ML20053A956
| ML20053A956 | |
| Person / Time | |
|---|---|
| Issue date: | 05/11/1982 |
| From: | Kammerer C NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Glenn J SENATE |
| References | |
| FRN-47FR3228, RTR-REGGD-10.008 47FR3228-232, NUDOCS 8205270500 | |
| Download: ML20053A956 (1) | |
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UNITED STATES
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'g NUCLEAR REGULATORY COMMISSION g.g WASHINGTON D. C. 20555 MAY I 1 1982 The Honorable John Glenn United States Senate 2'....n.-
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Washington, D.C.
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Dear Senator Glenn:
This is in response.to your letter of April 28, 1982, which transmitted a letter from Dr.
Robert
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Adolph concerning the Nuclear Regulatory Comission's proposed training and experience criteria for physicans who engage in nuclear medicine practice licensed by the Nuclear Regulatory Commission (NRC).
A Federal Register notice that the new criteria were under consideration and that public coments were invited was published on January 22,1982 (47 FR 3228, copy enclosed).
A final decision on adoption of the i
criteria has not been made yet.
The revised criteria evolved from proposals initiated by the medical community to reflect the training believed necessary for a physican to use licensed ma terial safely for protection cf workers, the public and patients.
These criteria are in addition to any clinical skills a physican must have to prac-tice medicine in his or her medical speciality.
k The proposed criteria are based on' the recomendations of the NRC's Advisory Committee on Medical Uses of Isotopes.
The Committee is composed of recog-nized experts in nuclear medicine with specialities in areas such as internal medicine, diagnostic and therapeutic radiology, medical physics, etc.
These specialized skills provide a broad range of medical expertise focused on NRC policies and regulations pertaining to nuclear medicine.
Selections of mem-bers of the Comittee are ordinarily based on recomendations or nominations from professional medical organizations.
For example, one present member of the Comittee was nominated by the Anerican College of Cardiology.
The proposed training criteria appear to have a substantial support in the medical community.
Thus far, the criteria have been endorsed by the Anerican Board of Nuclear Medicine, the American College of Nuclear Physicians, the Society of Nuclear Medicine, the American Osteopathic College of Radiology and the Federated Council of Nuclear Medicine Organizations.
Dr. Adolph's letter will be included with the comments received on the pro-posed criteria and will be considered in making a final decision on the tC criteria.
Sincerely, pgo1
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i Carl toNere77-94 or Office of Congressional Affairs 40P '-
Enclosure:
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3Cnifeb Sfafes Senale CCM M rTTEE ON GOVERNMENTA1. AFFAIRS SUSCOMMITTEE ON ENERGY. NUCLEAR PROUPERATION AND GOVERNMENT PRett'**eNe wAsNmeroN.o.c. assie April 28, 1982 The Honorable Nunzio Palladino Chairman U.S. Nuclear Regulatory Commission Mailstop 1159 H Washington, D.C.
20555
Dear Mr. Chairman:
Enclosed please find a copy of a letter frota one of my consti-tuents, Dr. Robert J. Adolph, concerning the NRC's proposed revisions of the regulations governing the training and experience requirements for nuclear medicine physicians.
I would appreciate your comments on the points raised by Dr. Adolph in his correspondence on this matter.
Please send your response directly to my office to the attention of Mr. Brian Dettelbach.
Thank you for your consideration, and best regards.
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Sincerely,
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l John Glenn JG/bdt Enclosure l
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s Universityof Cincinnati Collegeof Medicine M'edical Center Department of internal Mediciniv Division of Cardiology 231 Bethesda Avenue (Rm. 3354)
Cincinnati, Ohio 45267 Phone (513) 872 4721 l
March 3, 1982 Senator John Glenn 2235 Dirkson Senate Office Building Washington, DC 20510
Dear Senator Glenn:
The Nuclear Regulatory Commission has published in the Federal j
Register, revisions which will double the training and experience requirements for Nuclear Medicine Physicians and Cardiologists trained in Nuclear Cardiology. I am Professor of Medicine and Director of the Cardiac Research Laboratory at the University of Cincinnati Medical Center and am deeply involved in the training of Cardiologists in Nuclear Cardiology.
I am also a member of the Joint Task Force of the American College of Cardiology and the American Heart Association and the attached statement represents the official position of these two organizations regarding the proposed training and experience require-ments for isotope handling licensure of physicians performing diagnostic nuclear medicine.
The membership of the American College of Cardiology comprises over 11,000 physicians and scientists, and the American Heart Association represents approximately 37,000 physician members. As you will see from i
the attached statement, we believe that the current Nuclear Regulatory Commission regulations for a limited licence for by-products used in Nuclear Cardiology should be continued.
I personally strongly reject the proposal of the NRC Advisory Committee on the Medical Usus of Isotopes.
It is my conviction, that the revised training and experience criteria for Nuclear Medicine will result in no benefit to the public or to health care professione1s. As stated in the attachment, the proposal will continue the present I.ractice of allowing individuals coming from a non-cardiological background with little or no cardiovascular training i
to perform nuclear cardiology tests, placing the patient in potential jeopardy because of limitations in clinical expertise relative to cardio-vascular physiology and pharmacolog,,
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Patient Care
- Education
- Research
- Community Service
Piga 2 Senator Glenn
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J/2/82 The current regulations have been more than adequate in protecting the American Public as far as isotopic handling procedures are concerned.
During the time the current regulations have been in effect, the NRC has reported no case in which a cardiologists performing cardiovascular nuclear studies exposed others or himself to radiation risk that produce bodily harm and that might have been prevented by increased training and experience.
I hope that,you have the time to read the short attachment and will see fit to lend pour support to the position taken by the American Cardiologic conununity in the interest of good patient care.
Yours very sincerely, k..
Robert J. Adolph, M.D.
Professor of Medicine Director, Cardiac Research Laboratory ee RJA:jhh Enclosure
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Amo 1nne 94euc4u.seArt Woc L M Rasponea by Tht American College of Cardiolooy to the Notice of Revised Training and Experience Criteria for Nuclear Medicino Physicians (Federal Register, Vol. 47, No. 15)
The Nuclear Regulatory Commission (NRC) has published revisions increasing the training and experience requirements for nuclear medicine physicians including nuclear cardiologists requesting authorization to use reactor produced radioactive isotopes for nuclear medicine procedures, including nuclear cardiology.
The current authorization criteria consist of the following:
1.
200, hours of training in basic radioisotope handling techniques applicable to the use of unsealed sources.
2.
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of experience with the types and quantities of reactor by-product material for which the application is being made, or equivalent.
3.
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of clinical training in an 1nstitutional
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nuclear medicine program superviced by an NPC licensee.
At present,~these three criteria may be fulfilled concurrently in approximately three months total time. The revision mandates that the above criteria be fulfilled concurrently in a total time of at least six months.
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The American College of Cardiology (ACC) protests the revision _.t applies to the participation in nuclear cardiology by physicians primarily trained in the discipline of cardiology, (as opposed to physicians trained primarily in nuclear medicine) for the following reasons.
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Training and Experience Relative to Radiation Safety The current regulations have been more than adequate in protect-ing the American public as far as isotopic handling procedures are concerned.
During the time the current regulations have been in effect, the NRC has reported no case in which a cardiologist performing cardio-vascular nuclear studies exposed others or himself to radiation risk that produced bodily harm and that might have been prevented by in-creased training and experience time. The NRC has shown no reason why the current requirements have failed to protect either the professional or his or her patients, and has presented no information as to how the new regulations, specifically the increased training period, would
. enhance the radiation safety aspects of nuclear cardiology procedures either for consumers or providers of health dare. Furthermore, as tha NRC currently has authority only over reactor-produced isotopes, the onA.
isotope currently employed by the nuclear cardiologist directly affected by this change in requirements is technetium 99m. Among all isotopes in use in diagnostic medicine, Tc 99m has a unique safety record.
In view of tho exceptional safety record for"n: 90m, one might logically concider a reduction in current training requirements relative to isotope handling 1
techniques rather than an increase.
A further consideration relative to radioisotope handling safety is that the current structure of most cardiovascular training programs (which generally require the prior completion.of three years training in internal includestheteachingofhrinciples (including safety techniques) medicine) applicable to nuclear cardiclogy.
Through their training and experience with cardiac catheteri:stion and angiocardiography, cardiologists are
_3 already familiar with the principles of radiation exposure.
Hundreds of thousands of such angiographic procedures have been performed by cardiologists each year over mere than a decade, and no radiation-related safety bruech has been reported.
Training Aspect's Other Than That Recuired for Radiation Safety The new NRC proposal mandates that the criteria for authorization listed above (page one) be fulfilled in a minimum of six months of special education, training and experience, even though the authori=ation would be limited to by-products used only in nuclear cardiology. The effect of the new requirements would be to extend the number of hours of formal training for cardiologists doing nuclear cardiology from 500 (3 months) to 1000 (6 months).
With the fixed number of hours in categories A and B of the Training for Routine Diagnostic Procedures (Groups I-III), much of the increase in training hours would be in the area of the clinical aspects of training and experience, including study and discussion of case histories to establish the most appropriate diagnostic procedures, limitations, contraindications, etc.
As nuclear cardiology studies often involve unstable patients or the imposition of a stress such as exercise on a patient with potentially age tweTaA 1
severe cardiovascular disease, the ACC would certainly agree that such A
studies demand the presence of a qualified physician to monitor the patient, to supervise the study and to decide which patient should havo which type of imaging procedure and when imaging should be performed.
In addition, many of these tests ar'e performed during or af ter the adminis-tration of potent pharmacologic agents that can alter cardiovascular function, at times necessitating prompt medical intervention.
Therefore, tnere are important risks if nuclear cardiology tests are performed and interpreted
4-by physicians who lack formal training in cardiovascular hemedynamics, coronary artery disease physiology, exercise testing and exercise physiology, arrhytheda detection, and cardiopulmonary resuscitation.
In addition, there are significant risks frem (both false negative and false positive) interpretation of nuclear cardiology tests by physicians who do not have an intimate knowledge of the patient's history, physical examination, laboratory data, and clinical course, or the clinical compe-tence to integrate these data with the nuclear cardiology cata. The resultant false negative or false positive interpretations could lead to inappropriate medical management.
Ado nur Awh On the basis of the above considerations, the ACC doem support increased A
training in the cardiological aspects of nuclear cardiology for those physicians not having training in hemodynamics, coronary artery disease physiology, exercise testing, arrhythmia detection and cardiopulmonary resuscitation.
However, as the clinical training provided in cardiology fellowships provides a.large portion of the experience needed for these clinical aspects of imaging, it is our view that it is unnecessary for physicians who become involved in nuclear cardiology via the cardiology specialty route to increase their training in these aspects.
While a formal six month training period may be an appropriate requirement for the practice of general nuclear medicine, we believe that three months of formal training is adequate for a cardiologist who wishes to per-form nuclear cardiology procedures. The only aspect of clinical train-ing and experience which would be augmented for cardiologists by increasing the training tir.e would be in the area of interpretation of scans.
It is not clear why this rather narrow aspec: of nuclear cardiology should require six months of experience as opposed' to three.
While this y,
-S-component of training in cardiovascular disease and n'iclear cardiology is to be encouraged and supported, we believe six cenths is an excessive time requirement for physicians with prior cardiovascular training.
Although the NRC has for many years insisted cn some clinical nucle'ar experience, th4 proposed doubling of nuclear training experience to a six month period as a prerequisite for rue licensing of physicians, performing cardiovascular nuclear studies represents a severe federal intrusion into medical practice. The establishment of the standards for both general and nucar medicine practices has been primarily in' the domain of the individual states through their autonomous state boards of medical licensure, and of the specialty boards. The proposed NRC regulatory process represents a clear interference with this process; interference that neither the NRC nor any of the witnesses who testified before it have ever implied as necessary to correct shortcomings in the current state and specialty board programs. Certification of clinical competency should continue to be the responsibility of the various specialty boards of medicine, surgery, pediatrics, and radiology, and the state medical boards. The role of the NRC -should continue to be to assure safety in the use of reactors and reactor generated isotopes.
l It is our conviction that the revised training and experience criteria for nuclear medicine will result in no benefit to the public or to health care professionals.
In fact, the proposal will continue the present practice of allowing individuals coming from a non-cardiological back-t ground with little or no cardiovascular Eraining to perform nucicar cardiology tests, placing the patient in potential jeopardy because of limitatio..s in clinical expertise relative cc cardiovascular physiology l
. I,et ;, * ' !!;!! ::.i and pharmacology. We maintain that the additional training and experience requirements will serve to discourage persons well trained in cardiology from participating in nuclear cardiology and, therefore, will potentially deprive the public of the expertise which cardiologists lend to the performance and interpretation of nuclear cardiology studies.
he Tw ww The ACC recommends that radiation safety for patients and the public
.s be maintained by continuing the current authorization criteria.
We believe that for authorization to use by-products used in nuclear cardiology, physicians primarily trained in cardidiology should be allowed to obtain the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training in basic radioisotope handling concurrently with 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of clinical training in nuclear cardiology and with 500
, hours of experience with the types and quantities of reactor by-product material for which the application is being made. The perio,d of concurrent training experience should continue to be three months.
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