other than for teletherapy, are not normally issued to different departments of a medical institution, nor are they issued to individuals associated with the hospital.

The applicant should carefully study the regulations and this guide, and submit all information requested. The NRC will request additional information, when necessary, to provide reasonable assurance that the applicant has established an adequate radiation safety prograr. Such requests will delay final action on the application.

1.2 Acolicable Regulations In addition to 10 CFR Part 35, other regulations pertaining to l this type of license are found in 10 CFR Part 19, " Notices, Instructions, and Reports to Workers; Inspections," 10 CFR Part 20, " Standards for Protection Against Radiation," 10 CFR 30, " Rules of General Applicability to Licensing of Byproduct Material," and 10 CFR Part 170, " Fees for Facilities and Materials Licenses."

1.3 Items Requiring Seoarate Acolications

a. A separate application should be submitted for kilocurie sources used in teletherapy facilities. A specific licensing guide for teletherapy applications is available upon request.

b. Source and Special Nuclear Materials Separate applications should be submitted for these materials in accordance with Part 40, " Licensing of Source Material," and Part 70, "Special Nuclear Material,"

of Title 10 of the Code of Federal Regulation. Source material is defined in paragraph 40.4(h) of 10 CFR Part 40 as (1) uranium or thorium, or any combination thereof, in any physical or chemical form or (2) cres that contain by weight 1/20 of one percent (0.05%) or more of

s .-

(a) uranium, (b) thorium, or (c) any combination thereof.

Source material does not include special nuclear material.

Special nuclear material is defined in paragraph 70.4(m) of 10 CFR Part 70 and includes (1) plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, (2) any material-artifically enriched by any one of the foregoing but does not include source material.

1.4 As low As Is Reasonably Achievable (ALARA)

Paragraph 20.l(c) of 10 CFR states that "... persons engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation ,

l exposures, and releases of radioactive materials in effluents to unrestricted areas, as low as is reasonably achievable."

Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures as low As is Reasonably ,

Achievable," provides the NRC staff position on this important subject. License applicants should give consideration to the ALARA philosop'hy, as described in Regulatory Guide 8.10, in the development of plans for work with licensed radioactive materials.

1.5 Types of Material Licenses

a. The general license provided in Section 35.31 of 10 CFR Part 35 authorizes the registrant physician to posses and use limited quantities of prepackaged individual doses of  ;

iodine-131 for measurement of thyroid up-take, iodine-125 l and iodine-131 for blood and plasma volume determinations,  :

cobalt-58 and cobalt-60 for intestinal absorption of cyanocobalamin, and chromium-51 for red blood cell volume and survival time determinations. Section 35.31 explains the general license requirements and requires the physician to register with the Commission and receive a registration number prior to receiving or using the diagnostic radio-pharmaceuticals covered by the general license.

b. Section 31.11 of 10 CFR Part 31 establishes a general license authorizing physicians, clinical laboratories, and hospitals to possess certain small quantities of byproduct material (iodine-125, iodine-131, carbon-14, hydrogen-3, . iron-59, selenium-75, and mock iodine-125 reference sources) for in vitro clinical or laboratory tests not involving the internal or external administra-i tion of byproduct material or the radiation therefrom to human beings or animals. Section 31.11 explains the i

I

r .

general license requirements and requires the applicant to register with the Commission and receive a registration number prior to receiving or using the byproduct material for in vitro testing.

c. Licenses issued to physicians for private practice specify the radioisotopes and the clinical uses that may be per-formed by the physician to whom the license is issued.

• Such licenses are issued to physicians who are located in private offices and not on hospital premises. It is not required that a medical isotopes committee be formed.

The private practice license does not permit other physi-cians to obtain clinical radioisotope training and experi-ences under it. Section 35.12 of 10 CFR Part 35 outlines specific requirements for this type of license.

d. Specific licenses of limited scope issued to institutions specify the radioisotopes and the clinical uses that may be performed by physicians named on the institution's license. The regulations in Section 35.11(b) of 10 CFR l Part 35 require an institutional licensee to have a medical isotope committee (see Appendix B) to evaluate all proposals for clinical research, diagnostic, and therapeutic uses of radioisotopes within the institution.

l t

6-The physicians named on the institution's license conduct their programs with the approval of the medical isotopes committee. Institutional licenses provide a means whereby nonapproved physicians under the supervision of physicians named on the license may obtain basic and clinical radio-isotope training and experience which ray enable them to qualify as individual users. Training and experience criteria for physicians are outlined in Appendix A.

e. Specific licenses of broad scope for medical use, i.e. ,

licenses authorizing multiple quantities and types of byproduct material for unspecified users, are issued to l institutions that (1) have had previous experience operating I

under a specific institutional license of limited scope and (2) are engaged in medical research as well as routine l

! diagnosis and therapy using radioisotopes. Such programs operate under the supervision of a medical isotopes committee.

l i

l l

Individual users are not named on the license nor are radioisotopes limited to specified uses. Individual users and procedures are approved by the institution's medical isotope committee. Physicians may obtain basic and clinical radioisotope training and experience in the

use of radiopharamecuticals in such programs. This type of license is not appropriate for most institutions using byproduct material in medical programs and is fully l

discussed in a licensing guide dealing specifically with the broad license.

2. 0 LICENSE FEES An application fee is required for most types of licenses.

The applicant should refer to 9 170.31, " Schedule of Fees for Materials Licenses," of 10 CFR Part 170 to determine the amount of fee that must accompany the application. Review of the application will not begin until the proper fee is received by the NRC.

3. 0 FILING AN APPLICATION ,

A license application for specific licenses for human use should be submitted on Form NRC-313M " Application for Materials License-Medical." All items on the application form should be completed in sufficient detail for the NRC licensing staff to determine that the applicant's equipment, facilities, and ,

radiation protection program are adequate to protect health and minimize danger to life and property.

i I

1 Since the space provided on Form NRC-313M is limited, the applicant should append separate sheets of paper for Items 7-23 listed in the Form. Each separate sheet should contain the item number and the application date at the bottom right hand corner of each page.

The application should be completed in triplicate. The original and one copy should be mailed to: Radioisotopes Licensing Branch, Division of Fuel Cycle and Material Safety, Office of '

Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. One copy of the applica-tion with all attachments should be retained by the applicant, since the license will require as a condition that the licensee ,

follow the statements and representations set forth in the application and any supplement to it.

4.0 CONTENTS OF AN APPLICATION Form NRC-313M Item 1.a.

Enter the name, mailing address and telephone number of applicant. If the request is for a private license, enter the name of the physician or partnership.

l l

i Item 1.b.

List the addresses and locations where radioactive material will be used or stored if other than the address stated in Item 1.a. If multiple addresses are to be used, explain the

! extent of use at each address and the facilities and equipment l located at each place of use.

Item 2 Enter the name and telephone number (including area code) of the individual to be contacted.

Item 3 Indicate whether this is an application for a new license, amendment or renewal.

Item 4 List the full names of all physicians who will use or directly

supervise the use of byproduct material.

1 Item 5 State the name and title of the person designated by, and responsible to, the institution's management for the coordina-tion of the institution's radiation protection program (some-times designated the " Radiation Safety Officer").

Item 6.a.

For routine human use you may check the group numbers of Schedule A, Section 35.100, of 10 CFR Part 35 for which you are requesting a license. Groups I, II and III consist of the more commonly used diagnostic procedures that involve radio-pharmaceuticals; Groups IV and V consist of routine therapeutic procedures that involve radiopharmaceuticals; and Group VI consists of sealed sources used primarily for therapeutic procedures.

For Groups I, II, IV, and V, possession limits are not listed on the license.

For Group III, the possession limit will be two curies of each radioactive material listed unless a larger limit is requested in the application. The requested possession limit for Group VI and any radioactive material listed separately from Groups I-V should be stated. The possession limit for each radio-nuclide should include material held as radioactive waste.

Item 6.b.

For routine human use not listed in Groups I-VI and for non-human use, list each radionuclide to be used, the chemical and physical form, and'the maximum quantity (in millicuries).

p e List the manufacturer's name, model number, and activity (in millicuries) for all sealed sources.

A specific authorization must be obtained from the NRC to perform studies involving the use of radioactive material in

, animals.

Describe the intended use for each radionuclide and form listed in Item 6.5. If the radioactive material is for human ,

use and has not been approved for routine human use by the Food and Drug Administration (FDA), you should submit evidence that your procurement, preparation and use of the material will be in accordance with the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. If the study is conducted under a " Notice of Claimed Investigational Exemption for a New Drug" (IND) sponsored by the physician or institution you should state the radionuclide, chemical form, possession limit, use, and submit a copy of the IND acceptance letter from the Food and Drug Administration. -

Item 7 Medical Isotopes Committee In accordance with Section 35.ll(b), 10 CFR Part 35, an insti-tution applying for a byproduct material license for human use shall establish a medical isotopes committee. This committee '

1 w , . - . . , ,- . , - _ _ _ _ _ , _ _ . _ . , _ _ . . _ , _ . _ _ . _ . _ . . _ ,_._.,_,_m __

. _,__., , . _ _,. , ~r,,,_, ,,

should contain at least three (3) members to evaluate all proposals for research, diagnosis and therapeutic use of radioisotopes. Membership of the committee should include:

a. Physicians expert in internal medicine, hematology, therapeutic radiology.

b. A person with special competence in radiation safety,

c. A representative of the institution's management.

The following information should be submitted:

a. The responsibility and duties of the comImittee.

b. The meeting frequency of the committee (at least quarterly).

c. The name and specialty of each member of the committee.

Appendix B contains an example of typical responsibilities and duties for a medical isotopes committee. In response to Item 7 you may state that the responsibilities, duties and meeting frequency will be as described in Appendix B to this guide.

. - _ ~ . . = . . . _ - - _ _ . _ . . - - . . . ___ ___ .

1 If the responsibilities, duties, or meeting frequency will be different from those described, submit a complete description.

Item 8 Training and Exoerience

a. Authorized User (s)

If the physician has been previously authorized to use the radioactive material requested in this application, j it 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 Agreement State).

If the physician has not been previously authorized to use the radioactive material being requested, state where he is licensed to practice medicine and subm.it a complete description of has training and experience. Criteria for acceptable trailing and experience are contained in Appendix A. Supplements A and 8 to NRC Form-313M are forms that ma3 be used for the description of the physi-4 cian's training and experience.

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b. Radiation Safety Officer If the radiation safety officer is not one of the physi-cians named in Item 4, submit a complete description of his training and experience. Supplement A to NRC Form-313M 4

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may be used for the description of the radiation safety officer's training and experience.

Item 9 Instrumentation Instruments required in a typical nuclear medicine laboratory are:

a. Survey Instruments (1) A low level survey meter capable of detecting 0.1 milliroentgen per hcur to perform contamination surveys.

(2) A high level survey meter such as an ionization type capable of reading up to i roentgen per hour tc measure radiation exposure rates that may exist in the vicinity of Mo-99/Tc-99m generators and thera-peutic quantities of radioactive material.

b. Dose calibrators and other instruments to assay radio-pharmaceuticals.

c. Diagnostic instruments for all procedures (e.g., gamma camera, wall counter, thyroid probe).

1

d. Other pertinent instrumentation (e.g., liquid scintil-lation counter, area monitor).

Appendix C contains a form that may be used to describe your instruments. If you do not use this form, attach equiva-lent information.

Item 10 Methods, Freauencies and Standards Used for Calibrating Instruments Listed in Item 9

a. Survey Instruments An adequate calibration of survey instruments cannot be performed with built-in check sources. Electronic calibra-tions that do not involve a source of radiation are also not adequate to determine the proper functioning and response of all components of an instrument.

Daily constancy checks of survey instruments should be supplemented every 12 months with a two point calibration J

on each scale of the instrument.such that (1) one point is in each half of the scale, and (2) the two points,are separated by 35-50% of full scale. . Survey instruments should also be calibreted after repair.

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A survey instrument may be considered properly calibrated at one point when the exposure rate measured by the instrument differs from the true exposure rate by less than 10% of full scale.

If you propose to calibrate your own radiation survey and monitoring instruments, you should submit a detailed description of your planned calibration procedures. The description of calibration procedures should include, as a minimum:

a. The manufacturer's name and model number of the source (s) to be used.

b. The nuclide and activity (in millicuries) of radioactive material contained in the source.

c. The accuracy of the source (s). Traceability of the source to a primary standard should be provided.

d. The step-by-step procedures, including associated radiation safety procedures. These procedures should include a two-point calibration of each scale of each instrument with the points separated by 35-50% of full scale.

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If a consultant or outside firm will perform the calibration i

of your radiation survey and monitoring instruments you should

! specify his name, address, and the license number. You should contact the firm or consultant that will provide the calibra- l tion to determine if information concerning calibration proce-dures has been filed with the Commission. If this information has not been filed, you should submit it with your application.

t Appendix D contains a description of an acceptable calibration procedure for survey instruments and a form that may be used to supply the information required in Item 10 of the applica-tion form. >

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b. Dose Calibrator All radiopharmaceuticals should be assayed for activity

to an accuracy of 10% prior to being administered to patients. The usual method for performing assays is with a dose calibrator. Upon installation and periodically thereafter dose calibrators should be tested for accuracy I

of response for the energies commonly used, for geometrical variation, for linearity of response over the entire range of activities to be used, and for day-to-day constancy of operation.

You should submit a description of your calibration procedures. These should include as a minimum:

(1) The manufacturer's name and model number of any sealed sources to be used (unless authorized by Section 35.14(d), 10 CFR Part 35).

1 (2) The nuclide and activity (in millicuries) of radio-active material in the standards.

(3) The accuracy of the standard. Traceability of the source to a primary standard should be provided.

(4) The step-by-step procedures used fo~r calibration.

If an instrument other than a dose calibrator is used to assay patient doses, submit a complete description of:

(1) The assay method.

(2) The method of calibration.

(3) The frequency of calibration.

(4) The standards to be used for calibration (radio-nuclide, activity, accuracy.)

Appendix 0 contains a description of acceptable calibra-tion procedures for dose calibrators and a form that may be used to supply the information required in Item 10 of this application form.

c. Diagnostic Instruments Manufacturer's directions should be followed for calibra-tion and maintenance of diagnostic instrumentation.

Item 11 Facilities and Eouipment Describe the available facilities and equipment (e.g., remote handling equipment, storage containers, shielding, fume hoods) at each location where radioactive material will be used.

Include a description of the area (s) assigned for the receipt, storage (including waste), preparation, and measurement of radioactive material.

A diagram should be submitted showing the locations of shield-ing, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety. Any wall shield-ing, special storage area shielding, or movable shielding around storage areas, generators, kit preparation areas, etc.

should be indicated.

For facilities in which radioactive materici Nay cecome airborne, the diagrams should also include schematic descrip-tions of the ventilation system, with pertinent airflow rates, pressures, filtration equipment, and monitoring instruments.

Diagrams should be drawn to a specified scale, or dimensions should be indicated.

Examples of acceptable facility and equipment descriptions are ,

attached.

Item 12 Personnel Training Program Submit a description of training required for all personnel who work with or in the vicinity of radioactive materials.

The description should include the form'of training (e.g.,

formal course work, lectures), the duration of training and the subject matter included. The training program should be of sufficient scope to ensure that all personnel, including clerical, nursing, housekeeping, and security personnel, receive proper instruction in the items specified in Section 19.12 of 10 CFR Part 19, including:

a. Areas where radioactive material is used or stored.

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b. Potential hazards associated with radioactive material.

c. Radiological safety procedures appropriate to their respective duties.

d. Pertinent NRC regulations.

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e. The rules and regulations of the licensee.

f. The pertinent terms of the license.

g. Their obligation to report unsafe conditions.

h. Appropriate response to emergencies or unsafe conditions.

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i. Their right to be informed of their radiation exposure and bioassay results.

You should verify that personnel will be properly instructed:

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l a. Before assuming their duties with or in the vicinity of radioactive materials.

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b. During annual refresher training.

c. Whenever there is a significant change in duties, regula-tions, or the terms of the license.

Item 13 Procedures for Ordering and Receiving Radioactive Materials Submit a copy of written procedures for ordering radioactive materials, for receipt of materials during off-duty hours, and ,,

for notification of responsible persons upon receipt of radio-active materials. These procedures should be adequate to ensure that possession limits are not exceeded, that radioactive materials are secured at all times against unauthorized removal and that radiation levels in unrestricted areas do not exceed the limits specified in 920.105 of'10 CFR Part 20.

Security personnel, nursing personnel or anybody else who receives packages during off-duty hours, should be issued written instructions as to procedures to be followed for receiving, examining and securing the package and for notifica-tion procedures if the package is found or suspected to be leaking and immediate steps to be taken to prevent spread of contamination.

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

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4 Appendix E contains sample procedures and instructions for the l

receipt of packages containing radioactive material.

Item 14 Procedures for Safely Ooening Packages Containing Radioactive Material Describe your procedures for examining incoming packages for j leakage, contamination or damage, and for safely opening packages in accordance with Section 20.205 of 10 CFR Part 20.

The monitoring should be performed as soon as practicable after receipt of the package of radioactive material. The

{ procedures may vary depending on the quantity of radioactive i

material received, but should, at a minimum include instruc-l tions for surveying packages, wearing gloves while opening i

packages and checking packing material for contamination after l opening. Even though Section 20.205 exempts certain packages from immediate monitoring, procedures must be established for ,

i safely opening all packages containing radioactive material.

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! Appendix F contains a description of an acceptable procedure for safely opening packages. In response to Item 14, you may state that you will follow the procedures described in j Appendix F or you may submit a copy of equivalent procedures.

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I Item 15 Laboratory Rules for Use of Radioactive Material Submit a copy of general instructions to be followed by physi-cians and technicians while working with radioactive materials.

An acceptable example of such instructions is listed in Appendix G of this guide. The instruction should:

a. Outline control procedures for obtaining permission to use radioactive material at the institution.

b. Explain what laboratory apparel to wear and what equipment to use, e.g., wearing of lab coats, the use of disposal gloves, trays, etc.

c. Prescribe limitations and conditions relativ'e to handling liquid or loose radioactive materials and what laboratory equipment to use in working with them. For example, explain which materials and operations should be confined to radiochemical fume hoods or gloveboxes.

d. Explain what shielding or remote handling equipment is to be used when hard beta and/or gamma emitting materials i

l are handled. Preparation of radiopharmaceuticals from reagent kits should be done behind shielding. Syringe l shields should be used for the preparation and administra-tion of patient doses.

l i i

e. Give instructions for preparation and assay of patient doses.

f. Give instructions concerning movement of material between rooms, halls, or in corridors if applicable.

g. Explain requirements for storage of materials, labeling of containers, and identification of areas where radio-active materials are used. You should describe the shielding used for areas where large amounts of byproduct material are stored.

h. Specify personnel monitoring devices to be used, where to obtain them, and instructions for recording exposure results or properly turning in personnel monitoring devices for processing at appropriate intervals.

i. Instruct the user in waste disposal procedures to follow for each type of waste, (e.g., liquids, gases, solids, long-lived,short-lived). .

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j j. Describe contamination control procedures including pro-hibitions against smoking, eating or the consumption of j beverages in restricted areas and instruction for indivi-

{ duals who prepare doses and radiopharmaceuticals to moni-tor their hands after each procedure and at the end of j the day.

l1 .is i Appendix G contains an acceptable set of laboratory rules for use of. radioactive material. In response to Item 15, you may 4

state that you will follow the laboratory rules described in

, Appendix G or you may submit a copy of equivalent rules.

Item 16 Emergency Procedures Submit a copy of emergency instructions to b'e posted in all laboratory areas where radioactive materials are used. These instructions should (1) describe immediate action to be taken in order to prevent contamination of personnel and work areas (e.g. , turning off the ventilation, evacuation of the area, containment of the spill), (2) state the names and telephone numbers of the responsible persons to be notified in case of an emergency, and (3). instruct personnel on appropriate methods for reentering, decontaminating, and recovering facilities

! that may have been accidentally contaminated.

1

t An acceptable set of Emergency Procedures is contained in Appendix H. In response to Item 16, you may refer to Appendix i

H or submit a copy of equivalent procedures.

Item 17 Area Survey Procedures i

Submit a description of the routine survey program, including the areas to be surveyed, the levels of contamination considered to be acceptable and provisions for maintaining records of surveys.

If the application is to cover multiple users and areas of use, the individual user should supplement the surveys performed 4

i by the radiation safety staff. Acceptable procedures and fre-quencies for routine surveys are described in Appendix I to this guide. In response to Item 17, you may either refer to Appendix I or submit equivalent procedures.

Item 18 Waste Disposal Procedures Submit a complete description of specific methods used for disposal of waste byproduct material. A licensee may dispose of waste by:

a. Transfer to a person properly licensed to receive such waste, e.g. , commercial waste disposal firms. (See

Section 20.301 of 10 CFR Part 20.) Submit the name and NRC or Agreement State license number of the commercial firm selected.

b. Release into a sanitary sewer in conformance with Section 20.303, 10 CFR Part 20. You should describe your methods for controlling the sewage disposal of radioactive wastes in order to ensure that disposals do not exceed the Ifmits specified in Section 20.303 of 10 CFR Part 20.

c. Burial in soil in conformance with Section 20.304, 10 CFR Part 20.

d. Release into the air in conformance with Section 20.106, 10 CFR Part 20.

e. Other methods specifically approved by the Commission pursuant to Section 20.302,.10 CFR Part 20.

NOTE: No licensee may dispose of byproduct material waste by incineration unless specifically authorized by the Commission. (See Section 20.305 of 10 CFR Part 20.)

Appendix J contains a form that may be used to supply the information required in Item 18 of the application form.

Item 19 Therapeutic Use of Radiopharmaceuticals Describe special precautions for patients treated with byproduct material listed in Groups IV and V, Schedule A, Section 35.100 of 10 CFR Part 35. Although Groups IV procedures are often performed on an out patient basis, these patients sometimes require hospitalization.

Appropriate procedures should be established for all patients treated with byproduct material and should include:

a. Method for preparation and administration of therapeutic doses of iodine-131.

b. Methods for contamination control:

(1) assignment to private room (2) use of disposable items (e.g., dishes, utensils, etc.).

c. Procedures for surveys of:

(1) unrestricted areas

l (2) linens and other items removed from patient's room (3) patient's room before it is reassigned to another l patient.

d. Instructions to nursing staff.

e. Procedures for disposal of waste:

l (1) patient excreta

(2) surgical dressings l (3) disposable items.

l l f. Procedures to be followed in case of emergency surgery or death.

l

g. Procedures for release of patients:

(1) criteria for release of patients (2) instructions to patient and family.

( Guidance for the management of therapy patients can be found in National Council on Radiation Protection and Measurements (NCRP) Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," (NCRP Reports are available from: NCRP Publications, P.O. Box l 30175, Washington, DC 20014).

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Appendix K contains a description of precautions to be followed for patients treated with iodine-131, gold-198 and phosphorus-32 In response to Item 19, you may state that you will follow the procedures described in Appendix K or submit a copy of equiv-alent procedures.

Item 20 Therapeutic Use of Sealed Sources Describe special procedures for patients treated with byproduct materials listed in Group VI, Schedule A, Section 35.100 of 10 CFR Part 35. These procedures should include descriptions of:

a. The areas where sealed sources will be stored, including (1) placement and thickness of shielding and (2) proximity of the storage area to unrestricted areas.

b. Special precautions to be used while handling sealed sources.

c. Special instructions for nursing care of patients who are treated with sealed sources. (Appendix L contains a description of procedures to be followed for patients treated with sealed sources).

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

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d. Your method for determining the radiation doses to the extremities of personnel handling sealed sources, i

e. The equipment and shielding available for transporting ,

sources from storage sites to the place of use. '

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f. Your method for maintaining source accountability at all l times. This should include a description of your sign-in and sign-out procedures, periodic inventory, and your l method for determining that all sources are accounted for and returned to storage following treatment.  ;

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g. Surveys to be performed during the course of treatment l l

and at the conclusion of treatment. Your dismissal  !

survey should be adequate to determine that all temporary i implant sources have been removed from the patient and from all areas that the patient occupied.

1 l  !

You should submit detailed responses to Items Nos. 20.a.,

20.b., 20.d., 20.e., 20.f., and 20.g. In response to Item 20.c.,

you may either state that you will follow the procedures described in Appendix L or you may submit equivalent procedures.

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Item 21 Information to be Submitted for the Use of Radioactive Gases (e.g. Xenon-133)

The use of radioactive gases (e.g., xenon-133 gas or gas in saline) requires attention not only to the standard radiation safety considerations but also to an evaluation of expected air concentrations of the radioactive gas in restricted and unrestricted areas. The NRC requires that each applicant make such determinations for his own unique situation and submit sufficient evidence to the Commission in support of his request.

Appendix M contains sample procedures and instructions for i

submitting an application to use xenon-133.

Item 22 Procedures and Precautions for Use of Radioactive i Material in Animals Describe procedures to be followed if radioisotopes will be used in animals including (1) a description of the animal housing facilities, (2) a copy of instructions provided to animal caretakers for the handling of animals, animal waste and carcasses, (3) instructions for cleaning and decontam-inating animal cages, and (4) procedures for ensuring that animal rooms will be locked or otherwise secured unless attended by authorized users of radioactive material.

Item 23 Procedures and Precautions for Use of Radioactive Materials Soecified in Item 6.b.

Any additional radiation safety procedures to be followed while individuals are using these materials listed in Item 6.b. should be clearly stated, e.g., air sampling, other special surveys, bioassays.

Bioassays may be required when individuals work with millicurie quantities of hydrogen-3, iodine-125 or iodine-131 (depending on the chemical and physical form, the procedures followed, and the equipment used). Bioassays may also be required for other radionuclides if the chemical or physical form or proce-dures and equipment used make it likely that the radioactive material will be ingested, inhaled, or absorbed into the body.

The applicant should show in his application that the need for bioassays has been thoroughly considered and that the proposed bioassay program is appropriate for his intended use of radio-active material.

Item 24 State the name of the organization furnishing film badge or l thermoluminescent dosimeter (TLD) service. Specify the frequency l with which the badges are changed and evaluated, and give a description of the type, e.g., whole body, or finger badge.

Item 25.a. (For Private Practice Licenses Only)

State the name and address of the hospital that has agreed to admit patients containing radioactive material.

Item 25.b.

Submit a copy of the letter of authorization, signed by the administrator, from the hospital that has agreed to admit patients containing radioactivity.

Item 25.c.

If patients treated with therapeutic quantities under this license are admitted to the hospital, you should (1) describe the radiation detection instruments available at the hospital and (2) submit a copy of radiation safety procedures to be followed.

5.0 AMENDMENTS TO LICENSES Licensees are required to conduct their programs in accordance with statements, representations, and procedures contained in the license application and supportive documents. The license must therefore be amended if the licensee plans to make any changes in the facilities, equipment (including monitoring and survey instruments), procedures, personnel, or byproduct material to be used.

Applications for license amendments may be filed either on the application form or in letter form. The application should identify the license by number and should clearly describe the exact nature of the changes, additions, or deletions. Refer-ences to previously submitted information and documents should be clear and specific and should identify the pertinent informa-tion by date, page, and paragraph.

6.0 RENEWAL OF A LICENSE An application for renewal of a license should be filed at least 30 days prior to the expiration date. This will ensure that the license does not expire until final action on the application has been taken by the NRC as provided for in paragraph 30.37(b) of 10 CFR Part 30.

Renewal applications should be filed on Form NRC-313M appro-priately supplemented, and should contain complete and up-to-date information about the applicant's current program.

In order to facilitate the review process, the application for renewal should be submitted without reference to previously submitted documents and information. If such references cannot be avoided, they should be clear and specific and should identify the pertinent information by date, page, and paragraph.

The application should be completed in triplicate. The original and one copy should be mailed to: Radioisotopes Licensing Branch, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. One copy of the applica-tion, with all attachments, should be retained by the applicant, since the license will require, as a condition, that the institution follow the statements and representations set forth in the application and any supplement to it.  ;

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Appendices Order Apoendix Title A Acceptable Training and Experience for Medical uses of Byproduct Materia?

B Medical Isotopes Committee C Instrumentation 0 Instrumentation Calibration Section 1 - Methods for Calibration of Survey Meters, Including Procedures, L

Standards and Frequency Section 2 - Methods of Calibration for a Dose Calibrator E Procedures for Ordering and Receiving Radioactive Materials F Procedures for Opening Packages Containing Radioactive Materials l

G Laboratory Rules for the Use of Radioactive Material H Emergency Procedures I Survey Procedures J Waste Disposal Procedures l K Procedures for Use of Groups IV and V Radiopharma-ceuticals for Treatment of Patients L Procedures for Use of Group VI sources for Treatment l of Patients M Information to be Submitted for the Use of Radioactive

[ Gases (e.g., xenon-133) i i

1 t . _ _ _ . __. . _ _ _ _ _ _ . _ . _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _

4 APPENDIX A ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES OF BYPRODUCT MATERIAL l

Section 35.11 (d) of 10 CFR 35 provides that the Commission will approve a license application by an institution for medical use of byproduct l material if it determines, among other things, that the physician designated as the individual user is adequately trained and experienced in (a) basic radioisotope handling techniques and (b) the clinical use of byproduct material proposed in the application. Similar criteria are established in Section 35.12 (c) of 10 CFR 35 for approval of licenses for medical use of radiopharmaceuticals by individual physicians. Out-lined below are training and experience criteria that the Commission, with the assistance of its Advisory Committee on the Medical Uses of Isotopes, has found acceptable for physicians who use radiopharma-ceuticals. Each physician's training and experience are examined on a case-by-case basis. If a physician wishes to use~radiopharmaceuticals but does not have the training and experience described, he may submit an applcation listing his specific qualifications and this will be reviewed by the Commission with the assistance of the Medical Advisory Committee.

i

l t

l I. GENERAL TRAINING To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups I, II and/or III, Section 35.100 of 10 CFR Part 35, a physician should have:

A. Training in bas.ic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) consisting of lectures, laboratory sessions, discus-sion groups or supervised experience in a nuclear medicine laboratory in the following areas:

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

2. Radiation Protection ( 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)

3. Mathematics pertaining to the use and measure-ment of radioactivity ( 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)

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

5. Radiopharmaceutical chemistry ( 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)

(The hours listed next to each of the five subjects above are suggested values and should not be interpreted as specific requirements.)

B. Experience with the types and quantities of byproduct material for which the application is being made, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).

i-C. Supervised clinical training in an institutional nuclear medicine progra.n (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). The clinical training should cover all apprcpriate types of diagnostic procedure: and include:

1. Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed.

2. Collaboration in calibration of the dose and the actual i administration of the dose to the patient, including calculation of the radiation dose, related measurement and plotting data. '

3. Follow up of patients when required.

4. Study and discussion with preceptor of case histories to establish most appropriate diagnostic procedures, limitation, l contraindication, etc.

i

! Note:

l The requirements specified in Sections A, B and C may be satisfied concurrently in a three month training program E all three areas are integrated into the program.

3 Note:

i j For each physician named in Item 4 of Form NRC-313H complete Supplements A and 8 of Form NRC-313M (Preceptor Statement and the statement of i

! l

training in basic radioisotope handling techniques). For each subject covered in basic training, state where the training was obtained, the dates, total number of hours and type of training (e.g. , lectures, labo-t ratory sessions).

Alternative:

Certification by the American Board of Nuclear Medicine will be accepted as evidence that a physician has had adequate training and experience to use Groups I, II and III.

Certification by the American Board of Radiology in Diagnostic Radiology with Special Competence in Nuclear Radiology will be accepted as evidence that a physician has had adequate training in basic radioisotope handling techniques and has had adequate clinical experience to use Groups II and ,

III.

1 l

1 II. TRAINING REQUIREMENTS FOR SPECIFIC OIAGNOSTIC PROCEDURES 3

A physician who wishes to be authorized for only one or two specific diagnostic procedures should have training in basic radioisotope handling techniques and clinical procedures commensurate with the procedures and

, quantities of byproduct material being requested. Such requests will be examined on a case-by-case basis by the Commission with the assistance

, of the Advisory Committee on the Medical Uses of Isotopes.

I i

_ _ . _ _ _ _ . _ _ _ _ _ _ _ . _ . _ _ _ _ _ . _ . = . _ _ _ _ _ _ _ .

III. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING RADI0 PHARMACEUTICALS To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups IV and/or, V, Section 35.100 of 10 CFR Part 35, a physician should have:

A. Training in basic radioisotope handling techniques (80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) including:

1. Radiation physics and instrumentation (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />)

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

3. Mathematics pertaining to the use and measurement of radioactivity (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />)

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

(These requirements are in lieu of, not in addition to, those specified in Section I.A., above.)

8. Clinical training in specific therapy procedures:

For Group IV (i) Iodine-131 for treatment of hyperthyroidism and/or cardiac i

l conditions:

- Clinical experience in the diagnosis of thyroid function i and active participation in the treatment of ten patients.

1

(ii) Phosphorus-32 for treatment of polycythemia vera, leukemia and/or bone metastases:

- Treatment of three patients with any combination of these three conditions.

(iii) Colloidal phosphorus-32 intracavitary treatment:

- Active participation in the treatment of three patients.

For Group V (i) Iodine-131 for treatment of thyroid carcinoma:

- Clinical experience in diagnosis of thyroid function and treatment of hyperthyroidism and/or cardiac dysfunction, and active participation in the treatment of three patients with thyroid carcinoma.

(ii) Colloidal gold-198 for intracavitary treatment:

- Active participation in the treatment of three patients.

IV. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING SEALED SOURCES To qualify as adequately trained to use or directly supervise the use of I byproduct material listed in Group VI, Section 35.100 of 10 CFR Part 35, a physician should have:

A. Training in basic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) as

described in Section I.A. of this Appendix.

r i

l l

._ . _ _ . . ____ __ _ .._ ~ __.._ ___ _. .__ - _ _ _ _ _ _ _ _ _ . . . _ _ _ . _ _ _ _ _ -

4 i -s-

! B. Clinical training in specific therapy procedures:

(1) Radiation sourcer for interstitial, intracavitary, or I

surface treatment of cancer:

, - Active practice in therapeutic radiology with a minimum t

of three years experience.

(ii) Beta ray applicators .for the treatment of superficial eye disease:

1 1

- Active practice in therapeutic radiology or opthalomology and experience in the therapeutic use of beta rays or soft ,

I X-rays.

l (Evidence of certification by the American Board of Radiology in Radiology or Therapeutic Radiology may be submitted in lieu of the information >

t requested in Subsections A and B, above.)

4 i

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APPENDIX B

.i, MEDICAL ISOTOPES COMMITTEE' ,

y" i

l Responsibility:

The . Committee is responsible for:

l 1. Ensuring that all individuals who work with or in the vicinity of

. radioactive material-have sufficient training and experience to i

l enable them to perform their duties safely and in accordance with NRC regulations and the conditions of the license.

i

(

2. Ensuring that all use of radioactive material is conducted in a safe manner and in accordance with NRC regulations and the conditions of the license.

1 Duties:

The Committee shall:

1. Be familiar with all' pertinent NRC regulations, the terns of the l

license, and information submitted in support of the reque'st for l \

the license and its amendments. 1 l I

2. Review the training and experience of any individual who uses radioactive material (including physicians, technologists, physicists,

,f -

and pharmacists) and determine that the qualifications'are sufficient i

s t

i to enable them to perform their dutigs safely and in accordance with NRC regulations and the conditions of the license.

3. Establish a program to ensure that all individuals whose duties may require them to work in the vicinity of radioactive material (e.g., nursing, security and housekeeping personnel) are properly instructed as required by Section 19.12, of 10 CFR Part 19.

4. Review and approve all requests for use of radioactive material within the institution.

9 5. Prescribe special conditions that will be required during a proposed use of radioactive material such as requirements for bicassays, physical examinations of users and special monitoring procedures. ,

6. Review the entire radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with NRC regulations and the conditions of the license.

The review shall include an examination of all records, reports from the radiation safety officer, results of NRC inspection, written safety procedures and management control system.

i 4

m____________.__ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ __ . _ _ _ . _ . _ _ . __ _ . _ _ . _ _ . _ _ _ _ . _ _ .

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7. Recomend remedial action to correct any deficiencies identified in the radiation safety program.

1

8. Maintain written records of all comittee meetings, actions, iecommendations, and decisions.

9. Ensure that the byproduct material license is amended, when necessary,

p'rior to any changes in facilities, equipment, policies, procedures, ,

'and personnel .

Meeting Frequency:

The medical isotopes comittee shall meet as often as necessary to conduct its business, but not less than once in each calendar quarter.

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d 4

i APPENDIX C INSTRUMENTATION

1. Survey meters

a. Manufacturer's name:

Manufacturer's model number:

. Number of instruments available:

Minimum range: mr/hr to mr/hr Marimum range: mr/hr to er/hr 4

b. Manufacturer's name:

Manufacturer's model number:

Number of instruments available:

ranges:

Minimum range mr/hr to mr/hr Maximum range mr/hr to mr/hr i

M

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.

l I

t 4.. Other i

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rww,----u------.- e, vw-~g, - - - - ,---n,-m----,,n,,,,v--- ------., - ,- , , , -w --

APPENDIX D Section 1 METHODS FOR CALIBRATION OF SURVEY METERS, INCLUDING PROCEDURES, STANDARDS AND FREQUENCY A. Calibration of survey meters shall be performed with radionuclide sources.

1. The sources shall be approximate point sources.

2. The source activities shall be traceable within 5% accuracy to the U.S. National Bureau of Standards (NBS) calibrations.

3. The frequency shall be at least annually.

4. Each scale of the instrument shall be calibrated at approximately 1/3 and 2/3 of full scale.

5. The exposure rate measured by the instrument shall differ from the true exposure rate by less than 10% of full scale (read appropriate section of the instrument manual to determine how to make necessary adjustments to bring instrument into calibra-tion). Readings within,+ 20% will be considered acceptable if a calibration chart or graph is prepared and attached to the instrument.

NOTE: Sources of Cs-137, Ra-226, or Co-60 are appropriate for the performance of calibration. The activity of the calibration j standard should be sufficient to calibrate the survey meters on all ranges, or at least up to 1 R/ hour.

l

B. A reference check source of long half-life, e.g. Cs-137 or Ra D and E, shall also be read at the time of the above calibration. The readings shall be taken with the check source placed in specific geometry relative to the detector. A reading of this reference check source should be taken:

1. Before each use.

2. Af ter each maintenance and/or battery change.

3. At least quarterly.

If any reading with tne same geometry is not within +20% of the reading measured immediately after calibration. The instrument should be recalibrated (see Step A).

C. The instrument must be calibrated at lower energies if its response is energy dependent and it is to be used to measure in the I-125, Xe-133, or Tc-99m energy ranges.

This calibration may be done either:

1. As in A. above with calibrated standards of radionuclides at or near the desired energies, or

2. As a relative intercomparison with an energy independent instrument and uncalibrated radionuclides.

1 D. Records of the above, A, B-2, B-3, and C must be maintained.

E. Use of Inverse Square Law and Radioactive Decay Law

1. A calibrated source will have a calibration certificate giving its output at a given distance measured on a specified date by the manufacturer or NBS.

a. The Inverse Square Law may be used with any point source to calculate the exposure rate at other distance.

b. The Radioactive Decay Law may be used to calculate the output at other times after the specified date.

2. INVERSE SQUARE LAW S (Rj ) (R2 )

• __p

-___-_p ExposuregateatP 2 R

2 = (P3 ) X R) where (a) S is the po'at source (p )2 (b) R) and R2 are in the same units (mR/h or R/h)

(c) Pj and P2 are in the same units (cm, meter, feet 1

etc.)

1 i

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3. RADI0 ACTIVE DECAY LAW:

Exposure rate t units of time after specified calibration date:

Rt=Rg x e -[0 W x t] where (a) Ro and Rt are in the

' 1/2 units (mR/h or R/h):

(b) Rg is exposure rate on specified calibration date ,

(c)R tis exposure rate t unit of time later (d) T l/2 and t are in the same units (years, months, days,etc.)

(e) T l/2 is radionuclide half-life (d) t is number of units of time elapsed between calibration and present time

4. Example: Source output is given by calibration certificate as 100 mR/h at 1 foot on 10 March 1975. Radionuclide half-life is 5.27 years.

Question: What is the output at 3 feet on 10 March 1977 (2.0 years)?

-m- -

-s.g- es -- p -M u y -, seme n -w- --p n--,. . 77g- n -=+-- - w

• Wi# -e

a. Output at 1 foot, 2.0 years after calibration date:

R = 100 mR/hr x e -(0.693 = 100 x 0.77 = 77 mR/hr 53 at 1 foot on 10 March 1977.

b. Output at 3 feet, 2.0 years after calibration date:

R feet =

3 i t x77mR/hr=hx77=8.6mR/hrat 3 feet, 2.0 years after calibration.

1

1 _ CALIBRATION OF SURVEY INSTRUMENTS Check appropriate items

1. Survey instruments will be calibrated at least annually and follcwing 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 + 10%

of the calculated or known values for each point checked.

Readings within + 20% are considered acceptable if a calibration chart or graph is prepared and attached to the instrument.

3. Survey instruments will be calibrated

a. By the manufacturer

b. At the licensee's facility (i) Calibration source Manufacturer's name Model no.

Activity in millicuries Accuracy Traceability to primary standard (ii) The calibration procedures in Appendix 0,Section I will be used.

l or (iii) The step-by-step procedures, including radiation safety procedures are attached.

c. By a consultant or outside firm (1) Name lii) location (iii) Procedures and sources have been approved by NRC and are on file in License No.

are attached

CALIBRATION OF SURVEY INSTRUMENTS Check appropriate items

1. Survey instruments will be calibrated at least annually and follcwing 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 + 10%

of the calculated or known values for each point checked.

Readings within + 20% are considered acceptable if a calibration chart or graph is prepared and attached to the instrument.

3. Survey instruments will be calibrated

a. By the manufacturer

b. At the licensee's facility (i) Calibration source Manufacturer's name Model no.

Activity in millicuries Accuracy Traceability to primary standard (iil The calibration procedures in Appendix 0,Section I will be used.

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

c. By a consultant or outside firm li} Name (ii) location (iii) procedures and sources have been approved by NRC and are on file in License No.

are attached L_

APPENDIX D Section 2 METHODS FOR CALIBRATION OF DOSE CALIBRATOR All radiopharmaceuticals must be assayed for activity to an accuracy of 10%. The most common instrument for accomplishing this is an ionization type dose calibrator. The instrument must be checked for accurate operation at the time of installation and periodically thereafter.

A. Test for the following:

1. Instrument linearity (at installation and quarterly)

2. Geometrical variation (at installation)

3. Instrument accuracy (at installation and annually).

B. After repair or adjustment of the dose calibrator, repeat all of the appropriate tests listed above (dependent upon the nature of the repairs).

C. Daily or before each use of the the instrument:

1. Measure and record the activity of at least one reference source (e.g.,1-2 mci of Co-57). This check should be repeated during the day whenever sample readings are not within 10% of the anticipated assay. Variation greater than 5% in this test will indicate the need for instrument repair, adjustment or recalibration.

2. Measure and record the apparent activity of a long-lived standard radionuclide such as Cs-137 or Radium-226 at all of the commonly used radionclide settings (when the unit was fir st calibrated against NBS-traceable standards). Choose a source with activity in the 100 uCi range D. Inspect the instrument on a quarterly basis to ascertain that the measurement chamber liner is in place and that instrument zero is properly set (see manufactuer's instructions).

E. Test of InstrurnenL Linearity The linearity of a dose calibrator should be ascertained over the entire range of activities employed. This test will utilize a vial of Tc-99m whose activity is equivalent to the maximum anticipated activity to be assayed (e.g., the first elution from a new generator).

1. Assay the Tc-99m vial in the dose calibrator and subtract ~

background level to obtain net activity in millicuries.

2. Repeat step 1 at time intervals of 6, 24, 30, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after the initial assay.

1 e - ., m- , r -.--- y ,.

3. Using the 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> activity measurement as a starting point calculate the predicted activities at 0, 6, 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> using the following table:

Assay Time (hrs.) Correction Factor 0 32 6 16 24 2 30 1 i

48 0.125 Example: if the net activity measured at 30 hrs was 15.625 millicuries, then the predicted activity for 6 and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci x 16 = 250 mci and 15.625 mci x 0.125 - 1.95 mci respectively.

4. Plot the measured net activity for each time interval versus the predicted activity on log-log graph paper.

5. The activities plotted should be within + 5% of the predicted 4

curve if the instrument is linear and functioning properly.

Errors greater than + 5% indicate the need for repair or adjustment of the instrument.

i i

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

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6. If instrument linearity cannot be corrected, it will be l necessary in routine assays to either assay an aliquot of the eluate that can be accurately measured, or to use the graph l constructed in step 4 to relate measured activities to true  !

activities.

G. Test for Geometrical Variation There may be significant geometrical variation in activity measured as a function of sample volume or configuration, depending on the t

volume and size of the ionization chamber used in the dose calibrator.

L i The extent of geometrical variation should be ascertained for l commonly used radionuclides and appropriate correction factors l computed if variations are significant, i.e., greater than t 2".

(even though correction factors may be provided by the manufacturer, l the accuracy of these should be checked).

To measure variation with volume of liquid, a 30 cc vial containing 2 mci of Co-57 or other appropriate radionuclide in a volume of 1 ml will be used.

1. Assay vial at the appropriate instrument setting and subtract background level to obtain net activity.

4 I

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2. crease the volume of liquid in the vial in steps to 2, 4, 8, 10, 20 and 25 ml by adding the appropriate amount of water or saline. After each addition, gently shake vial to mix contents and assay as in step 1.

3. Select one volume as a standard (such as the volume of reference standard used in performing the test for instrument accuracy) and calculate the ratio of measured activities for each volume to the reference volume activity. This represents the volume correction factor.

Example: if activities of 2.04, 2.02, and 2.00 mC are measured for 4, 8, and 10 ml volumes and 10 ml is the reference volume selected, then 4 ml Volume CF

=% = 0.98

4. Plot the correction factors against the volume on linear graph paper. Use this graph to select the proper volume correction factors for routine assay of that radionuclide.

A

5. The true activity of a sample is calculated as follcws:

True Activity = Measured Activity x CF Where the CF used is for the same volume and geometrical configuration as the sample measured.

6. Similarly, the same activity of Co-57 in a syringe may be compared with that of 10 ml in a 30 cc vial and a correction factor calculated.

7. It should be noted that differences of 200% in dose calibrator readings between glass and plastic syringes have been observed for lower energy radionuclides such as I-125. Hence adequate correction factors must be established for this type of syringe.

An alternate to providing syringe calibration factors is to simply assay the stock vial before and after filling the syringe. The activity in the syringe is then the difference in the two readings Qdith a volume correction if significant).

H. Test For Instrument Accuracy The accuracy of the dose calibrator should checked for several radionuclides such as Cs-137, Co-57, and Ba-133 using appropriate reference standards whose activity is traceable to NBS. The

activity levels of the reference sources used should approximate those levels normally encountered, giving adequate attention to source configuration. The lower energy reference standards (Tc-99m, Xe-133, I-125) must be in vials with the same thickness of glass as the actual samples to be measured for best accuracy.

1. Assay the reference standard in the dose calibrator at the appropriate setting and subtract the background level to obtain the net activity.

. 2. Repeat step i for a LoLal of 3 determinations and average results.

3. The average activity determined in step 2 should agree with the certified activity of the reference scurce within + 5%

after decay corrections.

4. Repeat the above steps for other commonly used radionuclides for which adequate reference standards are available.

5. Keep a log of these calibration checks.

6. Calibration checks which do not agree within + 5% indicate I that the instrument should be repaired or adjusted. If this I

1 I

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is not possible a calibration factor should be calculated for use during routine assays of radionuclides.

7. At the same time the instrument is being initially calibrated with the NBS traceable standards, place a long-lived source in the calibrator, set the instrument, in turn, at the various radionuclide settings used (Cs-137, I-131, Tc-99m, I-125,

.- etc.) and record the readings. These valuas may later be used to check instrument calibration at each settings (after correcting for decay of the long lived source), without requiring more NBS traceable standards. Keep a log of these initial and subsequent readings.

I. Test for Instrument Constancy Two reference sources such as Cs-137 and Co-57 should be assayed using a reproducible geometry before each daily use of the instru-ment.

l. Assay each reference source using the appropriate instrument setting (i .e. , Cs-137 setting for Cs-137) .

i

2. Measure background level at same instrument setting.

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

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3. Calculate net activity of each source subtracting out back-ground level.

4. For each source plot net activity versus the day of the year on semi-log graph paper.

5. Log the background levels.

6. Indicate the predicted activity of each source based upon decay calculations and the + 5% limits on the graph as illustrated.

7. Repeat the procedure for the Cs-137 source for all of the commonly used radionuclide settings.

8. Variations greater than + 5% from the predicted activity indicate the need for instrument repair or adjustment.

9. Higher than normal background levels should be investigated to determine their origin and eliminated if possible by decontamination, relocation, etc.

l l

CALIBRATION OF DOSE CALIBRATOR A. Sources Used for Linearity Test:

Check as appropriate First elution from new Mo-99/Tc-99m generator or other* (specify)

B. Sources Used for Instrument Accuracy and Constancy Tests:

Radionuclide Activity Accuracy (mci)

I 57 Co 133 Ba 137 Cs l

other l

C. The procedures described in Appendix D Section 2 will be used for calibration of the dose calibrator.

j or Equivalent procedure are attached.

i

• Must be equivalent to the highest activity used.

J l

4 Item No. 10

, Date:

i l

APPENDIX E PROCEDURES FOR ORDERING AND RECEIVING RADI0 ACTIVE MATERIAL

1. The Chief Nuclear Medicine Technologist will place all orders for radioactive material and will ensure that the requested materials and quantities are authorized by the license and that possession limits are not exceeded.

2. During normal working hours carriers will be instructed to deliver radioactive packages directly to the Nuclear Medicine Department.

3. During off-duty hcurs security personnel will accept delivery of radioactive packages in accordance with the procedures outline in Mr. Jones' memorandum (attached).

Item No. 13 Date:

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

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MEMORANDUM FOR: Security Personnel FROM: John Jones, Administrator i

l

SUBJECT:

RECEIPT OF PACKAGES CONTAINING RADI0 ACTIVE MATERIAL Any packages containing radioactive material that arrive between 4:30 P.M. and_7 A.M. or on Sundays shall be signed for by the Security i

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 l hospital until it can be determined that neither he nor the delivery j vehicle is contaminated.

l

! RADIATION SAFETY OFFICER:

0FFICE PHONE:

HOME PHONE:

l i

i Item No. 13 L Date:

i J

RADI0 ACTIVE SHIPMENT RECEIPT REPORT 1

1. P.O.# SURVEY DATE TIME j SURVEYOR

2. CONDITION OF PACKAGE:

a 0.K. PUNCTURED STATUS WET 1-CRUSHED OTHER l 3. RADIATION UNITS OF LABEL: UNITS (mR/hr) ,

j 4. MEMEASURED RADIATION LEVELS: a. Package surface mR/hr i

b. 3' from surface mR/hr

!_ 5. DO PACKING SLIP AND VIAL CONTENTS AGRFE7

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 = ( ) l

b. Final source container CPM = DPM eff=( )

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

9. DISPOSITION OF PACKAGE AFTER INSPECTION

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

Item No. 13 Date:

I

i j APPENDIX F PROCEDURES FOR OPENING PACKAGES CONTAINING RADI0 ACTIVE MATERIAL

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

2. Measure exposure rate at 3 feet from package surface--record. If

>10 mR/hr--stop procedure and notify Radiation Safety Offier.

3. Measure surface exposure rate and record. If >200 mR/hr--stop procedure and notify Radiation Safety Officer.

4. Put en gloves.

5. Open the outer package (following manufacturer's directions, if .

i supplied) and remove packing slip. Open inner package to verify contents (compare requisition, packing slips, and label en bottle)

check integrity of final source container (inspect for breakage of l seals or vials, loss of liquid, discoloration of packing material). ,

Check also that shipment does not exceed possession limits.

Item No. 14 Date:

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6. Wipe external surface of final source container with moistened cotton swab or filter paper held with forceps, assay and record.

7. Monitor the packing material and packages for contamination before discarding:

a. if contaminated, treat as radioactive waste.

l-

b. -if not, obliterate radiation labels before discarding in regular trash.

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Item No. 14

Da te

APPENDIX G LABORATORY RULES FOR THE USE OF RADI0 ACTIVE MATERIAL

1. Wear laboratory coats, or other protective clothing at all times in areas where radioactive materials are used.

2. Wear disposable gloves at all times while handling radioactive materials. ,

3. Monitor hands and clothing for contamination after each procedure or before leaving the area.

4. Use syringe shields for preparation of patient doses and admini-stratio'n to patients except in circumstances, such as pediatric cases, where their use would compromise the patient's well-being.

5. Do not eat, drink, smoke or apply cosmetics in any area where radioactive material is stored or used.

6. Assay each patient dose in the dose calibrator prior to admini- )

i s tration. Do not use any doses that differ from the prescribed '

dose by more than 10%.

l Item No. 15 Date:

4

7. Wear personnel monitoring devices (Film badge or TLD) at all times while in areas where radioactive materials are used or stored. These should be worn at chest or waist level.

8. Wear TLD finger badges during elution of generator and preparation, i assay, and injection of radiopharmaceuticals.

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

10. Never pipette by mouth,

11. Survey generator, kit preparation, and injection areas for contamina 4 tion after each procedure or at the end of the day. Decontaminate if necessary.

12. Confine radioactive solutions in covered containers plainly identified and labelled with name of compound, radionuclide, date, activity, and radiation level if applicable.

13. Always transport radioactive material in shielded containers.

Item No. 15 Date:

t

P APPENDIX H EMERGENCY PROCEDURES Minor Spills:

1. NOTIFY: Notify persons in the area that a spill has cccurred.

2. PREVENT THE SPREAD: Cover the spill with absorbent paper.

3. CLEAN UP: Use disposable gloves and remote handl 1g tongs.

Carefully fold the absorbent paper and pad. Insert into a plastic bag and dispose of in the radioactive waste container. Include all other contaminated materials such as dispcsable gloves.

4. SURVEY: With a G.M. Survey Meter, check the area around the spill, your hands and clothing for contaminatien.

5. REPORT: Report incident to the Radiation Safety Officer.

4 Major Spills:

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

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

Item No. 16 Date:

3. SHIELD THE SOURCE. If possible, the spill should be shielded, but only if it'can be done without further contamination or without significantly; increasing your radiation exposure.

4. CLOSE THE ROOM. Leave the room and lock the door (s) to prevent entry. ,

2 5. CALL FOR HELP. Notify the Radiation Safety Officer immediately.

i

6. PERSONNEL DECONTAMINATION. Contaminated clothing should be removed and stored for further evaluation by the Radiation Safety Officer.

If the spill is on the skin, flush thoroughly and then wash with mild soap and lukewarm water.

RADIATION SAFETY OFFICER:

OFFICE PHONE:

HOME PHONE:

\

f Itsn No. 16 Date:

APPENDIX I SURVEY PROCEDURES A. All elution, preparation and injection areas will be surveyed daily with a G-M survey meter and decontaminated if necessary.

B. Laboratory areas where only small quantities of radioactive material are used (less than 100 pCi) will be surveyed monthly.

C. All other laboratory areas will be surveyed weekly.

i

D. The weekly and monthly survey will consist of

l i 1. A measurement of radiation levels with a survey meter sufficiently sensitive to detect 0.1 mR/hr.

(

l 2. A series of wipe tests to measure contamination levels. The method for performing wipe tests will be sufficiently sensitive to detect 100 dpm.

l E. A permanent record will be kept of all survey results, including negative results. The record will include:

1. Location, date, and type of equipment used.

2. Name of person conducting the survey.

3. Drawing of area surveyed, identifying relevant features such as active storage areas, active waste areas, etc.

4. Measured exposure rates, keyed to location on drawing (point out rates that require corrective action).

5. Detected contamination levels, keyed to locations on drawing.

6. Corrective action taken in the case of contamination or excessive exposure rates, reduced contamination levels or exposure rates after corrective action, and any appropriate comments.

F. Area will be cleaned if the contamination level exceeds 100 dpm/

100 cm2 ,

NOTE: For daily surveys where ~no abnormal exposures are found, only the date, the identification of the person performing the survey, and 1

the survey reports will be recorded. j l

J

APPENDIX J WASTE DISPOSAL PROCEDURES l

1. Liquid Waste will be disposed of Check as appropriate By commercial waste disposal service (See also No. 4 below)

In the sanitary sewer system in accordance with Section 20.303 of 10 CFR Part 20.

Other (specify):

2. Mo-99/Tc-99m generators will be:

(Check as appropriate)

Returned to the manufacturer for disposal Held for decay until radiation levels as measured with a low-level survey meter and with all shielding removed, have reached background levels. All radiation labels will be removed or obliterated and the generators disposed of aSnormal trash.

(Note: this method of disposal may not be practical for generators containing long-lived radioactive contaminants)

Disposed of by commercial waste disposal service (See also No. 4 below)

Other (specify):

3. Other Solid Waste will be:

(Check as appropriate) l Held for decay until radiation levels as neasured with a low-

! level survey meter and with all shielding removed) have reached i background levels. All radiation labels will be removed or obliterated and the waste will be disposed of in normal trash.

l l Item No. 18 l Da te: _

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Disposed of b No. 4 below) y commerical waste disposal service (See also Other (Specify):

4. The commerical waste disposal service used will be:

(Name) (City, State)

NRC/ Agreement State License No.

Item No. 18 Date:

APPENDIX K PROCEDURES FOR USE OF GROUPS IV AND V RADI0 PHARMACEUTICALS FOR TREATMENT OF PATIENTS

1. All patients treated with iodine-131 or gold-198 will be placed in a private room with a toilet.

2. The patient's room will be properly posted in accordance with Section 20.203, 10 CFR Part 20.

3. Surveys of the patient's room and surrounding areas will be con-ducted as soon as practicable after administration of the treatment dose. Exposure rates will be measured at the patient's bedside, three feet away and the entrance to the room. The Radiation Safety Officer or his designate will then determine how long a person may remain at these positions and will post these times in the patient's chart and on his door. The results of daily surveys will be used to recalculate permitted times which will be posted on the patient's chart and on his door.

i l 4. The form, Nursing Instructions for Patients Treated with

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Phosphous-32, Gold-198, or Iodine-131, will be completed immediately after adninistration of the treatment dose. A copy will be posted l in the patient's chart.

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5. Radiation levels in unrestricted areas will be maintained less than the limits specified in Section 20.105(b),10 CFR Part 20.

6. All linens will be surveyed for contamination before being removed from the patient's room and will, if necessary, be held for decay.

7. Disposable plates, cups, eating utensils, tissue, surgical dressings,

,, and other similar waste items will be placed in a specially designated container. The material will be collected daily by the Radiation Safety Officer (or his designatel checked for contamination, and disposed of as normal or radioactive waste, as appropriate.

8. Non-disposable items used for these patients will be held in plastic bags in the patient's room, and checked for contamination by the Radiation Safety Officer or his designate. Items may be returned for normal use, held for decay or decontaminated, as appropriate.

9. Urine and vomitus, from iodine-131 therapy patients will be stored for decay in our radioactive waste storage area. When it has reached background levels as measured with a low-level survey meter, it will be released to the sanitary sewer system.

1 l

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10. Before a therapy patient's room is reassigned to another patient, the room will be surveyed for contamination (and decontaminated if necessaryl and all radioactive waste and waste containers will be removed.

11. Nursing Instructions

a. Nurses should spend only that amount of time near the patient required for ordinary nursing care. Special restrictions may be noted on the precaution sheet in the patient's chart.

Nurses should read these instructions before administering to the patients. Call the Nuclear Medicine Department if you

have any questions about the care of these patients.

b. Visitors will be limited to those 18 years of age or over, unless other instructions are noted on the precautions sheet

, in the patient's chart.

! c. Patients must remain in bed while visitors are in the rocm and visitors should remain at least three feet from the patient.

i

d. Radioactive patients are to be confined to their rooms except for special medical or nursing purposes approved by the

, Nuclear Medicine Department.

m,

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

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

,,-,_9 --,..--m, .

c,._,.- ,,,-.p, ,.r-..,-,.... , .g.,.,-- , - - _ - _. _ _ , y. . . . m-, _ ,..ym,,,.

e. No nurse, visitor or attendant who is pregnant should be per-mitted in the room of a patient who has received a therapeutic amount of radioactivity until the patient no longer presents a radiation hazard. Female visitors should be asked whether they are pregnant.

f. Attending personnel must wear rubber or disposable plastic gloves when handling urinals, bedpans, emesis basins or other containers having any material obtained from the body of the patient. Wash gloves before removing and then wash hands.

The gloves must be left in the patient's room in the designated waste container. These gloves need not be sterile or surgical in type.

g. Disposable items should be used in the care of these patients, whenever possible. These items should be placed in the designated waste container. Contact the Nuclear Medicine Department for proper disposal of the contents of the designated waste container.

l h. All clothes and bed linens used by the patient should be placed in the laundry bag provided and left in the patient's room to be checked by a member of the Nuclear Medicine Department.

l

1. All non-disposable items should be placed in a plastic bag and left in the patient's room to be checked by a member of the Nuclear Medicine Department.

j _ Surgical dressings should be changed only as directed by physician. - Gold-198 leaking from a puncture wound will stain the dressings dark red or purple. Such dressings should not be discarded but should be collected in plastic bags and turned over to the Nuclear Medicine Department. Handle these dressings only with tongs or tweezers. Wear disposable gloves.

4

k. For iodine-131 patients:

(1) Urine from iodine-131 patients will be collected in special containers provided by the Nuclear Medicine Department. The patient should be encouraged to collect his own urine in the container. If the patient is bedridden, a separate urinal or bed pan should be provided.

The urinal or bed pan should be flushed several times with hot soapy water after use.

(2) If the nurse helps to collect the excreta, she should wear disposable gloves. Afterwards she should wash her

hands with the gloves on and again after the gloves are removed. The gloves should be plac^d e in the designated waste container for disposal by the Nuclear Medicine Department.

(3) Disposable plates, cups, and eating utensils will be used by patients who are treated with iodine-131.

(4) Vomiting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after oral administration, -

urinary incontinence, or excessive sweating within the first 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> may result in contamination of linen and/or floor. In any such situations or if radioactive urine and/or feces is spilled during collection, call the Nuclear Medicine Department, Ext. . Meanwhile, handle all contaminated material with disposable gloves and avoid spreading contamination.

(5) All vomitus must also be kept in the patient's room for disposal by the haclear Medicine Department. Faces need not be routinely saved, unless ordered on the chart. The same toilet should be used by the patient at all times and it should be well flushed (3 times).

i 3

1. Utmost precautions must be taken to see that no urine or vomitus, is spilled on the floor or the bed. If any part of the patient's room is suspected to be contaminated, notify the Nuclear Medicine Department.

m. If a nurse, attendant or anyone else knows or suspects that his skin, or clothing, including shoes, is contaminated, notify the Nuclear Medicine Department immediately. This person should remain in the patient's room and not walk about the hospital. If the hands become contaminated, wash immediately with soap and water.

n. If a therapy patient should need emergency surgery or should die, notify the Nuclear Medicine Department immediately.

o. When the patient is discharged call the Nuclear Medicine Department and request that the room be surveyed for con-tamination before remaking the room.

Date:

NURSING INSTRUCTIONS FOR PATIENTS TREATED WITH PH0SPHUUS-32, GOLD-198, or 100lNE-131 Patient's Name:

Room No.: Physician's Name:

Radioisotope Administered:

Date and Time of Administration:

Dose Received: Method of Adninistration:

Exposure Rates in MR/hr Date 3 feet from bed 10 feet from bed (Comply with all Check Items)

1. Visting time permitted:

2. Vistors must remain from patient.

3. Patient may not leave room

4. Vistors under 18 not perrmitted.

5. Pregnant visitors not permitted.

6. Film badges must be worn.

7. Use and complete the following tags:

door bed chart wrist

.g.

8. Gloves must be worn while attending patient.

t

9. Patient must use disposable utensils.

10. All items must remain in romm until OK'd by Radiation Safety.

11. Smoking is not permitted.

12. Do not release room to admitting until OK'd by Radiation Safety.

13. Other instructions In case of an emergency contact:

RSO /

name on/off duty telephone no.

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{'. t' APPENDIX L PROCEDURES FOR USE OF GROUP VI SOURCES FOR TREATMENT OF PATIENTS

1. All patients treated with brachytherapy sources will be placed in a private room with toilet.

2. The patient's room will be properly posted in accordance with Section 20.203, 10 CFR Part 20.

3. Surveys of the patient's room and surrounding areas will be conducted as soon as practicable after sources are implanted. Exposure rate measurements will be taken at the patient's bedside, three feet away and at the entrance to the room. The Radiation Safety Officer or his designate will then determine how long a person may remain at these positions and will post these times in the patient's chart.

4. The form, Nursing instructions for Patients Treated with Brachy-therapy Sources, will be completed immediately after sources are implanted and placed in the patient's chart.

5. Radiation levels in unrestricted areas will be maintained less than the limits specified in Section 20.105(b),10 CFR Part 20.

6. Nurses caring for brachytherapy patients will be assigned film badges. TLD finger badges will also be assigned to nurses who must provide extended personal care to the patient.

7. At the conclusion of treatment, a survey will be performed to ensure that all sources have been removed from the patient and that no sources remain in the patient's room or any other area occupied by the patient. At the same time all radiation signs will be removed and all film and TLD badges assigned to nurses will be _

collected.

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8. Instructions to Nurses

a. Special restrictions may be noted on the precaution sheet in the patient's chart. Nurses should read these instructions before administering to the patient. Call the Nucelar Medicine Department if you have any questions about the care of these patients.

. b. Nurses should spend only the minimum necessary time near a patient for routine nursing care, but must obtain and wear a 4

film badge.

c. When a nurse receives an assignment to a therapy patient, a film or TLD badge should be obtained immediately from the

Nuclear Medicine Department. The badge shall be worn only by the nurse to whom it is issued and shall not be exchanged between nurses.

d. Pregnant nurses should not be assigned to the personal care of these patients.

e. Never touch needles, capsules or containers holding brachy-therapy sources. If a source becomes dislodged use long forceps

' and put it in the corner of the room or in the shielded container provided; contact the Nuclear Medicine Department at once.

f. Bed bath given by the nurse should be omitted while the sources are in place.

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g. Perineal care is not given during gynecologic treatment; 4

the perineal pad may be changed when necessary, unless orders '

to the contrary have been written,

h. Surgical dressings and bandages used to cover the area of needle insertion may be changed only by the attending physician or or radiologist, and MAY NOT BE DISCARDED until directed by J

the radiologist. Dressings should be kept in a basin until -

checked by the radiologist or member of the Nuclear Medicine Department.

1 Special orders will be written for oral hygiene for patients

~

with oral implants.

l

1. No special precautions are needed for sputum, urine, vomitus, l

stools, dishes, instruments, utensils or bedding unless speci-fically ordered.

J. These patients must stay in bed unless orders to the contrary are written.

4 1

k. Visitors will be limited to those 18 years of age or over, unless other instructions are noted on the precaution sheet in

the patient's chart.

1. Visitors should sit at least three feet from the patient and should remain no longer than the times specified on the form posted on the pat.ient's door and in his chart.

m. No nurse, visitor or attendent who is pregnant should be per-mitted in the room of a patient while brachytherapy sources are implanted in the patient. Female visitors should be asked whether they are pregnant.

i l n. Emergency Procedures (1) If an implanted source becomes loose or separated from l

l the patient, or (2) If the patient dies, oz (3) If the patient requires emergency surgery, imediately call . Phone No. (days) ,  ;

(nights) .

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o. At the conclusion of treatment, call the Radiation Safety I.

\

Officer and request that the patient and room be surveyed to l be sure all radioactive sources have been removed, i

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j NURSING INSTRUCTIONS FOR PATIENTS TREATED

WITH BRACHYTHERAPY SOURCES Patient's Name:

I j R:om Number: Physician's Name:

) Isotope A'ctivity:

! Date and Time of Administration:

} Date and Time Sources are to be removed: Isotope:

Exposure Rates in mR/hr I

i Bedside 3 feet from bed 10 feet from bed j

4 (Complete checked items)

1. Wear film badge. .

2. Wear rubber gloves

3. Place laundry in linen bag and save.

4. Housekeeping may not enter the room.

5. Patient may not have visitors.

6. No pregnant visitors.

7. No visitors under 18 years of age.

8.

A dismissal survey must be performed before pattient is discharged.

9. Patient must have a private room.

10. Other Instructions i RSO , /

! name on duty /off duty telephone l number 3

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APPENDIX M INFORMATION TO BE SUBMITTED FOR THE USE OF  !

RADI0 ACTIVE GASES (e.g. , XEX0N-133) l The following information should be submitted in support of requests I to use xenon-133:

l

a. Quantitites to be Used:

(1) Patient information (a) Number of studies expected per week (b) Average activity per patient (2) State the. desired possession limit. This should be sufficient to provide for shipments whose calibration date is several days after receipt.  ;

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b. Use and Storage Areas:

(1) Describe the area (s) in which you plan to use and store xenon-133. Include a diagram indicating the availability of shielding materials and the proximity to unrestricted areas. i t

1 (2) Describe the ventilation in all areas where xexon-133 is used and stored. You should indicate the location of supply and

2-exhaust vents, the measured air flow rates for each vent and the fraction of air that is recirculated by the system.

(3) All areas where xenon is used should be under negative pressure. State how you will ensure that all airflow rates are maintained as specified in this application,

c. Procedures for Routine Use (1) Describe the procedures to be followed for routine use of xenon-133, giving particular attention to radiological safety factors.

(2) If you plan to use a special apparatus for administration and collection of xenon-133, specify the manufacturer's name and model number and include a description of its design characteristics.

(Inclusion of a brochure would be helpful.)

(3) Describe any special procedures that you plan to employ to reduce leakage, e.g., use of nose clamps or special enclosures.

d. Emergency procedures Describe the emergency procedures to be used in case of an accidental release of xenon-133. This should include such considerations as temporary evacuation of the area or increasing the ventilation of the area.

[

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e. Air Concentrations of xenon-133 in Restricted Areas l No licensee shall permit any individual in a restricted area to inhale a quantity of radioactive material in any period of one calendar quarter greater than the quantity which would result from inhalation for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks at unifonn concentrations of radioactive material greater than 1 x 10-0 uCi/ml.

You may evaluate your situation by making actual measurements of xenon-133 concentrations or by means of calculations. If you choose the latter approach, you may make simplifying assumptions, PROVIDING they are reasonable, conservative and stated explicitly in your request.

In actual use and storage, some xenon-133 will be released into the room from the storage and administration devices, rebreathing apparatus, collection systems, and escape from the patient. All sources of loss must be considered when estimating the fraction of xenon-133 that is lost.

The following procedures may be used to calculate the air con-centration of xenon-133 in restricted areas:

(1) Estimate the maximum amount of activity to be used per week (A).

. l (2) Estimate the fraction of xenon-133 that is lost during use and j storage (f). This fractional loss must include ALL sources of loss, e.g., during patient administration, storage, and disposal.

(3) Determine the measured airflow rate in the area (s) of interest and calculate the volume of air available per week for dilution l

} of the xenon-133 (V).

l

) (4) For restricted areas, Section 20.103 of 10 CFR Part 20 requires that:

t 5

A_ x f < 1x10 uCi/ml.

V (5) Sample Problem A nuclear medicine laboratory plans to use 10 mci xenon-133 per patient and will perform a maximum of 10 studies per week.

What ventilation rate is required to ensure compliance with Section 20.103 of 10 CFR Part 207 (a) Maximum activity used per week: ,

3 5 lx10 Ci = 1x10 uCi

! A= 10 mci x 10 patients x patient week mci week

(b) Assume a lose rate of 20% (f)

(c) V = fxj0 5 uCi/ml

, lx10 5uCi/ week x 0.20 lx10-5 uCi/ml 9

= 2.0x10 ml/ week.

The required ventilation rate is 9 6 2.0x10 ml/ week

• 1.7x10 cfm = 30 cfm 40 hrs / week ml/hr The answer shows that, in order to meet the requirements of Section 20.103 of 10 CFR Part 20, the imaging room (RESTRICTED AREA) must have a ventilation rate of at least 30 cfm with no recirculation of air. Where practical, the ventilation rate should be greater than that shown necessary by the calculations.

You must also consider every alternative in order to maintain the air concentration of xenon-133 as low as reasonably achievable in accordance with Section 20.l(c) of 10 CFR Part 20.

I l If the ventilation rate is inadequate to meet the requirements of Section 20.103, 10 CFR Part 20, you should consider methods l of increasing ventilation or reducing the patient load.

The following table gives the amount of xenon-133 that can be released per week without exceeding the permissible levels for xenon-133 in restricted areas.

133 Maximum Xe Released Ventilation Rate (cfm) per 40 hour-week (mci) 100 67,9 500 339.7 1,000 679.4

f. Methods of Xenon-133 Disposal (1) Dilution through Exhaust Systems (least desirable)

One method for disposal of xenon-133 is by release to the atmosphere through an air exhaust system. Licensees are required to perform surveys (measurements or calculations) to ensure that they are in compliance with Section 20.l(c) and 20.106 of 10 CFR Part 20. Section 20.1(c) requires that the concentrations of xenon-133 in effluents to unrestricted areas be as low as is reasonably achievable by the current state of technology, and Section 20.106 requires that the concentrations, averaged over a period of one (1) year, shall not exceed 3x10-7 uCi/ml.

Many facilities do not have sufficient air flow to achieve the necessary dilution. The following procedure may be used to estimate the concentrations of xenon-133 in effluents to unrestricted areas.

(a) Estimate the maximum amount of xenon-133 to be released per year (A). This should include all anticipated losses during administration, storage and disposal.

(b) Determine the flow rate of your exhaust system and describe the methods and equipment used for measuring the air flow rates.

(c) Calculate the air flow per year (V).

(d) Calculate the average concentrations for unrestricted areas. Section 20.106 of 10 CFR Part 20 requires that:

C=f<,3x10-7 Cf/ml (e) Sample Problems A nuclear medicine laboratory plans to use 10 mci per patient and will perform a maximum of 10 studies per week. A fume hood is available for 133 Xe, disposal of and has a measured air flow of 168 ft/ min with an opening of 8 ft .2 What is the

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average concentration of xenon-133 at the point of release from the' fume hood exhaust? (NOTE: All xenon that has been released, e.g., collection bags, filters, must be considered.)

A = 10 patients x 10 mci x 103 uCi x 52 weeks weeks patient mci year A = 5.2x106 Ci/ year 2 10 m "

V=168hn x 8 ft x 1.49x10 n

10 ml/ year V = 1344min bx 1.49x10 ft3/ min V = 2.01x10 13 ml/ year C = 5.2x106uCi/ year 2.0lx1023 ml/ year C = 2.6x107 pCi/ml The following table gives the amount of xenon-133 that can be released per week without exceeding and average 7

concentration of 3x10 uCi/ml.

r Average Release of Exhaust rate (cfm) 133Xe per week (mci) 100 8.6 500 42.8 1,000 85.6 1,500 128.4 If the exhaust is released to a restricted area, e.g., a roof to which access is controlled, or from a tall stack, you may use Sutton's equation (Refs. 1,2) to calculate the concentrations at the nearest unrestricted area. If this approach is used, you should describe the location of the exhaust system outlet, including proximity to unrestricted areas, air intakes, and open windows. You should also describe your methods for controlling access to the area where the exhaust is located.

(2) Adsorption onto Charcoal Traps This is the disposal method of choice. The advantage of this disposal method is that xenon-133 is trapped onto charcoal or other adsorbing medium. Filters containing xenon-133 are then stored for decay.

One difficulty with this approach is that charcoal is not 100% efficient for trapping xenon-133. If this is your method of disposal, you should consider the following points.

N H ,

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(i) Describe how you will handle the problem of leakage from such trapping devices. If the exhaust is vented to the outdoors (UNRESTRICTED AREA), show that air concentrations of xenon-]33, averaged over one (1) year, do not exceed 3x10-7 uCf/ml. (See example in Item F-1.)

(ii) Describe how you will ensure that collection and trapping devices are performing according to specifi-cations, both initially and on a continuing basis.

Include in your description how you will monitor traps to determine when saturation occurs and filter must be replaced.

(iii) Describe your procedures for handling saturated fil ters. Your discussion should include a description of the area (a diagram would be useful), available shielding, proximity to restricted areas, ventilation and an evaluation cf average concentrations of xenon-133 in air. (See example in Item e(5)).

9

.o REFERENCES

1. Blatz, Hanson, Radiation Hygiene Handbook. McGraw-Hill (New York, 1959), pp. 22-7.

2. Cember, Herman, Introduction to Health Physics, Pergamon Press (New York, 1969), pp. 334-9.

USEFUL CONVERSIONS 3

1 mci =

10 uCi 3 = 2.832x10-2 ,3 = 2.832x104 1 ft mi 3 6 l cfm =

1 ft / min = 1.699x10 ml/hr

= 7 6.797x10 ml/40 hr wk

= 1:484x10 10 ml/yr 1 week = 168 hr i

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