ML19254C406
| ML19254C406 | |
| Person / Time | |
|---|---|
| Issue date: | 07/20/1978 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Mondale W SENATE, PRESIDENT OF THE SENATE |
| Shared Package | |
| ML19254C403 | List: |
| References | |
| FRN-42FR10950, RULE-PR-35 NUDOCS 7910160004 | |
| Download: ML19254C406 (3) | |
Text
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/* ""g UNITED states 7I
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NUCLEAR REGULATORY COMMISSION
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- M July 20, 1978 CHAIRMAN 000R 01B M The Honorable Wa'ter Mondale
'The President of the Senate Washingten, D.C.
20510
Dear Mr. President:
As you knew ycu : eceive en a quarterly basis a report en abnormal occurrences involving facilities and activities regulated by the NRC (Report to Congress en Abnormal Cccurrences).
An abncrmal eccurrence is defined in Section 2CS of the Energy Reorganization Act cf 1974 as an unscheduled incident or event which the Ccx.ission de:armines is signifi-cant frca the standpoint of public health or safety.
Criteria for making these determinations were published in the Federal Recister (42 FR 10950) on February 24, 1977, and are also found in eacn of :ne abnormal occurrence reports.
One area which the criteria do net ccver is the medical misadministration because Cennissi:n regulations do not now recuire the reporting cf these misadministrations to the NRC.
By means of this letter I wcuid like to inform ycu of sene of the steps underway to develop a misadministration reporting rule.
Current regulations on medical uses of byproduct material are f:und in Chapter 10 par 35 cf tne C:de of Federal Regulaticns.
As part c# :ne Cc=ission's review of its policy and arc; ram f:r the regulaticn f
medical uses of bypr: duct ca:erial, the C: mission has voted :: Cublisn for public cement a prc::csed rule concernin; the re:Or:ing of misa:ministra-tiens to tne NRC, the referring physician an: ne :atient er a rescensi:le relative.
A c ?y of the Federal Register 30 ice anncuncing :na pr:::se:
rule is enclosed f r your infcrmaticn.
The pr: posed rule wcui: re:uire licensee's :: maintain re:Ords of all misadministrations anc :: re: r: :
the NRC potentially dangerous misadministraticns, cefined as ali thera;y misadministraticns and :nese diagnostic misa6-inis rations wnica nave a e-clinically detec:able acverse effect en the pa:ient.
Re;cr:ing :c :he NRC wculd pe nit investi;stien to :e: ermine whe:ner the ;r::ler.s leacin; to the misadministration have been adecuately ::rre::ed :: minimi:e ne possibility of recurrence ar.d whether :ne prebisms are cf a generi nature warranting notification of tne licensees.
Tce cr : sed re;ula: :n would aisc recuire that licensees notify referring :nys1:ians :f :::en:;aik danger:us -isadministrations.
This recuire en.. uld assure :ne ::mcie e-ness of the referring physician's record of rea: men; f:r his patient.
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Honorable 'Jalter Mondale Lastly, the proposed rule would require that the licensee notify the patient or patient's responsible relative unless the referring physician informs the licensee that in the physician's medical judgment harm might come to the patient or relative, respectively.
Cn this point, the Commission has expressed concern abcut the possibi~lity of undue intrusion into the physician-patient relationship.
Consequently, the Commission has asked that commentors particularly focus on those portions of the proposed amendments which deal with the manner in which referring physicians and their patients are informed of misadministrations.
Should the rule or a similar cne be adopted in final form, those potenti-ally dangerous misadministrations which meet the criteria for abnormal occurrence reportirg will be published in the quarterly " Report to Congress on Abnormal Occurrences."
I will keep you informed of progress in the area of misadministration reporting.
Sincerely,
' seph M. Hendrie L. '. 2.. ;. -
N arai :a h ',;;i:r 6
868 160
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P00R DIUGJUVi Identical letters to:
Honorable Thomas P. O'lleill, Speaker of the House Honoraiale Leo Ryan, Chaiman, Subcomittee on Environment, Energy and itatural Resources, Cemittee on Government Operations (cc: P,ep. Thomas Kindnes.
Honorable Tcm Sevill, Chaiman, Subccmittee on 'Public Works, Comittee cn Apprcpriations (cc:
Rep. John Myers)
Honorabl' J. Bennett Johnston, Chaiman, Subccmittee on Public Works, Ccmmittes e
on Appropriations (cc:
Sen. Mark Hatfield)
Honorable Morris Udall, Chaiman, Subccmittee en Energy and the Environment, Comittee on Interior and Insular Affairs (cc: Rep. Robert Bauman)
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Honorable Gary Hart, Chaiman, Subcomittee on fluclear Rej 11ation, Comittee On Environment and Public Works (cc: Sen. James McClure Honorable John Dingell, Chairman, Subcomittee on Energy and Power, Ccemittee on Interstate and Foreign Commerce (cc: Rep. Clarence Orewn)
Honorable John :'ioss, Chaiman, Subccamittee on Oversight and Investigations, Cc.mittee en Interstate and Foreign Cc.cerce (cc: Rep. James Collins) e c:
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Honorable John Glenn, Chaiman, Subcc.mittee on Energy, fiuclear Proliferation and Federal Services, Ccer.ittee on Governmental Affairs (cc: Sen. Jac::b Javits)
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