NUREG-0267, Reg Guide 8.18, Info Relevant to Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be Alara

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Reg Guide 8.18, Info Relevant to Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be Alara
ML20214R470
Person / Time
Issue date: 12/31/1977
From:
NRC OFFICE OF STANDARDS DEVELOPMENT
To:
Shared Package
ML20214R475 List:
References
RTR-NUREG-0267, RTR-NUREG-267 REGGD-08.018, REGGD-8.018, NUDOCS 8609290184
Download: ML20214R470 (26)


Text

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w% U.S. NUCL2/s.'1 REGULATORY COMMIS310N

                                                                                                                     -            r- c= == m e m December 1977 nu Rgt ug u!!vu se a w' , . ,N ,7-                     RE n_- nAme:sp
         \,                              OFF'.C~1 CF STANDARDS DEVELOPMENT                                                                                                  ,

REGULATORY Gul0E 8.18 INFORMATION RELEVANT TO ENSURING THAT OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL INSTITUTIONS WILL SE AS LOW AS REASONASLY ACHIEVABLE A. INTRODUCTION Paragraph *0.!(c) of 10 CFR Part 00. "Staridards Regulatory Guide 10.8 also includes for Protection Against Radiation, states that !!cen. information on an acceptable r.1anagement sees should make every reasonabfe effort to keep program for keecing ex;osures ALARA, as radiation exposures, as weit as releases of radioactive material to unrestricted areas. as far below the limits well as specific examples of radiation specified in that part as reaso'nably achievable. Regu. safety programs and practices acceptaDie latory Guide 3.10. " Operating Philosophy for Main. to the NRC licensing staff. These examples taining Occupational Radiation Exposures As Low As supplement the general outline of princiDies Is Reasonably Achievable." sets forth the philosophy and practices contained in this guide and and genersi management policies and programs that in NtJREG-0257. Licensees should follow to achieve this objective of maintaining radiation exposures to employees "as 4~9.3

        !cw as is reasonably achievable" (ALARA). l This guide is directed specifically toward medical
        .icensees and recommends methods acceptable to the~

NRC staff for maintaining occupational exposures  : t ALARA in medical institutions. An associated re.

   -    port. NUREG-0267. " Principles and Practices for Keeping Occupational Radiation Exposures at Medi.

cal Insututions As Low As Reasonably ~ Achievable" (Ref.1) provides more detailed infornastion for ci:ri'.

rolling exposures in these institution?,It also pro.

vides a bibliography of background informadon on radiation protection science and philosophy' radiation , protection standards, and planning and design infor. mation useful for radiazion protection programs in medical institutions. Sections of the NUREG report are keyed to the secdon numbers of this guide for the reader's convenience." This guide i generally directed toward occupa. The content of this guide is also applicable tional healtti protection. However, in a medical in. to veterinary medical institutions insofar ststution certain persons other than employees are ex. as scecifiC diagnostic or theraceutic pro-posed to radiation from NRC.llcensed radioactive cedures are cerformed. Similar orotection material. These persons include visitors as well as pa. practices are apDlicable for '<eepina emolayee uents other than those being treated with radioactive and visitor excosures ALARA, wnetner ;atients matettal. Protection of these individuals is also ad. are animal or human, dressed in this guide. T Ao utar.o.ny culoss..e ca==== ==== = - = ~ so... *a*- . . c-ea w s . . as,.

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ese 3 3 en as a eye, 8609290184 PDR 771231 REOGD 08.018 R PDR

Specific guidance regarding radioactive materials in effluents to unrestricted areas is beyond the scope Further details on this subject of this guide. This topic is mentioned only in connec-are given in Regulatory Guide tion with actions that influence bosh occupational ex-10.8 posure and c Yluent controt.Als addition. this guide and the associated report (Ref. !) deal only with radioactive .naterials s' abject to licensing by the Nu. clear Regulatory Commission. The regulations and

      , other radiation-operating                recommendations of other agencies should be con-equipn'ent ,                               suited in regard to controCing radiation exposures ff,/                         trom x ray macmas Aaruk non-NRC licensed mass-rials.             g.m. ;,     *7 a-             . .. '

4.N. 4..8. DISCUSSION W "bpNaciple of maintainin's occupational radiation

                                        'g exjoiuess ALARA is an extension of an original rec.

a*osunendation of the National Committee on Radia-

                                              , tiois Protection (now the National Council on Radia-
                                                 ' tion Protection and Measurements (NCRP)) in its
  • 1, 1949 report (published in 1954 as Report No.17 e (Ref. 2)). In this early repott, the NCRP introduced the philosophy of assuming that say radiation expo-sure may carry some risk and recommended that radi-scion exposure be kept at a level "as low as practica-ble" (currently referred to as "ALARA") below the recommended maximum permissible dose equivalent.

Similar recommendations to keep exposures ALARA have been included in NCRP reports up to the present time (Ref. 3), as well as in recommendations of the National Academy of Sciences 4ational Research , Council (Ref. 4), the Federal Radiation Council (Ref. 5), and other independent scientific and professtonal organizations (Refs. 6-8). The basic radiation p'rotec. tion philosopny of these recommendations has been incorporated in regulations and guides of the Nuclear Regulatory Commission. This guide and the associated NUREG report pro-vide a supp'lement for medical institutions of the l 1 ] 8.18.1 1 1

f

                                                                                                                                                    ;               /

I

-l l

i basic pnilosophy of Regulatory Guide 3.10, which lists for all specific licensees the types of manage-ment commitments and radiation protection programs that would help to achieve the objective of maintain. I leg occupational exposures ALARA Amen %is tuide. ene Regulatory Guide 3.10(will be usse as a basis for ' sand Regulatory Guide 10,3

'       evaluating !! cense applications and radiation safety progr:ms of NRC. licensed medical institutions, un-less tne licensee proposes an alternative method of l'

complying with specified portions of the Commis-sion's regulations. i C. REGULATOMY POSITION Methods or procedures given in this guide should be incorporated in appropriate sections of a license application according to the format of licensing guides provided to the applicant by the licensing staff 1 of the Division of Fuel Cycle and Material Safety. Cffice of Nuclear Material Safety and Safeguards. U.S. Nuclear Regulatory Commission. Washington, D.C. 20555. The considerations of this guide are in. tended to assist the applicants in preparing license applications that are acceptable to the NRC licensing staff as well as in accord with the philosophy of 2 ALARA. Unique features not addressed hers will re. - t quire specific rev:ew by the NRC licensing staff. A !!censee's radiation safety program will be con-sidered in compilance with the 10 CPR Part 20 ALARA requirement and in accord with the ALARA li philosophy if the,following major erinciples and orac-tices are adoptedAas part of sne insutuuon s posicies N and implemented and programs.

1. MANAGEMENT PHILOSOPHY AND OR.

GANIZATION . I The radiation protection responsibility of licensee management

  • at a medical institution is to maintain exposures ALARA for employees. visitors, students.
                                                                                                      *whom i

i and patients := "-- "- ' - ; M -- for4tne - administration of radiation or radioactive materials for therapeutic or diagnostic purposes. _ is not intended as part of their hospital care. j " Itis responsibility should be cacTied out by means 82M l of

a. Information and policy statements to the medical l

and hospital staff:

;               b. Periodic management audit of operational ef.

I forts to maintain exposures ALARA:

c. Continuing management evaluation of radiation l

i safety staffing. program, and budget requiremems:

d. Management programs to ensure that all hose -

tai staff and employees 4 receive appropnace onetangs

                                                                                                     'e who may be ex::Osed to radiatiCn l

and training in radiation safety, including ALARA fr0m licensed materials concepts: * * *

                                                                                                                                        /
             * "Manesernent'* is defined here as those persons authoftted try the caenet of the meetcal institunen to make its policies and                                                                                            e direet til activities.

8.18-2 ai

o.

e. Delegation of sufficient authority to the Ra6a-tion Safety Officer " (RSO) to enforce regulations and administrative policies regarcing radiation safetyt and i
f. Administrative direction to ensure that any new ,

hospital facilities or equipment that may affect radia-tion protection will be planned et designed in consul-tation with the RSO.

2. RADIATION SAFETY OFFICE FUNCTIONS The term " Radiation Safety Office" is used here only to indicate that some entity should be estab-lished to direct and coordinate administrative aspects of the radiation safety program. The extent of this program should be commensurate with potential radi.

ation protection problems. 2.1 Stamns and Organization Requirements A sample outline of the various tasks of a typical N.O Radiation Safety Office is presented in the appendia. medical institution g The time and effort recuired for each of the listed tasks vary widety witn tne size of mg - W and the nature and extent of radioactive material usage. Man-asement (1) should review the staffing requirements 27.3 for -sch of %e tasks and provide the necessary per-and carry cuts sonnel to establishAradiation safety program require. ments and (2) should evaluate them on an annual basis. ( 2.2 Radiation Safety Personnel Qualincadons Management should select radiation safety person-nel appropriate to the radiation safety program aften careful review of the nature of the program and the extent of effort and expertise required to carry out the tasks noted in the appendix. U 5". I and Equipment ' 2.3 Space r equipment, and # The Radiation Safety Offica saould have adequate e assigned in appropriate locationsa spacegto carry out the following functionst a h Maintain end repairjendiation safety and perfor-n electronic / W.y ""'P**"'- calibrations en i

                                                                      ' E Stock radiation safety supplies for labeling.

3hY c., surveying and decontamination, and personnel pro-

a. Calibrate in radiation fields taction and monitoring, radiation safety and survey equip.

ment (and check the calibrations d.' .. Conduct radiometric measurement of smear of other hospital radiation sources, tests from ' contamination surveys and source leak wnere radiation safety and medical tests. physics functions are ecmbined). e.; d. Store rad.ioactive wastes and sources not in use. !

  • T!e term '*Raoianos sasety Caficer yis 4 sed sy many heen.

(R$Q)/ sees and will se 1: sed en this gside en assignate the quahfied individual who is renouentle for carr)ang out the saantubca's radianon safety program and ehe in 1ssted as the Radiation A=ce

       $afetyT                                                         *eemm ofncer on ine inmtunce's ' Apphastion for Syproduct
       'i (see Exhibit A. Regulatory                                                                       ?

Guide 10.3) . 8.18-2 n.,

   .. s.

_. cChanged to "b.". See page 8.13.2

             - aw=

1 I)evimtaminate (Nrseninel. slothmy. and equip-ment.

g. I'rocew orders for licensed radioactive matenals and retene and dissnhute suen materials- 2  !(or as a minimtr1, to receive radio.
h. Revene. procew, and Gle re;ulations and li- iactive materials during work hours.)

weming corresemdence. gg

i. Prepare repirts and records of surveys and per-sonnel monitonny as required by 10 CFR Part 20.
i. Instrwt and hnef personnel a.s required by 10 CFR Part lia.

In addition. the tasks listed in the appendix should he esamined for other activitio thaa niay require spe-siGe space allocations for Radiation Safety Offico in the larger hmpitals. 2.4 Tasks and Procedures The RSO and the radiation safety statt are repim. 4ble for eunducting surveillanse programs and inses-tigation.s to ensure that occupational expmures are AI ARA. In addition they should be vigilant in warshing out new and better ways tu perform all radiation juos with le s opmure. A list of the type of taska earned out by a Radiation Safety Otfise in order to pmvide good radiation safety surveillance ( and meet regulatory and liseme conditmns is pre. wated in the appendix. For medical institutions where a full or part time profonional health physics staff is available the planning of radi.amn safst) pmveduro by this statf should he surned out in coordination with manage. ment to ensure optimum e!!'iciency and expnuro thus are ALARA. Thn soordination will also smvide for a snmoth transition betweenAproyram oi.nnine '4the _

                                                                                                    # O ' ',

andeupersamn os ine ongiung rausanon saasty pro. Nthe gra .i by the professmnal health phydsist under the general supersision of the RSO. 2.5 Administraalve Authurity The Radiaison Safety OfGee. superviwd by the RSO. should have responsibility for carrying out the radiation safety pmgram, including the tasks listed in the accendis. This resoonsibiliev hould beketevarco " Omally ing . _-- _. . . 2,- - - and saould meluce au.

  • Writing by re5Consible manageNent thonty for the RSO to sommunicate directly with the l level of management thus can take correettve astmn 37.3s N '#, M* / l
  • hen needed to enforce rules and procedures pertain.

ing to the institution's radiation safety pmgram. Ad. minsstruuve authoney to sinpend eertain astnitio , temporarily should also be provided to the RSO when needed in emerycneto to avmd immediate danger to life or health. However the authorts) os ine R50 to suspend activisio should tv essreiwd uni) w hen is n sonsistem with non intertstence with lite sasing medical pn.6edures that warrant an usernding pner. 1 8.18-3 a l 1

                                                                             - - . - ~ . -       .-                    -     --

y .. ity and that ennnot await alleviation of the tsdistion safety problems. 2.6 Sledical isotopes Committee The Chairman of the Sledical Isotopes Committee (required by 135.11 of 10 CFR Part 35) should pre. 3 pare for and conduct Sledical isotopes Committee i meetings. The RSO should be a member of the com. J be the Chairnan or may macee anu mayasss st the Chairman in conducting meetings and maintaining committee records. j y Any institution required to appoint such a con mit. tee as a condition of its license should es!! meetings at lesst quarterly. Every member of the Sledical Isotopes Committee should be invited. The purposes of the meetings should include the l ! (ollowing: I a. To discuss any rsdistion safety problems requir. I ing a general solution: 4

b. To determine whether current procedures are
c. To consider new proposals 53.4 maintaining e.tposures A!. ARA: and for the use of radioisotopes h To audit the radiation safety program to ensure j

and evaluate the safety of that it meets all the goals and requirements presented those uses and qualifications in Sections C.2.! through C.2.3 above. of users; and All Sledien! (sotopes Committee meetings should be documented by a record of minutes approved by l d* committee members and filed as part of the rsdistion j safety record system within 60 days following escit An example of Medical Isotopes fa,g m,, ting , Cennittee functions is given in Appendix 3, RG 10.8. 3. FACl!.!TY AND EQlJIPSIENT DESIGN 3.1 General Considerations g The design of humauer (seilities and equipment re. quired for the medical uses of radioactive materials depends not only on hospits! and medical este con. siderations, but also on the nature and ausntity of radioactive materials involved and the relative poten. i tist for e.tternal and internal radiation e.tposure. J Slsjor aspects of planning and design that should be

!                                                                                                eonsidered are discussed below.

4 1.1.1 Space Layour Facility Isyout should be planned to maintain em. ) ployee esposures ALARA while at the same time en. suring that e.tposure is not thereby incressed to other 'I persons in restrieted or unrestricted aress. Consid. while at the same time provid- 44G erstions should melude ing optimum separation between s. The need for access to esdistion or r:dioactive worker's " sit down* areas of dU,2 materials arens by medient staff, employees. patients, frequent occupancy and vuitors. and others/2; radiation sources or c0ntami- y e. ventounen reuuirements. includinnthe need to 6 natiCnj maancain amer pressures in rooms m wnich radiose. tt$e matenals , to te spilled or volailized: whether there may be a j

                                                                                             -        e. Finor loadtng in esse of heavily .hielded murees;                                                                                                               j i

i may possibly 4. Resetpt and snioment ot rauneastne materialk g and inclucirq radiation surveys of the shipoing containers; 3,33,3 3) i

e Ingres and egress ol w.me rudiation therupy and nuetear med (ine outpatients. including parking.

f. The need to protect suppif es of J I ., Mr. l.lsux stored diagnostic films frem Permanent shielding may be needed m some Saws radiation exposure. /N 8 for walls, thin. and eeilings to pnnide pniteetion gg, /
                                                                                    - radiatiCAS from againsteradioa tne matettals s unents)      noused m sne institution. a well a radioutise matenals th4t might he introduced into the area bs future medical eare re.

quirements.Neeupancy anu uw taetors snould ne See Section 3.2 for structural i' taken into account a recommended in NCRP hand. protection of radiation therapy g*g books. but usch faston should be chosen with the facilities. TeletheraDy instal-pnneipic of ALARA in mind. The NRC lisensint lations always require pennanent staff should also be consulted during the planning and Shielding. design stage to obtain lisensing guidanee un accept. able use and occupancy factors in shic! ding design.

       .t.1.J f*uutioon 5 suns und Interl.n 6 Assess to certain areas should be sontrolled or re.

stricted by the u_se of saution signs. signals, and in-terlocks as required b} 10 CFR Part 20. t ;0.203. 1 ).I.4 L'enulanen As far as powible:

a. Pruside an> necewar) toeal ethaust sentilation tsuch as chemical hoodst or general ventilation. as recommended by pmfessional health physicists for areas where breathable sensentratiuns of radioactise material ma> be preent.
b. Design ethaust systems to avoid transporting contaminated air through long ductwork passing through many other huspital are. on its way to the y St.ck on the rtm(.
c. Locate exhaust sents w as to provide adequate meteorological diffusion and dilution to meet 10 CFR.

Part 20. t 10.106 requirements for effluents to unre. Stricted areas. as well as ALARA exposure cunsid*

                                                                                        , as well as to avoid recirculating erstions for the public'                                                     Contaminated exhauSC Sir into the
d. Where appropnate. include specific types of fil. building, ters or air cleaners fur the exhaust air. S$,Z J.I.! Fire Constrol M. //

The need for personnel esit and for c!nsing the facility to prevent the spread o( radioactive matenals should be sunsidered for areas where lacoratory pro. cedures euuld result in discersal of radioactive mate. rtals in the event of a fire. Pmvision should be made for local shumers and fire cztinguishers, where necessary. For the vast majunty of medieal institu. tions. emergency prusedures and training should in. clude immediate fire euntrol e a pnont) item. J.I A $rses ml Lahr*run**y Denen frutures Considerattun should be ;tven to prmading laborn. tars surf aces that may be easel) sleaned and decon. tarninated daily to maintain minimal Sontamination lesels Jnd radiation etposure. As Mil as minimal in. 3.18-? g

  .* .-                                                                                                                                                        i i                                                                                                                                                              ',

l l 1 terf ereAe with medical and elineeal ensedures Lab-oratory need, ma) also tnelude j

4. Provision lot appnipnate pl.u.ement of radia-
  • tion. and contaminauon.monnonny instruments; 1

gp Designated;

                                                                       -        b. 9per si sinks tor nnsing and dnpuming of minor
,                                                                        quantities of radioactise wasto twitnin 10 CFR Part 20limienn es*

and : e. Special plumbing and ware storage prownman/ yy, y ,iv

d. Maximun separation between . in general. there is no j es in hospiial, ror St.f areas occucied by personnel and '"' "*"d*""es quanntic of mdioactive mate.

radiation sources or contami- nas surtleientiv radiototie that potential air enneen.

>         nation.                                                        trations may reaen levet%.-                        _: the cimeentration l                                                                          values given in to CFR Part Zu. Venulation and son-Sg. 4                      tamination contrul should be designed to masntain air j           g- WCu g use,,

soneentrations and contamination levels an low an apcroaching: O* reaumably achievable. Ceidance and requirement.s j for the une of Xe 133 in nuetear medieme se avaa. and- acte trum tne Ostice ut .Nuetear Matenat wee saset), Saregnants. C.s. Nuclear Regulamry Gunminion,

           , or frem Regulatory Guide 10.8, Accendix M.                                                    3.1.7 Smrune. Samrce contred. and inventurs i                                                                                in institutions ordering a number and variety or uvutves of radioactive material. it is often easier, los etntly. and more secure to pmvide a gentralized stor.

1 age room for radioactive materials not in use or used only occasionally. Such a facility is also helpful in keepmg esposure> ALARA. since it may result in a decreane in the amount of radioactive material stored in laboratorio occupied by personnel. J.I.H Shipping and Ree eartne raciCactive material, N'Y 86 * ' M 3" suCn deliveries: cay. mgns,'8'C"kt- anc weenene seoveries storage arean 'for so tna:Ameesswee may be received at any time and placed in a secure

l. locked location where they will not cause unneces.

, sary exposure to personnel while awaiting survey by d the Radiation Safety Office or the user. A wntten Procedure for receipt. sursey, and storage of deliv. eric should be provided to anyone responsible (nr

                                                                ,7f           the receipt or delivery of radioactive material.

j

                                                               ,M When packages may expose couriers                                     *"**'**'****"*'**"i8*'*'"**"
to measuraale radiation, make it iaan an asequ.de cutance oetween Lae;.: _ : andtne l

f radioactin matertal sackage,

                                                                  -f i            persen trans:arting the material                     ae              e. Provide nonce in the receiving area (nr an initial e

1 suru) ano smear test ut caen pacmagetto avmd trans.

'            , to keto expCsures ALArV                                         porting a euntaminated pa6kage thrnugh gnrotncted 7.p, f, 3 7, p
                                                                                ***#I*                'E"*I' When neCessary                                                         4. 6 ocate smpping anc receiving aresqso o to ():

4 s minimate the time required for transpornng radioac.

        , Or 3C tss to them frCm 3reas wnere radicactive materials                      @                uve matenal to seas whm u n ni be md and i:1
                                                                                "4      the need to transport radioactive matert:13 are used,                                                          through erowded areas or areas occupied by person.

net, patients, or initort

                                                                                                                                                    '          \

lu 3.18-.i l

U J.I u l..,tus; nwns (*,muelerinimn Ceneral teatures applicaele for equip nent enat will ( .A,#Mf. be used for handlingpontaintng rudioactive materials are a follows: 4g* ;g# , h, 9Q@

a. Surfaces should be cuity cleaned and decon.

taminated in case unsealed radioactive matettal is re. leased.

b. Equipment should be designed to optimize the case of carrying out procedures where personnel are exposed to radiation, thereby minimizing working times, and to maximize distances of personnel from the radioactive matertals with which they are work.

ing, consistent with the purpcses of the procedure.

c. Equipment should operate in such a fashion that it does not damage radiation sources and release radioactive materials if it fails,
d. Adequate shielding should be provided as part of the equipment. where feastbie, to keep exposures ALARA.
c. Appropriate caution signs, symbols, signals, and alarms should be provided as part of the equipment to reest the requirements of 10 CFR Part 20.1:0.203 and recommended standards of the medical physics profession. .

3.2 Radiation Therspy Equipment and Facilities

 ,         Specific NRC licensing guides are provided for
 's     licensed radiation therapy programs, and the NRC 11 censing staff reviews the safety aspects of facilities and equipment before issuing a license. In designing shielding for teletherapy treatment rooms, the medi.

cal institution should consult NCRP Handbook 34 or 49 (Ref. 9) for recommended design details, specifi. cations methods of shieldine sesinst direct and aest*  : and leakage tered4aciation, and general principles of radiation. %J safety design. In addition, the institution should

a. Protect each teletherapy treatment room from inadvertent entry by the following means:

(1) Provide a door intertock that allows a " Beam On" condition only when the door is closed. 4g 7J. /

O...... Independent audible signals also W'*
                                                                    ^
        ...... 7 ..., . _ ..
            . ~ . . . . . . - . . . .

m.... ...,.m..............  ;:rCvide added safety iri the event g lights fail . / 9, ,' n. a. N Provide independent back.up caution lights 7Y /# on the console. above the door, and inside the treat. (3) ment room to indicate the " Beam On" condition to j ,,g 7 radiotherapy technologists and other staff members. - gregg,:ent t*CCm v 7,7 M( Establish a procedure for checking whetner everyone escept the patient is out of thegseen sesore (1) M a w, the door is closed and the beam is turned on. sh Install independentreaution irgnisinear ine #(9A*I#II IOUIIAI /Y/ entry inside tele *herapy treatment rooms to provice a y jf 8.18-5 3.

l . . l

                                                                            '#ning to the therapy is.hnoloynt or others entering (5) Provide a " scram" button for emergency snutdcwn of the source              50.id          * * * *'
  • i " " ** **

id f ' " '"'"" ' P '# ~' ' "'i' * "* "

                                                                                                            *""d'""'

frem inside the teletheracy recm WE ' and provide audio ecmunication 'b. Consider leakage through the refetherapy head with the outside control panel. *ith th' 'ource in the "on" position when designing shielding. Data provided by the manufacturer of the

                                                                 '          '# I '#*"    * * *   "*'s ould W used for mis purpmc.
                . Or NCRP rec 0tnnendations,'
c. Design areas adjacent to the treatment room that will be occupied by personnel, patients, or visitors 74,i; who are not associated with the radiation therapy de.

planned preferentially toward 64<' // P***"* 5* 88 '" **i"'*i" **P'5"'es A LA R A . Re. duction of occupational exposures to radiation ther. unoccupied or low occupancy areas. 87.2 apy pen nnel s u!d In no case should it be necessary 33.3 sions. procedures, or *'ye - beamachieved orientationsbymee design provt. to design for instantaneous rates f. -f . _m

                                                                                         ' ~ - ' " ~ - ' ~ ' ~ " "           '""""'"

greater than 10 mrad /weex in re- g r. g stricted or unrestricted areas adjacent to teletherapy treatment , rCCms. . 3.3 Nuclear Meoscine Facilities

                                                .N. S s 3Z d                    To ensure that esposures are ALARA tayout and new '                                                       design foranuclear medicine facilities and equipment should cne meter and preferably _           M4                         t Attow sumeient sosee for personnel operating nuclear medicine equipment to oc at seasAtwo meters and other ccnditions "                 N ?.                  from any patient undergoing scanning whenever the Cr provide adecuate ICCaliced                               concuson os me pauenapermus, 9 pCrtable shields                                                b. Allow adequate space for stretcher patients N.,1 #                awaitine scans, as well asioutpatients. Ocsed pa.

f0P 4 fg, ./ tients awaiting scans may cause radiation ! vels on gfg ine orcer of;.? l' c or moreAThey may need to be segresateo from me generas waiting area to reduce ICmR/h 4 near the ecge Of the stretcher. radiation e.tposure to receptionists and persons pa,ss. ing through the ares, such as orderlies and aids. L0cate ;;hysicians' offices and; d&& ec__ ...., ..... . , . , ___ ar::: f er, / , */4//9 wid other occuoted stenstto needed radiopnarmaceu. witnin easy access - acais, out anow enouga distance (several meters is usually sufficients so that esposures from stored radiopnarmaceuticals and racioactive wastes will be minimized. , at leasti

                                          .     ,          f                    d. Provide adeuuste,shiel, ding for stored                       j racioonarmaceuticats ano'seenesa shielding for em.

j,fg/ue/2rDCdy; ployees prepartng cosage for panents, A

e. Supply an adequate number of syringe shields N. 4" 8ad bottle shields ins well as appropriate tongs or (Ref. 13): foreeest near the place of dosage preparation, a .,,, ,7 or jn , / M 2- f. Provice'seemewev ethaust ventuatiodin the lab.
                                            #L /2.                           oratorv nearathe radiocharmaceutteal storsterates ti, and dose preparation ,                                     protect against = airDorne racioactive or toaic ma.

y, , g, terials that might result from accidental release or spill of radiopharmaceuticals. ,

3. Include a special thielded easte receptacle for used Syringes and other radioactive wastes in the nu.

clear medicine f acuratory near the dmage preparation arta. is.5 3.18-5 l

i I 2 3. t h ! date a permanentis tised radiation sounter - near 9 f, 7 > andTie meist __ __ f me emranu to thebustear medig;ine ptsparation latioratory t'or em. l' ployees to shesk regularly for hand or clotning, con. tamination when leasing the department. A portattle survey metsr availabic at a convenient location will ,from -y,gg f f' g y , y,

                                                                                                                                                                                    .pg /g; /g J, also help keep esposures ALARA.                                                                                              .gy,f -
i. Provide individual labeled lockers and change when operations are such that i~

areas for segregating laboratory coats that may be Contamination levels On persons OP 4 contaminated $yruinst notning, Clothing may exceed action levels of Reg. Guide 8.23. J. Provide finger badges or dosimeters as well as body iroegestfor monitonng occupational esposure of

;                                                                                                                                                  dosimeters         4,7 personnel, J~2. s3 l                                                                                                                                                  involved in dose preparation and j                                 3.4 !a.Vltro C!!nical and Resenech I.aberssories Many of the design considerations for in. vitro clin.

injection and handling of patients. I ical and rewarch laboratories are similar to thou al. l

'                                 ready given for other facilities. Special consid.

erations include

2. Easily discarded bench paper, absorbent on the I top surface only for catching and easily disposing of small amounts of contamination that may dnp or be
 '                                 removed from laboratory apparatus and glasaware.
 '                                      b. Suitable. easily cleaned dnp trays for carrying out manipulations of radioactive materials where spil.

j lage rnay occur,

c. Protective cicthing, including rubber or plastic 1 disposable gloves. for persons working with radioac.

tive matenais. IDisposable gloves should be changed i frequentlyJ Equipment should be provided for monitonne clothing before laundenng. Asseamene l i l ,tacioacnve 6aundry and radioactive *astes snouis oe

                                                                                                                                               'S                        &                               ;

turned over to the Radiation Safety Office for further when surveys indicate. contamination l disposition, levels may exceed 10-3pci/CmZ J Additional recommendations for carrying out in . 1 vtro expenments with animals are given in Reference and ?!UREG-0257. lof

4. SAFE WORK PRACTICES AND PROCE.

DURE 5 4.1 General Principles i The following safe work practices and procedures for handling radioactive materials in medical institu. tails are given in ?!URE,a. -025,s, tions are recommended as a minimum. Additional de. f . .J .-, ,,, 4 ::'" 0 ; Z. - E89UIAD0f7 Odid8 8.23 And 4.1.1 Penndic Inventury and Contruf af All Radie. R*9U1*t0YY GU1A* 10'0' k i rinnSourwes I Many of the more serious occupational esposures. - misplaced or ICS** M"/ 7 as well as patient esposures. have resulted fromp

                                    .adradioactive matenal, which then may inadvertently i
'                                     expose unsuspecting persons or be subject to im.

l proper usage by unauthunted persons. The following i procedures should be taken to guard against thew E'"I'*" y periCdic 8 /.

a. Ahumummer insensory inould se made of all f radioactive sourses, and a continuous resurd ofA all 44. f
!                                                                                                                                                ' the ICCatiCns of i

3.18-6 tl 8 I

l r i . .. l sources and their usage should he maintained. The inventory should be comnined with an inspection to f.LJ gg ensure oroner tabeline tsee 10 CFR Part 20. I 4"" of sealed sources in Group VI '

                                                '     *inventuriotto
                                                               * ***""" be  ""'conducted
                                                                                 ' O CF"at lea
                                                                                            "*">t3'quarterly
                                                                                                     ". Inv e n.

and calibration sources tory procedures should also provide that the RSO will be alerted if all sources are not returned within a specified time, in order to avoid sending patients n./f. home with brachytherapy sources still in place.i (SeeReference11.),

b. Sources should be secured within locked rooms or storage areas when authorized users or their re.

I l of Containers: 88. M soonsible emoloveen are not stesent (see Section C.J.l.7 of titis guides. Speciti snie!aed vaultskhould be provided in the storage area for sealed sources,

c. Authorized persons should be required to sign for the removal and return of each source. The source los should be checked regularly by the Radiation 3t2ff. d'"I. J Safety Office /,

4.1.2 Shielding All radioactive matettal not.in use should be eso.

  1. elecola shielded so that etoosure rates in any area that

( ALARA) : may be occupied By personnet will oe well oetowethe levels for unrestricted areas of 10 CrR Part 20. Whenever radioactive materials are in use, the mate. rial should be unshielded only in the direction neces. sary for its use and to the extent that accessibility to the source is necessary. 4.1.1 Control of Canta-unarron ] Radioactive matenals in unsealed form or undergo. ing chemical or physical processing should be han. j died only in property designed facilines (as descr bed i [ Heat sterili:stion should be ia 8*ction C 3 3 260' *ad *i(8 PP*f Proc'duJ'8 . to avoid translang radioactive material to the str or avoided where it .might cause ' to surfaces where inhalation or ingestion of the mate. Source rupture. nal by personnet is possiote.MVhere necessary to en. (, f. [ sure that esposures are A!. ARA preliminary tests of procedures should be carried out with simulated non. radioactive matettals or colured liquids to check peu. visions for containment. handling, and ventilation. The Radiation Safety Office staff may make prelimi. ,. nary estimates of job esposure commitments, using tracer levels of radioactive matenal, i Trays and absoftwat matenals should be used as a j backup to catch and timit the spread of radioactive " contamination whenever there is a possibility that ! planned procedures will fail to contain the radioactive j material. , Protective clothing appropriate to the type and quantity of radioactive material being processed thnuld be worn whenever potential escape of rsdioac. j tive contamination is a consideration, t 41.4 Persper Work Ifuhurt i In icncral, all personnel handling radioactive ma. l teriala should be trained to use appropnaie snielding 1 M 8.18-6

 ;i i

masenals, maintain as much distance as pimable from radiation sources and limit the time of exposure to Except for very low level sources radiation wurces to the time necessary to carry out such as flood sources or other

           '"' '*4"'"d '** " # "'**' P**d"'**                              sources designed for manual use in The following good work habits are.particularly                checking instrumentation, important in :nsurtng that esposures are maintained                                    gy, /f ALARA:

a.Tyeakets or unsealed sources should not be touched or held with the fingers, but only with toegs or tweezers appropriate to the operation. sA,3, di rdosimeters*

b. Fingerhedges as well as bodyabadsee should be worn by personnel who are handilag or manipunassag
                                                                           - dosimeters            ft/!J unsealed or unshielded sources with tongs or forceps or who are holding partially shielded containers of radioactive material with their hands. However, these                                  MJ,[
                                                                          ~' dosimeters bedgeovere not needed tor personnet aanelsag osty the types of sources used for tracer level in vitre studiesJwnere cose rates are issa tasapr mrem per
                                                                          ; op                    gj hour at i em.
                                                                           -5                       [< /
c. When worklag with unencapsulated radioactive . y ec,.c l cr /Pr. M a , d g, ,,,q p,, ,,,g q.j,, y,,g,,//, ,pp.g.;,9
                                                                                                                      "'d'
                                                                                                                       , .y '
  • materials, personnel should wear rubber or plastic gloves and other special clothing. g g7
d. Care should be taken to av needless con. cy,, /,r.i t- w', r% j,.rhn-,f s ., -%!e tamination of oojects such as light switches, taps, or 7V/f d**' k "'

which radioactive materials have

e. Radioactive solutions should never be pipetted " been administered to by mouth.
f. Isting, smoking, drinking. and appilcation of cosmettes should be prohibited in laboratories where radioactive materials are handled. k. Surveillance of individual
g. Special precautions should be taken to avoid the operations such as " milking" possibility of small amounts of radioactive matenals generators should be provided to entenne into cuta. . ensure that workloads are distri-buted so that individual emolayee
h. The use of containers or glassware with sharp aM kept ME rdges should be avoided. Care should be taken in M working with.eemesmenesed animals to8svoso sites or IU* d scrateries,
i. Food and drtnk should not be stored in the same place (e.g., refrigerstor) with radioactive matenals. gr., y J. Radioactive matenals should be secured (e.g.. or general levels of radiation or placed in s locned room) when personnel are not 1 ,. Contamination, may be helpful if present.
  • With some finger dosimeters, 4.1J Radiastron <>r Radlovenrtry battrorent a problems may arise with 1Abels w&Sh*

ing off or the badge ripoing Pro-The independent radiation surveys, inspections, tactive gloves. [n these Cases, invensones. and imear tests to be carried ow by ine wrist badges may be preferable. In Radiation Safety Office staff were discussed earlier le 5estion C.:. In addition, eash user of radioactiv' any case, the user should be aware l metenals should survey radiasson and radioactivity levels within his or her own operations daily to help of the fact that neither of these maintain esposures Al. ARA. A umole fugemL of dosimeters will measure very hign desio readingsf -- x maintaines my sne uner to finger Contact doses, and handling indicate any caangen in radiation or radioactivits unshielded syrin es or bottles with ' the fingers snou d be absolutely avoided (Ref. 30). 3.18-7 ti 4 3, 4 .a g J 7 y,/ f, g J,2 , f /, J , f'. 7, 4' Y. // h YWN */ NWienec)fi/gr upqfgp.p.g f s wed' lfo 4//n! mmyL,.r.s to /rgh ar,eu hyg$, oghgnr, rat %

                                "',.4e 3 --                . s , %,

Regulatory Guide 8.23 and Regulatory ! Guide 10.3 gives further guidance en radiation surveys in medical in- ! stitutions (and nuclear phannacies). Iml> that show a ne:d for changes in procedures or cuuipment to meet ALARA radiation exposure objec. WJ In hospital situations where the higher exposure rates occur (e.g. in teletherapy rooms where in acci. dental cir umstan:ss the limits of 10 CFR Part 20 could be approached before an indication was pro.

                    "Self-reading" devices thay may be     _

vided by means of routine personnel monitoring de-read by the wearer viseu.W' f :; d_ __: t ... ..__ at least

                                               /g 4 / 7,43                  daily, as well as warning devices worn on the body.

may be use,neipful in maintaining exposures ALARA. 4.1.6 Training Employees should be made aware of the ALARA provisions of 10 CFR Part 20. 4 20.1 as well as those of Regulatory Guide 3.10. Employees should sb' in. structed in the philosophy and provisions of Regula-tory Guide 3.13. " Instructions Concerning Prenatal Radiation Exposure." whenever there is a possibility that pregnant women may be exposed to radiauon. Each employee should be ecquainted with the in-stitution's own procedures for handling radioactive sources and radioactive materials and with NRC licenses and their radiation safety provisions (includ. l ing license conditions incorporated from license ap-i 7gj> y y plications and correspondence). Copies of these pro. I for review by 4 eedures. licenses, and related correspondence should os maos availaolete-se employees as part of their t Professional education and develop- : *"*"'*d"'*'*di*""'"'"**"' ment to ensure that staff are up-4.t Radiatlos Therapy to-date on radiation safety methods should also be supportad. This guide provides recommendations for main. sg g taining exposures ALARA in three subdivisions of e radiation therspy: ,

s. Teletherapy--the treatment of patients with high. energy beams from shielded irradiators contain-ing sources of high gamma. ray emission ra'es.

{ b. Brachytherapy--the treatment of patients by insertion of sealed tources such as needles or tubes for interstitial or intracavitary irradiation. , or by surface application. . .-

c. Radiopharmaceutical therapy--4he injection
29,7 ,, o,ei aamini,traiian or solutions or colloids or radioactive pharmaceuticals that tend to concentrate in and irradiate the organs in which they are dis.

persed or absorced. 4.2.1 Teletherupy Radiation protectron messures in teletherapy should rely pnmanly on the adequacy of facilittes and equipment. since very intense radiation leve!s are generated (see Section C.J.21. Nevertheless. some besic routine operating pnnetples for maint.iining oc. cupational esposures ALARA should be followed:

a. With the aid of the maintenance and operating manuals provided by the manufacturer of the tele
  • therapy unit. procedures should be establi>hed for 97 3.18-7 i

1

routine m.mitenarAe and sheekout of salety related teatures ot tne teletherapy unit, b.'A d.uly mormng checkout srocedure should be b and posted

                                                                                                                                                                        ;f,y'7 jammmmmmmed establisheQtor the incrapy teenno6ogtu to earry out simple operational enecks of indicatur                                                                                             fig /

lignis, eaution lights and signs. key and door inter. locks, gamma radiatioc. Icvel indicators, and timer operation and interlock function.

c. A general safety check. including a spot or point
                           ,ananmasma eneet and eneck on osam alignment and                                                      d radiation output                         22. $

confining devices. should be made and recorded at least monthly. All records of the momhly.eghumuusmWoutput 4f.4

                                                                                                                                                                           ~

i and safety check, as well as the morning checkouts. should be signed and dated by the persons carrying out the tests.

d. During patient treatment or operation of the tele-therspv unit for calibration or maintenance proce-j dures.' care should be taken to follow written instrue. These procedures are also important when tions and use installed safety devices to ensure that personnel carry out test procedures with no personnel except the patient enesummun to be ex. phantoms on the treatment table, posed is in the teletherapy treatment room during the g7
                             " Seam On" conditions l                                   e. During " Beam On'* operation, the operator at the console should remain in a position of lowest radiation intensity consistent with vigilance of the                                                                           6f. %2j M. ( gg /C, 7, f I                             console and patient during treatment, as advised by                                                         In a well designed facilit7 the shield 189 the Radiation Safety Office staff usine the post-                                                    ' provides a very high degree of protection
installation radiation surveyhlli persons not requitec at the location of the console. However, I to remain new the console should remain or work in areas of lower radiationM intensity while the teletherapy unit is in operation. , Ouring " Seam Off" conditions, treatnant i

set-up should be accomplished with minimum j f. Emergency proecdures established as required occupancy of the room and minimum time scent by NRC license conditions should be tested by res- near the source, to keep exposures from ular familiarization sessions or by staging mock leakage radiation ALAoA. emergencies for the training of personnel. 1

'                             4.2.2 Bruchrrherapy                                                                                             .

Detailed recommendations for reducing radiation esposures in brachytherapy are given in NCRP Re. , port Number do (Ref.11), and additional recommen. dations pertinent to brachytherapy. as well as radiopharmaceutical therapy, are enntained in NCRP ' Report Number 37 (Ref.12). Some nf the most im. portant practtees for maintaining esposures Al. ARA . are as follows: gf

a. Modern after. loading devices should be used Remote afterloaders are particularly wherever medically acceptable. effective in keeping exposures ALARA.

1

b. Jigs /phould be prepared and tested for case in D or remote afterloaders foading sources i,nto after. loading devices in the ps.

tient's room. 7 j e)/igs for loading the after loaders should be set M When manual afterloading is used' j I up behind shields with lead glass viewing windows. and ausiliary ! cad brick shielding should be provided I to shield the arms of the personnel loading the after. i I 8.l8-8 8.1 t 4

   . - , , . - .m. ,,     ..--..--4       , . . , . - - . , - -      -.-- v., =- , .. - _              , , - . - - . . , - _         . _       - , . . - . . . _  .p         ,   , . _ . _ . - - - , --, , , ,   -,

_ __._ _ . _ z .__ ._ _ . _ _ _. loaders for as much of the duration of the pn% dure

                       - 42.1, 4.f, 7A U,73.S                     '" * * %                                             '
d. When)ynfter loading sleevo or osoids are i I the radf ation scurces of 4 loaded. they should he placjd in alequately shielded ,  ;

' or transcart deyicas d can *for stenlizanon and/for transport to the patient's gg,7 room when the pnysieran is ready to insert the after-liquid g loaders. These easts should he properly tagged and

;                                           gg                     sh uld at an dines be under the w supeMon of or a member of the radiotherapy staff * ,e              A "Muinn ehwsicist or rad,iaston safety staff,3 i
e. Similar protection should be provided for use in i

threading radioactive needles for implant therapy.

f. While manipulating sources, loading the after-loaders, and threading needles, personnel should be provided with tongs and surgical clamps to maintain the distance of the fingers preferably about 30 cen-timeters or more from these sources,
g. Finger dosimeters as well as body dosimeters should be worn by personnel when they are loading or preparing sources for insertion. Also. the Radia.

tion Safety Office staff should. periodically survey the loading procedures and provide job-time exposure in-g *9 *f i formation to helo emolovees maintain ex'posures mCnitorf Al. ARA. Use of a gamma atarm type .ammenemen chaener in the storage. loading area will indicate when radiation sources are outside their shields and help avoid inadvertent exposure due to lost or mis-placed sources. f

h. A continuing list and count of removals and re-turns of individual sources from the storage contain-N' ^, ) ers should be maintained to help ensure against inad-and exposure of cersonnel. >r venent loss -e of sources-
i. Sources maintained in fixed positioti for a con-stancy check on the operation of any intracavitary ton chambers should be maintained witnin shielded wells in constant geometry so they can be used for a rapid and safe check of ion chamber operation before the ggp treatment of each patient.

of exposed personnelN j. Time and engsmuse stuciesghould be carried out by the radiation protection staff on typical surgical implants and typical insertions of radioactive . sources-either in the operating room or by after-d toading in the patient's room. These' time exposure N 7'j studies should be recorded and reported to the per-sonnel involved to maintain an awareness of radiation exposures resulting from these pnxedures.

k. Transport of a patient containing tildioactive material to areas outside the operating room and to j*f his room should 5c directiv supervited by the Radia.

4 therapy staff, q' taon Safety Office statf or tne radiation w Also, transport of after loading sources and supplies for insertion of applicators. fead bedside shields for the nurses, and any other supplies and equipment re-quired for expediting an efficient after ioading pnwe-dure should be checked and supervised by the Radia-

7. / 7.

cr radiation therapy ( non 5asetygtaff. Radiation surveys should also be

                                                                                               ~

s.s 3.18-8

l l

                                                                                                                      \

earned out on a sample basis anJ recorded to main-

     !ain an awar:ncss of the espinurcs resulting from these pnisedures.

I. Nursing perwnnel should be provtded with per-sonnei dinameters tu reyutreu oy 60 brrt t' art .W M when 74 g and should be trained in tneir use. g/, a.

m. Patients should be surveyed in-nee ==mmens by H/

the radiation safety staff after removal of brachytherapy sources and before discharge as a 8Z".2/j D J Gnal step to check againsthleaxage or contaminanon incanplete removal of these sources from the from brachytherapy sources or inadvenent loss of , patient, these uurces. -.c_ .---.T Also, all linen and waste should remain in the 4.:.) Radiopharmureutical Therapy t.Vurieur room until checked by a survey meter or until

                  %fedicine T,crapy nuth Unsealed Radimnitre         al1 sources are accounted for.

Materialso y where feasible and in the best interests of the pa-tient. administration of millicurie quamities of the types of radioactive drags used for therapy of specific diseases should be carried out in a speciGe area or room separate from other nuclear medicine or radiotherapy operations. However. this special area or room should be in the general vicinity of the lab-oratory where the radiopharmaceuticals are stored to alleviate the need for transporting these matena!> over long distances or through other areas of the in-stitution. When these materials must be transported to 7Y Eb !E" a patient's room for administration.htne racianon good radiation safety practice and efficient f safety staff should monitor and assist in the prepara- medical procedure often dictates that t tion of the matenals and supplies. the transport of the matenals to the patient's room. and the administra. d*17.1 tion of the radioactive drugsfPrevalibrated containeo hs directed by the physician in Charge, sources te.g.. capsulest should be used whenever pouible. ; IWhen theracy is Carried out with potentially

                                                     ,                 volatile radiciodine comcounds, Regulatory After treatment. survevs of a!! arnelesAshould be         Guide 8.20 should be consulted to detemine made before releasCfrom tne room.1                -
                                                          .      ,     whether employees wna have participated in the imma-a. Contaminated articles must be released to the:           radiciodine acministration should be samaled Radiation 1mmmmmm=n OfGeer for decay or disposal.:               for bicassay, Also, the patient should be surveyed before release-gJ./f and should be instructed on ways to minimize-contarninstion of the enverenment and exposure of 4 or possible                Contamination f

other members of the public. D, ,* ^o+sf

                                                                   - afthem in supervising the administration of radiophar.

maceuticals to patients. the physician in charge and ?fafety 7f,27 the radiation safety staff may use many of the pnnei. pies given for brachytheracy in Seenon C.4.2.2 above, as well as principles and practices presented in NCRP Report 37 (Ref.13. The use of these procedures should help ensure that exposures to hospital staff and pnvate duty nurses are A!. ARA not only dunny the administranon of the dosage to the patient, but also during any hospital eare of the patient. dunng and after discharge of the patient. and in the esent of any later surger). autops). or burial of the patient. Additional guidance is also available from the

      ^
        .--.              Licenung Branch. Office of Nue! car faterial 8.18-9                                  t it

Material Salety and Sale;:uards. Nudear Regulatory Commisuon. 4.3 Diagnostic Nuclesc .\tedicine

                         %,/ gg                                                     Many of the principles at radiation protec: ton prac.
                                                                                'I'* I" dI"I""' ""#I**' **dI'I"' * * d#""#d '"
a. Use syringe shields for administerirg E " " " ' " " * * * * * ""' "' " "'**'

all inject 1Cns of radioactive medicine facilities and equipment (Sectron C.3.31 and material; only canpremise tm.s genual principles of safe work prxtices in handling pr0cedure on rare occasiens wnen radicactive materials (Section C.4.ll. Additional rec. acsolutely necessary. Also, use om gloves to protect against the large -4 "mendations are: 6 *. P! ace radionuclide generators im.m me==esesmee possible doses frcm hand contamination. aesasusst other nuclear medicine operations, with  ! as f ar as possible frem areas cccupied !p'd'4"* **"'i3*'i"" '"d 'ddi'i""*I ?hi'IdI"8 ** i by workees in 4* 9, r,3

                                                                                " * * * *#I '" "         *******'. **" **'"'#"*

sure to personnel during clution. samples in 9 Cd. Use m shielded bottles for checking the N<N assay of cluates in the nuclear medicine dose calibI i rator, or other suitable assay sy stem. :m==mene f.alibra. may sCCetimes reduce exposures ALAEA. tion precedures with a smaller quantity of radioactise (See Regulatory Guide 10.3 for / * *'"' a lo . Orccedures) g7, ja d/. Shield m chambu caliorators. where possible. to maintain employee exposures ALARA p e'f while nuclear medicine doses are being calibrated. Recalibrate refitted chambus as necenary, j (Ref. 13) -~ e A use tume n=esyne good conismination eoniroi I r.5 principles when preparing dosages of radiophar. or potential or, release frem rubber , maceuticals that have potential vol'asility,, septum syringes. u r,/ s

                                                                                .c%c. Keep shielded radioactive waste cans for used 7427                         gringes and otr.er tactu4etive wastes at art ap;repriate N                        5/. fi-                       " 4"C'      """                     -3rmmost frequently thoJe 4                               7u.79~
                                                                                """P'""      YP5""""'*"'"'""'E""'-

in the Iaboratcry < , 7 Consistent With ease of dis 00salf ,y,/ When they do not interfere with the diagnostic tests. use protective lead screens to protect employ. 5"3. lf, y [.3, j"/' ees and other oatients during procedures using (for example, when *.here is a recm full iewm or mnu iow. energy pmma cminusA ona. P Of patients waitirg brain scans) Me screens of only 2 mm Pb thickness will reduce of those without the screens. , a . 1 h,$ In fune_ perfusion or ventilation studies with g*74 - apDrCpriate thicknesses for ( Acun43Mo@u r_adioactt_*e rases or aerosols 'se additional lead snielding of 1.6 mm inickness around the absorcer cannister. oxygen bag. and waste recep. tacle to reduce occupational exposures when frequent { 2, fr .e././A., 4 & 4,, ,,,,,.^) 4 procedures are carried out. 8/30 ./ Jae A>'"* "' . e sospar,e -rts r t ,rsedn. of H,,e pwwmnt /c'a,ar*36.Her,se rAart>rW ceQ;r aer , nce,% ,w.w,,r,/ ,,w,4 fe,.;,, ,.;;,,fe ,j,, y.

     ,rs,.ses                                                                     4.4 Low-Level Clinical or Medical Research Labora.
                    ,,../ j.,g ,,,, j#                  # #**' ar    ,M.
                                              "" /'                                 tory Activides                                                                                l l
    &* l'J** G** Sec t'~      s.olNr pe/4 ,,/', wbc Ixw Laboratortes in medical institutions that use tracer                                           l 1'N         /M"<'rIWM*k re.ddp/rus,*wce.</s6r/s-                             amounts of the lew radiotoue nuclides may keep es.                 ,                              (

posures ALARA by uung the recommendations eisen

    /*        g# #3gC fjgNg' g, j"J                                in Scenen C.4.1. Many of the radionuefides used for in
                   ./                                                             nrr,e elinical tests such as s-                 radioim.
   / #'/'##c'.5 J4 .</4/ 6e, c,M//

3 munoanay. 'and other low.Ioel ne vriro or animal encoJ//w/ f, g ,, g 6b a-Whn ew---,;,aur a <d sic <.es/ W eide e g , y ,, 4 ,I',.>4 ec/,6,.r , 3.184 a ,>.{ Weel' y.s ni ne/s.clib<r geef;,,, [r,,,nf/s/he'**pfY'*"YIbll'" e Xe mor7WEr irr

                                                                                                                               ' *ll* ##

ecca'ct'.uv - 7%8 ' ' ' ' * ' ' ' f ^*II Y d4Nf0*>f W O /1f A*W (y

tudies involse pure Nta emitters or weak ganuna emit ters, with only microcurie or ubini rocurie cuantities handled and pnweswed by individual per-

     .mnet at any one time. thternal and internal radia-tion exposures to personnel in such laboratories should ordinarily be maintained well Niow 10's of the permissible oceupational exposure limits of 10 CFR Part 20 through careful initial planning of lab-oratory facilities, equipment, and procedures by the laboratory supervisor in conjunction with qualified health physics personnel.
5. MANAGEMENT AUDIT AND INSPECTION OF THE RADIATION SAFETY PROGRAM Ultimate resptmsibility for the establishment and continuation of an adequate radiation safety program in a medical institution has been placed with tl e gov-erning body of the hospital. The administrator report-ing to this govetning body should be sufficiently in-formed at all times to be sure that all regulations are faithfully adhered to and that :he use and safe han-dling of radioisotopes are property carried out to maintain exposures A1. ARA. .

g f7 The hospital administration shouldd an an- A Carry CtJt nual audit of the radiation safety program in etwpera-8.18=10 n.1 s. l i l i*

i 3 f tion with memners os the Medical Is.. sores Commh. l tee and tne RJiation Salety OfGee. The results os this audit may then be diwuswd at an arrnual Medie:1 l Isotopes Committee meeting to ensure that all uwrs and responsible statt are aware of surrent polie:es and , prueedures and methoda for their improvement. An  ! inspection ehecklist in NUREG.0267 gises items that may be inspected by the administration during tm> , annual audit. A report containing the results of the as well as for reference in further audit should be maintained by the Radiation safety auditing and imcroving the ALARA Crnee for possible use in expediting any inspections program, by regulatory or accrediting agencie5) s.t D. IMPLEMENTATION The purpow of this section is to provide informa. tion to applicants and licensees regarding the NRC staffi plans for using this regulatory guide. This guide reGeets practices currently acceptable to NRC staff. Except in those cases in which the applicant or licensee proposes alternative practices or methods for complying with specided portions of the Commis. sion's regulations. the practices or methods described herein witi ce usecMs a basis for the evaluation of together with those in Regulatory Guideyl 10.8 and 3.23 spplications for specine materials licenses for medi. sai institutions. 3.18-10 10

3-APPENDIX RADIATION SAFETY TASKS INVol.VED IN KEEFING OCCUPATICNAL EXFOSURES ALARA

1. Surveys of the following radioactivity areas:
a. Nucicar medicine
b. Radiation therapy
c. Oncology
d. Pathology
e. Cardiology
f. Pediatrics
3. Radioactive waste disposal and storage
h. Other research and clinical laboratories using radioactive materials.
2. Surveys of diagnostic and therapeutic machines and generators, includingt
a. Teletherapy sources and machines
b. Computerized axial tomography scanners
c. Interlock and safety checks
d. Calibrations
c. Fluoroscopes
f. Radiographic X-ray
3. Personnel monitoring
a. Review of personnel exposure data and reports
b. Preparation of reports required by regulations
c. Filing collection, and mailing of personnel monitoring devices (including late f.nd lost)
d. Special investigations of exposure and notifica.

{ tions to regulatory agencies where appropriate g g- > g'7

             <                                                          e. Calibration of persennel :nonitoring
4. Radiation safety instrument eslibration and
               ***"'*"*"**                                                  dosimeters, including ceninerciall~v sucolied film badge service.
a. Calibration *
b. Battery replacement and adjustraent
c. Pocket chamber and TLD calibration
d. Light repair (electronic)
                                                 ~
e. Instrument selection and distribution
f. Check. source calibration
5. Decontamination and waste disposal
a. Collection and packaging
b. Surveying
          ' c. Recording
d. Shipping arrangements
e. P!acarding
f. Decontamination of surgical instruments, rocms, and Iaooratories
6. Leak testing radioactive sources using the follow.

ing techn; ques:

a. Wiping ,
b. Counting ,
c. Calculations I
d. Recording
e. Counter calibration l

l l l 8.18-11 3.18

                                                                                                                   \
7. Evaluation of internal exposure by means of:

S*U .. auccuon of samplesh including air sampiing wnere applicable F b. Radiocherrical or setatillation bicassay analysis

c. Counter calibration
d. In vivo' counting
e. Computer analysis of results
8. Special surveys of padents and rooms for implant, intracavitary, or unsealed radiopharmaceutical therapy including:
a. Room preparation and protective covering
b. Labeling (bed, chart, door)
c. Nursing staff and housekeeping staff briefings
d. Background surveys
c. Source insertion and after.toading surveys
f. Surveys of patients in operating room and re.

ecvery room *

g. Fiv.ing oflead barriers
h. Recovery of sources and wastes

(,3. /$ ,

i. Survey of room cleanup and decontamination and to family of patient, as appropriate s- j. Instrucuans to pauenp
k. Measurement of radiation frcm cadavers,
                                                                                      """5"I'*". "' '"*I"d.'"8 9 Ad*i"i85'*'I " '"d briefings to pathology staff and funeral directors, wners appropriate.                   a. Approval of facilities, equipment, and proce.

dures used in areas where radioactive materials are handled

b. Preparation of license applications and amend.

ments

c. Preparation of hazard evaluation reports for9i.

censing

d. Programming of routine required surveys
c. Supervisien of routine radiation safety opera.

tions

f. Revisions to radiation safety manual
g. Periodic radiation safety instruction for hospital staff and administration ,
h. Training of residents and medical staff
i. Conferences with physicians and other safety staff
j. Coordination of radiation safety committee meetings and minutes 7 *g
k. Inspections and discussions with government
q. regulatory agency representatives Planning incicents andprcmpt effective emergencies involving responseI. Professional Okl meetings radiation. m. Selection and ordering of equipmens and
                                                                          '*s
r. Providing instructier/ direction for ,,  ;,g and budgeting outside persons (for example, firemen - o. Facility and shield design and meetings with ar.

who would rescend to an emergency chitects situation involving or potentially p. Record maintenance and related computer pru. involving radiation. gramming

s. Pre::aration of Radiation Safety Office' -p re:: orts to Acministration. 4 N
                                                          .it                         8.18-11

E3 REFERENCES

1. U.S. Nuclear Regulatory Commission. 12. National Council on Radiation Protection and Draft-Pnneiples and Practices for Keeping Occu- Measurements. " Precautions in the Management of pasional Radianon Espmares at Medical Institutions Patients who Have Received Therapeutic Amounts of As Low As Reasonahiy Achievable." NUREG-0267. Radionuclides." Report No. 37. Washington. D.C..

g970.

                                                                                                                         )

1977.

2. National Bureau of Standards.
  • Permissible .

1 Dose from External Sources of Ionizing Radiation." 13. Cannittee nn Irdu: trial YeTt11ation l Handbooit 59. Recommendations of the National American Conference of Governmental Industrial ' Council on Radiation Protection (NCRP Report No. Hygienists, " Industrial Ventilation," Lansing, i 171. Washington. D.C.. September 24. 1954. Michigan, 1975.

3. Na ional Council on Radiation Protect on and Measurements. Review of the Current (He r 14 J.G. Kertiakes and X.R. Corey, Editors' 43*
                                                             " Biophysical Aspects of the Medical Use of                 '
5. 975 Technetium-99m," American Association of a i on C..Janu Physicists in Medicine, New YT AN .Y . 1976. v
4. National Academy of Sciences-National Re-search Council. "The Effects on Population of Expo
  • 15. R.C. Barrall and S.I. Smith, " Personnel sure to 1.ow Levels of tonizing Radiation." Washing. Radiation Exposure and Protection from ton. D.C. 1972. 99nrTc Radiations," submitted October 4,1978 ~

l 5. Federal Radiation Council. " Background Mate. With C0ments on Regulatory Guide 8.13', Public l rial for the Development of Radiation Protection Document Room, U.S. Nuclear Regulatory Standards." Report No.1. Washington. D.C. 1960. Comission, Washington, D.C. 20555, 1

6. International Commission on Radiological Pro-  !

testion. "!mplications of Commission Recommenda-

16. D. Frost and H. Jammet, " Manual on tions That Doses Be Kept As 1.ow As Readily Achiev, gon protection in Hospitals and General able." Report No. 22. Pergamon Press. Elmsford. P ractice. /alume 2: Unsealed Sources,"

3,, yorg, g974, World Health Organi:ation, Geneva, Switzerland, 1975 (available frem WHO Publications Centre,

7. C. E. Braestrup and K. J. Vikterlof. "Manust 49 Sheridan Avenue, Albany, NY 12210).

on Radiation Protection in Hospitals and General Practice." Vol.1. " Basic Proceetion Require-

                                           ,                   17. World Health Organization, Technical mems." World Health Organizanon. Geneva. Swit.

S'32"d 1974-Report Series 611. "Use of Ionizing Radiation and Radionuclides on Human Seings for Medical S. Department of Hesith. Education, and Welfare. Research, Training, and Nonmedical Purcoses," Health Physics in the Hesling Arts." Publication (available frem WHO Publications Centre, No. (FDAl 73-8029, proceedings of the Seventh 49 Sheridan Avenue, Albany, NY, 12210,1977). Midyear Symposium of the Health Physics Society. San Juan, Puer:o Rico. December 1972. 18. International Comission on Radiological

9. National Council on Radiation Pro:ection and Protection, "The Handling, Storage, Use and Measurements. " Medical X. Ray and Gamma Ray Disposal of Unsealed Radionuclides in !!cspitals Protection for Energies up to 10 MeV-Structural and Medical Research Establishments," ICRP Shielding Design and Evaluation." '4CRP Report Publication No. 25, Pergamon Press, Elmsford, No. 34. Washington D.C. 1970. Reissued as NCRP New York,1977.

Report No. 49. " Structural Shielding Design and Evaluation for Medical Use of X. Rays and Gamma 19. U.S. Nuclear Regulatory Comission Rays of Energies up to 10 MeV." Sept. 15. 1976. Regulatory Guides (RG): RG 10.8 " Guide for the

                                        ~
10. National Council on Radiation Protection and Preparation of Aeolications for Medical Programs" Measurements. " Radiation Protection for Medical Oct.1980; RG 8.23, " Radiation Safety Surreys at and Allied Health Personnel." Report No. 48. Wash. Medical Institutions," January 1981; RG 3.10, ington. D.C. 1976. " Operating Philosophy for Maintaining
11. National Council on Radiation Protection and Occupational Radiation Exposures As Low As Is Measurements. " Protection Against Radiation from Reasonably Achievable," Septemoer 1975.

Brachytheracy Sources." Report No. 20. Washing-ton, D.C. 197t. ,d d 2 74 J/ UN4TEo sTAfts asvCLgam neouLAroMV COuusssioM

  • p.2svaes aseo arts rato Wes**tesoToN. o. c. 2GSSs u.s. mwCLamm etGun.a femv l

oF8tCIAL SuseNEss egneasegstose M l PSN AL?V Fo M P8tV Art WsE. s*00 ("M )

i APPENDIX A COPIES WITH REVISIONS INCORPORATING PUBLIC COMMENTS ON REGULATORY GUIDE 8.18, "INFORMATION RELEVANT TO ENSURING THAT OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL INSTITUTIONS WILL BE AS LOW AS REASONABLY ACHIEVABLE" AND NUREG-0267, " PRINCIPLES AND PRACTICES FOR KEEPING OCCUPATIONAL RADIATION EXPOSURES AT MEDICAL INSTITUTIONS AS LOW AS REASONABLY ACHIEVABLE" as Revisions on the attached copies of the above documents indicate the changes F3 made in the original "For Coment" documents. Numbers in the margins are matched to the same numbers assigned in the comment letters and responses in Appendix B, so that: a) original coments may be examined, together with any revisions, and/or the task leader's responses ( hich include consideration of other comenters' opinions) and I-b) all coments relevant to a given section or revision may be intercompared. j Places in the NUREG report where proposed modificatiens have been made are indicated by numbers in the margin. As mentioned, the numbers also identify the coment responsible for the modification. S

( 9 1

E h i f;0TE T0: Document Control

 ;                     Room 016 FROM:    /bryof       [ fc      v66,1/ 7 fG          3?gfq/

h I; i Please place the attached document in the PDR using the following file and file points: [ PDR File Related Dccuments I (SelectOne) (Enterifappropriate) Proposed Rule (PR) ACRS Minutes No. Reg. Guide f./ R Proposed Rule (PR) ' Draft Reg. Guide Draft Reg. Guide Petition (PRit) Reg. Guide W Effective Rule (RM) Petition (PRii) Effective Rule (Rii) Federal Register Notice ( SD Task flo. NUREG Report 44/#rf - on 67 Contract tio.

Subject:

&ccusdea+-). Emewe &f-
                                                      /We    te      S w f N / b b ?!/ x f - -

Acobhos of74J% Gnnab 4 e eu

( 6 -

 . -- a APPENDIX B 1 i

COMMENTS RECEIVED ON GUIDE (R.G. 8.18) AND NUREG-0267;

SUMMARY

OF STAFF RESPONSES In this Appendix, all of the letters and memoranda of comments are provided in their entirety, numbered from 1 through 75. Further, each numbered comment letter is subdivided into numbered sections or paragraphs that contain substantive ideas or specific suggestions, as indicated in the right-hand margins. Follcwing the complete comments, Appendix B-2 presents a summary of the staff response to each comment or suggestion. Each response is numbered by paragraphs jgg3 TG keyed to the preceding letters and documents so that the reviewer may read the {f?',

                                                                                                 ;#r original commenter's statement if desired, and also examine the actual changes made in Regulatory Guide 8.18 (R.G. 8.18), and/or NUREG-0267, as indicated in Appendix A by the same paragraph number.       In writing the responses consideration has been given to making them understandaole without reference to the original comment, while at the same time avoiding lengthy repetition of the original cannent.

i Some letters of comment provided specific suggestions for changes in only one or the other of the two documents (R.G. 8.18 or NUREG-0267), while same letters of comment provided suggestions on both documents, or suggestions that were appli-cable to both documents. Thus, both documents have been revised together while reading through the comments. e

9

e o ( A a &hy juo yuhe Eniurrait2 gIIchiral Can p ................ t o.$.$o. o$ e[. Io c... 12 July,1977 g r0 y, , , , , , , , , _ , I

                                                                          ~
                                                                           -                            -s            2 JUL19 m7               -

7%

                                                                                                        ?l NN Leo Wade, Jr., Ph.D.

Division of Fuel Cycle and Material Safety D c) Radioisotopes Licensing Branch U.S. Nuclear Regulatory Commission Washington, D. C. 20555

Dear Doctor Wade:

I have reviewed the copies of Regulatory Guide 8.18 and l NUREG-0267 per your request. In my opinion, the people responsible for preparation of this material are to be [ co== ended for a task well done. The documents are reasonably },/ concise and will serve as a valuable reference and guide for medical licensees. " Sincerely, O p1 eg AB. Worknan, 2.i MM.D. nu JEW /bu . CDP!ESSENTTO OFF.S INSPEm0N AND EWORCEMDIT 10 f a . .; . edF3'; ~ -

O e

                 =

(

   . e Atomic Energy Committee oF       the       NATIONAL                       FIRE                 PROTECTION                                 ASSOCIATIO
                                                                                                                             .-1 470 A R AN !!C AVENUE, B O ST O N,          M ASS ACH USETTS 02210                        =    TELEPH O N E    ','4 8 2 3755 A;t E A C o 0 E,    6 C. E. War.cos, Chairmen                                                                        WA1.*ER W. MAY3EE, 8ecrefgry Factory Mun:21 Research Corporation                                                            EnerEy Research and Development Administraci 1151 Boston. Providence Turnpike                                                               Divisaan of Operatienal Safety Norwood. MA 02C62                                                                              Washington. CC 20545 January 16, 1978
                                               . . .    :: .. .I . 1 - 4 4 d e,.

Secretary of the Coc=:issica U.S. Nuclear Regulatory Co:nnission d* M l g Washingten, D.C. 20555 g g Attention: Docketing and Service 3 ranch 9,I

Subject:

Reg. Guide 8.18 Dece=ber 1977 0 9 NUREG 0267 il M' 413 p

                                                                                                                                          . q 5ed
                                                                                                                                     #@*T.#*

Gentlenen: D V 6

                                                                                                                                      # chi H4 Copies of these have been reviewed.                                                                                         -        ~

We ce==ent as follows:

1. We feel that NFPA Pa=phlet 801 should be included in the list of references /

beginning on page R-1 of NUREG 0267. A copy of NFPA 801 is attached for I.f your ready reference. This relates back to Section 3.3.1.5 Fire Control c:: page 3-7. J 2. We note that Appendix D ends on page D-6 with half a sentence. Should there be another page? (Note - This is for editorial benefit only. I am 34 sure that an infinite nu=ber of people will pick this up) . ,_ Yours very trul , II (.S ( . E. Weldon, Chai:=an NFPA Atocic Energy Co=nittee ,

                                                                                                 .   .{            ,

GEW: prs j Enclosure -),ta,b ,-4.h j  ? n+h)1W w,M f '*ff l-Y };. cc: Mr. Walter Maybee - EHDA j Mr. G. C. Koch - NFPA

     .            TI?

GZW 1

                                                                        >                                                                                    l l

l l l The safesuarding ofd' fe and crocerty from fnes in which I l { i i

T 4 e i I I s I i ? i .f 4 l I i, i f i 4 7 I i i t l 1 4 t i 1 4

i 1

i 4 l 1 ( ( g I i

(. .

      ~
                                                                                                  ~

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                 & '. 4 D ,. . .:                 W,                     ^

Oncology Therapy, Inc. g;g OR. LOUls F. WAILLY, Pres. E/ g \ Cansufrant in Mediest usa at Radiacion g%

                                                                                                     ~

Q January 19, 1978 b ggg, MS7B , g b Secretary of the Corr::lission U.S. Nuclear Regulatory Commission g k". # Washington, D.C. 20555 Atta: Docketing and Service Branch i

1. Reference R. B. Minogue's letter dated January 6,1978, with enclosures
                           " Regulatory Guide 8.18 and NUREG - 0267, both of which referred to the "ALARA Program."

[ 2. Tne philosophy of " Maintaining Occupational Radiation Exposures

                     } ~ As low As Possible Within Reason is totally endorsed as " spelled out in L

corn tne reference guice ano cne proposed NUREG - 0257.

                        ~

t 3. The following sections of NUREG - 0267 were of greatest interest and i

                     ;    applicability to our facility: Under Chapter 3: 3.1, 3.2.6, 3.3.2, I    3.4.1.2, 3.4.2.1 and 3.4.4, and without exception each of the topics i

were coverec in an excellent manner. If one point were to be added; it

              /           would be to emphasize more strongly the necessity of initialing and '

dating the checklists and to use the checklists more frequently 1.e., practice the use of calibration verification procedures more often than are required just to meet the regulation. The references used and the participating agencies' addresses were appreciated.

               ,          4.      Rec:= mend approval as submitted.

g ,d h s , _ Louis F. Wailly, Pres. Oncology Therapy, Inc. Terre Haute, IN 47804

                                 -:m-      ::.; -   :::!.1. h 7 4%..

l 1 C Wes 121 1. Tbd fe. I  ?.- w e.d mad; erg Addms: P. O. Som 482 rw em .

f G O 3 e j e

   , , - ~ w   - - - - -         -

m 4- / .A. i THE CLEVELAND CLINIC FOUNDATION

            8 CL:NIC OSNTER H00 EJL:0 A.ENCE. M.E./'a OH:0 ut06. J 3 4    ;'6im.;;?o . 0AaLE CLEvCLNC OLv
               ? VISION CP 4AD!CLOGY Depar%ect of Radio 6agy, C.ng Cesartment of tadiology, Hosodel Ceoartment of Raciot on Therapy one m e.., -e. .n.

January 20, 1978 i j Allen Bredsky, Sc.D. P. O. Box 34471 i West Bethesda, Maryland 20034

Dear Allen:

,           Let me comend you on the fine job you have done with " Principles and                                                  '
~

Practices for Keeping Occupational Radiation Exposures at Medical Insti- I tutions ALARA". As a full-time medical health physicist, I appreciate i b,, I i this attention which has been so long overdue. Permit me to direct some " coments: .a

1) Why the need for space for parking? (from a radiation ] .y ;

safety standpoint) 4~ j 2) In pointing out the usefulness for a lab monitor, include "j the need for a g-m with speaker for surveying, and a ',; cutie-pie for accuracy. I would say that these three $ items are an absolute minimum for Category III hospitals. .,

3) I would consider many users of Xe-133 to more safely dis- 1 l i

pose their waste via dilution rather than trapping. I know of accidental releases of " trapped" xenon while I cannot appreciate the environmental concern for this radio-d nuclide,shouldthisbeyourreasonforthestatedpreference..k 1 You may note the new mailing address. I've taken over some of the activities

following the passing of Ed Chernak. You may be pleased to note that the Delta-X alloy and tissue compensation units are still in use here. Do call when you're in town. I live close to CRC publishing.

Regards, Bill Pavlicek, M.S. Radiation Safety Officer

      - 4. - +-     -      A        n __,,                                   ,

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1 f: FEDERAL REGIONAL CENTER A THCM ASVILLE. GEORGI A 31792 January 23, 1978 Secretary of the Commission V. S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Docketing and Service Section .

Dear Sirs:

Reference is made to your recent draft of NUREG-0267, titled, " Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable."

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exposure of 400 Roentgens whole body would be lethal to about nalf of  !,, those exposed if received in a short period of time (i.e., acute exposure,;/ i hours to a few days). However, if 400 R were received over a period of ( 20 years, the acute syndrome would probably not be observed. While most health physicists will understand that acute exposure is implied, you may wish to clarify the statement for the layman. W Sincerely, R. H. Boyett Health Physicist o s

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EIDP-RP 24 January 1978 U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATTENTION: Docketing and Serrice Section

Dear Director:

In response to letter dated January 6,1978 from Director, Office of Standards Development, I have reviewed NUREG-0267 and recommend the following:

                                                                                                                                       ~
1. Include a glossary of health physics terms such as radiological monitoring, radiation survey, personnel l monitoring, etc. -
2. Include a Chapter on nuclear accidents and handling nuclear accident patients. ';, _ ,

Sincerely, WFT/dp Wm\ t%EOxtg-WILLIAM F. TROLENBERG, Diteptor Radiological Intelligence Section Encl.-RDAM 14-3 CF: H. Collins, NRC Mr. Grushky, ODP Mr. Davies, Health File: Plans-Nuclear Accident-Hospital l

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i RDAM 14 -3 i I RADIOLOGICAL DEFENSE ADVISORY MANUAL No.14 - 3 FEB. 1977 1 HOSPIT AL PL ANNING TO COMB AT R ADI0 ACTIVE CONT AMIN ATION 1 FE , 3 R w 'yoS* STATE OF NEW YORK DIVISION OF MILITARY & NAVAL AFFAIRS i RADIOLOGICAL INTELLIGENCE SECTION Pubile Security 8vilding State Omco Svilding Compus Albany, N. Y.12226

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N.Y. State Dis ion of Military and Naval Aff a..a RDAM 14-3 Office of Disaster Preparedness February 1977 Radiological Intelligence Section Bldg. 22, State Campus Alb any , N . Y . 12226 PREFACE

This manual has been prepared to provide information in response to inquiries l

from local Civil Defense Offices regarding hospital planning in connection with l the handling of personnel involved in nuclear accidents. In N.Y. State, the N.Y. State Department of Health is the " lead agency" with respect to nuclear accidents - nothing in this manual RDAM 14-3 should be con-sidered to preempt the State Health Department procedures. It has published

 " RAD-320" which describes procedures for reporting ninor and major radiation accidents.

In the event of Military aircraf t or nuclear weapon (Broken Arrow) accident, notify the nearest military installation. The State Health Department can be reached in an emergency through the State CD Warning Point on NAWAS or on (518) 457-2200. During normal business hours, State Bureau of Radiological Health in Albany can be reached quickest by calling direct to (518) 474-2886, 474-2846, or 474-2882. The Statewide Civil Defense radiological personnel and equipment resources are available for nuclear accident support upon request frc= the Health Department l (See the N.Y. Emergency Operations Plan, Annex K (RDAM 2-5), Appendix 5). ' 1 l l At the Federal level, the U.S. Energy Research and Development Administration (ERDA) is designated the agency responsible for directing the administration, i implementation, and application of the provisions of the U.S. Interagency Radiological Assistance Plan (IRAP) with the cooperation of the other partici-pacing Federal agencies.  ; One of the purposes of IRAP is to encourage the development of state and local plans and capabilities to cope with radiological incidents. (See RDAM 2-5, i Appendix 5.b.). I sr t ff pw p WILLIAMF.TROLENBEFG,D'1% tor  ! Radiological intelligence saletion i I Note: The material in this manual, except for the attachments, is reproduced from the Journal Of The American Medical Association, August 17, 1963, by permission of the author and the American Medical Association.

e Jternated From The fomenal of The Amencea Hed ,sacistaa Augsus t r.1963. YoL i8s, pp. 578,sb RDAM 14-3 cepvns ar19sa,av 4= ,nc.a x<enasAnon.no. Feb. 1977 What steps should a hospital take for protecting a community against possible large scale radioactive contamination? Hospital Planning To Combat Radioactive Contamination Eugene L. Saenger, MD, Cincinnari pital plan should be coordinated with the needs of IN tal, OUR PRESENT however small or complex specialized, society, each should have a hospi- the particular radiation facility, so that the injured well-planned disaster program. This program should may be properly' handled. Certain plants of this have provisions for intensive care of fewer than 50 type may have regulations for industrial secrecy patients and emergency care for large segments of and national secunty, and special provisions may its potential population in case of mass catastrophe. be required to allow ready medical access. Prompt With the expansion of the uses of atomic energy communication between hospitals and sites of po-and the distinct possibility of atomic and thermo- tential accidents should be arranged in anticipation nuclear warfare, the emergency hospital program of such events by unlisted phones which do not go must make special provisions for the unique prob. through hospital or site switchboards which can be lems created by radiation-expressly contamination. jammed by public curiosity or panic. Preplanning for radiation accidents is essential.'

  • There may be smaller radiation facilities which The possibility of such occurrences can almost are potential foci of accidents, such as hospital and always be anticipated and adequate provisions university radioisotope laboratories. They should made. If the hospital is required to care for highly be listed so that their locations, radionuclides used, contaminated patients without having some type of and levels of radioactivity are known. Each site simple prearranged program, it can be placeo in should be visited by hospital representatives, so an absurd and difHeult position, with resulting con- that the type of radiation problems which might tamination of many of its facilities which may then be encountered can be anticipated. All such plans be lost to other patients. The expense of decon- should be coordinated carefully with police, fire, taminating buildings may cost hundreds of thou- and local health authorities, so that they are fa-sands of dollars and require weeks of cleaning.* miliar with the detailed emergency programs and Sources of Accidents.-These accidents may be can provide training for their personnel. Liaison of three types: transportation of large amounts of with local Civil Defense groups may be desirable.

radioactive material involved in collision or wreck: The Nature of Radiation Accidents.-A radiation high level fallout fmm nuclear warfare: and acci- accident may be defined as an unforeseen occur-dents within installations using large amounts of rence, either actual or suspected, involving ex-radioactivity in or near the community. Reactors, posure of or contamination on or within humans nuclear fuel plants, and radiochemical processing and the environment by ionizing radiation. The plants are examples. In accidents of the first type, accident will be considered as occurring within a one or more couriers usually accompany hazardous short period of seconds up to several days. shipments and can give proper notification. In the Human beings can be involved by radiation in second type of accident, notification is given by two ways. The source of radiation may be outside Civil Defense or other government agencies. The of the body so that the radiation senkes the indi-handling of the third type of accidents can be vidual and is absorbed, depending upon its physical

       , improved by suitable preplanning.                                   characteristics. Radiation from x-ray generators, In large plants, such as reactors, there are one                particle accelerators, sealed sources of radio-or more well quali8ed health physicists and phy-                    nuclides, and reactnrs are examples of this type.

sicians in charge of a rigorom plant safety pro- The radiation may be heta, gamma, or neutron. In gram. Liaison between these specialists and el e partele accelerators deuterons or alphas or other hospital emergency team can anticipate the types high-energy particles can be foimd. l of accidents which could be encountered. The har The secund way in which humans can be in-t - volved is by contamination with radioactive nu. l eU**[,, $'$".'.*'".I',% c "d "**""*** ' " * ' " *

                                            .                                clides. These radionuclides can be deposited on the i                                                                      !

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Vol 153, No T MDICACTIVE DECONTAMINATION-SAENGER 579 skin, inhaled, agested, or enter throuch wounds. should contain the items that follow in the lists. Radioactive nuclides may also be formed within the body after exposure to an extemal source of 7 ,, p g neutrons. These most commonly detected are Na" Coveralls or surgical scrub suits and P". Induced radioactivity due to neutrons is Surgical caps not usually dangerous to others. Individuals may Rubber or plastic gloves (cotton liners, industrial be involved both from external radiation and by or household type, are more comfortable) radionuclide contamination. Surgical rubber gloves The single error of commission to be avoided at Plastic or rubber shoe covers or overshoes all costs in handling contaminated patients in the Highway flares hospital is that of bringing them into the admitting hiasking tape 2 in wide or adhesive tape or elec-room and further into the hospital, spreading high tr:c tape levels of radioactivity along the route. Such an act Radiation sigris: Caution: High Radiation Area would re ult in contamination not only of the Caution: Radiation Area rooms and corndors traversed, but also of the air, Caution: Radioactive hiaterials air conditioning ducts, other patients, and medical Caution: Airborne Radioactivity supplies and equipment. The radioactive particles Radiation tags for attachment to patients: are carried as are other dus:s or bacteria and can Danger: Radioactivity (a tag to be tied to pa-be spread widely and quickly, particularly when tient) such a situation is handled by inexperienced per- Caution: Radioactive hiaterial (a roll of sonnel. The hospital authorities can handle this gummed tape which can be affixed to the problem in one of two ways: A hospital team can patient) he diapatched to the accident site for preliminary Dust respirators with filters to remove particles decontamination, or a special admission routine for larger than Ig. Extra Siters should be provided. such cases can be planned prior to the accidents. 500-ft rope for restricting contaminated areas The Hospit.21 Radiation Team.-Afost hospitals Personnel dosimeters and dosimeter charger,200 with departments of radiology and radioisotope milliroentgen (mr) and 20 roentgen (r) Icvels laboratories have a Radiological Safety Officer. His Flashlight and batteries, wire cutters, screw driv-routine duties are to enforce proper radiation _ er, pocket knife, pliers safety practices.' He may be a radiologist, radia-tion therapist, radia: ion physicist, or health physi- For Patients cist. Any physician or other scientist can qualify Scissors for this position, with some training. This individ- Ijing patient gowns or coveralls ual should head the emergency team. He may have Blankets one or more deputies and several technicians Foot covers trained for radiation accidents. These technicians Cloth or plastic bags,1 large, for collection of can be from the x-ray department or radioisotope contaminated clothing laboratory. One or more physicians, nurses, and Tags and gummed labeis trained ambulance attendants would be such a team. Crayons, pencils, chalk A supply kit for radiological first aid should be Notebooks, paper provided. Quantities of materials are not speci6ed, I pint and 1 quart ice cream containers for col-since they depend on the type and magnitude of lection of urine and feces the accident and the size of the hospital team. Cotton swabs with envelopes Because of the possibility of contamination at the plant site, the hospital team should stockpile most Survey hieters items. Radiation detectors may be provided by the Portable beta gamma ionization chamber survey hospital, the plant where the accident occurs, or meter by the pohce or fire department. Except for dust Ceiger-hfueller portable survey meter-portable resp . tors, the supplies are readily available. Sup- scintillation detector, portable ionization chamber plied air packs are commonly used by skin divers or proportional counter and, in an emergency, often can be obtained from Portable alpha detector-scintillation, ionization sporting goods suppliers. chamber, or proportional At the site of the accident the hospital team Extra batteries for each instrument. Extra Ceiger-can survey the injured and contaminated patients, Afuel!ct tubes carry out preliminary decontamination, and render Screw driver Srst aid. Crossly contaminated clothing can be re-(Note: Batteries should not be left in instru-moved and the patient transported to the hospital, ments unless used frequently. Instruments shonid covered sufficiently so that he will not contaminate be tested prior to field use.) the hospital premises. The team can carry otit the Earphones are useful for survey work with same functions s' the hospital. The supply kit Ceiger Afueller and scintillation detectors

530 RADIOACTIVE DECONTAMINATION 'ENCER JAMA, Aug 17, 1983

                                                       .                        showers, large drains, and suitable radiation de-For Transportation tectors. Such an area could be utilized for ordi-I                 Several rolls of 36-in,60-lb weight bmwn Kraft                  nary medical purposes except in radiation acci-
!             paper, or                                                         dents. It is economically unsound to reserve one Plastic sheets, or                                              or more rooms solely for radiation accidents, since Cloth sheets                                                    these accidents are extremely rare as compared to i                 Masking tape 2 in wide                                         all other emergencies. There is no objection to l                Blankets                                                       establishing such special rooms in the admitting t

Care of Radiation Accident Patients at time Hos- suite, prodded a highly trained staff is always pital.-Patients exposed only to external radiation available to insure proper use.

!             present no unusual admission problem, since they                        A logical admission route for contaminated pa-are not radioactive. The hospital should be notified              tients is via the autopsy room. The autopsy room i)             before a contaminated patient is sent for admis-                  provides excellent facilities and location for de-i            sion. The location of the accident, number of peo-                contamination of nonambulatory patients. Showers

'j ple involved, an estimate of the amount and kinds are usually available for ambulatory individuals of radioactivity, and an estimate of the extent of - with contamination. Patients unable to cleanse injury of patients should be furnished to the hos- themselves can be decontaminated on autopsy pital. The person at the hospital should instruct the tables. Emergency surgical care can be provided. caller exactly where to bring the patients. When the patients have been suitably decontami-Special techniques for their admission should be nated they can be moved to regular hospital areas. planned. If possible, some decontamination prior Until decontamination is complete, all hospital to arrival at the hospital is desirable. Contaminated areas through which these patients pass must be clothing can be removed using the supplies from monitored. Monitoring stations should be set up the list For Patients, even if washing at the site of at the doorways to the decontamination room. No accident is not feasible. The contaminated patients materials should leave the room until they have should not be admitted through the general emerg- been monitored. The rooms should not be used ency area unless they can be diverted immediately for other purposes until a survey shows them to to an isolated area which has been prepared pre- be free of significant contamination. viously. A Bow chart for admitting patients follows. Procedures for Protection of Hospital Personnel. Radiation Accident Reported to Hospital -Hospital personnel caring for contaminated indi.

,                                             1                                 viduals require special training and protection so 4

Notification of Radiation Safety that they themselves do not become contaminated. Officer and Responsible Physician Contamination can be transferred by direct con-1 tact with radioactive materials on skin, clothing, j Arrival of Patient at Prescribed or in the process of decontamination with aqueous

!                                      Admitting Area                           solutions; the radionuclides may dry and become I                                 airborne particles. The environment may become
Rapid Survey for Contamination contaminated in the same way as personnel.

, 1 1 In order to protect personnel and the hospital

;                  If Contamination          If No Contamination, First         environment, certain procedures are recommended.

4 Present, Gross Aid and Emergency (1) Personnel shall wear surgical scrub suits, Decontamination Treatment surgical caps and gowns, and rubber gloves (either by Trained Personnel 1 surgical, household, or industrial, depending upon 1 Release of Patient to Hos- their duties), (2) Masks, respirators, or supplied i First Aid and Emergency pital Ward, Surgery, or air packs may be required, depending upon the Treatment Home, as Indicated type of radionuclide and amount. (3) Rubber or i plastic shoe covers are desirable. Those individuals Further Definitive who perform actual decontamination with water Decontamination should wear plastic or rubber laboratory aprons. 1 Cood temporary shoe covers for dry areas can be Release of Patient to improvised from brown paper bags held on with Surgery, Hospital adhesive or masking tape. (4) Air conditioning Ward, or Home, and forced air heating systems should be turned as Indicated off, so that radioactivity is not carried into ducts Admitting Routine.-There is diversity of opin- or to other rooms. (S) The floors should be pro-ion concerning the bmt route of admission for con- tected with a removable coverin;; which confines , 4 taminated patients. Many authorities recommend radioactivity. Brown paper rolls (3G in wide,60.ih . a special isniation room in or near the admitting weight) are ideal where water is not used. Plastic area. A separate entrance to this special room is sheets are useful where spillage of liquids is a desirabl . This room should be equipped with problem. (6) All contaminated clothing should be ! ) ! i l l N - - - .-- - - - - - --- - -

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Vol 155, No 7 RAD CTIVE DECONTAMINATION-SAENGER 581 placed in plastic or paper bags as quickly as pos. and washing facilities make this table ideal for sible. (7) Splashing of solutions used in decon- this purpose. It can be covered with a rubber pad famination should be avoided. (S) Patients and and used as a treatment table for minor operations
personnel should go to areas with a low level of except when needed for decontamination. A spe-i radioactivity only after surveys show satisfactory cial basin or fountain for irrigation of eyes. Except

! decontamination. If a highly contaminated patient in special AEC installations, where contamination 1 or material is brought into a low-level area, the by plutonium and other highly toxic radionuclides j low. level area then becomes useless. (9) All pas- is probable, the installation of waste tanks to con- , sage between high- and low-level areas of radio- tain contaminated wash water is economically un-activity must be regulated by monitoring teams. JustiSable. If large amounts of radionuclides are ! (10) Individuals who are untrained in radiation present in the water, the water should be moni-1 techniques and who do not have speciSc duties tored and diluted in accordance with maximum should be excluded from these areas. (11) Supplies permissible concentrations for water.' In certain !' must be passed through monitoring stations from cases, isotopic dilution with a stable nuclide may j lower to higher level areas of contamination. Re- be feasible. (2) Floor. Any commercially available j floor covering is satisfactory. If standard 9 X 9 in verse flow should not be allowed. (12) Fiberboard or steel drums with tight-Seting tops should be blocks are used, the contaminated areas can be obtained as soon as possible for contaminated ma- removed and replaced as needed. Solid linoleum l terials. Labels describing the contents should be sheets are thus less desirable. (3) Wall paints affixed, so that proper disposal can be carried out should be easily washable. A glossy, nonporous 3 without reopening the drums. They may be sealed Snish is desirable for case of decontamination. (4) { with stripping plastics.' Drums should also be pro. Any air conditioning in such rooms should be sepa-1 vided and labeled for noncontaminated waste. rately entrolled and preferably should not connect i This step will minimize disposal problems. (13) with the remainder of the building. Where serious

  ,                                     Pocket dosimeters and Sim badges should be sup-                                                  airborne particles are expected, pressure in the de-plied to all personnel. Monitors should check radi-                                              contamination room should be negative in respect J                                        ation levels about contaminated individuals. If only                                             to an access corridor to the " clean ~ part of the a few patients are involved, personnel should be                                                 building. (5) The room should be equipped for

, rotated after a dose of 5 units of absorbed radia- minor operations. If gas anesthesia is carried out

tion (tad) is received. Only if there are mass cas- in such a room, all survey meters requiring external j ualties under unusual circumstances should indi- power simuld be fitted in advance so as to fit j vidual doses to 25 rad be permitted. (14) All readily into explosion-proof electrical outlets. (6) lf }j l personnel in contact with contaminated patients separate access from outside is provided to such '

1 i must be surveyed by the Radiological Safety Ollicer a room, the room can be adjacent to the emergency before leaving or working with other patients. area and can be used for routine patients as well.

Disposal Problemr.-Victims dead and with con- (7) Emergency power supply and an emergency j tamination should be sealed in plastic sheets and communication system should be provided.

j refrigerated until surveys can be carried out by This work was supported in part by contence with the l ' radiation monitors. Corpses need only be stored Division of Biology and Medicine, US Atomic Energy Com-until the emergency is terminated. Further instruc- mbion. ] tions concerning disposal can be found in National Radioisotope ! aboratory, General Hospital, Cincinnati 29. l Bureau of Standards Handbook 56.' Contaminated dry or damp wastes should be placed in drums as previously described and stored 1. Saenger, E.L: Radiation Accidents, Amer J Roentgen j in a remote area until the emergency is terminated. 84:715 728 (Oct) 1980.

2. Saenger, E.L: Planning for Radiation Accident. Amer

? Planning Problems.-Most hospitals at present Indoser Hyg Aae / 20:482 487 (Dec) 1959. are not specially equipped for decontamination of 3. Saenser, E.L. et ab Emerzeney Measures and Precan. t patients. Usually available facilities can be adapted tions in Radium Accidents, JAMA 149i813 415 Oune) 1952.

for these needs at relatively little expense. Special 4. National Burees of Standards Nendbook 76, Medical feature, desirable in decontamination areas are as x-ray Protection up to a Minion volts, Washinst<m,11C.

I Covernment Prinung omee. j follows: (1) Washing facilities for ambidatory 5. Needrmel Burceu of Stendards llendbook $6, Safe flan. +

patients. Showers for total body contamination. dlins'of Cadavers Conuining Hadioactive != torn $. hh-Access from "the dirty" side and egress to the clean inut n. D.C.
Comnment Prinung Osce.
6. National Bureen of Standards Handbook 09, Masimum side via a monitoring station should be provided.

Permisuble Body Hnedens ami Maximum Permiwihle Con.

Surgical scrub sinks or slop sinks with deep bowls cent,neions of Radamudides in Air ami Water for ocenpa.

j for decontamination of upper extremities. A deep tional Exposure, Washington, D.C.: Covernment Printing i sink at floor level similar to a whirlpool both for 08ce. ! Anhiitional depled informanon enn be frmnd in the re. cicanin8 of lower extremities. An s autoU'Y table cently inued Medical Aspects of RedMion Accidents, Y.L for decontamination of patientt unable to. help Saencer, ed, Washington, D.C.: US Government Printune themselves. The perforated surfaSe, cicvated edges omee. s rmues m uns

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a . N.Y. State Division of Military and Naval n. fairs RDAM 14-3 Office of Disaster Preparedness (ODP) Attach.l.0 Pg.1 Radiological Intelligence Section February 1977 Bldg. 22. State Campus Albany, N.Y. 12226 Reference List NUCLEAR ACCIDENT HOSPITAL PROCEDURES

  • 1. RDAM 14-2, Planning A Medical Unit for Handling Contaminated Persons Following a Radiation Accident.
  • 2. RDAM 14-3, Hospital Planning to Combat Radioactive Contamination.
  • 3. RDAM 14-4, Pg.G.3, July 1975. Effects of Radiation or Man, Tables from NCRP Report Number 42.
                *4. RDAM 10-7, External Radiation Exposure Guide For Civil Defense.
  • 5. RDAM 10-7A, Biological Effects of Radiation.
  • 6. RDAM 13-1 Fundamentals of Mobile Radiological Survey.
7. Emergency Handling of Radiation Accident Cases, 1969, U.S. Covernment Printing Office.
8. The following pamphlets dealing with the Emergency Randling Of Radiation Accident Cases, are available without charge from U.S. ERDA Technical Information Center, P.O. Box 62, Oak Ridge, Tenn. 37830.

ERDA-17, Physicians ERDA-20, Ambulance / Rescue Squad ERDA-18, Nurses ERDA-21, Police ERDA-19 Hospital Administrators ERDA-22, Sheriffs

9. Dose Limiting Recommendations, Table 6, from NCRP Report Number 39, Jan.1971.
10. Acceptable Surface Contamination Level, Table 1 - USAEC Regulatory Guide 1.86.
11. Radioactive Material Package Contaminat1on Limits from "A review of the DOT
                   , Regulations for transportation of Radioactive Materials, Table 7".
12. Radioactive Contamination Guides, from Army Regulation AR 700-64
13. DOD, FG-E-5.9, Handbook For Radiological Monitors.
14. DCPA CPG l-6, Change 1 Nuclear Facility Accidents.
15. Movies " Radiation Accident Patients", a 17 minute color film available from the Radiological Intelligence Section, shows techniques for proper handling of radiation accident patients.
16. Movie: "Date With Disaster", a 29 minute color film available from the Radio-logical Intelligence Section at above address, shows need for general disas-ter planning and how it works in California.

RDAM 14-3 Attach.l.0 Pg.2' February 1977 Reference List NUCLEAR ACCIDENT HOSPITAL PROCEDURES (cont'd)

17. U.S. NUREG-75/111, Guide and Checklist For Development and Evaluation of State and Local Government Radiological Emergency Response Plans in Support of Fixed Nuclear Facilities, U.S. Nuclear Regulatory Commi-sion, Washington, D.C. 20545.

1 f

                                                                                                          ?
  • N.Y. State Radiological Defense Advisorv Manual (RDAM) are prepared by the I Radiological Intelligence Section of ODP and available without charge from above address. I 1

l l

l N.Y. State Division of Military and Naval Affairs RDAM 14-3 Office of Disaster Preparedness (ODP) Attach.2.0, Pg.1 Radiological Intelligence Section February 1977 Bldg. 22, State Campus Albany, N.Y. 12226 COMMON PLANNING ERRORS

1. Lack of leadership from the community and from the health professions.
2. Lack of central coordinating authority for medical care.
3. Lack of areavide medical communications capability.
4. Lack of organized teams for onsite emergency medical care and sorting.
5. Lack of equitable distribution of casualties to hospitals.
6. Lack of effective disaster plans in hospitals.
7. Lack of method if identification for disaster health workers.
8. Lack of police security at the disaster site and at the hospitel.
9. Lack of traffic control throughout the disaster area and adjacent to I

hospitals. 1 Lack of early attention to prudent use of onhand inventories.

11. Lack of coordination of disaster relief activities
12. Failure to establish adequate triage procedure at t'he hospital.

To summarize, all the difficulties included in the list above have been noted time and time again in disasters, but they are still frequently overlooked in predisaster planning. These are errors which can seriously hamper the efficiency of emergency medical services. Source: The Role of Medicine for Emergency Preparedn,ess,, edited by Francis C. Jackson, M.D. and Christopher Earl Kennemer, D.D.S., U.S. Government, Washington, D.C., 1968, 70 p.

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

f N.Y. State RDAM 14-3 Office of Disaster Preparedness Attach.2.1, Pg.1 Radiological Intelligence Section February 1977 Some Recommendation For Disaster Preparedness At Hosoitals

1. An internospital communication program should be organized to aid in orderly transportation and assignment of patients in order to distribute the communi-ty load as equally as possible.
2. Control of traffic in the invcived area is essential to implement care of I

the injured and to minimize confusion of volunteers and spectators.

3. Hospital receiving areas should be designed to permit ease of access and egress of ambulances so that the injured can be unloaded without requiring the vehicle to turn around.

1 4 Emergency patient identification and treatment tags must be available. Recording of therapy should be provided. j {

5. Physicians trained in triage should be continually on duty. '
6. Standard treat =ent routines for common injuries must be utilized.
7. Relatively well and convalescent patients should be sent home or to hotels or dormitories where simpler care f acilities can be employed.
8. X-rays may often be postponed for 24-48 hours until the emergency has been stabilized.
9. Blood bank facilities should be provided sufficiently far from the hospital so as to minimize the flow of people through the institution.
10. Public information via press and radio should be planned so that excessive quantities of blood are not obtained,
11. Hospitals should be provided with unlisted telephone lines so that important emergency calls can be =ade and received.
12. Emergency morgue and embalming procedures should be prepared. Embalming may be required without permission of the family of the deceased.
13. A careful public relations program for the hospital is required with atten-tion to the following aspects:

(a) Transmission of information to the public by press, radio and television. (b) Identification of dead and injured. (c) Tactful handling of volunteers and crowds of curious onlookers. (d) Community reaction towards the hospital on a long-term basis. Public relations are most important in minimizing resentment by individuals and the community at large. Ref e rence-

      " Medical Aspects of Radiation Accidents", E.L. Saenger, M.D. , Editor, U.S. Atomic Energy Commission; Superintendent of Documents, U.S. Government Printing Office
        '4ashington 25, D.C.

N.Y. State Division of Military And Naval Aff airs RDAM 14-3 Office of Disaster Preparedness (ODP) Attach.2.2,Pg.1 Radiological Intelligence Section February 1977 Bldg. 22, State Campus Albany, N.Y. 12226 i INITIAL CHECKLIST - RADIATION ACCIDENT PATIENT

1. Victim Number
2. Check for life threatening respiratory or hemmorrhagic injury:

None found. Emergency Therapy i 3. Survey for radiation contamination and label victim. R per hour @ meters. 4 Decontamination procedures Undress Shave (save hair) Shower Surgical Not required

5. Registerandassignhoskitalnumber:

Name: Lasc First Middle Hospital No.

6. Phlebotomy: One lavender top tube Three red top tubes Cytogenetic tubes i Two green top tubes
                       ~

1

7. Remove all clothing, bag and label each item (including pocket 1 contents).
8. Give patient containers for all excreta and vomitus - label.
9. Physicians physical exam and history, chart orders.
10. Notify relatives.
11. Whole body counts and lineer scans l l

Yes Inappropriate 1 1 1 l l I l-- ., .. - .-. - - , - . _ . . - - _ . _ - -- _ . , - - --- - , . . -

N.Y. State Division of Military And Naval Aff airs RDAM 14-3 Office of Disaster Preparedness (ODP) Attach.2.2,Pg.1 Radiological Intelligence ecction February 1977 Bldg. 22, State Campus Albany, N.Y. 12226 INITIAL CHECKLIST - RADIATION ACCIDENT PATIENT

1. Victim Number
2. Check for life threatening respiratory or hemmorrhagic injury:

None found. Emergency Therapy

3. Survey for radiation contamination and label victim.

R per hour @ meters. 4 Decontamination procedures Undress Shave (save hair) Shower Surgical Not required

5. Register and assign hospital number: ,

Name: Last First Middle Hospital No.

6. Phlebotomy: One lavender top tube Three red top tubes Cytogenetic tubes Two green top tubes
7. Remove all clothing, bag and label each item (including pocket contents).
8. Give patient containers for all excreta and vomitus - label.
9. Physicians physical exam and history, chart orders.
10. Notify relatives.
11. Whole body counts and linear scans Yes Inappropriate

i ERDA Radiological Assistance Regions & Coordinating Offices 1% l NICHLago O I g h / G, . g! E  !

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                                                 ?                     Phone: Ac 516 315-2200             4                                                  From: ERDA-10, Apr. 1975 N
                                                                                                                                                                                        -                                                                                                                                                                                                                    1 RDAM 14-3
                                                                                                                                                                                                                                                                ,                                                   Attache 4sl,Pg.1,Febl97                                                                  '

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P. O. Box 117

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                                                         . % C. C. Lushbaugh, M.D. Directer. . '. - . . . . .                                                                                         .                          : .~ ,.1; ..,. .                                                                                                                             ..
                                             .;... '. . , ' . Kad       .           F. H0bner, M.D., Associate Director J .'. .. . b'                                                                                                                                                                               .. *              .
                                                                                                                                                                                                                                                              . . .                l . .... . .                                    -
i. ' .l. Roger J.Cfoutier, Chairman, Special Trainir$g Division '.~'.{-,.'...
                                                                 ..T. t.incoln, M.D., Medical Director, Oak Ridge National Labor'atory
                                                           - Rcbert C. Ricks. Assistant Director
                                                                                                                                                                                                                                                                                    - .- - " - ' " ~                                              9 f         - James D. Berger, Safety, Oak Ridge Associated Universities
                                                                                          .           . ,, . ..s..                                   .   .
                                                                                                                                                                                                          's                          ..                                    .-            .,
                                                                - W. G. A. Andrews, fA.D., hematof ogy '
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. L Beck, Jr., health physict . .

                                                                 . Jarnes W. Chesney, safety                                                                                                        '

f,^.' G enda S. Fritts, safety.~ '

                                                                                                                                                                                                                                                                                                .n              .                         .,*                              .

W. D. Gibbs, whole-bcdf counting , . Gretchen Humason,pathologt . .

  • Eug.n. E. Joiner, cy t'ogenet;es '

L. Gri ef Littlef; eld, cyte;<nenes ' Sallie L. McCaskill, cytogenetics

                                                                                                                                                                                                                                   '.                                                       ~

Eleanor B. Seil.t, pathology ' Ann S.pe, etin cal nurs. J. R. Stevens. pathologf . A. G. Webster, pathology I l

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9 Pamology  ! l; Human treadiation reaiaing of f. and Ciammu- ] l j' j] lI Emergenw .1 La b. Cau F.cuiry , a nons Il Hoeding Room

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p em ew--=o .gmasemm m - .- - E] Ee2! REACfrS provides the most gical follow-up if necessary, c modern multipurpose facilities - Specialized courses for physi-available for handling radiation cians, health physicists, and cara-emergencies. It is designed to cope medical personnel are provided on with any type of radiation-expo- a routine basis. Each' course includes

                                                                         . sure accident which might occur                                     instruction on radiation detection
                       ,              ,                          ,         in Oak Ridge or elsewhere. The                                     and monitoring, radiation biology, REAC/TS staf f, in conjunction                                     and emergency procedures.
                                                    .              -      with the Oak Ridga Hospital of                                     -

REAC/TS is a major source of

                                               .                           the United Methodist Church                                         information on the epidemiologic Disaster Team and staff, is pre-                                    asoects of human exposure to
        ,                             ,                                    pared to treat radiation victims                                    radiation. A computerized data quickly and competently and to                                      bank of human radiation effects provide advice and assistance when                                  from accidental and medical expo-radiation accidents occur outside                                   sures on a worldwide basis has been the Oak Ridge area. Following                                        nitiatec and serves as a basis for treatment in REAC/TS, the                                           epidemio:ogic studies, as well as patient (s) can be tra 'sferred to                                  providing timely data to those in-the adjoining Oak Ridge hospital                                    volved in handling radiation for conventional medical and sur-                                  accidents.

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NEW YORK STATE ,e 1 oi s i gi - OFFICE OF DISASTER PREPAREDNESS ,,~' Bldg. 22, State campus ( )

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Albany N.Y. 12226 ,'

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(,- ~~ 1: g; civil DEFENSE DISTRICTS ( < _.3 9*3 "!HKEEPSIE  ? and New York City s. \ $._.i , ";. m

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O es 4N nwe some e PERMANENT DISTRICT OFFICE e'[(- - d n O STATE

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f .._,m m. - . . -;o E.O.C.- MERGENCY OPERATING CENTER y a-Emergency Phone: 518, 457-2200 --, M

a , j RDAM 14-3 , OCP DISTRICT OFFICES Attach. 5.0, Pg. 2 Feb. 1977 State of New York Division of Military and Naval Affairs Office of Disaster Preparedness (0DP) , CENTRAL DISTRICT OFFICE 213 Union Street Cneida, New York 13421 Tele. No.: Area Code 315; 363-8524 Access Code 180 EASTERN DISTRICT OFFICE Unper West Street Oneonta, New York 13820 Tele. No.: Area Code 607; 432-1771 Access Code 188 SCUTHERN DISTRICT OFFICE Creek Road Peughkeepsie, New York 12601 Tele. No.: Area Code 914; 454-0430 Access Code 152 WESTERN DISTRICT OFFICE P.O. Box 692 221 State Street Batavia, New York 14020 Tele. No.: Area Code 716, 343-1465 Access Code 171 NORTHERN DISTRICT OFFICI Fox Farm Road Glens Falls, New York 12801 Tele. No. : Area Code 518; 793-6646 Access Code 160 LAKE DISTRICT OFFICE P. O. Box 164 , Rt .31 Newark, New York 14513 Tele. No. : Area Code 315 331-4880 Accass Code 181 i

e RDAM 14-2 RADIOLOGICAL DEFENSE ADVISORY MANUAL No.14 -2 JUNE 1%9 PLANNING A MEDICAL UNIT FOR HANDLING CONTAMINATED PERSONS FOLLOWING A RADIATION ACCIDENT NEW YORK S1 e f CIVIL DEFENSE COMMISSION RADIOLOGICAL INTILLIGENCI SECTION Pubils Security Building State Osco Building Campus Albany, N. Y,12226

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New York State Civil Defense Commission Radiological Intelligence Section Bldg. 22, State Campus, Albany 12226 I 1 RDAM 14-2  ! June 1%8 l Planning a Medical Unit for Handling Contaminated Persons Following a Radiation Accident By R. W. Holland, M.D.* [ Editor's Note: Many nuclear facdines are somewhat isolated IAt me hasten to point out, however, that accidents are from neighbonng commumnes. A medical case involving also quite possible at smaller chemical plants,universi-radianon at such a facillry is thmfore liable to requise ties, and power-reactor stations, and some advance emergency decontammadon prior to transport to the com-preparation needs to be made in anticipation of such mumty hospital for longer term care. An ORNL study group, of which Dr. Ho!!and was a member, visited several nuclear eventualities. This article presents my ideas and recom-instalianons in 1966 to obtam whatever data and information mendations on these advance preparations, formulated nugnt be helpfulin the design of a medical-decantammadon on the basis of ORNL expenence and projected needs, urut at L ANL We therefore asked him to discuss this problem as well as expenence.and attitudes of medical person-and to make recommendanons appropnate to the dengn of new medical-treatment rooms or modification of exisung nel at other AEC installations. rooms at small umversines with nuclear research facilines, Let me make quite clear that the kind of radiation radiochemzcal plants, or powes' reactor stacons. The pumary injury being discussed in this article is one in which a audience for this arecle is therefore the medical consultant or severe but relatively conventional industnal accident is the radtacon-safety ofncer of a nuclear facility.I complicated by significant radioactive contamination. I Abstrace Inrunes sustamed at the time ofa radiation accident am ut Mg abat ms f massnve Ms d ac retartvely rare in the Umred States. but as the use of radiation requinng special antiintection care and bone-nuclear energy expands, there may be more of them, la the marrow transplant or cases in which a worker is so yearr smce the SL./ sncident m which three worken died- heavily contammated internally as to require chelating there has been much private escusnan about the adessabatty agents. I am concemed rather with injuries the general of consmecnne d contammation facdines at utes where re$ anon accidents are pcmble, but little has been wrrrten to, practitioner or hospital clinicians could treat ade-publicanon. In dus arttete. Ideas and recommendarsons are quately (if the interfering contamination were effec-prerented ors ne design of ruch a decontammation facility. tively disposed of) and would have to treat rapidly. These tJess mere formed by bods menstnal meaicalpractice at Nuclear onented facilittes should have definite OR.VL and by discumon wsth perronnel at vanous other suces. plans for decontammation of workeis who may be inv ed in radiation acdem Es planning nud not "A radiation accident may be defined as an unforeseen occurrence, either actual or suspected, myolving expo-

                                                                                    ** ***' * * *           ".", e#Pnwnt, and penond
                                                                                #"           **     I*       *"    '# * *       ***

sure of or contamination on or withm humans and the Plans should be general rather than specific, environment by ionizing radiation."' At the present E"#E"*'.

                                                                                     ***' I        ****"""'#**********"**""'

time the large AEC installations probably present the greatest potential for major ra6ation accidents. In large multipurpose facilities, where researchis continu-

                                                                                **" # * *"** *' " " **** E * *            '    """'

ing at a rapid pace, accidents are more likely to occur  !" . Preventing the spread of contamination;and, third, m identifying the role to be played by those at the site than they are at the more conventional power reactors. of the injury vs. the role to be played by the local hospital staff. He formulation of advance plans will

                *Dr. Ho!!and is a graduate of the (fruverney of Tennessee's allow an orgamzed, orderly decontammation effort. It College of Medicme. He has been pracucing in occupanonal medictne at Oak Ridge Nanonal Laboratory's Health Dtvision           seems reasonable that the finer details must be left to unce 1961.                                                           ingenuity and improvisation. De AEC has a radiologi-WCl.Esa serefv. Ves la Ms J. Jos-res Iset

oPeRATIPeG EXPeRiefeCES 73 cal assistance program s hat t may be utilized if needed, Medical Director culminated in an agreement for but one should keep in mind that this assistance would ORAU to assist ORNL in the management of persons probably not be fully effective until some 6 to 12 hr injured in radiation accidents. following the accident. The AEC has arranged 3 a series The various levels of contammation that should of seminars on Medical Planning and Care in Radiation normally be permitted in the hospital may vary, but,if Accidents. The next seminar is scheduled for Oak Ridge, lifesaving surgery were necessary, the patient would Tenn., in the spring of 1969. Although diagnosis and probably be admitted to the hospital regardless of treatment of radiation injury are beyond the scope of contammation level. The final decision, though, would this article, a few references are suggested for rest with the Medical Director of the ORAU Hospital. I perusal.* -" do think, however, that some decisions should be made The community hospital should not be assumed to about guidelines for permissible contamination levels, have already planned on their own initiative for the since the numbers usually available 82 are not guide. decontamination of patients, although some research lines by which entry into a hospital should be decided hospitals have already thought about this problem and but, rather, are maxunum permissible contamination may even have decontamination capabilities in their levels to which skin and clothing must be decontami-emergency rooms or nearby.as.se Even so, it seems nated for normal usage off. site. One hesitates to pick a realistic to expect the nuclear energy industry to number, such as some arbitrary multiple of the usual assume the prime responsibility for planning the best IIgures, lest a victim slightly above be rejected. A more way to care for an injured, coraaminated person. valid approach would be to limit the accrued dose to Although at some locations the hospital may prefer to the medical staff based on eeneral radiation levels and have the patient placed in a large plastic bag and dosimeter readinas to some level approaching the transferred directly to thens with information and acceptable emergency dose of 25 rems. detads conceming the accident, at most sites it wdl be preferable to carry out the major decontamination General Requirements of Medical Units effort at the facdity rather than at the hospital. Dere may be certain instances in the future when hospitals would have to cany out ernergency decon. Currently Operational Medical Units tamination on their own. For example,when used fuel at AEC Facilities or medical isotopes are transported, vehicular accidents

                                                                   **I                                    "

Some of the AEC installations have already con-activity releases following such occurrences, but it is structed penonnel decontamination facilities. To pro-

                                                                          ** **       ****     * " "8'""~""               ** 7 vide for Hanford personnel, in addition to local first
                                                                  "***"                ##* ***I       * * " " " '

aid stations a high-level surgical decontamination unit is operational"-" adjacent to the Kadlec Hospital in ti n, a I cal hospital that has formulated plans s$ 9e city of Richland, Wash. His structure is probably f r efficient decontamination (perhaps using the the most elaborate personnel decontamination unit in aut psy room) would be able to handle victims existence today. First, a contaminated worker would

  • 8"" *" "" ***
  • planning, however, it would be far more appropnate to be placed in a spray-wash barner bay and surface contammation would be removed by scrubbing. Adja-arran88 ff rapid transportation by state highway cent to this, there is an area in which shielded patrol m genumnt Woptu to a agronal Wal a" exp"tise m the can of radation injuy.

wn t operatmg tables are avadable for highly contaminated A partiallist such hospitals is given in Table 1. patients requiring major surgery. There are less elabo. Many utdities either own aircraft or contract for rate facilities at other AEC installations " 2' where their use in patrolling transmission lines or in remote-skdled and experienced medical personnel are readily

 *****                                                           area construction. TVA has installed
  • attachments for Stokes litters (modified for wind and cold-protection)

The Oak Ridge installations have perhaps a unique to its helicopters. Since 1967, the helicopter has been situation in that the Oak Ridge Associated Universities credited with saving one life. The FAA General (ORAU) Hospital is located approximately 13 miles Aviation District Office in large cities maintains a from ORNL, and the hospital staff is skilledin the use of radioisotopes and radiation in medical treatment. .Heucopter speeds Transportation of injured workers. Planmng discussions between ORNL and the ORAU Elec.16'orld.170(14): 62 (Sept. 30.1968). NWa2AA 8AFETY. VA le Ms I.Jem = fen J 00* l

o . { . f 7e orenariseo expemesecsa Table 1 Regional Hospitals when it was needed most, in addition, there would always be the possibility that the radioactivity released I#****" . into the atmosphere could cause radiation levels high l Areonne Cancer Hospital Chicago. !!!. enough to interfere with decontamination, or direct Hospitalof the Metcal Upton, Lone radiation could render the unit inaccesible. Research Center, Idand N. Y. The entrance for contaminated workers should be Brookhaven Nadonal clearly identified.' Attending personnel should use an

                                                 y l                                                                                                                             ' alternate route of entry, preferably at the other end of j                                    Hospimi                                                                                      the budding.                                                                         1
Donner Peniton, Cowell Baskeley, Calif i Memonal Hospital Floor Plan and Equspment Layout Oak Ridge a =acimand Oak Ridge, Tenn.

Univesneles Hospital Although the medical unit may be a separate Kadloc Hospital Richland Wash, structure, existing floor spect may in some instances be Presbysanon-Univesnty Pitabassh, Pa. redesiped to serve as the medical unit, with the flow.

Hospital of traffic, ventilation, etc., strictly controlled in order C ,y " " " '*" "'" to prevent further spread of contamination.

Los Alamos Medical I os A amos, N. Max. De two basic philosophies in setting up emerpacy

Cener plans result in two different floor plans that would be
suitable for a small medical dispensary, perhaps at a
university or a lary industrial plant..In the type !
,                         listing of contract helicopter and aircraft ambulance                                                 philosophy, a professional health physicist and trained services.                                                                                        . (specialist) radiation monitors would provide complete                                 '
It seems obvious that each major nuclear facility, shift coverap and would be assumed to be immedi-l and even some of the sma'ller ones, should also have ately available at the site of the radiation accident.

suitable equipment and definitely formulated plans of Plans usually call for partial disrobing and decontami-action to be put into use at the time of a radiation nation at the site of an incident, hus the decontami-accident. De medical unit does not have to be alary nation unit has less elaborate provisions for showers i elaborate structure, and the requirements wdl doubt- and for traffic control than type !! '(Fig.1).8 in the l less vary at different sites. Careful thought must be l given to designing and maintaining a unit that will aweULa=CE j etTectively serve its intended purpose. **** l t Accessibility and Isolation g i Obviously the medical unit at a nuclear facdity or the decontammation unit at a hospital must be easdy fo'E / \ sN T , accessible. Several approach routes should be planned _ c f in case one or more is blocked at the time of a /

'                                                                                                                                                /                                       (

radiation accident. De unit need not be incorporated in the existing office space, but it should be cloes 7'  %. 1. ,,, / O ~ G@ e 1 enough to allow prompt arrival of medical personnel si==

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Although easy accessibdity is essential, relative isola. -

mE ==== g - tion also appears desirable. It is less likely that the *ED'CA'l raciutits watta-

                                                                                                                                                                                           ""E",'["

i medical unit itself would be directly involved in an

accident if it were located away from the center of the i j facdity, such as at the facdity pts. At some of the  !

! utility power reactors, a public-relations information i center, which ideally fits these qualifications, may be

                                                                                                                              %1 Roor plan of decontanunacon cener at 1.lvermore i

constructed (or modified) in such a manner that it . Rossasch and Development Laboratory, IJvermore, CaliL $ could serve as the decontamination unit. Suffice it to tunessauve of rype I meecal facmty in widch a profesM say that, if the decontamination facdity were in a heele phynetst and redisson speciailes would be svedable.

central congested area, it might well be inaccessible & tom Ref.1.)

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e o OPERATING EXPERIENCES '7e type 11 philosophy, operations personnel are trained in place. The second should be a relatively clean area the rudiments of self-protection. Health-physics- where follow-up care could be administered after oriented personnel would not be immediately available. decontamination. The third should probably be a small Plans usually call for immediate removal to a con- waiting room where less seriously injured personnel venient location, where the initial decontamination could wait for further disposition after they had measures can be taken (Fig. 2). Although the received adequate medical attention. following discussion is based on type I coverage with Ths major decontamination area should be large M.D.'s on duty during the daytime, the principles are enough for the attending personnel.to move about generally applicable to type !! plans. freely and quickly in order to work effectively. It The space allowed for the decontamination portion should contain a double shower large enough to of the unit should be variable, but equipment should accommodate a litter. Deep sinks to facilitate decon-not be squeezed into cramped quarters. The floor plan tamination of extremities would be desirable. A table should allow traffic to flow freely and be without on which even a litter-borne patient could be placed sharp corners and stairs that would present difficulty in for further scrubbing, such as a standard autopsy table, handling a stretcher-borne patient. would be suitable. Containers for the storap of The unit should be large enough to be divided into contaminated clothing and waste materialt should be three basic sections. The first, located adjacent to the readily available and clearly marked. Portr.ble shields contaminated-workers entrance, should be the area may be constructed of iron or lead, with a.: upper where the major decontamination effort would take section of lead glass, and mounted on wheels or rollers M AIN ENTRANCE TO CLINIC 1r d C

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i L I e ma a i Fig. 2 Floor plan of decontanunation suise, Brookhaven National Laboratory. [Ilustrative of medical dispensary for use of operanons personnel wtth knowledge of the rudirnents of self-protection; health-physicumented personnel would not be i immediately aradable. Wrom Ref.17.1 1 MLC2An SAvtTT. Ves it Ms I.lem-!*6 8 900

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7s OPERATING EXPeRieNCET to facilitate positionmg around the table;attematively. Special Building Services a supply of lead bricks or %-in.-thick lead sheet should be avadable so that ~a relatively light, multdayered, W er' drains from the entire medical unit should be connected to a properly vented 500. gal protective bamer (some 90G effective against the betas holding tank, which should be kept drained. Although and soft gammas usually encountered from freshly n most instances of low-level contamination it is l released fission products) could be constructed probably perfectly safe to drain the water directly into quickly. This would require modifying the table the existing sewer facilities, the holding tank would be slightly to provide suitable attachments for this shield- needed for the wash water after high-level contamina- ]I mg. Lifesaving tirst aid can be administered in the "kir tiow through the medical unit shculd be decontamination bay, and further definitive procedures unidirectional toward the decontarmnation bay and might be carried out in the clean area after decontami- should be controlled by exhaust fans equipped with nation. With patients emanating high-level radiation high-efficiency air filters located in the decontamina-from particles embedded in the tissue, major surgery

  • tion bay. This would prevent the further release of wou'd have to be performed from behind protective contaminated particles into the local atmosphere and barners. Local surgeons and anesthesiologists could be '

should prevent recirculation to other areas. - l on call, and surgery could be carried out in the I decontamination bay. If, on the other hand, the nearby Use During Normal Operations hospital had participated in previous planning and was , properly equipped, the patient might be transferred The possibility that a medical unit may never be there directly for the definitive surgical procedure. used for its primary intended purpose certainly must The waiting room should simply be a small area not mean that it should not be constructed. Rather,it where less senously injuredindividuals could wait after should be a versatile ' unit so that it neither stands idle they had received preliminary medical attention. This nor is so cluttered with stored items that it is rendered would remove them from the arena of activity and unusable in case of a radiation accident. render them less likely to be recontaminated. The Office of Civd Defense has followed this line Followmg use in a radiation accident, the medical of reasoning in planning public fallout shelters. Sup-unit would have to be decontaminated to acceptable plies and equipment have been placed in locations radiation levels. De floor and walls should be properly constantly being used (school- and office-building 1 painted. Plutic sheets and blotting paper laid down basements), where they wdl be cle:e to the people in 4 rapidly at the ume of the accident could make attended areas. decontammation a relatively easy task. The unit might otherwise have to be completely renovated if con- Provision for a Decontamination tammation could not be reduced to a safe level. Unit at ORNL When we began to think about construction of a Special Equipment and Supplies personnel decontamination umt at ORNL, we realized in his article on hospital preparedness, that the major. accident aspect ofits usage wouldlikely L2ndauer is has listed suggested supplies and instru- be quite limited, since past history and discussion of ments to be stored at the decontanunation unit. This future research trends with ORNL division directors list may be modified for specific needs, but generally it showed the more likely injunes to be relatively simple seems to be quite comprehensive and adequate for its wounds and bums. The majonty of the required recommended purpose. Plastic bags large enough to decontammations wdl be handled at the workmg area contam an entire human body should be avadable, and m a local unit by the health physicist. The decontami-survey meters, both alpha and beta-gamma, must be nation unit wul therefore be located in a satellite shop i maintamed in proper workmg order. Although health- area for routme use as a dispensary, it wd1 be staffed , physics personnel could be relied upon to keep by a nurse and wdl be in almost constant use on the 8 accurately calibrated functior]Wiestruments avadable a.m. to 4:30 p.m. shift. Our plan of action here at for survey needs at nuclear facdities, this might not be ORNL is to decontanunate a highly contanunated the case at hospitals, when theirruse would be quite patient as much.as is pracucal pnor to transportation l infrequent, and the facility mightisave to supply them to the ORAU Hospital for definitive medical proce-1 on demand. dures. l wcwa smn m on s. u -r,u,(,) _ , l l r'

                                         .d*    a                 w~
                                                                                                                                           , o OPERATING EXPeRiefeCES                                                 77 Description of Combination Dispensary                                     would be met there by the area radiation monitor and and Decontamination Unit                                                  initially decontaminated. He then would be taken to the plant medical department or to the ORAU Hospi.

The decontamination bay (Fig. 3) will be unclut. tal. tered and will not be used for storap. The area may be For large decontamination tasks in older plant used for a rest ward or for routine industrial patient areas without these provisions, a small bus was therapy (such as the application of hot packs to the , equipped in 1959 to serve as a mobile change house. It back) as long as the space can be quickly vacated. The was replaced in 1%3 with a larger semitrailer (Fig. 5). clean area will normally be used in the same manner as the average industrial dispensary, except that patients g gg g g gg will be sent to the central rnedical facility if their as Decontamination Units treatment cannot be easily interrupted in case of or Alternate Control Centers emergency. The nurse assigned to the facility will be responsible for periodically checking the supplies on Many utility power reactors have or plan public. hand to be sure they are readily available and in ' relations information centers that could be designed so - adequate quantity. that they might, when needed, serve as decontamina.

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Auxihary Decontamination Provisions tion units or altamate control centers. Such cen.ters, would normally have adequate floor space. The main Each major ORNL buddin5 or area in which work problem would be visitors who might be in the center involves radioactive matenalhas a health-physics office at the time of an accident. Visitors.however.could be where survey instruments, smear counters, decontami. controlled by tttending personnel, and the center nation kits, etc., are kept. This is the headquarters of could be made ready for decontamination etTorts in a the local radiation monitor, who is famdiar with the relatively short period of time. radiauon hazards in that area. In certain other recently completed structures, Cm MM PMe special rooms or entrances provide protective features. At the High Flux (sotope Reactor, entrance to the Typical floor plans of current PWR (Fig. 6) and retstor pool arca is through air. lock room :07 (Fig. 4), BWR (Fig. 7) plants indicate that access to and from which has built.in showers.8* In case of a radiation radioactive areas was laid out for normal traffic. The accident, the victim would be brought into the air lock tortuous path from the reactor building shown in Fig. O by the other crew members or by a rescue team; he 8, with a sharp turn, stairs, and a srnall hall with 2

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i Fig. 8 Budding anangement of Monticello Nucles Generstmg P! Ant. (From Ref. 27.) ill sm.sa saan. vu sa ns 1.m.r n ino i

s: onRATING EXMRieNCES sing!e shower, is eificient for a single radiation monitor separated from the reactors, and they may have their

hecking a group of people one by one so that none own ventilation and plumbing systems and separate bypass the control pomt and for sending them to clean access roads. They normally have a good overview of areas through the shower area. This route would be the plant area. Some utdities are considenng installing impractical for transporting stretcher-bome victims of remotely controlled closed-circuit IV monitors in the a serious accident. Should a widespread release of control room and reactor and auxdiary buildings by contamination occur in the plant, the normal " access means of which the public may view from the informa-control area" would probably be used for the area tion center the important equipment in operation.

where a worker's outer coveralls would be removed. He Since the basic budding and normal services are would then have to go elsewhere for a thorough already avadable as all that is needed is to add the morutonng in a low-background area and for any necessary equipment and provide specialized services, subsequent decontammation. as shown in Fig. 9. The relatively small additional cost would be well worth the investment. The equipment Flexibility of the Public Infoemation Centee '" E' "* ' * **I *' "* *' " doors operung off the auditonum. The ventilation air The public information centers currently in exi> inlet and exhaust should have high-efficiency air filters. tence meet most of the criteria for both a decontami. Perhaps the wall nearest the reactor should be a nation unit and an emergency control center. They are windowless wall constructed either of solid concrete ENTRANCE ENTRANCE

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MESENT 'LXR DLAN $UGGESTED VCCIPCATICN Fig. 9 Inforroation center iPeach Bottom) and suggested modtfIcation to provide a decontanunacon area. IFrorn Ref. 28.) vmten sartry va is se u .r s one l l l l

                                                                                                               ~~

o openArimo exPenteNCEs ge block or, if preexisting, with the usual hollow concrete 8. J. S. Karas and J. B. Stanbury, Fatal Radiadon Syndrome block filled with concrete for shielding; an enclosed from an Accidental Nuclear Excurmon, New Engi. I veranda would allow normal sightseeing. Drains should N,272: 755461 (1%5) , be piped to the reactor waste tanks. A special entryway

  • C il Pu ad !!3 963.

for contanunated persons would contain the showers.

10. G. E. Doma and N. Wald, The Diagnosis and Manapment Stored plant records, survey and emergency equip- of Accidenial Radiation injury,4 0ccup.Med. 1: 421447 ment, auxiliary communication equipment, plus the (1959).

closed. circuit TV would allow easy conversion of the 11. E. R. King, The C1irucal Enluadon and Manapment of information center to an emergency control center. Radiation Accident Exposum Padents, Radiology 77: The local civil. defense unit would probably welcome 77 82(1 % I). the opportunity to cooperate in this project. 12. R. A. Sulit, E. J. Leahy, and A. L Baietti, #rracapter of Rodianon and Contemination Conaal, Superinendent of Documents, U. S. Gomament Punting OfSce, Washington. Summary and Conclusions 1960. 13.Rodological #esich #endbook, Supenatendent of Docu. Every nuclear energy inhallation should have some ments, U.S. Government Printing OfBee, Washington, ' Pl ans for decontamination and, preferably, an available decontamination unit. This need not be an elaborate 14. A. Brodsky and G. V. Beard (Compe, and Eds.), A Compendium of Informadan for Use in ControGing Radie, structure, b;;t it should be adequate to serve its tion Emerpncies, USAEC Report TID 8206(Rev.), pnmary intended purpose. Indeed,it may be a versatile September 1960; structure serving a twofold purpose Its stock of 15. R. S. Landauer, Sr., Hospital Propandness for Handling needed supplies should be continuously maintained. Contamanaasd Persons Requinng Medical ' Care, in Rada. Arrangements and definite plans should be made with non A ccidents and Emagencier in Medem. Rmarch. and nearby hospitals in the event seriously injured patients Indasay, pp. 122 136, r'haria= C nomas, Publisher, Spang0 eld, Ill,1965. need definitive care. Local surgeons and anesthesiol*

16. E. L Saenpr M.D., Hospital Planens To Combat psts should be educated in this matter so that their Radioactive Contamination, I Amer. Med. Ass.,185:

effectzvc response can be relied upon in time of need. 578 581 (Aug.17,1963). By cooperstmg and planning with the local medical 17 W. D. Norwood, M.D., Planning for Case of injured groups. I believe that we in occupational medicine at Radiating Psdents, USAEC Report HW.SA.2859. Hanford nuclear installations can render injured contaminated Atomic Products Operadon, Dec. 29,1962. patients the best possible medical attention. 18. C. M. Unruh. H. V. Larson, and P. A. Fuqua, De Hanford Radiosurpry Facility, June 1968, available from Hanford Ermronmental Health Foundadon, P. O. Box 100. Rich-land, Wash. 99352. References 19. W. D. Norwood and E. J. Quigley, Experimental Radio. surpry for Care of Irgused Radiating Panents, Excerpre

1. E. L Saenpr, M. D. (Ed.), Medical Aspects of Radiadon Medics (to be published in 1969).

Accidents. Supenntendent of Documents, U.S. Govern.

20. R. A. Love, M.D., Planmng for Radiadon Accidents, ment Pnnung Office, Washington,1963.

Norpersis, 38: 50 56 (Feb.16,1964).

2. F. R. Zintz, AEC Racaological Assistance Program Nuct.

Safety. 4(1): 81-86 (1962).

  • 21. T. A. Lincoln M.D., Oak Ridy Nadonal Latoratory, personal communicadons, from M. R. Powou, M.D.,
3. Seminars on Medical Planmns and Care in Radiadon Lawrence Radiadon laboratosy, Feb. 16, 1966; S.V.

Accidents.Nuct. S4/erv. 9(6): 521 (Nov. Dec.1%8).

4. Safe #meding of Bodier ConannerRadometryeIsotopes. Guzak, M.D., Dow Chemical Company (Rocky Flats.

NCRP Report 21 (NBS Handbook 65), Supennwndent of Colo.), July 1,1966: T. L Shipman, M.D., Los Alamos ents, U. S. Govemment Pnnans OfBee, Washington, Scwntine Laborstory, June 27,1966, and July 25,1966.

22. E. L Saenpr. M.D. (Ed.), Medical Aspects of Radiadon
5. Exposure to Radiatto, ur an Emerywy, NCRP Report 29 Accidents, Tabies 18.653 and 18.654, pp. 276 277. Super.

Superintendent of Documents. U.S. Government Prining " " " "* *""*"* """"'"* - "" ##'I 01 flee, Washington,1%3. OfSco %m 6.Preca4nons in the Management of ponents Who # ave 23.W. S. Klutz, Procedure Manual for Manapment of Radia-Recerved Therapeutre Amountr of Radionuclides. NCRP tion Accidents. 1965, avanlable from Ropt Williams Report 36, An Updanns and Extenmon of NCRP Report General Hospital, 825 Chalkstone Ave., Providence, R.1. 21 (to be published). 02908.

7. H. G. Donald (Ed.), Nuclear Medicine, Bibliography from 24. F. T. Binford and E. N. Cramer (Eds.), De High Flux Nuclear Science Absaects. Vol. 2J. USAEC Report TID-Isotope Reactor, A Functional Descnpdon, USAEC Report 3319. June 1%8. ORNL.3572(Rev. 2), Vol IB, June 1%8.

Eer.eu sacrr v.oa .v. un-m 4m i I

se OPERAftNG EXPERIENCES

25. Duke rower Company, Pretimanary Safety Analyns Re- 27. Northem States Power Company, Facuity Description and port. Oconee Nuclear Station l' ruts ! and 2. Vols. I and II, Sdety Analynn Report. Monticello Nuclear Generating Dockets 54:69 and 54270, December 1967. Plant, Vols. IA and IB,ilA and IIB, Docket $4263, August
26. .New York state Electric and Gas Corporation. Preliminary 1966.

Sdety Analyns Report. Bell Station, Vols.1. II, and III. 23. Peach Bottom Atorme Power Station. Phaadelphia Electric Docket $4319. March 1968. Company, Phdadelphia, Pa. tnformation brochure.

            " Nuclear Safety" is prepared bimonthly in cooperation with the Nuclear Safety Information Center at Oak Ridge National Laboratory for the U. S. Atomic Energy Commission Division of Technical Information. For subscriptions, address Superintendent of Documents, U. S. Government Printing Office, Washington, D. C. 2042, $3.50 per year.

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uary 27, 1978

                                                                                                                     ,c-Secretary of the -ommission U.S. Nuclear Regulatory Co.": mission
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20555 - w Attention: Docketing and Service Section '# Nl ? Re: Comments on Draft Regulatory Guide 8.18 (December" 1977)

Dear Sir:

It is important to review this Guide in the context of its use by NRC inspectors in =aking judgments on the adecuacy of I radiation control and protection in medical institutions. From  ! this standpoint, the document suffers by implicitly describing i a "Radiatien Safety Office" with little indication of flexibility k in organi::ation and duties, describing procedures and standards - with little indication of their relative im ortance. Some of the I standards so described seem unduly conserval:ive. A classic examole .f of this conservatism is in Section C.4.1.4 (B) which reco:=. ends ~ 'i^ . the use of finger badges. This section noted that "these badges are not needed for personnel handling... sources...where dose  : rates are less than 0.1 mrem /hr at 1 cm." This would innly that , finger badges should be worn when the exposure rate is about ten

                                                                                                                   ~

times background. A source which delivers 0.1 mrem /hr will de-liver 4 mrem /wk if the source is handled for 40 hrs /wk. This is far less than 1% of the maxi =um permissible finger dose. Even if the limit were raised to 1 mrem /hr the finger dose would only be i 2.5% of MPD. Since it is hard to conceive of sources being han- ' died for more than a few hours per week, the use of finger badges I could certainly be relaxed to apply to sources over 1 mrem /hr at i 1 cm, and indeed a level of 5 mrem /hr at 1 cm could be readily ' justified. It must be remembered that the finger badge has n'o effect on maintaining the dose AI. ARA. Moreover in the dose range 0.1 - 1 mrem /hr, the doses on the finger badges would be so low as to be unreadable. - ~ i 1 The follcwing are specific comments on the document: 2.3.G. It is unusual for Radiation Safety Officers to process ) 1

 .                   orders for licensed radioactive materials, and it is also unusual, for them to distribute such materials. The duties as outlined                                                         Y,1 for the Safety Office are already large enough that they do not                                                          -

need supplementing by taking over some of the duties of the Pur- i chasing Department and the Receiving Room. It is suggested that i

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Memo to: NRC Secretary Jan'uary 27, 1978 item G be reworded as follows: " Receive incoming radioactive ' 7,1

                                                                                                           ~~

materials during working hours." - 3.2 Para 1, line 9 The cited NCRP reports also contain meth- a"'1 ods for snielcing against leakage radiation. Therefore read:

                            " Direct, scattered and leakage radiation."

3.2.C. The last sentence seems to offer a peculiar piece of advice. It suggests that persons in unrestricted areas should / be exposed preferably to persons in restricted areas! It is , .i f suggested that the last two lines be rewritten as follows: '

                            "Or planning beam. orientations preferentially towards unoccu-pied or low occupancy areas."                                               -

3.4.C. All laundry from radioactive facilities is potentially7 contaminated. Therefore this sentence suggests that all laun- l dry from radioactive areas should be turned over to the RSO i for disposition. I believe this is going too far. Moreover, . the personnel should be trained to check their own contamina- q'3' tion as indicated earlier in this Guide. Therefore the last sentence should either be deleted or the word "potentially"

                        --should be deleted2 and a specific contamination level quoted r

(e . g . , 10- 5pCi/cm ) before involving the RSO. .

                          -4.1.1.a.       The third sentence of this section contains, I believe, an error. Section 35.14 relates to Groun VI sealed                         ]'
   ~,                     sources, and therefore the quarterly inventory do'es not apply to unsealed sources.        The conduct of an inventory of unsealed sources is onerous and time-consuming,and it is not evident                              , ','. o, that it is needed if a continuous record of all receipts and use is kept by each user, as later specified. Therefore the following changes should be made to this subsection (a) : "A periodic inventory should be made...         . Section 35.14... requires inventories of sealed sources to be conducted at least quarterly."

Section 4.1.5. It is not realistic for many users of low level' radioactivity to maintain a log book of daily survey readings. I Obviously the results of weekly or monthly surveys shall be recorded. In the case of the low level user, the maintenance b' D-of a daily log book would constitute an unnecessary nuisance.  ; This is something the inspectors should not be looking for. - a section 4.2.1.c. This particular section is in conflict with' the new teletherapy rules which are a'proaching p publication. For example, the new teletherapy rule, in deference to the '

                                                                                                              ,y fact that some users of teletherapy equipment do not have im-                      -l, )

mediate access to dose-measuring equipment, do not specify a spot calibration check. However, checks on beam alignment, l

3 -- . i . Memo to: ' 3

                                                                                                                              ~

h NRC Secretary January 27, 1978 beam symmetry, on the timer and on the distance indicator are  ; specified to be made weekly, t,7

                                                                                                                    \ s, s It is of importance that the new teletherapy rule and                              '

this subsection c be brought into conformity with each other. , Section 4.2.1.e. The size of the typical console is small '1 and the operator has very little choice in position while I watching the console and the patient. Moreover one would not 'a y - expect any significant variation of exposure rate in the area '/ close to the console. Therefore it is suggested that the first sentence be deleted. ' In the second sentence the word " background" is mislead-ing and should be deleted. _ 4.2.2. There are it would appear thata the couple of examples Radiation SafetyinOffice this secti'on where "] is staffed  ; with large nu=hers of persons who have very little to do and whose function is often to hold the hands of the radiotherapist.. It should be recognized that the radiotherapy staff physicians and. residents have received or are receiving training in radi - T.l# ati.on protection, much of it very specific with regard to the handling of patienes and sources. The time of the Radiation

                                                                                                                     ~

Safety staff should be respected and their presence should not be required during routine movement of radioactive sources. Examples are items (d) and (k). - 4.2.2.d. Suggest deletion of all words after " tagged. " There d is noaccompany ally reason why thethe physicist cart or safety when moved personnel to the patient's should room. actu fd.l[ { 4.2.2.k. Again there is no reason why the Radiation Safety office or physicist should "directly supervise" the transport 'f of a patient containing radioactive materials. Radiotherapy l technologists, residents and radiotherapy staff should be l y'j ~a' quite capable of seeing that the patient is safely moved. ( Suggest deleting the first sentence. 1 4.2.2.m. This section is incomplete. The last two lines ~ should be rewritten as follows: "To check for incomplete removal 4; of the sources, inadvertent loss of the sources in the patient's!I9 - room or contamination of the patient from leaky sources." - 4.2.3. The first paragraph of this section makes an interest- ~ Ing comparison with common practice in the diagnostic field. Often 20-30 mci of technetium-99m is administered in patients' {.pf rooms. The radiation levels will be rather similar to those I r l -

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   .        Memo to:                                                     3 NRC Secretary                                  January 27, 1978

. near " mci quantities" of radioactive drugs used in therapy. l It is not the practice of Radiation Safety staff to accompany I all physicians and nuclear Medicine technologists to the . patients' rooms for a technetium-99m injection. Therefore  ! ,f 9 y it is suggested that the presence of the Radiation Safety staff is routinely necessary for the administration of large therapeutic quantities (e.g., exceeding 25 mci of I232). The physician himself should be capable of administering small therapeutic quantities and of monitoring the scene of the -- admini-stration. . - Signed: E.W. Webster, Ph.D., Member, Advisory Committee on Medical Uses of Isotopes cc: Dr. L. Wade, FCMS Isotopes Branch Medical Advisory Co=mittee lNotel The above comments will also ( apply to the corresponding 1

         .           parts of the RURIG-02.67 draft        f                 ..            ..

dated for publication Dec.1977. L (

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METMCOS NC.v 14 USC. IHC ADDITION OF MCRC SH I ELO IN C TO THC WALLS CF THERARY ROCMS THAN OURPCNTLY REQUIRCO C CRT A I Nt.Y 'R I L t. INCACA7C COSTS ANQ C A N *t 0T SC JUSTIFICO SY CNVIRONMCNTAL OQNSIOCRATIONS. S***CHCNRICN RCLATIVE TC RACIATICN CFFCCTS IS AL9CA3Y AT AN A t. l. TIMC HIGM. NUNC?OUS RATICNTC REFUSC 3lAGNCSTIC AHO THCRARCUTIC RAOlCLO3fCtL DRCOCCURC3 BCCAVCC OF A*RACHCNSION RELATIVC TO ALL RAOlATION. A MAJCR INC3CASC l ts SuavCvlNa ANc uCNITomlNG *e 0CCOURC S #1Lt. FustwCR ALARM RATICNTS AHO T HC R C 8' O R C RC SUt. T IN LCSS AOCOUATC UTILICATION OF RAOBOL MIC.=L FACILITICT FOR Tktl9 MCALTM CARC. SINCCAELY, .

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w w am scua.Cic i994 m 3oc e GREATER NEW YORK CHAPTER VOL. 5 NO. 1 METROPOU TAN FEBRUARY 1978 SPECToA The last several issues of the national society's

        ?MILI? M. LORIO                                newsletter contained essentially no items frem EDITOR-IN-CHIEF the Greater New York Chapter, but they did con-MARTI WHEAT                                    tain much information from other active chapters.

ASSISTANT EDITOR  ? lease send items or complaints to the Secretary, Kathy Burke, 310 East 57th Street. New York, N.Y. 10021, or to Phil Lcric. Identify that your items are for the national newsletter. 'de have a simi-CHAPTER OFFICERS ' lar lack of input :c " Spectra".

        ?RES - J. MCLAUGHLIN PRES ELECT - R. CASEY SECRETARY - K. SURKE TREASURER - A. TRAPPIER                                             .

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r.a G tacCUTI,/E COUNCIL A six chacrer icint meeting will be held at 3=cuf f gy , s '/a'lley forge Metel , Route 353 North. PHILI? M. LCRIO, CHAI? PAN King of Prussia, ?a., en May 12, 1978. The Dela-

are '/ alley Chapter will hes: the meeting. The JE.'vJ ST. GERMAIN other Chapters included in this join meeting are
       ?CEERT ?HILLI?S                                the Baltimore-Washing:cn, Ccnnecticut, Greater JAMES MCU.UGHLIN ROBERT CASEY New York, New Jersey, and Western Pennsylvania.

A $20.00 registration fee, paid in advance,

       /ATHY SURKE                                    by ' fay 1, will include lunch and cocktail hour ARTHUR TRA??!ER                                after the meeting.
                    .     .       .                         The title of the meetin8 will be " Health Physics - Curren State of the Art" and the speakers will include Jack Selby (3NW), Dr. H.

UlAP_ltS .i,.,d3 t  :-: . Rcssi (Columbia Univ.), Dr. John Auxier (CRNL), John C. '/ illf or th (5?H), and Dr. Nield Wald (Univ. of Pittsburgh). CONGRATULATIONS TO THE The deadline fer reservations is May 1, 1978. FOLLOWING NEW MEMBERS: STE'/EN EAGLES JAMES R. KNOWLES WV!.' $Cf CC M M C W .: W

     ?ATRICIA CHAM 3ERS                                   r OLGERTS TAMUZS JCHN SCHMITT N@F bd5                   .

JOHN KELLY I AFF B00R500R GIAf. RAGAZIONI 1

o Proposed Amendment of 10 CFR Parts 19 S 20 R.S.C. Qu1Cifications In a tecent fettet to tre Campas Radia, tion Safe,ty Of- Another example of the fice,ts, Walt Regst (Sountcin CaLifornLa Cltapic,1) disctibuicd 3RC's Offire of Standar,d2 Ques.tionaite on Qualifications fo.1 a T> toad License CRS0". Develooment. verbiage wnicn makes their litera-it appeats tltd t!ie VRC's c^'Mi~h hch is lteCL- bestt ture tantamount to garbage on Robaticing as teltlt taert Regai1w.ty Gtu.aes and NUREG'4. or garbiage is the summary of their proposed amend-Walt, we ic 44y appteclaic you,t ef fort to work teitit Utc mants to 10 CFR Parts 19

    .;RC's Standatds Gianc!t before tltey go of f oato CEcud 9 Like and 20 which would require niej did fo.1 Regu:Mo.ty Guide 3.13 and % REG-0:67 nitit utelt                        licensees to:

so-called pltilosoph.ies of ALARA at Medical institu.tionts. (1) obtain more informa-TI:ese U.^opian acenarios a,te not only wt.tecLLstic but tion from highly piobably not .teasonable ot feasible. exposed individuals... Fa.: exampic: Reg. Gu.ide 3.13 .staica diat ute R.S.O. (2) furnish prompt esti- - sitould have adequate 4 pace; sitaald have tite audiority 2.0 tem- mates of doses,... para ~1Ly suspend aetwaies witen needed h1 emergencies to avoid 4 mediate danget .to Life or healtlt as long as it is (3) and keep appropriate con.s4 stent xLt!t non-intetjerence of Life saving mediccf pto- records. cedu,tes tl tat tatztant an overtiding p.tio.~Jty and Stat cannot av.ci. die allevia. tion of iltc .tadiation 4afety p.tobiem. For It's no wonder why the sitielding pai;xscs, occupancy and use factors sltouid be 22- general public is so mis-Een btto accomte a4 .tecommended in NCRP ltandbooES, 6ui sucit i.iformed about radiation. faciots siteuid be chosen widt Ete ptincipai of ALARA in mind. It appears that the NRC's Office of Standards Deve-Tite 4e ate a fcx of die many m: explainable sta.tements made lopment is the munitions bt utis Reg. Guide and NCREG report. Shtce Jean St. Ge,1m1bt - factory Ecr those anti-xiLE be expounding furtltet on t.itLs at die one day apposium; Y nukes who stand out there ptior to die Annu 4 Sasiness meeting on May 17 at 3rookitaven,, in limbo and take pop shots i :clit leave you dangling so uiat Jean can furtltet info.tm , at us. you of Ote 54Cu144cn. l ? lease Mr. Walter S. Cocl, in your summary you use an expression, " highly ex-a 7 a 7 a 7

g. I- pesed individuals", which does not appear in the proposed amendment and also, please' define " prompt and appropriate".

The comment period expires A FULL SPECTRUM OF Aoril 7, 1978.

                                                                                           ~

HEALTH PHYSICS SERVICES TO SUPPORT RADIATION SAFETY PROGRAMS * *

  • m ao.oactive waste o.sposai TLo saoge serv.ce The Annual Business Meeting will aao,o.og cas safeiy surveys s instrumentasia" 9.cassay Licensing Services be at Brookhaven on May 17. Carl Heastn Phys.cs consuitai.on Unruh will speak on the " Environ-Nu,i,ceasea er rne u.erea, negs,,ory comm,sw ano avouc mental Imapct of High Level Ra-e..ra ser ,ces dioactive Waste Disposal This PTELEDYNE ISOTOPES will be Preceeded by a continu-ing Education Program on the So Van Buren Ave.. Westaood. N J. 07675 pnene- acu 664 7070 e reie.: 04 4r4 ..ggg gg gggg,. g, 9:30AM - 4:00PM. The Business Meeting is at the usual' time of
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j GENERAL DYNAMICS Fort Worth Division P.O. Box 748. Fort wort *s, Texas 76101 e 317-732 4811 2 February 1978

                                                                                                     /iL,

, o t I d'

  .                   Dr. Allen Brodsky U.S. Regulatory Commission
                       'Jashington, D.C. 20555

Dear A1:

Ihank you for asking me to connent on the drafts of Regulatory Guide 3.18 and the report NUREG-0267. (Keeping Cccupational Radiation Exposures at Medical Institutions as low as reasonably achievable). I have reviewed both documents carefully and have several suggestiens which, in my view, would be improvements.

1. I am firmly convinced that an audible indicator, both in the treat =ent ]

rocas and at the control consoles, (for teletherapy, x-rays, fluoroscopes,) i etc.) activated by a radiation detector, i.e., a cositive indicator, )/f[ vould go a long way towards preventing serious accidents. Caution i lights and electric circuits are fine, but it has been our experience i s they just won't do the job. __.

2. There is a total void in the document towards'lfmiting exposures to 1 eatients. If we are going to remind the technician to have dosi=ecers, 'I ' ' '

we should also remind the physician to limit exposure to the patients. - This should include other parts of the bcdy as well as to the creat=ent ' site.

                                                                                                                  ~
3. I did not see any section on shielding of radio sensitive fi1=. I have-; _' ':

noticed this is sc=ec1=es overlooked in facility designs. 4 I would like to suggest that we start looking at other vays of disposing 7 of radioactive material -ather than using sewage systems. I think the ,, whole matter of disposing of radicactive material via the sewer needs to be re-ernehed. ~

5. Reference #17 (ACGIE Industrial Ventilation Manual) shculd be referred

whenever ventilation in general is mentioned and especially where / exhaust ventilation or hoods are mentioned. Some examples are: Section -3 3.3.3.5, 3.3.4.8, 3.4.3.3. There are several other sections that I did not jot down numbers. n=

                                                                                                               ./

Dr. Allen Brodsky . ?ege ' Pao l l l I find it objectionable when regulatory agencies attemot to to into too much detail, and try to specify specific equipment or actions rather than let the user make the decision on what is best in their specific case. I chfnk it is much better for you to say what you went to be achieved, rather than try to tell them how you think it should be done. Such detailed regulations cause people to get into ruts and prevents them from making improvements. Three exangles follow: _ Some

6. In a number of places, you specify lead bricks should be used. [ ,

examples are: 3.3.3.6 and 3.4.2.3. I think it would be much better f jw fa, for you to require adequate shielding in your regulation and let the  ! user decide whether he wants to use lead bricks, concrete blocks, J water tanks, etc.

7. In a number of places, you specifically require body badges. F.xamples are: 7 3.3.3.10, 3.4.1.4, and 3.4.3.6. I think it would be much better to specify [. 2' 9' a dosi:oetry device and let the user decide whether he wants to use badges, ;

TLD's or pocket chambers. S. In several places you use the words " transport by cart". An exanele is:W.I,l 3.4.2.2. A facility may went to use something else, such as pneumatic - tubes or gravity; chutes. In 96, 7, and 8, I suggest that you state the objective and let the user work out his best methods. In cenclusion, both reports appear to be fhirly complete. I think you have ' done a fine job. I hope my suggestions might prove helpful in future drafts. ; Best personal regards,

                                         -       3
                                          " w
7. L. Paschal, Jr., Mministrator 31oenvironmental Health FLP: bis i

l

                                                                                                      )

i

(ps,n) RAOlATION IMAGING PRODUCTS DIVISION National Electrical Manufactwers Association February 2, 1978 2101 .' Suset. N.W. wasnington. D.C. 20C37 . ( 30)4573400 4 1, I f ( Mr. Robert B. Minogue, Director Office of Standards Development U. S. Nuclear Regulatory Commission

Washington, D. C. 20555 t

4

Subject:

Drafts of Reculatorv Guide 9.18

 }                                                           and NUREG-0267 i

4

Dear Mr. Minogue:

The National Electrical Manufacturers Association's

(NEMA)
  • Radiation Therapy Equipment Section has just i recently received a copy of the subject drafts and plans to discuss them during their March 28, 1978, meeting. We would like an opportunity to submit ecmments which are expected to be created as a result of that meeting.

However, we are concerned that comments submitted at this late date may be deemed too* late for consideration by the Cc= mission. 1 We would appreciate your censideratien of extending the comment period to allow industry to provide these comments. 3 Sincerely,

                              ,,4                                               -

,i dil s /4 l' ,44 %

 !                                                                       Charles R. Press 1

Executive Secretary i { CRP:ev

  • I NEMA is One principal national trade associaticn of the l l electrical manufacturing industry. The Association has scme  !

550 member manufacturing companies, which are affiliated ' ! with one or more of its 70 product Sections, each Section representing in essence a separate and distinct industry. The electrical products within NEMA's scope are used either as components or as end-equipment in all major phases of the generation, transmission, distribution, centrol and I utilization of electrical energy. I 1 l .i i i

O e HOWARD UNIVERSITY DEPARTMENT OF RADIOTHERAPY COLLEGE OF MEDICINE AND 2041 GEORGIA AVENUE, N.W. HOWARD UNIVERSITY HOSPITAL WASENGTON, D.C. 20060 TELEPHONE: (202) 745-1421 February 2,1978 The Secretary of the Commission U.S. Nuclear Regulatory Commission Attn: Docketing and Service Branch Washington, D. C. 20555 Re: Draft of Report "NUREG-0267", titled,

                                                " Principles and Practices for Keeping C.ccupational Radiation Exposures at Medical Institutions as Low As Reasonably Achievable"

Dear Sir:

I went through some chapters of this report and I find it very useful as a reference 1 document for physicians, physicists and technologists. I am sure anybody, who .... goes through this report would be happy to have it. - However, I would like to comment on the following: A) In appendix D, page D-1, under definitions, 7 Roentge n: le.s.u/c.c could be written as le. s.u/c. c. of air and somewhere

                     'at standard temperature and pressure' could be inserted. Also while referring to LD50 of 400 R, it should be made clear that this applies only for one-shot irradiation.
                                                                                                            ..L Rad:        Saying that the ' rad' is about the rate of energy absorbed from 1 Roentgen of x or gamma rays near surface of the body is not true; depending on what energy we are referring. 'Near surface' means at what depth in the skin.

Rem: I think at the end one could add the energy of x-rays as 250 KVP.

3) I think maximum permissible radiation levels in terms of rems and not exposure ,;

rates in terms of roentgens, are to be stated here. -~ C) Unde r Section 3. 4. 2. , Radiation The raov , the de scription of the te rm ' Tele - therapy is not a general one but very restricted one. Teletherapy does not mean !

                                                                                                        'l only high-energy beam therapy and also does not mean only with sources of high                     -

gamma-ray e mis sion rate. Therapy from a distance using any kind of radiation irrespective of energy is teletherapy. s

                                                                +
                                                                                      .../2 s
                                                  . o I hope I made some helpful suggt reions.

Thanking you, Sincerely yours, ppC J. Rao Nibhanupudy Chief Physicist JRN /Ir I

I LAW R E N C E MEMORIAL H O S P ITA L O F M E D F' O R D 1 170 OOvCRNORS AVENUC - MCOFORD. MASSACHUSETTS O2tSS TELCre. opec see.easo CHARLES F JOHNSON s.acw er.s v.ca messeos=v

                                                                                                        'p' Februarf 3, 1978           4 cocc F.'LT                   -
                                                 .                                                       ecc,.            i 3.

f'- usnaq p3020gD 2ULE ' . Secretaw. of the 'esien United States Nuclear Regulatcry Cann.ssicn 3" EEB em. e n. s 22197.8E anssaw a mens Washington, D.C. 20555 y j ATIECICN: Decketing and Service Branch D $&I We would like to canent en several statarents in a recent guide Wich you publie.ed regarding the general policy of keeping radiatica exposures AIAPA. We were spaci#ically interested in the suggestica regarding the receipt of radicactive maeaH =1=. It was suggested that the persen delivering  ; the ma*a*ial be provided with a cart, and that a wipe test be perferned in the receiving area. We felt that this particular precess is not appli ,l j '" cable to a = 11 hospital. In cur institutien, any radinactive ma*arial= are delivered directly to the Nnclaar Medicir.e Ect Lab. This circcrxents de need for wipe testing in the receiving area ce for the provisica of a cart to daliver the radinactive maeadal= to the Het Iab. We wculd suggest that this al'= mate p e % for receipt of radicactive maead al= be available. We would also suggest a regulatica to pre e the cpening of a package cf radioactive =atad a' until such tire as a trained technologist is preser.t to perfc=n the wipe test. -

                                                                                                                 ~

We also feel that the insallaticn of a pa" anent Geiger Mueller Coun'ar cutside of the Tah, rat ~ / preparation area is not necessary, and in scne

i. stances, may be unwise. A percable reniter is available for use at any tire, and if it is present in the preparaticn area, can be used by the tech j .- ~, >

nelcgist easily. We feel that this is the area in which it rest likely will; be used, and questien whether there wculd be satisfactorf ccc:pliance if the acnitor were not as raadily avaii=hle. We are concerned accut radiaticn expcsures and are interested in keeping then AIAFA. We hcpe that cur suggestions will meet with ycur due censideraticn. M b e k 111 sSh!)' AY)k GWer.colyn 3. Niccols M.D. l Tb6/ iuw1 r . i'--anfaiaticn Safety Car:rittee

                                                                                                    ^

AIll erd 46W Franc:.s X. Masse, C.H.P. James /J. Fallen, M.3.A. l Padiaticn Safety Officer /Asscciate Administrator, Iawrence , l W e-4a1 Ecspital of Medford ._ l J M;;w;;:n w u rcant. & h & b &

l 1 1 InternationalBrotherhccd enaries H. Pillard P.11ph A. Leigen rnational Intematsonal or Electrict forkers ecent

                                                                                                                     -i s :.-

secretary .N i i JID L 8 - February 7, 1978 w 4 ' (? *A Secretary of the Commission

                                                                         '1; gY dyb
                                                                                               $'d to                           g U. S. Nuclear Regulatory Commission                                      ,

Attention: Docketing and Service Secticn  % s o-Washingten, DC 20555 Cear Sir: - Regulatory Guide 8.18 NUREG - 0267 It is unclear in reading 8.18 what category our member of the building trades (construction electrician) working for a contractor at a medical facility falls in. The third paragraph of Section A' mentions certain persons other than ermloyees (patients, visitors) who are exposed. Of particular concern is the electrician working at a medical facility today, who may be working at a power reactor tomorrow. A " worse"

   ,      case would involve an electrician " burned out" at a power reactor yesterday who goes to work at a medical facility today and receives additional occupational radiation exposure. If the difference on " burn out" between the administrative limit and the legal limit is small, an additional small amount of exposure could result in a technical overexposure.

It is by no means, unusual fot construction electricians to have several different assignments at several types of facilities in a short time frame. Our member working at a medical facility who receives radiation " exposure is receiving occupational radiation exposure.

                                                                                                           .y,yy .

I 10 CFR 20.202 only requires the licensee to provide personnel monitoring equipment if the calendar quarter dose is expected to exceed 25 percent of the dose expressed in 20.101. . Cf.O. The concept of ALARA should not permit occupational exposure to go unrecorded especially as it applies in the case of the building trades where our member moves from facility to facility. However, the questien _.. is, "Is the occupational dose described above being recorced?" "If not, f_ . why not?" '?jff[2 1m m.asb.4m:..a ( ..m r95-

                                                                                                 ~ **~ - MiidE- -

International Brotherhcod of Electrical $Norkt U. S. Nuclear Regulatory Commission February 7,1978 Page 2 Appendix 0 of NUREG - 0267 is of concern as it is misleading. Maximum permissible exposure rates are not those given in appendix D but those contained in 10CFR 20.101'. There is no weekly limit. A licensee may have an administrative guide suggesting a weekly limit. Many of our members receive in excess of the weekly limit shown in Appendix D. The pregnancy limit in Appendix 0 is misleading. Our female members at power reactors must make a personal decision to limit their exposure to 500 mr for the pregnancy. Their choices essentially are: O.('g

1. stay where they are and receive more than 500 mr, N{ t
2. request transfer to a non-radiation area if i auch is available, or j
3. quit.

10CFR 20 occupational exposures are the same for male or female. Sincerely, WW Paul R. Shoop International Representative N Utility Operations Department PRS:seb 9 l

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Minnesota Pd ution Control Agency February 9, 1978

                                                                                             -1 g

Secretary of the Commission O.S. Nuclear Regulatory Cccmission g.?$ ['hy Washington, D.C. 20555

                                                                                  ~
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hp?$ 4

                                                                                                                 ~

L Attention: Docketing and Service Section h; go\ f# g COMMENTS TO h  :.$. .M d 'j ,ca ,.e REGULATORY GUIDE 8.18 "Information Relevant to Ensuring ..a w occupational Radiation Exposures at Medical Institutions will be As Low As Reasonably Achievable" and NUREG-0267 (draft)

     " Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions As Lcw As Reasonably Achievable."

The Minnesota Pollution Control Agency (MPCA) has a significant interest in radioactive waste management to which our comments will be generally confined. Radioactive wastes or topics related to wastes appear in the textual material in a scmewhat subsidiary fashion under certain main headings, so:because there is no index one must search page by page to find the few remarks devoted to radioactive wastes. MPCA would suggest that radioactive wastes be given a more preminent visibility in both Regulatory Guide 8.18 and NUREG-0267.  ! The monitoring of radioactive waste streams seems to be rather ill-addressed. The discussion on special sinks and rinse statiens does not mention periodic monitoring of the drain trap or the desirability of a special catch reservoir so as to prevent licuid l wastes frem entering the sewer system. The discussion ventilation j and fu=e hcods does not mention stack monitors or safeguards against unusually large releases of gaseous, volatile, or aerosol material. MPCA would suggest considerable effort be devoted to improving these topics. The discussion on solid radioactive wastes appears to be confined l to waste receptacles and does not mention procedures and criteria l for the handling and disposition of wastes after their collec- l tion in laboratories, hospital recm, etc. Moreover, no mention abshep .. 1935 Wes! Ccun:y accc 32. Resevi!!e. Minnesetc 55M3

                                                                                                        @             l l

Regicnc! Crnces Cuu:n s 3rc:ne:c / Mrqus ?cus / versncti / Rcenester / Rosevme l

 '                                                                      \

Sacratary of the Comr 1sion Page Two I February 9, 1978 i is made of two common hospital practices, particularily at the larger institutions, of laundries and incineration. MPCA believes the matter of controlling incineration and airborne release of radioactive material is of more than passing importance. In an overall sense the treatment of radioactive wastes in Regulatory Guide 8.18 and NUREG-0267 is altogether too sketchy and reflects an apparent unconcern on the part of the Commission. MPCA does not believe Regulatory Guide 8.18 meets the test set forth in the Atomic Energy Act of 1954 as amended at Chapter 1, Section 3,d and Chapter 14, Section 161, b wherein programs and regulations are to be consistent with and promote the health and safety of the public. Sincerely, anc&a S'rdebringJ6 Ga 1 Executive / Director - SSG:jb s/ l

E.%.'7;f 2 7_

                     ^

t- N' C LE AF:t ASSOCl/ ES, INC.

                '{b b

s.6 4.,y et alADIATICN-MEDICAL PRCOUCTs CORP.

                  ~4               400 VOIC E ROAD                  CARLE PLACE,NEW YORK 18514
 ,           February 10, 1978                   .       --

e

                                                                                                          \l'a c

CW

                                                            ---- -       _4. hlg~                         $mC a

Secretary of the Comission -

                                                                                               . ~.                                11' U. S. NUCLEAR REGULATORY COMMISSION                                                h 9.301g 1978 >                     '

Docketing & Service Branch d **.s.r ge Washington, D.C. 20555 M '# M - RE: REGULATORY GUIDE 8.18 44 gg # Gen tlemen: - Fi rs t, Guide 8.18,I wish to the and commend theassociated excellent thoroughness reportofNUREG-0267 the proposeddrafted Regulatory }F', j by Dr. Allp'n Brodsky. ~ e. Tne Guide makes specific mentien to Medical Institutiens; however, q there should be some notation that the Guide should also be used by I the private clinics and offices, where applicable. While the Guide makes reference to the " Radiation Safety Officer", 80 *S. It can be readily understcod that most small hospitals, private clinics and offices do not have an R.S.O. I feel the Guide should recommend that these specific groups have available at their disposal, for cen-sultation, a R.S.O. The following are specific comments to the proposed guide: 3.2a(5) " It should be specifically stated that the independent cautien lights EI 2 should be ganma-ray sensing or radiation type of detectors. 3.3h Change " radiation counter and rate meter" to "radiatien counter and/or n' rate meter". ,'.'Y 3.3J --- I am not aware of a commercially available direct reading finger dosimeter. f-< L v 4.2.1c m

                                                                                                                      .,     4 "A general safety check including spot or point calibration check",                                      ~ 6' N
                                                                                                               ~

cen t i n ued . . . lGh tQf . ,

                                                                                                    ,,                         h i
     .-   , + =l. ,.

T ~&l Secretary of the Commissien U. S. NUCLEAR REGULATORY COMMISSION Feb rua ry 10, 1978 should be changed to "... radiation output check". The term "ca l ib ra-  ? tion" tends to intimate that high accuracy calibration instruments k T are necessary for monthly output checks; however, this type of instru- 4 ment may not be necessary. 4.2.2d ' The word "sterliization" should be omitted from this paragraph. After- O\' F loading sleeves and ovolds are not necessarily sterli tzed with the radiation sources. { 4.2.2g 1 "Use of gamma-alarm type ionization chamber" should be changed to  %

                   "gansna-alarm meni tor". A ment ter utilizing gelger-tubes in lieu of           %g Ionization chamber is satisfactory for menitoring purposes.

4.3c

                   " Shield ionization chamber calibrators" should be changed to " shield chammer calibrators". Isotope calibrators using gelser tubes in a             'k'g 1

chamber configuration are commercially available. _l Yours truly, Ra-H. Glasser 516-741-7614 HG:Jck l l [ l l l l __

1 l THE UNIVERSITY OF ROCHESTER 601 ELMWOOD AVENUE RCCHESTER. NEW YORK 14642 HEAtTH PHYSICS DIVISION DiaECTOR PHONE: f*tS) 275 37S1 H. DAVID MAftt!E. PH.D. HEALTH PHY5tC 37 February 13, 1978 w Ntoe: o. carcony. x.s. u, . _; wr.."i$- S

                                                                                                           '\
               ~                  -

Secretary of the Commissi n

                                              . M,                                  & sa w                         s U. S. Nuclear Regulatory Cor:: mission                               D@t g *L 7 N p* %o            ,Il Washington, D. C. 20555 k.g% *,L,,hg' s;;.

4-  ;'

                                                                                                              }h, .

Attention: Docketing and Service Section y,

                                                                                         %, ,,, ,_, N nf '7

Dear Sir:

b'7','. V] /

I have reviewed Regulatory Guide 8.18, "Information Relevant to Ensur- '

ing That Occupational Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable", and the companion report, NUREGL O267. I think , that they will serve as a useful cdjilation of radiation safety practices. dd l However, they should not be used as an inflexible inspection check guide j since each institution has its own procedures and methods. i There are a few places that I see problems, and perhaps chese areas, should be clarified further.

                    .l . Section 4.1.5 " Radiation or Radioactivity ".onitoring".
                    "'his section suggests that the users should take daily wipe saeples and record the results in a daily log.         I think that it should be made very clear            Q3,4 that this should not apply to all labs., but only the labs. that use large 1            quantities of radioactive =aterial.         It should also be based on the user ex-perience of contamination problects.        In many case's it is a rare occurrence that a lab. has any contamination.                                                          _
2. Section 4.2.2 "Srachytherapy".

l When brachytherapy sources are removed, the individual capsules can be inventoried eliminating the need for a survey before discharge of the patient. It should be noted, hot ever, that there is the possibility that a sources can become dislodged or misinserted, and be collected in the linen or trash. For this reason all linen and waste should remain in the room until checked by a q'),} survey meter or until the sources are accounted for upon removal. Paragraph "m" should be rewritten to clarify the difference between precautions needed 4 'for seed implants and for capsules or needles, and the precaution fer saving linen and waste in the room should be added. s

                                                      .,2//7h8%

U. S. Nuclear Regulatory Commission Washington, D.C. 20555 2 February 13, 1973

3. Section 3.4.1.1 in NUREG-0267 only. -'

Subparagraph 7 suggests posting of areas around storage locations that have a radiation exposure rate in excess of 0.2 mrem / hour. To me this would CE3* I

  =ean a " Radiation Area" sign and would detract from the effect of posting true radiation areas. Perhaps these areas should be posted with the ter             t ology " Caution - Low Radiation Area".

_]

4. Section 3.4.1.6 in NURGE-0267 only " Training" d

I cuestion the need for training sessions with all persons on an annual basis. This kind of refresher trainig and new safety indoctrination can also 43,8 be handled using printed =aterial that and bulletins. is distributed such as memos, pamphlets], I trust that these comments will be helpful in any revisions of these tuo publicatiers. Please contact =e if my com=ents need further explanation. 1 Very truly yours,

                                                       -l                       .

W. D. Gregory WDG:kf I l t

I C N U C LE Af:t AS S O C I ATE S . INC. d son.d.ry w aAcianoutoicAt nooucis coer. i Y 100 volC E ROAD CARLE PLACE.NEW YORK 195l4 Februa ry 13, 1978 Dr. Allen Brodsky U. S NUOLEAR REGULATORY COMMISSION Office of Standard Development Wash in gton , D .C . 20555 Cear Dr. Brodsky: I am in receipt of NUREG-0267, and I wish to complement you on thi s excellent document. 3.,1 This is the first document that I have come across which provides s'~.- I detailed information on minimizing occupational exposure in nuclear

nedicine and radiation therapy.

b Sincerely, 6 h, , PW

     'H. Glasser 516-741-7614 HG:Jnk 4
  • l 1

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            ~

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  *     ,W.

T GEORGIA INSTITUTE OF TECHNOLOGY IS A ' h - OFFICE OF INTERDISCIPLINARY PROGRAMS 2c5 CLC CIVIL ENGINEEAING BUILOING ATLANTA. GEO AGI A 30332 ENVIRCNMENTAL RESCURCES CENTER February 13, 1978 BICENGINEERING CENTER t404# 69 A2375 (404s 99&2375 Dr. Allen Brodsky Division of Siting, Health, and Safeguards Stardards Office of Standards Development U. S. Nuclear Regulatory Comissicn Washingten, D.C. 20555

Dear Allen:

We have received copies of Regulatory Guide 3.13 which is cut " for cement, and the draft of " Principles and Practices for Keeping Cccupatienal Radiatien E:c:csures at Medical Institutiens as Lcw As Reasc= ably Achievable." We greatly appreciate these cateri'als being sent to us for review and cerment. 1 I I am very pleased to see the NRC enter this area of guidarse at {t *3 { nedical institutions. In additien, these docu:nents appear to be cen-prehensive, and reflect a careful review and selecticn of the litera-  ; ture.  ; Pased en ny review, I do not have any substantive suggestions ) fer changes. j Thanks again for ycur thcughtfulness in sending this friernation to us, and best perscnal regards. Sincerely ycurs, 7/ Melvin W. Carter Director MC/ pan y& -

MEMORANDUM MAR EM M HEAM, NCAN, AE hfEIJARE PUBLIC REALTH SERVICE FOOD AND DRUG ADMINISTRATION g Chief, Standards and Regulations Branch Division or Compliance, BRH 3373, g g4 g Special Assistant for Scientific Affairs Office of Medical Affairs scaJECT: Review of NRC Reg. Guide 8.18 and NUREG-0267, Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable. I have reviewed the subject documents and I am very favorably impressed ) - with their contents. However, one area for insuring the ALARA is not f addressed adequately. This concerns the availability of written plans in case of a radiation accident particularly one involving patient or [. g. l personnel contamination. The Accreditation Manual for Hospitals of the Joint Comissicn on Accreditation of Hospitals requires such an Internal Disaster Plan. The subject documents do refer to the need for fire control and cleanup procedures following a contaminating accident, I consider these as basic to any disaster plan. However, to adequately insure that radiation doses are minimized, a predetermined, well thought-out plan is highly advisable. Such a plan should include a routine to be followed in case of accidents. For examp.le, first-aid measures, decontamination procedures, and actions to be avoided in order not to interfere with subsequent decontamination measures. Some excellent guidance can be found in " Medical Aspects of Radiation' Accidents," E. L. Saenger (USAEC,1963) and in " Safe Handling of Radioisotopes - Medical Addendum," Safety Series No. 3, IAEA, Vienna, 1960. In addition, to insuring ALARA and being available for accidents which occur within a nuclear medicine department, a plan of this nature would be invaluable for emergency incident planning for external disasters, such ! as at fixed nuclear facilities, etc. - I realize that an up-to-date "model plan" is not available and outside the scope of this document. In that case, the need for such a plan should be alluded to. I plan to suggest the composition of a "model plan" of this  ; type under HEW responsibilities for Emergency Radiation Response Planning. . Bernard Shleien, Pharm.D. cc: Dr. Johnson, OMA Dr. Paras, DRMNM Mr. H. Collins, NRC gl Dr. A. Brodsky, NRC

          -                                         i

EiARVAR.D .\WDICAL SCHOOL DE?ARDGXT OF R.tDIATIOX THERA?? .q 3tNNEY snEET DIVISIOX OF ?HYSICS ym%d Boston, . MASSACHUSETTS ozut3 h+"(; - 9 9 &

        . c. ..u., . .A-   IN ~       444 . k=                    15 February 1978               d                     'b
n. ,

k,r A c Secretary of the Commission Q$$ U.S. Nuclear Regulatory Co= mission Washington, D.C. 20555 [

                                                                                                   $EO g'le
                                                                                                                    # N3    i- 7 :".

4%# Att: Decketing and Service Section b # 6 O a Re: REGULATORY GUIDE 8.18 m/ 6

Dear Sir / Madam:

In general I believe the referenced Guide to be reasonable,1 well written and needed. I have a few ccc=ents which I GI offer for your consideration: -

1. Section 1: Add g. Administrative direction to gi ensure that any purchases of radioactive material
       ~

will be processed and receiv'ed only through the l Radiation Safetv- Office.

2. Section 2.1 (1): Managenent should provide necessary d3 personnel not only to establish program requirements, but also to carrv out the program.
                                                                                                                                  . .g
3. Section 3.1.4a... areas where measureable airborne .,

ff concentrations.... " Breathable concentrations" is meaningless unless there are seme concentrations . which are not breathable.

                                                                                                                                       .i:
                            ~
4. Section 3.2c: The last sentence indicates an aggressive policy to increase erposure to a group of individuals. It would be better to simply state

[-( that therapy facilities and cperating procedures should be designed to maintain occupational e:cposures L, ALARA. . 2 Thank you for the opportunity to comment. .

                                                                                                                                            ~

Sincerely, -

                                       ,/*
  • r.2 Kenneth R. Kase, Ph.D. -

KRK:dh .[N

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(2!3) 453 3253 R O. DCX 447 62the199.et e GUILFORD. CONNECTICUT C4437 m B. eR A CWRU P. F. A C P-cantmro =*oio6concA6 vsicier February 15, 1978 Secretary of the Ceanission U.S. Nuclear Regulatory Commission Docketing and Service Section Washington, D.C. 20555 A::n: Mr. Robert B. Minogue , Director Office of Standards Development Re: Regulatory Guide 8.18 NUREp - 0267 De ar Mr. Minogue : In accordance with your =e=o of January 6, I mn offering below some co==ents on above docu=ents relating to the "as low as reasonably achievable" radiation exposure philosophy (ALARA) . My suggestions cencern =ainly the sections on telecherapy equipment and facilities, subj ects I sn particularly interested in. Referring to Regulatory Guide 8.18: 3.1.2 line 3 insert: agains: " radiations frem" radioactive 7 g8,1 materials. . s line 6 add: "See par. 3.2 for structural protection of 7 radiation therapy facilities. Telecherapy (9 1 installations always require permanent shielding."1 3.2 a (2) add: . . .is closed "and beam if off." ];j,3 b made long before the make of equipment has beenTheshieldingdes selected. Suggest structural shielding design be based on NCRP leakage requirements in report #33, 29'i

                                                                                                               ^'

rather than on the data of a particular make. e line 8 inser: "not" increase... 29,Ji General: It is recc= mended that the Guide crovide a numerical intercretation of ALARA for shiel' ding design purposes ) Otherwise, :he margin of safety would depend too =uch on the financial status of the hosoical or ccmmunity supporting it. In most cases, cost is the principal (3,>, factor in limiting per=anen: shielding. I: is sug-gested that the design limi: b,. set at 10 = rad / week. for both restricted and unres tricted areas . This is the value proposed by Dr. H.O. Wyckoff and me based en a cost study of dose reduction in shielding design. (Radiology May '73) -" 4.2 b add: "or by surface applica:icn." } 4g,7

                                                                                                              ^

a.2.1 d line 5 change to: "no cersons exceot the patient to be exposed" ...(patient and phan om are'not personnel)

                                                                            ~

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                                                                                .     . l l

l I Rc,bert 3. Minogue February E, 1978 1.2.1 e Suggest deletion of paragraph. The location of the 1 mi"* mtm dose rate nea console will decend on beas

                                                                ~

direction. In the case of moving 'ceas therapy, it would require the cuerator to =ove from one position to another during treatments to be where the stray RJ,i radiation is lowest. In a well designed facility the shielding provides a very high degree of protection at the location of the console; this permits the operator to stay there and give her full attention to the patient. l e Suggested revision: During "3eas off" conditions, consideration should be given to tne lea'< age rad-iation while setting up patients. "his should be carried out with minimr ti=e spent close to the d..'" source. 'for should there be unnecessary occupation of the treatment room which should be used enclusively for teletherapy. - Most of the above suggestions apply also to the draft of %~ RIG-0267I by Allen 3rodsky. In addition, I would suggest that in Section 3.3.2 pa . 2, ma; lor attention be called to the shielding required agains :he useful bea=. mhere is a trend away fro: equipment [.// with built-in beas interceptor necessitating structural "pri=ary protec;ive barriers." 3e'<4=g you for the opportunity to review these i=portant documenta, I am 4 1 Te y sincerely yours, e - 1 i,-

      ,1 ' I i h- U% L.

C. 3. 3raestrup -

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                                          \ HEALTH CARE CENTER SERVING THE TOTAL HEALTH NEEDS OF THE REdlDENTS OF LEWISTON. AUBURN AND THE CENTRAL X1AINE CONL\ilNITIEd.

February 15, 1978 Robert B. Minogue, Director Office of Standards Development Nuclear Regulatory Commission Washington, D.C. 20535 Re: Distribution List for Regulatory Guide 8.18

Dear Mr. Minogue:

My only concern regarding the Regulatory Guide comes under the item' of radiation safety office function, subparagraph 3, entitled

                         " Space". It would seem that you are suggesting that the radiation                      i f

safety office have within it all the capabilities of doing all the functions listed under that paragraph. In this hospital, as in many hospitals, radioactive waste and sources not in use are stored in a cement safe which is not within the radiation safety office. I believe that, in this hospital, this results in ALARA 1g j 8 being obtained. Thus , I do not believe the radiation safety office must be the site for disposal of radioactive waste. Certainly, a site for 1 this must be present within the hospital but it can be in a site other than the actual radiation safety office. - I am also surprised there is not a section on receiving of radio ' active sources , particularly in surveying the package to be certain M,, that leakage of the material has not occurred, such that k'Ans is not being achieved. J Warm regards, Jon P. Pitman, M.D.

                                                                    /

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ROS;iELL PARK ."D'ORIAL INSTITUTE - Buffalo, New York 14263 February 15, 1978 Dr. Robert ?!inogue Director Office of Standards Development United States Nuclear Regulatory Commission Washington,D.C. 20555

Dear Dr. Minogue:

At your request I submit ny comments en regulatory guide 8.13 concerning occupational radiation exposures: (1) This, like ALARA, is pretty much a sham. There is the appearance of protection but not the reality. (2)

      ,                          The basic mistake is to try to control the technology without controlling the human being in the system (the system consists of hardware, environment, and human components).

(3)

      )                         The only way to tell whether personnel are actually
      !     exposed or not and whether their health is affected or not is to keep reliable records on personnel exposures and heal:h records (possibly on family health).

(4) The attitude of medical personnel (that I.have seen) is that all this is so much more meaningless red tape. The only interest is in giving the appearance of compliance while evading the inconvenience. The choice of person to oversee these things is usually seneone who isn't competent to do anything. He is likely to put here so as not to 4 endanger patients. With this attitude regulatory guides have little or no real effect. (5) at the same time try to enforce a 0.5 level.The NRC cannot set 5 ren/ year a The usual attitude is: if it is permitted, there cannot be a serious ha:ard at 5 rem (or so it would seen). Therefore why bother with 0.5 rem exposures. NRC can't have it both ways. Ver- 'ncerely " s, . A sin ross, Ph.D. irector of Biostatistics P.S. This business of pernissible levels recuires, I believe, an immediate statenent fron NRC to the effect that there is not actual or inplied guarantee or worker safety at these levels. IDJB/C'E 3  ;

Colorado state University Environmental Healtn Serwces h5 3 B11o Microtnology February 16, 1978 Secretary of the Comission U.S. Nuclear Regulatory Comission Washington, D.C. 20555 Attention: Occketing and Services Branch

Dear Sir:

I have read through NRC Regulatory Guide 3.18 and find that it out- 'T lines a comprehensive approach to radiation control applicable in .p,j its general aspects to non-medical as well as to medical institutions. I do have coments on two subjects and one section of the text. -

                - I believe that the subject of training of staff and employees,"q^,

mentioned in sections 1.d and 4.1.6, deserves greater emphasis" ( in the Guide.

                - Since veterinary med.ical personnel refer to this Guidi, I <

would like to see some indication of the degree of intended 3/d applicability in non-human medicine of the recomendations j of the Guide.

                                                                                                                 ~
                - In section 2.3 of the Guide, I find parts a. and e. to be y4 ei*ther unnecessarily redundant or else not quite unambiguous.3 Thank you.                                                                                ,       j Sincerely,                                               /

L . ,& - f5 ev, IEj* g y,%O A A Lovaas Health physicist b @4 "* " AL/ekb

12. N M; 8....a T 3\

e e The University J O/

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2. eeen-m 3 A-=.:'.v] e vnM Secretary of the Cocsission U. S. Nuclear Regulatory Coc=tission ((l

                                                                     . J.;

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          'Jashington, D. C. 20555                                    w.      e== d ^*s e v      =c='b Attention: Docketing and Service Section                                   ([ ,
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Dear Sirs:

I have reviewed Regulatory Guide 8.13 and the associa:ed report NURIG-0267 and would like to submi co==ent. I as quite happy with Regulatory Guide 8.18. It incorporates mos: needed philosophy quite well without being overly restrictive. I was particularly happy to see the areas of space and staffing of a Radiation Saf ety Office being mentioned as many Radiation Saf ety Offices operate with inadequate staf f, space, funding and equip =ent. Guide 3.18 by itself is a very useful document. 'ihen combined w1:h  ;  ; NUREG-0267 however, these docu=ents become qui:e unwieldy and in scme g, f cases useless.

                 'Taen a medical insti:ution is granted a broad license to use radioac:ive sacerial, the qualifications of the Radiation Saf ety Officer ;

are evaluated along wi:h the preposed program. The R.S.O. in =ose  ; cases could then be assur.ed to be a competent professional. NUREG-0267 however reduces medical heal:h physics to a twenty-five or :hirty  ; page " cookbook" of "how to 's". Reports such as NUREG-0267 when attached to regula:ory guides tend to become vir:ually :he only acceptable pro-

                                                                                                                  ,-       .g cedures, effec:ively removing the judgement of the professional. If                          i                   4 medical heal:h physics was as simple as NUREG-0267 indicates, this repor:

would reduce the qualifications of :he R.S.O. :o that of a f airly good lj {V.i

                                                                                                              .g technician.                                                                               --
                                                                                                              )V NUREG-0267 i far too simplified.        Recom=endations a-f on page                               'y 3-20 for instance (See:1on 3.a.2.3), are obviously =eant for . iodine                            j           j .4
herapy. They are put forth, however, as needed for all unsealed '

radionuclide therapy. Many of these precautions are unnecessary with ps N oener forms of radionuclide therapy such as ?hosphorus-32 or Gold-198 for intracavi:ary treatment of =alignan: effusions. There is also no i L~ & d by *:,*d,2,/, V. .~sw~ er a.. fl _. - 'L.. G.

                          .* ~ ~        .a%                                                                 !
                                         ,              UNIVERSITY                       PENNSYL VANIA PHII.ADELPHIA 19174
                   ' The Moore School of Electrical Engineering D2                                      February 20, L  9     7       8.

Dr. Allen Brodsky Office of Standards Development U.S. Nuclear Regulatory Commission i Washington, DC 20555 l

Dear Dr. Brodsky:

Thank you for sending me the document NUREG-0267 and Regulatory 9 Guide 8.18. My naive reaction to the two documents is that the Guide 8.18 ' is excellent--clear and concise. However, when I finished that bj document and started on the Draft I became more and more con- ""' I fused and finally ended up feeling that NUREG-0267 is completely unnecessary. As I said before, my reaction is probably very naive. A few minor criticisms of the Regulatory Guide 8.18: f

1. The second paragraph of Section 2.4 should be re- 7u ,

j worded to make it clearer. " ' ' j 2. j InI think Section the3.2, word Item Sc,is4th "not" line from the bottom,1;g 3 missing. j"' j 3. j Your Agency must consider the appointment of " Medical , " Isotopes Committees" whereas a licensee such as the , University of Pennsylvania has a " Radiation Safety 33.P Committee" because we deal with the uses of isotopes and other radiation sources. Perhaps a footnote could clarify this point. - 7

S<ihcer., -mely yourp, -
                                                                          ,       /
                                                         .ffN '

S. Reid Warren, Jr. f Emeritus Professor of

!                   Electrical Engineering and                                                                                              -
                                                                                                                                                    ~~

I Radiological Physics , i 4 ** W 6 l _- __ __ - . _ _ _ _ _ . _ . ._ . _ . _ . _ ~ . - . . - _ . _ _ _ _ . _ - . - - . _ _ - -

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Mr. Robert 3. Minogue, Director Office of Standards Development United States Nuclear Regulatory Comiss?on

                'Jashington, D.C.          20555

Dear Mr. Minogue:

I have one coc: ment on Regulatory Guide 8.18, which refers to The National

  • Council on Radiation Protection and Measurements (NCRP) Reports occasionally.

The Guide should use the same meaning of the words "shall" and "should" that is used in the NCRP Reports to avoid confusion. The NCRP defines "shall" 3f.[ and "should" as: "(1) Shall indicates a recomendation that is necessary or essential to meet the currently accepted standards of protectiori. (2) Should, is recommended, is advisable, indicates an advisory recommendation that is to be applied . ten practicable." Section 4.1.4 of Guide 8.18, Proper

                'Jork Habits, would list work habits which violata NRC Regulations as "shall" and other reco= mended work habits as "should".                                                                      -

This coc: ment could also be applied to NUREG-0267, Principles and Practices for Keeping Occupational Raciation Exposures at Medical Institutions as Low As ON A Reascnably Achievable, but this report would be difficult to alter. Sincerely yours,

                                                                   ,     ,Jsk l Mf~-

JAMES S. KUMAGAI, Ph. l i Deputy Director for Environmental Health l

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     ,    Atomic Energy              L'$nergie Atomique                    Pinawa. Manitoba.

of Canada Limited du Canada, Limitde conodo. ROE ILO (20 t) 753 2311 Whiteshell Nuclear Ntoblissement de Recherches Research Establishment nucleaires de Whiteshell JLW-78-046 Health and Safety Division 31 arch 1,1978 Dr. R.B. Minogue Director Office of Standards Development United States Nuclear Regulatory Com.M. ssion Washington. D.C. 20555 U.S.A.

Dear Dr. Minogue:

Thanic you for your letter of January 6,1978 and for the copy of Regulatory Cuide 8.18. This guide has been read by myself and by several of my colleagues and although we are not a medical institution, I some of the situations described in the document were sufficiently compar9ble to our operatiens that we found it very interesting. We g) j have no adverse comments and my only question would relate 'to the 'g availability of compliance training facilities for the affected institutions, g This is simply a variant of the old observation that any safety procedure or regulation is about as effective as the people it seeks to control. We did not receive a copy of NUREG-0267. Yours sincerely, n u5

              ~U J.L. Weeks, M.D.(Lond. ), D.I.H.

Director JLW:is 4 f

u\ f v JOHN F. KENNEDY MEDICAL CENTER 00:'IET IN'JSER g , nsa.on..w .ter y own sc?ag3 gi,g F Ft '

                                                                                                       -ii EM March 2, 1978                       ,

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                                                                                          ~i                             E Secretary of the Commission                                                             3 S@j.p. og       Y US NF.C                                                                                 ',

S Washington, cc 20555 'O '

                                                                                                      /,       a Attention:            Docking and Service Branch Gentlemen:

At our February 13, 1978 meeting of the Hospital's Medical ' Isotopes Coertittee, the members had the opportunity to review; the proposed Regulatory Guide 3.18. We, of course, share the NRC's concern for radiation exposure and fully support the ALARA concept where practical. s'j 4, In our opinion, the majority of the specifics contained in l che guidelines present little or no difficulty in thei.: i=plementation. ' There, are, however, a nu=ber of reco==endations which, if i=plemented, would cause disruption in the normal operation of Nuclear Medicine and Radiation Therapy Departments and result in excessive and unnecessary costs for many hospitals. Cur major points of contention are outlined below: 1 The requirement that all hospital staff and employees " l receive briefings and train.ing in radiation safety, 3 I including the ALARA concept, would seem to be unnecessary,372* l excepcionally time consuming, and expensive. The . vast majority of hospital employees have no contact i om a ** 3b

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Secretary of the Cormaission US NRC 3/2/78 Page 2 or involvement with radioactive material or sources of radiation. It would seem necessary that only particular groups of hospital employees (ie: nursing, ER personnel, and Security) need be aware of appropriate radiation safety procedures. Specific personnel from other departments who may, on occasion, be involved in the handling of, or contact with, j'/, L radioactive patients or sources could be informed on an individual basis. For all hospital, employees to be thoroughly trained-in radiation safety and ALARA concepts would be aimassive undertaking, j requiring hundreds of man hours of time. It would also, of necessity, have to be continued en a very frequent basis, because of hospital turnover. We

     ,                          fail to see the need for applying this requirement indiscriminately to all hospital employees.                         j
2. 'The requirement that the responsibi$ty and authority 9 of the Radiation Safety officer be s'pelled out in the Medical Staff By-Laws is inappropriate. The RSO f' duties are described in the By-Laws of the Medic al p3 Isotope committee and in the Policies and Procedures of the Nuclear Medicine, Radiation Therapy, and Radiology Depa. h nts. The functions of the Radiation Safety officer are more of an ar*
  • 4 =trative and technical nature; and, therefore, not appropriate to the Medical Staff By-Laws. _

i 3. The requirement to survey and perfor:s a wipe test on

   !                           shipments of radionuclides at their arrival point
   !                           would create an unnecessary hardship.for the hospital. For most institutions, the arrival point for isotopes is the Emergency Room or Security office, neither of which are appropriate places for          ) ?, f storage of isotopes. Individuals not fully trained

) , in Nuclear Medicine radiation safety procedures t i should not be conducting wipe tests or package l surveys. It is impractical to wait for a Nuclear Medicine Technologist to arrive in the morning, who could perfor=- the package survey and wipe test. l l l

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

O *

         ,                   Secretary of the Commission US NRC March 2, 1978 Page 3 At present, these materials are transported to nuclear medicine by security personnel on a special cart lined with absorbent material. Written instructions for this operation are in the department's 'N,' f policies and procedures manual. The wipe test and package surveys are conducted early the next morning                                        I when the nuclear medicine technologists arrive.

We have experienced no difficulties or problems

       '                                   involving the spread of contamination through the hospital during the seversl years this procedure L                                  has been in effect.

i 4. We question the requirement for a " beam on" light ~ inside the Linear Accelerator rocm. Our present safety interlock system and procedures for ascertaining that all personnel are out of the room, appear to be l more problems. than adequate to avoid potential exposure The use of this " beam on" light inside ,N y the room, presupposes that the individual inside wculd understand the meaning of such an indicator. We feel that, in the case of many hospital employees, such would not be the case. v 5. Your requirement for nuclear medicine personnel ~1 to maintain a 2 meter distance from any patient being scanned, whenever possible, is reasonable. i However, practical necessity dictates that it should '

     '                              be designed.

applied only in new facilities which can be so Many existing department utilize imaging g(, rooms whose dimensions are too small to allow this distance rule to be utilized. It is unreasonable to expect the hospital to tear down anci reconstruct ,

    '                               the physical facility, which, when it is built, was in full compliance with exis d g NRC guidelines.

Again, we feel that this is a reasonable recommendation for new construction oniv.

                                                                                                                                   )

6. For individual lcckers ,and change areas, the comments 77,7 made in number 5 apply. j3 .) I

Secretary of the Commission US NRC March 2, 1978 Page 4 i .

         ;                        7. The proposal requiring us to make exposure estimates 7 i

of the radiation burden resulting from particular operations would involve, again, considerable labor i expense to obtain. If general data were available 3('g either from the NRC or in the published literatures, f such data could be utilized by the nuclear medicine

  • community without the need for each to make specific
              ,                       exposure measurements thereby duplicating efforts.                    j
8. The requirement to provid's new employees, within 7 the department of nuclear medicine, with copies of

.i cur radiation safety manual, NRC and State Licenses,

)                                     etc. seem unnecessary. The location of these                            i

' documents are known to all department employees, and posted as well. Information concerning the location of these documents is posted and each is 4 available to any employee to examine. It would L j seem to us that this is sufficient compliance with the t spirit of this regulation. To make xerox copies of these documents (which are quite lengthy.in some cases) and hand them out to employees appears to serve no useful purpose at all. J

9. The requirement for use of lead bedside shields for ~

the protection of the nursing staff, that may be ' handling an implant or internal dose patient, seems unnecessary and costly. If a hospital is able to

utill
e distance and time to reduce the exposure of nursing personnel to minimu= levels, that should suffice. We have, in the past, carefully monitored vg y,

our nursing personnel, who care for implant patients, and have found their exposures to be, in most cases, j well under 10 mR. We feel that the small advantage to be gained by purchasing bedside shields will not

offset the high c=sts.

t J

10. The requirement for the use of protective lead screens to shield patients undergoing diagnostic v 'g nuclear medicine precedures is totally i : practical:-

i l r i 1

3 Secretary of the Commission US SRC March 2, 1978 Page 5 n

   ;                            a)          Such screens are not, to our knowledge, readily I                                        available at the present time.

s i b) Draping lead apron material on tope of the patient I is uncomfortable or even intolerable in many cases. . n 7. ll J 1 c) This operation will greatly complicate and slow l down work of the technologist, thereby increasing hospital costs and piEbably involving more 1 i exposure to the technologist in " fooling around" f j with the shield then he would otherwise have [ 3 gotten, d) It is well known that the primary e.gosure problem for a nuclear medicine technologist is during the preparation of radiopharmaceuticals and their administration and not during the t course of the actuni exam. j, 1 - 4 11. Your tecommended mingum scaffing for radia tion 7 safety" seems redund,ent. If a hospital is in l l compliance with the guidelines and is able to accomplish ,

  !                            them with their radiation safety among several clinical cechnologists; burden on hospitals. This                             M /1 .
! l                            regulation seems to have been formulated without any regard as to its impact on health care costs.                                     ,

l i - Thank you for giving us the opportunity to comment on the proposed guidelines and hope that you will consider our comments before drafting your final proposal. If I may be of any further assistance, feel free to contact me. J l 1 Very br.:ly/yours,7/

                                                                                /

f // wlO JNA Richard S. Pollack, M.S. Technical Director /uuclear Medicine, Ultrasound, and Radiation -'herapy and Radiation Safety Officer

TH::: Uh:*lIRSITY CF t. ENI:CI'ICUT HIALTH CENTER Radiation Safety March 3, 1978 00 /ET W *e 8 y 2R0 3 57.3 kJLE 4 ..

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Secretary of the Co=sission (q T g,9 U.S. Nuclear Regulatory Cc=sission Washington, D.C. 20555 D-4 N4 Attn: Docketing and Service Section ** p"* A p[

                                                                                                                      %                  er Gentlemen:                                                                                        4  ,     \

I wish to off er the following co==en s concerning Regulatory Guide 3.13, "Infor=4 tion Relevant to Ensuring that Occupational Radiation Ex-posures at Medical Institutions Will Be As Low As Reasonably Achievable" and NUREG-0267, " Principles and Practices for Keeping Occupational Radi-ation Exposures at Medical Institutions As Low As Reasonably Achievable." ' gj I do not have any real objections to the Regulatory Guide 8.18. Rowever, f two sections of NUREG-0267 deserve com=ent. -

                                                                                                                                 ~

Training, pg. 3-15. This section requires training sessions with all persons handling licensed nacerials on at least an annual basis. Repeat training sessions should not be a =andatory require =ent. The necessity i for repeated training should depend upon an individual's previous training, y experience and performance record. To force knowlegeable technicians to attend training lectures that would not be of nacerial benefit to them can lead to aggravation, resent =ent and loss of rapport. - Control of Contand"ation in Patients' Room, pg. 3-20. The measures M to control concs ' nation in rooms with patients hospitalined for radio- I pharmaceuti"i therapy need not be ar extensive as required by this section. Many radiotherapy procedures present little or no contamination problems. Even in those cases where such precautions are desirable, they cust be , balancedagainstthepacientsabilitytocopepsychologicallyvichelaborachg' precautions. On occasion such elaborate procedures produce an unreasonable ) fear in the patient. I fir =ly believe in taking all precautions necessary to control contamination. However, the extent of these precautions should be left to the discretion of the radiation safety officer. e Sincerely, s) . X( V. T. Pen 1kas, Ph.D. Radiation Safety Officer

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Monmouth Medical Center s DEPARTMENT OF RADIOLOGY ',, A Marvin Brod:e. M.D., Director LONG BRANCH. NEW JERSEY DIAGNOST!C RADIOLOGY SECTION THERAPEUTIC RADIOLOGY SECTION Sidney Schultz. M.D-. Director Erwin Tepper. M.D Director Gordon B. Manash21. M.D. John R. Glover. Ph.D Rad. Phys. , Wa:cer S. Rose M.D. Evelio R. Bofdl. M.D. Irv:.9g H. Stein. D.O. Raymond E. Campbell. R.T Adm. .bst. 3/03/78 l Mr. A. Brodsky Div. of Siting Office Standards Development U.S. Nuclear Regulatory Commission Washingten D.C. 20555 Cear Mr. Brodsky,

                                                                                                                   ; t,,7   m I am in the process of reviewing your recent draft decurrent NUREG - 0297 At this time I have one comment, namely, that in Appendix E (which I think is a good idea and has already made an impression on my administrator) you have rrade reference in i'e_'esik IA, 8; II P, V, W, X to 10 CFR 34 But                                                     d,l 10 CFA 34.1,last sentence, states "Nothing in this part shall apply to uses                                                "

of by.oreduct material for medical diagnosis or therapy." And yet that is the full intent of your document. I suggest finding or issuing appropriate regulations that do cover ( and will be believed by hospital administrators) , medical situations, eg. substitute 10CFR 35,14b5v for 34.26. Sine,erely, -

                                                                                                             /,..y N ' */

t . John R. Glover, Ph.D. Radiation Safety Officer i JRG/sb

                                                     -w   ?

Fully approved by the Joint Commission on Accreditation of Hospatals. A CA. A.M A., member of A.H.A., N J.H.A. Teachtnq Alltitate of Hahnemann Medical College 1

       .            .\ '. S I '. V
 ?
        }           Homital
                       .m    -
                                   -a-I Pride & Locust Streets
               ! Pittsburgh. Pennsylvania 15219 Telephone (+12) 232. 7805
                                                            >! arch 6,1978 i
               , The Secretary of the Cemission,
              ; U. S. Nuclear Regulatory Ccmission,
              ; Washington, D. C. 20555 l                          ATr3 TION: Docketing 6 Service Section

Dear Sir:

i Re: Comments on USNRC Regulatory Guide 8.18 and Accompanying , Document, Nureg-0267 I i I read with great interest the new Regulatory Guide 8.18 and the i acccmpanying report, Nureg-0267. I

             !             I would like to offer the following coments on the above:

l

(1) Please cengratulate Dr. Brodsky for the bold steps he has -

I suggested in the guide. The radiatien safety offices at medical

             ' institutions throughout the country have been so very badly neglected Iby the hospital administrators that you will find it difficult to
             'believe. 5fy personal thanks to Dr. Brodsky. This guide will cer-N.
            ' tainly bring to the attention of the hospital administrators the financial and perscnal needs of the Radiatien Safety Office in a
            , hospital.
            ,                                                                                              {
            !              (2) Although the guide is excellent, I am only afraid it will       #
increase the paper work needed for documentation of every bit of activity in a typical Radiatien Safety Office. So, I would request y08' that the Comission pay special attentien to this problem. We should '

4 try to be realistic or else people will simply produce falsified docu-

           , ments to acquire licenses. I can assure you that the Ccemission cannot i check every bit of these documents in their enforcement inspections.               -

l (3) A mention of " Radiological Physicist" who carries out the radiation safety activities at a hospital should, also, be made along

           < with the mentien of the ' Health Physicist." At very many hospitals,                J0j'
           ; the cualified radiological physicists carry out the activities of
           ; the Radiaticn Safety Office.                                                     ;

g i v............,...2 . . , . . .. .

J i He Secretary of the Comission Page 2 March 6, 1978 (4) In our opinion, please add a section on " Administration of Radiepharmaceuticals to Pregnant or Potentially Pregnant Wcmen." r Tg'f he Comission should provide a guideline in this matter, (although NCRP Report #54 does touch this matter). 1 j R anking you very much, i

Sincerely,
\                                                                                                   &. . . -        \ ' \%                   J._         :- -   ,

s J - J. P. Bhatnagar, Sc.D., Director, l Division of Radiation Physics j JPB/du ) CC: Dr. Allen Brodsky, USNRC i I \ l f l I t 4 1 i i f I

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                                               ,                                                  Shg#                       g Secretary of the Oc==_ssion U.S. :!uclear Regulatory Cc==ission                                                      h\ h g Ah                   h 2
       'Iashing;ca, D. C. 20555                                                          l.                   #

Att'n: Decketing and Service Section y 06 Re: Regulatory Guide S.18 and :iUREG-0267 fit

  • Ge=tle=en!'

I have reviewed Regulator / Guide 3.18 "Infor=ation Revelant to Insuring S at Cecupational Radiaiton Ex;osures At Medical Institutions

      '4111 3e As Low As Reasonably Achievable" and its ce=panion IiUEIG-0267 several ti=es.                 I think, that in general, se=e bread guidelines for
      =edical progrs=s are 1: order. Hevever, Regulatory Guide 6.13 and :iUR                                     ,     ,/

EG-0267 see to be quite specific on =ost points. Any atte=pt to ho=cg-enice all =edical progrs=s is unwise. The scope of =edical progn=s is 9 too rast to atte=pt any standarization. '4 hat =ay be appropriate for a s M pregn= =ay be unacceptable for a large c=e and vice versa. In s= aller progra=s, it =ay be totally appropriate for laboratory " to order, receive and dispose of s=111 quantities of radioactive =aterial independent of (for exa ple) the !!uclear Medicine Prega=, which could also function independently. This vculd eli=inate a function of the Radiatics Safety Office, ie, process crder, receive, inspect and distribute 1 e the=. For=al inspectica of packages vould not be required per 1CCFR20.205 @, L i 2 (b) (1). In addition, vaste storage and disposal vould be handled , indepe=dently. In larger institutions, where possession li=1ts or sever l disposal ec centratiens =ight be a proble=, this independent set-up =ay l net verk and the coordinatica of a Radiation Safety Office =ay te required. t, ^ In sectica 3.h.2.1 (3), I still disa pee vith =enth7 spot calibratices of teletherapy, A:ISI recc==endations aside. 31-=enthly calibratien is = ore . /, "3 than sufficient ence calibra 1c= is established. doneIina= Table alsoI. vary of setting

!u=erical fer=ulas =ini=u= require rather than as needed =ents fortends basis persen=el, to etc. a lead to medicerity. W Excellence in ?adiation Safety Progn=s cannot be achieved through sc=cgeniety. Rather, perhaps, sc=e bare =ini=u=s should be established for all and let individuals preps:s be judged on an individual basis founded en what is required. I l

Sincerely,

                                    , '/         M ..                                    -

d

                                                                        ?onald 7. Scheele
                                                        .,             Radiatien Physicist kCS 3rcokr11ge Streec                                ~

3'75:11 Green 3ay,'Jiscensi: Sk 301--~ e e

Pacianon Safety Office UNIVERSITY OF MISSOURI 413 Cark Hail Caumeia. usscun 65201 Telecnore. 1314) 882-3721 SIarch 7,1978 Allen Brodsky, Sc. D. Office of Standards Development U. S. Nuclear Regulatory Commission Washington, D. C. 20555

Dear Allen:

Thank you for sending the material on the recent activities of the HPS sub- ] committee on tritium. I agree with your appraisal that the effort has become , unnecessarily tangled. I am not sure how to take your reference to our RSO \ effort as being similar to what the NRC licensing people are using. (What I makes :ne uncomfortable is the implication that NRC IIcensing has agreed to something I believe in. ) What seems to be the hangup is the subcommittee's I > f efforts to encompass large-scale (industrial and nuclear power) users in the u% ' ' same package containing small-scale (university or research) users. Anyway, I please continue to try to keep the subcommittee within reasonable bounds. ' i I admired your gumption in presenting testimony in contradiction to the re-suits of the 3Iancuso, Stewart, and Kneale study. Your testimony was printed in the Atomic Enerev Clearing House Newsletter a week or so back. Because I do not understand enough of the question to argue one way or the other, I am relieved that somecue who does understand has spoken out on the problem. J The preposed Reg. Guide 3.18 about which you have solicited comments has a philosophical posture that makes me uneasy. SIy interpretation of intent g is that it is directed to the management of the medical facility that must make decisions on the provtsion of resources to the radiation safety program. Reach- N, 1 Ing this audience and impressing upon them the importance of providing adequate resources is important, but spelling out in detail the tasks to be performed by the I health physicist seems to circumscribe too closely the cperational fle:tibilitf needed by the health physicist. '~ I have enclosed a copy of the Guide with a few editorial suggesticos. On page " 9.18-6, at the top of the second column, I found what I believe to be an error in i that 10 CFR 35.14 does not ratuire quarterly inventories for all licensed materials '4,j only sealed sources in Group VI and calibration sources are to be !nventorted. Cth-erwise, there were a few inconsistencies in format, such as: listing radiation safety j officer and NCRP Report No. 37 in different ways. I also stumbled over the use of I r x- ~ u.,

Allen Brodsky, Sc. D. , Page 2. March 7,1978

        " radiation safety office" in an active sense as though the office performed the tasks                         'Q7 when It was the staff of the office that performed.

Since you were so kind to send the material on tritium, Iwill reciprocate by 9 helping to fill your file cabinet. First, the marked copy of Guide S.18 is enclosed. Second, a copy of a recent communication from Walt Wegst and its reply is added. And last, a copy of an internal communication on risk management is forwarded. p{, f Because of your allied interest in industrial hygiene and your interest in the manage-4 ment of radiation safety programs (Guide 8.18) , you may be aware that a threat exists to subordinate viable radiation safety programs within an otherwise ineffective i risk management activity in the university. The NRC will need to be concerned about -! this threat. -' Sincerely yours, j H. Tolan Radiation Safety Off!cer JHT/djf l n ( y{ L

7& &!Ce.,pu,,, K -Fu 4/,m%.g U.C. NUCLEA] REZULATCRY C2MMISSISN Dec:mber 1977 (W,g

          \.v REGULATORY G.aU, WIDE,                                                                         =                           ..- a
                  % .                             OFFICE OF STANDARDS DEVELOPMENT                                                                3=1 $n U k i ./ 6. ;g REGULATORY GUIDE 8.18                                              g. 3 g g INFORMATION RELEVANT TO ENSURING THAT OCCUPATIONAL RADIATION EXPOSURES AT MEDICALJITS, TENT 10NS                                                                                      '

c.m WILL BE AS LOW AS REASONABLY ACHIEVABQu[-,Qy' - ,- A. INTRODUCTION Specific guidance regarding radioactise materials in efGuents to unrestricted areas is beyond the scope

        , Paragraph 20.l(c) of 10 CFR Pan 20. " Standards                                                  of this cuide. This topic is mentioned only in connec-ter Protecuan Against Radiation.- states that licen-                                                            '

tien with actions that induence both occupational ex-sees should make every reasonable effort to keep radiation exposures. as well as releases of radioactive posure and et0uent control. In addition, this guide and the associated report (Ref.11 deal only with matenal to unrestricted areas. as far below the limits radioactise materiais subject to licensing bv the Nu-specified m that part as reasonably achievable. Regu- clear Regulatorv Commission. The regula"tions and latory Guide S.IO. " Operating Philosophy for Slam- recommendatior$s of other agencies should be con-taining Occupanonal Radianon Exposures As Low As ' suited in regard to controlling radiation esposures Is Reasonably Achievaole." sas forth the philosophy from t ray machines 2nd. non-NRC licensed mate. and general management policies and programs that nals ~ licensees should follow to achieve this objective of maintaining radiation exposures to employees as low as is reasonably achievable" ( ALARA). B. DISCUSSION This guide is directed specifically toward medical The pnnciple of maintaining occupational radiation licensees and recommends methods acceptable to the exposures ALARA is an etension of an original tec-NRC staff for maintaining occupational exposures ommendation of the National Committee on Radia. ALARA in medical institunons. An associated re. tion Protection (now the National Council on Radia-port. NUREG-0267 Principles and Practices for tion Protection and Nica3urements (NCRPO in its Keepmg Occupanonal Radianon Exposures at Aledi. 1949 report published in 1954 as Report No.17 cal Insututions As Low As Reasonably Achievable" (Ref. 2h in this early report, the NCRP introduced

      .Ref.1). provides more detailed information for con-                                                 the philosopny of assuming that any radiation expo-trelhng exposures in these institutions. It also pro-                                               sure may carry some nsk and recommended that radi-vides a bibliography of background information on                                                   anon esposure be kept at a lesel "as low as practica-radianon protecuon science and philosophy, radiation                                                 ble" Icurrently referred to as " ALARA") below the protecuon standards, and planning and design infor-                                                 recommended maximum permissible dose equivalent.

manon useful for radiation protection programs in Similar recommendations to keep esposures ALARA medical institutions. Sections of the NUREG report have been included in NCRP reports up to the present are keyed to the secuan numbers of this guide for the time (Ref. D. as well as in recommendations of the reader's convenience. . National Academy ot' Sciences-National Research This guide is generally directed toward occupa-Council (Ref. 41. the Federal Radiation Council iRef. nonal heaith protectiert However. in a medical in- 5), and other independent .crent:Sc and professional sutution certain persons other enan employees are ex- organizations iRefs. 6-41. The basic radianon protec-posed to radiation from NRC licensed radioacuve t on philomphy of these recommendations has been matenal. These persons include visitors as well as pa* incorporated in regulanons and guides of the Nuclear Regulatorv Commission. tients other than those being treated with radioacuve matenal. Protection of these individuals is also ad- This guide and the associated NUREG report pro-dressed in this guide. vide a supplement for medical institunons of the USNRC R N*.~a.,re-.3.=aem +.s=,c ,.2." c - , a u a w.

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basic philosophy of Regulatory Guide 8.10. which e. Delegation of sufficient authority to the Radia-lists for all specific licensees the types of manage. tion Safety Officer " (RSO) to enforce regulations ment commitments and radiation protection programs and administrative policies regarding radiation safety:  % that would help to achieve the objective of maintain- and inst occupational exposures ALARA. Both this guide f. dministrative direction to ensure that any new an'd Regulatory Guide 3.10 will be used as a basis for. hospital facilities or equipment that m.ny affect radia-evaluating license applications and radiation safety ~ ti n pr tecti n will be planned or designed m consul-programs of NRC-licensed medical institutions, un. tati n with the RSO. less the licensee proposes an alternative method of complying with specified portions of the Commis-ston's regulations. 2. RADIATION SAFETY OFFICE FUNCTIONS The term " Radiation Safety Office" is used here C. REGULATORY POSITION , only to mdicate that some entity should be estab. Slethods or procedures given in this guide should lished to direct and coordinate administrative aspects be incorporated in appropriate sections of a license of the radiation safety program. The extent of this application according to the format of licensing program should be commensurate with potential radi-guides provided to the applicant by the licensing staff ation protection problems. of the Division of Fuel Cycle and Staterial Safety. Office of Nuclear Statenal Safety and Safeguards. 2.1 Staffing and Organization Requirements U.S. Nuclear Regulatory Commission. Washington, D.C. 20555. The considerations of this guide are in. A sample outline of the various tasks of a typical tended to assist the applicants in prepanng license Radiation Safety Office is presented in the appendix, applications that are acceptable to the NRC licensing The time and effort required for each of the listed staff as well as in accord with the philosophy of tasks vary widely with the size of the hospital and the nature and extent of radioactive material usage. Man-ALARA. Unique features not addressed here will re. quire specific review by the NRC licensing staff. agement (1) should review the staffing requirements for each of these tasks and provide the necessary per-

     , A licensee,s radiation safety program will be con-               sonnel to establish radiation safety program require-sidered m compliance with the 10 CFR Part 20  ,

ments and C) should evaluate them on an annual ALARA requirement and m accord with the ALARA basis. philosophy if the.following major principles and prac. trees are adopted as part of the institution's policies and programs. 2.2 Radiation Safety Personnel Qualifications b t se e n sa e perm-

1. AIANAGE> TENT PHILOSOPHY AND OR- riel appr priate t the radiation safety program after GANIZATION careful review of the nature of the program and the The radiation protection responsibility of licensee extent of effort and expertise required to carry out the management
  • st a medical institution is to maintain tasks noted in the appendix.

exposures ALARA for employees. visitors. students, and patients not under medical supervision for the 2.3 Space administration of radiation or radioactive matenals The Radiation Safety Office should have adequate for therapeutic or diagnostic purposes. space to carry out the following functions: This responsibility should be carned out by means a. Calibrate, maintain, and repair radiation safety of&v equipment.

2. Int'ormation and policy statements to the medical b. Stock radiation safety supPli es for labeling.

and hospital staff: surveying and decontamination. and personnel pro-

b. Penodic management audit of operational ef. tection and monitonng, forts to maintain esposures ALARA: c. Conduct radiometric measurement of smear
c. Cortinumg management evaluation of radiation tests from contamination surveys and source leak safety staffing. program. and budget requirements: tests.
d. Nianagement programs to ensure that all hospi. d. Store radioactive wastes and sources not in use.

tal staff and emplof ees receive appropnate bnefings and training in radiation safety. including ALARA " The term " Radiation Safety Officer" is used by atariy ficen-sees and etil be used in this guide to Jesignate the qualified , ggnggpgg. individual aho ts responsible for carrying out the instituuen s i * "\tana(ement" is defined here as those persons authortred by radianon safety program and *no a listed as the Radiation Pro. the enarter of the medical insutunon to maae tes polactes and testion Offiser on tne insutunon s " Applicanon for Syproduct Jirect <ts xuvinen statenal L. cense " Form AEC.313 3.13 2 4 hy I

e. Calibrate radiation safety and survey equipment icy and that cannot await allesistion of the radiation and check the Jalibrations of other hospital radianon safety problems.

I sources.

f. Decontaminate personnel elothing. and equip-ment. The Chairman of the Niedical Isotopes Committee
g. Process orders for licensed radioactive materials f required by (t35.Il of 10 CFR Pan 35) should pre-and receise and distribute such materials. pare t r and conduct .\ledical Isotopes Committee meetings. The RSO should be a member of the com-
h. Receise. process, and file regulations and li* ~

mittee and may assist the Chairman in conducting eensing correspondence, ' meetings and m'aintaining committee records.

i. Prepare reports and records of surveys and per-sonnel monitonng as required by 10 CFR Pan 20. Ans institution required to appoint such a commit-
                                                                                           ,,, ,, a condition of its license should call meetings J. Instruct and brief personnel as required by 10           at least quarterly. Every member of the .\ledical CFR Pan 19.                                                    Isotopes Committee should be invited.

In addition, the tasks listed in the appendix should The purposes of the meetings should include the be examined for other actisities that may require spe- following: eifie space alloestions for Radiation Safety Offices itt i the larger hospitals a. To discuss any radiation safety problems requir-ing a general solutton; 2.4 Tasks and Procedures b. To determine whether current procedures are The RSD and the radiation safety staff ara respon- **I"'#I"'"I **P *" * ~^NM # sible for conducting surveillance programs and inses. e. To audit the radiation safety program to ensure tigations to ensure that occupational exposures are that it meets all the goals and requirements presented ALARA. In addition, they should be vigilant in in Sections C.2.1 through C.2.5 above. searching out new and better ways to perform all All .\tedical Isornpes Committee meetings should radiation jobs with less exposure. A list of the types be documented by a record of minutes approved by of tasks earned out by a Radiation Safety Office in committee members and filed as pan of the radiation order to provide good radiation safety surveillance safety record system within 60 davs following each

                                                                                                                   ~                        ~

and meet regulatory and license conditions is pre- meeting. ' sented in the appendix.

                     ,         For medical institutions where a full- or pan time         J. FACILITY AND EQUIP.\ TENT DESIGN professional health physics staff is available. the            3.1 General Considerations pianmng of radiation safety procedures by this staff The design of hospital facilities and equipment re-l                           should be carried out in ecordination with manage-           quired for the medical uses of radioactive matenals ment to ensure optimum efficiency and exposures               depends not only on hospital and medical care con-that are ALARA. This coordination will also provide siderations. but also on the nature and quantity of for a smooth transition between program planmng               radioactive matenals involved and the relative po' ten-and supervision of the ongoing radiation safety pro-          tial for external and internal radiation exposure.
;                          pam by the professional health physicist under the            .\lajor aspects of planning and design that shnuld be general supervision of the RSO-considered are discussed below.

2.3 Administrative Authority 1/./ Space I.ayour

!                              The Radiation Safety Office. supervised by the                Facility layout should be planned to maintam em.

RSO. should have responsibility for carrying out the ployee exposures ALARA while at the same time en-radiation safety program. including the tasks listed in sunng that exposure is not thereby increased to other the appendix. This responsibility should be delegated persons in restnered or unrestricted areas. Consid-in the \tedical Staff Bylaws and should include au- erations should include @ thonty for the RSO to communicate directly with the

2. The need for access to radiation or radioactise i lesel or management that can take corrective action matenals areas bv medical staff. employees, patients, when needed to enforce rules and procedures penain* visitors, and others; ing to the institution's radiation safety program. Ad-ministrative authonty to suspend censin activities b. Ventilation requirements. including the need to maintain lower pressures in rooms in which radioae-
;                          temporanly should also be provided to the RSO when needed in emergencies to avoid immediate danger to            tive matenals are likely to be spilled or volatilized; life or health. Nowever, the authority of the R O to              c. Floor loading in case of heavily shielded suspend activities should be exercised only when it is        sources; l

consistent with non interference with life saving d. Receipt and shipment of radioactive matenals: l

medical procedures that warrant an overnding pnor- and l 1133
                                                                                                                                              , ,f l
  . - - , . - - . _      -               - - . - --,                    ,-       -                         - - , -   ~.,.nn- - - , - .

F. T. Germ

e. ng ss) and of some radiation therapy terference with medical and clinical and nuete medicine outpatients, including parking. oratory needs may also includeO , procedures. Lab 3.l.2 Shielding a. Provision for appropriate placement of radia- '

ti n- and contamination monitoring instruments; Permanent shielding may be needed in some cases for walls, floors. and ceilings to provide protection b. Special sinks for rinsing and disposing of minor against radioactise materials currently housed in the quantities of radioactive wastes (within 10 CFR Part institution. as well as radioactise materials that might 20 timitsn and be introduced into the area by future medical care re-

c. Special plumbing and waste storage provisions.

quirements. Occupancy and use factors should be taken into account as recommended in NCRP hand- In general, there is no justification in hospitals for books, but such factors should be chosen with the any procedures using quantitics of radioactive mate-principle of ALARA in mind. The NRC licensing rial sufficiently radiotoxic that potential air concen-staff should also be consulted during the planning and trations may reach lesels near or at the concentration design stage to obtain licensing guidance on accept- values given in 10 CFR ?.rt 20. Ventilation and con-able use and occupancy factors in shielding design. tamination control should be designed to maintain air c ncentrations and contamination levels as low as 3./.3 Caution Signs and Interlocks reasonably achievable. Guidance and requirements Access to certain ueas should be controlled or re- for the use of Xe 133 in nuclear medicine are avail-stnered by the use of caution signs. signals, and in- able from the Office of Nuclear .N!aterial and Safety terlocks as required by 10 CFR Part 20. 4 20.203. Safeguards. U.S. Nuclear Regulato y Commission. 3.1.4 Ventilatten 3./.7 Storage. Source Control, and invent <>ry

         ^* # ** E * *
  • In institutions ordering a number and variety of
a. Provide any necessary local exhaust ventilation sources of radioactive material, it is often easier less
 , ,g (such as chemicalfondst or geneni ventilation. as             costly, and more secure to provide a centralized stor-

ta recommended byqrofessional health physicists) for age room for radioactive matenals not in use or used reas where breathaote concentrations of radioactive only occasionally. Such a facility is also helpful in material may be present. keeping exposures ALARA. since it may result in a decrease in the amount of radioactive material stored

b. Design exhaust systems to avoid transporting in laboratories occupied by personnel. )

contaminated air through long ductwork passing inrough many other hospital areas on its way to the 3./.3 Shipping and Receiving stack on the root.

e. Locate exhaust vents so as to provide adequate N!edical institutions should@

meteorological diffusion and dilution to meet 10 CFR a. Plan specific radiation source storage areas for Part 20. 4 20.106 requirements fo effluents to unre- day. night. and weekend deliveries so that sources stricted areas. as well as ALARA exposure consid- may be received at any time and placed in a secure crations for the public. locked location where they will not cause unneces-

d. Where appropriate. include specific types of fil- san exposure t personnd w ters or air cleaners for the exhaust air.

the Radiation Safety Offic(*,ge or the user. awaiting A written survey procedure for receipt, suney. and storage of dels,v-3.!.S Fire Control eries should be provided to anyone responsible for The need for personnel exit and for closing the facility to present the spread of radioactive matenals b. N!ake available a cart or carrier that will main-should be considered for neas where laboratory pro- tam an adequate distance between the courier and the cedures could result in dispersal of radioactive mate- radioactive material package. rials in the event of a fire. Provision should be made

c. Provide space in the receiving area for an initial for local showers and fire extinguishers, where survey and smear test of each package to asoid trans-necessary. For the vast majority of medical institu-porting a contaminated packste through unrestricted tions. emergency pocedures and training should in- ~

areas of the hospital. c!ude immeciate fire control as o pnonty item.

d. Locate shipping and receiving areas so as to (1) 3./.o Special Laboratory Design Features minimize the time required for transporting radioac-Consideration should be given to providing labora- tive material to areas where it is to be t. sed and 42) tory surfaces that may be easily cleaned and decon- avoid the need to transport radioactive matenals taminated daily to maintain minimal contamination througn crowded areas or areas occupied by person-levels and radiation exposures, as well as mmimal in- nel, patients, or visitors.

3.18-4 Iw*A h & g '3 L s

3.1.9 Eqmpment Considerations warning to the therapy t:chnologist or others entering General features applicable for equipment that will the room in case the door interlock system fails when ' I' be used for handling. containing, or contacting the beam is in the on condition.

            ' radioactive matenals are as follows:                                 b. Consider leakage through the teletherapy head
        ~
a. Surfaces should be easilv cleaned and decon- with the source in the "on" position when designing taminated in case unsealed radioactive matenal is re-shielding. Data provided by the manufacturer of the leased. teletherapy machine should be used for this purpose.
b. Equipment should be designed to optimize the c. Design areas .idjacent to the treatment room that ease of carrying out procedures where personnel are *ill be occupied by personnel. patients, or visitors exposed to radiation, thereby minimizing working w.ho are not associated with the radiation therapy de-times. and to maximize distances of personnel frotn Partment so as to maintain exposures ALARA. Re-the radioactive materials with which they are work- duction of occupational exposures to radiation ther-ing, consistent with the purposes of the procedure. apy personnel should be achieved by design provi-sions, procedures. or planning beam orientations that
c. Equipment should operate in such a fashion that would increase exposure to persons in unrestricted it does not damage radiation sources and release areas.

radioactive materials if it fails.

d. Adequate shielding should be provided as pan of the equipment where feasible, to keep exposures 3.3 Nuclear .\fedicine Facilities ALARA.

To ensure that exposures are ALARA. layout and

e. Appropriate caution signs. symbols signals, and design for nuclear medicine facilities and equipment alarms should be provided as part of the equipment to should(i)
a. Allow sufficient space for personnel operating 4, .//A ., meet the requirements of 10 CFR Part nuclear 10.120.q03and medicine equipment torecommended be at least two metersstandards pr fession.

from any patient undergoing scanning whenever the 3.2 Radiation Therapy Equipment and Facilities c nditi n I the patient permits. Specific NRC licensing guides are provided for b. Allow adequate space for stretcher patients

      ,        licensed radiation therapy programs, and the NRC li-           awaiting scans, as well as outpatients. Dosed pa-
i censing staff reviews the safety aspects of facilities tients awaitingeans may cause radiation levels on
     ,         and equipment before issuing a license. In designing          the' order of Iti, n R;hr or more. They may need to be shielding for teletherapy treatment rooms the medi-            segregated from the general waiting area to reduce est institution should consult NCRP Handbook 34 or            radiation exposure to receptionists and persons pass.

49 (Ref. 9) for recommended design details, specifi- ing through the area. such as orderlies and aids. estions. methods of shielding against direct and scat-

c. Provide for easy access to pny.sicians' offices tered radiation. and general principles of rad,ationi and other occupied areas to needed radiopharmaceu-safety design.

ticals. but allow enough distance (several meters is In addition. the institution should usually sufficient) so that exposures from stored

a. Protect each teletherapv treatment room from radi pharmaceuticals and radioactive wastes will be
                                                ~

inadvenent entry by the following means: minimized. t 1) Provide a door interlock that allows a " Beam d. Provide adequate shielding for stored On" condition only when the door is closed. radiopharmaceuticals and partial shteiding for em. ployees preparing dosage for patients. (2) Connect this interlock in series with a green

               ;icht above the door to indicate its proper connection            e. Supply an adequate number of mynnge shields inen the door is closed.                                      and bottle shields (as well as appropnate tongs or               ,

forceps: near the place of dosage preparation. (3) Provide independent back-up caution lights on the console. above the door, and mside the treat. . Provide additional exhaust ventilation in the lab-ment room to indicate the " Beam On" condition to rat ry ne r the r di pnarmaceutical stcrage area to radiotherapy technologists and other staff members. protect against any airborne radioactive or totte ma-tenals that might result from accidental release or (4) Establish a procedure for checking whether spill of radiopharmaceuticals, everyone except the patient is out of the area before the door is closed and the beam is turned on.

g. Include a special shielded waste receatacle for g g gg y
15) Install independent caution lights near the clear medicine laboratory near the dosage preparation entry inside teletherapy treatment rooms to provide a area.

3.18 5 ,,

                                                                                                                                       +
h. Locate a permanently fixed radiation counter sources and their usage should be maintained. The and rate meter immediately outside the entrance to inventory should be c.mbmed with an inspection to the nuclear medicine preparation laboratory for em- ensure proper labeling (see 10 CFR Part 20. }

playees to check regularly for hand or clothing con- 20.203). Section 35.14 of !0 CFR Part 35 reoutres ] tamination when leaving the department. A portable inventones to be conducted at least quanerly. Inven-survey meter available at a convenient location will tory procedures should also provide that the R also help keep exposures ALARA. be alerted if all sources are not returned within a g eef3,, .

i. Provide individual labeled lockers and change specified time, in order to avoid sending patients ye, uur areas for segregating laboratory coats that may be home with brachytherapy sources still in place. caly contaminated by other clothing. b. Sources should be secured within locked rooms
j. Provide finger badces or dosimeters as well as or storage areas when authorized users or their re-body badges for monitor'ing occupational exposure of
        ~

sponsible employees are not present (see Section personnel. C.3.1.7 of this guide). Special shielded vaults should be provided in the storage area for sealed sources. 3.4 In irro Clinical and Research Laboratories c. Authorized persons should be required to sign Stany of the design considerations for inevitro clin- for the removal and return of each source. The source ical and research laboratories are similar to those al- log should be checked regularly by the Radiation ready given for other facilities. Special consid- Safety Office.r/a#. erations include (f) 4.1.: Shielding

a. Easily discarded bench paper, absorbent on the top surface" only for catching and easily disposing of All radioactive material not in use should be com-small amounts of contamination that may drip or be pletely shielded so that exposure rates in any ares that removed from laboratory apparatus and glassware. may be occupied by personnel will be well below the
b. Suitable. easily cleaned drip trays for carrying levels for unrestricted areas of 10 CFR Part 20.

out manipulations of radioactive materials where spil- Whenever radioactive materials are in use. the mate-rial should be unshielded only in the direction neces-IdEC *"Y CC" ~ sary for its use and to the extent that accessibility to

e. Protective clothing, including rubber or plastic the source is necessary.

disposable gloves. for persons working with radioac-tive materials. (Disposable gloves should be changed J./.J Control of Contamination - frequently. ) Equipment should be provided for Radioactive materials in unsealed form or undergo'- monitoring clothing before laundenng. Potentially ng chemical or physical processing should be han- -' radioactive laundry and radioactive wastegould be died only in properly designed facilities tas desenbed turned over to the Radiation Satety Officejor further disposition. in See: ion C.3.3 above) and with proper procedures to avoid transferring radioactive material to the air or Additional recommendations for carrying out in to surfaces where inhalation or ingestion of the mate-vivo expenments witl animals are given in Reference rial by personnel is possible. Where necessary to en-

10. sure that exposures are ALARA preliminarv tests of procedures should be carried out with simulated non.
4. SAFE WORK PRACTICES AND PROCE- radioactive materials or colored liquids to check pro-DURES visions for containment, hand'ing. and ventilation.

4.1 General Principles The Radiation Safety Office staff may make prelimi-The following safe work practices and procedures nary esumstes of job exposure commitments, using for handling radioactive materials in medical institu- tracer levels of radioactive matenal tions are recommended as a minimum. Additional de- Travs and absorbent materials should be used as a tail is given in NUREG-0267. backu'p to catch and limit the spread of radioactive J././ Periodic Inventory and Control of All Radia. contamination whenever there is a possibility that rion Sources planned procedures will fail to conta:n the radioactive Alany of the more serious occupational exposures. as well as patient exposures, have resulted from loss Protective clothing appropriate to the type and of radioactive material, which then may inadvertemly quantity of radioactive material being processed expose unsuspecting persons or be subject to im- should be worn whenever potential escape of radioac-proper usage by unauthonzed persons. The following tive contamination is a consideration. procedures should be taken to guard against these problems: J.1.4 Proper Work Habits

2. A frequent inventory should be made of a11 In general, all personnel handling radioactive ma-radioactive sources, and a continuous record of all )

tenals should be trained to use appropnate shielding l 2 3.18-6

                                                                                                                   - ,t,)

7,A 1

                                                                                                                                  .l

materials, maintain as muc'h distance as possible from levels that show a need for changes in procedures or radiation sources, and limit the time of exposure to equipment to meet ALARA radiation exposure objee-

      /         radiation sources to the time necessary to carry out             tases.

the required task or clinical procedure. In hosp.ital situations where the higher expo <ure The following good work habits are particularly rates occur te.g.. in teletherapy rooms where in acci-important in ensunng that exposures are maintained dental circumstances the limits of 10 CFR Part 20 ALARA: could be approached before an indication was pro-

a. Scaled or unsealed sources should not be Y ***" # "# I*" "" * " ""E touched or held with the fingers, but only with tongs
                                                                                 *      **            "I           "' * " " d * ' # * "

or tweezers appropnate to the operation. daily, as well as warmng devices worn on the body, are helpful in maintaining exposures ALARA.

b. Finger badges as well as body badges should be 4./.6 Training worn by personnel who are handling or manipulating unsealed or unshielded sources with tongs or forceps Employees should be made aware of the ALARA or who are holding partially shielded containers of provisions of 10 CFR Part 20.120.1 as well as those radioactive material with their hands. However. these of Regulatory Guide 8.10. Employees should be in-badges are not needed for personnel handling only structed in the philosophy and prostsions of Regula-the types of sources used for tracer level in vitro tory Guide 8.13. " Instructions Concerning Prenatal studies, where dose rates are less than 0.1 mrem per Radiation Exposure." whenever there is a possibility hour at I cm. that pregnant women may be exposed to radiation.
c. When working with unencapsulated radioactive Each employee >hould be acquainted with the in-matenals. personnel should wear rubber or plastic stitution's own procedure for handling radioactive gloves and other special clothing, scurces and radioactive materials and with NRC
d. Care should be taken to avoid needless con- licenses and their radiation safety provisions (includ-tamination of objects such as light switches. taps. or ing license e nditions incorporated from license ap-door knobs. plicati ns and correspondence). Copies of these pro-cedures, licenses. and related correspondence should
e. Radioactive solutions should never be pipetted be made available to the employees as part af their by mouth. orientation to radiation safety requirements.
f. Eatine. smoking, drinking, and application of cosmetics should be prohibited in laboratones where 4.2 Radiation Therap*y radioactive materials are handled. This guide provides recommendations for main-
g. Special precautions should be taken to avoid the taining exp sures ALARA in three subdivisions of possibility of small amounts of radioactive matenals radiation therapy:

entenng into cuts.

a. Teletherapy-the treatment of patients with
h. The use of containers or glassware with sharp high-energy beams from shielded irradiators contain-edges should be avoided. Care should be taken in ing s urces f high gamma ray emission rates.

working with contaminated animals to avoid bites or scratches.

b. Brachytherapy-the treatment of patients by insertion of sealed sources such as needles or tubes
i. Food and drink should not be stored in the same f r interstiti i r intracavitary irradiation.

place te.g., refrigeraton with radioactive matenals. c. Radiopharmaceutical therapy-the injection

j. Radioactive materials should be secured ic.g.. r ral administration of solutions or colloids of placed in a locked room) when personnel are not '* "#' N#""*"**'* 9" ' # " #"'#*'#

present. in and irradiate the organs in which they are dis- { persed or absorbed. l' I n.l.3 Radiation or Radioactivity Stontrorrng 4.2.1 Telerheraps The independent radiation surveys, inspectrons, Radiation protection measures in teletheraps inventories, and smear tests to be carried out by the should rely primanlv on the adequaev of facilitte's

                                                                                                                        ~

1 Radiation Safety Office staff were discussed eariter and equipment since'verv intense radiation levels are  ! in Section C.2. In addition, each user of radioactive sencrated (see Section C.3.21. Nevertheless, some matenals should survey radiation and radioactivity basic routine operattne principles for maintaining oc-cupational exposures ALARA 3hould be followea: levels within his or her own operations daily to help maintain exposures ALARA. A simple logbook of a. With the aid of the maintenance and operating daily readings should be maintained by the user to manuals provided by the manufacturer of the tele-indicate any enanges in radiation or radioactivity therapy unit procedures should be established for s. 3.13-7 .

                                                                                                                               ,  cp l

l l l

routine maintenance and checkout of safety-related loaders for as much of the duration of the procedure features of the teletherapy unit. as possible. .

d. When after loading sleeves or ovoids are 4
b. A daily morning checkout procedure should be posted and established for the therapy technologist to loaded, they should be placed in adequately shielded carry out simple operational checks of indicator carts for sterilization and for transport to the patient's lights. caution lignts and signs. key and door inter. room when the physician is ready to insert the after-locks. gamma radiation level indicators. and timer loaders. These carts should be properly tagged and operation and interlock function. should at all times be under the direct supervision of the radiation physicist or radiation safety staff.
c. A general safety check. including a spot or point calibration check and check on beam alignment and e. Similar protection should be provided for use ir.

confining devices, should be made and recorded at threading radioactive needles for implant therapy. least monthly. All records of the monthly calibration f. While manipulating sources loading the after-and safety check, as well as the morning checkouts, loaders, and threading needles, personnel should be should be signed and dated by the persons carrying provided with tongs and surgical clamps to maintain ut the tests. the distance of the fingers preferably about 30 cen-

d. During patient treatment or operation of the tele. timeters or more from these sources.

therapy unit for calibration or maintenance proce- e. Finger dosimeters as well as body dosimeters dures, care should be taken to follow written instruc- should be worn by personnel when they are loading tions and use installed safety devices to ensure that or preparing sources for insertion. niso. the Radia. no personnel except the patient or phantom to be ex- tion Safety Office staff should periodically survey the posed is in the teletherapy treatment room during the loading procedures and provide job-time-exposure in-Beam On condition. formation to help employees maintain exposures

e. During " Beam On" operation. the operator at ALARA. Use of a gamma alarm typ: ionization the console should remain in a position of lowest chamber in the storage loading area will indicate radiation intensity consistent with vigilance of the when radiation sources are outside their shields and console and patie'nt during treatment. as advised bv help avoid inadvertent exposure due to. lost or mis-the Radiation Safety Office staff using the post"- placed sources.

installation radiation survey. All persons not required h. A continuing list and count of removals and re-to remain near the console should remain or work in turns of individual sources from the storage contain- s areas of lower radiation background intensi v while ers should be maintained to help ensure ag'ainst inad-

                                                  ~

the teletherapy unit is m operation. vertent loss and exposure of sources.

f. Emergency procedures established as required i. Sources maintained in tixed position for a con-by NRC license conditions should be tested by reg- stancy check on the operation of any intracavitary ion alar familiarization sessions or by staging mock chambers should be maintained within shielded wells emergencies for the training of personnel- in constant geometry so they can be used for a rapid and safe check of ion chamber operation before the J..,.., Brachytherapy treatment of each patient.

Detailed recommendations for reducing radiation

j. Time and exposure studies should be carried out exposures in brachytherapy are given in NCRP Re. by the radiation protection staff on typical surgical port Number 40 tref. III. and additional recommen- iEiplants and typical insertions of radioactive dations pertinent to brachytherapy, as well as sources--either in the operating room or by after-radiopharmaceutical therapy. are contained ,in NCRP loading in the patient's room. These time-e'sposure Report . Number 37 tref.12). Some of the most im- studies'should be recorded and reported to the per-portant practices for maintaining exposures ALARA sonnel involved to maintain an awareness of radiation are as foHows:

exposures resulting from these procedures.

a. Modern after-loading devices should be used k. Transport of a patient containing radioactive
                                                                                                          ~

wherever medically acceptable, material to areas outside the operating room and to

b. Jigs should be prepared and tested for ease in his room should be directly supervised by the Radia-loading' sources into after loading devices in the pa. tion Safety Office staff or the radiation physicist. ,
        ~

tient's room. Also, transport of after loading sources and supplies i for insertion of applicators. lead bedside shields for  ;

c. Jigs for leading the after loaders should be set the nurses, and any other supplies and equipment re-up behind shields with lead glass viewing windows. quired for expediting an efficient after loading proce-and auxiliary lead brick shielding should be provided dure should be checked and supervised by the Radia-to shield the arms of the personnel loading the after- tion Safety staff. Radiation surveys should also be
                                                                                                                              /

3.18-8 V q

earried out on a sample basis and recorded to main- Statenal Safety and Safeguards. Nuclear Regulatory

   ,      tain an awareness of the exposures resulting fror"             Commission.

8 these procedures.

1. Nursing personnel should be provided with per. 4.3 Diagnostic Nuclear Sledicine sonnel dosimeters tas required by 10 CFR Part 20 Ntany of the principles of radiation protection prac-and should be trained in their use- tice in diagnostic nuclear medicine were discussed in
m. Patients should be surveyed in their rooms bv previous sections on recommendations for nuclear the radiation safety staff after removal of medicine facilities and equipment (Section C.3.3) and brachytherapy sources and before discharge as a -eencral principles of safe work practices in handline final step to check against leakage of contamination radioactive materials (Section C.4.!L Additional rec'-

from brachytherapy sources or inadvertent loss of. ommendations are: these sources in the patient's room. 2. Place radionuclide generators in an area separate L2.3 Radiopharmaceutical Therapy v Nuclear from the other nuclear medicine operations, with

                 .tfedicine Therapy with Unsealed Radioactive          adequate ventilation and additional shielding as
                 .tfarerials)                                          necessary to reduce external as well as internal expo-sure to personnel during elution.

Where feasible and in the best interests of the pa- b. Use separate shielded bottles for checking the tient. administration of millicurie quantities of the assay of eluates in the nuclear medicine dose calib-types of radioacnve drugs used for therapy of specific. rator, or other suitable assay system, to allow calibra-diseases should be carried out in a specific area or tion procedures with a smaller quantity of radioactive room separate from other nuclear medicine or material. radiotherapy operations. However this special area or room should be in the general vicinity of the lab, c. Shield ionization chamber calibrators, where oratorv where the radiopharmaceuticals are stored to possible, to maintain employee exposures ALARA alleviate the need for transporting these materials while nuclear medicine doses are being calibrated. over long distances or through other areas of the in- Recalibrate refitted chambers as necessary. stitution. When these matenals must be transported to d. Use Mme hoeds and good contamination control a patient's room for administration. the radiation safety staff should monitor and assist in the prepara-principles when preparing dosages of radiophar-maceuticals that hase potential volatility, tion of the materials and supplies, the transport of the materials to the patient's room. and the administra. e. l<eep shielded radioactive waste cans for used tion of the radioactive drugs. Precalibrated contained synnges and other radioactive wastes at an adequate sources (e.g., capsuleh should be used whenever distance from the laboratory areas most frequently possibie. occupied by personnel, to the extent possiole. After treatment, surveys of all artic!cs should be f. When they do not interfere with the diacnostic made before release from the room to the general tests, use protective lead screens to protect er'nplov-public. Contaminated articles must be released to the ees and other patients during procedures usir$e M ry Radiation h - Officer for decay or disposal. Te 99m or other low-enerev ear'nma emitters. Portal Also, the panent should be surveyed before release ble screens of oniv 2 mm"Pb thickness will reduce Te 99m gamma-ra'v exposure rates to less than 0.5 and should be instructed on ways to minimize percent. contamination of the environment and exposure of otner memeers of the public. g. In lung perfusion or ventilation studies with xenon 133 or other radioactive gases or aerosols. use In supervising the administration of radiophar- additional lead shielding of 1.6 mm thickness around maceuticals to patients, the physician in charge and the absorber cannister, oxygen bag. and waste recep-the radiation safety staff may use many of the princt- tacle to reduce occupational exposures when frequent pies given for brachytherapy in Section C.4.2.2 above. procedures are earned out. as well as princ:ples and practices presented in NCRP Report 37 (Ref.12L The use of these procedures should help ensure that exposures to hospital staff 4.4 Low Level Clinical or Stedical Research Labora-and pnvate duty nurses are ALARA not only during tory Activities the administration of the dosage to the patient, but Laboratories in medical institutions that use tracer also dunng any hospital care of de patient. dunng amounts of the less radiotoxic nuclides may keep ex-and after discharge of the patient. and in the event of posures ALARA by using the recommendations given any later surgery, autopsy, or bunal of the patient. in Secuon C.4.1. Stany of the radionuclides used for in Additional guidance is also available from the vitro clinical tests such as blood volume, radioim-Radioisotopes Licensing Bran:h. Office of Nuclear munoassay, and other low level in vetro or animal 3.18 0 go#

l studies insolse pure beta emitters or weak gamma tion with members of the Niedical Isotopes Commit- , emitters, with only microcurie or submierocurie tee and th~e Radiation Safety Office. The results of ' quantities handled and processed by individual per- this audit may then be discussed at an annual Afedical N sonnel at any one time. External and internal radia- Isotopes Committee meeting to ensure that all users tion exposures to personnel in such laboratories and responsible staff are aware of current policies and should ordinartly be maintained well below 109 of procedures and methods for their improvement. An the permissible occupational exposure limits of 10 inspection checklist in NUREG 0267 gives items that CFR Part 20 tnrough careful initial planning of lab- may be inspected by the administration during this oratory facilities, equipment, and procedures by the annual audit. A report containing the results of the laboratory supervisor in conjunction with qualified audit should be maintained by the Radiation Safety

health physics personnel. Office for possible use in expediting any inspections by regulatory or accrediting agencies.
5. SIANAGE31ENT AUDIT AND INSPECTION OF THE RADIATION SAFETY PROGRASI D. IMPLEMENTATION Ultimate responsibility for the establishment and continuation of an adequate radiation safety program The purpose of this section is to provide informa, in a medical institution has been placed with the gov- tion to applicants and licensees regarding the NRC erning body of the hospital. The administrator report- mff's @s b W Ws @m M ms guide reflects practices currently acceptable to NRC ing to this governing body should be sufficiently in-formed at all times to be sure that all regulations are staff. Except in those esses in which the applicant or faithfully adhered to ind that the use and safe han- I censee proposes alternative practices or methods for dling or radioisotopes are properly carried out t complying with specified portions of the Commis-
                                                                        ~

maintain exposures ALARA. sion's regulations, the practices or methods described herein will be used as a basis for the evaluation of The hospital administration should consider an an- applications for specific materials licenses for medi-nual audit of the radiation safety program in coopera- cal institutions. l 3.13-10 9

3 9 APPENDIX f RADIATION SAFETY TASKS INVOLVED IN KEEPING OCCUPATIONAL EXPOSURES ALARA

1. Surveys of the following radioactivity areas: L Evaluation of internal exposure by means of:
a. Nuclear medicine a. Collection of samples
b. Radiation therapy b. Radiochemical or scintillation bioassay analysis
c. Oncology c. Counter calibration
d. Patholog'v d. In vivo counting
e. Cardio[7gy e. Computer analysis of results
f. Pediatrics
g. Radioactive waste disposal and storage
h. Other research and clinical laboratories usmg
3. Spec al surveys of patients and rooms for implant, radioactive materials. intracavitary, or unsealed radiopharmaceutical
2. Surveys of diagnostic and therapeutic machines therapy, including:

and generators, including: a. Room preparation and protective covering

a. Teletherapy sources and machines
b. Labeling ibed, chart. door)
b. Computenzed uial tomography scanners c. Nursing staff and housekeeping staff briefings
c. Interlock and safety checks d. Background survevs
d. Calibrations e. Source insertion a"nd after loading surveys
e. Fluoroscopes f. Survevs of patients in operating room and re-
f. Radiographic X rays covery room
8. Placing oflead barriers JA4m 3. Personnel monitonng h. Recovecy of sources and wastes
 .bmd                .     .                                                 i. Survey of room cleanup and decontamination
a. Review or personnel exposure data and reports
b. Preparation of reports required by regulations j. Instructions to patient
c. Filing. collection and mailing of personnel monitanng devices (including late and lost) 9. Administration and consultation. including:
d. Special investigations of exposure and notifica-tions to regulatory agencies where appropriateG
3. Approval of facilities. equipment. and proce-dures used in areas where radioactive material's
4. Radiation saferv instrument calibration and
                                ~                                                are handled maintenance                                                     b. Preparation of license applications and amend-ments
a. Calibration
b. Battery replacement and adjustment
c. Preparation of hazard evaluation reports for li-censing
c. Pocket chamber and TLD calibration
d. Light repair telectrome) d. Programming of routine required surveys
e. Instrument seiection and distnbution e. Supervision of routine radiation safety opera.

tions

f. Check-source calibration
f. Revisions to radiation safety manual
5. Decontamination and waste disposal g. Penodic radiation safety instruction for hospital 2.

staff and administration Collection and packaging h. Training of residents and medical staff

5. Surveying .
c. Recording i. Confere'nces with physicians and other safety I staff
d. Shippmg arrangements ,
e. Placard.'1g
j. Coordination of radiation safety committee  !

meetings and minutes

f. Decontamination of surgical instruments. ~
k. Inspections and discussions with government l

rooms. and laboratories regulatory agency representatives

6. Leak testing radioactive sources using the follow-
                                                  ~
                                                                      /         Professional meetings ing techniqizes:                                                m. Selection and ordering of equipment and

[ supplies

a. Wiping n. Planning and budgeting
b. Counting I
o. Facility and shield design and meetings with ar-
c. Calculations f chitects
d. Recording l p. Record maintenance and related computer pro-
e. Counter calibration >

gramming sHendance ! pertado.do'cn ' 3.18-11

                                                                                                                       & , ct

REFERENCES

1. U.S. Nuclear Regulatory Commission. Practice. ' Vol.1. " Basic Protection Require- -
   " Draft-Principles and Practices for Keeping Occu-     ments." World Health Organization. Geneva. Swit-pational Radiation Exposures at stedical Institutions  zerland.1974 As Low As Reasonablv Achievable." NUREG-0267 g977'                                                     3. Department of Health. Education, and W.e lfare.
                                                           ' Health Physics in the Healing Ans." Publication
2. National Bureau of Standards. " Permissible No. (FDA) 73-8029, proceedings of the Seventh Cose from External Sources of ionizing Radiation." Slidyear Symposium of the Health Physics Society.

Handbook 59. Recommendations of the National San Juan. Puerto Rico. December 1972. Council on Radiation Protection (NCRP Report No. I .1. Washington D.C.. September 24. 1954. 9. National Council on Radiation Protection and A!easurements. 'N!edical X. Ray and Gamma-Ray

3. National Council on Radiation Protection and Protection for Energies up to 10 NteV-Structural N!easurements. Review of the' Current State of Shielding Design and Evaluation. ' NCRP Report Radiation Protection Philosophy" Report No. 43. No. 34. Washington. D.C. 1970. Reissued as NCRP Washington. D.C.. January 15. 1975.
                               ~

Report No. 49. " Structural Shielding Design and

4. National Academy of Sciences-Nanonal Re. Evaluation for Atedical Use of X-Ravs and Gamma Ravs of Energies up to 10.\teV." Sept. 15. 1976.
                                                              ~          ~

search Council. "The Effects on Population of Expo-sure to Low Levels of ionizine Radiation." Washine.

                                 ~                    ~
10. National Council on Radiation Protection and ton. D.C. 1972. Sleasurements. " Radiation Protection for Stedical and Allied Health Personnel." Report No. 48. Wash-
5. Federal Radiation Council.
  • Background N!ste- inston D.C. 1976.

rtal for the Deselopment of Radiation Protection ' Standards." Report No. I. Washington. D.C. 1960. I1. National Council on Radiation Protection and Steasurements.

  • Protection .isainst Radiation from
o. International Commission on Radiological Pro- Brachytherapy Sources." Report No. 40. Washing-tection. 'Impliestions of Commission Recommenda- ton. D.C. 1972.

tions That Doses Be Kept As Low As Readily Achiev-able.' Report No. 22. Pergamon Press. Elmsford, 12. National Council on Radiation Protection and New York, lo74 Steasurements. "Precaunons in the Stanagement of Patients Who Have Received Therapeutic Amounts of 7 C. E. Braestrup and K. J. Viiterlof. .\tanual Radionuelides." Report No. 37. Washington. D.C.. on Radiation Protection in Hospitals and General 1970. vmrEo stares NUCLE Aa a E cuLAron y couMissICN AasmNGroN o.c.20155 posvaos ano acts paso u.s. muc6 tan escuLA f omv oF8'CI AL SVs NESS C O M M I S SI O ne M

      .Es ALrv 8ca netV ArE vsE Saco k   MM j x

l l i _.

RADIATION SAFETY OFI ..E h9.a&lE

                                                                               ?

hedi bj UNIVERSITY OF MISSOURI

h. -

413 CLARK HALL January 30, 1978 COLUMBIA. MISSOURI 65201 tNTEM.CEPARTMENT CORRESPONDENCE TO: 11 embers, Radiation Safety Committee SIembers, Radiation Control and Human Use Committees Health Physics Staff

SUBJECT:

A place for radiation safety in a risk management program 9 Everyone knows that resources provided to support higher education are shrink-ing while pressures to comply with regulatory constraints on the administration of higher education are expanding. Regulations directed to control of hazazds of all varieties are expanding as well to add to the costs of maintaining programs in higher education. For the most part, a judgment about how these costs are allocated is not permitted; either the resources are provided or the regulated program cannot be ccnducted. All that can be accomplished is to attempt by good management to mini-mize the costs. A case in point is biohazard control. 31aterials that constitute a biohazard are not unusual in a university, especially if a medical school is present. Traditionally, the investigator making use of these materials in research has been responsible for 4 ,'- jTs' ' safe containment and control of them. A new class of these materials labeled "re- g combinant DNA" has received special attention. This special attention has serted j as a reminder that we have other and equally hazardous materials around and maybe i something should be done about them too. At the administrative level this leads to a , reexamination of what we are doing about all hazards. An assessment of what shculd be done to control risks of all varieties is the ad- f ministrative exercise called " risk management." Risk management in the University ' of SIissouri is at present being reexamined. 'Ihose of us with an Interest in radiation safety will want to know how it fits into the overall risk management effort. Further-more, because radiation safety is the only operational program of consequence, we will want to be sure that its performance is not compromised withcut good reason. To Jet a foundation for the purpose of discussion, the attached essay on " Risk IIanage-ment and Radiation Safety Programs in the University" was prepared. Your comments and suggestions related to the content will be appreciated. -

                                                                            ~

John H. Tolan Radiation Safety Officer JHT/djf cc: A. G. Unklesbay, Ph. D.

                                                                                                      ,       g L)

A. H. Emmons, Ph. D. ,, i. .g N Enclosure 4-\ - y

l DRAFT #2,1/78 ' 1 RISK AIANAGE31ENT AND RADIATION SAFETY PROGRAMS l 2 IN THE UNIVERSITY  ! 3 INTRODUCTION l 4 Risk management is the term applied to a strategy 6 tended to confront and 5 contend with a collection of loosely related problems in the university. Occupa-6 tional safety, industrial hygiene, wozicmen's compensation, liability insurance, 7 fire prevention, biohazard control, radiation safety and so forth are among the S related problems. A risk management program specifies the administrative re-9 action to be made to each of these risk categories. It is primarily a phnning 10 functien, although it may extend into operational activities. A radiation safety 11 program conducted in a university is an operational activity that represents but 12 a part of the institution's overall strategy to manage risks to prevent loss of re-13 sources, but the radiation safety program is much more an obligatory response to 14 Federal and state regulations. Without the program to satisfy the regulator / con-15 straints, impor: ant research and teaching activities cannot be conducted. 16 An operational program for radiation safet'/ is usually administered sepa-17 rately from the program constituted to contend with other risks because of the is unusual characteristics of the problems to be resolved. These characteristics 19 include the need for compliance with the applicable regulations. Radiation safety 20 is related more closely to the research activities of the institution than it is to the 21 general instructional function. Hazardous sources of radiation within the univer-22 sity are deliberately isolated and insulated from the mainstream of university 23 activities. Other hazards to be found in the university have been identified for a 24 Icng time, but not much is done to control them beyond application of common 25 sense measures by the faculty and staff. Provisten for additional control meisures 26 has been cost limited without an incentive for correction provided beyond ethical in-27 ducements. Pressure to increase control measures now comes from insurance 28 carriers and from the Occupational Safety and Health Act. 29 RISK 3IANAGEMENT 30 The typical university environment presents a bewildering variet/ of risks to 31 life, limb, and health. It is not an overstatement to say that with pecple present,

                                                                                                     .. i \

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4 1 anything can happen. And there are many people present in the university. Side-2 walks, stairs, streets, elevators, floors, walls, lighting fixtures, furniture, 3 structures, windows, radiators, water lines, and so on are among the elements 4 of the manmade physical plant. For the most part, these elemalts are mann-5 factured, installed, used, and maintained within specifications developed over 6 time that ensure safe and reliable performance. Within the physical plant of 7 the university, are found laboratories with fragile glassware, bottles with corrosive 8 reagents, apparatus with hnzartlous emissions, fume hoods with toxic vapors, 9 machines with rotating parts, containers with flammable liquids, boxes bristling 10 with high voltage, and on and on. The inside is a hazazdous place. All of these 11 things are important; all of these things deserve attention. What to do? Is it 12 appropriate to devote a significant effort to control of one hazard while we over-13 look hazards of greater peril? We do that. Very few institutions can afford the ' 14 luxury of providing voluntarily for control of an unregulated hazard to the same 15 degree provided for a regulated hazard with an obligatory safety program. A 16 risk management program attempts to assess these risks in terms of the rescult:es 17 available to control them such that human loss and prcperty loss are minimized. la Even though it is a trivial hazard by comparison with certain other hazards all ' 19 about us, radiation is carefully controlled by regulation whereas most other hazards i 20 are not similarly regulated. Even radiation is only partly controlled, although an 21 attempt is made to control non-redulated sources as well as the regulated ones. The 22 Occupational Safety and Health Administration (OSHA) has a bag full of toothy regu-23 lations designed to protect the worker at his job. The Environmental Protection 24 Agency ( EPA) has a yet unused mandate to protect the citizen from pollutants cast j 25 into the environment by other citizens, but pressure from the EPA in the radiation 26 arena is growing and is being felt. The Food and Drug Administration ( FDA) guards 1 4 27 us from fads, fancies, and quackery as well as from ineffective radioactive drugs.. 2s The Bureau of Radiological Health (BRH/FDA) protects us from the unsafe emann- I 29 tions of electronic products. The Federal Aviation Administration ( FAA) insures 30 our safe transport in commercial aircraft. The Department of Transportatica 31 ( DOT) regulates shipment of hazardous material in interstate commerce. And there 32 are more. What more do we need ? 2

1 The Occupational Safety and Health Act of 1970 is worthy of some comment be-2 cause its intent and its execution are often misinterpreted. Intended to protect the 3 worker at his place of employment, implementation of the provisions of the Act have 4 been found to be almost hopeles' sly complicated. The Occupational Safety and Health 5 Administration (OSHA) established in 1971 to provide the implementation of the 6 Act has become a classic example of bureaucratic ineptitude. Almost nothing this i 7 agency has done has been effective. Now, a heroic effort is demanded merely to S correct past mistakes with little left to devote to its intended mission. A new S management (the fourth) is attempting to reestablish credibility in the agency. 10 Compounding the problems facing OSHA is the serious shortage of the basic skills 11 required of an inspector to evaluate and judge the seriousness of occupational 12 hazards. These hazards include both safety and health threats that are sufficiently 13 dissimilar as to require two people to evaluate them. The agency has hired every 14 warm body possessing some industrial hygiene skills it can find and is still short-15 handed. There are lawyers aplenty to write regulations, but there is a woeful 16 scarcity of skilled personnel to apply these sensibly in the field. 17 To settle the politically touchy question of state government sovereigntf , the IS Congress wrote the Occupational Safety and Health Act in such a way that any 19 state could assume its responsibilities whenever it chose to do so provided only 20 that an equivalent program was ready to operate. I*ntil a state elected this course, 21 the Federal program would function in the state. Under a Federsi program, all 22 Federal and state agencies within the state are exempt from the OSHA regulations, 23 although Federal agencies are expected to develop and implement equivalent pro- t 24 grams. Consequently, any state-sponsored academic institution in a state without 25 an OSHA agreement is exempt from the provisions of the Act. Some universities 26 in these circumstances have declared an intent to comply voluntarily with the 27 regulations in anticipation that the exemption will be short lived. Also, it is 28 possible that an individual contract or grant accepted by the university from a 29 government agency will stipulate that voluntarv compliance with the OSHA regu-30 lations is a condition of the contract or grant. Thusly, a university can expose , 1 31 itself to the full impact of the regulations, even though otherwise exempt, in 32 order to receive the benefits of the contract or grant. Q { Sk

A Costs of compliance with the OSHA regulations are staggering and very likely 3 beyond the means of any institution public or private. Something has to yield, and 3 the likely candidate to volunteer to back off is the Federal agency itself. A few j 4 steps in this direction have been taken already. A prudent administration of an 5 exempt, state-sponsored academic institution will wait before committing itself 4 6 beyond a token program for compliance. The resources to do otherwise are 7 simply not available, and the risks may in the end need to be lived with anyway. ) 8 Is a slippery floor more hazardous than a vial containing 10 MCI of radio-9 active phosphorous left unattended on a laboratory bench ? It certainly can be. Is 10 an exterior door of a building that is blocked or opens inward more hazardous than 11 the x radiations from a color television set ? Definitely. Can inadequately stored 12 flammables create more of a risk than an unnecessary x-ray examination? You 13 had better believe it. Can an overloaded electrical circuit create more damage 14 to an individual than the act of establishing residence in Grand Junction, Colorado, 15 where buildings are made of radioactive material? Very likely. How can the 16 individual be protected in his workplace, his home, where he shops, where he 17 seeks his recreation, or where he travels ? We delude ourselves if we think a 18 safe - absolutely safe - environment can be managed. To the extent other commit-19 ments of our resources permit, we must dedicate what we can to the elimination 20 of the hazards in the university environment. This action being insufficient to 21 correct all problems must be directed to the correction of those that present the 22 greatest risk of damage. Here damage is measured in units of human suffering 23 rather than in units of property damage or cost of insurance premiums. 24 5 tost hazards to which we are exposed are self evident and avoidable or at 25 least avoidable by practice of common sense. Where we need help is in the 26 avoidance of hazards that are not easily recognized by the average citizen. Ra-27 diation is one such hazard. Food additives, drugs, pesticides, and other toxic 28 agents used in large quantities in consumer goods are examples of other hazards 29 that the normal citizen cannot evaluate for himself and for which he needs some i t 30 protection on his behalf from his government. The citizen is due a safe workplace 1 31 which if the employer can not or will not keep it safe, the government must force 32 the employer to do so,. This is the justification for the OSHA regulations. Common 4 4 l

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. o 1 sense has not been provided to individuals in uniform increments. Some of us 2 were left out entirely and must rely on the help of others to avoid hazanis. Others 3 of us not only lack common sense but ignore the help provided by others. Nothing 4 can be contrived to help these people. 5 A university as an employer and as a custodian of what amounts to a public 6 facility must provide a reasonably safe environment within its boundaries for its

        ;    staff, for its students, and for the memNrs of the general public that are permitted a    to wander around on the premises. Responsibility for maintaining this safe environ-9    ment must fall upon all of the residents of this community - the staff, the students, 10        and the administration. No one is exempt from this responsibility. A mechanism 11        mus+ exist to report and to correct defects, but everyone must participate in main-12        taining the safe environment. An overall surveillance and evaluation of the program 13         mus: be provided, and an active, continuing-education effort is essential to its suc-14         cess. A risk management operation is necessary to provide the monitoring and 15         educational programs, but the actual control measures are provided by everyone.

16 Without an awareness and participation by everyone, no safety program however 17 funded and staffed will make much headway in reduction of accidents. 13 But what of the hazards that escape casual detection ? What of the hazards that 19 must be kept isolated from the casual observer? Toxic chemicals or bacterial and 20 viral infectious agents including poisons, mutagens, carcinogens, and teratogens 21 are hazards that escape our normal senses except when they are clearly labeled. 22 To the extent that the presence of such materials creates a risk of exposure to the 23 unwazy occupant of the environment under the custody of the university, suitable 24 control measures must be applied to limit the risk of a hazardous exoosure. Sp e-25 cial training in the control of these hazards is provided to the industrial hygienist, 26 although no individual can become expert in all control measures for all hazardous 27 materials. If a university has such materials normally present to supply its re-28 search and teaching needs, a control operation comprised of one or more industrial ' 29 hygienists to supplement the control measures applied by the investigator who is { l 30 using the materials must be established to limit the university's vulnerability to a 31 loss of resources. Such a supplementary internal control cperation falls under the 22 umbrella term of " loss prevention," but it is highly technical and specialized in its 5 YRhk l l

e . l l 1 execution. That is, " loss prevention" is usually encountered as an administrative 2 term rather than an operational one. It says "what" but not "how. " 3 Radiation is the other hazard that escapes casual detection. Consequences of 4 exposure to radiation are dreadful indeed, but they are so rare as to be almost non-

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i 5 existent. Should we relax and devote some of the effort we now expend on radiation 6 hazards to the correction of other hazards of greater actual consequence? This i 7 would seem to be a reasonable course of action, but the public will not permit such 8 an adjustment. In the present mood of the public, the lid we keg on radiation haz- I 9 ards must be pressed even tighter rather than easing back. This forces a dispropor-  ! 10 tionate effort on the control of radiation hazards as compared to the control of other 11 hazards. But as long as we do main +=fn this effort to control radiation hazards, why - 12 not use the talents already employed in that activity to monitor at least the other haz-13 ards that coexist with radiation in our research and instructional facilities ? ' 14 Detection of hazardous sources of radiation is so easily accomplished that this 15 sensitivity is both a blessing and a curse. Instruthents to detect radiations are so 16 sensitive even in primitive form that the natural background is easily measured. Be-17 fore radiation becomes a serious concern in uncontrolled areas, egosure rates sev-18 eral times the background must be present all of the time; and for short-term expo-19 sures, serious concern is not warranted until exposure'; rates exceed ::atural background 20 by thousands of times. In controlled areas where monitoring of radiation levels is pro-21 vided, even more radiation can be tolerated. Detection of other hazardous agents in the 22 environment is not so easy. With radiation, detection of truly trivial exposure rates 23 may alarm a person unschooled in the consequences of the exposure. For other haz- P 24 ardous agents less easily detected, truly injurious exposures may occur at levels be- , 25 low the threshold of detection. It is possible to be in a toxic environment and not be  ! 26 able to detect the contaminant. On a relative basis, therefore, control of radiation 1 27 hazards may be more easily managed, but the public perceives these manageable 28 quantities as hnznrdous while ignoring other more serious hazards simply because they l 29 are not detected. Effective control presupposes a capability to measure the toxic agent. , , 30 RADIATION SAFETY 31 To state the obvious, radiation safety programs grow with an expanding use of In-32 diation sources. Use must come first. These developed uses are justified by appropri-6 l l l _ _ _ . _ - _ _ _ - . _ , -. -

l 0 o l 1 ate standards applied to the measure of their contributions to university programs in 2 research, instruction, and service. No radiation safety program has been established 3 without there first being a significant use pattern already developed. If the use pattern 4 expands, the radiation safety program established to support it will need to expand also;  ! 5 but it will always be behind in available resources because of the time lag in getting to-  ! 6 morrow what you need today, if you get it at all. In the recent past, proliferation of 7 regulatory requirements has been experienced with expanded use. Even if the use j 8 pattern remained constant during the past ten years, resources provided to the radiation 9 safety cperation needed a 50-percent increase just to maintain compliance with the ex- 1 10 panded regulatory requirements. 11 Programs for radiation safety grew in stages. The first stage occurs when the 12 first individual of an institution applies to the Nuclear Regulatory Commission (NRC) 12 for a license to use byproduct, source, or special nuclear material for instruction, 14 research, nuclear medicine, or whatever. ( A few years back, the institution may 15 have had an unregulated program of use of radiation isources not controlled by the 16 NRC; but new, most such sources are regulated by state governments. ) In the 17 application, a radiation safety program must be described that will satisfy an NRC 18 license reviewer of the capability of the institution as licensee to control the risks of 19 the proposed use. These requirements are exolicitly stated in Regulatory or Licensing 20 Guides published by the NRC. Obviously, if the preposed use is routine and the quantities 21 of hazardous materials are small, not much of a program will be needed to satisfy the 22 reviewer. After review and approval, a license will be issued to the institution with the 23 tedividual identified as the authorized user. At this stage, the resources required for 24 a radiation safety program in compliance with the regulations are trivial and can be 25 supplied by a grant or by departmental allocations. The individual authorized user is 23 most frequently serving the secondary role of radiation safety officer for the project. 27 At stage two, the individual program will have grown in scope and complexity to 28 the point that several persons may now be involved under a single license with more than 29 one of them identified to the NRC as authorized users. For this type of license, individ-30 cal users are identified, their credentials are submitted to the NRC, and these are Individ-31 unlly evaluated by the NRC. Nuclear medicine programs in a university medical center l 32 are typical of a stage-two status. Starting with one physician identified as both de au-33 thorized user and the radistica safety officer, the program blossoms in short 1 l 7 b - .

1 order into operations with two or more physicians, associated professional staff, 2 technologists, clerks, and so forth. Only one of these can be named as the radia-3 tion safety officer. As soon as this operation grows to the size at which some staff 4 member [other physician, allied scientist, or technologisti can be delegated the 5 Job, a new radiation safety officer is idatified to the NRC. Qualffications of the 6 individual named as radiation safety officer in a stage-two program do not need to 7 be very strong in the sciences of radiation protection. Practically anyone can be an 8 acceptable radiation safety officer at this stage. Frequently, an outside consnitant 0 is employed on a retainer basis for parttime contributions to the solution of technical 10 problems that are beyond the capability [or interesti of the staff in residence. 11 A stage-three program develops when the single program becomes so large that ] 12 radiation safety is occupying the near fulltime attention of one staff member. Possi- l 13 bly, some other departments in the university have individual staff members with an 14 interest in a teaching or reses2t:h use of a licensed material. Individuals from other 15 departments can identify themselves as radiation safety officer for their own projects 16 when they file an application for a license, or they can borrow the person serving in 17 this capacity from the more developed program. Depending upon the internal politics 18 and the fundir.g patterns involved, several independent radiation safety programs may 19 develop helter-skelter; or a single program providing a service to all departments 20 will grow within the department that first developed the need. For this stage, the 21 NRC is relatively unconcerned about which choice is made because there are not yet ! 22 many people whose activities they need to monitor. But the growing responsibilities 23 of the pez on serving as radiation safety officer may now begin to exceed the appoin-24 tee's capability to contend with them. The consultant employed to help a stage-two 25 program cannot contribute the time necessary to contend with the many more prob-26 lems involved in a stage-three program, so more technical competence must be 27 developed by the staff in residence. 28 ' With limited growth, a program may remain in stage three forever. Many 23 universities have such a program and are not likely to grow out of them. What can  ! 30 happen, however, is that the relative position of the person serving as radiation 31 safety officer may be upgraded. That is, without enlarging the staff, the responsi- ' 32 bilities for radiation safety may be reassigned to a higher-level staff = ember who S a (e M

1 is better equipped by training and experience to contend with them. Or, when the 2 need for another position to be added is realized, the position can be defined to in-3 clude radiation safety with the recruiting effort directed to finding such a capability. / 4 The person previously serving can now be relieved of these responsibilities and be 5 given other assignments. For other licensed activities conducted within the univer-6 sity, as long as demana made by other departments on the time of the radiation 7 safety officer are not large, the department providing this service initially will S cooperatively tolerate this leak of its resources and continue to provide the service. 9 Growth to a stage-four program sneaks up on an institution unless they are look- ' 10 ing for it to develop and have prepared for the transition that must te made. This 11 stage occurs when the accumulated obligations for radiation safety for the entire 12 institutten cannot be satisfied by the informal compacts between departments that 13 characterize stage three. De NRC may serve a catalytic role if coincidentally the 14 licensing needs of the institution are being reviewed. If severalindividuallicenses 15 have been accumulated by the institution over a period of time and one or more of 16 them is scheduled for renewal, the NRC will likely suggest the consolidation of all 17 licenses [for byproduct materialsl into a Type-A or a Type-B License of Eroad ( 19 Scope. Such a suggestion is usually nonnegotiable. Either of these broad-scope 19 categories (based on activity in use] requires an internal review committee and a 20 well-defined administrative control of radiation safety. At this stage, the single 21 using department that had provided the resources can retain control of the opera-23 tional radiation safety program but logic dictates otherwise. It is unlikely that the 24 user department can afford the commitment of resources, and a user department 25 will have difficulty establishing an absence of self-service in the mungement of a 26 program. A number of university programs in the United States have reached a 27 stage-four status characterized by an NRC bread license, a radiation safety opera-28 tion separated administratively from academic departments, and a review committee 2 29 that takes an active part in the formulation of policy and in the development of pro-30 cedures. One or more professional-level health physicists, one or more health 31 physics technicians, a secretarial capability, and an extensive inventory of radia-32 tion instrumentation have all been provided and dedicated to the management of risks k j r 33 from hazardous sources of radiation within the university. These hazardous sources l 3 +M l

1 under control are not limited to those regulated by the NRC but include all equivalent 2 sources such as x-ray machines and nonionizing sources such as lasers, l 3 To be complete, a fifth stage may be described. For a multicampus institution,

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4 a collection of stage-four units without central supervision can be developed, or the l 5 collection of stage-four units may be supervised centrally with the assemblage repre- i i 6 senting a stage-five program. Alternatively, the entire program can be directed T centrally as a stage-five program. Many multicampus institutions developed their 8 management structures before radiation safety became a concern. At these, such as 9 the Universities of California and New York, each campus operates autonomously 10 with a stage-four radiation safety program under a separate broad-coverage license 11 with no central supervision from within the institution. Both California and New 12 York are " agreement states,"* so central supervision is already a state government 13 responsibility and does not need to be provided within the university administration. 14 Other multicampus institutions consisted of independent colleges that had operated 15 stage-four programs under single licenses before they became multicampus, and 16 these have retained their stage-four programs without central supervision. 17 When a university administration has changed its organization or its techniques

18 for the management of its aHairs, the radiation safety program simply becomes a I

19 part of the change without necessarily modifying how it conducts its operation. It 20 should be self evident that the university administration will not change to suit the 21 radiatica safety program. Not only must we search for the identification of a pro-22 gram that will satisfy the NRC license reviewer to say nothing of our own conscience 23 (with respect to moral issuesl, but we must also strive to accomplish these things 24 with the least cost to the system. l 25 CONCLUSIONS 26 Risks encountered in the university can be divided into those that are readily 27 reccgnizable and avoidable and those that require some specialized help to recognize 28 An " agreement state" is one that has volunteered to assume responsibility for 29 regulatory control of byproduct, source, and special nuclear material. An 30 agreement by the state has been negotiated with the NRC that commits the state 31 gove::nment to provide a regulatory program equivalent to that of the NRC that it 32 replaces. By 1977, 25 states had executed such agreements with the NRC. 10

I and to avoid. At many universities, an existing occupational safety activity has con-2 tended with the first group and should continue to do so. Where a separate radiation f 3~ safety program has contended with the radiation portion of the second group, the 4 responsibilities assigned to this program can be extended to include toxic chemicals 5 and other hazardous agents used in the research and teaching program. Because the 6 types of problems encountered and the mechanisms of dealing with them are essentially i 7 dissimilar, occupational safety should be separated administratively from radiation 8 safety considered together with Industrial hygiene. Occupational safety relates closely 9 to physical plant activities, and the operational program developed to contend with 10 these problems is most conveniently placed in the administrative branch that in-L 11 cludes manngement of the physical plant. Radiation safety and industrial hyviene, on 12 the other hand, are research oriented in the university and belong in the branch of the 13 administration that deals directly with research matters. Control of biohazards is 14 herein considered within the scope of industrial hygiene. This is not intended to suggest i 15 an absence of commonality between the two programs. Quite to the contrary, there are 16 many points at which the concerns of one group will touch on the concerns of the other. 17 Functionally, however, the two groups are very much different and need an administra-18 tive separation to perform effectively. Obviously, reporting channels must join at some 19 level in the administration. For a multicampus university, it is recommended that this 20 juncture be at the level of the chief administrator of each campus and at the level of the 21 President's office for the central administration. January 1978 Prepared by, John H. Tolan Radiation Safety Officer University of Missouri Columbia, Missouri 65201 yW{k 1 11 t i

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I KADif.Ti0.*1 GT ~ C o.'E j M.%" Ell!TY CF a.. vu.il e December 7, 1977 TO: Campus Radiation Safety Officers FRCM: Walter F. Wegst, Jr.

                                                                                                    -1 SU3JY.CT: NRC Request for Input Defining Qualifications of the RSO on a                        i
                   " Type A" 3 road License.                                                           ,

i I recently spent several hours with Jack Bell of the NRC Standards Branch, discussing his plans to write a regulatory guide defining the qualifications for various types of RSO's (University, Reactor, Medical, Broad License, etc.) . The writing of this guide has not been started yet, and Jack is most anxious - to receive input from various groups prior to his preparing a draft of the j guide. Presumably, we will also have a chance to comment after the guide is ,, written (in draf t), but any input we can make now will have a much greater f.,' . , impact. I have put together a questionaire that I hope will stimulate your thinking on this matter. I will summarize the results of the questionaire and pass them on to Jack, but soecific comments bv vou will carry much more weight and I plan to pass on such com:: rents, in toto, to Jack. I hope,you will all take this opportunity to get your thoughts into the NRC before#1s guide is issued "For Comment." My impression is that this is one chance to have a really significant effect on something that the NRC turns out. You can return the questionaire to me by folding it in thirds, stapling, affixing a stamp and mailing. I hope to hear frem all of you. 4 .s \ o *% Wr l l 1

e UNIVERSITY OF MISSOURI i 413 C: ark Hall l Columbia, Misscun 65201 1 Telephone: (314) 882-3721 Walter F. Wegst, Jr. , Ph.D. February 16, 1978 Mail Code 25-6 c/o California Institute of Technology 1201 East California Boulevard Pasadena, California 91125

Dear Walt:

In response to your letter of transmittal dated December 7,1977, and the attached questionnaire on the subject of qualifications for the university radiation safety officer, I have a few modest observ:itions to offer. Most of these are in-cluded in the attachment as addenda to the questionnaire, but I have a question of my own. How come your letter of December 7,1977, did not arrive until Janu-

     ,    ary 30,1978 ? I hope this does not mean the requested response is already too late.

I applaud your effort to reach Jack Bell before he generates a Regulatory Guide ~

           "for comment. " In fact, I applaud his good sense to invite such an input. I hope he '

gets a firm and resolute consensus to advise the NRC to quit meddling. I have ac- f quired with time an acute skepticism of the value of government intervention in the 4

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  • affairs of its citizens. I see less intervention as tetter. The balance point I favor l 1s that at which the venal motive is firmly discouraged but well short of what it may i take to suppress it entirely. I realine the location of this balance point is perceived I according to whether one is the giver or the receiver in the transaction. j I have distributed copies of your questionnaire to each of our health physicists in case they were missed by being absent from your mailing list. I hope they will all find the opportunity to respond. Phil Lee has informed me that he mailed the questionnaire before my note arrived.

I will appreciate a copy of the CRSO mailing list to use in a mailing of my own. Ihad expected to see this list as a part of the Proceedings of the Houston meeting, but that document hasn't shown up yet. Sincerely yours, Jo' H. Tolan Radiation Safety Officer JHT/djf ec: R. L. Carter, Ph. D. ; W. J. Fields, Jr. ; T. Freelich; P. K. Lee, Ph.D.; O. L. Olson; J. G. Shotts; N. R. Sunderland

Enclosure:

Questicanaire and Addenda

                                                                                                                                                                        &i g hk'

m Qusseiofiro en Qualification:s for o Bro 2d License CRSO

1) Should a CRSO for a " broad" license (Type A) have a:

BS MS X Any Sciences PhD

2) Should a CRSO for a " broad" License have a specialized degree in Health Physics ,

at the following level: h hs BS X NS X PhD X

3) Should a CRSO be certified by the ABHP?

Yes No X

4) What do you consider the equivalent of ABHP certification?

15 yrs, exp. BS & 10 yrs . exp. MS & 8 yrs. exp. PhD & 6 yrs. exp. , other X (please specify) MI 4"#

5) Should the NRC and State agencies move in the direction of more specific &

detailed regulations governing broad licenses? Yes No 'X

6) Do you think that detailed qualification specifications for an RSO are more workable and desirable than detailed specifications for how to operate a radiation safety program at a University?

Yes No X lbo'k allinsaliver are egually repufnaal The following is a sensitive ques tion, but I'm sure of interest to the NRC in ter:ns of assessing professional responsibility of RSO's.-

7) If certification were required - as opposed to many specific, detailed requirements that could be administered by a high level technician, would you opt to try for certification or accept the detailed license specifica tions?

Certification u/ 8,f m f re/uefa,,et Performance specification (Currently Certified 48 )

8) Should a Type A broad license require a fulltime RS07 Yes )( No
9) Do you think this is an important issue for the CRSO organization to beceme involved with?

Yes X No

10) If a. " grandfather" clause was included in the proposed Regulatory Guide, would you favor ABHP certification of Broad License CRSO's in the future?

Yes No X Time Limit [crever

11) Do you have any specific comments, sugges tions .or slanderous remarks to add to this survey? Any definitive comments supportive or otherwise are urgently requescad? ggg AW,,a/d
12) Should CRSO answer to high level of University (V.P. Level)?

Yes >< No \ c$. y.Q'&

Adda;nda to Questionnaire on Qualifications for a Broad License CRSO Preamble Any response to be offered to a specific request on the questionnnire is strongly influenced by individual prejudices and biases. It should aid the interpretation of the responses if these prejudices and biases are stated in advance. The questionnaire contains three subjects that are controversial, in my view, in the sense that opinions  ! about them depend critically on one's own perspective. These are: 1. training re- I quired for a given level of performance, 2. value of certification, and 3. degree or  ! extent of government Intervention in the conduct of the aff.tirs of the licensee. Some of my biased opinions about these subjects are the following:  ;

1. Training - In the context of the university environment, academic training -

has great importance - more so than in the world outside. What we need in a discussion of qualifications is a definition of the job to be performed and a realistic assessment of the mix of training and experience required to perform ,

;          that job. The health physicist in the university must be qualified to perform           '

health physics tasks, and it is the needs for training and experience necessary to satisfactory performance that must be specified. Unfortunately, most such necessary training and experience is not available in the classroom. If the health physicist in the university is also qualified by training and experience to teach and conduct research, the university derives a secondary benefit. This result may not turn out to be a benefit at all if the health physicist devotes his attentions to the teaching and research role to the neglect of his health physics responsibilities. - Health physics needs to be recognized in the university as a profession hav-ing its own attributes rather than as something secondary to teaching and research. Conventional wisdom in university administration is that once the Ph.D. is acquired (the earned doctorate) , the awardee is instantly capable of managing any complex task. We find, therefore, health physics responsibilities sometimes assigned wiHy-nuly to young assistant professors for whom the preparation of daily lectures is a task yet to be mastered. l The health physicist needs academic traintng to the equivalent level of an M.S. degree in physics, chemistry, engineering, biology, or similar rigorous science , plus lots of experience. For an individual to conduct a Type A License of Broad Scope program on his own without the support and counsel of associates, at least five-years of experience is barely enough. And this assumes that the program to I be managed is small enough that one person can contend with it. To direct a larger program including the supervision of other health physicists, much more experience but no more academic training is indicated. I i This is not to say more academic training is undesirable; it is justified as an I l end in itself. What is meant is that sufficient training for the health physicist is ! acquired at the M.S. level. When more training to the doctorate level is acquired, 1 c. i ' l l l

l I Addenda to Questionna._a . . . , Paga 2 the individual has many more career opportunities opened and an interest in health physics at the operational level ( and this is what we are talking about) i will wane. Therefore, encouraging academic training to the doctorate level ,y has the effect of encouraging an individual to give up operational health physics f 49, as a career. Continuing education is another matter. The NRC can serve a , useful purpose by suggesting to licensees the need for continuing education to maintain the competence of operational personnel. I

2. Certification - The process of certification establishes for the public record that certain individuals have attained by training and experience a level of performance that has been validated by a peer-group examination.

The function of the certification process is to inform the purchaser of services j that he need not rely entirely upon his own evaluation of competence. For those that can make such an evaluation of a potential employee on their own, the pos-session of a certification should have a positive but not an overwhelming effect. , A university is capable of making such an evaluation. An individual offering

!                    services for sale on the open market will sell them more easily if his qualifica-tions have been certified. On the other hand, an individual " selling" radiation safety in the halls of learning will find his qualifications challenged acutely, and it will be his performance rather than his credentials that will sell his product.

Certification is not entirely trustworthy. In health physics it is getting better, but there remain too many " grandfathered" certificates, and the system is fallible. There is a place for the certified health physicist in the consulting i business, but certification as a prerequisite for qualification as a university radiation safety officer is ridiculous.

3. Government Intervention - NRC Regulatory and Licensing Guides perform .*

a useful purpose in specifying certain expectations to be communicated to a l-prospective licensee. Once a licensee has graduated to the Type A License of Broad Scope, the I!censee has satisfied these expectations and a record of per-formance has been established. Anything, at this point, beyond broad-brush guides to account for significant enlargements in program scope is meddling in the management of the university. Proposed Regulatory Guide 10.5 is a case in point. In the form distributed for comment, the guide stipulated an information gathering and submittal burden of monstrous proportions when, by this time, the NRC should have been satisfied with the commitment made by the licensee to a broadly-based program. In other words, the help of the NRC is needed at the time a program is started. When started properly, the detailed constraints placed upon the program by the NRC should be relaxed and removed as the program grows and matures. Too many controls and too much guidance restricts the proper development of a program and removes the Intellectual challenge from the development. 1 Another proposed Regulatory Guide on a closely related tcpic has been cir-l l culated for comment. This is Guide 8.18 on ensuring occupational exposures { N. 7 a.j \ nv

Addenda to Qur.stionnane . . ., Pago 3 at medical institutions to be as low as reasonably achievable. The present content of the Guide is directed to management to ensure an adequate attention (meaning funding) is provided to the radiation safety program. How can a health physicist struggling with his administration to obtain a sufficient budget ,. quarrel with an effort by the NRC to help him get it? Is that heresy ? Much as g I concede I need all the help I can get, I view Regulatory Guide 8.18 as meddling by the NRC because it tells my management in excrutiating detail what the NRC expects me to do. It, as much as, establishes criteria for management to use to ' evaluate my performance. However well Intentioned it is, I cannot accept such l help because no room is left for individual initiative and for technical management. l It leaves me in a box the dimensions of which are established by the NRC but the construction of which is left to my management. . Comments on Items in the Questionnaire

1. No additional comment.
3. It is my opinion that a specialined degree in health physics does not exist. I recognize the existence of academic programs in radiation science adequate for preparation to enter the profession, but no such program offers the experience l necessary to qualify as a health physicist. Even the ABHP recognizes this dis-tinction.
3. No additional comment.

4.' These are apples and oranges except that the ABHP requires training plus experience at minimum levels before the examination is taken.

5. They have done so already, and I resent such an encroachment. ~
6. When a Regulatory Guide specifies in general terms wg must be done rather than NM how and when I am provided the oppormnity to argue that my methods will accom- I.4r plish the what must be done, Iwill accept the Regulatory Guide. Any more than hpg that I regard as an intrusion upon the rights of the university to mannge its own affairs. Furthermore, I do not accept the delusion that a bureaucrat in Bethesda by writing detailed instructions can replace informed professional judgment at the place of application.
7. This is a no-choice proposition. If I could be persuaded that a requirement for certification would get a better job done, I would answer differently.
8. I believe the definition of a Type A License of Broad Scope implies a program of such magnitude that more than one health physicist is required. Furthermore, I believe the radiation safety officer must be a health physicist, although I can con-ceive of circumstances wherein the RSO was not fulltime as long as adequate support staff were available.

s lc4

Addenda to Questionna._ e . . . , Page 4 I

9. No additional comment.
10. No additional comment.
11. Comments are contained herein.

I

12. More important than the reporting point is that the RSO be separated administra-tively from academic departments. An action loop must be established such that essential remedial steps can be taken expeditiously. This requires that the re-porting step, at least for correcting deficiencies, be high enough to be effective.

While this kind of thing is going on, or just the possibility exists, the health physicist must be sheltered from the influence of self-serving interests that may be brought to bear upon him. A committee may serve to provide this shelter, but the committee will rarely have more than an advisory function in administra-tive matters. Therefore, the radiation safety function needs to be sufficiently

  • independent of the units that use the radiation source to be insulated frcm their !

Influence. ' An Alternative

                                                                                                  ~

There are at least two situations that come to mind for which a statement of desirable qualifications may be helpful. One of these is probably established sub rosa. It is the " standard RSO" that the NRC must use to evaluate the credentials of the in-dividual identified in a license application as " Radiation Protection Officer. " This is speculative, of course, but it would seem to be pointless for the NRC to ask for a statement of the qualifications of the individual named as the Radiation Protection Officer without having some standard against which to compare these qualifications. i Naturally, these " criteria" cannot be rigid nor can the NRC publish them generally without compromising the judgment' factors used in the evaluation. But the NRC can I ask for advice out11de the establishment to help formulate these criteria, and I guess we are responding to such a request. i The other situation is the rectorocal of the one just mentioned, to wit: a licensee may ask the NRC to identify a set of criteria acceptable to the NRC for the licensee to , use in recruiting and selecting a radiation safety officer. We might expect to find such criteria explicated in a licensing guide, but they have not been included to date. While not losing sight of what precipitated this questionnaire and what I have already . , stated as my reaction to it, I now wish to add a suggestion about how the NRC might 1 make known to the licensee what qualifications it expects the RSO to possess. ,e Ipropose that the Conference of University Radiation Safety Officers organize an ad hoc committee to formulate a statement of qualifications essential to the per-formance of the tasks of the RSO, to formally adopt this statement (as we did with the tritium bioassay criteria) , and invite the NRC to use the statement as a reference document in its guidance to licensees. To link the NRC to the project, we can ask Jack Bell or some other suitable representative to serve as a non-voting liaison mem-

Addends to Qurstionnt...o . . . , Page 5 ber of the committee. The singular advantage of this approach is that the result derives from the experience of those performing the tasks rather than from the isolated environment of the regulators. A secondary benefit to the NRC (perhaps the primary benefit to the NRC) is that they cannot be criticized for the content. 1 0 8

                  ,             CEPARTMENT OF THE AIR FORCE                          =%

HEACQUARTERS UNITED STATES AIR FC ACE k:i I* t WASHINGTCN. Q.C. 20314 9

                                                                                   , p[.

g, ;. ",S73 v 3 M. Robert 3. Minogue, Director Office of Standards Development U. S. Nuclear Regulatory Commission Washington, D. C. 20555 Dear Mr. Minogue We have reviewed Regulatory Guide 8.18 as requested by your ~l letter of 6 January 1978. In general, we find the guide to be comprehensive and reflective of gecd practice. We are concerned abcut hcw clcsely medical institutions will be required to adhere to the specific procedures given in f4l the guide to obtain a license. We believe that shculd i

             " guidance" become a requirement for " licensure," the                               l
             =echanics of the licensing precedure will beccme mere compli ~

cated and slower. The following specific ccmments are offered for your consideration:

a. The terms Radiation Safety Officer (RSO), Radiation Safety Office (RSC), Radiation Protection Officer, and Profes- ,2 sional Health Physicist, should be defined for the purposes ,
                                                                                                    \

of this guide and differences in responsibilities clarified. j

b. Consideration should be civen to providine guidance 7 -

as to the minimum qualificaticn the radiaticn protection IN3 0 cfficer shculd possess. ~J

c. Scme confusion exists abcut the nucher of and place '

ment of certain lights for teletherapy recms as called for in paragraph C.3.2a. The lights called for in paragraph C. 3. 2a ( 2) indicates the status of the dec interlock. The

             " independent back-up cautien lights" called for in paragraph ,93 ' F C.3.2a(3) indicate a " beam-on" condition. The additional lights called for in paragraph C.3.2a(5) seem to be an                           >

unnecessary duplication, for if the interlock system fails the " independent" lights required by C. 3.2. (3) should warn

                                                                                         ~~

that the beam is on.

d. Paragraph C. 3.3i calls for " individual labeled ' l1 ('

lockers and change areas fer segregating laboratcry coats VJTICS Os 1 l h  ? N 4 o rs.,ce - 1

that may be contaminated by other clothing." The necessity for ' individual" lockers depends on the work assignments  ; cf those in Nuclear Medicine. Where a minimal risk for . , . , , contamination exists, the need for lockers is questionable. l7,0 J. Ferhaps a general statement should be made that locker , facilities and showers (see paragraphs C. 3.1. 5) , sufficient ' for the ongoing operatien, shculd be made available. All references to finger badges and bcdy badges 7f),,b e. (paragraph C.4.1.4) should be changed to finger desimeters . and body desimeters. a A

f. ParagraphC.4.2.2fdescribesthetransportofloaded]
                          "afterloading" devices to the patient's recm.                           This para-          i crach was probably meant to discuss handling of "prelcading" !d,",,7' devices. Aftericading devices are not loaded prior to                                        j placement in the patient.                                                              -

Sincerely t

        * ' U 2. E * '.'I.T. Li Cci, ' '$/. 7, 3 - -                                                                        .

i

        .* *2.*          0 010.1                       ; :i. a 2.,,-l 3

{:;";* :~% :i 7 'Es:taa-a se .;;u, , .i 4HaC3 07 'J.3. S.tr;+cn Q,t.:r .i . l l l l I l l l I 9 4.

J Mayo Clinic Rochester, Minnesota 33901 Telechone 507 282-2311 Alan L Oms, Ph.D.

       \ledical Radiacon PMsacs n erw euce ram oiogy                                      March 8, 1978 Allen 3rodsky, D. Sc.

U. S. Nuclear Regulatory Commission Office of Standards Development

           '4ashington, D. C. 20555

Dear Allen:

Thank you for the copies of NUREG-0267 and Regulatory Guide 8.18 and for inviting my comments concerning those documents. I believe that both 8.18 and NUREG-0267 are excellent guidelines ~} that will do adequate cuch R.S.O. to provide progrs=s. support forindividualR.S.O.'sandwillencouragelg# Therefore the concept of ALRA will be achieved { to a higher degree. The docu=ents are well written, well organized, under- j standable and capable of implementation. The few changes that I shall suggest are basically trivial, but I believe worth =entioning. These comments, however, should in no way be con-strued to detract from the overall excellence of the works.

1. I believe that the word " occupational" should be deleted from both ,,

titles. Theexposuresbeingconsideredareclearlynotonlythoseofesployees], #~ but also those of the general public and of the environs. -

                                                                                                  ~

1 The word " hospital" should be = ore limited in its use. In many in-stances where " hospital" is used the word " institution" or " medical institution" would be more appropriate, e.g. , 8.18, .?l.c.. ; 2.1; 2.3; 3.1, etc. Likewise in NUREG. The " hosp 1tal" is only a sub-unit in many medical institutions such #g $ as curs. lead possibly The use of both terms in sisilar contexts in the two docu=ents could l to confusion. . _a

3. The discussion of special laboraccry design features and space layout '

(3.1.1 and 3.1.6) sight mention the desirability of separating .orker's sit-down space (unconta h eed) from the working area (contaminated). I find architects to be unable to comprehend this concept. Instead, so=e are ena=ored y,7, with the idea of "=odules," wherein the worker works, studies, eats, etc. Thus, a waste disposal can sight be found i= mediately next to a study dask (all used by the same worker), a "sodule."  ; I

Allen 3rodsky, D. Sc. darch 8, 1978 4 I hope that we will be allowed to use the dilution factor "10-4 or core" vg g in NUREG ,7 3.3.1.4 at our next license renewal. At present we are allowed no, ' -- dilution factor for a > 100 f t high stack located "out in the country." -

1. Monitoring patients' rooms before discharge (NUREG p. 3-21 # 5.) is )

difficult, if not impossible, in many cases when the patient still has milli- # 4 *f, curie body burdens of, say, 1311 We speak to the patient before discharge but we only monitor the room after, unless some unusual event has occurred. J

                                                                                             ~
6. The reprint from NCRP Report 37 (D-4 to D-6) is poorly reproduced and 15 hard to read. Since any R.S.O. should have a copy of that report, per-haps the exerpt need not be included in NUREG.

M7

7. Should not the definitions in appendix D include the S.I. units? l y'f f
3. Would a consideration of =edical research progra=s, other than 9
      " low-level," be appropriate for inclusion as a category in table l? The re-search component in =any =edium to large medical institutions is the most de- g' < a/    <
      =anding, frustrating and administratively unclear segment of the radiation safety progra=.                                                                      ,

_9_ . The stata=ent in 8.18 .7 2.5: "The r.uponsibility should be delegated 1 in the .Medien1 Staff Sylaws . . . " is apt to be inappropriate occasionally. . I do not believe that we have bylaws in this institution. If we do, however, @./# no mention of the R.S.O. would be appropriate. In our case a Board of Governor'si minute would be the most appropriate way of providing the authority needed by an R.S.O. or any s1=ilar person. 3 I hope to see you at the Health Physics Society =eeting in Minneapolis

     .this June.

Sincerely, I l Alan L. Orvis i ! alo/lh l l e

I

                                                   \                          cc.' $ W ' X :f.c l                                                te f,&

e.g. d e UNIVERSITY OF MINNESOTA scncolof Puche Health __ TWIN cmEs 1360 Mayo Memonal Builcing -

     -                                               420 Delaware street s.E.
Minneaccus. Minnesota 55455 March 9,1978 Dr. Allen Brodsky Office of Standards Development SD:0HSS U.S. Nuclear Regulatory Comission Washington, D.C. 20555

Dear Allen:

This is to acknowledge receipt of your note and the copy of NUREG-0267 for comment.

                                                                                                 ~

I have only a couple of coments. There is somewhat of a special problem in nuclear pharmacies with respect to potential air and sur-face contamination because of the need to maintain a reasonably constant ui./ pressure in vials with rubber septums. The contamination may result from moving open-ended syringe pistons to specific positions for the sake of injecting known volumes of air into vials. _ Another problem peculiar to large nuclear pharmacies, which may serve ' as distribution centers for numerous hospitals, involves the return of . unused materials to the pharmacy 1.n shields which may have become con- M1 taminated by the user. In an active phar nacy there is a need to watch closely not only the contamination on outgoing vials and shields but the inccming ones as well. ' Contamination surveys need to be made regularly in nuclear pharmacies. 9 ll 4., a v.a.6 It may be assumed erroneously that because the background displayed by 11 ' calibrators in the phar-nacy show no increase with time that no con-tamination occurs as a result of operations. It is to be remembered that these calibrators are calibrated in units of millicuries and from gi, ') the contamination standpoint we are concerned about fractions of micro- ' curies. So one can have a problem without being aware of it if one relies upon readings on calibrators as an indication of the state of  ; affairs in the labnratory.

                                                                                              ~

These are just some thoughts that might be of use in the next revision , of your document. In general, I think it is a good product. Yf, ,f Sincerely,

                   .-                                                            ) . -< , . .~

Donald E. Barber, ph.D. - professor and Director of Graduate Study Environmental Health k, e;' DE3/ho dEAt.D4 sC:ENCss

 . a
       ;.: s .,,

[ O 's igm; t,d j UNITEC STATES ENV!PON*.tENTAL PROTECT!CN AGENCY

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                 ~

W A S H I N G TO.N . O .C. 2:40 MAR 9 1978 000;H ::'., 3u = cp \ won msPN M Secretary of the Co= mission s. t

                                                                                      .(                             o-U.S. Nuclear Regulatory Commission                                                 c$2d f-Washington, D. C. 20555                                                f-6              Dq%4 ATTN: Docketing and Service Section                                    k,
                                                                                            $hQ  ,

7 o9

Dear Mr. Secretary:

p We are pleased to provide co==ents on Nuclear Regulatory 1 _ Co= mission (NRC) Regulatory Guide 8.18, " Info:::ation Relevant to -..- Ensuring That Occupational Radiation Exposures at Medical Institutions Will Be As Lcw As Reasonably Achievable." These co==ents also apply to the companion report NUREG-0267, " Principles and Practices for

  • Keeping Occupational Radiation E:<posures at Medical Institutions As ~~
            ,1.cw As Reasonably Achievable."

7 We believe the draf t guide represents a significant positive step forward and cor=:2end the NRC for this progress in an area which has long deserved attention. However, although cost =atters are well covered, we do not believe that Regulatory Guide 8.18 is sufficiently - complete, either independently or with other NRC guides, to assure i that occupationil exposure of medical personnel will be as low as can  ! be reasonably achieved. There are two related deficiencies: ' i

1. The failure to specify mini =um qualifications of personnel .:.i
espcnsible for the use of licensed materials. ,
2. The failure to require measures to assure accurate dosages of radiation and of radioactive =aterials. '

We believe that it is fundamental to proper radiatica protection that persons licensed by the NRC to receive, possess , use, or transfer i source sacerial, by-product sacerial, or special nuclear material be ' required to assure the use of properly qualified personnel. Therefore, the licensing process for =edical license applicants should evaluate information about the organizational structure , personnel qualifications, and conduct of operations of applicants, as is already required for other licensees, such as production and utili:ation f acilities under 10 CFR Part 50. Information requirements relative to

hese evaluaticas should be incorpora:ed into Regulatory Guide 8.18.
                                                                                                                ~~~
                                                                        - tfrf.     /N%".. ;Jg,;   .

s . [ 2 Informed judgments on the medical application of NRC-licensed materials with proper consideration of minimi:ation of occupational (as well as patient) exposure can, we believe, be made only by { qualified physicians of nuclear medicine or of radiation therapy, with, of course, additional inputs, as required, from the Radiation Safety Officer. Appropriate qualifications of such physicians should

  • include recognized professional certification in radiotherapy, nuclear medicine, or equivalent training and experience. Similarly, .

technologists who administer prescribed radionuclides or radiation treatments should also be properly qualified to carry out the instructions of physicians so as to achieve minimized occupational (and patient) exposure. As an example of similar requirements for personnel who prescribe and administer diagnostic x rays, I have (- enclosed a copy of the recently approved " Radiation Protection f Guidance to Federal Agencies fcr Diagnostic X Rays" (43 F.R. 4377). t Recommendations 1, 8, and 11 contain the analogous requirements for j professional qualification.  ! ) The prescription and administration of accurata doses of I 1 diagnostic and therapeutic radioactive materials also affects the reduction of occupational exposure. Dosages larger than medically g. [ required may be expected to contribute to unnecessary occupational (and patient) exposure. Ccnversely, dosages smaller than medically required will usually lead to a requirement for further diagnostic or [ therapeutic irradiation, also with attendant unnecessary occupational exposure. Accuracy in prescription and administration of radioisotopes should be encouraged by the above suggested requirements for qualification of those who prescribe and administer radiation or radionuclides .; In addition, we recommend that Regulatory Guide 8.18 . be expanded to: include requirements for quality assurance procedures to insure accuracy in preparing, acministering, and monitoring 1 prescribed radiation sources. ' In sumary, efforts to reduce occupational exposure at =edical institutions are much needed and we co= mend the NRC foi- the excellent i start made in draft Regulatory Guide 8.18. We strongly recommend, , however, that the final version be expanded to include requirements for user personnel qualification and for programs to assure accurate radiation dosages. With the inclusion of these suggestions in Regulatory Guide 8.18, we believe it will prove most useful in the [ reduction of occupational exposure due to radioisotope usage in > medical institutions . Sincerely yours, <

                                        ']          h       /: %

f

                                         /

[/ (Ihv G' # s 'Mi William A. Mills , Ph.D.

                                                     , Director Criteria & Standards Divisien (AU-460)

Office of Radiation Programs

                                                                                             , ?, *;: F

ll1 WEDNESDAY, EBRUARY 1,1978 PART V _ .a EL

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4 presidentici documents [3195-01] Title 3-The President Recommendations approved by the President January 26,19"3

                                                                                                                                         ~

Radiation Protection Guidance to Federal Agendes for Diagnostic X Rays Recommendations 1 through 12 contained'in the above1 memorandum are approved for the guidance of Federal agencies; the A'dmmistrator and the Assistant Secretary for Health are directed to conduct programs,in accordance with their respective authorities and their Memorandum of Understanding (42 3, FR 5123), to interpret and clarify, as necessary, each of these recommendations ~, in cooperadon with affected Federal agencies: the Administrator is authorized to .' issue these interpretations and clariScations in the FanzaAt. Rzctsmt: and this memorundum shall be published in the FEDERAr. Rzctsmt. . n NM' AA- Q Recommendations have been developed and are hereby transmit:ed for the guidance of Federal agencies in providing radiatiori protection for patients irs the aoolication of diagnostic x rays. Execuave Order 10331 and Public Law 86-373 (42 U.S.C. 2021(h)) charge tne Administrator of the Environmental Protection Agency (EPA) to ". . . advise the President with resoect to radiation matters, direedy or indireedy adecung health, including guidance for all Federal agencies in the formulation of radiation standards and in the establisnment and execuuen of programs ot*

                                                                                                                                  -i,""g cooperation with States." In addition. the Assistant Secretary for Health in the Department of                         S'(.i Health. Education, and Welfare (HEW) bs a variety of resoonsibilities under tne Puolic Health                              . ~ . .

Service Act (Secuens 301,310. 311. and 354-360(f)) and the r ederal Food. Drug, and Cosmerte .ht ." bearing on the setting of health care policy and the use of radiation in the healing arts. These 'OR - responsibilities, which have been delegated to the Food and Drug Adnunistration (FDA). include research and training concerning radiacon hazards, the development and romul con of recom-mendadons for radianon users, advue to the States, information for .e pub c. performance h

                                                                                                                           ..N1 standards for electronic producu that emit radiation. and regulauons for the sale. distnbution, and use of medical devices.                                                                             - '- .             4M w -

Beause of the special respo uibilities of HEW involving national health care policy, which ' '- Federal radiacon guidance for diagnosue x rays may impact directly, the Administrator and the * ',' "[ 7

                                                                                                                              * ;,t:::

Assistant Secretary join in requesting your approval of these recommendadons. In this regard. on -4t January 18.1977, tne two Agences entered into a Stemorandurn of Understanding (42 Fil 3123), which provides for the future development, within each Agency's respecuve authortties, of radiation protecuon guidance and, when necessary, updadng of such guidance for uses of radiacon in the healing arts. l ~ ** MCXGROCVD Information on the diagnostic use of x rays in medicine and notential controis that could be applied without compromismg bene 6u have been reviewed, and scienusts and professionals widsin 7 ~ and outside the Government have been consulted in developini these recommendanons. In this regard, we have bene 6ted from the et! ort begun by the Nauonai Academy of Sciences-National Research Cc,unct for the former Federal Radiadon Counal to evaluate. interpret, and advise with respect to new lutowledge on radiauon e:Tects and sources of populauon exposure. Tse re NAS-NRC Comrnattee on Biological Effects of torunng Radiatiors was issued One in 1972. of inport of the signailcant findmgs was that "{miedical diagnosuc radiology accounts for at least 907, of the total man-made radiadon dose to which the U.S. population is exposed." More importandy, the Comnuttee recommended that "[mledical radisuon exposure can and should be reduced consider. abiv by limiting its use to chnically incicated procedures utdizing etTicent exposure techmques and opumal operauon of radianon equipment." It is widely recog tized by medical practitioners, medical nhuicsts. and other scienusts concerned with ruciauon protecuon that exposure due to medical uses of ionamt radiacon represents a sigmficant and gromng source of exposure for the U.S. populadon and is also one that can be reduced by good pracuce. The Nanonal Counc1 on Racisuon Prctect: ors and Measurements 1 In the enginal document Recommendacons 1 12 preceded :he statement of Presidenual appcovaL

                                                                                                                            %M *;w-FECtRAL XtG13712. VCt. 43, NC. 22-W1:NI.$3AY, FEs2UARY I,1773                                              p l                                                                                                                                  . .           \
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4080 - THE PKHIDENT the recommendadons as required to resect new information and s. hanging technology,3r so doing, it is expected that an ach:evable and reasonable reduction in x ray exposure wd1 be accompEshed commensurate with a condauadon of the ntal benests realized by the unEzadon of t!us important technology. If the foregomg recommendadons are approved bv you as guidance for Fede-al agences in providing radiadon protecdon for padents m the apoheadon os diagnosde x. rays. it u further ) recommended that slus memorandum be pubEshed in the FrotmAr.Rzctzrza. Doucus M. CosTu, Adminktratar, . EnvirmsmentalPmtxtion Agerwy. 1 Juuus B. Rzcsosown M.D., . > 1

 '                                                                          Auktant Secretary                                                                          :.

Department of Health, Education,for Health,and Welfarr [FR Doc. "S-2776 Filed 1-27-73; 3:31 pm] . r.,

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  • 4Mb THE PH51 DENT -

has concluded that" whereas " . there can be no raconal means . . . to !imit radiation exposure j

-                                                   orescribed for patients for necessary and proper diapostic or therapeutic purposes be taken to minimize unnecessary or medically unproducuve radrauon exposure.                                                  { 1... steps can
                                                                                                                                                                        . Advantage should be taken of any new technology or procedure that will sigmilcandy reduce unnecessary daposde or medical exposure, both in mdividual examinations and trest:nents and in the adopuon of group screening prscuces.**

An Interagency Wurking Group on Medical Radia* ion was formed by the Administrator on ulv 5.1974, to assat m developmg proposed guidance for diaposuc x rays. *!1e Interagency Wore {mg Group determined that it is desirable and posuble to reduce exposure from the diapostic use of x rn s in Federal facslities by: (I) elimmaung clinically unproductive examinanons. (23 assuring the use of opdmal technique when examinadons are performed, and (3) requinng appropnate equipment. to be used. As a result of this consensus a subcomnuttee on prescrtption was established to mmme factors to eliminate clinically unproductive examinadons. Another subcommittee on technique was formed to examine the second and to some extent the third subject ares where it might not be .

  • regulated by FDA's x ray equapment performance standards, which became etTective August 1.1974.

The reports of these subcomminees were made available for comment (41 FR 10705 and 27998) s ' prior to cornpletion of the Interagency Working Group report. Proposed recommendations based upon the report of the Interagency Workit.g Group were published for public comment (42 FR 4834) on January 26. 1977. In addiuon. there has beert extensive commentary and discussion between EPA and HEW. as weil as formal review by Public Health Sernce and other aTected Federal agencies. The comments received have been careiuity considered and a complete record. includmg a response to comments, is available to the public frons the Public Informadon Reference Unit. Room 29:c2. U.S. Environmental Protecuon Agency. 401 M Street SW. Washington. D.C. 20460. 1 .

                                                   . These recommendadons were developed and reviewed in accordance with standard EPA.

procedures. Development of new or revised recommendadons wGl be carned out under the alemorandum of Understanding referred to. above, which provides also, w hen applicable, for the 'ase of HEW procedures. DISCUS $i0.V The most important factor in reducing radiation exposure is to avoid the prescription of clinically unproductive examinations. Appropriate presenpuon of x.rav exammadens involves two major consideranons: (1) the clinical dension to order a particular exarnmanon. and (2) the mmunization of the number of radiographic Mews required in an exammadon. In particular, attemion should be given to the quali5 cations of those who order exammadons, the e!immation of unproductive screemrts programs, and the use of appropnate clinical procedures to assure that i unproductive views are not performed. tion of an unproductive x ray examinadon. padent exposure can also be red . . examination is performed with good techmque. The fundamental objecove in performing an x.rar exanunauen is to obtain opdmum diagnostic information with mmimum patient exposure. Achieve-ment of this isobjective (2) equipment requires operated only assurance thac (1) equipment is calibrated and property by adequately funcuoniny. . prepared, and (4) technique factors that will mm,qualuted untze exposure personnet. (3) the pauent is appropnatety are selected. It has been demonstrated that the same technique factors used with different x rav generators .

  • may produce widely vary ng panent exoosures. Thus the performance of x rav equipenent uuiired .*'@.,

for diaarnosuc x-rav procedures is animportant factor in 14mmng panent and ooerator esposure. Die . Federal Diagnosue LRae Eauipenent Performance Standard (21 CFR Part 1020) requires that x.rav equipment manufactured alter August 1.1974, be certified bv manufacturers to compi, with radiauon safety requiremenu issued by the FDA pursuant to the Radiadon Control for Health and *G Safety Act of 19M tPL 90-602). Uulization of medical and dental x.rav equipment that performs in1., . **Q .. ,; accordance with the requirements of this performance standard by Federal health care facliues ~ would provide a signincant conenbution to the mirunnession of patient exoosure.

  • T ;. . t Without question the use of x rays in the healing arts provides large benedts to society through .

improved health care: thus,in developmg guidance for raoiation protect:en for diagnostic x raws it ts essendal to assure that bene 6ta to panenu from the use of medical and dental x rays are maintained.

  • Medical personnel in bod the Federal and the pnvate sectors have been consulted and we are impair the ability of Federagagencies to provide necessary radiologic servtces. co Appropnate follow-up and coordinanon wid Federal agenctes is also important to assure that 1

these recommendations are implemented so as to maximtae their e:Tectiveness in reduent unneces. , health care. The Merr.orandum of Understanding between EPA and HEW refe

designed to assure that the dual objecuves of radiauon protection and hesith care deriverv are j

healmg arts. achieved in the isuplementauon of this or any future radiacon proteccon guidance applicable 3

tECOMMENDMTONS .

In view of the considerations presented above. the fo!!owing recommendations are made for the guidance t.a.e healmg of aru:Federal agences in their conduct of radiation protecuon for ciapostic uses of x rays us

  • i
1. Gener:1 radiographic or !!uorescocie examinations should be presenbed onf r by !*censable Doctors of .\ledicine or Osteopathy or, tor specded limited procedures. ;ostpsduate phvsican i 1

trainees and quairfied allied mecical professionais under their direct supervision; specalized studies . should be presenbed only by those phvstctans wnh experuse to evaluate examinanons m the partscular specialty. Excepuon for speciied procedures may be made for dent should be based on climcal evaluation of symptomattc patienu. and should state the diaposuc objective and detail re!evant medical history.

3. Rourme or screenmg exarnmanons. in whrch no pner clinkal evaluadon of the padent ia made, should not be performee unless exception has been made for specfed poups of peopie on ,

4 .. . FMIRM 2tGl!T!2, VCl. 43, NO. 22 WIDN830AY, H18UA27,f,1973

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e s i o t THE PRESIDENT k the basis radisuon of and nsk, a careful economicconsideration of theExam and social factors. magmrude and medical beneSt of $e .dispostic yield l rouunely performed unless such excepuon is made are: ples of ex.ammauons that should not be I requirement for emplovment,a. chest and lower back x ray exammations in routine physical exam

b. tuberculosis screemng by chest radiography,

[ patients under age 40 unless . clinical indication of chest disease exists.c. ch 5 d. chest radiography in routme prenatal care. and { a personal or strong family history of breast cancer.e. mammography examinauona of wome { t 4. Prescription of x-ray examinations of preinant or possibly pregnant patients should assure i that medical measures consideration are applied. has been given to possible fetal exposure and appropnate protective

5. The number, sequence and ty cally-oriemed and kept to a minimum. pes Dia of standard views for an e=stmanrion should be c!ini.

x-ray examinations and, where pracicable,posuctans should closelv monitor the performance of direct examinauons to obtain the diagnostic objectives stated by dinicans through appropnate deletion, subsutuuon, or addition of prescnbed views. Technique protocols for performmg medical and dental x ray exammations should detaal the operational procedures for all standard radiographic projec-ions, panent preparation requiremenu, use of techmque charts, and image receptor soecficanons. Equipment Performance Scandard. oe as a mimmum for equipment fluorescopy umts should provide image-intensdocon: fluorescop(,v use should have electron c image-holdmg features unless such use is demonstrated to be tmoracaca. ble for the dinical use invohed. Photocuorographic x-ray equipment should not be used for chest radiography. satisfy diapostic requirements with mirumal panent exposure:7. X-ray faci such programs should contain ments, quality dupliate ~~mns. control of image prx,essing, and operational procedures demonstrated proficiency to produce diagnosuc quality radiograons with required: such pro 6ciency should be assessed througn nauonal performance onented eva[eosure uatiors procedures or by didacue traming and prac:ial experience idenocal to, equivalent to, or greater than trammg programs and exammacon requirements of recognized credenualing organizacons. dinial area ofinterest and mthm the dimensions of the image receptor - furtherlimit the exposure of the fetus and the gonads of patients wsth reproducuve potential (21

                                                                       ~

CFR Part 1000.50) when such exdusion does not intertere with the exammacon bemg conducted. .

10. Technique appropnate to the equipment and matenals available should be used to mamtman exposure as low as as reasonably achievable without loss of requisite diagnostic information; 5 ~,

measures should be undertaken to evaluate and reduce, where practicable, exposures fer toucne nonspecalty examinacons wiuch exceed the following Entrance 5 kin Exposure Guides (ESEC): Examination (Projection) ESEG (milbroentgens)*

                                                                                                                           * - K.gO N:

Chest (P/A) Skull (Lateral) 30 300

                                                                                                                             ~ $y$

Abdomen (A/P) ~a 4"

  • Cervical Spine (A/P) 730 ,
  • Thorace spine (A/P) 250 Full Spine (A/P) 900 t Lumbo-Sacrai Spine (NP) 300 l Retrograde Pyelogram (NP) 1000 i Feet (D/P) 900 270 (

Dental (Bitewing or Periapica0 ' 700 l for a panent havmg the follomn' Entrance skin exposure determined by the Nationwide Evaluatio abdomen /23 cm, and foot /8 cm. g body part/ thickness: head /15 c:n. nect/13 cm, thorax /23 c:n,

11. X-ray examinations for dental purposes should be presenbed only by licensable Doctors of Dental Surgery or Dental Mediene or properk supervised postgraduate dentuu on the basis of pnor climcal evaluauon or perunent histery; neither a full-moutn senes nor bitewmg radiograohs should be used as a routme screemar tool in the absence of c'.mcal evaluation m prevenuve dental <

care. Excepuon may be made forjusunable forenste purposes. i

12. Open techmque ended to perform shielded routine position-indicaung intra-oral radio dences should be used mth the paralleiing the size of the image receotor as practicable. grapny and snould restnct tne wray beam to as near desetop detaded standards storen to meetIt is expectes mat ezen Federal agency mil use t its prucular requirements. In order to sasure soproortsteimplementauon ot these recommendations. the Adminutrator and tne Assutant Secre.

Memorandum of Underst.ndmtary for Health w.;l cocoerate m armnt out their resoective funtuons n a l acnieve an effecuve Feceral pro,g (42 FR S!23L The necessary coordinauon mil be conducted to gram. inuucing penodic meerprecauorrand dartficauon of each at t f70 tral 2!011772, yC1. 43, NO. 22 WICNf 30A f, HaaVAAY I,1975

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e a o l l 1 1 DEPARTMENT OF THE ARMY "V - - 'M u5 Aawf ENVIRO N M ENT A L HYGIENE AGENCY E .[Yi[e ..h, asc===rs =acusc caounc. u4avt.e.c 2:agTC Lodde /tla/584-3525

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eentlemen: I have reviewed the Draft Regulatory Guide 8.18 and have the following T~ comments: a. and addParagraph the words "3.2a(4), treatment page 8.18-5, room" line 2: to clarify the delete intent.the word " Area" '{N.el .

b. Paragraph 3.2c, page 8.18-5, line 6: change "shculd be" to read -p' z "should not be" or revise to be consistent with page 3-9, : UREG-0267. _
 -                 c. Paragraph 4.1.ab, page 3.18-7, line 1: chan'ge the word " badges"h'j
o " dosimeters" to be consistent with paragraph 4.2.2g, page 8.18-8. J Regulatory Guide 8.18 and :tuREG-0257 are very important documents and 1 -
                                                                                                                          - l-are urcently needed in the medical community. Recommend that copies of the fiilal documents be for.varded directly to all medical licensees.                               j7I Sincerely,                                          ,
v. : .

y... q, GORDON l1. LCDCE LTC, MSC Chief, Health Physics Division

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e ih $ H OEPARTMENT CF HEALTH. EDUCATION. AND WELFARE , 4 PUBLIC HEALTH sERVfcE NATIONAL INSTITUTES OF HEALTH SETHESCA. %4 ARYLAND 200f4 March 13, 1978 Allen Brodsky Office of Standards Development U.S. Nuclear Regulatory Commission

                   '4ashington, D.C. 20535 Re: Regulatory Guide 8.18

Dear Mr. Brodsky:

In response to your request for. comments on Regulatory Guide S.18, may I suggest the following:

                                                                                                "7 That the use of syringe shields in Nuclear Medicine be more forcefully recommended in section 3.3 or 4.3 of Regulatory Guide 8.18. (Their use         ; Y,[
                                                                                                  'y should be mandatory where a study of work load indicates that the 75 r/ year limit could be exceeded). Supplying syringe shields does not ensure their use. The necessity of using them is not generally appreciated.

w Finger tip radiation exposure (approaching 1 R/ min) from manipulating . 13-20 mci Tc-99m in syringes during I.V. injections is perhaps the nost frequently ignored serious radiation safety hatard in Nuclear Medicine today. Cloutier's survey indicated that less than half the Nuclear Medi-eine workers are taking any precautions. The work of Husak, Henson, Howley et al, and Cloutier et al are in substan-cial agree =ent concerning the dose rate at the surface of the syringes (see attached). Note that Howley's comparison shows that Cloutier has one TLD =easurement at the finger tip of a glove which is in substantial agreement with the other three authors. Conscientious workers are lulled into a false sense of security because they see only acceptable exposures on their wrist and ring badges. However, this can be very misleading. Note that the exposure drops off very fast as you sove back on the syringe. Ring and wrist badges cannot be expected to reveal the high surface exposure over the radionuclide in the syringe. Most users, over 30-60 secs, inject with their index finger right against the syringe barrel and very near or over the syringe vole =e containing the radionuclide. TLD =aasurements at the finger tips are very difficult to control, but when done properly give a better indication of hatard chan ring or wrist monitors. j

2. This finger tip TLD monitoring would not be accepted on a routine basis. , I The dose rates obtained in the references by calculation, TLD, and film for the syringe surface exposure are more reliable and seem to agree with properly obtained finger tip TLD measurements as far as dose rate. Timing of injections varies with the skill of the worker and the differences in patients. i In a worst case of 1 R/ min X 35 doses X 5 days / week X 50 weeks X 20 years = 175,000 R. Bio-statisticians,howevertheymodifytheeffectofthis exposure, (assuming a risk somewnere around 1/10 /R)3would have to come up with a risk of skin cancer somewhere between 1/10 and 1 in 5. A risk any greater than 1/10* is generally unacceptable in our society. (Auto risks are 1/10*). 1 Any syringe shield if used would be better than nothing. The NIH developed retractable syringe shield, available commercially, allows for radionuclide calibration immediately prior to administration without removal of the syringe shield from the barrel of the syringe. The shields are available in tungsten or depleted uranium. Approximately 1,000 users are known to have tried this shield. A little practice is all that is necessary to learn to use them. Their use at NIH has been mandatory for over four years. No insurmountable problems have come to our attention regarding their use in the last four years. Attached are draf ts of our papers on the subject presented at several Nuclear Medicine Meetings: San Diego,1974; Philadelphiir,1975; AAPM, Charlottesville, Va., 1976; Nuclear Medicine Techs, Hershey, Pa., 1976; j H.P. meeting Texas, 1974; plus some correspondence with intypsted physi-cians at the National Academy of Sciences and bio-statistics at the Bureau of Rad. Health. Sincerely yours, Mfkt

                                                            ' John R. Howley       /

Health Physicist (u 4 ( I l l l

Catalog No. 27 L i . _ - 3

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                                              = REDUCES EXPOSURE FRO .1 ""'Tc BY A FACTOR EXCEEDING 000
                                              = f.iEETS MRC/CFR FOR MIM!MU?.1 HAND EXPOSURS
                                              = LIFE TIME GUARANTEE                                                           ,

L Y Wsay. the ultir ate Syringe Shis!d concaived and de. the dansa metal cor ;ietes the shielding portion, s ; ed at :be Nat:osal Institutes of Hasith. The NIH/ Loaded syringes must be removed from c: nun. Tw ;; ten Syringe Shield of advanced unique design 2nd tional syrings shields for calibration, The NIH/Tur;stan Tataria's reducts exposure of 33mic by a factor ex. Syringe Shield obviates this high exposure stap by 21!:w. ned.g 200.. Ing the tunisten shield to-be retracted in the estibrator. The shield itself is constructed of tungstan. or de- Thus. at no time is the foadad syrirge ever removed from

    ;:2::d ursn!um ma: sis. 50*i densar than fasd yet with :he                                tha high dens.*ty sM i s! ding.

isss::e stre";th of stael. To reducs bulk and weight the The tungs:an shia!d. axtendsd or retrac*ed is train. eswt:al sh:e!dic; is c:nfined only to that part of the sy. tsined in. position by an automatic lecking davice. The

    *:e volums actually *:aded with the radienuctida. The                                     sluminum shaft sif:..1 for smo h ext nsion or retraction and of the shield is ts::ared to allow the c!inician maxi-                                of the shiefding. The syringe Is kept sa:urely imm:5!!a
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                                                       " patent amies for TUNGSTEN                                                                    DEPLETED URANIUM 07113 N:H Syr'r;s Shiefd 3 cc with Fixture . . . . . . . . . . . . $ 124.50                    07 3:3 ::e           ..     .        ...       . .       .     $: 2.;3 07115 .N!H Syrie; CNeld                                                       07*777       '#           *                        -     - -   S III' 3 5 cc with Fixture . .  .......                  . $ 1:4.i]                                                                                         __.

13

ME ABSMACT HERE:(BE SURE TO STAV MmlN BORbER) l * 'g. c BSTRACT' .CBOOUCTION A REITdCTABLE FORM DEPLETED LIPA N SYRINGE SHIELD FOR Tc-992 A'ID Ca-67 n!JECTIO?S. J. Ho. ev, H Tipton, M. Preter, _M. Green, M. Dickinson, E. Adams , W. Wanner, R. Zoon, R. Bros-eus, A. J nes, G. J hnston. 'fational Institutes of Health, V!ORLD cEDERATION sechesda, Maryland. 0; NUCLEAR ringer eip radiation exTosure (approaching 1R/ Min) r.;EDICINE AND fra manipulating 15-20 sci Tc-99m in unshicided syringes c! OLOGY d"#i"8 I # i"3*"*i "" i'

  • f'"9" "*1 7 18" **d **f**7 hazard in Nuclear Medicine. The risk of skin cancer for the unwary Nuclear Medicine worker is analogous to that of SECOND INTERNATIONAL the ill-fated dentists, physicians, and radium workers CONGRESS whose fingers received comparable radiation exposures earlier in,this century. Available shields often are not used because they are deemed too cumbersome.

CHECK caly one preferred To alleviate this problem, retractable shields, first s4ect class 6caricn of tantalum, then tungsten, and now depleted uranium have C Sicchem/Physiclegic Veasures been constructed and tested in actual clinical settings. C Sene/jc;nt These materials have linear attenuation coefficients equal C Cardievascular to or greater than lead and tensile strengths in the range C Computed icmegraphy of steel. Bulk and weight have been reduced by confining C Cata prccessing/ disc!ay the dense. shielding material as much as possible to the a Ocsir etry and health physics syringe volume actually containing the radionuclide. The C Encccrine/metabclism shield assembly is kept on the syringe barrel from loading time through calibration and injection. During the final C Gas:rcenterc!cgy isotope calibration procedure prior to injection, handling C Hematclogy is reduced by simply retracting the forward section of the C :nstrumen:atten shield. C '/ecical Physics While the weight of the entire depleted uranium shield C Neurc!ogy is just over 3 ounces, film dosimetry indicates that a few

    ,      C Nuc: ear Medical Technology       milli =eters of uranium reduces the radiation surface
C Cncelegy exposure rate to the fingers from Tc-99m by a factor in j

C Pu'menary excess of 1,000. Surface exposure frem the more energetic C Paciccicicgy Ca-67 is reduced by a factor in excess of 200. Brass coat- {tj C Pacicassay ing of the uranium reduces the non-penetrating uranium C Radiccnemistry surface exposure to 0.1 mr/ min. . ?cnetrating exposure f rom C Ps::cpharmaceutical science the depleted uranium is li=ited to .01 mr/=in. C Recal/ s!ec:rclytes C L'itrascund C Cther (spec:fy) TYPE FULL NAME OF AUTHOR PRESENTING PAPER: John R. Rowley EXAMPLE:

E ACt.tNE TECHNETIUM-99m POLYPHCSPHATE SCNE IMAGING IN LEGG PERTHES
          & e ~ st te receaec ey                  OISEASE. James A. Danigelis, Robert I.. Fisher, and Maer B. C:enoff. Newington Children's Hospital, Newington, Conn. USA U.tPC R TANT                     This investigation was undertskon to ccmpare the All 4::stracts ac:2::ed fcr the pro. diagncstic usefulness of radionuclido bene imaging pam a te pnt ac cirecuy ficm l         :ne :ypec c::y on :n s sheet. To in.        List the name, address, and te!ephonc numect et the principal authcr l         sure pn:r] Quauf. :ne >nstruct cns       who should receive all Certespendance:

must e !c:to,ved CGMPt.ETELY for \ J// J0stracts. Atstr3 cts that do nCf we Houley John s.m R. ( us w e ... . c:M:rm udi r ct te ::uctisbec in :ne :nsuut cn National *stitutes of itcalth O 4 71 a:suac: vcfur e. I Actress 3ethesda, Maryland 20014

              # TEASE CPECX AeSTAACT l            CAAEFULLY FCR AF AEAA ANCE                                                                       1 01-406-5774 1

SEFCEE MAlUNG IDOUC EMOUf l Nar es anc 3:nndates of all Authers a ycu usn to be consrcereo for tne Hevesy Pn c-

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FILM EXPOSURE AT THE SURFACE 11.2 mci OF semTc IN 1cc OF A 3cc PLASTIC I SYRINGE l DEPLETED URAN 1UM SillELD EXTENDED DEPLETED URANIUM SillELD RETRACTED  ! 3ms/ min. . 0.7mr/ min. 5' '" q ALUMINUM DEPLETED IflGil DENSITY GLASS T UllANIUM

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l 0.3mr/ min. l 130mr/ min. a h Aluminum) FILM EXPOSURE AT THE SURFACE 2.7 mci OF "GA IN 1cc OF A 3cc PLASTIC SYRINGE DEPLETED URANIUM StilELD EXTENDED DEPLETED URANIUM SillELD RETRACTED Amt/ min. 0.3 mr/ min. DEPLETED llIGl SITY . ALUMINUM l l 9mr/ min. l 120mr/unin.

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l - l FILM EXPOSURE AT THE SURFACE 29.2 mci in lcc of a 3 cc PLASTIC SVRINGE I 14 mr/ min 3 mr/ min 3 mr/ min 3 mr/ min i 210 mr/ min (EDGE OF SHIELD) bx

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SURFACE DOSE RATE FROM 99'"Tc LOADED DISPOSABLE PLASTIC SYRINGES 1 ' l{usak's Formula P = 33 g AI' mr/ min P = dose rate (mr/ min) at the outer syringe surface

            '( l j                      11 = length of solution in syringe (cm) g

, g l r = internal radius of syringe (cm) 1 I A = activity in syringe (mci) r ('N I, = specif.ic gamma constant for . isotope

                    .                         (R-cm2/ mci-hr)                                                              ..

1 For 0.5 cc P = 33 x x 1 mci x .5G = 41 mr/ min / mci 1.0 x .45 cm NIH Film Measurement = 40 mr/ min / mci , 1 5 cc P = 33 x x 1 mci x .5G = 7.1 mr/ min / mci 4.0 x .G5 cm ORAU TLD Measurement = 10.0 mr/ min / mci 1

                                                                                   = 4.G mr/ min / mci 10 cc P = 33 x 5.5 x .75 cm x 1 mci x .56                                                                       .

Husak Film Measurement = 4.0 mr/ min / mci e I e

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                                    "Tc EXPOSURE AT THE SURFACE OF PLASTIC DISPOSABLE SYRINGES 10 0         ,       i    i      i     i     ,    i   i i      i NIH (FILM)
                           -                                                    a Calculated (Henson) a                                                 o Measured-Film (NIH) 50   -

o Calculated (Husak) 40 a '*"" ' 6 ML SYRINGE 30 - 3 12 ML SYRINGE E 20 - a g i ML SYRINGE

                  'E                                      a s

5 CRAU (TLD) 10 - o

                          ~

e 5 - ejHUSAK(FILM) 4 - cr 3 ' ' ' ' ' ' ' ' ' ' O I 2 3 4 5 6 7 8 9 10 VOLUME (cc) INJECTED k w ,. w

LINEAR ATTENUATION COEFFICIENT (photo-electric) LEAD VS. TANTALUM EXPERIMENTAL AND CALCULATED 106

                 .                                                                   Mass Arten Coeff (Tantsfum) = MAC 7
         ,c 3    -
                                                                                     ""c,-(#+),,(g(=c: )                                                 .
                 ~

.i , For Tantalum .Z = 73 W = ;31

                 ~
                                                                                                     #pb/p = 2.3 cm /gm Mi-C        = 12.31                       2
                                                                                                                                = 1.65 cm fg, T                    a C/M 10       -

pb

/

3 7 A

                                             /      L if o r,,, = 16.6 gmiem              enen 3

4Ngh energy) Tant = 16.6 gm/cm x 1.55 cm2 /gm

                         # = 693                  contaminants)
                ~             "V' 1
                                                                                           # Tant
  • 27 ##C*
,       '0 3       Hvt. = 026 cm -(eicenmentan
                ~

I # ob = 11.35 gm,em3 s 2.3 cm2 'gm L

                -     Mia. Pb = '                  = 26.S cm 400 = 26.1/cm

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g Mass Atten Coeff (lantalum) = MACT

                                        =.f!  ph h                                            '

MAC T [Z h h - [(.W207.2

             ~

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 ;y For Tantalum -Z = 73
    'd                                           W = 181 ll pb/p = 2.3 cm /gm 4

I 8 4

    'i                                                  /73 3           /207.2 3 i                          MAC         = (2.3)l               4
                                                                                      - 1.65 cm 2 /gm
     ]

T (82j (181 j p If p = 16.6 gm/cm 3 then Tant - 3 2

    ;                  ll Tant = 16.6 gm/cm x 1.65 cm /gm
  .]                             llTant = 27.4/cm l                             !*pb = 11.35 gm/cm 3 x2.3cm 2 /gm j            -

i j llpb = 26.1/cm l Mg ( d 'A] ('

l

        -k                                                                                         ,                  g THE WRONG MONITOR CAN BE DANGEROUSLY MISLEADING!
         !        (Survey meters are n0t designed 10 measure this surface exp0sure)

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f  ! s s . OME " CUTIE PIE" SYRINGE INJE ACTIVITY IN ERROR ED SURVEY METER FlW SYRINGE

           ;                                                                                       FACTOR                                        :

M'"Tc mr/hr mr/hr . 1 ml 1 ml 30 1800 2.04 mci GO 3 ml 1 ml 40 3450 2.00 mci BG 3 ml 100 4500 5.05 mci 45 G ml 1 ml 40 2700 1.89 mci G7 4 ml 100 5850 7.32 mci 59 12 ml 2 ml 55 3000 3.02 mci 65 5 ml 120 0900 U.80 mci 58

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              '%,,       *s                                                                                  March 25, 1977 Q,
                           -e
               ,$ i7. N Mr. John R. Howley 5
               '..j.Jb'&3uilding21,Roomllo
                     ,   5 M National Institutes of Health fj R 33ethesda, MD 20014 Q'DE         4 4 y

Dear Mr. Howley:

N e. D,, " (. ;, In response to your letter of March 15, 1977, regarding a

            %d                  ipossible serious radiation hazard facing workers is nuclear
h. S'4 kedicine, I took the liberty of sending a copy to Dr. Arthur Upton V.iand then discussing it with him.
                $y       , % '-

i;! 4 . ' As I told you on the telephone yesterday, he and I agree that [3

  • 3*4 situation.1This '% there is alsois acertainly situationain potentially which the guidelinesserious ha:ard and as you describ
                 . ' N Dstandards recom= ended by the tiCRP report no. 39 (75 R =ax1=um
                .t-M I%er year to skin) seem to be completely ignored. We both feel that
                . .].

q the NCRP recocnendation is a reasonable one and should be folicwed. In respect to vour calculation of overall risk of skin cancer

                   ;3     g(,,%y                                        , we would generally agree with this
                   ;      r .'g-(approxi:tately calculation but1/100/ have arad) feeling, based upon ani=al experi=ents as
  • p'Nwell as human data, that the skin is not as sensitive, as far as
                  ,      d G., cancer production, as bone = arrow, thyroid, breast and lung may be.

a*'::v<Certainly at the localized doses you describe, there is a high 1 d potential risk of infla==ation, necrosis and ulceration of the l dskin. The potential cancer risk as you have calculated =ust also j h4,,,,-j. k (be considered only with the caveat. that it =ay be a correct calcula-T d eion if one assumes linearity of effects. If the effect is non-

                              ' linear, then the calculation could be high by several factors.

I hope that you will be successful in your efforts to alert responsible people as to the potential hazards to workers in nuclear nedicine so that they may be able to at least bring the levels of exposure within the limits of the reco== ended standards. I hope that we have been of so=e help to you and I appreciate your having called my attention to this problem. r Sincerely, E

  • Albert W. Hilberg, M.D.
           ~~ e .'.at;onal Resear& Queest is the vri reinal ocerating ar,ncy of the National Academy at Scien:rs and the N.tional Ac.sle qsQqs[ q*i t,

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                                                                 .          !! arch 15, 1977               -

Albert Hilberg, M.D. Uctional Acade=y of Sciences 2101 Ccnstitution Ave. , N.W. k*ashington, D.C. 20418

                                 ': car Dr. Hilberg:

T Thsnk you for agreeing to take a look at what seems a serious radiation I hazard facine yrLworkers in Nucicar Medicine who are injecting (unshicided) [ 15-30 =C1 ic into patients. l - A varst case vould be a busy hospital with a physician or technician injecting "*Tc into 35 patients a day, five days a week, 50 weeks a year for 20 years with a radiation exposure to finger tips from the surface of the syringe of approxi :stely 1 R/nin, and allowing 1 min syringe handling ei=e. f 1 R/=in x 35 doses x 5 days /vcek x 50 weeks x 20 years = 17f,000 R b

                                                        ...-                                                                                               .\ s For the sake of calculation let us assume that the risk of skin cancer (                                                 -

s is similar to that7or-other cancers, leukenia, thyroid cancer, etc. f

                    / , dapproximately 1/10 /R,P, I would then expect to see 1 in'10 to 1 in 5 .j Y,s .O\.'

of these workers exhibiting skin cancer (such as squarcus cell carcinoca) in 10 years if they continue the way things are going in the field of

                               '*uelear Medicine.                                                                                             t-7-\ ' \~@_

i J Frem 1974 atour paper " Radiation Safety in Nuclear Medicine", presented1 in June Iv there is the Muclear fairly Mcdicine about good agrecuent "ceting in San Dicco, California, you can see exposure rate (Revicy, Husak, Henson) D 4 at the surface of the unshielded syringes. 5 Another hasard exists from 1.stely 5 Rads /uci theoretical e contanination on the finger tips (apprcx- < and experi.:entally with the extrapolation Q p. . .',

                                                                                                                                                            )..
   ;              ,(          chamber). About half the workers in Nuclear Medicine laboratories don't V .,%

i voar gloves, so that finger contamination is inevitable (see attached I report and notof a centamination incident repeated frequently around the world \, reported). . '. lvO V,

                                                                                                                                                  'J        V    -
  .                                                                                                                                             i 4 .l Contrary to the NRC inspectors' watuation of our reported contanination N,...

incident, the yRP report no. 39, pg. 39 (attached) veul.d scen to favor 'F , the use of I cm as a significant ares. The experience with cataracts ,b a: d 7.-ray diffraction finger exposure accidents vould also seem to favor

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2. l using small significant areas of exposure (see attached XRD data 113 111 pg.3, Par.1 and paper by Howley and Robbins). partly as a result of our studies, the NRC licensing and Inspection divisicas have recently begun to stress better finger p'rotection. Some licensees have aircady been cited for not vcaring gloves .ind not using syringe shielding. Some still regard 'the NaC as Interfering and a nuisance, so that even for those possessing syringe chicids, co=pliance is frequently a pretence. Part of the safety co=pliance probles will be the develop =ent of suitable and acceptable syringe whicids. (See syringe shield studies, a ttached) . L' hen this data of ours is published, I would like not only to point out that =any workers have been violating established safety guidelines for

        -I               finger exposure, but to also give some range of estimate of the increasing
       .                 risk that these workers are taking if they choose to persist in the established cavalier approach to radiation safety existing in =any Nucicar J
                         ..edicine laboratories.

On this last point, I would like to be on as fir = groun'd as possible; if j assu=ptions must be =ade, I would like them to be ress' e nable. On this r point, I would welco=e your advice or that of others who sat on the BEIR co=sittees. i In looking at the 3EIR tables e es =a e e sk for lenke=fa, thyroid cancer, etc. , the nu=ber 1/10 6/R cce=s to be a somewhat co==on ball park j figure for risk. In the absence of firmer data for human skin cancer,

could this nu=ber be used as a reasonable e.sti= ate of risk for Health
    !                    Physics purposes? Are we using the risk estimate correctly and in a reasonable =anner?                                                        -

Thank you again for your interest. . . Sincerely yours, John R. Howley

    ;                                                              Health Physicisc i

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Finger Tip Radiation Exposure in !!uclear !cdicine Finger tip radiation exposure (approaching 1R/ min) fr:m manipulating i 15-20 nci Tc-99s in unshielded syringes during I.V. , injecticas is a frequently ignored safety ha:ard in !!uclear Medicine. The inevitable { contamination of the hands when gloves are not worn presents an addition-al hazard of 1-5 Rads /uci re aining on the skin. *Jhile

                                                                    .      minimum radiation exposure should be the goal (1), half the technologists responding to a 1973 published survey (2) were using no protective shielding during the injection of radiophar aceuticals.      If the results of this su:vey are typical, a serious radiation safety problem has existed for so=e ti=a in the ::uclear Medicine field. To correct this situation, the Medical Section of the licensing division of the 2;uclear Regulatory Cocsission has begun requesting more detailed data from their licensees on the specific safety precautions taken during syringe dispensing of radio-phar:aceuticals. Gloves and available syringe shields, it seems, have not been used censistently because they were dee=ed too cumberso=e and partly because many physicians and technicians apparently do not fully appreciate the radiation risk.

A worst case sight be a busy hospital with a physician or technician injecting 993 ic into 35 patients a day, five days a weeks, 50 weeks a year for 20 years with a radiation exposure to finger tips frem the surface of the syringe of approximately 1 R/ min, and allowing i sin syringe handling ti=e. 1 R/ sin X 35 domes / day X.5 days / week X 50 weeks Y 2n years = 175, ann R

l 2. i If we assu=e that the risk of skin cancer is roughly ce= parable to that for other cancers (leukemia, thyroid cancer, etc.) (approxt=stely 1/10 0/R) (2A, 23) we would then expect to see 1 in 10 to 1 in 5 of these workers exhibiting skin cancer (such as squa=ous cell carcinosa) in 20 years if things continue the way they are going in the field of Nuclear Medicine. Varicus modifying factors such as dose rate, etc., will tend to reduce the risk esti=ste by factors of 10 to 100. If the risk could even be shown to be 1 in 1,000 it would still be an unnecessary and generally unacceptable risk in our society. The NRC standards for radiation protection (CFR Title 10 Part 20) saggests that available technology be used to achieve the lowest practical exposure below reguistory limits of 75 rads / year to the hands. Instead, most of us have been lulled into a false sense of security by relying on unsatis-factory monitoring syste=s. Unfortunately ring and vrist conitors as presently worn simply do not give suf ficient indicatica of the high finger tip exposure at the surface of unshielded syringes. Our film dosimetry 1 at the surface of unshielded syringes agrees substantially with other calculated values found in the literature (3,4,5). This data gives strong indication that =any Nuclear Medicine workers are in fact receiving finger tip exposure far in excess of established legal limits. yer those who are faced with correcting lorig established radiophar=aceut-ical injection proce'dures, it =sy be well to review s::e of the available data that has influenced the setting of our presenc radiation safety standards. Dentists in the past have developed squa=ous cell carcincea I

3. fron holding X-ray fils in their patients' :ouths (6-13) . Early radiolo-3 1 sts experienced a similar fate. M.any of the pioneers with X-radiation l and radioactive =aterial died as a result of sequaelia produced by' excessive radiation exposure (14,15) . Radiation-induced skin tumors have been observed in rats with as low as 200 rads with the tumor incidence rising abruptly between 1,000 and 2,000 rads. In = ice, tu=or induction following superficial beta irradiation has been reported to be proportional to the square of the dose. In humans, skin cancer has been reported with doses as low as 450 rads. The relative risk increases with the accu =ula-tion of exposure (16) as is seen with other carcinogans. While dose rate is a =odifying factor, delayed effects are to be expected from the gradual accu =ulation of radiation exposure. The fils expcsure at the surface of a Tc-99= leaded syringe is 300 =r/ sin for 20 sci in 0.5 cc of a 3 ce plastic disposable syringe (?igure 1) . The fils exposure at the surface of the Tc-99s eluate collection vial can exceed the table top exposure frem a fluoroscope (Figure 2). Husak has given us a si=ple dose rate for=ula that allows us to estimate the exposure for any ga==a emittar and any volu=e in any size syringe. , We need know only four factors to determine the surface exposure (Fig. 3). The calculations are co= pared with two fils =easure=ents and one with TLD. The effect of volume injected is seen in figure 4. Our fil: =easurc=ents co= pare favorably with Henson (3) and Husak's (4,5) calculations. The fils =easure=ent of Husak and the TLD =easure=ent of Le=bardi et al (2) show agree =ent with calculations. Revised calculations of Husak and M

4. Henson (17) would sees to be in even closer agreement with the NIH film exposures. Film is the =onitor of choice since survey meters and other ion cha=bers are noted for errors due to geometry factors (13). Figure 5 illustrates gec=etry factor errors with survey meters. The film calibration (Fig. 6) was perfor=ed with a Tc-99s source and an NZS calibrated R-meter. The Syringe Shield Historically, syringe shield design has left =uch to be desired. To alleviate this problem, an NIH team of Nuclear Medicine physicians, health physicists and paramedics of various kinds and the NIH Divisien of Research Services joined forces to atte=pt varicus solutions to an acceptable syringe shield. One design that has shown considerable promise is a retractable shield

         =ade of tantalum, tungsten, or most recently nickel-coated depleted uranius (U-238) (Fig. 7). These hard metal shields have a tensile strength considerably greater than lead and of co= parable or superio'r radiation stopping power. Bulk and weight are reduced by cenfining the shielding in the forward section to the volume actually containing the radionuclide.

The rear section of the asse=bly can be steel or aluminum without significantly sacrificing protection for volumes up to 1 si in a 3 ce plastic disposable syringe. Using aluminum in the rear section rather than steel reduces total assembly weight by 10%. The shield asse=bly is kept on the syringe barrel fres loading ti=e thrcush calibration and injection. During the final isotope calibration precedure prior to

injection, handling is reduced by si= ply retracting the forward section O(J A l

l l -- - - .. .

5. of the shield under the rear sheath. The forward section of the shield is maintained in a retracted and elevated pos'ition during isotope cali-bration. Ca=sercial sodifications have made the shield universally adaptable to any make syringe. The basic design is also adaptable to various syringe volumes. Fils dosimetry (Fig.1) de=onstrates the effectiveness of the tantalus shielding with the result that a few millimeters reduces the exposure race to the fingers hy a factor in excess of 200. Distance alene accounts for a reduction factor of four on the front end. Fils dosimetry for an alum-inus rear sheath and a tungsten forward section give comparable results. Nickel placed depleted uranius has a significantly greater stopping power for radiation than either tantalus or tungsten, but requires a special MRC license to fabricate. The linear attenuation coefficient. 'or various dense metals and alloys have been determined theoretically and experimentally (Fig. 8) for 140 ? K4V photons. Lead, tantalus and tungsten are quite comparable. Cepleted uranius has a radiation reduction f actor of four greater than the other 67 1 three considered for ca. Surprisingly, 38U is only 1.5 ti=es as effective as tungsten for "Tc radiation. .010 inches of brass covering on the depleted branium shield reduces the residual _ exposure from the uranium itself to 0.14 sr/ min 3 and .02 =r/ min r. The bend in the curve i of the experimentally derived attenuation data for lead and tantalus is believed due to Mo-99 and other high energy contaminants in the generator eluate. Additional shielding between 2 =m and 8 cm of lead or tantalus had little effect in attenuating the higher energy photons of the Y

6. contaminants. Consequently we limited the design to a tapered shield from a =inimum of 1.5 =s to a =aximum of 3 =s thickness. The retractable syringe shield in use is seen in Figure 9. Another significant harard that should be noted in the handling of radio-nuclides in Nuclear Medicine is the danger from contamination persisting on the fingers. If gloves are not worn, contamination of the hands is inevitable. The beta type exposure from *Tc persisting on the hands can amount to 5 Rads /uC1/cs' (Fig ). An extrapolation chamber measurement of radiation exposure from the surface of thin dry sources of "Ic agrees favorably with calculated values (Fig. ). In su= mary, suitable gloves and syringe shielding are essential if Nuclear Medicine workers are to avoid the undesirable effects of excessive and unnecessary radiation exposure during manipulation and injection of i radiopharmaceuticals. t

l 7. References

1. Ccde of Federal Regulations, Title 10 Part 20: Standards for protection against Radiation, par. 20.1 (c)
2. Lc:bardi MH, Beck WL, Cicutier RJ: Survey of radiophar=aceuticals use and safety in 69 hospitals: DHEW Publication (FDA) 73-8029; Health Physics in the Healing Arts'.,,far. 1973, p. 22S
3. Hensen, PW: Radiation dose to the skin in contact with unshielded syringes containing radioactive substances. 3ritish Journal of Radiology, 46, 972-977, 1973 4.' Husak V, Kleinbauer K, Lidova L, Erban J: Exposure of hands of personnel administering radiophar=aceuticals in Medicine (!n Ccech).

Jaderna Energie 17, 164-168, 1971

5. Husak V: Exposure rate at the surface of syringes containing radioactive =aterial. J. :;ucl. Med 12: 574-575
6. Surg. Clin. of :; orth A= erica, vol. 13, 427-30
7. Oral Surgery Gral !ed. Oral Path, vol 34 no 1-6, 650-639
8. 3 oyes JH: 3unnell's Surgery of the Hand; Sch ed. , J. 3.Lippincott Co. 680-685, 1970
9. Jer:atitis involving the dentist's hands: Journal of A=erican Cental Assoc 63: 651-652, 1961
10. Saunders and Montacmery: Dermatitis. JAMA vol. 110: 26-28, Jan 1938 3r(J *
   ~~*.e   em

8. i

11. Mohs, FE: Roentgen ray cancer of the hands in dentists. Journal of the A=er. Cental Assoc., 45: 160-164, 1952 4
12. Toung HH, Kunkel MG: Diagnosis, creat=ent and prognosis of Roentgen ray injuries to dentists. Journal of American Dental Association, 5:

1-5, 1955 ,

13. Curtis AC, Kirk =an LW: Radio der =atitis. Cral Surg., Oral Med, Oral Path 3: 294-297, 1950
14. Alexander 7: Atomic radiation and Life. Penguin 3coks 14'4-145 i ~ 15. Early :'.artyrs to Radiation
16. Tha Ef fects on Populations of Exposure to Low Levels of Ionizing Radiation - National Acadeny of Sciences National Research Council, 132-135,
1972 l 17. Private co=munication - V. Husak
18. National Bureau of Standards RBIII, p.10
19. Aconic Products Corp. , ?.0.20x 657, Center ::criches, N.Y. 11934 2A. The effect_on Population of Exposure to low levels'of Ionizing Radiation. National Acade=y of Sciences ::ational Research Council: 132-135, 1972 2 3. 3asic Concept of Risk: Reactor Safety Study, chrpter 2 USNRC, Wash 1400 ( CREC - 75/014) i
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A T.U;TALUM SYRINGE S'dIELD FOR 99s-Tc I UECTIO:l3

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Finger tip radiation exposure (approaching 1 R/=in) from =anipulating * .  ; 15-20 =Ci 99=-Tc in syringes during I.V. injections is a frequently ignored  ! safety hs ard in !!uclear Medicine. Available shields often are not..used . ~ l because they are dee=ed too . cumbersome. To alluviate this problem a tant's- ,

           . 1c.s shield with several novel features was constructed specifically for use vith 99.-Tc. -    Tantalum . a videly used =ecal -in. the missile- and nuclear ~ -- -                                                     .

reactor fields, offers several advantages over other possible ' syringe' .

                , shielding =a'terials. It has a-linear attenuation coefficient equal.co lead, a tensile strength in the range of steel, and is still =achinesble with high                                                       ._ .;
    .            speed tools. 3ulk and weight have begn reduced by confining the tantslum -

shielding as =uch as possible to the syringe volu=e actually containing . the radionuclide. The shield asse=bly is kept en the syringe barrel from

  • loading ti=e through calibration and injection. The barrel of the syringe is kept i==obile in the shield by twist'ing the flange into a groove until a tiny spring ball plunger snaps into lpek position. During the final isotope calibration procedure prior to injection, handif=g is reduced by-
       .        si: ply tetracting the tantalum section of the shield ; Tha tantalum section;_

of the shield is =aintained is a retracted and elevated position by another - ball type locking device. A stainless steel shaf t e_. ploying Delrin (Dupont) - hushings allows secoth extension or retraction of the tantalum. shielding. .1 recently = edified clear hubbed needle .snd standard Luer Lok disposable.= ~- gyrin ;2 (2-D) cosplete the assembly. Fil desf=etry has de=onstrated the effectiveness of the tantalum shier. ding with the result that a few =1111-neters of tsacalum reduces the surface exposure rate to the fingers.by a - factor in excess of 200.

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A Tantalum Syringe Shie'id for "Tc Injections Finger tip radiation exposure (approaching 1 R/ Min) from =anipulating 15-20 rCi 'Tc in syringes during I.V. injections is a frequently ignored radiation safety hazard in Nuclear Medicine. Available shields often are not used because they are deemed too cu=ber-so=e. Slide 1 To alleviate this problem, a tantalum shield with several novel features was constructed specifically for use with *Tc. The forward section of the assembly is a retractable shield made of tantaluz, a =etal =uch harder than lead and of equal radiation stepping power. 3ulk and weight are reduced by confining the dense tantalum shielding in the forward section to the volu=e actually containing the radionuclide. The rear section of the assembly can be steel or alu=inum , without sacrificing protection for volu=es up to 1 al in the 3 ce plastic disposable syringe. Using alusinum in the rear rather than steel reduces total asse=bly weight by 10%. The barrel of the syringe is kept ir=obile in the shield by twisting the flange into a groove until a tiny spring ball plunger snaps into lock position. I The shield asse=bly is kept on the syringe barrel from load-

           ,                      ing ti=e through calibratien and injection. During the final l-*
                                  "sotope calibration procedure prior to injection, handling                                                           ,

1 4l As reduced by si= ply retracting the tantalum section of the I shield under the rear sheath. i; if , l

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[ Page 2 The tantalt:= section of the shield is maintained in a retracted c and elevated position during isotope calibration by another ball-type locking device in the rear between the tantalum shield and the outer sheath.

In this, our latest model, the extension and retraction tabs on the side are spring loaded to increase friction and reduce slippage. This may eliminate the need for a locking device in the forward or retracted position, an ites that requires the skill of a Swiss watch maker to load in position. The whita bushings are delrin by DuPont. A recently modified clear-hubbed needle and standard 3 cc Luer-Lok disposable syringe (by 3ecton-Dickinson) complete the asse=bly.

Slide 2 Film dosimetry has de=enstrated the effectiveness of the tantalum shielding with the result that a few millimeters of tantalum reduces the exposure rate to the fingers by a factor in excess of 200. Distance alone accounts for a reduction factor of four on the front end. Film dosi:etry for an alt =rinum rear sheath is essentially the same as for steel. Slide 3 The next slide st:==arizes some of the significant properties of tantalum versus lead shielding. I , The tensile strength and non-corrosive preperties of cantalu: plus a slightly better total attenuation coefficient lead us i i to favor it over lead.

          )

t i The greater density of tantalum does not necessarily lead to { greaterradiationftoppingpowerthanlead. Atomic nu=ber and i atomic weight also play a part as can be seen from the calcu-1 lations and seasure=ents in the next slide.

       !                 Slide 4      The next slide co= pares the linear attcntiation coefficients i

1

      ?                               (photo-electric)of lead versus tantalum experi= ental and calculated) .
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3 To the left is a plot of " Sc attenuation in lead and tantalum, experi=entally determined by =casurement of the photo peak in a i multi-channel analyzer. Both =etals are equally effective for equal thickness. The bend in the curves is believed due to Mo and 4,ther high energy contaminants. l.<*M Frem this data, we "see that additional shielding beyond 2 =m g of lead or tantalum d has little effect in attenuating the higher energy photens "m the contaminants. . W J n ; ? ta Sx d le.se n % ni__ L -litc h "' :t 'a  ;: teme-' ; -N u-6.w . ...% jha.6, l ~ . . .._vM m Sh'M'"; "7 M. 3 :=of=nad cY ranralum@.cd- li:-R ;f9 set-en ohe-MM energy-photans. Consequently, we decided to go with a tapered shield from a minimum of 1.5 =s to a maximum of 3 =m thickness. We have considered other =etals, tungsten, Californium and spent uranit_% %thinthelast few weeks, ons of our' collab-orators, Atom Lab-Atomic Products Corporation, an exhibitor at the show, has constructed a tungsten alloy shield following 1 our design. With ce= parable ata=1c veight and nu=ber, the 90-

95 i

3 tungsten alloys have densities between 17 and 18.5. It P' A i s cheaper and may eventbe better as a shield.

       -1 In conclusion, the last
'.:                                                              three slides shew the retractable
  .:                                  syringe shield in use.

j i p Slide 5 First, we see a technician, wearing gloves, incidentally, { h withdrawing-w ""Tc from a shielded vial into the shielded syringe. , h Slide 6 r In the next slide, the forward section is retracted, reducing

  • handling during the calibration procedure. ,

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i t i I I D 4 9 SIGNIFICANT PROPERTIES OF TANTALUM , vs LEAD SHIELDING (d  ; Property Tantalum Lead , Atomic number 73 '82 j Atomic weight 180.95 207.19 l 11.35 I Density at 20' C gm/cc 10.G Tensile strength (psi) 130,000 - 3,000 Corrosion resistant non-resistant l i .- Total linear attenuation i' coefficient for 140 kev 30.8 cm-1 26.3 cm-1 i i I, i it e i 1

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L / ;'/ Q) t - .] j fv J. Hovicy, 7.iDIATION SAFETY IN NUCLEAR MEDICINE. M.Creen, M. Dickinson, E. Adams, W. Wagner, R. I Broseus, A. Jones, G. Johnston, National Institutes ! of Health, Bethesda, Maryland. Hand and finger exposure is an. insidious radiation safety hazard in nuclear cedicine. While mini =um i radiation exposure is the b , half the technolo-

   +

gists responding to a recent published survey were using no protective shielding during the injection of radiopharmaceuticals. The inevitable conta=1-nation of the hands when gloves are not worn pre-sents an. additional hasard. Surface exposure from unshielded syringes containing 99=Tc increases . vich decreasing volume to *.0 cr/=in/=Ci for 0.5cc (SCO er/ min for a 20 =Ci_ injection. ). Co= par-able exposures are ootained for other less used isotopes. The calculated beta-like surface cose from 99mTc contamination persisting on the hands can a=ount to 5 rads /uci to the active skin layer. I Ring and wrist conitors do not adequately re- , flect the true radiation burden to the hands. Suitable gloves and syringe shielding are essen-tial to avoid the undesireable effects of ex-cessive and unnecessary radiation exposure. I e ee. y gg ,

                                                                  * "**       e w . amiule e a e- e      me w w -                                                                                     * " ' "   se. .***   *+=semm>    w.                 , ,, ,

re s ha p3 thc musC ;"'L'""h"'""""''***** ' ' ' ' ' ' ' ' ' tc, Jay is hand - .I finger exposure frc:a manipu . ions with unshicided. jj vials

                **                                                                                                                             l
                                                                                                                              ,,        ,3     i nd syringes.

In addition, contamination of the hands presents an addition-oi hasard. The seriousness of the problem is not generally ~ appreciated, and if considered at all, the danger is frequent!y crossly undcrestimated. ging and wrist monitors give no hint of the real peril. As presently .. . ..orn,

                     .          they simply do not measure surface exposure.

If the results of a recent Oak Ridge survey of 69 hospitals is typical, half the technoligists today, it would seem, use no protective shielding

      ,             or gloves. Should these unfortunate folk persist in this folly, the latent
      .             result cay be squa=ous cell carcinoca, as shown in the first slide.

Slide 1. This case was a cale physician whose hand was exposed to an estimated l 2 to 7 R/ week of fluoroscopic I-ray for a period of approxi=ately 20 years. De first lesion was noted in 1967 on his right middle finger. The finger was re=oved in 1968. Slide 2 Lesions soon appeared at the elbeu and shoulder. Because of pain, y the a rm wa s ""E""* E in 1971. At this time, a lesion in the hip appeared 35 en a Sr scan, and chest film s,trongly indicated =etastatic carcino=a. In April 1973, a biopsy the right, buttock indicated squamous cell carcinoza. He died in May 1973 -- the cause, metastatic carcino=a.

ine physician associates of this victim, taking the same risks, ucre reported suffering frem the same problem, several with missing fingers.

Dentists, in the past, have developed squaccus cell carcinc=a from

 !lI            helding X-ray film in their patients' =ouths.

ff _ s

                                   ~.--      L ~ .&%.~-.;-~ ~        ~f h *    '
                                                                              .       E -* h .~ '    ~.~.~_T.~~L.~*~'

an 1- Wa ncv . va a growing probica conf:ont  ; us in Nucicar Medicine fro:s the handling of millicurie Icvels of radiopharmaceuticals for diagnostic procedures. This w,. #:y technician wears no 31cves and uses no syringe shicid.

     ~

ne 2 conitors give her and her e=ployer a false sense of security. Slide 4 The fil:n exposure at the surface of a e Icaded syringe is 800/nr/mic for 20 :Ci in 0.5 cc. 0.3 cm lead reduces the exposure by a factor of 1000. ..Q Slide 5. T!t{l-s The syringe inc is bad enough, but the situation can be worse. In order to get a better purchase on the vial, technicians are frequently te::pted to grasp the vial in this canner. ',Jhat's the hand exposure now? Slide 6. I The unshielded surface exposure is 7.2 R/ min for a 600 =Ci batch of D Tc in 10 ml. 0.5 cm of lead reduces the exposure by--EC (1 111Lon).- I However, the surface exposure through the unshielded cap is 3.7 R/ min. Slide 7_. . Husak has given us a sir- le dose rate for=ula that gives us an esti= ate of exposure for an; . ;ma emitter and any volume in any si=e syringe. We need know only four factors to deter:.ine the surface exposure . a s shcun. De calculations are ec pared with two film mearurc=ents and one with TLD. Slide 8. . In this slide, we have compared our film =edsurc=ents s(qam/d r,gr++s ) t vith calculations by Husak's formula (J:01) (o.:.e <r .oy dots) and Henson's calculations (British Journal of Radiology). Our NIH data falls between s, the two theoretical groups. Cne TLD value of Lc:bardi, et al, (CRAU), is plotted for a volume of 5 cc in a 10 ce syringe. For the same activity, increasing volume reduces the surface exposure.

                                                                    ~

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hJLd*2*  : ting these film measurements se also noted "cutia pie" tihile The rather censistent readings as near the syringe surface as possible. error of a factor of 60 is due to distance as well as the comparative si:e

          ,              of the gnmma beam and the size of the monitor, e

Slide 10. (iio-glove s.) . So much for the surface exposure from syringes and vials. The other significant hazard that should be noted in the handling of radionuclides is the dangeb from contamination persisting on the hands. Th s,tche technician is wearing no gloves and contamination is inevitable. s

                                                                                                 *5     r je
                                           '                                        eg'"('II.bd4 Slide 11. G A '('![t, - '                 9h Ic #*can amount to 5 Rads /uct/cm              2 The electron exposure from                                                                   .

S 3efore I go on, I cust acknowledge that surface exposure is a very difficult area of dosimetry. I *e. .14xpect to be challenged for almost any assumptions or approximations. Since our concern is principally with safety, we have si= ply ec= pared our =easured extrapolation chtsber data

   '                     with some available theory.

Slide 12. Our apprcach to . theory has been one of practicality, so=ething si=ple, that works, and anyone can use--a rule of thucb. t

       !                          The approach presented in this slide is one of the sL=plest, and agree favorably with seasurecents and so=e core rigorous theoretical approaches.

A dose to infinity can be expected for undetected or unremoveable contsein-ation. The depth selected is based on range and attenuatien. Extrapolatic cha=ber ceasurements indicate that 697. of the surface dose reaches the

  -                      active skin layer.

'-l - yg<M e-

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                                                                    -gure  = = = - = = = . - * -
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                         ..        ni    > .de shows the results of extr. lation chan.ber measurements cc. pared with theoretical approaches to the dose at the surface of liquid
                   /      -

and the dose very near the surface of thin, dry sources. These thin, dry sources simulate contamination on the hands. While these messurements Icave room for further technical refinements, they are important in arriving at the best estimate of Jose. l In conclusion, frors available data, it would appear that many Nuclear I . Medicine technologists could be exceeding present safety limits for hand

          !                  and finger exposure, and are taking serious and unwarranted risks to their
          -                  health and possibly their lives.

i

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FILF.!1 EXPOSURE AT SURFAdE OFI - semTc LOADED SYRINGEi j

                           ~800 mr)'inin
                                       ~

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                    /        NON PENETRATING RADIATION DOSE
                  /                    FROM CONTAMINATION WITH j
                /                     SS* Tc PERSISTING ON THE HAND
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                                                                                                                                       .I APPROXIMATE DETA TYPE DOSE FROM D D'" Tc                        ,                                      '

h (DRY, INFINITELY TillN) ON Tile SKIN , N  ! [p? x-f,44 y - x g E' g reds / day x 1.4,Tg  !

                                                                                                                                       !l Ci' p ,,, !25.5 x .02, x .017 MEV x 1.44 x .25 = 7.5 rads                                                               i C        =.Serface concentration of beta emitter (pCl/cm?)                                               J X3      =41alf value layer (gm/cm2)                                                                     %          !.

IIp = .017 MEV p type radiation per MIRD DATA NIH Extrapotation Chamber measured HVL for "*Tc = 12.02 mg/cm2 linear absorption coefficient p= ' = 9 f2x = 53 cm-1 Dosc from 99mTc (non penetrating Radiation) to reference area .007 cm pci below surface of skin: I D = Doe'F" D 7.5 e 53 c,ct x .@7 cm = 7.5 x e'.37 = 7.5 (.69)

                                             =

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     /                        AND BETA TYPE NON-PENETRATING RADIATION EMITTERS DRY AND IN SOLUTION 10                                                                                  "

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                                         . y; n. u= , S : 3.y 7ed:j'.i) 6xrRf MM:.v ch = #G63 mesM6NvTui'                                                                  32

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                  ' ' % ELECTROMETER; B A, BATTERY; R, RESISTOR.

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r . . . . - ELECTROMETER VOLTAGE VS. ELECTRODE SEPARATION i n b  %, e , z ' O I

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_J AV Volts h O = change in vottage per unit separation of electrodes, A = orea of lower collecting electrode, cm2 W s

                                                        !O R = resistance of electrometer resistor, ohms O               Q            D = 1.00 x 10-13 amperes /cm3/ Rad /hr in nIr (7)

T F y 03 C = speelfic activity of solution, pCI/ml O W

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                                . W AV X 1 X 1          X      l  X    l_        Rad /hr AS          A    R          D        C         pCi/ mi                                   ,

ELECTRODE SEPARATION (S)

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 ;       NT4 YCRK STATI DE?AP T IT OF HEALTE
 !             Sureau of Radiol ical 20cith
 !        I=oiro Stata Plaza, Tower Building i                    Albany, N.Y.       12237
 -                     Tel. 518-474-2346 TO:

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FRCM: G.)nCYc fJ L.wkYhf"Y.

                                        , y Goldie L. 'Jacki=a , M.P.H.

DATE: J('/ Y

                          ,/

March 14, 1978 Mr. G. Wayne Kerr Assistant Director for Stata Agreements Program Office of State Programs U. S. Nuclear Regulatory Caumnission Washington, D. C. 20555

Dear Mr. Karr:

Bank you for the opportunity of reviewing Regulatory Guida 8.18 "Infornation Relevant to Ensuring that Occupational Radiation E:cposures at Medical Institutions will be as Low as Raasonably Achiavable" and its cv5 report, NUREG-0267, on the same subject. ne guida and report have been reviewed with the assistance of our Medical Ad-visory Comunittee; comuments are kayed to Regulatory Guids S.18. C. 3agulatory Position

2. Radiation Safety Offica Functions 2.5 Ariministrative Authority -

This section states that the asiministrative authority for radiation safety should be delegated in the Medical Staff Sylsws. This is very rsrely yI . the case witir most hospitals and considering the complexity of changing hos- - pital bylaws, it seems extrasely nn14'r=1y that this rec-dation could be followed. The equivalent section inJ3UREG-0267.does:not males such Estatement ' but indicates generally that the line of administrative authority should be i' clear. ~

3. 7acility and Equipment Design 3.1 General Considerations )

3.1.1 Spaca layout

b. Ventilation requirements l

Improving ventilation in many of the older buildings in nadical 7 l institutions may not be reasonably achiavsble financially. The , g, 9- j equivalent reconnendation in NUREG-2067 does not include the need to i maintain lower pressure in rooms in which radioactive materials may be j spilled or volatilized.

e. Ingress and egress of outpatients J]f.)*b)g This level of control over patient egrees at a point where no con- ] g~< <,
trol over pacient whereabouts is imminant does not appear to be warranted.j l l l - . _ . . - ____-_-. __ - - - _ - _ - __. -

1

   =

G. Wayna Karr March 14, 1973

j. Finger badges 7

The r=e - dation for using fingar badges ~ is an excellent one; i however, there are still a insaber of technical problems in the ) .Dea,/'7 use of these badges such as the labela washing off or the badge i l ripping the protective gloves normally used when preparing syringes. Wrist badges may be prefarabia and should be considered.,, , i 1

4. Safe Work Practicas and Proceduras i l

4.1 Canaral Principlea l

4. Proper work habits consider making rec h =tions e, f, i and j requirementa; the W, / z. ;

protective features of these rechndations are extremely inportant.

                                                                                                                       ~
3. Diagnostic Fuel - Medicina
a. Placanent of generators This sentence which i=dicates that radionuclide generators should be placed in an area separata frces other nuciaar adicina operations -

q- '",2 may need clarification. The rae - and=H nn would exclude placing a generator in a nucisar medicina pharmacy or hot lab which is not the j intended purpose of it. j

b. Assay of elustaa 9
                             . The suggestion to use separata shieldad bottias for charledmf the assay of aluates fram 3saarators in nuciaar medicina is not necessarily a step toward reducing radiation exposure to ampicyees. Assays of the                            fl/P entire eluata when properly done should result in less exposure to the individual performing the assay as well as more accurate dose datar-sinations.                                                                                    l
c. Ioni=ation chamber calibrators 1 Ionization e4==haes should be es11brated periodically such as daily EY or at least weekly with NBS type calibrated radioactive standards.
                                  .idditionat tend shta1 ding                                                            -
                                                                                                                              \

3 1 l Without specifying what the other radioactive gases or aerosols are, 7 ) it is nottse to r=en====nd an additional 1.6 num of lead; Krypton 85 gr. has a unsch highee gamma photon emission. Note that most comunarcially available Ianon 133 trapping systems already are adequataly shieldad. j 4.4 Low-Level Clinical or Medical Research Laboratory Activicias " 31ood vohans studies are used as an example of a clinical in vitro tasc. Ofi7 Since the radioactivity is ~4-4*4 = cared to the patiant, this is cou-- sidered an in vivo test. J 4 QCcsO)

s&

  • W k' i&.!zm- de - G. N
 // , , Gilbert / Commonwealth en; mars anc censuitants w' !     G;LSE:iT ASSOC:ATES, INC. P 3. 2cx 498. :ncag, PA :SEC1Tet 2*5 775-2500 r.a:ie Giiase:.Tetex S354 March 14, 1978 Dr. Allen Brodsky Office of Standards Development C. S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Dr. 3rodsky:

At a recent meeting in Harrisburg with the radiation protection and control co=mittee you gave a description of R.G. 8.18 and the corresponding NUREG-0267 (Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions As Low As Reasonably Achievable). From i your presentation and the subsequent discussion it appears to me that a 1 I valuable input to such guidance would be some actual data from operating nedical facilities. Radiation doses from a facility with a particularly jj good design which promotes desirable ALARA practices should be compared with facilities which do not have this ALARA design. Facilities that have ALGA procedures should be surveyed to determine if the radiation dose to their employees is lower than the radiation dose to employees where poor { ; g'[ procedures have been employed in radiological operations. _,,, Also, it would be very helpful to the medical facility and radiation protection officer to know what operations at other facilities contribute si;;nificantly to de worker person-rem dose. Again, a survey of operating facilities would be necessary. To increase the acceptance of -NUREG-0267 and R.G. S.18 a cost / benefit I analysis would be very helpful. I suspect that implimentation of =any i of the recommendations in these documents would result in little or no lf expense to the facility. If structural design changes are incorporated ' for new facilities during the initial design again the benefit should (' far outweigh the cost. Data should be available to substantiate the I dose saving benefit of a design modification. It follows that if design  ! changes are to be made to an existing facility the C/3 analysis must be j looked at very critically. 125tuus ,a.enase m sa < wr;wec.a sua. w w sem ;a ; s rs tsac 2'3 East .usmestan a.ean .xison 'At 517 ~38Gub 30 8ee $:rvet w 're w I 2 42 rn

4 e G. Wayne Karr March 14, 1973

j. Finger badges
                                                                                            ~l The rae-dation for using fingar badges' is an excellent one;          I however, there are still a number of technical problems in the                        j Me o /'7 use of these badges such as the labela washing off or the badge                       !
ripping the protective gloves normally used when preparing  !

syringes. Wrist badges may be preferabia and should be considered., 1

4. Safe Work Practicas and Procedures 4.1 General Principlas
4. Proper work habits l

Consider == Iring rec-adationa e, f, i and j requirementa; the Pf,/ z. procactive features of these rechadations are extremely important. l

                                                                                             ~
3. Diagnostic W e h Medicine
a. Placensat of generators This sentance which indicatas that radionuclide generators should be ,2 i
                                                                                                       '"    I placed in an area separate frein other nuciaar medicina operations may need clarification. The r=e - -adation would exclude placing a generator in a nucisar medietna pharmacy or hot lab which is not the        ,

intended purpose of it.

                                                                                            ]
b. Assay of elustas 9 The suggestion to use separata shielded bottles for cha.: king the assay l of aluates from generators in nucisar medicina is not necessarily a l stap toward r=An-4ng radiation exposure to amployees. Assays of the , f//F '

entire elusta when properly done should result in less expesure to the individual performing the sassy as well as more accurate dose datar-sinations. J

c. Ioni=ation ch-her calibrators ]

Ionization chambers should be calibrated periodically such as daily Y I or at least weekly with NBS type enlibrated radioactive standards. k <

g. Additional lead shielding -
                                                                                                  \

Without specifying what the other radioactive gases or aerosols are, 7 it is notdas to r=er===ad an additional 1.6 na of lead; Krypten 85 g //, has a : mach hf shme gemsa photon emission. Note that most ecume* cially ) available Isnan 133 trapping systems already are adequately r' . idad. j 4.4 Low-Level Clinical or Medical Research Laboratory 1:tivities "- 31ood wbsne studies are used as an example of a clinical in vitro test. 4D7 Since the radioactivity is ad=44stered to the patient, this is con-sidered an in vivo cast. J 4 RCtd 1 1

G. 'Jayne Karr March 14, 1978

\                                                                                      .

The guide and report are well prepared and should herve to facilitata medical ' I licensees implementing :nora camprehensive radiation protection programs. provided f the Radiation Safety Officer has been selected on the basta of the provisions in Section 2.2 of the guida. The very general nature of the reehations would f probably make it difficult for tha less experienced user to know exactly what should I be done to implement them; e. g., should special sinks be installed in all parts of { the nuclear medicina laboratory, should all rooms be placed at negative pressure in respect to the hallways, should the entire laboratory have special exhaust systanst !py,/p As regulaters, we must carefully evaluate the appropriateness of the training and i experience of Radiation Safety Officers for the nuciaar medicina program they are to ' be responsible for; in too many instances in the past, physicians have been per- ' mitted to be designated as Esdiation Safaty Officers. Weareinvolvedincorrecting{ situations where this has become a problem in upstate New York. I hope the cr-a=nes we have provided will prove to be helpful. Sincerely, Goldie L. Waekins, M.P.H., C21ef

     -                                                                      Radioactive Materials Licensing CI'J:eh                                                           and Certification Section l

I l I c D' '*f i L _. . - - - - - -

____ . . = . . . - - - __ - . .

                                                                                                                      <-     2'Eu
                                                                                                                     .!.A -
                                                                                                                        ,&km te  G.E NI, ,Gilbiert/ Commonwealth en ners ans censunanu G;LEEqi ASSCC:ATES, INC. P. O. Sex 496. :eacng PA 96C3,Tet 2'S 775 2500 Caste Gdasac. Tetex S36-431

! March 14, 1978 i i s Dr. Allen Brodsky Office of Standards Development U. S. Nuclear Regulatory Commission

                            ~4ashington, D.C.            20555 Dear Dr. 3rodsky*

At a recent meeting in Harrisburg with the radiation protection and control committee you gave a description of R.G. 8.18 and the corresponding NUREG-0267 (Principles and Practices for Keeping Occupational Radiation i Exposures at Medical Institutions As Low As Reasonably Achievable). From i your presentation and the subsequent discussion it appears to me that a 1  ! j

 '                          val ible input to such guidance would be some actual data from operating meuical facilities. Radiation doses from a facility with a particularly                                          ,

good design which promotes desirable ALARA practices should be compared I with facilities which do not have this ALARA design. Facilities that have AI GA procedures should be surveyed to determine if the radiation dose to their employees is lower than the radiation dose to employees where poor { ,- , procedures have been employed in radiological operations. J Also, it would be very helpful to the medical facility and radiation protec: ion officer to know what operations at other facilities contribute i si;;nificantly to the worker person-rem dose. Again, a survey of operating l l facilities would be necessary. To increase the acceptance of NUREG-0267 and R.G. S.18 a cost / benefit I  ! analysis vould be very helpful. I suspect that implimentation of nany t 1 , of the recommendations in these documents would result in lictie or no l/ f l expense to the facility. If structural design changes are incorporated ^ [i for new facilities during the initial design again the benefit should far outweigh the cost. Data should be available to substantiate the I dose saving benefit of a design modification. It follows that if design l changes are to be made to an existing facility the C/3 analysis must be j looked at very critically. i 7 (M SW& 8 Y M NL $ w ! 23 im annegian A.ew .x, san 'm W :18 20, 30 pre 5:rm we eri NY 2

  • 22W l

1

                                                                                                                                                   \
                                                                                                                              .   . .       ..         .~

Gilbert /cammenweesen ., .- Dr. Allen 3rodsky u m osx m .x >2 w e w e w March 14, 1978 Page 2 Having been concerned with ALARA radiation doses associated with nuclear \_ , power plants for a number of years I am encouraged to see this philosophy [, < p .a .1 being applied to other nuclear areas. I am sure this guidance will result in a better, safer nuclear industry. _. Very truly yours, E. E. Gutwein Staff Health Physicist Applied Engineering Analysis Dept. 1 EEG:atk ! cc: G. M. Kowal i i y I

   , . _ _ _ . , _ _   _ _ _ ,       . _ , _ . . _ _ - - _ . . -           -     - . _ ~ - - -                        -             -   ---       - --     -     --   --
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March 17, 1978 , l i k I l 1 i l Dr. Allen Brodsky . . Of fice of Standards Development U. S. Nuclear Regul atory Commission

,                   Washington, D. C.           20555

Dear Allen:

I was in Washington, D. C. last weekend looking for a meal , Saturday ni ght. I tried several times Saturday to catch you but was unsuccess ful . Then I tried Senlomo and couldn't get  ! nim efthe'r. S o r ry , i t didn't work out. I would have contacted you earlier but my plans were very shaky when I left Hous ton.

                                                                                                                          ~

I did have an opportunity on this trip to review your Regulatory Gui de 8.18 an d N UREG--0 26 7. Thanks for sending them to me. You've really done a fine job with these. I agree with the genera! aporoach and most of the content of the guides. Let me pass on a few comments for your consideration. They are i brief because it's been my experience that you guys don't pay ;6I I 2 < much attention to us out here anyway. You' re going to write

  >                 your regulations regardless of our input!                            My comments are
  ,                 indexed to Age and section.                  Fi rs t follows Regulatory Guide 3.18.           I                                                                                       .

cage J--3.1.2 If available licensing guides and NCRP documents are not suf ficient, s omethina 's w rong. Why should the

                                                                                                                       ~

j NCRP licensing staff be consulted? (I'm not aware of all the licensing guides available. Can you send me copies of those pertaining to Xenon-133 j'[ 1 in nuclear medicine, radiotherapy f acilities , Regul a tory Gui de 8.9 "acceptabl e concepts , models , equations and ass umptions fo r bioass ay p rogram" and Guide 8.13, " Ins truction concerning prenatal i rradiation expos ure.' s page 7--4.1. 5 Daily s urveys a re unneces s a ry in mos t 1 hospital facilities. The log book ' serves little purpose. Caily eval ua- t l '/'S

tion of self-reading personnel monitors in radiotnerapy is likewise unnecess ary, 1
                                                                                                                     ~

i 5 ' a $ '$ *. s' . *s* * * * [',, *s - $ **)((

                                                                                                                                              ,                   o Dr. Allen Brodsby March 17 0 1978 Page Two Page 9--4.2.2.1                        I'have eval uated many hospi tal situations 7                                                  '
                         '                        and have found none where nursing personnel should routinely be provided with personnel dosimeters.                                                                  ]j/./

Page 9- l.3e In nearly all instances, radioactive waste receptacles can be housed in f/. I the l abo ratory. The following comments pertain to NUREG--0267. 1 Page 5--3.2.6 The JCAH suggests radiation safety c committee meetings at least twice a s74 year and I agree, that's sufficient. Page 6--3.3.1.4 Th a r.k s for the tip that a 10 meter dis tance will provide 10-4 I have looked for such a number dilution.])'['7 before but haven't found it in any o f my sources. - Page 9--3.3.2 Design objectives of 10% or less are 1 not the leas t cos t effective. I don't t' believe that sentence should be in "ff the report. 1005 is quite adequate.

                                                                                                                                            ~

P a ge 10-- 3. 3. 3. 5 Hood ficw rates are unimportant in

nearly all nuclear medicine laboratories dS and twice yearly surveys are unnecessary.s P a ge 10 -- 3. 3. 3. 6 I object to lead lined was te receptaclesl principally because their cost is }{[* ~jg outrageous. I advise our hospitals to trash their waste for decay behind a suitable protective shield, a Pace 13--3.J.1.1.1 Inventories of radioactive material 7'///
             ~

l shauld only be required for sealed i d sources. 4 . P a ge 13-- 3.4.1.1. 7 Posting of such low level areas is un n ece s s a ry . Usually such an exposure ' j g, area is transient. - Page 21--3.4.2.3.4 I recommend additionally that all waste deposited to a bag or container for decay have any radioactive materials labels removed. The bag should be f2/3 dated at the time it is sealed. Page 23--3.4.3.5 I agree completely. ]f/./p' , Page 0-1 Your definition of the roentgen should ,,

be updated. )l> "

l i l

31EMORLAL SLOLN-KETTERING CANCER CENTER

075 y 044 AVENUE. NEW v0Rs. NEW YOak i002t (2123 7 9 A- 7 4 8 3 1 i
                                                                                      .    [

Office of Chairman - Department of Medical Physics Memorial Hospital July 28, 1978 Dr. Allen Brodsky Office of Standards Develcpment U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Dr. Brodsky:

In response to your invitation I am offering some comments on the draft document: " Principles and Practices for Keeping I Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable". Although I think most of the provisions of the document are useful, I believe there are i

                                                                                                                                             }M certain deficiencies with respect to the definition and duties of the radiation protection officer (Radiation Safety Officer) as well as the functions of the " Medical Isotope Committee".                                                 -

E-fore making specific comments on the document, I should 'l like to offer the following general principles:  ;

1. Each institution above a certain size (corresponding to categories II, III, IV, in Table 1) should have a -

full-time Radiation Safety Officer.

2. The Radiation Safety Officer should be a qualified radiological physicist with experience in hospital
                                                                                                                         '). b radiation protection problems.
3. The Radiation Safety Officer should report directly to the Administration of the medical institution.

Normally, this is the Chief Medical Officer or General Director. - It is important that the Radiation Safety Officer have the 7 confidence of all of the major users or exposees of radiation ' including specifically: radiologists, radiation oncologists, nuclear medicine physicians, pathologists, surgeons, nurses, d,1 laboratory investigators, morgue room staff, etc. However, in addition to having the confidence of his colleagues, it is important that his position be sufficiently independent that he (m b ! MEMORIAL HOSPtTAL FOR CANCER AND ALLIEO OBSEASES SLO AN-(ETTERING INSTITUTE FOR CANCER RESE ARCH SLO AN KETTERING OtvisiON.GR AOU ATE SCHOOL GF MEDIC AL SCIENCES. ConNELL UNIVERSITY

Dr. .en Brodsky July 28, 1978 can report directly to the top Administration. It is an obvious I conflict of interest to have him report only to one of the major users of radiation. t i With regard to qualifications, the experience requirement is very important since the daily interaction of the Radiation Safety Officer and his staff with different nursing specialties, radiological staff, surgeons, pathologists, investigative staff, etc., is most important in addition to regulations with regard . to reduction of radiation exposure. aFMf 53,3 With regard to the functions of the Radiation Safety Office, it is important that it be audited by the Administration in the i same way in which they would audit any other responsible department , in the medical institution. Although a committee can be helpful in o an advisory capacity, no committee can actually operate a major i function such as radiation safety. The Radiation Safety Officer i should be expected to keep his committee informed on major radiation safety developments, but his reporting responsibility should be to the top Administration as well as to his colleagues. The Radiation Safety Officer has a responsibility for the development of radiation protection procedures and regulations as well as for assisting in their implementation. Scecific Comments: e 3.1.5 of radiation - Delegation protection of sufficient proceduresauthority as well should as include development enforcement of regula- [1'I tions, etc. F 3.2.1 - In Table 1, which will be discussed below, from Category II ! on, under Professional time, a full-time radiation safety officer k "1 4 ' should be specified. - In a Category II hospital, some of his time would be required 1 for calibration measurements in diagnostic radiology. An important distinction can be made between diagnostic radiology and radiation , oncology. In the latter, computation of dose in treatment planning if.S is a major professional occupation in itself and should not be the 1 concern of the Radiation Safety Officer. However, proper calibration of the diagnostic radiology equipment in a smaller hospital could appropriately be carried out by the Radiation Safety Officer, thereby justifying a full-time physicist for Category II. This is particularly appropriate, of medical radiation since diagnostic exposure x-ray andexposures vary widely areinan important different portion l institu- . tions depending on the degree of radiological physics involvement. ,_ The distinctions made in the last paragraph of this section (3.2.1) are very pertinent since these operations should not be the]hj,7 responsibility of the Radiation Safety Officer. ,

Dr . .. .en Brodsky July 28, 1978

3. 2. 2 - h'ith regard to qualifications , the Radiation Safety ,z Officer should be a qualified radiological physicist with specific **'9 -

experience in hospital radiation protection procedures. , 3.2.3 - In a major medical institution, the reliability of the personnel radiation dosimeters should be monitored on a monthly ] basis. If a commercial service is employed for the film badges, ' . ,

        " dummy badges" should be exposed to a calibrated amount of                   .
                                                                                      *~'

radiaticn and should be inserted as a check on the accuracy of the commercial service. Space for this monthly calibration should be included. - 3.2.5 - This paragraph should be modified to indicate that the l,,, Radiation Safety Officer has the authority to develop radiation 4 0" ~ exposure procedures as well as to enforce such rules. - 3.2.6 - As indicated in the discussion above, a Committee cannot effectivelyrunanoperation,whetheritbesurgery, radiology,or} radiation safety. Accordingly, in this section (3.2.6), item 3 i should be modified to read" "to review with the Radiation Safety Officer whether..." Item 4 should read" "to receive and review reports presented to the Administration by the Radiation Safety j ;l Office." Also, in the second sentence of tne first paragraph in ~' this section, the wording should be changed to something along the following lines: "The RSO must be a member of the Committee, possibly its Chairman, and may assist the Chairman in conducting meetings and maintaining Committee records. The Committee on Radiation should include representatives from all of the departments involved in the use of radiation or in exposure to radiation." Appendix B Section 3 should include: "e. Calibration of personnel .. - monitoring dosimeters including commercially supplied film badge 'e'~ service." , Section 8 should include a section on instructions to l families of the patient where the patient has received a permanent implant. Also there should be a separate section on measurements et ;2 on cadavers and instructions to funeral staff. Further, there ~ ~ ' should be a section on the report by the Radiation Safety Office to the Administration. Appendix D

                                                                                    ^

In item 2, " Maximum Permissible Exposure Rates", the term t l

       " ordinary employment" appears followed by the maximum permissible                          1 recommendations of the NCRP for those who are occupational 17                            y exposed. In a medical institution it is rarely necessary for a                  d.f .

staff member to receive anywhere near the permissible amounts permitted by the NCRP. This sub-heading should be re-titled:

       " Maximum Permissible Levels for Occupationally Exposed Individuals".

(} wU 'k 1 1

                                                                                                                  .           o j                                                                                                                          __

a Dr. A1 en Brodsky July 28, 1978

Table 1 '

! As indicated above in the comment parallel to Category II j under " Professional Time" should be modified as follows: "1/2 j time by diagnostic professional health physicist possiblyIII, including calibra- f ' $ lf tion of x-ray units". For Category I would

strongly recommend changing the " Professional Time" comment to
                  "1 full-time health or radiological physicist (possibly performing i                some diagnostic calibrations)".                                                               J 1

l I shall be happy to discuss this with you in much more detail'l l at some mutually convenient time. For the past 25 years, Memorial !

Radiation Safety has operatel on-the principles briefly outlined i' above. During that time the use cf radiation has substantially i increased. The amount of radioactivity being employed in the i
institution has increased to over 350 Curies per year. The number of patients treated annually with external radiation has increased c?'" g

{ to 3500, not including brachytherapy patients who are at the level , i of about 600 per year. The number of diagnostic radiology patient t examinations is more than 72,000 per year. Despite these substantial increases in the uses of radiation, actual annual radiation exposure 4 for practically all staff is kept below 0.5 rem per year. 1 The NRC could make a contribution to the reduction of medical i exposure by being comprehensive and specific in its recommendations

along the lines indicated above. There are other specifics in your sections on applications in radiation therapy, diagnostic radiology and nuclear medicine which should be discussed. I should be happy o discuss these further if desired. ,f s ,, ,_

f }SincerAy'yours, f

                                                                     \v //     Q i

[ { f e- M Laughlin, Jo hn S. tM.W [ Ph.D., FACR i Radiation Safetp Officer i . JSL:mb l l r I (,3 J'l

t- ,. .

                                                                                                                                                         ,    2 Tile JollNS 110PKINS UNIVERSITY                                                  \

SCllOOL Ol' .'IEDICIN: i and THE JOllNS 110PKINS Il0 SPIT tL i DEPAR r;!E:. T OF RADinLOG Y h AND .t!.tnurg A ddress R.1DIOLOGICAL SCIEACE THE JOHNS HOPKlNS liOSPITAL

                        *)/LTSION OFSUCLEAR .t1EDICINE                                                                                                     Baltimore.11D 21203 i

Henn x. mner. ir.. .st D.. carector 301-955-8448 l September 6, 1978 i } Otha W. Linton

,                                   Director of Governmental Relations i

American College of Radiology 6900 Wisconsin Avenue Chevy Chase, Maryland 20015

Dear Ms. Linton:

i I have reviewed the draft publications of Dr. Brodsky of the NRC 7 and feel they are well done and complete. I would like to make one suggestion g for an addition, an'd this could .be included in the ACR response. l

                                                                                    ~

l can be quiteThe use oftoradian'uclides pertinent nuclear' medicinein research technologists studies is other and not mentioned. nuclear This] - i medicine personnel. Due to the " availability" of these people they are often I i asked to volunteer as subjects for radionuclide research procedures. Since ] they realize the low amounts of radiation involved, they usually agree to

participate. This practice obviously does not keep their exposure "as low as $
.                                  reasonably achievable". Accordingly, it is our policy at Johns Hopkins that no l                                   radiation worker can serve as a volunteer in a research project. This policy is administered through the Radioactive Drug Research Committee, of which I am j                                   Chairman, and the Radiation Control Conmittee.                               I recommend that the ACR officially

( support the concept that radiation workers should not be permitted to volunteer as i subjects in resaarch involving radiation exposure, and that this statement be

included in Mr. Brodsky's document. ,

1 Sincg{ely, Dj. ' '

                                                                                                                        .SA% , ft Philip 0 lderson, M.D.

f Associate Professor of Radiology Associate Director, Division of Nuclear Medicine J } P0A/jyk N i } l 1 I

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

Pace D-1, sectica 1, --Pc,antgen (1 esu/.0Cl293g)" (The ss.-iol "ca" ^s i

                                                                " , an intemationally agreed upcn s.-tol and if this were chab~' 'o c "3 ^"^.,v                                                 4.   .
                                                                                                                                                                                                           ~

c..-y apply at standard terparature and prassre.) Pape D-1, definition 1, curie - Should:t't enc use "transfocning" rather I#

                                                                ---                s- ~egrating ?     (It is scretires difficalt to think, for er.a.*le' o# O'N'                                 '

l an electrca capture as being a disintegratien,) Page D-1, last paragraph, line 3 "200 erad in a year" (Cne does not %i -) Qasure a dose in ter:rs of rcentge".s nor c n one give a dose in tems of a rate ) ' L. ~ should say that the annual absorbed dose is fairly unifonn over the whole bc6 f Page D-2, section 3(c) - Is it necessary to staad beh. ind the lead shield L7

                                                                                                                                                                                                                      -4 w,._,a a rad.ation source is not present?

4 i f 1 D i l i 4 5 3 i 1 1 i + i h, 1 1 1 r b 1

Cc.nr'.ts en UJ:ES-02G7 As Sis dec ent will pr2 ably be used for a n= der of years, shouldn't 1 One intrcduce de nce=acic .al Syscem of Units a::d t'.e special n=es for scre Dg of d em? (See the Sepce:ter,1978 issues of Padiclc>gy a-d the American Jou nal of Rcentgenclegy for a brief su reary.) d' Page 1 Wouldn't it be well to include the defiz:itions of " unrestricted. @ and restricted areas"? J In de remainder of this doct ent please see the ecmts made on Regulatory . p' Guide 8.18 because sc:m of the same cc:ments apply to this dcc=mnt. J '" Secticn 3.2.4, 2a " investigate unusually high exposures". 3.,y Section 3.3.1.1, last sentence -Is this clear? Could cne interpret this 9 as reanine that filters should be placed in the duct werk so that no radienuclides 6,M are passed through the duct work beycnd the filters? d Section 3.3.1.4, paragraph 2, line 8 " filters or air". f4,.3/ Secticn 3.3.1.4, paragraph 2, last line "faccor of 104 or core". h5,32 Sectica 3.3.1.5, last line "without interference due to censideraticns of".f(y! J Section 3.3.1.7, last paragraph 'Ihe " raising and lcwering of the source 1 remotely" assu es a ce-tain type of source and shield configuraticn. Isn't d"3y it also possible that the calibraticn facility would use a beam-type sc,urce with a shutter? . Section 3.3.3.,1 ' his state. ment is different frca that given in 1,' ' -' ' :,[ Pegulatory Guide 8.18. _ Section 3.3.3, 2 - "as well as for outpatients" and " radiation levels , cf 10 rcR/h or cere". . Secticn 3.3.3, 5 - Paragraph 2, line 8 " rest of the room and enn be ,j7 used" . Section 3.3.4,12, line 3 "a linear face velccity of 150 feet per minute". g3

                                                                                            ~

Page 3-12, last line - hhat is acant by "lcading strengths". gg

                                                                                             ~

Secticn 3.4.1.1, 5 - With all of the specificity that is given in the g re:ainder of this dccu ent, it is not clear why " users" is given here. . Secticn 3.4.2.1, 3 - Here, again, it seems that the RSO is providing a 1 calibration service that duplicates the routine calibratien of the unit. The f.,TI7 reascn for such duolicaticn should be indicated and if it can be justified, the recular calibrator'should be notified of the results. d

         ~

(,(

  • I-Section 3.4.2.1, 5, last sentence - hhy? M)

Secticn 3.4.2.2-12d, line 5 " exposure to any other part of the ' physician's 'f f3 body". M

.i 1

Sec-icn 4.1.1, line 2 and 3 -- t
culd "micplaced" ba batter than "lcss of"? -

f.24 Se::icn 4.1.2 - It is not clear ./nat is esnt by "c=pletely shielded". ~ Cculd ' -b " -s: .ccrd be dele:cd wi2 cut prejudicing tne rerninder of the . se.:s.:e? And in additien, shculdn't it be " ay be occupied by ncn-radiationi#g'g 1 3

                                      'acrker personnel will be well".

i 1 l Section 4.1.4, line 3 - Pather than "possible" wouldn't it be better to ,,g,pf use " practicable"? , i 4 Secticn 4.1.4, b "0.1 =re Vn at 1 cm." (By international agreement l cne does not use a mixture of unit nane and symbols in a eccpound unit.) M,10 l i Seccion 4.2.1, b "should be established and posted" ']hN -

!                                                       Section 4.2.1, e, last senter.ce - Is this clear? As an exa::ple let us suppcse that the exocsure rate at the console is 0.2 Ira /n and that at the back                                                                                                     -

cf the rocc the expcsure rate is 0.15 rR/h. Wouldthissentencerequirethat/gp persens other than the operator can only be at the back of this rocm? -

Section 4.2.2, h - Ehat is meant by " exposure of sources"? Would it be ;g (i better as "1 css of scurces and resultant expcsure of personnel"? .-

34 Secticn 4.2.2, j, line 1 " studies of expcsed personnel". Ob v. Sec-% 4.2.3, paragraph 2 "after trestrent, surveys of all articles foe l ,,, pessible centaminatien should be rade before release of them frcm the rocm." p.C I 4 4 4 I i

                                                                                                                                                                                         .4 d

4 l 1 I

Cchents en T Reculatorf Cuide 8.18 a Section 2.3,e -- Shculd there be a note sc e place (cerhacs here) that all -

i".strenen's er sources used fcr calibratica should have a' calibration traceable co the standards at the National Bureau of Standards?

f Section 2.6 - Shouldn't this be "Fedical Radienuclide Cemittee"? Frcm the context it appears that this cemittee will not deal with stable nuclides and "radienuclides" nere properly defines the area of interest to the ccmitteeg [ Seccien 2.6, last paragraph - Should one asscne tMt such records are to gj he filed in the institution and not with the NRC? Sectica 3.1.1, d - Shouldn't there also be provision at the receiving 9 point for checking the radiatien field around the shipping centainer? Such a g check teuld identify packages for which the shielding has been breached or a spill occurred during shipnent. " Section 3.1.1, e - This is not clear. Wat is meant by "sar.a" and what is meant by " parking". -- 4sf e Section 3.1.3 - Can areas be "centrolled er restricted" by the use of signals er signs? Pedestrians frecuently ignore red traffic lights. They are ,p*

                        " centro 11ed" cnly by fear of getting a ticket.                                                        -

m 4 Secticnraterials"? radicactive 3.1.4, a - Ihat is meant by " breathable concentratic .s ofDoes this mean c

Section 3.1.8, a - Shouldn't a monitoring instrument be available to chec5(,$.3
for excessive radiation leakage from such containers before they are stored? J Sectica 3.1.9, line 2 - What is meant by " contacting"?
                                                                                                                           ]/80 I                               Secticn 3.1.9, e , line 4 - Ecw does one distinguish betxeen " medical                          p'
physics profession" and " health physics profession" in this centext? .

I i Sectica 3.2, c - The first part of this sentence seems to apply to occupational exposures and the second part to an increase (!) of exposures , i to persons in unrestricted areas. Perhaps it would be better to use t.c (Ad j sentences and correct the thought in the second part of the present sentence. Section 3.3, b, line 2 "as well as for outpatients". J g/P , Section 3.3, b " exposure rate of 10 mR/h cr nore". ('Ihe internationally 1bg' accepted symbol for hour is "h".) Also, one shculd indicate the lccatien at which j such exposure rates exist. 4

                                                                                                                  < 't L -

f s Section 3.3, c - Said better in EUREG 0267. ($ # Secticn 3.3, d -- hhat is r:eant by " partial shielding"? R:uld " shadow ', f shields" be better? .,

                                                                                                                                ~

Section 3.3, f - Shculdn't there be provisicn for exhaust ventilaticn in gfp the radiopharraceutical storage area?

m a J-=.---a4 -.a4 e--- A se__ _ - - -..-4 m+4 4. H-+--- -+- a J-%-.Ea4E + .-A .-' d' 7cgy Inte, national Commission on ' l

Radiation Units andMeasurements i

7910 ",'OCD.'.tCNT AVENUE. SUITE 1016. WASHINGTON, D. C. 20014 e TELEPHONE (?,01) 657 2652 , I'

                         ** ARC'.O C .WCKOFF. 0%am wa                      -       . ,     7* 1g7*p                   KURTLl0E'4. b rn I                       A*4c A E ALLisy, ve, cnan,                        *- E %                                     w. ROGER NEY. Tee =a' Imere Mr. Otha Linton i                       Director, Washington Office A.erican College of Radiology                                                                                                                          ,

i 6900 Wiscensin Avenca ( j Che'.'r Chase, Maryla .d 20015

Dear Otha:

i j >~1csed are -/ cc:ments en the NRC Regulatory Guide G 18 and the . I NUR m-0267. I hope they will be useful. I I Sincerely yours,

                                                                                  $A Harold O. h'yckoff Chair:ran                                       .~                                                      I
'                        HCN/Slc                                                                                             !

enclosures i 1 i ( , 1 ] i i k ) i

                                                                  *f L

e* I 1

' _ - _ - . _ _ , _ _ . . . _ _ _ _ _ _ _ . . . _ . _ . _ .~,- _ _ _ _ . _ . . - . . - _ - --_. , .- ._ ,_ . _.._ _.-..-_.._. -. __-      _ - .._.. , .__,.. ,- , _-

D E 4

                    ,b                          O EPA 9* '.' EN T C.                    HEALTH EO'JO ATIC?. ANO V.ELFARE N o .t: stA C .sEnv'0I C                                                       roos /
  • s onuc e.o.un:nq AT:on .

M cCK V4LC M AN Y LANO 2;E; 1 j September 20, 1972 i Mr. Otha Linton i American College of Radiology ! 6900 Wisconsin Avenue Chevy Chase, Maryland 20015

Dear Otha:

In response to your request to CRUSP members for comments on the two NRC draft documents, Reg. Guide 8.18 and flUREG-0267, I will l j not corcent directly since BRH comments were formally submitted. i Some points that you may wish to consider are the following: There is no general requirement of a written plan for response 1, to emergency or unolanned radiation exposure to or contamination (3r[ of personnel, patients or other persons. - Differences in organization of the Reg and Guide make it difficult 2. to relate the various sections. j - t The appendix of the Guide refers to x-ray machines. [40 The use of terms relating to staffing personnel in health physids, , I radiation physics, radiation safety etc is inconsistent. ' i ) h.I 1 A caution regarding the potentially extreme hazards of sterilization ' of radioactive materials would be in order. - i  ; Sincemly yours, , j a -m  : Gordon C. Johnson, M.D.

  • Acting Associate Director for Medical i Affairs i Bureau of Radiological Health l

l (,t. m l l u

                                               ,m-i 4

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

i o ..

       ~~
                  *W g           ;cv s

( University Community. fQ3p((Qj, September 22, 1978 ) i Mr. Otha W. Linton ' Director of Governmental Relations ' American College of Radiology . 6900 Hisconsin Avenue 1 Chevy Chase, Maryland 20015

Dear Mr. Linton:

7 Thank you for foraarding to me the drafts provided by Dr. Allen t of the Nuclear Regulatory Ccamission. to argue with the concept of keeping occupational radiation exposure However, , medical institutions as low as reasonably achievable (ALARA). 3 it is not clear to me that there is documentation of any clear abuse  !' this area, nor is it clear that there is any documented evidence to sup- ' port the concept that minor deviations from ALARA has led to any demonstrable medical problem. not the efforts made to achieve ALARA are cost public must be protected. from radiaticn but not to the extent tha degree of protection provided results in the substitution of a worse hazard for the radiation avoided. attempt at the reduction of small risks even further at the cost of la

sums of money that spent otherwise would clearly produce grea The statement on Page 3-2 of Dr. Brodsky's draft notes that " Institu
using larger, potentially more hazardous amounts of radioactiv however, may require full time professional staff and technition ass devoted just to carrying out the requirements of the NRC License an Regulations and com31ying with the ALARA exposure philosophy a mendations for good radiation safety practice " d down whether or not a specialty which is already over-regulated and bogge in paper-work will have added burdens placed en it with ALARA Tnose of us concerned with Cost Containment often wonder why c is never given to the exponential bureaucrat impacts on patient care.
                                                                             }
r. s.

TAMPA. FLORIDA 33G12 - (813)971-6000 3100 EAST FLETCHER AVENUE

4 1 1 l Page 2 i t' In su:rmary, the concept of ALARA is as philosophically sound as apple i pie and motherhood. However, I seriously doubt that the cost of 4 mandating, regulating, inspecting, and administering this- program can ,; " '/ be justified in any rational manner. l ~ i Thank you for the opportunity to coment on these drafts. - 1 I Sincerely, (, l 4(;f. I .v l Lawrence R. Muroff, M.D. Member, Commission on Nuclear Medicine American College of Radiology i I

LRM/h

} + 1 I i i 't L a I b1 i i . i I I 4

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i Q V._ ] LA JOL'. A, CALIFOkNlA %;M3 SCHOOL OF MEDICINE DEPARTMENT OF RADIOLOGY 5046 Basic Science Building, M-010 September 22, 1973

       ,              Mr. Otha W. Linton j                      American College of Radiology                                                                                                                        I f

i 6900 Wisconsin Avenue p Qpj ! Chevy Chase, Maryland 20015

Dear Otha:

i I have reviewed the two NRC documents which accompanied yottr Special ' i 3ulletin of August 29. My comments on NRC Regulatory Guide 8.18 and the booklet l .11 REG-0267 are enclosed. As you will see I am quite critical of both. Ibelievethatthetone.] of both are quite threatening. Although one would prefer to hr.ve these completely 49,( rewritten, I don't believe this to be possible. However, I would suggest that as a minimum we protest the sections indicated in the attached comments. -, l With best regards. , Sincerely, ! ) . l ?L 6 SQ . l Norman A. Baily i Professor of Radiology Dictated but not read. NAB:jlj f.

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

NURP.C - 0267 , Table : cvar:stimates the time and perdonnel required. h,2 3.2.3 - The requirement for facilities to check the calibrations of other hospitaI ~ 0.3 radiation sources should be removed. This is the duty of a properly trained Medical Physicis,. 3.3.1.1 - Ynat has outpatient parking got to do with the purposes of this document? g Certainly a patient going to and from his or her car does not pose a significant i e hazard to anyone.

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1 3.3.2 - Reduction of levels to 10% of those set forth by 10 CFR Part 20 would add (,15 considerable cost and require considerably more space. For example, a TVL for , 60 Co is 20.6 cm concrete and for a 6 MeV accelerator 34.S cm concrete. 3.3.2.1 - Therequirementsforwarninglightswouldturnalltherapyinstallationsh into a Christmas tree. J 3.3.2.2 - Any qualified physicist will take this into consideration and it will 47,7 appear as part of his calculations.

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3.3.2.3 - The last paragraph dealing with calibrations should not refer the readers to any sort of literature. They should be required to use the services I?i' i of a Board Certified Physicist (in Radiation Therapy Physics). " 3.3.3.1 - Sections 1 through 4 shot:1d be eliminated and a requirement stating 1 such designs must be in accordanc with the recommendations of a competent physicist I added. l 3.3.4 - Good work habits make this recommendation fall in the class of an , gp unnecessary expense, both monetary and spacewise. 3.4.1.2 - Again, we have a requirement for excess shielding adding to cost and # space requirements. The philosophy expressed here and in other parts of this f [ff.lj ] document is an attempt to lower permissible limits by disguising it as ALARA. , 32 3.4.1.4.1 - Using high-density glass for an isotope like P will only increase the exposure. This very erroneous statement must be removed or modified. I 3.4.2.1.3 - This is not the business of the R.S.O.--it is the responsibility 7 1 of the Medical Physicist. hI

                                .h.4 c l u t . ma n da t a r,s that the cper 2rcr ! in a position to     ,

3.2.2.1.3 -

. is g f, j y e -' e e r 2 t'.. .:. ": at all tine:.
                                                                                                           ~
                     - To state that in an emer;ency an exposure of only 10 mn can he                               /S' 1.4.2.1.0                                                                                                    ff'tmL '

cbtained is ,ure , nonsense. Ainost any conceivable em.er;cncy 1.culd most probably

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invol.e hi;her exposures. -r 3.4.2.3 - The recuirement for a member of the radiction safety staff to be present 1 A properly at all administrations of therapy doses is impracticabic and unnecessary. trained nuclear medicine technician can do all that is necessary. Similarly, for gj(

 'ection 2, last paragraph.                   If the nuclear =edicine technician is to be considered            1 as safety staff then this should be made explicit. In most institutions this is                              J not the case.

(p9. b Accendix S - Remove Section 2.

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_ . ._ _. _ _ . - ._ _ __ ~ .- _ _ _ _ _ . _ . _-_ __ 4 , , i l I  ! N"C - REGULiTORY Gill:E ?.18 ' l l 2.3 - The ca!! bra: ion of other hospital radiation sources such as these used j in bra:hytherapy, teletherapy, or of isotopes used in therapy applications is . 4 tne province of the medical physicist and therefore space for this activity is beyond that needed for a perfectly adequate radiation safety program. The f9,II specialized instrumentation needed for this and its calibration is also beyond that needed for a perfectly adequate safety program. In addition, the average radiation ; i safety officer is not qualified to perfoi a such calibrations. " i j ,

2. 6 - A medical isotopes committee is not needed where an institution already has 'l j met the F.D. A. requrements for a Radioactive Drug Research Committee or when a 1

j hospital is subject to J.C.A.H. requirements. These requirements state the hospital

-ust have a radiation safety committee. The requirements placed on both the above-a mentioned committees are the same as listed in this section and their duties would be j redundant. J 3.1.1.b - What in the world have parking facilities got to do with AIARA? SW 3.1.2 - hhy should the NRC licensing staff have anything to do with use and I occupancy factors? NCRP are the recogni
ed experts. Their recommendations are the 51d best opinion of people well recognized for their knowledge in this field. This section k i

is outrageous bureaucracy.

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4.1.6 - This section contains so. man'y legal implications that most large insti-l ' tutions have been advised by legal counsel to ignore this requirement. ffAL ] _ 1 4.2.1 - This is approaching a Q.A. program but is rather incomplete from this aspect. The ACR - Q.A. program could be referenced rather than have tnis fragmented 3O a section published as a regulation.

                                                                                                           ~7 APPENDIX - Surveys of diagnostic machines are beyond the jurisdiction of NRC.                                 ,j We certainly don't need another bureaucratic layer added.                                        ;                     i l

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RADIOLOGY CONSULTANTS 1100 MEDICAL TDWERS BillLDING Uttle Rock Arkansas 72205 Telephone 501227 5130 James R. Searden. M. D. Doyne Dodd. M. D. Jonn W. Lane. M. D. H. W. McAdoo Jr M. D. George H. Brenner, M. D. September 2a. , 1978 Henry A. Lile. M. D. Cm. Clyde Glover. M. D. G!enn V. Dalrymple, M. D. Jonn W. Joyce. M. D. Samuel B. Caruthers. Jr., M. D. Rcbert L Fincher. M. D. The Secretary U.S. Nuclear Regulatory Commission ,,, Washington, D. C. 20555 Attention Docketing and Service Branch

Dear Sir:

These are comments in response to NUREG-0267, " Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions as low as Reasonably Achievable". I have read the material with some interest. Certainly the principles outlined are desirable. I am concemed, though, that development of large, co=prehensive, radiation safety programs will greatly increase the cost of g/ medical care--particularly for small hospitals that provide important but some-what limited services. It seems to be a current situation that one regulatory agency will issue extensive requirements while another regulatory agency works equally hard to prevent the providers from collecting an honest return for the,,,,, costs generated. I am a member of a group of twelve radiologists. Wecoverthreehospitalsl that have nuclear medicine services--567 beds at the Baptist Medical Center, 202 beds at Memorial Hospital in North Little Rock and 75 beds at Rebsamen Memorial Hospital in Jacksonville, Arkansas. From the recomendations described, auf hospitals would need approximately 2.5 F.T.E. of radiation safety officer effort and probably 2.0 F.T.E. of secretarial effort to carry out the programs as described. On the assumption of a $20,000 per annum cost for the radiation i. safety officers, $10,000 per annum for the secretarial support, and $10,000 per N* year operating budget, costs for radiation safety programs would be approximately 380,000 per year, without inclusion of costs for any equipment or cost for space. Since the regulations specify space to calibrate, maintain, and repair radiation safety equipment, stock radiation safety supplies, process orders for licensing materials, store radioactive wastes and sources not in use, etc., additional costs would certainly be generated. Conservatively, our costs would be approxi-

          =ately $100,000 per year.

7 N e-l \

Secretary, USNRC -

                                                                                        -2 September 25, 1978 During 1977 we performed 3,673 radioisotope studies at Baptist Medical Center, 2,389 at Memorial Hospital, and 720 at Rebsamen Memorial Hospital.              ;

Cn the assu=ption of a $100,000 per year cost, it would be necessary to increase l0 L the cost per examination by a factor of SS.49. Will HEN be willing to allow an increase in cost of this magnitude? - Workers in the health professions are becoming so enmeshed in page after page of regulations that a staff of administrative / legal experts is necessary in order to provide the documentation which indicates compliance. As an example, I on Page 3-15, Paragraph 3.4.1.5, it is stated that "A simple log book of daily I readings (of radiation surveys) maintained by the user in specified areas will q'/, i help the user maintain an awareness of any changes in radiation or radioactivity levels that may indicate a need for changes in procedures to meet ALARA radiation l exposure objectives." 'Ihe draft is full of small " helpful" little statements such as this. It is very easy to see how those in the field can be in non-ccmpliance, and at risk to lose their license, because of failure to maintain this simple log book of daily readings. J Another example is Page 3-21, Paragraph S. Personnel Monitoring and Bioassav Evaluation. If a hospital is performing extensive tnerapy witn raaloactive isotopes, a full-scale bioassay program may be logical. For the hospital that does a small number of patients per year, the requirement for g "te=porary dosimeters provided for personnel monitoring... , the results recorded by the radiation safety staff,..., air sampling evaluations, whole ; body counting, etc., represents over kill. Again, the cost will increase l expcnentially with the addition of these techniques. In short, the goals of the program are admirable. If these proposed regulations were to be looked upon as " recommendations" for perfor=ance as opposed 'to formal regulations, I believe the practice of nuclear medicine ,f would be enhanced and the cost / benefit ratio muld be proper. Consequently, 6't.5 I reconraend that these proposals not be carved into stone in the form of fornal regulations which would, at best, increase the cost of medical care throughout the country and at worst, drive many smaller hospitals and practi-tieners from the i=portant area of nuclear medicine. - If I can add additional material, please do not hesitate to contact me. Sincerely Un v wQi Glenn V. Dalrfmple/M.D. GVD:mh Copy to: Mr. Otha Linton

  • American College of Radiology hf Dr. James Christie University of Iowa Hospital ,

D. Atomac Eirmgy L :swye Atomeque

  \'  of Canada Lmted            du Canada, Linntee
   -   Commercsal Products       Products Commerciaux P.O. Box 6300             CP. 6300                                Tet (613) S2-2790 Ottawa.Canaca             Ottawa Canada                           Telet 053-4162 K2A 3W3                   K2A 3W3 MS-503/78 MP-505 September 26, 1978 Secretary of the Commission, U.S. Nuclear Regulatory Commission,                                           /

Washington, D.C. 20555. r Att'n: Docketing and Service Branch

Dear Sir:

Please find enclosed our response to one section of NUREG-0267, Principles and Practices for Keeping Occupational Radiation Exposure at Medical Institutions As Low As Reason-ably Achievable. Yours sincerely, i:; y [ljl - . - k R. B. Boulton, Brachytherapy Specialist. RBB/ms Encl.

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       . Atomic Energy            .'!Energie Atomique 7?  of Canada Limited        du Canada.Limitee Commercial Products      Produits Cw,nnwciaux PO Scx 6300              C.P. 6300                            Tet (6131592-2790 Cr.awa. Canada           Cttawa.Canaca                        Telex.053-4162 K2A 3W3                 K2A 3W3 RESPONSE TO NUREG-0267: PRINCIPLES AND PRACTICES FOR KEEPING OCCUPATIONAL RADIATION EXPOSURE AT MEDICAL INSTITUTIONS AS LOW AS REASONABLY ACHIEVABLE Section 3.4.2.2      Brachytheraov A) Procosal The technique of remote afterloading should be re:ognized as the method for eliminating radiation exposure to all nosoital staff during intracavitary applications.      Section 3.4.2.2 should be               77, modified to recommend remote af terloading as the technique of                  -

choice for keeping radiation exposure at medical institutions ALARA. B) Introduction Throughout section 3.4.2.2 it is recommended that manual after-loading techniques be used wherever medically acceptable. When compared to the use of preloaded applicators, these techniques offer a great advantage in radiation protection for some hospital staf f, in particular the radiotherapist and the operating room j staff. However, manual af terloading does nothing to protect 7,7 ' ., nursing staff and others who visit the patient during the treat-  ! ment since the sources are lef t in the patient throughout the ' treatment. k

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Remote af terloading provides complete radiation protection for , all hospital staff, including nurses. 4 C) Remote Af terloading m When a remote af terloader is used all source transfers are by remote control, thus eliminating radiation exposure normally incurred during source handling. Several commercial (conventional-dose-rate) systems are available, but three essential features are common: (1) An af terloading applicator is inserted in the operating room, 'ff, ) and the patient is taken to her room. Ejection sleeves are then connected between the remote af terloader and the appli-cator in the patient. (2) To start the treatment sources are transferred from a safe "l@ g>, storage position into the patient. This is done by remote control from outside the patient's room. (3) Whenever a nurse or doctor wishes to enter the room the sources are temporarily wi thdrawn, again by remote control from outside the patient's room. ,

                                                                                       ../2...
 . s   Atomic Energy          L'$nergie Atomique
   %<    of Canada Limited      du Canada, Limit 6e Commercial Products    Produits Commerciaux P.O. Box 6300          CP.6300                                 Telt613)592-2790 Ottawa. Canada         Ottawa.Canaca                           Telex. 053-4162 K2A 3W3                K2A 3W3 Page - 2 D) Worldwide Acceotance The technique of remote af terloading is widely accepted in Europe and other parts of the world, and is now beginning to be used in North America. By the end cf 1978 there will be at least six conventional-dose-rate remote afterloaders in the United States, and this number is expected to increase steadily.                                                                     p E) Conclusion it is therefore appropriate that section 3.4.2.2 should give                ;

considerable attention to remote af terloading (as opposed to I manual afterloading), since it has considerable benefit in f keeping radiation exposure in medical institutions ALARA. l ,

                                                     /           .

R. Boulton, Brachytherapy Specialist.

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September 26, 1978.

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CLEVELAND CLINIC DIVISCN CF RADICLOGY o... . . E.... .. c c o...-.........,..

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      ..d Nvet..r me.icine September 29, 1978 Dr. Allen Brodsky                                                                                                        ..

Division of Siting, Health, & Safeguards Standards s Office of Standards Development j U.S. Nuclear Regulatory Commission - Washington, D.C. 20555

Dear Doctor Brodsky:

I have received for comment from the American College of Radiology copies of Regulatory Guide 8.18 and NUREG-0267 both concerning the concepts and recommended procedures so as to maintain radiation exposures "as low as is reasonably achievable" (ALARA). Both of these documents explain these concepts comprehensively and clearly. The concept of ALARA is a ~) reasonable, well-thought out policy and one that has been supported by most of the workers in the radiation field ' 7/, f for some time. For example, most technologists and others in the field of Nuclear Medicine have traditionally received, in most cases, less than one-tenth of the maximum permissible dose for occupational workers. Even so, there has been a steady progression in this area to develope new equipment, new techniques, and new procedures that would tend to reduce j

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even more the already low exposures. In general, I believe the Regulatory Guide 8.18 expresses 7 this philosophy well and recommends practices that are reasonable and can be put readily into operation.

                                                                                                                          'TI. 7 The        approach of NUREG-0267 is, however, somewhat                                                    '

i different. Perhaps this is best characterized by the first sentence in the introduction that is common to both. NUREG- l 0267 states that "... licensees should make every effort to 4 THE CUNIC CENTER . NINETY FIVE HUNORED EUCUD AVENUE. CLEVELAND. CHIO 44106. U.S.A.

  • 216 /229 2200
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l Letter to Dr. Brodsky { September 29, 1978 Page 2. i ! maintain exposure to radiation, as well as releases of

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! radioactive material to restricted areas, as low as is j reasonably achievable", while Regulatory Guide 8.18 states Tb i that " ... licensees should make every reasonable effort...". l A small difference but a significant one as to the j differences between the two documents. -4 ! NUREG-0267 makes some very specific recommendations, 1 not found in Regulatory Guide 8.18, that are not necessarily j accepted by the medical community.

l. For example, I am not sure all physicians would 3 welcome the idea of having the radiation safety officer (p.3-21) explain the radiation exposure philosophy to the Jj,3 patient. The cost-benefit ratio of radiation therapy or even diagnosis is a very complicated one and involves much j more than a set of concepts and numbers. d I #
!                                2.          The use of syringe shields during administration of j                       dosages has not been universally accepted. Some physicians believe.the possibility of misadministration with many available syringe shields far outweighs the reduction of                                           7/gn j                      dose to the fingers. Others believe that no commercially available shield is considered adequate at this time.                                       s
3. The estimated minimum radiation staff requirements in Table I does a great deal for the job security of health physicists and technicians but adds one more increased "
;                      expense to the rising cost of medical care that may not 77j really be justified.                   I believe that most institutions are doing complete coverage of the radiation safety requirements with less personnel.                                                                            -

9

4. I am not sure everyone agrees with the recommendation l of a separate room for radionuclide therapy administration (p.3-19). The thought has been expressed that there is more danger of contamination by taking a patient who has just been gg administered radioactive material back to his hospital room 4 than by transporting the radionuclide to the patient and ad-ministering the material in his room.  ;
.                                Although most of NUREG-0267 expresses principles and                                     ')

l practices in common use and acceptable everywhere, there are some areas where such attempts to recommend specific practices 1(7 are premature, I believe greater contact with actual hospital problems and procedures should be made before such specific

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recommendations be expressed. l In addition, there are many little points that should be 9,j? checked. Is it really desirable (p.3-3) that the office of i ni e J**

Letter to Dr. Brodsky September 29, 1978 page 3 the radiation safety officer be as far away as practical f _ from the areas where radiation sources are used? Should 7f ,7 the considerations in keeping radiation exposure ALARA j be involved with outpatient parking? (p.3-6). s Lastly, the statement on D-1 that "about 400 Roentgens to the whole body would be lethal to about half of those exposed" is not correct unless the time of exposure is specified, i.a. 10 Roentgens a year for 40 years would not 17'/ y be lethal to ha'f of those so exposed. (It is rather surprising to f. 4 this under the subtitle of " Definitions"!) d In summary, I repeat that the concept of keeping radiation exposure ALARA should be highly endorsed and the practices to do so have been well described. I believe the credibility of the documents would be greater, however, if the recommendations were somewhat more consistent with other recommended practices in the field. Sincerely,

                                                      .. ~

William J. MacIntyre, Ph.D. Department of Nuclear Medicine WJM/sdh cc: Mr. Otha W. Linton Dr. James H. Christie

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KING FAISAL SPECIALIST .JSPITAL f xJi M di jus AND RESEARCH CENTRE 4:WI N.VI ff; KINGOoM OF SAUDI ARABIA ka IhA  ! P. O. Des age . AtVACH

                                                                     ).yy,g9,j RC/891/78 4th October, 1978 U.S. Nuclear Regulatory Commission Office of Standards Development, Washington D.C. 20555, U.S.A.

Dear Sirs,

This is in response to your invitation to comment on the draft of " Principles and Practises for Keeping Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable, NUREG/0267", as published in draft form in December 1977, and to the proposed regulatory Guide 8.18. I believe these publications are appropriate and long overdue. 1 It is my observation from many years of experience in the field f of radiation protection that many possible improvements in radiation protection are easily achieved, and usually at very low cost. However, too often these possible improvements have not been achieved simply because no one has appeared to be interested. Publication of the "As low as Reasonably Achievable" concept, as applicable to medical institutions, should evoke positive responses from those who previously have been comforted by the fact that exposure levels were below =aximum permissible  ; limits. --- i j / One copy of " Personnel Radiation Exposure and Protection from "Tc Radiations" is enclosed. As Technetium-99m is the most used isotope in Nuclear Medicine, I believe you should consider referencing this document in both publications. Although I speak from the prejudiced viewpoint of an author, I believe this paper is highly relevant to the subject at hand. For example, in Figure 5 ~7 2 - } it is shown that the personnel exposure per unit workload of one nuclear medicine department was reduced by more than a factor of 10 by in essence adopting the ALARA concept. This method of attempting continued / Telex 201060 ( RO8PEC SJ ) . Cable : Spactaitat g 1* W -(.g.g L u)f.1.e. A Telephone No. 35555 re... c,pL; Form No. 978,1 s- s - M

U.S. Nuclear Regulatory Commission Page 2 4th October 1978 to relate the allowable exposure to the amount of work performed as judged by the amount of Technetium-99m injected into patients y,'L. provides at least one benchmark which may be used to judge progress in achievable ALARA. - Thank you for the opportunity to comment. If I may be of assistance in any way related to this matter, please advise. Sincerely,

                                              &c &all Raymond C. Barrall Director, Research Centre Enc. 1 copy title page AAPM Monograph No. 1, 1976 1 copy of " Personnel Radiation Exposure and Protection from 99"Tc Radiations".

I w f Tatax asses novspec sJ . cAeLa : specraust ! Telephone No. J5555

                                                                *   .A~ C# b >>f**** N, Form No. 978.1 a
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