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

.

PDP MEDICAL REGULATORY REVISIONS 0

PART 35 W

O c,

e m

CD tm Pt*, -

h, tift Division ofIndustrial and Medical h Nuclear Safety 5s U.S. Nuclear Regulatory Commission

$ Washington, D.C. 20555 *l lg '

D vv:*

u_4_., pr3r hvA cJ uu - . .

/

@g

-o R

RE q H 2 3' OKb

j. .-

l l

l i

PROCESS i

! Public Participation in Process

! NRC / State Working Group Proposeo Rulemaking Final Rulemaking i

2 i

l l COMMISSION DIRECTION l - Continue ongoing program with i Improvements

! - Capture not only Relevant Safety -

l Significan;: Events, aut also Precursor

! Events Consult with ACMCI and Medical

! Communify E se ofProfessional Standards and Guidance

.___.._......,.._........,.._.._._.....s . .. s_. .., . .,- _ , , ._ _ _ .. ..., ... _ . . ,, .

. , ..... . .__ .,_ _ .. ._ . .. . ...... __. ,., , . ,., , 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)

I

\

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

i Concurred with Commissions' Position to:

j - Continue the Ongoing Medical Program, with-l Improvements l - Decrease Oversig at of Lew Risk Activities; and

- Continue Emphasis in High Risk Areas l

Supported use of Professiona:L Medical j Organizations and Societies

i j.

i

! ACMCI VIEWS AXD

\

i RECOMMEXDATIONS (Continued) j

- Recommended " Quality Improvement

) Approach" vs " Quality Management l Approach"

! ~

Believed that the NRC Should not Intrude l Into Medical Judgments i

)

i

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _________m..__. _ _ __________ _ _ _ _ _ _-__.-_ ___ _ _ _____m___-____m._---__-__--_ -___ --- s. , w ~ wT-e - 51N

-'*-TN4 v w-+ v s ~'NM'* iw

~

l-ACMUI MEDICAL POLICY l STATEMENT #2 PROPOSAL l ._

i l

• 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

]

will reference comparable risks and comparable

! modes of regulation for other types of medical

practice.

i i

I

e l

l l

ACMEI MEDICAL POLICY .

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.

I l

1

_ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ . _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ .______.__.____..___..____________.___________________.___.,-~-v-..--4v,-~,._,,--- - , , -

ISSUES i

l QM Requirements Misadministration vs Medical Event i

- Training and Experience l

Capturing Emerging Technologies Accreditation Process I

4 i

I

.,-,.-.c.-%, ,, ., m v- ,c,--..-.,-.,,~o,.,. ,,. , . . , mp., , .c.,. , . . , . . ..- , ,,.w.% ,wy.. , , . , ,, , ,..,,,,v._,.y., . .,,,-%,., w,,,. ,.,%,.y e- --2.w ,,

[

! ISSUES 4

l Medical Judgment i

Sophistication of Practice i

" Bad Apple" Factor i -

Authorized User I

l I

i . ,

i l

MODALITY APPROACH i

j i i

Who Licensed? i i Technical Issues: (e.g., surveys, access contro_s)

\ ..

l Training and Experience l Licensee Event Reports: CMisadministrations, etc.)  :

i l

- Quality Management I

Records

! Organization / Internal QA L -_ _ - _ - - - .---- ___