ML20126E352
| ML20126E352 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1980 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20126E354 | List: |
| References | |
| AA73-1, NUDOCS 8101200311 | |
| Download: ML20126E352 (9) | |
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V UNITED sT ATEs
,'<j NUCLE AR REGUL ATORY COTM.'.!SSION j
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V.t.SHING T ON. D. C. 20555
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TO ALL tiRC MEDICAL LICEtiSEES
Dear Licensee:
On September 28, 1979 we sent you a letter about an ALAPA program to be implemented by December 4, 1979.
h'e subsequently infomed you that the irplementation date was being delayed until 14 arch 4,1980 in order to revise the model ALARA program to take into account many coments we received. Enclosed is a revised program which should be implemented by August 15, 1980.
Additional time is being allowed so that licensees can make appropriate adjustments in their programs.
During the past two months we have sought and considered the opinions and coments of many professionals in all areas involving the use of radiation in medicine. These discussions have led us to modify several program elements and to clarify others. The revised program reduces the administrative burden on the liter.see while still meeting the original goal; to provide management a tool for maintaining occupational ekposures ALARA and to provide liRC with a basis for inspecting ALARA programs.
The original program provided for establishment of an Action Level which was misinterpreted as a lowering of. the maximum permissible dose limits.
The revised This was not, and is not, the intention of the program.
program applies the concept of " Investigational Levels" as defined in ICRp Report tio. 26 "Recomendations of the Comission on Radiological protection," January 17, 1977.
The Investigational Levels in the revised program are not new dose limits but, as noted in the ICRp report, serve as check points above which the results are considered sufficiently impprtant to justify further investigations.
Investigational Levels are tools to be used by those in your institution responsible for the management In detemining compliance with regulations, of radiation safety programs.
tiRC will be concerned with whether a review and/or investigation has been carried out rather than whether the Investigational Level has been exceeded.
There was concern on the part of some licensees that improved measurements Current methods of recording would be required to comply with the program.
personnel exposures for purposes of compliance with 10 CFR 20, 520.101 are also adequate for use in detennining the need for a review or investication in accordance with the ALARA program.
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, I The new program has been revised to considerably reduce the paperwork Actions to be.taken under the revised ALARA program will be included in, or covered by.. documentation already required to be maintained burden.
Results of personnel monitoring are already recorded at by licensees.
least quarterly on Fonn !!RC-5 or an equivalent. form as required by 10 CFR 20, 520.401. _Results of investicati_ons yod make when an Investigational Level is exceeded should_baAade part of the Radiation
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Safety Co:miittee minutes, thus eliminating the need for a s e
e f these licensees
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, review or investigation records but since the majority oem create no undue burden.
In the original program, reference was made to guidance provided by U.
1 uclear Regulatory Guides 8.10 and 8.18.
The guidance given in for strict adherence to all aspects of these guides.these docum additional dose reductions, are justified by the cost of those reductions.
Both guides are now used by the i;RC licensing staff as part of the basis fo t;RC will evaluating license applications and radiation safety programs.
continue to consider equivalent alternative methods of complying with the principles contained in the guides and with specified portions Co r.ission's rer,ulations.
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.many sources of information available to guide you in maintaining occupaAnothe radiation exposures at medical institutions ALARA.
source available from fiRC is !!UREG-0267, " principles and Practices for Keeping 0:cupational Radiation Exposures At Medical Institutions As low The model program applies only to the As Reasonably Achievable. radiation exposure of personnel arisi 1icensed byproduct materials.,ixcanding the program to_ cover _o_tha4 radiation workers in your institution is an option availaose toyu.
The revised model of an ALARA prr> gram is provided as an r
After August 15, 1980 this letter.
equivalent alternative program for review by !!RC.
you will submit your program when you submit your next renewal orIf nec significant amendment application.
or emphasis, you are encouraged to add explanatory te program.
There is no need to submit your ALARA program to of your I;RC license.
!!RC urf.if such time as you amend or renew your licen Those licensees who have already if you have not already done so.
submitted programs in accordance with the original model or an equivale alternative program may either resubmit a revised program or maintain the program as proposed unless notified otherwise by fiRC.
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- k. would like to emp,hasize. that the LARA concept is not new and that most'of the co:mitments in the enclosed formal program are already l
- adhered'to by those'who traintain good radiation safety programs.
Sincerely,
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's/ William J. Dircks, Director Office of Nuclear liaterial Safety and. Safeguards Approved by GAO
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e-p Ibdel Trogram.for Itaintaining 0: cup 5s bnal Radiation Exposures at Medical Institutions ALAD.A (Licensee's f(ame)
(Date) 1.
Management Commitment We, the management of this (medical f acility, hospital, etc.)
are committed to the program described in this paper for a.
keeping exposures (individual and collective) cs low as reasonably In accord with this cormitment, ie hereby achievable (ALARA).
describe a g strative organization for radiation ta The instrucuan_s__to_fostar the AL AR/tcoACRpt within our institution.
organization will include a Radiation Safety Committee (MSt)l' and a Radiation Safety Officer (RS0).
We will perform a _ formal annual review of the radiation safety This shall T cliide b.
procramln.tludina ALARA _consiFEFEITons.
reviews of operating procedures and past exposure records, inspections, etc., and consultations with the radiation protection staff or outside consultants.
Modification to operating and maintenance procedures and to s
ecuipment and facilities will be made where they will reduce c.
exposures unless the cost, in our judgement, is considered to We will be able tn demonstrate. if necessary, be unjustified.
th a t i mo rnv am an + dave 4e emsou g ht._tha t_moJ i f i c a t i on s ha v e t
been consid_ fred _and thal _they_ta.ve_been imolezented7nere ' reasona
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Where modifications have been recommended but not impTemented.
we will be prepared to describe the reasons for not implementing them.
In addition to maintaining doses to individuals as far below d.
the limits as is reasonably achievable, the sum of the doses received by all exposed individuals will also be maintained at the lowest practicable level.
It would not be desirable, for example, to hold the highest doses to individuals to some fraction of the applicable limit if this involved exposing additional people and significantly increasing the sum of radiation doses received-by all involved individuals.
Private practice. physician licenses do not include a RSC.
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m-Radiation (%jety ComTittee (RSC)2
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a.
Review of Proposed Users and Uses 1.
The RSC will thoroughly review the qualifications of each
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applicant with respect to the types and quantities of
.. materials and uses for which he h'es applied to assure that the applicant will be able to take appropriete measures to maintain exposure ALARA.
2.
When considering a new use of byproduct naterial, the P.5C will review the efforts of the applicant to maintain exposure ALARA.
The user should have systematized procedures to ensure ALARA, and shall have' incorporated the use of special equipment such as syringe shields, rubber gloves, etc., in his proposed use.
3.
The RSC will ensure that the user justifies his procedures and that dose will be ALARA (individual and collective).
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b.
-Delegation of Authority (The judicious delegation of RSC authority is essential to the enforcement of an ALARA program.)
1.
The RSC will delegate authority to the R50 for enforcement of the ALARA concept.
2.
The RSC will support the R50 in those instances where it-is necessary for the R50 to assert his authority. _Khere the R50 has been overrul_e_d. the Commi11e* will record _the tasis f or its action _in_1he_ninuits_ of the Comittee's
-quarterly meeting.
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c.
Review of ALARA Program
-1.
The RSC will encourage all users to review current procedures and develop new procedures as appropriate to imple: rent the ALARA concept.
,The RSC will perform a _ Quarterly rcYieW_Qf_p;Cydaliojtal 2.
_ r.a d i ati on expos ure__witiLp a rt i c ul a r a ttenti on_to_.inshe e s whete InvesligalionaLLeye15 in_ Iable_I_helow_are_exc eeled.
The principle purpose of this review is to assess trends ir occupational exposure as an index of the ALARA program quality and to decide if action is warrented when Investigationi[
Levels are exceeded (see paragraph VI).3 i
2The R50 on private practice physician licenses will assume the responsibilities of the P,5C under Section II b
The HRC has emphasized that the Investigational Levels in this program are not new dose limits but, as noted in 1CRP Report 26, Recomendations of the International Commission on. Radiological Protection", serve as check points.
above which. the results are considered sufficiently important to justify further investigations.
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The RSC will evaluate our institution's overall efforts This for maintaining exposures ALARA on an annual basis.
3.
review will include the efforts of the R50, authorized users, and workers as well as those of manegement.
I 111. Radiation 5afety Officer (R50)
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Annual and-Quarterly Review a.
The R50
_ Annual review of the Radiation Safety _ Program.
will perform an annual review of the Radiation Safety 1.
Reviews of program for adherence to ALARA concepts.
specific procedures may be conducted on a more frequent basis.
Quarterly review of Occupational Exposures._ The R50 s
T1117evWal TML quarterly the external radiation 2.
expos'ures of authorized users and workers to determine that their exposures are ALARA in accordance with the provisions of paragraph VI of this program.
The Duarterly review of record 5_nf Radiation Level Surveys.
R50 will review radiation levels in unrestricted and --
3.
restricted areas to determine that they were at ALARA levels during the previous quarter.
Education Responsibilities for an ALARA Program i
b.
- 1. __The 250 will schedule briefinQs and educational se to inform workers of ALARA program efforts.
anure that author.izeLuserL_ workers and Lho Rio will (ancillarv personnel who may be exposed to radiation will be 2.
AlARA nhilosophy and informed t~h'Et instructed in_the manacement, the DtC and the RSO are committid to implementir "the ALARA concept.
Cooperative Efforts for Development of ALARA Procedures c.
Radiation workers will be given opportunities to participateill:be requir
,g in formulation of the procedures that they w
< ' follow.
The R50 will be in close contact with all users and workers in order to develop ALARA procedures for working.
1.
with radioactive materials.
The R50 will establish procedures for receiving and 2.
evaluating the suggestions of individual workers for
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improving health physics practices and encourage the use of, hose procedures.
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d.
Reviewing Instances of Deviation f rom Good ALARA Practices The RSD will inv tioate all known instences of deviation from '
c35o nu practices: and. if_possihm c'etermine the causes.
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E the cause is known, the R50 will require chances in the program to maintain exposures ALARA.
IV.
Authorized Users New Procedures Involving Potential Radiation Exposures a.
The authorized. user will consult with, and receive the I.
approval of, the RSO and/or R5C during the planning stage before.using radioactive materials for a new procedure.
2.
The authorized user will evaluate all procedures before using radioactive materials to ensure that exposures will be kept ALARA.
This may be enhanced through the application
- of trial runs.
b.
Responsibility of the Authorized User to Those He. Supervises 1.
The authorized user will explain'the ALARA concept and his commitment to raintain exposures ALARA to all of those he supervises.
2.
The" authorized user will ensure that those under his supervision who are subject to occupational radiation exposure are trained and educated in good health physics prectices and in maintaining exposures ALARA.
V.
Persons Who Receive Occupational Radiation Exposure The worker will be instructed in the ALARA concept and its a.
relationship to his working procedures and work conci; ions.
b.
The worke u ill imow what recoursrs_are_a.va13ah.le_ H he feels that ALARA is not beino prompied on the job.
VI.
Establishment of Investigational Levels In Order to Monitor Individual Occupational External Radiation Exposures shis institution (or' private practice) herehy establishes Investigational
. Levels for. occupational external radiation exposure which, when exceeded, will initiate review or. investigation by the Radiation Safety Committee and/or the Radiation Safety Officer. The Investigational Levels that we have adopted are listed in Table 1 below.
Tnese levels apply to the exposure of individual workers.
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Table 3 investicational Levels -
(mry.i_6er g qdan y ter)
LEVEL ]
LEVEL 11 125 375 1.
k' hole body; head and trunk; active blood-forming organs; lens of eyes; or. gonads 2.
Hands and forearms; feet and 1875 5525
- ankles 750 2250 3.
Skin of whole body *
- Not nomally applicable to nuclear medicine operations except those using significant quantities of beta emitting isotopes.
The Radiation Safety Officer dill review and record on Form NRC-5, Current Occupational External Radiation Exposures, or an equivalent form (e.g. dosimeter processor's report)..results of personnel monitoring, not less than once in any calendar quarter, as is required by 10 CFR 20, ~ 520.401.
The following actions will be taken at the Investigational Levels as stated in Table 1:
Quarterly exposure of individuals to less than Investigational a.
Level 1.
Except when deemed appropriate by the R50, no further action will be taken in those cases where an individual's exposure is less than Table I values for the Investigational Level 1.
personnel exposures equal to or greater than Investigational Level b.
1, but less than Investigational Level II.
The RSO will review the exposure of each individual whose
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quarterly exposures equal or exceed Investigational Level I.
He will report the results of his reviews at__the first __RSC m e e t i n g f olloxin g _the._ quarter _whe n_the_ex po s u r_e, wa s,.r_e_c o r d e d.
n Ine exposure does not eatal or exceed Irgestiga11ppal'Lievel II, no action relatedapecif.irally_to_the_ expo.sure is ' required The Comittee unless. deemed appropriate by_the_Comittee.
will, nowever, consider each such exposure in comparison with those of others performing similar tasks as an index of ALARA program quality and will record the review in the Comittee minutes.
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, Exposure ecL) to or greater than Investigvonel Level II.
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c.
J The RSO wil.1 investigate in a timely manner the -ceuse(s) of 3
. all personnel exposures equaling or exceeding Investigational Level II and, if warranted, take action.
A report of the investigation, actions taken, if any, and a copy of the individual's Form NRC-5 or its equivalent will be presented to the RSC at the first RSC meeting following completion of the investigation.
The details of these reports will be recorded in the Committee minutes.
Committee minutes will be sent to the management of this institution for review.
The minutes, containing details of the investigation, will be made available to HRC inspectors for review at the time of the next inspection.
d.
Re-establishment of an individual occupational worker's Investigaticnal level 11 Above That Listed In Table I.
In cases where a worker's or a group of workeNexposures need to exceed Investigational Level II, a new, higher Investigational Level II may be established on the basis that it is consistent with good ALARA practices for that individual or group.
Justification for a new Investigational Level II will be q
documented.
The Radiation Safety Comittee will review the justification for, and will approve,- all revisions of Investigational Levels II. In such cases, when the exposure equals or exceeds the newly established Investigational Level II, those actions listed in paragraph c above will be followed.
4 VII. Sicnature of Certifying Officia1 I hereby certi_fy that this institution (or private practice),
has implemented the ALARA Program set forth above.
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' Signature
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Allston J. Mor'ris, M.D.
i fiame (print or type)
Vice' President for Medical Affairs i
Title
' Institution (or Private. Practice) flame and Address:
The individual who is authorized to make comitments for the administration of the institution (e.g., hospital administrator, etc.) or, in the case of a private practice, the licensed physician.
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