ML20202D235
| ML20202D235 | |
| Person / Time | |
|---|---|
| Issue date: | 12/06/1976 |
| From: | Karen Chapman NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| SECY-76-574, SECY-76-574-R, NUDOCS 9902010345 | |
| Download: ML20202D235 (21) | |
Text
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OFMCHAL USE ONU umiso sims
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December 6,.1976-NUCLEAR -RECUT.ATOV CONSENT ". t.END AR ITEM g
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For:
The Commissioners
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Kenneth R. Chapman, Director.
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Thru Executive Director for Operations Subiect:
AMENDMENT TO 10 CFR PART 35: " HUMAN USES OF BYPRODUCT MATERIAL *: SPECIFIC LICD;SES FOR HUMAN USE OF BYPPODUCT MATERIAL IN SEALED SOURCES
Purpose:
To seek Consnission approval of a notice amending Section 35.13 of 10 CFR Part 35 that would require
' licensees to have a qualified expert perform periodic full calibration and spot'-check measurements of each teletherapy unit used for treatment of patients.
category:
This paper covers a major policy issue.
Issue:
Should the cot: mission require calibration and spot-check measurements of teletherapy units?
4 Decision The Commission should act i @ diately to ensure criteria:
that the safety and interests of the public, specifically certain patients, are not compromised in the use of a teletherapy unit for treatment of humanpagients.
Alternatives:
1.
Continue to license persons or institutions for teletherapy units without specifically requiring full calibration or spot-check measurements.
2.
Issue notice of proposed new regulations requiring each licensee to have a qualified expert perform periodic full calib,ation measurements and establish r
spot-check procedures.for -eai::h' unit in accordande with accepted standards..
Contact:
Leo Wade NOTE: This paper, originally issued as SECY-76-420 492-7463
,and 50bsetiuently, withdrawn, is beinQ reissued as a result of the 3riefing on SECY-76-529. There are no changes from the original version.
9902010345 761206 PDR SECY 76-574 R PDR
OFRCMJL USE ONW
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CONSENT ".-a.END AR ITEM j,. c c
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Fort The Coamissioners n-f ~ g' g/6 M..
From:
Kenneth R. Chapman, Director.
O g'/Y Office of Nuclear Material Safe h
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Thru Executive Director for Operations Subjects AMENDMENT TO 10 CFR PART 35:
" HUMAN USES OF BYPRODUCT MATERIAL *: SPECIFIC LICENSES FOR HUMAN USE OF BYPRODUCT MATERIAL IN SEALED SOURCES Purposes To seek Comission approval of a notice amending Section 35.13 of 10 CFR Part 35 that would require
' licensees to have a qualified expert perform periodic full calibratica and spot'-check measurements of each teletherapy w.it used for treatment of patients.
Category:
This paper covers a major policy issue.
Issue Should the Commission require calibration and spot-check measurements of teletherapy units?
Decision The Commission should act imr3ediately to ensure Criteria that the safety and interests of the public, specifically certain patients, are not compromised in the use of a teletherapy unit for treatment of humanpagients.
Alternatives:
1.
Continue to license persons or institutions for teletherapy units without specifically requiring full calibration o,r spot-check measurements.
Issue notice of proposed new regulations requiring 2.
each licensee to have a qualified expert perform periodic full calib, ration measurements and establish spot-check procedures.for esi::h' unit in accordande with accepted standards..
Contact:
Leo Wade NOTE: This paper, originally issued as SECY-76-420 492-7463
,and subseciuently. withdrawn, is beina reissued as a result of the 3riefing on SECY-76-529. There are no changes from the original version.
9902010345 761206 PDR SECY 76-574 R PDR i
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The t'
.ssioners,
3.
Same regulations as in Alternative 2, but issued in effective form, bypassing any period for public coannent.
Discussion:
Byproduct material licenses are issued on the basis that the licensee is qualified b1 training and experience to use licensed material in such manner as to protect health and minimize danger to life or property. Inplicit in the issuance of the license on that basis is the concept that the licenaea is i
expected to* be aware of the accepted standards of practice in his particular area of usage and to establish administrative procedures sufficient to ensure that the 2icensed material is used in accordance with NRC regulations and accepted standards of practice.
In the area of teletherapy, existing standards include National Council on Radiation Protection and Measurements (NCRP) Report No. 33, " Medical X-Ray and nawam-Ray Protection for Energies Up to 10 McV -
Equipment Design and Use", American National Standards Institute, Inc. (ANSI) Publication N449-1974,
" Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment" and the criteria for accroditation of the Joint Commission on !!ospital Accreditation.
Despite the existence and general acceptance of these standards, recent evidence indicates that a significant number of teletherapy units may deliver a radiation dose that differs from the intended one by more than 10 percent (with proper calibration the radiatian output of a teletherapy unit can be determined with an uncertainty of less than 3 percent).
The evidence also indicates that as much as five years has elapsed since the last calibration of a significant number of teletherapy units.
In a recent incident approximately 400 patients treated for cancer with a cobalt-60 teletherapy unit received radiation doses that exceeded the prescribed doses by as much as 414. This incident occurred because the radiation dose rate from :he teletherapy unit had not been properly determined.
It therefore appears that the Counission should impose such controls as are necessary to ensure that
1 The Coesnissioners teletherapy units are used in a manner so as to deliver radiation doses that are not significantly different from the doses prescribed by the physician.
The proposed regulation would require each licensee authorized to use teletherapy units for human use to l
have a qualified expert perform full calibration measurements and to establish monthly spot-check l
l procedures in accordance with accepted standards.
The proposed rule defines the qualifications of the expert, the measurements to be made, the manner in which the measurements are performed and the frequency and conditions under whi e the measurements are required. It also requires the licensee to maintain records of calibrution and spot-check measurements for inspection by IE staff.
The recent evidence that led to a reconsideration of Consiission policy regarding calibration of teletherapy units suggests that issnediate steps be taken to correct potentially hazardous situations. The suggested immediate action involves adopting the regulation and omitting the usual period for public comment. It should be noted that there are 470 teletherapy licenses covering an estimated 590 units. Approximately 150 treatments per unit are performed each week, or a total of approximately 90,000 treatments each week for all units licensed by the Comission.
The commission say expect some adverse comment on the regulation even though it conforms with the recommendations of the various standards setting organizations. Some individuals may believe that such a regulation interferes with the practice of medicine in radiation therapy. They may believe that calibration of a teletherapy unit is intimately connected with the determination of the dose given to a patient.
NCRP Raport No. 39, " Basic Radiation Protection Criteria" states, "In the judgement of the NCRP, there can be no rational means to regulate uniformly or to limit radiation exposure prescribed for necessary and proper diagnostic or therapeutic purposes. On the other hand, steps can be taken to minimize unnecessary or medically unproductive radiation exposure".
5 s
The Commissioners The staff believes that the suggested
.an is appropriate to protect the public he dt and safety and does not involve the Commission in the practice of medicine. In the near future, the HMSS, SD and IE staffs will describe other policy questions with regard to medical licensees and recommend a course 4
of action.
In thet interest of public health and safety, the Connission should ensure that (1) teletherapy atics are properly calibrated so that the prescribed dose can be delivered accurately to the patient and (2) that these units continue to operate in the expected manner.
Alternative 1.
Continue to license teletherapy units without specifically requiring full calibration and spot-check measurements.
Pros (1) Additional regulations for the use of therapy units would not be imposed.
Cons (1) Ignores the current evidence that patients may not be receiving the dose prescribed by the physican because a significant percentage of teletherapy units are not properly calibrated.
Alternative 2_.
Issue proposed new regulations requiring each licenses to have a qualified expert perform periodic full calibration measurements and to establish spot-check procedures in accordance with accepted standards.
Pros (1)
Reeponds to the current evidence that patients may not be receiving the dose prescribed by the physician because a significant percentage of teletherapy units are not properly calibrated.
(2) Perlaits full consideration of public consnents and suggestions prior to adoption.
Cons (1) Imposes additional regulations for the use of teletherapy units.
(2) The period for public coc: ment will delay implementation of action deemed necessary to correct the situation as indicated by current evidence.
,c The Comunission Alternative 3.
Same regu1**~
as in Alternative 2, but issued in effectiva
, bypassing the period for public ecament, Pros (1) Om8
_on of the period for public coment i_A1 speed implementation of action deemed necessary to correct deficiencies as indicated in current evidence.
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(2) Responds to the current evidence that patients may not be receiving the dose prescribed by the physician because a significant percentage of teletherapy units are not properly calibrated.
Cons (1)
Imposes additional regulations for the use of teletherapy units.
(2)
Does not permit full consideration of public comments and suggestions prior to adoption.
Recommendation:
The crunni ssion s 1.
Approve publishing in the Federal Register a notice of adoption of an amendment to 10 CFR Part 35 requiring licensees to have a qualified j
expert perform periodic full calibration measurements and to establish spot-check procedures in accordance with accepted standards (Alternative 3).
2.
Note The amendment would be published in the t.
Federal Register _with an effective date forty-five (45) days af ter publication.
l b.
The 45 day period would allow affected licensees an opportunity to have necessary measurements made. The Radiation Therapy Committee of the American Association of Physicists in Medicine has advised that there are sufficient qualified experts available to perform these measurements within the specified time, Although the period for public comment is c.
being omitted, the notice invites interested l
parties to submit written coments and suggestions on the rule. If significant
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Ttie Co.anissioners '
questions or advr.rse coaments are received, an amendment to the new regulation will be considered.
d.
The calibration procedure in the proposed rule has been reviewed and approved by the Connaission's Medical Advisory Cesuittee and by the Radiation Therapy Cosmittee of the American Association of Physicists in Medicine.
All teletherapy licensees will be notified e.
by mail of the rule change concurrent with its publication in the Federal Recister.
f.
The Joint Connittee on Atomic Energy will be informed.
g.
A public announcement (Enclosure 3) will be issued when the amendment is filed with the Office of the Federal Register.
h.
Approval of the record keeping required in Section 35.13(b)(6) will be obtained from the General Accounting Office prior to publication of the rule in effective form.
Coordination:
The Agreement States will be informed of this rule statnge and the appropriate background information and will be encouraged to take similar actions.
Some Agreement States already have similar regulations.
The Offices of Inspection and Enforcement, Standards l
I Developnent, State Programs and Executive Legal Director concur in the recommendations of this The Office of Public Affairs prepared the paper.
draft public announcement.
Because this issue has been discussed *, EDO requests issuance without normal OGC/0PE coordination to avoid delay.
eEr nneM apman office of Nuclear Material Safety and safeguards DISTRIBUTION _
Enclosures:
1.
Federal Register Notice of Adoption of Amendment Comissioners Comission Staff Offices 2.
value Impact statement Executive Director for Operations 3.
Public Announcement Secretariat Conmissioners commentsor consents, should be.proyided. directly to the Nort:
office of the Secretary by C.o.s.
Tuesday, December 14, 1976 xeference memo from the Secretary to the E00 dated August 5,1976.
- 5Ecy Nort.:
Title 10 - Energy CHAPTER I - NUCLEAR RECULAMRY COMMISSION PART 35 - HUMAN USES OF BYPRODUCT MATERIAL Human Uses of Teletherapy Units Notice is hereby given of the amendment of the Nuclear Regulatory Consission's regulation " Human Uses of Byproduct Material",10 CTR Part 35.
Following its organization under the Energy Reorganization Act of 1974 (Public Law 93-438), the Nuclear Regulatory Comission (NRC) has stated its intention of reviewing those of its regulations and procedures pertaining to the licensing and regulation of nuclear facilities and materials that were originally promulgated by the Atomic Energy Commission, with a view to considering what changes should be made. In this context, the Commission is currently reviewing its regulations pertaining to the human use of byproduct material including teletherapy units.
Syproduct material licenses are issued on the basis that the licensee is qualified by tr.sining and experiene,e to use licensed material in such manner as to protect health and minimize danger to life or property.
Implicit in the issuance of the license on that basis is the concept that the licensee is expect'ed to be aware of the accepted standards of practice in his particular area of usage and to t:stablish e.dministrative procedures sufficient to ensure that the licensed material is used in accordance with NRC regulations and accepted standards of practice.
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2-In the area of teletherapy, existing standards include National Council on Radiatic,n Protection and Measurements (NCRP? Report No.
?',
" Medical X-Ray and Gamma-Ray Protection for Energies Up to 10 MeV -
Equipment Design and Use", American National Standards Institute, Inc.
(ANSI) Publication N449-1974, " Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment" and th,e criteria for accreditation of f
the Joint Committee on Hospital Accreditation.
Despite the existence and general acceptance of these standards, recent evidence indicates that a significant number of teletherapy units may deliver a radiation dose that differs from the prescribed dose by (With proper calibration, the radiation output of more than 10 percent.
a teletherapy unit can be determined with an uncertainty of less than 3 The evidence also indicates that up to five years has elapsed percent.)
since the last calibration of some teletherapy units.
The Commission is currently conducting an investigation of a recent incident in which approximately 400 patients treated for cancer with a cobalt-60 teletherapy unit received radiation poses that exceeded the i
This incident occurred prescribed doses by as much as 41 percent.
because the radiation dose rate from the teletherapy unit had not been properly deterLined.
It therefore appears that the Commission should impose such controls as are necessary to ensure that teletherapy units are used in such manner as to deliver radiation doses that are not significantly different
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! from the doses prescribed by the physiciar
,secordingly, the commission
.is amending 535.13 to require that a qualified expert perform periodic full calibration measurements and establish monthly spot-check procedures in accordance with accepted standards. The new regulation defines the qualifications of the expert, the measurements to be made, the frequency end circumstances under which the measurements are to be performe) and the procedures to be used.
The Commission has determined that since protection of the public health and safety requires that the new regulation become effective as soon as possible, good cause exists for omitting notice of proposed rule making The cad publiq procedures thereon as contrary to the public interest.
in order to effective date of the new regulation will be give each licensee an opportunity (a) to submit a statement of the training and experience of the qualifisd expert who will perform the calibrations and (b) to have the necessary measurements performed.
Only those teletherapy units that have not been calibrated within the last twelve (12) months in accordance with,.the procedures specified in
, but monthly spot-check the rule need be recalibrated by measurements should be initiated immediately. Licensees should also submit the name and credentials of the qualified expert as soon as possible, but should not await approval of the expert before performing the required measurements.
- Insert date 45 days after publication in the Federal _Paqister_.
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i Licensecs who f
.nat they will be unable to achievo complianco within this s* ntied time period should apply to the Comission for an The request should include a justification for the delay and extension.
a description of interim actions that will be taken to ensure that the proper dose is being delivered. These requests will be considered on a case-by-case basis.
Accordi.ngly, pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended,'and sections 552 and
'553 of title 5 of the United States Code, the following amendments to Title 10, Chapter I, Code of Federal Regulations, Part 35 are published as a document subject to codification.
The Commission invites all interested persons who desire to submit written coments or suggestions with regard to the new regulation to send them to the Secretary of the Comission, U.S. Nuclear Regulatory Comission, Washington, D. C.
20555, Attention: Docketing and Service Consideration will be given to such submissions Section by with the view to possible further amendments. Copies of coments received J
say be examined at the Comission's Public Document Poom at 1717 H Street, N. W., Washington, D. C.
1.
Section 35.13 is amended to read as follows:
535.13 Specific licenses for human use of byproduct material in sealed sources.
I (a) An application for a specific license for use of a sealed source for human use will be approved if:
- Insert a date 45 days after publication.
(L) Tho applicant cratiaties tho general requirements specified in 530.33 of thin chapter; and (2) 'the applicant or, if the application is made by an
. institution, the individual user (i) has specialized training in the therapeutic use of the radioactivo device considered (tclotherapy unit, beta applicator, etc.)
or has experience equivalent to such trainings and (ii) is a physician.
(b)
(1) Any licenscc who is authori=cd to ute teletherapy units for human use shall cause full calibration measuremente on cach teletherapy unit. to be performed:
(i)
Prior to the fient use of the unit for treating humans (ii) Whenever the radiation meter or other devico eclated to radiation output chowc a contiaued uignific. ant change in itu normal reading:
(iii)
Following replacement of the s adiation cource or following reinutallation of the unit in a new location and prior to Lhc uco of the unit for treat 4ng humans:
(iv) At intervals not exceeding one year.
Full calibration measurements ethall include determination of (2)
(i) The exposure rato or done nite for the range of field for sizes uned and for each tavatment. distance une.1 radiation therapy (ii)
The congruence between the radiation field and the field indicated by the localizing device when localizing devices aro used:
4 f-(iii) The uniformit y of the rcdiation field and its detiend. nce upon the direct ion of the useful beams (iv) Tir.or accuracy.
(3) Pull calibration meanurement.c t. hall be modo in accordance with the procedures recemow nded by flia Scie'ntific Committee on P.adiation Dosimetry..f the An rietan Asnociation of Physicists in i4ed i cino (P,hy >,i r :. i n 14cen i c i ne..inr1 til.eloqy, W..
16, No.
3, I
l'371, pp. 37'J-3')G).
(4)
Spot-check me. mort:me nt s shall 14: tu?rformed at interv.ija not 1
cxceedinij one month and shall include:
(1)
Determinarion of timer accuracy, (ii)
Determination e.8 congrunnc/ of the useful beam with the light localir.ir, (iii) lieterminatiren ot t ho cr.p :nore iato, doru rato or a ya,intity rre la teel i n.: h ue r.n mann. r f.e e I hor:e entcu for one i.ypical.ot of m.. chine op. rating conditions, and (iv)
Comparison of the-acasurenenta made in section (iii) of this paragraph with valuen cajrulated from phynical decay of t.hu radiatirin ::oarce.
(5)
Calit, ration meanurtw'ntn rotin treil by para <jr..ph (n) (li of thin section chall t,c performent 1.y a spi.s t i fied expert :.ne h m an
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individual certified by the American coarc of Radie, logy in 1This incorporation by reference provinion was approved by the Acting Director of the redoral_ ttegister on August 6,1976. Copien are availablo a
for inspoetion at, or may bc obenined from, U.S. Nucle.*4r ftr.'jnlatory Commission, Public f)ocument Room, 1717 !! Stront, N.W. Washington, D.C.
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, Therapeutic Radiologicci Phyuics, Radiological Physic
.,v a tgo n acs or an Ray and Gansna Ray Physics or X-ray',and Radiue -
individual who has equivalent qualifica*' as.
(A description of the qualified expert's training and qualification shall be submitted to the Comission for review. If the qualified expert is certified in one of the specialties 1.'.sted in this paragraph only a statement of.tha'e fact and the date of ' certification is required). Spot-check measurements required by paragraph (b)(4) of this section shall be performed and evaluated in accordance with procedures established by the qualified expert. The qualified expert shall review the results of spot-check measuren.ats and shall recommend corrective action when significant diffe.ences are noted.
The licensee shall maintain records of the measurements made (6) pursuant to paragraphs (b) (1) and (b)(4) of this section for inspection by the comission.
Rffective date. The foregoing amendments ara effective on
_, 1976.
Soc. 201, (Sec.161, Pub. L.83-703, 68 Stat. 948 (42 U.S.C. 2201):
Pub. L.93-438, 88 Stat.1243 (42 U.S.C. 5841)).
Dated at Washington, D.C. this day of 1976.
FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Chilk Secretary for the Commission
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MEMORANDUM FOR:
S. J
.iiilk, Secretary Of..ce of the Secretary of the Commission FROM:
T. A. Rchm, Assistant to the Executive Director for Operations, EDO
SUBJECT:
i'E %.ST FOR RESUBMISSION OF CONSENT ITEMS During the Commission briefing on SECY-76-529 " Issues Concerning NRC Involvement in the Regulation of Nuclear Medicine", the Chairman indicated that papers withdrawn pursuant to this briefing could bc submitted for Commission consideration if the staf f desired.
SECY-76-420, Amendment to 10 CFR Part 35: "liuman Usc; of Dyproduct Material, Specific Licenses for Human Use of Byproduct Material ia Sealed Sources", and SECY-76-383, Proposed Amendment to 10 CFR Part 35, " Human Uses of Byproduct Me terial, Specific Licenses to Individual Physicians and Institutions", can be considered independently of the Chairman's request to acquire ACMI opinions on issues raised in SECY-76-529.
It would be wise to consider them now because:
SECY-76-420 woulrl impose a requiremt for licensees to routinely calibrate teletherapy units, thereby preventing situations such as the Riverside Hospital incident; SECY-76-383 would require institutions to be licensed rathat than individual physicians working in those institutions, thus placing the responsibility for safety on the institutions i
where it more properly belongs since staff members other than the physicians are usually involved.
Early consideration of SECY-76-383 is important bect.use a large number of individual physician licenses are coming up for renewal in a few months.
Request you reinstitute these two papers, subject to Commissioner Kennedy's agreement, in view of the fact that he had an interest and missed the briefing on SECY-76-529.
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T. A. Rehm, Assistant to the Executive Director for Operations Office of the Executive Director for Operations cc: R. Minogue, SD L. Wade, HMSS K. Chapman, NMSS E. Podolak, SD
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December 16, 1976 T,,
MEMORANDUM FOR Chairman Rowden Commissioner Mason Commissioner Gilinsky Commissioner Kennedy Peter L. Strauss, General Counsel FROM:
SUBJECT:
SECY-76-574 (AMENDMENT TO 10 CFR PART 35: " HUMAN USES OF BYPRODUCT MATERIAL")
I have no objections, legal or otherwise, to the proposed amendment, as far as it goes, but this is not far enough.
For example, I would feel more confident that miscalibra-tions would be brought promptly to the Commission's atten-tion if the proposed rul.e required licensees to make reports when a miscalibration er.ceeding a certain amount is detected, rather than simply " maintain records", which may or may not come promptly to the attention of the Commission, depending on the frequency of inspections.
l Further, the rule is in no way responsive to the follow-up concerns expressed in the attached OGC memo of August 5 and For example, there is no noted by Commissioner Gilinsky. licensees in steps to remedy provision to guide (or compel) the consequences of past errors in dosages which calibration Accord-i checks pursuant to the new rule may bring to light.
ing to an earlier staff document (SECY 529, "The Issues l
Concerning NRC Involvement in the Regulation of Nuclear the staff is still considering amendments Medicine" page 14) to 10 CFR Part 35, proposed by the AEC and published Septem-Fed. Reg. 6399), that would require reports ber 9, 1973 (38 to the Commission and to the patient of any "misadministra-tions of byproduct material," defined to include administra-tion of radiation "outside of the intended dose range This proposed rulemaking was prescribed by the physician."
based on a GAO recommendation "that was in turn based on GAO's review of the AEC's investigations of twelve instances of misadministrations of radioactive material (involving 20 patients) between 1961 and 1972."
The subsequent Riverside
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Contact:
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E. Leo Slaggie 49-28155 L
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The commission incident appears to point up strongly the need for something like what the GAO recommends.
I continue to regard Commission action in this direction as an immediate need and would hope to see a staff recommenda-tion shortly on the proposed AEC rule for dealing'with the With regard to the specific problem of misadministration ingen the teletherapy case and as a response to the concerns raised in this memorandum, I suggest replacing paragraph (b)(G) of the rule proposed in SECY-76-574 by the following two paragraphst Sec. 35.13(b)
When measurements made pursuant to paragraphs (b) (1)
(6) and (b) (4) of this section indicate that patients treated by teletherapy units may have received a radiation dose differing from the prescribed dose the licensee shall notify by more than 10 per cent, the appropriate Regional Office of Inspection and Enforcement listed in Appendix D of'10 CFR Part 20, and, where practicable, the ai2thorized physicians.
This notification shall be of affected patients.
made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licenzos's discovery that such misadministration is likely to have occurred.
The licensee shall maintain for inspection by the (7)
Commission records of the measuraman'.s mada pursuant to paragraphs (b)(1) and (b) (A) cf 'DI.s section and of reports made to authorized physicions pursuant to paragraph (b)(6) of this section.
Attachments As stated cc/with attachment V. Gossick EDO M~.
K. Chapman, NMSS B. Huberman, OPE SECY (2) l 94
.g, 888N UNITED STATES NUCLEAR REGULATORY COMMISSION wA 6HNOTON. D. C. 20SS5 y
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cresca OF THE COMM,lS$10NER August 26, 1970 HEMORANDUM FOR:
Chairman Rowden Comissioner Mason Comissioner Kennedy FROM:
Commissioner Gilinsky Calibration Errors in Teletherapy
SUBJECT:
(Riverside Hospital Incident)
I believe that the General Counsel'c momerandum of August 5,1976 (attached) should be carefully considered.
I suggest that the GC's proposal for an organized follow-up effort be discussed at an early sesnion.
cc S. Chilk, SECY m
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August.,,1976 MEMORANDUM FOR:
Chairman Rowd'en
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Comissioner Mason Comissioner Gilinsky g 3
Comissioner. Kennedy g
Peter L. Strauss, General Counsel k FROM.
AUGUST 2, 1976 BRIEFING ON RIVERSIDE HOSPITAL
SUBJECT:
INCIDENT 1
l
' In my view the'results of this meeting represe'n't an appropriate first step to dial with the most pressing imediate problem namely the fact that because of disclosed by the incident,letherapy patients. throughout the calibration errors many te country are probably receiving doses significantly different The concluding emphasis of the meet-from those prescribed.
ing rightly focused on t,he need to be.sure that these machines are calibrated correctly now and henceforth.
While the Comission obviously has a paramount -concern that futura damage be avoided, it also seems clear.that action should be taken to identify and remedy where possible the human con-Mor., attention to this sequences of past errors in dosages.
subject appears to be needed than the August 2 briefingIt is my impre
,';provided.
documentation of this incident that physicians of Riverside Hospital patients who received a dose substantially different It from the one prescribed are being~ notified of this fact.
was not clear from the briefing, however, that an organized effort is bein's planned to identify patients elsewhere and pro-where.the NBS study or futsre vide notification and follow.-up,ihood that doses in error have NRC evaluations indicate a likel been delivered.
I recognize that there is a major resource
. problem in. accomplishing this task' in view of the fact thatAs stas recognized
- 25,000 o'r more patients may b'e' involved.
at the briefin, there are also sensitive questions concern-Nevertheless, the ing possible 1 ability"of the hospitals. nature of the affair makes it prudent "potentially explosiveas well as humane for the NRC.in its position of radiation safety leadership to.make a substantial effort to assist thosa who mAy have.been injured.
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E.L. Slaggie 492-8155
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2 altant Dr. Saenger, in his letter of May 26, 1976, NRC cir' ind# xes that many months of study are needed, once aner Thus a program for identifying the needs of the patient.
patients affected by these errors and notifying theirtly hnd probably
- physicians is needed promp during the NRC grogram for correcting existing calibration Once t'2e latter program is effectively underway, the question of how best to proceed with identification and notifica-errors.
tion might be the subject of a future Comission briefing.
~
ces Ben Huberman SEGY (2)
Lee Cossick e
R. J. Voegeli
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NUCLEAR REGULATORY COMMiss!ON 1
WASHINGTON, D. C. 20668 k*****
JAN 311977 f
MEMORANDUM FOR: Chairman Rowden Comissioner Gilinsky Comissioner Kennedy Robert 8. Minogue, Director FROM:
Office of Standards Development g.,,
Lee V. Gossick, Executi m Mrector for Operations THRU:
MEMO FROM OGC TO C0KMIS51udERS CONCERNING SEC (TELETHERAPYCALIBRATIONRULE)ALSORECOMMEND
SUBJECT:
DISPOSITION OF THE 1973 PP*0 SED " MISADMINISTR OSD received a copy of the subject memorandum (Enclosure 1) that communi-In that cates OGC coments on the NMSS teletherapy calibration rule.
memo OGC urges prompt disposition of the 1973 AEC proposed rule (Enclo-sure2)thatwouldrequirephysicianstorecortmisadministrationofAs the OGC mem
-tent.
byproduct material to the NRC and to t" e proposed " misadministration" noted, there was a limited discussion of NRC Involvement in the Regula-rule in SECY 76-529 (The Issues Concc-tion of Nuclear Medicine, p.14) and ;......;cr is still under staff consideration.
OSD recommends that the 1973 proposed " ' ",inistration" rule not be con-sidered by the Comission until the 1-Ilcy question of HRC's future resolved. OSD intends to role in the regulation of nuclear mcf orting in the issues to be include the question of misadministrn.:..
.c considered at the upcoming NRC meetings with interested members of the public and the Advisory Comittee on the Medical Uses of Isotopes now. pot scheduled for May 1977. Some of the -
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Contact:
Edward Podolak 443-6910
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2-Multiple Addressesses
- 1tcy in regulating nuclear Comission when considering NRC's over'.'.
medicine, will be foreclosed by prematm : tion on the misadministration I
rule. HMSS concurs in this position.
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' s igaed bys 1" '
MUCOUE n-
.tiinogue, Director l
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.. Standards Development i
Enclosures:
- 1. December 16, 1976, OGC Mac 2.
Federal Register Announcement of : 73 Proposed "Misadninistration" Rub 3.
Sumary of Public Coments on 1973 Proposed Rule l
bec w/ enclosures:
i KRChapman, NMSS CSmith, NMSS i
RECunningham,NMSS EVolgenau. I&E i
PLStrauss. GS LSlaggie, GC GWKerr, SP HKShapar, ELD MGMalsch, ELD Secy l
Distribution _
Central Files SD Alpha SD RF i
TBSF r/f RBMinogue RGSmith i
GAArlotto DNussbaumer l
RFBarker i
EMPodolak LVCossick j
WJDircke TARehm
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