ML20238C788
| ML20238C788 | |
| Person / Time | |
|---|---|
| Issue date: | 10/15/1986 |
| From: | Ryan Alexander NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Belote C NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20238C730 | List: |
| References | |
| FOIA-87-403 NUDOCS 8709100372 | |
| Download: ML20238C788 (4) | |
Text
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..OCT 1 5 1986 l
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MEMORANDUM FOR:
J. Calvin Belote, Acting Section Leader Control of Rulemaking Section Regulation Development Branch, RES FROM:
Robert E. Alexander, Chief 1
Safety Research Applications Branch, RES
SUBJECT:
CONTROL OF RULEMAKING: " QUALITY ASSURANCE AND PENALTIES FOR 3
NEGLIGENCE" l
As requested by your September 2,1986 memorandum, we have reviewed the proposed new rulemaking submitted by NMSS entitled " Quality Assurance and Penalties for Negligence."
The draft staff recommendation is that NRC should initiate the subject
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rulemaking.
l Enclosed is our draft independent review package. The RES task leader is Judith D. Foulke, X 37681.
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Robert E.-Alexander, Chief Safety Research Applications Branch, RES losures:
1 Rulemaking review package judh J 'Ip NM S 3 received from NMSS 2.
RES Staff Review 3.
Results of RES Staff Review m%-8-(os s 3 8709100372870904[
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RES STAFF REVIEW N;
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The package submitted by NMSS for'a new rulemaking on radiation' therapy quality assurance and penalties for medical licensee negligence consisted of a Draft x.
Regulatory Agenda Entry, a Draf t Commission Paper, a Preliminary Regulatory Analysis, and an Advance Notice of Proposed Rulemaking for the Federal Register.
1 The need for the rulemaking.
This ruleniaking is needed in order to reduce the number of misadministration in radiation ~ therapy.
Consistency of the rulemaking with appliable policies and planning guidance.
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A policy statement ~regarding the medical use of byproduct material was l
published in the Federal Register on February 9, 1979. Am9ng other policies, it is stated that NRC " regulates the rediation safety of patients where justified by.the risk to patients."' Howewr, the eicent of applicability to the therapy situation has not,creviously been clear.
Importance of the rulemaking relative to accomplishing the HRC's mandate.
As noted above, it is HRC's responsibility to ensure patient safety when I
byproduct material is,used for medical purposes.
s Environmental Assessment We agree that this rulenaking does not require an environmental assessment or impact statement because the rule would nqt. change the amount of radiation released to the environn.ent (See Environmental Impact Assessment, Enclosure 7).
i Backfit analysis and interaction with CRGR.
Because medical lice'nsees are not regulated under 10 CFR 50, no backfit analysis or interaction with the Committee to Review Generic Requirements is required.
Recommendation Based on this review,' the staff finds that the proposed rulemaking should be o
initiated.
L Thepresehtaction,anAdIanceNoticeofProposedRulemaking,containsalist of questions on quality assurance and negligence for which answers are sought from the medical community and other affected parties.
It'is very likely that' the responses will permit the development of a practical and effective. rule.
ENCLOSURE 2
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-l RESULTS OF RES STAFF REVIEW t
1.
The issue to be addressea.
There are two issues involved in this proposed rulemaking: quality
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4 assurance and negligence.
Ideally, a complete quality ' assurance program that addresses each step in the radiation policy ' process should be
. required., However, only certain procedures are essential and the l
i personnel and equipment needed for a stringent quality assurance program may not be available. As discussed in the Advance Notice of Proposed-Rulemaking, an operating definition of " negligence" is needed. This will involve minimally acceptable levels of quality of medical care, methods of reimbursement for medical. care, tort law, state regulation of rnedicine, and coordination with other federal agencies.
2.
The necessity and urgency fo'r addressing the issue.
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There have been occasions when large doses of radiation were misadministered to patients.
In most cases, the patient was given much more radiation than prescribed by the authorized user (physicians).
In some cases the wrong-patient is 1-adiated.- Because of the very large
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doses involved, serious ' harm, inciuding. death, can result, i
It is believed that independent verification of individual doses and penalties'for misadministration will reduce the incidence of these misadministration.
3.
Alternatives to Rulemaking Alternative 1.
Take no action.
This is unacceptable because some patients have unnecessarily been harmed.
Alternative 2.
Provide quality assurance guidance and request voluntary irrplementation.
4 The staff believes most licensees already have some kind of quality assurance program in place to ensure quality care and avoid lawsuits claiming negligence. However, because of cost containment objectives, many -
licensees probably would not provide a more stringent quality assurance pro,qram unless.a regulatory requirement is placed on them.
l Al ernative 3.
Require implementation of a quality assurance program and provide penalties for either noncompliance or program failure due to human error.
This is the alternative chosen by the staff. However, information from the-affected community is needed to decide on the scope of the requirement and determine its cost and corollary consequences.
ENCLOSURE 3 i
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How the issue will be addressed through rulemaking.
The staff intends to prepare a rule that would require implementation of a quality assurance program and provide penalties for radiation therapy misadministration.
However, because of the difficult policy issues and the lack of knowledge of the impacts on the medical comunity, the staff is proceeding in steps.
First, an Advance Notice of Proposed Rulemaking will be issued to request public comment on the need for and proper scope af regulations for radiation therapy quality assurance and penalties for medical licensees; negligence.
5.
How the public, industry, and NRC will be affected.
Requirements for radiation therapy quality assurance programs and imposition of penalties for negligence will in all likelihood lead to fewer misadministration. This will benefit the patients who might otherwise have received unnecessary exposures.
The effects on the medical industry are many, including the considerations j
4 involved in the " practice of medicina" and the costs of implementing a The Advance Notice of Proposed strong quality assurance program.
Rulemaking solicits comments and information on costs.
It is expected that there will be a significant impact on the NRC in terms 4
of the inspector training budget and the need for additional staff in the Office of Inspection and Enforcement ard the Regions.
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NRC resources and sch'eduling.
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NMSS estimates it will need at least 2 staff years to publish the final Based on the j
rule and develop a model quality assurance program by 8/88.
l steps involved, this is a reasonable estimate.
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