ML20137S018
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.7 $t NUCLEAR REGULATORY COMMISSION W ASHINGTON, D. c. 20586 s.3****v
- OCT 211976 l
TO ALL MEDICAL LICENSEES:
This is to clarify our recent letter concerning the revised criteria for i training and experience for medical users of byproduct material.
Sections 35.11 and 35.12 of 10 CFR part 35 provide that the Comission will approve a license application for medical use of byproduct material if it determines, among other things, that the physician named as the individual user is adequately trained and experienced in basic radioisotor handling techniques. The Commission establishes its criteria for acceptable training and experience with the assistance of its Advisory Comittee on the Medical Usts of Isotopes.
These criteria are not requirements, but are intended to describe to license applicants the type of training that will be considered acceptable.
If a physician wishes to use radiopharmaceuticals, but does not have the exact training and experience described, he may submit an application listing his specific qualifications and this will be reviewed by the Commission with the assistance of the Medical Advisory N 4ttee.
The changes that have occurred in the nuclear medicine field in the past several years required that the Comission reconsider the amount of training in basic radioisotope handling techniques that would be acceptable.
The quantities of radioactive material used in most nuclear medicine laboratories have increased by factors of one hundred to one thousand.
Instead of being purchased in prepackaged, pre-calibrated form, many radiopharmaceuticals are now eluted from radioisotope generators or prepared from reagent kits in the nuclear medicine laboratory. This requires more handling of large quantities of radioactive material and thus more need for knowledge of proper radiation safety measures, instrumentation and handling procedures.
Taking these and other factors into consideration, the amount of training in basic radioisotope handling techniques that an applicant should have has been increased to 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />. All forms of training, e.g., lectures, laboratory sessions, discussion groups and supervised experience in a 8509250179 850906 PDR PR 35 50FR30616 PDR
I To All Medical Licensees '
nuclear medicine laboratory, should be included in the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />. The hours listed for each subject in Section lA are suggested values and
' should not be interpreted as requirements.
There has been no change in the total training time. The criteria for 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 />), experience with the types and quantities of byproduct material for which application
- is being made (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />), and supervised clinical training in an institu-tional nuclear medicine program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />) can be satisfied concurrently in a total of 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> if all three are included in the training program.
While many programs have provided t' raining that meets these requirements, we recognize that documentation of the training in each subject area may be difficult to obtain. If the training in basic radioisotope handling techniques has already been received but complete documentation from the training institution is not available, the physician should state where the training was received, the total number of hours for each subject and the type of training.
The Nuclear Regulatory Commission is preparing a new licensing guide to aid physicians and hospitals in preparing applications for the medical use of radioisotopes and the training and experience criteria will be included as an appendix to that guide. The Commission will welcome any comments pertaining to the training and experience criteria or to items that should be included in the guide. h nts should be made before December 31, 1976 to:
U.S. Nucl<aar Regulatory h 4 salon Office of Nuclear Material Safety and Safeguards Divisien of Fuel Cycle and Material Safety Radioisotopes Licensing Branch Washington, D. C. 20555 V
ard S ge , Chief Radioiso pes Licensing Branch Division of Fuel Cycle and Material Safety
Enclosure:
Revised Appendix A s -,. w----w.w.---- - - - - ----y-
APPENDIX A ACCEPTABLE TRAINING AND EXPERIENCE FOR MEDICAL USES OF BYPRODUCT MATERIAL Section 35.11 (d) of 10 CFR 35 provides that the Commission will approve l 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 user is adequately trained and experienced l in (a) basic radioisotope handling techniques and (b) the clinical use of byproduct material proposed in the application. Similar criteria are established in Section 35.12 (c) of 10 CFR 35 for approval of licenses for medical use of radiopharmaceuticals by individual physicians. Out- ,
i lined below are training and experience criteria that the Commission, )
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 j have the training and experience described, he may submit an application '
listing his specific qualifications and this will be reviewed by the Commission with the assistance of the Medical Advisory Comittee. i I
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4 I. GENERAL TRAINING 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:
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 />)
I consisting of lecture, laboratory sessions, discussion' groups or supervised experience t'n a nuclear medicine 1 laboratory in the following areas:
- 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 />)
(The hours listed next to each of the five subjects above are ~'
Juggested values and should not be interpreted as specific requirements.) s i B.
l Experience with the types and quantities of byproduct material for i
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.
Supervised clinical training in an 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 appropriate types of diagnostic procedures and include:
1.
Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed.
i 2. Collaboration in calibration of the dose and the actual administration 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 procedures, limitation, contraindication, etc.
Note:
The requirements specified in Sections A, B and C may be satisfied concurrently)in a three month training prograh IF,all three areas are i L ---- J
! integrated into the program.
Note:
For each physician named in Item a of Form NRC-313 complete a separate Page 3 of the Form NRC-313a (Preceptor Statement) and append the statement i of training in basic radioisotope handling techniques. For each subject covered in basic training, state where the training was obtained, the j dates, total number of hours and type of training (e.g., lectures, laboratory sessions).
Alternative:
Certification by the American Board of Nuclear Medicine will be accepted ;
as evidence that a physician has had adequate training and experience to use Groups I, II and III.
b d l l
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. 4 II. TRAINING REQUIREMENTS FOR SPECIFIC DIAGNOSTIC PROCEDURES 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 procddures commensurate with the procedures and quantities of bypmduct material being requested.
Such requests will be examined on a case-by-case basis by the Comission with the assistance of the Advisory Comittee 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:
1 A. Traininginbasicradioisotopehandlingtechniques(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
! raeasurement of radioactivity (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />) i 4. . Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
! j (Theserequirementsareinlieuof,notinadditionto,thosespecified I inSectionI.A.,above.)
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-S-B. Clinical training in specific therapy procedures:
For Group IV (i) Iodine-131 for treatment of hyperthyroidism and/or cardiac conditions:
- Clinical experience in the diagnosis of thyroid 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 wit ny combination of these three conditions
'r (iii) Colloidal phosphorus-32 for intracavitary treatment:
3 lt - Active participation in the treatment of three patients.
$ For Group V (i) Iodine-131 for treatment of thyroid carcinoma:
1 - Clinical experience in diagnosis of thyroid function I'
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 pa tients.
- - ~
- IV. TRAINING REQUIREMENTS FOR THERAPY PROCEDURES INVOLVING SEALED SOURCES To qualify as adequately trained to use or directly supervise the use of 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 described in Section I.A. of this Appendix.
B. Clinical training in specific therapy procedures:
(i) 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.
Evidence of certification by the American Board of Radiology in Radiology or Therapeutic Radiology may be submitted in lieu of the i i
information requested in Subsections A and B, above.)
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PDR H.5 54378 Federal Register / Vol. 47. No. 232 / Thursday. December 2.1982 / Notices t'
b) s t
Revloed Training s'id Experience Criteria for Nuclear Medicine Physicians AGENCY:Nucleat Regulatory Commission.
ACTION: Notice of revised training and experience criteria for physicians who apply for authorization to perform nuclear medicine procedures.
sumasany:The Nuclear Regulatory Commission is publishing revised training and experience criteria for physicians who request authorization to use reactor-produced radioactive isotopes (byproduct material) in nuclear medicine procedures. This revision -
f increases the minimum time appropriate for a physician to obtain acceptable training and experience for authorization to perform diagnostic nuclear medicine studies.
EFFECTIVE DATE: July 1.1984. This.
revision does not affect physicians who begin their nuclear medicine training prior to the effective date.
FOR PURTMER INFORMATION CONTACT:
O' Joseph DelMedico. Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards.
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CC Federal Register / Vol. 47. No. 232 / Thursday, December 2.1982 / Notices 54377 p U.S. Nuclear Regulatory Commisstoa expressed opposition. Most of the C. Comments CallingforMore Stringent Q Washington.D.C 20535,3m-427-4052.
suppi.aMENTARY INFOnesATION:NRCis opposing enmments either supported or actually enclosed a copy of the position Criteria Over 50 commenters stated that six revising Appendix A of Regulatory taken jointly by the American College of months of training was minimum or not Guide 10.8. Appendix A concerns Cardiology (ACC) and the Amencan enough. Some recommended that only training and experience criteria for Heart Association (AHA). Allcomments board-certified physicians should be
. physicians who apply for authorization were carefully considered and. authorized. Many of tha commenters to use byproduct materialin medical wherever possible, the new criteria were noted that six months of specific study diagnosis and therapy. Regulatory Guide changed to take them into account. In nuclear medicine may not allow 10.8 describes the type and extent of Copies of the comment letters are enough time to satisfy the radiation information needed by the Nuclear available forinspection at NRC's Public safety training as well as the clinical Regulatory Commission (NRC) staff to Document Room. requirements of that specialty.The evaluate an application for a specific increasing complexity of the field, license for the possession of byproduct Discussion of PubM"" especially as related to equipment and material andits use in or on human clinical procedures, was cited by several beings. This type of license is provided A. Comments of an EditorialNature commenters. In determining that the for under 10 CFR Part 35. " Human Uses All comments of an editorial nature published criteria are justified, the staff of Byproduct Material" The revisaan of were accommodated in the new cnteria. took into account the facts that these Appendix A is based upon the These changes included: (a) Revision of criteria received strong support during recommendation of NRC's Advisory Section VII.A to eliminate confusion the public meetings and that no Committee on the Medical Uses of concerning colloidal gold 198. which is significant new information has been isotopes (ACMUll- currently not in use-(b) modification of presented to support a period of training Essentially the revised criteria Section IX to include all of the radiation longer than six months. Commenters are indicate that physicians who apply far therapy certification boards listed in therefore referred to the meeting authorization to use byproduct material Table 1: (c) mention of th : accrediting transcripts.
for diagnostic nuclear merhrma studies, authority for osteopathic training in meluding cardiovascular nuclear D. Comments Concerning Table 3:(d) inclusion of > enon 133 Documentation of Training and medicine stud.es should have a studies in the training criteria: (e) use of minimum of six months of special Experience the term" cardiovascular nuclear education, training, and experience in Comment: A number of comments medicine"in place of th less these uses.The previous enteria e neerned the nethod for documenting descriptive " nuclear car diology;" (f) e indicated a nunimum of three months.
The revison does not affect physicians modifications to emphasize that the new traming and experier
'}ne commenter who are presently authorized to perform criteria represent the n.inimum that typeNRC suggested credentials to athat NRC .. e certificat qualified cuclear medicine procedures, nor finds acceptable: and (g) revision of the physicians. The u.omenter stated that physicians who begin their nuclear Federal Register notice to stress that the the certificate would be convenient for medicine training prior to the effective new critena will not affect physicians physicians changing jobs. The premise date.%e effective date was chosen so who are currently authorized to perfann was that a physician once licensed, as to allow the various training nuclear medicine studies orphysicians could thereafter show a new employer programs sufficient time to restructure who begin their trammg prior to the or radiation safety committee the their curricula, effective date. certificate as evidence that NRC Background B. Comments Concerning Table I accepted his credentials.
Response:The staff feels that the The revised Apperidix A evolved from A number of commenters questioned current Supplements A and B of Form proposals initiated by the medical why certain medical specialty NRC 313M are adequate for community to reflect the training certification boards were or were not documenting training and experience.
believed necessary for a physician to included in Table t and whether certain Physicians authonzed as users on NRC use licensed materials safely and to procedures should or should not be licenses may make copies of the license protect workers, patients, and the public authorized on the basis of various board to present to a new employer as from unnecessary radiation exposure. certifications. Eachindividual board , evidence of such approval.
This topic was discussed at public initiates action to become accepted by E. Comments Concerning the Medical ku t 18,1980, and Augus 31 981. Competence ofPhysician-Users c in p d . b s
, Information concerning these meetings Comment-Several commenters asked was published in the Federal Register the Commission evidence of eligibility NRC to not# physican and hospital prior to each meeting (44 FR 73170. 45 FR requirements accreditation. programs. licensees that NRC authorization relates 42904, and 46 FR 32354). Transcripts of . de a ti dure s nly to radiation safety and not to these meetm, as are available from NRC's RbP m medicalcompetence.
Public Document Room at 1717 H Street.
Additional boards may be m.cludedat Response-In 1979, the NRC published any time provided that they approach NW., Washington. D.C. R=h of the Medical Uses of 1 A Federal Register notice that the new NRC and present this information. These Radioisotopese Statement of General criteria were under consideration and submissions are exammed by the staff Policy" (44 FR 8242).The third and final that public comments were invited was and by appropeista members of the specific area in the policy stated. "The 1 published on January 22.1982 (47 PR ACMUI. A recommendationis made to NRC will minimiza intrusion into l 2228).ne Commission received 232 the full ACMUI at an open public rnedical judgements affecting patients 1 comment letters.of which 159 supported meeting.na boards listed inTable 1 and into other areas traditionally i the new criteria. 36 expressed support met the requirements specified above, considered te be a part cf the practice of but suggested specfic changes, and 33 medicine." The staff has and vedi l
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54378 Tederal Register / Vol. 47. No. 232 / Thursday, December 2,1982 / Notices continue to interpret this to mean NRC The concept of concurrent training in have traditionally been addressed by approval of a physician to use three month programs originated the State medicallicensing authorities byproduct materials in humans for because such programs were offered as and by peer review grog,s and treatment and diagnosis relates to part of the residency training leading to professional societies within the medical r:di: tion safety and to training certification by the American Board of profession. As stated previously. NRC sufficient to avoid unwarrented Radiology (ABR).The ABR and A03R published its decision to minimize rzdiction exposure to the physician, programs have recognized the need for a intrusion into areas traditionally '
medical workers and the public, minimum of six months of training and considered to be a part of the practice of in!cuding patients. Such authorization experience and have voluntarily taken medicine in 1979 ( 44 FR 8242).
does not imply a standard for action to restructure their programs Comment:If the training and prof:ssional clinical achievement as accordingly. The new programs will be experience criteria are increased to six would be evidenced by a medical in place by July 1.1984. NRC's action months, the only aspect that would be specialty board certification. Further will maintain its criteria equal to the augmented for cardiologists would be in clarification of NRC's position is being mmimum standards set by the the area ofinterpretation of scans.
c nsidered in connection with a profession. Response:NRC believes that actual separate revision to Part 35 of Title 10 Comment: Technetium 99m is the only experience handling unsealed Code of Federal Regulations. This NRC-licensed material used in radioactive materials (Item B of Table 2.
revision is under way at the present cardiovascular nuclear medicine studies Appendix A) should be augmented.
time, and its properties make it uniquely safe presently there is little incentive for a f r handling and use; therefore, an physician-in-trainirt to acquire such F. Comments Opposing the New Criterio increase in the training and experience experience. It is the physician, however.
Thi concerns of those who object to enteria is unwarranted. who is listed on the NRC license as the the criteria (as paraphrased by the NRC Response: The criteria in Section V of authorized user and who may be listed staff) and the staff response are Appendix A apply to physicians who as the radiation safety officer. The
- summarized below: use or supervise the use of molybdenum physician is responsible for the use of Comment:The current criteria have 99/ technetium 99m generators and the material. To fulfill this been more than adequate in protecting reagent kits to prepare Tc-99m labeled responsibility, the physician must have the public: therefore, there is no basis radiopharmaceuticals. These materials had adequate " hands on" experience f;r an increase. do present serious safety hazards if they during the training period.
R:sponse:The current criteria have are misused or improperly supervised. Comment: Additional requirements been adequate because they have been Tc-99m radiopharmaceuticals are also w 11 serve to discourage persons well revised whenever necessary to keep available in prepared, unit dose form, trained in cardiology from participating p c2 with developmente in nuclear ready for patient inlection. If a physician in cardiovascular nuclear medicine and medicine, a rapidly expanding, wishes to use this form for one or tw will therefore deprive the public of the technology based clinical specialty. In types of diagnostic studies and accepts expertise that cardiologists lend to these 1972, the Atomic Energy Commission, a limited possession limit, he or she may studies.
NRC's predecessor agency, had apply under the provisions of Appendix Response:The NRC licensing process physician training criteria that involved A.Section VI. does not prohibit cardiologists or any cnly 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of training in basic Comment:Through their training and other physicians from being present, radioisotope handling techniques. Since experience with cardiac catherization providing patient care, and participating that time, the criteria have been revised and angiocardiography, cardiologists are in the diagnosis during cardiovascular and increased three separate times. already familiar with the principles of nuclear medicine procedures. The Transcripts of NRC's ACMUI meetings radiation exposure. .. license specifies only what physician (or sh:w that each change was made in Response Any hours of trainmg that physici:ns) may use or supervise the use resp:nse to the increasing complexity of are specifically applicable to basic of the radioactive material that is tha fi:ld, not in response to accidents or handling techniques using unsealed needed to perform the procedure. In incidents. radioisotopes may be meluded in the many hospitals, these procedures are Tha transcripts of the public meetings physician's application to NRC. performed as a coordinated effort conc:rning the present changes indicate Comment: There are important risks if between the nuclear medicine physician that there has been an increase in the cardiovascular nuclear medicine studies and the cardiologist.
complexity of the diagnostic , , are performed by physicians who lack The revision to Appendix A of ,
interpretation of nuclear medicme formal training in cardiovascular . Regulatory Guide lad is printedin its - l studies and that this has resulted in a hemodynamics, coronary artery disease -
physiology, exercise testing and
,,,jyfy 3,7,y, I cincomitant increase in the portion of 3i the time that is allotted to this aspect of exercise physiology, arrhythmia Appendix A-Acceptable Training and trrining during the three month detection, and cardiopulmonary Experience for Medical Uses of programs. it is apparent from the resuscitation. Byproduct Material transcripts that, in order to stay within Response: The implication here is that I. GeneralCriterio thi three month limit, many programs NRC should not allow physicians with have made proportionate decreases in little or no training in cardiovascular Paragraphs 35.11 and 35.12 of10 CFR the aspects of training involving basic disease to perform cardiovascular Part 35 provide that the Commission will rcdioisotope handling techniques and nuclear medicine studies. Training and approve a license application for act ial experience handling unsealed experience criteria set by NRC relate medical use ifit determines, among r:dioactive materials. In order to specifically to safe handling of the other things, that the physician l miintain the previous level of training in reactor produced radioisotopes that are designated as the individual user has these last two areas. the increase to used during the medical procedure. NRC adequate experience in the proposed program of six mont: s duration is does not regulate the quality of medical use, the handling and administration of justified. practice. Matters of medical competence isotopes, and where applicable ^.e l
M Federal Register / Vol. 47. No. 232 / hrsday. December 2.1982 / Notices 54 m clinical management of radioactive I II. and III of I 35.100.10 CFR Part 35, a eews patients. In addition. 8 30.33 of to CFR physician should have the ' raining and i am na pime w =1_ s Part 30 requires that applicants be m experience listed in Table 2.. a promma es
( ) qualifled by training and experience to V use licensed material for the purpose Vi, TminingforSpecific Diagnostic *"***"*****
requested in the application. Procedures
'Ihis appendix outlines training and A physician who wishes to be experience criteria that the Commission, authorized for only one or two specific Vll/. Tminingfor Thempy Pmcedums with the assistance ofits Advisory diagnostic procedures should have involvingSealedSouxes(Cmup VI)
Committee on the Medical Uses o'l . training in basic radioisotope handling Isotopes (ACMUI). has found acceptable techniques and clinical experience To qualify as adequately trained to
, for physicians 8 who wish to use commensurate with the types, quantitles use byproduct material listed in Group byproduct material for human use.' We VI of I 35.100.10 CFR Part 35, a g and uses of byproduct material being recommend that this training and requested. Such requests will be physician should have the training and experience be obtained in a formal, exper ence listed in Table 3.
examined case-by. case by the accredited training program for :esident Commission with advice from the Wh physicians.
g7;j' a physician g is not board ACMUI.
Physician training and experience can specialties listed in Table 1. his or her be examined on a case-by-case basis. A VII. Tminingfor ThempyPmcedures training will be reviewed with the physicit.n wishing to use radioact2ve favolving Radiopharmaceuticals assistance of the ACMUI.In addition to (Croups Ivand V) Supplements A and B as described in material but not havfrg the training and experience described, may submit an A. Physicians who meet the criteria Section III. above, the appIicant shouId application listing specflic for Groups I-III may qualify to perform rubmit letters of evaluation from each qualifications: and these will be specific therapy procedures with the physician who served as preceptor.
reviewed by the Commission with the following clinical experience: These letters of evaluation should assistance of the ACMUI. 1.1-131 for treatment of describe the scope and extent of the hyperthyroidism and/or cardiac appqcant's training and experience and II. Acceptance ofMedicalSpeciaity conditions, should state whether, in the opinion of Boanf Certification Clinical ' experience in the diagnosis of the preceptor, the applicant is fully Certification by the medical specialty thyroid function and active participation qualified to independently perform boards listed in Table 1 will be accepted in the treatment of ten patients. Group VI therapy procedures.
as evidence that a physician has had 2. Soluble P-32 for treatment of IX. TminingforPhysicians Wishing To adequate training and experience for the polycythemia vera. leukemia, and/or Use SR-Br/ Eye Applicators Only corresponding procedures listed in the bone metastases:
table. Active participation in the treatment To qualify as adequately trained to bg .
U) 111. Documenting Tmm. .mg and Expenence of three patients with any combination of these three conditions.
use a Sr-90 eye applicator only, a physician should submit evidence of
- 3. Colloidal P-32 for intracavitary certification by one of the radiation Supplements A and B of Form NRC treatment: therapy specialty boards listed in Table 313M are used to document training and Active participation in the 1 or, as a minimum, evidence of:
experience. Physicians who wish to intracavitary treatment of three patients A. Active practice in therapeutic qualify on the basis of board using colloidal forms of either P-32 or radiology or opthalmology.
certification need only complete Items 1 Au-198
- 2. and 3 on Supplement A. Other 4.1-131 for treatment of thyrm' applicants should submit Supplements.A carcinoma: ,,
a r, . n e ,--*y and B with allitems completed. A Clinical experience M & w f ,mu n.n.s cn.
separate Supplement B for'n should be . cues 14 completed and signed by each preceptor thyroid function, perdD ned "le ;y tion i
- """"8"***"'*'"""*"a e in the treatment of tef c E "[*.".*cs ',"ta,".o sw v .no 9
who provided training or supervised hyperthyroidism and/or cardiac nu'=awa' a' raa='* *
. experience.
dysfunction, and active participation in *""""**
- IV. Time f. imitation on Acceptable the treatment of three patients with Training and F.xperience thyroid carcinoma. This information should be submitted .
- 5. Colloidal Au-198 for intracavitary on Supplement A of Form NRC-313M.
Training and experience must have treatment:
been obtained within five years of the The hours listed next to each of the four date Active participation in the subjects are suggested mimmum values apph,0f the application. or else the intracavitary treatment of three patients and should not be interpreted as specific cant must demonstrate continuing involvement in the procedures since the using colloidal forms of either Au-198 or requirements.
P-32.
time of training. C. Active participation in the B. To perform only Group IV and V treatment of five patients (to be V. Trainingfor Routine Diagnostic therapy procedures, physicians who do submitted on Preceptor Statement. Form Procedums (Croups I-III.
- Including not meet the criteria for Groups I-III NRC 313M. Supplement B).
CardiovascularNuclearMedicine) need to obtain the specific clinical experience listed in VII. A. above and, .. Active participation" should include To qualify as adequately trained to supervised examination of patients, 88 8 n use byproduct materiallisted in Groups collaboration and calculations concerning the dose to be administeled.
- As defined in to Cnt 31s administration of the dose to the patient.
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- Physicians authoru.d for Group u or in may
.lso use Xenon-12 7,,,n,,,
,,.anc.%, - ,,. ,.,.,osos.
- ,, m. nana sowem w m.wecaem ecunng orng em, m followup and study of patient case so histories.
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54380 Federal Regleter / WI. 47. No. 232 / Thursd1y. D:cember 2.1982 / Notices ' -
TAsts 1.-Act.tPTAfeCE OF MEoiCAL SPECLALTY BOARo CERTFICATION ,,m,,
A Tr.rwig si t; ewe redesec.coe h ndisq apeN P'UD"A'*8 reques ag.duasy spac.D. m F. use of esamuif aiasc.8 ADr r'.repF droc. tap.A cor tak Asnrv.rt bo.rd ce 88 utter hiesiS 9.mme H.eite o,oup. 6-v. e, ce i.ctres, meoreteiry a.smiers, c>ncu.'.en ce. , s ne nu a .nc. . e. io.o 4=re , sonris ce maaoew_ o.wene Raaman so. cia campa.nc. Grow. Mn e, arms 2co Nuces Radology i Raeshon physcs no ristwnerwahon_ _ 150 oroup Vt Ramology in ==vaca.sceow Arn. rices Osi.ie. ret Bo.ro of oingreetic Raeology '
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hours).This experienca should cover the types and quantities of byproduct Table 2.-Miminum Acceptable Training inisadministration of materials to material requested in the application for Routine Diagnostic Procedures patients. and should include:
(dtoupe I-III) 6. Emergency procedures to handle t Ordering, receiving, and Concurrent Trainingin six month and contain spilled materials safely, unpackaging sealed sources safely.
Progicms. The criteria specified below including related decontamination including performance of the related indy be solis [iedconcurantlyin a ptocedureS. '* b * 'i U" *"*Y**
. r nnance of operational checks
/dtmalintergrotedsIx. month tmining 7. Elution of Tc-99m from generator progtum. Note, however, that all of the n i n chambers and survey maters.
systems, assay and testing of the eluate tequirements in Sections A., B. and C. 3. Safe handling of sealed sources for Mo-99 and alumina contamination. during preparation, insertion and must be fully intergrated into the and processing the eluate with reagent prostem. Physicians who do not recieve kits to prepare Tc-99m labeled their training in such a program should 4. Quality control and emergency radiopharmaceuticals. (Required when obtain the specifled number of hours in procedures.
physicians apply for Group III , ,
each area: C. Clinical tratmng in Group VI authorization.) procedures: Active practice in C. Supervised clinical training in an therapeutic radiology with a minimum of anse institutional nuclear medicine (or 3 years experience of which at least 1 tiame Q8're, cardiovascular nuclear medicine) year should have been in a formal e ,, nw ,,n, .noue con ,. ,, program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).The chmcal training pregram approved by the
- y* ube**rt , g,gg training should cover all appropriate Residency Review Committee for ineo,.io,y e. mao,,, ,== 2eo types of diagnostic procedures and Radiology of the Accreditation Council i Paarea chr=* ew ==w=raaen ico should include: for Graduate Medical Education or the
$ Yv5.ie. "" , . e. .no , 1. Supervised examination of patients Committee on Postdoctoral Training of
- acmy the American Osteopathic Association.
, g o,,',,,,, g to determine the suitability for s p.eeeean,.c.,ecs cr .,y. ao radioisotope diagnosis and Dated at Silver Spring. Md this 27th day of g g,, ,,, recommendation on dosage to be September 1982.
- e. ut,ma wi == wimaa not i ,=re.n.: prescribed. For the Nuclear Regulatory Ccomisalon.
- 2. Selection of the proper Richard E. Cunningham, ik Experiente handling unsealed radiopharmaceutical and dosage. Director. Dinsion offue/ Cycle andMorenal radioattive materials under the calculation of the related radiation dose Safety. Office o/NuclearMotenalSafety and supervision of a qualified instructor (500 and collaboration in the interpretation Scfeguards.
hours). This experience should cover the of the radioisotope test results. Ini ox. az-r,se ri:.a i:-i-a . .s . i types and quantities of byproduct 3. Follow.up of patients when swno cm me.ei.=
material tequested in the app!! cation required.
tnd should include: 4. Study and discussion of case
- 1. Ordering, recieving and histories with preceptor to establish the un ackaging radioactive maten.a ls most appropriate diagnostic procedures, se ly including performance of the limitations, contraindications, etc.
related radiation surveys. ,
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- 2. Calibration of dose calibrators and Table 3.-Minimum Acceptable Training diagnostic instrumentation, and for Therapy Procedures Involving performance of operational checks on Sealed Sources (Group VI) survey meters. l
- 3. Calculation, preparation and To qualify as adequately trained to calibration of patient doses including use byproduct material listed in Group radiation safety considerations. . VI of 5 35.100.10 CFR Part 35, a
- 4. Administration of doses to patients, physician should have:
including proper use of syringe shields.
S. Appropriate internal control procedures to prevent the i
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. #-.,.,'% UNITED STATES POR f r . ,. , j NUCLEAR REGULATORY COMMISSION g'73 g-: ..j WASHINGTON. O. C. 20555 k.....,/ J'Ji 1.G 1220 8
TO ALL NRC MEDICAL LICENSEES
Dear Licensee:
On September 28, 1979 we sent you a letter about an ALARA program to be implemented by December 4,1979. We subsequently informed you that the implementation date was being delayed until March 4,1980 in order to revise the model ALARA program to take into account many ccmments we received. Enclosed is a revised program which should be implemented by August 15, 1980. Additional time is being allowed so that licensees can make appropriate adjustments in their programs. During the past two months we have sought and considered the opinions and comments of many professionals in all areas involving the use of radiation in medicine. These discussions have led us to modify several program elements and to clarify others. The revised program reduces the administrative burden on the licensee while still meeting the original goal; to provide management a tool for maintaining occupational exposures ALARA and to provide NRC with a basis for inspecting ALARA programs.
The original program provided for establishment of an Action Level which was misinterpreced as a lowering of the maximum pernissible dose limi.ts.
This was not, and is not, the intention of the program. The revised program appifes the concept of " Investigational Levels" as defined in ICRP Report No. 25 "Recent::endations of the Commission en Radiological Protection," January 17, 1977. The Investigational Levels in the revised program are not new dose limits but, as noted in the ICRP report, serve I as check points above which the results are considered sufficiently important to justify further investigations. Investigational Levels are tools to be used by those in your institution respcnsible for the management of radiation safety programs. In determining ccmpliance with regulations, NRC will be concerned with wnether a review and/or investigation has been carried out rather than whether the Investigational Level has been exceeded.
There was concern on the part of some licensees that improved measurements would be required to ccmply with the program. Current methods of recording
- s personnel exposures for purooses of compliance with 10 CFR 20, 520.101 are also adecuate for use in determining the need for a review or investigation in accordance with the ALARA program.
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The new program has been revised, to considerably reduce the paperwork burden. Actions to be taken under the revised ALARA program will be included in, or covered by, documentation already required to be maintained by licensees. Results of personnel monitoring are already recorded at least quarterly on Form NRC-5 or an equivalent fom as required by 10 CFR 20, 520.401. Results of investigations you make when an Investigational Level is exceeded should be made part of the Radiation Safety Comittee minutes, thus eliminating the need for a separate record. A private practice nuclear medicine licensee would need to maintain review or investigation records but since the majority of these licensees employ few staff requiring personnel monitoring this obligation should create no undue burden.
In the original program, reference was made to guidance provided by U.S.
Nuclear Regulatory Guides 8.10 and 8.18. Some interpreted this as a comitment for strict adherence to all aspc:ts of these guides. The guidance given in these documents should be reviewed to determine if the benefits, in tems of additional dose reductions, are justified by the cost of those reductions.
Both guides are now used by the NRC licensing staff as part of the basis for evaluating license applications and radiation safety programs. NRC will continue to consider equivalent alternative methods of complying with the principles contained in the guides and with specified portions of the Commission's regulations. You should be aware that these are only two of many sources of information available to guide you in maintaining occupaticnal radiation exposures at medical institutions ALARA. Another good reference source available from NRC is HUREG-0267, " principles and Practices for Keeping Occupational Radiation Exposures At Medical Institutions As low As Reasonably Achievable." The model program applies only to the .
radiation exposure of personnel arising in whole or in part from NRC licensed byproduct materials. Excanding the program te cover other radiation workers in your institution is an option available to you.
The revised model of an ALARA program is provided as an enclosure to this letter. Your institution should adopt this program or develop an equivalent alternative program for review by NRC. After August 15, 1980 you will submit your program when you submit your next renewal or significant amendment application. If necessary for clarification or emphasis, you are encouraged to add explanatory text to the model program. If accepted, your program will be incorporated as a cc7dition of your NRC license. There is no need to submit your ALARA program to NRC wtt44 such time as you amend or renew your license. However, you should implement the program within your institution as soon as possible, if you have not already done so. Those licensees who have already submitted programs in accordance with the original model or an equivalent alternative progra;a may either resu'mit c a revised program or maintain the program as proposed unless notified othemise by NRC.
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I would like to emphasize that the ALARA concept is not new and that most of the cemitments in the: enclosed formal program are already adhered to by those who maintain good radiation safety programs.
Sincerely, n JAL x, William J. Dircks, Director Office of Nuclear Material Safety and Safeguards Approved by GAO !
B-ldO225 (R0658)
Expires 83-05-31 6
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o Model program for Maintaining Occupational Radiation Exposures at Medical Institutions ALARA i
(.icensee's Name)
(Date)
I. Management Commitment
- a. We, the management of this (medical facility, gospital, etc.)
are comitted to the program described in this paper for keeping exposures (individual and collective) as low as reasonably achievable (ALARA). In accord with this commitment, we hereby describe an administrative organization for radiation safety and will develop the necessary written policy, procedures and instructions to foster ~the ALARA concept within our institution. The organization will include a Radiation Safety Ccmmittee (RSC)1 and a Radiation Safety Officer (RS0).
- b. We will perform a formal annual review of the radiation safety program including ALARA considerations. This shall include reviews of operating procedures and past exposure records, inspections, etc., and consultations with the radiation prctection staff or outside consultants.
t c. Modification to operating and maintenance procedures and to equipment and facilities will be made where they will reduce exposures unless the cost, in our judgement, is considered to be unjustified. We will be able to demonstrate, if necessary, that improvements have been sought, that modifications have been considered, and that they have been implemented where reasonable.
Where modifications have been recomended but not implemented, we will be prepared to describe the reasons for not implementing them.
- d. In addition to maintaining doses to individuals as far below the limits as is reasonably achievable, the sum of the doses received by all exposed individuals will also be maintained at the lowest practicable level. It would not be desirable, for l example, to hold tha highest doses to individuals to some fraction of the applicable limit if this involved exposing i
additional people and significantly increasing the sum of radiation doses received by all involved individuals.
1 private practice physician licenses do not include a ASC.
b II. Radiation Safety Committee (RSC)2
- a. Review of Proposed Users and Uses
- 1. The RSC will thoroughly review the qualifications of each applicant with respect to the types and cuantities of materials and uses for which he has applied to assure that the applicant will be able to take appropriate measures to maintain exposure ALARA.
- 2. When considering a new use of byproduct material, the RSC will review the efforts of the applicant to maintain
- exposure ALARA. The user should have systematized procedures to ensure ALARA, and shall have incorpora~ted the use of special equipment such as syringe shields, rubber gloves, etc., in his proposed use.
- 3. The RSC will ensure'that the user justifies his procedures -
and that dose will be ALARA (individual and collective).
- b. Delegation of Authority (The judicious delegation of RSC authority is essential to the enforcement of an ALARA program.)
1 2. The RSC will support the RSO in those instances where it is necessary for the RSO to assert his authority. Where the RSO has been overruled, the Ccmmittee will record the basis for its action in the minutes of the Committee's quarterly meeting.
- c. Review of ALARA Program
- 1. The RSC will encourage all users to review current proc'edures and develop new procedures as appropriate to implement the ALARA concept.
- 2. The RSC will perfom a quarterly review of occupational radiation exposure with particular attention to instances where Investigational Levels in Table I below are exceeded.
The principle purpose of this review is to assess trends in occupational exposure as an index of the ALARA program quality and to decide if action is warranted when Investigational Levels are exceeded (see paragraph VI).3 2 The RSO on pri'vate practice physician licenses will assume the responsibilities of the RSC under Section II 3
The NRC has emphasized that the Invessigational Levels in this program are not new dose limits but, as noted in ICRP Report 26, "Reccmendations of the 1
- nternational Cc. mission on Radiolcgical protection", serve as check points above which the results are considered sufficiently imcortant to justify further investigations.
, - . . , . , . . , , - , , . _ . , . . _ _ . , ,_ ___m..,,y.,_. , _ _ _ , , , . . ,.__,,.,y_ m,_,._,.m_ ,,__,_%,.._-,_,.,__r.,. .,_.,..,.,,,,.._,_y,-,,mm.,7._y,,.,,,
. 3. The RSC will evaluate our institution's overall ' efforts for maintaining exposures ALARA on an annual basis. This review will include :he efforts of the RSO, authorized users, and workers as well as those of management.
III. Radiation Safety Officer (RS0)
- a. Annual and Quarterly Review
- 1. . Annual review of the Radiation Safety Program. The RSO will perform an annual review of the Radiation Safety program for adherence to ALARA concepts. "leviews of specific procedures may be conducted on a more frequent basis.
2.* Quarterly review of Cccupational Exposures. The RSO '
will review at least quarterly the external radiation exposures of authorized users and workers to determina that their exposures are ALARA in accordance with the provisions of paragraph VI of this program.
- 3. Quarterly review of records of Radiation Levei Surveys. The RSO will review radiation levels in unrestricted and restricted areas to deter =ine that they were at ALARA levels during the previous quarter.
- b. Education Responsibilities for an ALARA Program -
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- 1. The RSO will schedule briefings and educational sessions to inform workers of ALARA program efforts.
- 2. The RSO will assure that authorized users, workers and ancillary personnel uno may be exoosed to radiation will be instructed in the ALARA pnilosophy and informed that .
management, the RSC and the RSO are committed to implementing the ALARA concept.
- c. Cooperative Efforts for ::evelopment of ALARA ?rocedures Radiation workers will be given opportunities to participate in fannulation of the procedures that they will be required to J follow.
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- 1. The RSO will be in close contact with all users and workers in order to develcp ALARA procedures for working with radioactive materials.
l 2. ,The RSO will establish procedures for receiving and L evaluating the suggestions of individual workers for I . improving health physics practices and encourage the use of those procedures.
m.
- d. Reviewing Instances of Deviation from Good ALARA Practices The RSO will investigate all known instances of deviation from good ALARA practices; and, if possible, determine the causes.
When the cause-is known, the RSO will require changes in the program to maintain exposures ALARA.
IV. Authorized Users
- a. New Procedures Involving Potential Radiation Exposures
- 1. The authorized user will consult with, and receive the approval of, the RSO and/or RSC during the planning stage before using radioactive materials for a new ' procedure.
- 2. The authorized user will evaluate all procedures before using radioactive materials to ensure thac exposuras will be kept ALARA. This may be enhanced through the application of trial runs.
- b. ResponsibilityoftheAuthorizedUsertoThoseHeSupervises
- 1. The authorized user will explain the ALARA cnncept.and his commitment to maintain exposures ALARA to all of those he supervises.
- 2. The authorized user will ensure that those under his
' supervision who are subject to occupational radiation exposure are trained and educated in good health physics practicas and in maintaining exposures ALARA.
V. Persons Who Receive Occupational Radiation Exposure
- a. The worker will be instructed in the ALARA ccncept and its relationship to his working procedures and work conditions..
- b. The worker will know what recourses are available if fie feels that ALARAfis not being promoted on the job.
VI. Establishment of Investigational Levels In Order to Monitor Individual Occupational External Radiation Exposures This institution (or private practice) hereby establishes Investigational Levels for occupational external radiation exposure which, when exceeded, will initiate review or investigation by the Radiation Safety Ccmmittee and/or the Radiation Safety Officer. The Investigational Levels that we have adopted are listed in Table 1 below. These l levels apply to the exposure of individual workers.
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- 5 Table 1 Investigational Levels -
(mrems per calendar quarter)
LEVEL I LEVEL II
- 1. Whole body; head and trunk; 125 375 active blood-foming organs; lens of eyes; or gonads
- 2. Hands and forearms; feet and 1875 5625 ankles
- 3. Skin of whole body
- 750 2250 i
- Not normally applicable to nuclear medicine operations except those using significant quantities of beta emitting isotopes.
- The Radiation Safety Officer will review and record on Form NRC-5, Current Occupational External Radiation Exposures, or an equivalent form (e.g. dosimeter processor's report), results of personnel monitoring, not less than once in any calendar quarter, as is required by 10 CFR 20, 120.401. The following actions will be taken at the Investigational Levels as stated in Table 1:
- a. Quarterly exposure of individuals to less than Investigational Level I.
Excect when deeced appr:priate by the RSO, no fur-her action will be taken in those cases wnere an individual's exposure is' less than Table I values for the Investigational Level I.
- b. Personnel, exposures equal to or greater than Investigational Level ,
I, but less than Investigational Level II.
The RSO will review the excesure of each individual whose quarterly exposures equal or exceed Investigational Level I.
He will report the results of his reviews at the first RSC meeting following the quarter wnen the exposure was recorded.
If the exposure does not ecual or exceed. Investigational level II, no action related specifically to the exposure is required unless deemed appropriate by the Committee. The C:=mittee will, however, consider each such excesure in comparison with those of'.others performing similar tasks as an index of ALARA program quality and will record the review in the Cornaittee minutes.
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- c. Exposure equal to or greater than Investigational Level II.
The RSO will investigate in a timely manner the cause(s) of all personnel exposures equaling or exceeding Investigational Level II and, if warranted, take action. A re; ort of the investigation, actions taken, if any, and a cc y of the individual's Fonn flRC-5 or its equivalent will be presented to the RSC at the first RSC meeting folicwing completion of the investigation.
The details of these reports will be recorded in the Comittee minutes. Committee minutes will be sent to the management of this institution for review. The minutes, containing details of the investigation, will be made available to flRC inspectors for review at the time of the next inspection. ,
- d. Re-establishment of an individual cccupational worker's Investigational Level II Above That Listed In Table I.
In cases where a worker's or a group of worker's exposures need to exceed Investigational Level II, a new, higher Investigational Level II may be established on the basis that it is consistent with good ALARA practices for that individual or group.
Justification for a new Investigational Level II will be documented. .
The Radiation Sa'fety Comittee will review the justification for, and will approve, all revisions of Investigational Levels II. In such cases, when the ex:csure equals or exceeds the newly estabitshed Investigational Level II, those actions listed in paragraph ^c above will be fo11cwed.
VII. Signature of Certifying Official d
. I hemby certify that this institution (cr private ;ractice),
has implemented the ALARA Program set forth acove.
Signature flame (print or type) i 1
Title .
Institution (or Private Practice) Name and Address:
a The individual who is authorized to,make c:::mitments for the administration of the institution (e.g., hospital acministrator, etc.) or, in the case of a private practice, the licensad ?nysician.