ML20202F244
| ML20202F244 | |
| Person / Time | |
|---|---|
| Issue date: | 05/05/1978 |
| From: | Shapar H NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD) |
| To: | |
| References | |
| SECY-78-244, SECY-78-244-R, NUDOCS 9902030372 | |
| Download: ML20202F244 (14) | |
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4 May 5.1978 UNITED STATES NUCLEAR REGULATORY COMMISSION SFr"-P "A CONSENT CALENDAP " s For: The Commissioners Howard K. Shapar From:_
Executive Lega' .. rector Thru: Lee V. Gossick Executive Director for Operations
Subject:
DELD's RECOMMENDATION ON PROPOSED AMENDMENTS CFR PART 35 TO REQUIRE REPORTING OF MISADMINIST TIONS OF BYPRODUCT MATERIAL
Purpose:
' Response to the Commission's directive of March 6,1978, to elaborate on ELD's recommendation about informing the patient of misadministrations.
Issue:
Should NRC require the licensee to report directly to the patient, in addition tu reporting to the referring physician, those misadministrations that he is required to report to NRC?
Discussion:
On March 2, 1978, the staff briefed the Commission on i current medical licensing practice, the attendant l proposed medical policy statement, and two proposed '
rules consistent with that proposed policy.
l The Commission approved for publication in the Federal Register the proposed medical policy statement (SECY ;
- 68) and a proposed rule deleting diagnostic clinical These j
. procedures from NRC licensing groups (SECY-78-69).
17,1978, for 60 days proposals were published on MarchThe Commission reque ,
public comment. l proposed misadministration reporting requirement (SECY-7 '
- 70) be returned to the sttff for an elaboration of the legal and administrative aspects of an ELD recommendation that the licensee be required to report directly to the patient those misadministrations reportable to NRC. )
As requested by the Commission, Enclosure 1 is the Federal Register notice in SECY-78-70, changed to reflect ELD's recommendation on how the patient should be informed
Contact:
T.F. Dorian 492-7437 l
l 9902030372 780505 l PDR SECY 78-244 R PDR
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l 2-of misadministrations. The essence of the rule is that when a misadministration involves either a diagnostic procedure that could cause a clinically detectable adverse effect or a therapy procedure, the licensee shall L
notify the accrooriate NRC Regional Office, the patient's ;
l referring physician, and the patient or the patiert's !
responsible relative, unless the referring physician ;
informs the licensee that in his medical judgment '
telling the patient or the patient's responsible
' relative would be harmful to one or the other, '
respectively.
Basically SECY-78-70 discussed two issues: (1)Whether the NRC should require licensee reports of misadminis- i trations; and (2) Whether the NRC should require the licensee to inform the patient, the referring physician, or both the referring physician and the patient. t All of the staff agreed that NRC should require licensees .
to maintain records of all misadministrations and report I l
to NRC only potentially dangerous misadministrations (which were defined as all therapy misadministrations and those diagnostic misadministrations causing a clinically detectable ~ adverse effect on the patient). [a
! All of'the staff also agreed that, as a minimum, NRC should require the licensee to tell the patient's referring physician of misadministrations reportable to NRC. As noted in SECY-78-70:
"The vast majority of medical procedures using !
radioactive material are performed or, a referral i basis. The NRC [ Staff] proposal, to notify the patient's referring physician, is consistent with contemporary medical practice."
As also noted in SECY-78-70, "The majority of the regula-tory staff also believe that the patient does have the j
- right .to be informed about his condition."
All of the staff agreed in SECY-78-70 that as part of I
current medical practice "usually, the referring physician decides whether to inform the patient of misadministrations or other events that may adversely affect the patient's I health."
i The staff differed about who should inform the patient (the discussion of the pro's and con's of the alterna-tive means for informing the patient are detailed in l
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SECY-78-70). NMSS, IE, and SD recommended that NRC !
require the licensee to inform the referring physician l only. SP recommended that the licensee be required to j infom the patient directly (or a responsible relative). i ELD recommended that NRC require the licensee to inform ;
the referring physician and, unless the referring i physician objects, the patient.
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The staff argued in SECY-78-70 that:
(1) Many physicians would consider it an intrusion into the physician-patient relationship for l NRC to require the licensee to report not only to the referring physician, but also to.the patient--even if the requirement were so worded as to allow the referring physician to object to the licensee informing the patient directly; and (2) "A reasonable expectation is that the referring physician will inform the patient, unless he believes that the patient will be harmed by the infomation."
The physician-patient relationship is built not only on custom but also on law. While the physician is charged to keep confidential most matters related to him by his patient, this duty is not_ absolute. For example, under current law, a physician's duty to make full disclosure to the government about a patient's health may supersede his duty to.the patient to keep the matter confidential. Thus, as a general matter, nothing in present law would preclude a licensee's physician _ (the licensee typically would be a hospital) from directly notifying a patient of a misadministration.
Medical customs and the laws and policies driving them have '
been changing-from a patient's point of view. Today, many State courts and legislatures would argue that a patient '
is entitled to infomation concerning his medical records and the condition of his health, especially when that ;
information is held by someone other than his personal physician. Several State courts in fact have held that a medical facility has to provide medical infomation about a patient to him upon his reouest. ELD's aporoach would be more consistent with this trend than the acproach
[ originally favored by tiMSS, IE, and SD.
Also, today a licensee's, physician may be in a better posi-tion than a referring physician to describe to the patient the possible effects of a misadministration. On the otF hand, the referring physician might wish to divorce himself from a misadministration. Thus, the referring physician might not object to the licensee informing a patient directly, and, in fact, might welcome the sugges-tion. Moreover, a licensee's physician might not object to directly informing the patient, for he might be able to provide a clearer and better explanation than would the referring physician. perhaps for these and other such reasons several physicians and representatives of medical groups informally polled by NMSS after the March 2 public Commission meeting endorsed ELD's suggestion.
NRC can control whether a licensee tells a patient of a misadministration and what he tells him; it cannot directly control the actions or inactions of a rcierring physician who is not a licensee. Thus, while the staff may be correct that "a reasonable expectation is that the referring physician will infonn the patient unless he believes that the patient will be harmed," under the original IE, NMSS and SD proposal, NRC would have no authority or means to insure that this expectation is, in fact, realized.
From the NRC's viewpoint then, it appears that there is no impediment in the so-called physician-patient relationship for the licensee to tell the patient of a misadministration reportable to NRC. Rather, there are sound administrative and policy reasons for imposing such a requirement.
ELD's approach also reflects the concern that, in some circumstances, the licensee should not or could not inform the patient, but would have to turn to the patient's responsible relative. These circumstances could include, for example, the patient's referring physician telling the licensee that in his medical judgment informing the patient would be harmful to the oatient; the patient being a minor; or the patient being unconscious and not being able to comprehend the information. The rule reflects the view that the circumstances where the relative should be notified as coposed to the patient cannot be orecisely specified in the rule. Therefore, the rule leaves it to the licensee to decide whether to inform the patient or
! the patient's responsible relative, with the proviso that the referring physician could veto by informing l
the licensee that in his medical judgment telling the patient or the patient's responsible relative would be harmful _ to one or the other, respectively.
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I ELD's approach should not give rise ' _.iy enforcement problems for NRC. The licensee'- ..ords of misadministra-tions would indicate whether . patient or relative has been ' informed. l'oreover, Nre should be no problems in contacting the patient's relative, where necessary. In virtually all instances, when a patient enters a medical :
facility he must fill out a form (it is invariably a i contract) which has a space marked " nearest relative" to indicate whom the facility should contact in case of an ,
emergency or unforeseen eventuality. Where the patient j is an outpatient and has not filled out such a form, the i
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licensee could discover the patient's responsible rela- l tive from the referring physician, whom the licensee would have to contact in any event.
Therefore, it seems reasonable to require the licensee to tell the patient or the patient's responsible relative.
Recommendation: That the Commission accept OELD's recommendation on' the !
proposed amendments of 10 CFR Part 35 to require reporting i of misadministrations of byproduct material. !
Coordination: The Offices of Inspection and Enforcement, Nuclear i Material Safety and Safeguards, Standards nevelop-ment and State Programs concur.
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/Howard K. Shapar
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' Executive Legal Director i
Enclosure:
Proposed Federal l
. Register Notice '
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6- I Commissioners' comments or consent should be provided directly to the Office of the Secretary by close of business Thursday, May 18, 1978. :
I Commission Staff Office comments, if any, should be submitted to the Commissioners NLT May 12, 1978, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional time for analytical review and comment, the Conmissioners and the Secretariat should be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of May 22, 1978. Please refer to the _ appropriate Weekly Commission Schedule, when published, for a specific date and time. l A
l DISTRIBUTION Commissioners Commission Staff Offices
! Exec Dir for Operations Secretariat q l
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NUCLEAR REGULATORY COMMISSION
[10 CFR Part 35]
HUMAN USES OF BYPRODUCT MATERIAL Misadministration Reporting Requirements AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission is considering amending its regulations to require licensees to (1) keep records of all misadministra-tions of radioactive material or radiation from radioactive material, and (2) promptly report potentially dangerous misadministrations to the ,
to the patient's referring physician and to the patient or the patient's responsible relative.
DATES: Comment period expires .
ADDRESSES: Written comnents or suggestions for consideration in connection with the proposed amendment should be submitted to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch. Copies of comments received may be examined at the Commission's Public Document Roem at 1717 H Street, N.W., Washington, D.C.
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- Insert cate 60 days f rom publication in FEDERAL REGISTER.
Enclosure 1
i FOR FURTHER INFORMATION CONTACT: Edward Podolak, Office of Standards Development, U.S. Nuclear Regulatory Commission, 'dashington, D.C. 20555 (Phone: 301-443-6910).
SUPPLEMENTARY INFORMATION: Following its organization under the Energy Reorganization Act of 1974 (Public Law 93-438), NRC, with a view to possible changes, began reviewing its regulations and procedures about licensing and regulation of nuclear facilities and materials originally promulgated by the Atomic Energy Commission (AEC).
On March 9,1973, the AEC published a proposed rule in the FEDERAL REGISTER (38 FR 6399) that would have required licensees to report to the AEC and to the patient all misadministrations of byproduct material and also would have required licensees to determine that paramedical (allied health) personnel were adequately trained in the safe use of radioactive materials. Because 5 years have elapsed since the AEC requirement was l proposed, it is being withdrawn and a new NRC proposed misadministration recordkeeping and reporting requirement,10 CFR 5 35.33, is being offered for public comment. The NRC proposed rule reflects the public comments on the AEC proposal.
' One purpose of the misadministration reporting requirement is to allow NRC to investigate the incident; determine if there was a violation of NRC regulations; evaluate the corrective action taken by the licensee to minimize the citance of recurrence; and, if there is a cossibility of other Enclosure 1
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L., l l i licensees making the same error, to allow MC to begin generic correr" action which, as a minimun, would inform other licensees of & ;~cential j problem. Another purpose is to inform the' patient or " patient's I l
responsible relative'so that corrective action can ce taken.
Specifically, flRC's proposed 5 35.33 would require licensees to maintain for inspection by the Cor. mission, records of all misadministrations of .
radiopharmaceuticals or radiation from teletherapy and brachytherapy i
sources. Licensees would also be reouired to report promptly all misadministrations that involve a theracy procedure and those disgnostic misadministrations that could cause a clinically detectable adverse effect on the patient: (1) to the fiRC, (2) to the patient's referring physician, and (3) to the patient or the patient's responsible relative, unless the referring physician informs the licensee that in his medical judgment telling the patient or the patient's responsible relative would be harmful to one or the other, respectively.
It is expected that the licensee would report. to the patient's responsible relative rather than the patient when, for exwele,the referring physi-cian tells the licensee that in his medical judgment informing the patient would be harmful to the patient; the patient is a minor; or the patient i
is unconscious and incapable of comprehending the information. The licensee would have the discretion of reporting either to the patient or i
' to the patient's responsible relative. The record or report which would l
be- supplied t0 MC would contain a brief descriction of the event, the l The effect on the patient, and the action taken to prevent recurrence.
I nares of individuals would be maintained in the licensee's record but rot !
e reported to the MC. . A cooy of the recort to ?;".C would be furnished by !
-li.censee to' the catient or the patient's resconsible relative.
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l An exar:ple of the follow-uo action NRC H take upon receict of a l misadministration report was the investigation of an incident where 400 patients treated for c= .er with a cobalt-60 teletherapy unit received radiation doses that exceeded the prescribed doses by as much as 41 percent. This incident occurred because the radiation dose rate i from the teletherapy unit had not been properly determined. Soon after ,
its investigation, NRC acted to ensure that all teletherapy units licensed by it were properly calibrated. URC also published in the FEDERAL REGISTER (42 FR 25743) a proposed amendment to 5 35.13 requiring tele- !
therapy licensees routinely to calibrate and check their teletherapy devices. The teletherapy calibration proposal also included a specific l misadministration reporting requirement that would be replaced by 5 35.33 (a more general proposal). Comments received in response to the earlier teletherapy misadministration reporting requirement will be considered in conjunction with the proposed rulemaking.
In this newly proposed rule, 5 35.33(e) (4) and (5) define misadministra-tions in part as administrations differing from the total prescribed dose or exposure by more than 10% for thercpeutic procedures or 20% for diagnostic procedures. These limits should not be viewed as the normal ,
calibration limits for these procedures but rather the points where ,
an error obviously has occurred. The narrower tolerance for the i therapeutic procedures recognizes the greater risk to the patient from
- therapeutic misadministrations.
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorga-nization Act of 1974, as amended, and Sections 552 and 553 of Title 5 of the' United States Code, notice is hereby given that the 1973 AEC proposed
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. 1 rule (~ .t 6399) is withdrawn and adoption of the following new acend-
..ts to 10 CFR Part 35 is contemplated.
l A new 135.33 is added to 10 CFR Part 35 to read as follows:
5 -35.33 Records 'and r corts of misadministrations. 1 (a) When a misadministration involves either a diagnostic procedure .
that could cause a clinically detectable adverse effect or a therapy procedure,within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee's discovery that the i
misadministration is likely to have occurred, the licensee shall notify 1
by telephone:
(1) The appropriate lip.C- Regional Office listed in Appendix D of Part 20 of this cf. apter: )
(2) The patient's referring physician; and (3) The patient or the patient's responsible relative, unless
.the referring physician informs the licensee that in his medical judgment _ telling the patient or the patient's responsible relative would be harmful to one or the other, respectively.
(b) If the referring physician, or the patient's responsible relative,
' is unavailable within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licenset shall' make the notification under paragraphs (a)(2) or (a)(3) of this section as soon as practicable after that person becomes available. Attempts to notify the referring physician or the patient's responsible relative shall not defer needed medical care for the patient.
'(c) Within 15 days after the licensee's discovery that the nis-admir.istration is likely to have occurred, the licensee shall cake a
>:ritten re:crt to the NIC Regional Office initially- teleorcned, and fur '."
alcopy of the reDort' to the patient or the patient's responsible relative.
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I (d) The written report rade under paragraph (c) of this section shall include the licensee's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; ,
1 and whether the licensee informed the patient or the patient's respon-l
.sible relative, and if not, why not. However, the report should not include the names of others involved in the misadministration, such as .
the patient, physicians, and allied health personnel.
(e) Each licensee shall maintain for 5 years for Commission inspection records of all misadministrations of radiopharmaceuticals I or radiation from teletherapy or bra hytherapy sources. These records l
shall contain the names of everyone involved in the event (including the licensee, the authorized user (s), allied health cersonnel, the patient's referring physician, the patient, and, where approoriate, ;
1 the patient's responsible relative); a brief description of the event; l
the effect on the patient; and the action taken to prevent recurre'nce.
(f)'For this section, misadministration means the administration i
of:
1 (1) A radiopharmaceutical or radiation from a source other than the'one intended; i (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administra- l 1
tion other than that intended by the prescribing physician; (4) A diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 20T,; or ;
4-Enclosure 1 L
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(5) A therapeutic dose of a radiocharraceutical or ex:osure from a radiation source such that the total treatnent dose e exposure differs fron the crescribed dose or exoosure by -ore l i
i than 105.
l (g) Aside fron the notification reouirerent, nothing in this , l section shall effect any rights or duties of licensees and ohysicians )
in relation to each other, oatients or responsible relatives.
(Secs. 81,161 Pub. Law 83-703, 68 Stat. 935, 948 (42 (U.S.C. 2111, 2201):
Sec. 201, Pub. Law 93-439, *S Stat.12a2 (a2 U.S.C. 5841))
Dated at this day of , 1977.
F09 THE ?!UCLEAR PEGULATORY C0f'i'ISSIO1 Sanuel J. Chilk Secretary of the Commission l
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WASHINGTON, D. C. 20555 h
%, % o May 11, 1978-MEMORANDUM FOR: Chairman llendrie Commissioner Gilinsky Commissioner Kennedy
-C 'iys er Bradfo FROM: PIde M "
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SUBJECT:
OELD RECOMMENDATION ON PROPOSED AMENDMENTS TO 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMINISTRATION OF BYPRODUCT MATERIAL (SECY-78-244)
I support the proposed regulation requiring licensees to keep records of all misadminintrations and to report to NRC all potentially dangerous misadministrations, as such reports will be helpful to the.NRC in preventing similar incidents in the future. I question, however, the proposal that NRC should require licensees to report to referring physicians and report to patients those misadministrations reportable to the NRC: ,
-- A regulation requiring reports to referring physicians seems'un-necessary because it is already current medical practice to inform referring physicians of events having potentially adverse health effects on their patients. There is no indication that licensees are not voluntarily complying with such practice.
-- A regulation requiring reports ' to patients (or next-of-kin) seems excessive because it would intrude into the physician-patient relationship without adequate justification in terms of the radiation safety.of patients.- Such intrusion is not lessened (and may be increased) by the escape clause provided, namely on the basis of a statement by the referrinz ahrsicians that in their medical judg nent such udica:Lun will harm those informed.
Thus, the proposed regulation, as presently written, seems not in harmony with NRC's proposed medical policy,to minimize intrusion into areas considered to be part of the physician-patient relationship, except where voluntary standards.are inadequate or not followed or where justified by risk to the patient. On this basis, you may wish to consider revising the proposed amendment to 10 CFR Part 35 to delete the notification requirements to referring physicians and patients or next-of-kin.
l i-cc:- James Kelley ~.
Sam Chilk
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CONTACT:
Pat Comella-(OPE) '-
634-1541 .
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UNITED STATES NUCLEAR PT ATORY COMMISSION #
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...../ May 12, 1978 l l
MEMORANDUM FOR: Chairman Hendrie .
Commissioner Gilinsky Commissioner Kennedy Commissioner Bradfo d FROM: Stephen F i
~ Acting Ge ~1D o sel !
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SUBJECT:
SECY-78-244, MISADMINISTRATION REPORTING REQUIREMENT
'The Office of the Executive Legal Director proposes that in the event of a misadministration, licensees would be required to report promptly to NRC, the patient's referring physician, and to the patient or the patient's responsible relative.
OELD bases its proposal on policy considerations and also on what it considers to be changes in medical customs and in applicable law. We would suggest that licensees be required to report misadministrations only to NRC, and to the refer-ring physician. As a follow-up, NRC would also inform refer-ring physicians. .The referring physician would then have the same discretion to provide or withhold information that he possesses with respect to other information about the patient.
Having NRC inform the referring physician could prevent one obvious problem'-- that of the licensee who states that he informed the referring' physician, while the referring physician states he never received the information.
We believe that the OELD proposal to include a report to the patient as well as to the referring physician presents a number of problems :
- 1. In the absence of. citations to cases or statutes, the assertion of changes in applicable lau is difficult to test.
- 2. The paper appears not to distinguish between the
-patient's ' right to obtain information on request CONTACT:
Peter Crane, OGC l 634-1398
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'The. Commission 2 May 12,1978 and the creation of an affirmative obligation on the'part of the licensee to inform the patient, j whether'or not the patient requests information. l
- 3. As OPE points out in its memorandum of May 11, the
' regulation would insert'NRC into the physician-l patient relationship without a demonstrated benefit. 1
.The result of ELD's proposal .would be the creation of'an unprecedented exception.to the general rule that it is the doctor's responsibility to determine what information should be provided to a patient l regarding his condition. As OPE notes, it is not {
enough that there is- an " escape clause", by which o l
the referring physician may act to prevent disclo-
.sure to the patient. Creating the presumption in favor of disclosure would.seem likely to make physi-cians reluctant to take the affirmative action j necessary to prevent notification of the patient.
- 4. The ELD proposal does not explain why a different legal standard should be applied to information about a patient which a doctor receives from an NRC licensee, on the one hand, and from the hos-pital's' pathology laboratory, on the other. (In both cases, the news may be unduly disturbing to some patients ,. While others would wish to be fully informed.) If the proposal stems from a concern ,
that patients? generally receive insufficient l information from their physicians,,this concern l
' would. seem more properly addressed either by the ,
Congress or by HEW.
cc: OPE i ELD l SECY l
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