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O 4 UNITED STATES ,h y 'g NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20665
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TO ALL MEDICAL LICENSEES Enclosed is a copy of revised criteria for training and experience for medical users of byproduct material. These criteria have been adopted with the concurrence of the Advisory Committee on the Medical Uses of Isotopes.
The requirement for total time spent in training has not been changed, but the requirements for training in basic radioisotope handling techniques have been increased coninensurate with the quantities of material now being used by most medical licensees.
1 This policy is effective immediately, but is not retroactive and does '
not affect physicians who are already listed as an authorized user on a medical license.
l ernar ing r Chief sotopes icen ng Branch Division of uel Cycle and Materi afety
Enclosure:
As stated g92 GOB 6850906 35 50FR30616 PDR
APPENDIX A
. ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES OF BYPRODUCT MATERIAL o*
l Section 35.11 (d) of 10 CFR 35 provides that the Comnission will approve 1 i
a license application by an institution for medical use of byproduct material if it detennines, among other things, that the physician designated as the individual usei ~is' adequately trained and experienced in (a) basic radioisotope ' handling techniques and (b) the clinical use of byproduct material pmposed in the application. Similar criteria are established in Section 35.12 (c) of 10 CFR 35 for approval of licenses for medical use of radiophamaceutichls by individual physicians. 0ut-lined below are training and experience criteria that the Comission, with the assistance of its Advisory Comittee on the Medical Uses of Isotopes, has found acceptable for physicians who use radiopharmaceuticals.
Each physician's training and experience are examined on a case-by-case basis. If a physician wishes to use radiophannaceuticals but does not have the training and experience described, he may submit an application listing his specific qualifications and this will be reviewed by the Comission with the assistance of the Medical Advisory Committee. l i
1 I. GENERAL TRAINING l
To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups I, II and/or III, Section 35.100 of 10 CFR Part 35, a physician should have: ;
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l A. Training in basic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) l including: 1 I
, 1. Radiation physics and instrumentation (100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />)
- 2. Radiation protection (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)
- 3. Mathematics pertaining to the use and measurement of radioactivity (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
- 4. Radiation biology .
( 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
- 5. Radiophannaceutical chemistry ( 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)
'B. Experience with the types and quantities of byproduct material for which the application is being made, or equivalent (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).
C. Clinical training in a supervised institutional nuclear medicine program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). 'The clinical training should cover all 1
appro' p riate types of diagnostic procedures and include:
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- 1. Supervised examination of patients to detennine the suitability for radioisotope diagnosis and reconsnendation on dosage to be prescribed. -
- 2. Collaboration in calibration of the dose and the actual adminis-I tration of the dose to the patient, including calculation of the radiation dose, related measurements and plotting data.
- 3. Follow-up of patients when required.
- 4. Study and discussion with preceptor of case histories to establish most appropriate diagnostic p'rocedures,I limitations, contraindica-tion, etc.
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~ THE REQUIREMENTS SPEC (FIED IN SECTIONS A, B AND C MAY BE SATISFIED CONCURRENTLY IF ALL THREE ARE INCLUDED IN THE TRAINING PROGRAM.
FOR EACH PHYSICIAN NAMED IN ITEM 4 0F FORM NRC-313 COMPLETE A SEPARATE PAGE 3 0F THE FORM NRC-313a (PRECEPTOR STATEMENT) AND APPEND.THE ST OF TRAINING IN BASIC RADI0IS0 TOPE HANDLING TECHNIQUES. FOR EACH SUBJECT COVERED IN BASIC TRAINING, STATE WHERE THE TRAINING WAS (E.G., OBTAINED, THE DATES TOTAL-NUMBER OF HOURS. AND TYPE OF TRAINING LECTURES, LABORATORY).
II. TRAINING REQUIREMENTS FOR SPECIFIC DIAGNOSTIC PROCEDURES I
l A physician who wishes to be authorized for only one or two specific ,
diagnostic procedures should have training in basic radioisotope handling techniques and clinical procedures connensurate with the
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procedures and quantities of byproduc't material being requested.
.Such requests will be examined on a case-by-case basis by the Connission with the assistance of the Advisory Comnittee on the Medical Uses of Isotopes.
III. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING RADI0 PHARMACEUTICALS To _ qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups IV and/or V, Section 35.100 of 10 CFR Part 35, a physician should have:
A. Training in basic radioisotope handling techniques (80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) including:
- 1. Radiation physics and instrumentation (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />)
- 2. Radiation protection (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />)
- 3. Mathematics pertaining to the use and ~
measurement of radioactivity (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />) 1 4. Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
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-4 B. Clinical training in specific therapy procedures:
For Group IV ,
(1) Iodine-131 for treatment of hyperthyroidism and/or l
cardiac conditions:
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- Clinical experience in the diagnosis of thyroid l 1
function and active participation in the treat-ment of ten patients.
(ii) Phosphorus-32 for treatment of polycythemia vera, leukemia and/or bone metastases:
- Treatment of three patients with one of these conditions.
(iii) Collodial phosphorus-32 for intracavitary treatment:
, o j - Active participation in the treatment of three patients. ,
For Group V
- (1) Iodine-131 for treatment of thyroid carcinoma:
- Clinical experience in diagnosis of thyroid function
. and treatment of hyperthyroidism and/or cardiac dys-function, and active participation in the treatment of three patients with thyroid carcinoma.
(ii) Colloidal gold-198 for intracavitary treatment:
- Active participation in the treatment of three patients. /
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IV. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING SEALED SOURCES I To qualify as adequately trained to use or directly supervise the use of l byproduct material listed in Group VI. Section 35.100 of 10 CFR Part 35, .
a physician should have:
A. Training in basic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) as i described in Section I.A. of this Appendix.
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B, Clinical training in specific therapy procedures: ,
(1) Radiation sources for interstitial, intracavitary, or surface treatment of cancer: ,
- Active practice in therapeutic radiology with a minimum of three years experience.
(ii) Beta ray applicators for the treatment of superficial eye disease: -
- Active practice in therapeutic radiology or ophthalmology and experience in the therapeutic use of beta rays or soft X-rays.
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