ML20236T464
Text
. s.- e AC65-1 1
PDR Note to:
Document Control System, 042 From: Norman L. McElroy, NMSS re:
Regulatory History for Basic Quality Assurance in Radiation Therapy The attached table of contents, notes for historians, and documents comprise the regulatory history of the subject rulemaking.
Please enter the documents in the document control system, and print a listing of the documents for transmittal to the Rules and Procedures Branch.
Please return the originals to me at 396-SS.
Thank you.
l dygzkh :,
/ [
Norman L. McElroy Medical and Academic Section l
8712010271 871201 PDR PR 35 52FR3,6942 PDR
AC65-1 PDR Tof C Regulatory History for Basic Quality Assurance in Radiation Therapy 52 FR 36942 1.
Comments recd fr ACMUI--not for PDR 2.
Zech comments on revision of 10 CFR Part 35 3.
AE0D report on therapy misadministration 4.
Wrong patient treated 5.
SRM and draft staff response (SRM= staff requirements memo) 6.
Interviews with Human Factors personnel 7.
Coments on select enforcement actions 8.
Draft action plan j
9.
Request for permission to initiate rulemaking
- 10. Wrong pharmaceutical administered 11.
Staff undertakes practicum in radiation therapy
- 12. AF00 report synopsis published i
13.
Licensee administered 2000 rad whole body instead of 1200 l
14.
Licensee administered 20 mci 1131 for a diagnostic study l
15.
NMSS distributed complete AE0D report (had demurred due to length) l 16.
Zech exhibits interest in misadministration definition 17.
Request for concurrences on ANPR "QA and Penalties for Negligence" 18.
Bernthal pushes for increased oversight l
19.
RES approves initiation of rulemaking l
- 20. Concern over use of the work " negligence" 21.
Research on the word " negligence" 22.
Immediate imposition of a basic QA rule considered f
23.
First draft of basic QA rule
- 24. Agenda for meeting with outsiders to determine completeness, impact 25.
"Two-pronged approach" raised 26.
Davis briefed on FRN 27.
Supplemental SRM with questions on Medical Use program issued 28.
Commission Paper transmitted for concurrence Christmas Eve as the Willste Building is shut down due to a flood (leak in supply on top floor) 29.
Carr visits a hospital (apparently a Commission first) 30.
Comments on December 24, 1986 draft Commission Paper 31.
NRC gets summary of AE0D report published in trade newsletters 32.
AE00 published report on 1131 misadministration 33.
Stello and Davis modify Commission Paper 34.
ELD modifies Commission Paper 35.
Chronology of misadministration since 1972 36.
Commission Paper submitted on " Misadministration" 37.
Chairman Zech visits a hospital (except for his visit to Walter Reed a few weeks preceding, another Commission first) 38.
AE0D reports on misadministration for 1986 39.
SRM directing markup issued 40.
Definition of misadministration clouded by leaky seed 41.
IE issues update on misadministration 42.
Bernthal speaks on misadministration at a Part 20 meeting 43.
Another misadministration occurs 44.
Enforcement action for treating wrong patient 45.
Congress interested in device malfunctions 46.
Commission Paper submitted on " Misadministration" 47.
Possible brachytherapy misadministration 48.
Report of multiple teletherapy misadministration 49.
Commission briefed on " Medical Use of Byproduct Material" 50.
Commission exhibits interest in regulating NARM 51.
Staff visits Radiological Physics Center to discuss QA inspections 52.
Commissioners mark up FRN's 53.
FRN's submitted for publication 54.
Notes for historians
AC65-l' PDR
. 54 Note to historians The Commission's interest ip; misadministration appears to have been piqued
.by the publication of the December 1985 AE0D report on therapy misadministration--
real rads for real people, not' theoretical rads to hypothetical people under worst case' scenarios--followed in February 1985 with the treatment of tr.u wrong patient. Commissioner Bernthal apparently used the word " penalties for negligence" to indicate " screw-ups" in the' directive.
NMSS Director Davis said "I can't believe they used the word negligence to regulate doctors.
Give them what they asked for. Maybe we can head this off."
Nothing was done for several months while NMSS patiently awaited for RES.
approval. to initiate rulemaking.
ll hen a' patient was given 2000 rads whole body instead of 1200,. things began to move.
NMSS decided to forego obtaining RES_-
. permission, and continue working on the rule.
The. Commissioners' assistants got word that the staff was only working on an l
ANPR. Thus,.the supplemental directive of December 16 to write a real rule with real' requirements.
Both were submitted in February 1987.
The staff finally got an opportunity to brief the Commission on medical use in July. The briefing appeared to 90 well; the Chairman came around the table after the briefing to personally congratulate me.
The rule was turned over to RES, in conjunction with an EDO directive that all rules be done in RES, upon publication in the Federal Register.
Both notices were published October 2, 1987.
l L
)
i