ML20202D928
| ML20202D928 | |
| Person / Time | |
|---|---|
| Issue date: | 06/01/1978 |
| From: | Shapar H NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD) |
| To: | Bradford P, Gilinsky V, Hendrie J, Kennedy J, The Chairman NRC COMMISSION (OCM) |
| References | |
| SECY-78-244-C, NUDOCS 9902020174 | |
| Download: ML20202D928 (3) | |
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uNITEO STATES NUCLEAR REGULATORY COMM!5SN.4
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MEMORAN00M FOR:
Chai rman 'iendrie Commissioner Gi' a xy Commissioner.annedy Commissioner Bradford-FR0ft:
lioward X.' Shapar Executive Legal Director &,
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Lee V. Gossick-Executive Director for Operations i
SUBJECT:
OGC MEMORANDI.'M OF M.AY 12, 1978, ON SECY-78-244, MISA0 MINISTRATION REPORTING REnllIREMENT In a memorandum dated May 12, 1978, OGC raises several issues regarding SECY-7A-244.
For the most part, OGC raises policy issues, not legal objections to -the OELD, ONMSS, OSO and OSP unanimous staff proposal.
In a memorandum, dated May 11, 1978, OPE also raises several policy issues with regard to the paper.
Insofar as the legal issues are concerned, it is clear that a patient has a right to infornation incident to medical diagnosis and treatment.
See Tootnote 1 in the Attachment to this memorandum.
Moreover, disclosure to a responsible relative is not forbidden in the circumstances envisioned by the rule.
See f actnote 2 in the Attachment.
Furthermore, there are no cases forbidding a Federal agency from imposing by regulation within its statutory authority an affirmative obligation such as that of the licensee to infom the patient of a misadministration.
See footnote 3 in the Attachment.
In fact, aside from referring physicians, medical institutions and'their personnel also have responsibilities to their patients.
See footnote 4 in the attachment.
All the cases and articles cited in the Attachment are readily available.
OGC raises an issue as to why ?!RC should carve out an exception for mis-administrations involving radioactivity from what may or may not be a prevalent standard for misadministrations generally, This is a problem inherent in nuclear regulation and, in fact, in the regulation by every Federal agency.of any particular activity involving public health.
There is no way the problem can be' avoided, short of creating some " super" Federal' public health agency with comprehensive authority over all health NRC should do what 'it believes makes good policy sense in the care.
limited area in which it exercises authority.
Con tact:
T. Oorian
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NRC would not be unique a-ceral agencies in requiring persons under L
its regulatory contro1
. <ed in Mblic health matters to notify j
affected persons of pu1ble hazarcs.
For example, FDA requires manufac-turers of prode:M such as diagnostic and cabinet x-ray systems and radio-I graphic anc' CJoroscopic equipment to notify purchasers upon discovery o f a de ' e or failure to comply with applicable Federal standards.
See footr. 5 in the-Attachment.
OSHA requires employees to be notified b) th^ir employers directly or through the National Institute for Occupational Safety and Health of potentially toxic effects 'of substances at the place of employment.
See footnote 6 in the Attachment.
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Finally, the underlying premise of OPE's comment is that the proposed rule somehow " intrudes into the physician-patient relationship." OGC seems to subscribe to this premise irt its memorandum.
We disagree.
We do agree with the Commission's proposed medical policy statement that actions that would have the effect of restricting the physician's choice of the type of care to provide to the patient should be minimized.
The objective of this policy is to protect the patient--not to protect the physician. The proposed rule would in no way interfere with the delivery of care to the patient or' result in harm to the patient.
Under the pro-posed rule, the. physician has the absolu'te right, free of any hRC "second guessing", to veto a licensee proposal to inform the patient if this would be harmful to the patient.
There is no reason at this juncture to suppose that the physician will breach his duty to act in the best interest of the patient and inform the patient when this would be harmful to him.
OGC's allegation that the rule would encourage physicians to tell their patients about misadministrations even when this would be harmful to them is sheer speculation.
Thus, there is no unwarranted " intrusion" into the physician-patien t relationship.
The questions here are not legal ones.
The basic question, as we see it, is simple:
How far as a matter of policy should flRC go in assuring that persons affected by NRC licensed activities (here, the patients) are notified when the licensed activities harm them? We submit that this proposed rule is entirely proper and should be published for comment.
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Howard K. Shapar Executive Legal Director
Enclosure:
Footno tes a.
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FOOTNOTES t
./ Holland v. Sisters of Saint Josech of 3eace, 522 P.2d 208 -(Ore.1974);
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Can terbury v. Soence,15
- F.2d -772 (P.C. Ci r.1972 ), cert. denied, 409 U.S.1064 (1972); and see Gotkin v. 'iiller, 514 F.2d 125 (2d Cir.
1975); Karo v. Coolev, 493 F.2d 408 (5th Cir.1974), cert. denied, oso., 382 F.2d 163 (D.C.
419 U.S. Sc5 (1974); Alden v. Providence u
Cir.1967); Niblack v. United States, 438 F. Supp. 383 (D.C. Col.1977);
Harridan v. United States, 408 F. Supo.177 (0.C. Pa.1976); Pearam v.
Sisco, 406 F. Supp. 776 -(0.C. Ark.1976), aff'd, 547 F.2d 1172 (1976);
Betesh v. United States, 400 F. Supp. 238 (D.C.O.C.1974); Ciccarone v.
' United States, 350 F. Supp. 554 '(0.C. Pa.1972), aff' d, 486 F.2d 253 (1973); Cannell v. Medical and Surcical Clinic, S.C., 21 Ill. App. 3rd 383, 315 N.E. 2d 278 (1974),- and Hendrickson v. Hodkin, 276 N.Y. 252, 11 N.E. 2d 899 (1939).
2/ See Emmitt v. Eastern Discensary and Cas. Hoso., 396 F.2d 931 (D.C. Cir.
1967); Garfield t'emorial Hoso. v. starshall, 204 F.2d 721 (D.C. Cir.1953);
and Clark V. Geraci, 208 N.Y.S. 2d 564, 29 Misc. 2d 791 (1960).
_3/ See, e.g., Betesh v. United States, supra, concerning the Veterans Administration..
4_/ For the responsibility of a hospital to a patient (as in the instance of a licensee under the rule), see United States v. Brown, 348 U.S.110 (1953); Hohenthal v.' Smith,114 F.2d 494 (0.C. Cir.1940); Sine v i
Thunig, 2 N.Y. 2d 656,163 '!._Y.S.
2d 3 (1957); and Sheehan v. N. Country Hoso., 273 N.Y.163, 7 N.E. 2d 28 (1937); and see Note, The Hosoital and the Staff Physician-- An Excandino Outy of Care, 7-CREIGHTON L. REV. 249 (1974); Note, The Hospital-Fnysician Relationship: Hosoital Resoonsibilicy for Maloractice _of Physicians, 50 WASH. L. REV. 385 (1975); Note, in fo rma c Consent and the ?atient's Richt to "No":
Cobbs v. Grant, 6 LOYOLA U.
uosoital to of L. A. L. REV. 384 (1973); Leonard, Indeoendent Duty of a Prevent Physicians' Maloractice,15 ARIZ. L. REV. 953 (1973); and South-wick, The Hosoital as an Institution--Exoandino Resconsibilities Chance Its Relationship with the Staf f Physician._, 9 CALIF. WEST. L. REV. 429 (1973).
5] 21 CFR 551002.61(c)(2),1003.10,1003.21,1020.30,1020.31,1020.32 and 1020.40.
6/ 42 CFR 55 85.1-85.12.
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