ML20141E904

Package Consisting of Viewgraphs of Medical Regulatory Revs Part 35

ML20141E904
Person / Time
Issue date:	07/01/1997
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUDOCS 9707010203
Download: ML20141E904 (13)

Text

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PDP MEDICAL REGULATORY REVISIONS PART 35 0

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Nuclear Safety 5s U.S. Nuclear Regulatory Commission lg Washington, D.C. 20555

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PROCESS i

Public Participation in Process NRC / State Working Group Proposeo Rulemaking Final Rulemaking i

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COMMISSION DIRECTION Continue ongoing program with l

l Improvements i

Capture not only Relevant Safety -

l Significan;: Events, aut also Precursor Events Consult with ACMCI and Medical Communify E se ofProfessional Standards and Guidance

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l COMMISSION DIRECTION (Continued)

E tilize Risk-Informed Performance-Based Approach Higher Risk Activities Should be Primary Focus of Efforts and Resources Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities

e SRM ITEMS Focus Part 35 on Procedures that Pose Highest Risk Oversight Alternatives for Diagnostic Procedures Consistent with Risk Capturing of Relevant Safety Issues and Precursors Change " Misadministration" to " Medical Event"

l SRM ITEMS l

(Continued)

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l Redesign Part 35 to Allow for Timely Incorporation of New Modalities Revise to Focus on Patient Safety 1

E se of Available Industry Guidance and i

Standards i

ACMLI VIEWS AXD RECOMMENDATIONS 4

Concurred with Commissions' Position to:

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- Continue the Ongoing Medical Program, with-l Improvements l

- Decrease Oversig at of Lew Risk Activities; and

- Continue Emphasis in High Risk Areas Supported use of Professiona:L Medical l

j Organizations and Societies l

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i ACMCI VIEWS AXD

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i RECOMMEXDATIONS (Continued) j Recommended " Quality Improvement

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Approach" vs " Quality Management l

Approach" Believed that the NRC Should not Intrude l

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Into Medical Judgments i

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ACMUI MEDICAL POLICY l

STATEMENT #2 PROPOSAL l

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• Tae NRC will regulate the rac iation sa:Pety of patients only where justified by the risk to the patients, and only where voluntary standarc s or comphance with these l

standards are i'nadequate.

i Assessment of the risks justifying such regulations

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will reference comparable risks and comparable modes of regulation for other types of medical practice.

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l ACMEI MEDICAL POLICY l

l STATEMENT #3 PROPOSAL The NRC will { minimize intrusion} not intrude l

into medicaljudgments affecting patients and mto other areas traditionally considered to be a l

part of the practice of medicine.

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ISSUES i

l QM Requirements Misadministration vs Medical Event i

Training and Experience l

l Capturing Emerging Technologies Accreditation Process I

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ISSUES 4

l Medical Judgment Sophistication of Practice i

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" Bad Apple" Factor Authorized User i

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l MODALITY APPROACH i

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i Who Licensed?

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Technical Issues: (e.g., surveys, access contro_s)

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l Training and Experience l

Licensee Event Reports: CMisadministrations, etc.)

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- Quality Management I

Records Organization / Internal QA L -

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