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i 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
SUBJECT:
REQUEST FOR CONCURRENCE ON COMMISSION PAPER: QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE In response to your December 24, 1986 memorandum to Mr. James G. Keppler, we concur with the subject Commission Paper. We strongly support publishing the rule in Enclosure 2 as soon as possible and no later than the proposed schedule of September 1987. However, we still prefer an immediate effective Order be issued to all medical licensees pursuant to our December 5, 1986 memorandum to.
you.
We have enclosed comments on the responses proposed in Enclosure 3, which should aid in your response to the Commissioners' memorandum.
QpkYY (dack A. Hind, Director Division of Radiation Safety {
and Safeguards j l
Enclosure:
As stated i cc w/ enclosure:
W. C. Parler, 0GC E. Beckjord, RES P. G. Norry, ADM G. W. Kerr, OSP J. M. Taylor, IE C. J. Heltemes,Jr., AE00 l Regional Administrators l l
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b712O20101 871201 PDR PR 35S2FR36942 PDR
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Enclosure l
Comments on Elements Proposed by the Commission
'in its December 16, 1986 Memorandum to Mr. Stello
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- 1. Should remove the phrase, "each three years, but rarely fully achieved" i and replace with "each three years" in the last sentence of tha e ~:rd !
- paragraph on page 3 of Enclosure 3 to H cubject Lommission Paper. The ;
V- inspections are normally performed every 3 years. ,
- 2. Element-Question 1: 1 7 We have no comments regarding this issue. The proposed response appears 5
adequate. l i
- 3. Element / Question 2- !
l The change needed in the inspection program is not more frequent ;
inspections for all medical programs. In some cases,.it would be better
/ to restructure the tranual chapter / inspection module to emphasize the ,
V quality assurance area. We do suggest increasing inspection frequencies !
for some programs. These and other suggestions are in the attached l December 31, 1986 memorandum to Mr. Glen Sjoblom. l I
- 4. Element / Question 3: l It appears that the level of training and expertise of technologists and l (j dosimetrists is lacking in the basic areas of good health physics practices and knowledge.- Currently, this group is usually licensed or l
l registered by the State and, as such, the NRC has required little j training, experience or qualifications except that required by 10 CFR Part l y>\o 19. l s i Region III has noted over the years that several escalated enforcement l I actions were caused by nuclear medicine technologists not fully under-i j\/
E g,j 9)J standing basic health physics practices such as adequate surveys, l
k'M radiation safety hazards associated with radiofodine, radioactive material .;
uk l inventories, understanding 00T requirements, proper assay techniques for !
diagnostic and therapeutic quantities of nuclear materials, and proper ;
handling techniques for Group VI sources, j
- 5. Element / Question 4:
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[ This should be addressed by OGC. );
- 6. Element / Question 5: l In essence, the current reporting requirements'of 10 CFR 35.42 require l
} that a misadministration involving any therapy procedure be reported to the referring physician and the patient. If the referring physician so
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- chooses not to inform the patient, he or she may do so if, in their The NRC should
/ f n)(medical not further judgement, tellingbetween intuject itself the patient the could doctorbe harmful.
/ patient relationship. The
,f NRC should rely upon the doctor to accurately explain the significance or !
non-significance of each therapy misadministration to the patient. If the i patient or referring physician asks for the NRC view of the ;
misadministration, then the NRC can have it independently evaluated by our medical consultant. <
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Enclosure 1
- 7. Element / Question 6:
(
1his is clearly not the role of the NRC. However, it is the responsibility of the physicians. The NRC is not qualif ted to practice O medicine. What will the NRC do with such information? Who will evaluate this information to determine if " proper" followup patient care is being carried out or considered? The NRC should concern itself with preventing misadministations and not utilizing limited resources to determine the patients affects from misadministration.
- 8. Element / Question 7:
There is merit to this issue, and it can be easily implemented by making
/ it a requirement pursuant to our IE MC 2800. We feel it would be appro-priate to develop a separate manual chapter inspection procedure entitled
" Followup on Misadministration." The procedure can require the inspector to verify that referring physicians and/or patients have been properly notified. The procedure can also provide in depth guidance to the 4 inspector to review the circumstances surrounding the incident and corrective measures taken to prevent recurrence, etc.
- 9. Element / Question 8:
'; We have no comments regarding this issue. We feel adequate mechanisms already exist to inform the medical community of medical misadministration.
- 10. Element / Question 9:
Need to also state that the Proposed Rule in Enclosure 2 lists the
, improvements the staff deems could substantially improve quality and minimize human error,
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8 [o,, UNITED STATES
!, o NUCLEAR REGULATORY COMMISSION
$ ;$ WASHINGTON, D. C. 20555
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. MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fue'l Cycle and Material Safety Office of Nuclear Material Safety and Safeguards FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
DRAFT COMMISSION PAPER: QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE As requested by your December 24, 1986 memorandum, we have reviewed the Commission Paper entitled, " Misadministration of Radiation Therapy," and concur in its issuance.
Minor editorial suggestions are indicated in the enclosed copy of the paper; these suggestions were telephoned directly to Mr. McElroy in accordance I with your request.
p a k s) . A ,
Eric S. Beckjord, irector Office of Nuclear egulatory Research
Enclosure:
CP Subj.: Misadmi'.:istration of Radiation Therapy l
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