ML20202D965
| ML20202D965 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1978 |
| From: | Kelley J NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Bradford, Gilinsky V, Hendrie J, Kennedy, The Chairman NRC COMMISSION (OCM) |
| References | |
| SECY-78-244-C, NUDOCS 9902020191 | |
| Download: ML20202D965 (2) | |
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NUCLEAR RE U T RY COMMISSION 2
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.s June 16, 1978 I'.EMORANDUM FOR:
Chairman Hendrie Commissioner Gilinsky Commissioner Kennedy Commissioner Bradford FROM:
Db vames L. Kelley, Acting General Counsel
SUBJECT:
SECY-78-244 - AMENDMENTS TO PART 35 TO REQUIRE REPORTING OF MISADMINISTRATION OF BYPRODUCT MATERIAL Sy memorandum of May 12, 1978, this office raised several questions about the OELD proposal to require reporting of misadministrations to the patient.
Having given this issue more thought and in light of Howard Shapar's memorandum of June 1, we are now persuaded that notification of patients who have received misadministrations is sound as a general principle, except where the referring physician obj ects.
However, we want to suggest a few refinements on the pro-posed rules.
(1)
The rule as written would require notification of the patient if the referring physician could not be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
In practice, it will be difficult to reach all doctors in so short a time, and the result is likely to be the notification of some patients who probably should not be informed of the misadministration -- for example, those patients likely to respond to the information by abandoning medical therapy altogether.
We therefore sug-gest substitution of the " reasonable time" formula in the rule, backed up by an easily changeable regulatory guide with specific time frames.
(2)
We believe that the rule should be drafted so as to encourage the referring physician to focus on the particular patient and exercise his judgment about likely harm to that patient before any notification takes place.
That is, the doctor should be required to do more than check the
" objection" or "no objection" box on a form.
Under this
Contact:
Peter G.
Crane 634-1398 9902020191 780616 PDR SECY 78-244 C PDR
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.1 The Commission 2
approach, the patient would be notified of the misadminis-tration only if the physician is willing to sign his name to an affirmative statement that in his medical judgment it would be harmful to the patient to receive the information.
While some doctors may come to sign such statements per-functorily, it may cause some to reflect first.
(3)
The present rule would have the licensee notify the referring. physician and the patient.
We believe considera-tion should be given to having NRC perform the notification function, in order to assure that the notifications take place.
If notification is made the responsibility of the licensee (a busy hospital staff with too many forms to fill out already), NRC should at least follow up in each case.
(4).
As presently written, the rule seems to provide that although the referring physician can veto the telephonic notification of the patient, the written report would be sent to the patient in every case.
The rule should be clarified to make explicit that the written report will not be sent to patients when the referring physician has certi-fled that receipt of the information would be harmful.
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