ML20236U303
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.k 8[$) Eg / nE NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 205ES (() ( @ A)
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l MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: Eric S. Beckford, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: "00ALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" Based on our independent review of the subject rulemaking sponsored by NMSS,
?ES recommends that the rulemakino be initiated.
On April 14, 1986, the Commission directed the staff to submit a rulemaking package to provide the authority to require independent verification of
-therapy doses and to penalize medical licensees for negligence. The purpose of the rule is to reduce the chance of therapy misadministration; i.e.,
exposing a patient to too much or too little radiation or administering radiation to the wrong patient.
The reasons for our recommendation.are based on our belief that quality assurance programs and penalties are effective in reducing errors in many operations. We believe independent (redundant) calculations of therapy doses would uncover mathematical errors; additional verification procedures would assure that the proper patient is irradiated. With regard to penalties, the deterrent power of financial loss, we believe, will lead to greater care in conducting therapy procedures.
We note that the present title of the rulemakino is vacue and misleading, and suggest changing it to " Quality Assurance and Penalties to Reduce Misadministration of Radiation Therapy," or something else. -
The com lete RES independent review package has been sent to OED0 (Attention:
DEDROGR and the Director, NMSS.
l Eric S. Beckjord, frector Office of Nuclear Regulatory Research l
1 g20g424871201 35 52FR36942 PDR
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,1 D O T RES INDEPENDENT REVIEW PACKAGE 4
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RES STAFF REVIEW The package submitted by NMSS for a new rulemaking on radiation therapy quality assurance and penalties for medical licensee negligence consisted of a Draft Regulatory Agenda Entry, a Draft Commission Paper, a Preliminary Regulatory Analysis, and an Advance hotice'of Proposed Rulemaking for the Federal Register.
' The need for the rulemaking.
This rulemaking is needed in order to reduce the number of misadministration in radiation therapy.
Consistency of the rulemaking with applicable policies and planning guidance.
A policy. statement regarding the medical use of byproduct material was published in the Federal Register on February 9, 1979. Among other policies, it is stated that NRC " regulates the radiation safety of patients where justified by the risk to patients." However, the extent of applicability to the therapy situation has not previously been clear.
Importance of the rulemaking relative to accomplishing the NRC's mandate.
As noted above, it is NRC's responsibility to ensure patient safety when byproduct material is used for medical purposes.
Environmental Assessment We agree that this rulemaking does not require an environmental assessment or impact statcment because the rule would not change the amount of radiation released to the environment (See Environmental Impact Assessment, Enclosura 7). l Packfit analysis and interaction with CRGR.
Because medical licensees 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 initiated.
The present action, an Advance Notice of Proposed Rulemaking, contains a list 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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-e RESULTS'0F RES STAFF REVIEW
'1 - The issue to be addressed.
' There are two' issues involved in this proposed rulemaking: ' quality.
assurance.and negligence.- Ideally, a complete quality assurance program
' that ' addresses each step in the radiation policy process should be requi re'd. However, only certain procedures are essential'and the personne1'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 1 reimbursement.for medical care, tort law, state regulation of medicine, and coordination with other federal l agencies. 1
- 2. The necessity and urgency for addressing the issue.
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 irradiated. Because of the very large doses involved,. serious harm, including. death, can result.
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 implementation.
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 program unless a regulatory requirement is placed on them.
Alternative 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
- 4. How the issue will be addressed through rulemaking. ;
The staff intends to prepare a rule that would require implementation of
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' 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 Proposeo Rulemaking will be issued to request public comment on the need for and proper scope of regulations for radiation therapy quality assurance and penalties for medical licensee 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 involved in the " practice of medicine" and the costs of implementing a strong quality assurance program. The Advance Notice of Proposed Rulemaking solicits comments and information on costs.
It is expected that there will be a significant impact on the NRC in terms of the inspector trainirg budget and the need for additional staff in the Office of Inspection and Enforcement and the Regions.
- 6. NRC resources and scheduling.
HMSS estimates it will need at least 2 staff years to publish the final rule and develop a model quality assurance program by 8/88. Based on the steps invcived, this is a reasonable estimate.
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