ML20006B897
| ML20006B897 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1990 |
| From: | Carr K NRC COMMISSION (OCM) |
| To: | Marcus C CALIFORNIA, UNIV. OF, LOS ANGELES, CA |
| Shared Package | |
| ML20006B898 | List: |
| References | |
| NUDOCS 9002060067 | |
| Download: ML20006B897 (2) | |
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wAswwaTow o.c.rosos January 19, 1990 CHAIRMAN Carol S. Marcus Director, Nuclear Medicine Outpatient Clinic Building A-13 University of California, Los Angeles 1000 Carson Street Torrance, California 90509 1
Dear Dr. Marcus:
I am responding to your letter of November 30, 1989, in which you reviewed our i
November 17, 1989 meeting and voiced concerns in the nuclear medicine community about some aspects of the Nuclear Regulatory Comission's (NRC's) regulatory program for the medical use of byproduct material.
I was pleased to meet with you to discuss these matters.
The Comission appreciates your views and is working to improve the NRC's
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regulatory program to ensure protection of the public health and. safety, while
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not impeding the delivery of medical care.
I.have noted the information you submitted in your letter regarding the safety record of the nuclear medicine:
'i comunity, the risk of nuclear medicine procedures, concerns about quality assurance (QA) requirements, education and staffing, and reimbursement problems. The NRC will consider the information that you submitted as it continues to develop its regulatory program for-the medical use of byproduct' i
material. Contrary to your understanding of my position, however, I do believe i
that medical misadministrations, when they occur, represent significant risk to l
the public because of the acute and chronic adverse effects that may result, such as organ dysfunction and increased risk of cancer.
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Regarding your specific concerns, the Commission agrees with your suggestion I
that development and implementation of quality assurance requirements require careful consideration and constructive comunication with the medical community..As you are aware, the NRC published proposed QA requirements in the Federal Register on January 15, 1990 (55 FR 1439), and is. currently soliciting public comments on the proposed rule.
In addition, the NRC will conduct a pilot program to evaluate the impact of the QA requirements on medical programs. An important portion of the pilot program will be the public workshops, in which licensees that participate in the pilot program will be able to state their experiences in implementing the QA requirements.
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The staff is currently developing a respense to the petition for rulemaking-from the American College of Nuclear Physicians / Society of Nuclear Medicine on 5
nuclear pharmacy and other issues. At this time, we have not determined whether a Comission meeting or presentation by the petitioner is necessary.
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Carol S. Marcus ;
The staff is also examining medical training and accreditation programs, and will ensure that the public, the Advisory Committee on the Medical Uses of t
Isotopes, and licensees have an opportunity to participate if rulemaking is' initiated.
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In response to your concerns about reimbursement, the staff plans to meet with representatives of the Health Care Financing Administration to open a dialogue betwton our agencies and to discuss our objectives in improving medical uses of r
byproduct material. The information that comes from those meetings will be considered as we continue to develop our regulatory program.
I appreciate your offers to work with the NRC to develop an improved reguletory -
program and to continue communication with the nuclear medicine community about regulating nuclear medicine in a manner that best serves the public.
Sincerely, Kenneth M. Carr l
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