ML20238C885
| ML20238C885 | |
| Person / Time | |
|---|---|
| Issue date: | 12/05/1986 |
| From: | Hind J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20238C829 | List: |
| References | |
| FOIA-87-403, FRN-52FR36942, RULE-PR-35 AC65-1-066, AC65-1-66, NUDOCS 8709100429 | |
| Download: ML20238C885 (3) | |
Text
- '
- xi j, <l A
~
. >* tie UNITED STmTES /,e j f [9,,
n NUCLEAR REGULATORY cOMMisslON 4
nEciou m
- j .... ou _ .o.o '
o M) i cu~ ruv~ n.u~ois um -
7
~
..... DEC 0 51986 i w '
MEMORANDUM FOR: Richard E. Cunningham, Director, Division of Fuel Cycle and Material Safety, NMSS FROM: Jack A. Hind. Director, Division of Radiation Safety and Safeguards, Region III l
SUBJECT:
REQUEST FOR C0 MENT AND CONCURRENCE ON ADVANCE NOTICE OF PROPOSED RULEMAKING: " RADIATION THERAPY QUALITY ASSURANCE I AND PENALTIES FOR NEGLIGENCE" This is in response to your November 24, 1986 memorandum to Mr. James Keppler requesting coments and concurrence on the subject advance notice. We concur '
with the approach of publishing an advanced notice on quality assurance, :
however, we have several suggestions we would like to have incorporated. They I are presented in the enclosure.
We feel that Immediate Effective Orders should be issued to all licensees authorized for human uses of byproduct material (10 CFR 35) except medical users of the Lixi Scope or Bone Mineral Analyzer. Prompt interim measures will help prevent serious therapeutic or diagnostic misadministration. Some form of interim regulatory action is clearly warranted now rather than waiting one or possibly two years for a QA/QC regulation. The Orders should require, as a minimum, the following:
- 1. All prescriptions for nuclear medicine procedures (therapeutic and diagnostic) should be in written form.
- 2. All written diagnostic and radiopharmaceutical therapy prescriptions should be reviewed for accuracy by a nuclear medicine physician 4 (authorized user) and verified by the technologist prior to administration of doses to patients.
]
- 3. Before beginnir.g the first treatment of any teletherapy procedure or implantation of brachytherapy sources, the prescribed dose calculation '
should be independently perfonned by two qualified individuals and the results compared to ensure accuracy. Further, prior to the first
- teletherapy treatment, the technologist will verify, by patient chart )
review, that exposures parameters were based on two independent t calculations.
- 4. Any of the above requirements may be relaxed i( the attending or referring physician (s) deem the therapy or diagnostic procedure to be a medical emergency requiring imediate medical attention.
Vol 41 I' 03 D !
8709100429 870904 PDR FOIA POTTER 87-403 PDR L.
i
- 8 Richard E. Cunningham 2 DEC 0 51986 -
. 5. Records should be maintained for all of the above activities.
Regarding " penalizing licensees for their negligence or that or their employees,- agent or practitioners," we believe this is inconsistent with any current enforcement practices. The word " negligence" itself will only create.
unneeded controversy and likely distract the agency effort to achieve its main goal which is to improve the quality assurance of radiation-therapy. We reconnend that section be modified to indicate that appropriate enforcement action will be considered by the NRC if.the licensee fails to adequately implement its QA/QC program. We h ve further comments on this issue in the enclosure.
If you have any questions or require clarification on any of our comments or suggestions, please contact Bruce S. Mallett of my staff at FTS 388-5742.
Mac A. H , i Division of Radiation Safety and Safeguards
Enclosure:
Comments - Advanced Notice of Proposed Rulemaking cc w/ enclosure:
W. C. Parler, OGC E. Beckford, RES P. G. Norry, ADM G. W. Kerr, OSP J. M. Taylor, DIE Regional Administrators i
l
~
, Enclosure
- ...e
- i Comments
- 1. We recommend that the method of addressing the Commissioner's request for a rule to penalize negligence, as suggested in page 3 of the proposed memorandum from Mr. Stello and in Enclosure 1, be changed. As suggested by the questions in page 6 of Enclosure 1, the term, negligence, is too ambiguous and controversial to use as a basis for penalties. In addition, no other NRC enforcement is based on this, but on procedures or performance. We recommend the NRC propose the procedures necessary to ensure accuracy in delivering a therapeutic dose as a basis for enforcement and penalties. Negligence due to careless disregard can be dealt with by enforcement related to these procedures. For example, recent therapeutic misadministration in Region III were caused by human error due to improper calculation of dose to be delivered. If the licensee, in each case, would have been required to independently double verify dose calculations, enforcement' action would have been taken for not following this procedure.
- 2. The Summary section in page 1 of Enclosure I would be less confusing if the fourth sentence concerning radiopharmaceutical therapy is moved to the end ofcomment.
public the section
. . and
." modified to say "In addition, the NRC is requesting
- 3. Question 4, page 5 of Enclosure 1 should be modified since there are Quality Assurance Programs available and the NRC is aware of some of these (e.g., AAPM Report No. 13, May 1984 entitled " Physical Aspects of Quality Assurance in Radiation Therapy," ACR,1982 manual entitled " Quality !
Assurance in Radiation Therapy a Manuoi for Technologists"), i
- 4. The emphasis of the section on Quality Assurance in Enclosure 1 should be changed to indicate the NRC is eliciting public comments on the topics that should be included in a quality assurance program. The proposed ,
j enclosure appears to emphasize instead whether we need a quality assurance program.
b I
t
,