ML20202D221
| ML20202D221 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/1977 |
| From: | Karen Chapman NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| SECY-76-574-C, SECY-77-194, SECY-77-194-R, NUDOCS 9902010342 | |
| Download: ML20202D221 (17) | |
Text
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b t OFFHCHAL USE ONLY April 8, 1977 umsso sva:ts , ,
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NUCLEAR REGULATORY 'COMMfS$10N '
CONSENT CALENDA .(EM Fort The Commissioners From: Kenneth R. Chapman, Director Office of Nuclear Material Safety and Safeguards Thru:
' Lee V. Gossich, Executive Director for Operation
Subject:
SECY-76-574 AMENDMENT TO 10 CFR PART 2'is "HU}GN USES OF BYPRODUCT MATERIAL" SPECIFIC LICENSES FOR HUMAN USE OF BYPRODUCT MATERI'AL IN SEALED SOURCES
Purpose:
To request reconsideration of the misadministration ;
' reporting requirement specified by the Comission as part of their approval of SECY-76-574.
Category: This paper covers a minor policy question. .
Issue:
Should SECY-76-574 include requirement for reporting misadministration from teletherapy devices as suggested by OGC memorandum of December 16, 1976.
Alternatives: Publish proposed teletherapy rule, as approved by the Commission, including a reporting requirement on misadministration.
Withhold publication of the proposed teletherapy rule change until the staff can develop revised reporting requirements which take into account the comments of the Advisory Comittee on the Medical Uses of Isotopes (ACMUI) . The staff would consult with the members of the ACMUI and with the American College of Radiology. Development of revised requirements would require approximately 45 days.
Publish teletherapy rule change in proposed form without the misadministration reporting requirement.
consider matter of misadministration reporting i
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Contacts f Leo Wade, Jr. , NMSS 7 // f) j
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i 9902010342 770408 PDR SECY 77-194 R PDR l a
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OFFHCHAL USE ONLY April 8, 1977 umito stans ~
NUCLEAR REGULATORY T,OMMfS5 ION CONSENT CALEND_A r . s EM ,
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4 The Comaissioners l For:
From: Kenneth R. Chapman, Director Office of Nuclear Material Safety and Safeguards Thru:
- Lee V. Gossick, Executive Director for Operation
Subject:
SECY-76-574 AMENDMENT TO 10 CFR PART 27:
" HUMAN USES OF BYPPODUCT MATERIAL" SPECIFIC LICENSES FOR HUMAN USE OF BYPRODUCT MATERIAL IN SEALED SOURCES
Purpose:
To request reconsideration of the misadministration reporting requirement specified by the Com=ission as part of their approval of SECY-76-574.
Categorv: This paper covers a minor policy question. .
Issue:
Should SECY-76-574 include requirement for reporting misadministration from teletherapy devices as suggested by OGC memorandum of December 16, 1976.
Alternatives: Publish proposed teletherapy rule, as approved by the Commission, including a reporting requirement on misad=inistration.
Withhold publication of the proposed teletherapy rule change until the staff can develop revised reporting requirements which take into account the cocments of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) . The staff would consult with the members of the ACMUI and with the American College of Radiology. Development of revised requirements would require approximately 45 days.
Publish teletherapy rule change in proposed form without the misadministration reporting requirement.
Consider matter of misadministration reporting f
Contacts f)
Leo Wade, Jr., NMSS 7 //
42-74232 , j,.
s 9902010342 770408 PDR SECY 77-194 R PDR
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The Commissioners requirements for teletherapy as part of development of overall NRC policy in medical use of byproduct material.
Discussion: Item V of Mr. Chilk's memorandum of March 7, 1977 stated that SECY-76-574 had been approved by the Commission with certain specified changes to be made in the rule change proposed. The principal change specified by the Commission was inclusion of a reporting requirement on misadministration. Also, instructions were given regarding certain changes in the Statement of Consideration and the news release.
The Statement of Consideration and news release for SECY-76-574 (Enclosure 1) have been changed to indicate publication in proposed form with a 45 day period for public comment.
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Both documents were also revised to indicate that the Commission took actions soon after the " Riverside incident" to ensure that all teletherapy units ;
licensed by NRC were properly calibrated. The i i
documents also state that the Commission believes that these actions are adequate to prevent recurrence of overexposure events due to calibration errors during the time required to implement this rule l change. We added the phrase "due to calibration errors" because overexposures may be due to errors other than in calibration (e.g. , timer inaccuracy or malfunction).
We respectfully suggest that the Commission reconsider the inclusion of the misadministration reporting ,
requirement. In 1973, the AEC published a proposed l l
amendment to its regulation (38FR 6399) that would have required reporting misadministrations. The AEC received many adverse comments on its proposed rule change, including comments from the American Medical I Association, American Board of Radiology and Society of Nuclear Medicine. No final action was taken on the proposal. Enclosure 2 su=marizes the comments received.
Because of the sensitivity of misadministration in the medical community, we thought it prudent to l discuss the proposed teletherapy reporting requirement l h.
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.. Comissioners speciff.ed by the Comission wich our consultant and with mexbers of the Comission's Advisory Comittee on the Medical Uses of Isotopes (ACMUI). The Committee members and consultants thought the misadministration reporting requirement needed substantial changes and clarification. Some were opposed to any reporting requirement. Their major comments and suggestions are listed in Enclosure 3.
The staff suggests that the Commission consider the following alternative actions.
Alternative 1: Publish proposed teletherapy rule change including a reporting requirement on misadministration as approved by the Commission.
i Pro (1): Responds promptly to OGC memorandum of December 16, 1976.
Pro (2): Allows immediate publication of proposed teletherapy rule.
- Pro (3): May ensure that the Commission is made aware, on a timely ba.is, of incorrect radiation doses given to patients.
Con (1) : Fragments consideration of entire matter of nisadministration by separating out teletherapy.
Con (2) : May prejudice later consideration of matter of misadministration in connection with NRC policy on medical use of byproduct material.
Con (3) : Publishes proposed rule in a form that the staff knows to be ambigious and objectionable to the medical comunity.
Alternative 2: Withhold publication of the proposed teletherapy rule change until the staff can develop revised reporti.ig requirements which take into account the comments of the ACMUI. The staff would consult with the members of the ACMUI and with the American College of Radiology. Development of revised requirements would require approximately 45 days.
The Commissioners .
Pro (1) : Resolves known deficiencies before publishing proposed rule.
Con (1): Minor delay in Lpplementing necessary .le change while considering reporting requirements.
Delay is undesirable because spot-checks required by proposed rule would detect malfunctions due to cau,es other than improper calibration.
Con (2) : Fragments consideration of entire matter of misadministration by separating out teletherapy. .
Con (3) : May prejudice tter consideration of matter of misadministratmn in connection with NRC policy on medical use of byproduct material.
Alternative 3: Publish teletherapy rule change in -
proposed form without the misadministration reporting requirement. Consider matter of misadministration reporting requirements for teletherapy as part of development of overall NRC policy in medical use of byproduct material.
Pro (1): No delay in publishing proposed teletherapy calibration rule due to reconsideration of misadministration reporting requirement.
Pro (2): Allows consideration of misadministration reporting requirement for all medical uses in light of overall NRC policy in medical use of byproduct materials thereby not prejudicing overall policy consideration.
Pro (3): Would allow more rapid implementation of ;
needed teletherapy calibration rule by avoiding '
controversial area of misadministration.
Con (1) : Does not ienediately respond to OGC j memorandum of December 16, 1976.
Con (2): Some risk that the Commission may not be made aware, on a timely basis, of incorrect radiation doses given to patients, a situation which has existed for the past 25 years.
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The Commissioners r Recommendation: NMSb recommends that the Cor:r ' aon withhold publication of the propose' celetherapy rule change i I
until the staff can de m op revised reporting requirements which take into account the comments of the ACMUI (Alternative 2) .
Coordination: SD and IE concur in this recommendation.
Anticipated Scheduling: Week of May 2,1977 '
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i qf 7,.,--------_
Kenneth R. Chapman,Ai; rector ,
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[ Office of Nuclear Material Safety and Safeguards f
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Sunshine Recomends Open. OGC and CPE concur.
Enclosures:
- 1. SECY 76-574 Federal Register Notice and Press Release DISTRIBliTION Comments on 1973 Proposed Commissioners ,
2.
Misadministration Reporting Comission Staff Offices l Exec Dir for Opers Requirements -
- 3. Comments and suggestions on Secretariat Proposed Teletherapy Reporting !
Requirements EDO Comment I concur in NMSS's recommendation that misadministration reporting be reconsidered by the Commission.
Rather than delay the rule (Alternative 2) or publish it without the misadministration reporting requirement (Alternative 3), I recommend the following:
, publish the proposed rule as it now stands modify the statement of considerations to note that the reporting is being considered question of misadministrationof as part of the development overall NRC policy in medical use of by-product material, and solicit comments on this specific issue.
This solution allows us to go forward expeditiously while framing the issue in a better light. ,
ee V. ossick Executive Director for Operations Commissioners comments or consent should be provided directly to the Office of the Secretary by close of business. Friday, April 22, 1977_.
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TITLE 10 - .d i
CHAPTER I
.M. REGULA'IORY COMMISSION PART F aUMAN USES OF BYPRODUCT MATERIAL HUMAN USES OF TELETHERAPY UNITS Followin; 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 i
materials that were originally promulgated by the Atomic Energy Comission, In this context, with a view to considering what changes should be made.
the Comission is currently reviewing its regulations pertaining to the human use of byproduct material including teletherapy units.
Byproduct caterial licenses are issued on the basis that the licensee is qualified by training and experience 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 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 licensed material is used in accordance with NRC regulations and accepted standards of practice.
t 1 Enclosure 1 h4
1 in the area of teletherapy, existing standards include National council on Radiation Protection and Measurements (NCRP) Report No. 33, )
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" Medical X-Ray and Gamma-Ray Protection for Energies Up to 10 MeV - l Equipment Design and Use", American National Standards Institute, Inc. i i
(ANSI) Publication N449-1974, " Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment" and the criteria for accreditation of
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the Joint Co m ttee on Hospital Accreditation.
Despite the existence and general acceptance of these standards, recent evidence indicates that a significant number of teletherapy unite, may deliver a radiation dose that differs from the prescribed dose by more than 10 percent. (With proper calibration, the radiation output of a teletherapy unit can be determined with an uncertainty of less than 3 percent.) The evidence also indicates that up to five years has elapsed since the last calibration of some teletherapy units.
The Comission has conducted an investigation of a recent incident in which approximately 400 patients treated for cancer with a cobalt-60 teletherapy unit received radiation doses that exceeded the prescribed doses by as much as 41 percent. This incident occurred because the radiation dose rate from the teletherapy unit had not been properly determined.
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soon after its investigation, the Commission took actions to ensure that all teletherapy units licensed by the 1 RC vere properly calibrated.
The Commission celieves that these actions are adequate to prevent recurrence of overexposure events due to improperly calibrated units during the time required to implement necessary changes in its regulations.
Because of the events described above, it appears that the Commission should impose such controls as are necessary to ensure that teletherapy units continue to be used in such manner as to deliver radiation doses that are not significantly different from the doses prescribed by the physician. Accordingly, the Ccemission is proposing an amendment to
$35.13 to require that a qualified expert perform periodic full calibration measurements and establish =onthly spot-check procedures in accordance with accepted standards. The proposed regulation defines the qualifications of the expert, the measurements to be made, the frec.ancy and circumstances ,
under which the measurements are to be performed and the procedures to be used.
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, notice is hereby given that adoption of the following amendment to 10 CFR Part 35 is contemplated.
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All interested persons who desire to submit written coments or saggestions with regard to the proposed amendment should sen' .a to the Secretary of the Commission, U.S. Nuclear Regulator; Comission, j
Washington, D. C. 20555, Attention: Docketing and Service Section by
- Copies of coments on the proposed amendment may be examined at l the Comission's Public Document Room at 1717 H Street, N. W. , Washington,
- D. C. 20555 .
- 1. Section 35.13 is amended to read as follows:
535.13 Specific licenses for hur.an use of byproduct material in sealed sources.
(a) An application for a specific license for use of a sealed source for hu=an use will be approved if (1) The applicant satisfies the general requirements specified in 130.33 of this 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 radioactive device considered (teletherapy unit, beta applicator, etc.) , or has experience equivalent to such training; and (ii) is a physician, 4
- Insert a date 45 days after publication. h.
Any liu= s a who is author #~ s use teletherapy units (b) (1) for human use shal) .e full calibration measurements on each teler'..apy unit to be performed:
(i) Prior to the first use of the unit for treating humans; (ii) Whenever the radiation meter or other device related to radiation output shows a continued significant change in its normal reading; (iii) Following replacement of the radiation source.or following reinstallation of the unit in a new location and prior to the use of the unit for treating humans; (iv) At intervals not exceeding one year.
(2) Full calibration measurements shall include dt. termination of:
(i) The exposure rate or dose rate for the range of l
field sizes used and for each treatment distance used for radiation therapy; 4 .
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.A) The congruence betveen the radiation field and the field indicated by the localizing device when localizing csvices are used; (iii) The uniformity oi the radiation field and its dependence upon the direction of the useful beam; (iv) Timer a'ecuracy.
(3) Full calibration measurements shall be rade in accordance with the procedures recoceended by the Scientific comittee on Radiation Dosimetry of the American Association of Physicists in Medicine (Physics in Medicine and Biology, Vol. 16, No. 3, 1971, pp. 379-396).1
- (4) Spot-check measurements shall be performed at intervals not exceeding one month and shall includes (i) Determination of ti=er accuracy; (ii)
Determination of congruency of the useful beam with the light localizers
- This incorporation by reference provision was approved by the Acting Director of the Federal Register on August 6, 1976. Copies are available for inspection at, or may be obtained from, U.S. Nuclear Regulatory Commission, 20555.
Public Document Room, 1717 H Street, N. W., Washington, D. C.
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(iii) Determination of the exposure rate, dose rate or a quantity related in a known manner to these rates for one typical set of machine operating conditions:
(iv) Comparison of the measurements made in Section (iii) of this paragraph with values calculated from physi'al c decay of the radiation source.
(5) Calibration measurements required by paragraph (b) (1) of the section shall be performed by a qualified expert such as an individual certified by the American Board of Radiology in Therapeutic Radiological Physics, Radiological Physics, Roentgen Ray and Ga=ma Ray Physics or X-ray and Radium Physics or an individual who has equivalent qualifications. (A description of the qualified expert's training and qualifications shall be submitted to the co= mission for review. If the qualified expert is certified in one of the specialties listed in this paragraph only a statement of that fact and the date of certificacion is required.) Spot-check measurements required by parsgraph (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 measurements and shall recommend corrective action when significant differences are noted.
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(6) The licensee shall maintain records of the measurements l made pursuant to paragraphs (b) (1) and (b) (4) of this section for inspection by the Commission.
Dated at Washington, D. C. this day of 1977.
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l FOR 71IE NUCLEAR REGULA1VRY COMMISSION l d
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Samuel J. Chilk Secretary for the Commission P
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NRC PROPOSES TO AMEND REGULATION ON 4
1 HUMAN USES OF TELETHERAPY IF The Nuclear Regulatory Commission is proposing to amend its regulations concerning human uses of byproduct material to require that licensees have a qualified expert perform both full calibration and spot-cneck l measurements of teletherapy units used to treat patients with cancer.
Recent evidence obtained by the NRC indicates that a significant number of the teletherapy units may deliver a radiation dose 'that differs frem the prescribed dose by = ore than 10 percent. The evidence also indicates that some units have not been calibrated for as long as five years.
The NRC has investigated an incident in which approximately 400 patients treated for cancer with a cobalt-60 teletherapy unit received doses that exceeded prescribed doses by more than 10 percent. These overexposures occurred because the teletherapy unit had not been properly calibrated.
i Soon after its investigation, the Co= mission took actions to ensure that all teletherapy units licensed by the NRC were properly calibrated.
l The Co= mission believes that these actions are adequate to prevent recurrence of overexposure events due to improperly calibrated units during the time required to implement necessary, changes in its regulations.
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i The propose ..endment to Part 35 of NRC regulations defines the T l
qualifica' sns of'the expert who wculd perform the periodic full calibration and spot-check measurements, the measurements to be made, the frequency of the measurements, and the procedures to be used.
j The Commission invites interested persons to submit written coments or suggestions on the proposed amendment. These should be addressed to the j
Sec etary of the Commission, U.S. Nuclear Regulatory Conunission, Washington, D. C. 20555, Attention: Docketing and Service Section by * .
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- Insert a date 45 days after publication in the Federal Register.
COMMENTS ON 1973 PROPOSED MISADMINISTRATION P2 PORTING REQUIREMENT The following is a su= mary of comments received on the 1973 proposed "miradministration" reporting rule.
~. Six comments favored and 13 comments opposed the proposed rule without making specific suggestions.
- 2. Twenty-seven objected to reporting misadministrations as self-incrimination; some cited constitutional protection against self-incrimination.
- 3. Fourteen objected to reports of misadministrations being pub'ic records. These commentators did not appear to object to reports to the Commission for information and investigation, if they could be reported privately. The commentators who objected on the basis of self-incrimination and public records usually stated that such reports would invite or increase malpractice suits and increase the cost of medical care.
- 4. Eleven objected to requiring reports to patients on the basis that such requirement would place the government as a third party in the physician-patient relationship. Several of these physicians stated that patients are informed of misadministrations which adversely af fect them as a matter of medical ethics but that such reports should not be regulated.
- 5. Ten commented that there are no comparable requirements for any other drug or for physicians in any other field or practice.
- 6. Fourteen commented that reports of misadministrations should be limited to therapeutic or significant amounts of radiopharmaceuticals and the misadministrations of diagnostic quantities (which are safe in normal use and which would not injure a person, if administrated j
.under conditions defined as misadministration) do not justify l reporting. The Society of Nuclear Medicine commented that reports of such minor misadministrations would make it impossible for the l Commission to sort out and act on the important misadministrations.
- 7. Ten commented that " demonstrably adverse effect" should be clarified in view of such concerns about low doses av the no threshold concept and genetic effects.
- 8. Four commented that these misadministration reporting requirements are not warranted by the number of misadministrations that have occurred.
Enclosure 2
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COMMENTS AND SUGGESTIONS ON PROPOSED i
MISADMINISTPATION REPORTING REQUIREMENT IN TELETHERAPY RULE CHANGE (SECY-76-574) j
- 1. Some members of the Commission's Advisory Committee on the Medical Uses of Isotopes disagreed with the basic concept of a reporting requirement because of possible malpractice suits and the resulting i increased cost of medical care.
- 2. Most disagreed with the circumstances under which a licensee must l
. report a misadministration.
- a. Many felt that the 10 percent value was too restrictive and
'l suggested values up to 20 percent.
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- b. Some suggested re-wording to eliminate a numerical value, i
e.g. , report events that have a " probability of causing a significant biological ef fect on the patient".
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- 3. Many believed that the 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> time limit was too restrictive.
would not allow the licensee to check his instruments, have independent measurements made, or notify the relatively large number of referring physicians involved (20-40). Some suggested time limits of 48-72 hours or up to one week.
- 4. Several said that the rule is unclear as to whether it refers to a 1
single teletherapy treatment or to a course of 20-30 treatments.
If a physician realizes that one or several treatments are incorrect, he can compensate by adjusting the remaining treatments.
j 1 - For example, if
- 5. Several asked how far back the licensee should go.
l March 1 spot-check measurements differed by more than 10 percent from February 1 measurements, when should the licensee assume the change took place? February 2, 15, 28?
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- 6. The rule should clarify how the licensee is to report, j f telephone, telegram, letter. !
' ; 7. Some suggested that the licensee identify the probable cause of the error and specify what corrective actions he has taken or plans to taka.
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- 8. The phrase " authorized physicians" should be changed to " referring physicians". The term " authorized physician" refers to a physician We who is named as a user on an NRC or Agreement State license.
believe the intent is to notify physicians who have referred :
affected patients for teletherapy treatment.
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. Enclosure 3 1,
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