ML20202F303

Informs That OGC Was Not Made Aware of Staff Concerns or Proposed Course of Action Prior to Publication of SECY-77-194 Re Reconsideration of Misadministration Requirement Specified by Commission as Part of Approval

ML20202F303
Person / Time
Issue date:	04/22/1977
From:	Strauss P NRC OFFICE OF THE GENERAL COUNSEL (OGC)
To:	NRC COMMISSION (OCM)
References
SECY-77-194-C, NUDOCS 9902040014
Download: ML20202F303 (3)

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,> April 22, 1977 l

! MEMORANDUM FOR: The Commissioners >

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FROM: Peter L. Strauss, General Counsel

SUBJECT:

SECY-77-194, REQUESTING RECONSIDERATION I l OF THE MISADMINISTRATION REQUIREMENT 'l SPECIFIED BY THE COMMISSION AS PART OF i THEIR APPROVAL OF SECY-76-574 1 l

Although this paper directly concerns a comment arising in my office, OGC was not made aware of staff's concerns or pro-posed course of action prior to publication of the paper. The course suggested by EDO (alternative 1 with a special request for comment) should be followed.

L The staff's grounds for the requested reconsideration and fur-i ther' delay in promulgating the amendments appear to me unper-l suasive at best. I do not see how even the narrowest conceptica of NRC's regulatory mission can justify the repeated 3y expressed l concern for the " sensitivity" of the medical community without l any expression of concern for the patients who have by hypothesis received doses seriously at variance from the prescribed dose.

l i The adverse comments to the 1973 proposed rule change (Enclosurc l 2 of SECY-77-194) are simply not, applicable to our present pro-posed Part 35 reporting requirement, which does not call for reports to the patient. Further, the notion that the reporting i requirement could be "self-incrimination" in the constitutional sense verges on legal nonsense.

The comments by the ACMUI (Enclosure 3 of SECY-77-194) have  ;

If " referring physicians" is the correct l some relevance. '

phrase, rrther than " authorized physicians," then I cor-i tainly concur in making this change before publishing the i proposed rule. This should not require another 45 days.

Also, the 10 per cent crror criterion and the 24-hour time l limit,are clearly open to some amount of change without i compromising the principle of the reporting requirement.

i llowever, these matters can be adjusted during and following F

9902040014 770422 PDR COMMS MtCC CORRESPONDENCE PDR _ _ , _

Contact:

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E. Leo Slaggie 492-81'25-(

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2 the 45-day public comment period in response to suggestions ,

from the public rather than delaying the publication of the proposed rule as the staff now suggests. The present recom- ,

mendation for further delay is hard to reconcile with the staff's earlier recommendation in SECY-76-574 that because of urgent need for a teletherapy rule the normal public ,

comment period prior to effectiveness should be omitted. I  !

would agree with EDO's comment that the rule be published as '

it now stands with a modified statement of consideration i soliciting comments on the specific reporting requirement issues which trouble the staff and the ACMUI.

The supposed ambiguity and lack of clarity which apparently  ;

bothered the ACMUI would not in practice be of significance in carrying out the purpose of the rule. For example, if  :

measurements indicate that dosage errors of more than 10 per cent have occurred, I see no reason why reporting of this fact should depend on whether a single treatment or a course of 20 or 30 is involved. The point is that the medical ,

significance of this misadministration should be determined by the referring physician. The reporting requirement will at least alert the physician to the need for making a deter-mination and for possibly compensating by adjusting the i remaining treatments. The ACMUI seems to suggest that the teletherapy operator could on his own adjust the remaining  :

treatments to compensate for his earlier errors without consultation with the referring physician. This is somcwhat akin to letting the pharmacist, without telling you or your doctor, adjust the dose in your next prescription to make up for the fact that he previously failed to give you the

. medicine as prescribed.

Whether or not the proposed reporting requirement will in the end survive the searching examination of the Commission's involvement with nuclear medicine that the staff is going to conduct some day or other should not be a factor in a deci-sion to impose it now. Unless misadministrations actually occur, the rule will simply never come into practico. If mis-l administrations do happen, it is unconscionable that they not be reported to the person who is primarily concerned with the patient's welfare -- the referring physician. The  ;

very documents to which this memo responds indicate that thin report should be required by regulation rather than left to the discretion of those whose primary concern is wi th mal-practice suits against the hospital. Unless and until a better rule is proposed or another agency takes over the l

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l responsibility of insuring that some regard will be pair' i l

to the pet.ient's welfare, I think that the considerat.uns favoring our propose:d Part 35 amendments overrida the staff's ,

reasons for still more delay. No one so f ar has suggesteci l that the reporting requirement as we have draf ted it cot:1d cause injury to the patient, while it appears obvious that the continued lack of a reporting requiremeat may have the effect that serious injuries will go without remedy.

cc: Lee V. Gossick, EDO Ben Huberman, OPE Howard K. Shapar, ELD Clifford V. Smith, :ESS SECY (2) T g t

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