Byproduct material; medical use: Speciality boards and medical speciality boards; solicitation,
[Federal Register: November 2, 2000 (Volume 65, Number 213)]
[Proposed Rules]
[Page 65793-65798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no00-27]
NUCLEAR REGULATORY COMMISSION
RIN 3150-AF74
Medical Use of Byproduct Material--Speciality Boards and Medical Speciality Boards: Solicitation
AGENCY: Nuclear Regulatory Commission.
ACTION: Solicitation.
SUMMARY: The Nuclear Regulatory Commission (NRC) is beginning a new process to recognize speciality boards and medical speciality boards (whose diplomates would fulfill the training and experience requirements for an authorized medical physicist, authorized nuclear pharmacist, authorized user, and/or a Radiation Safety Officer) by listing the boards on an NRC website instead of including the names of boards in 10 CFR Part 35, ``Medical Use of Byproduct Material.'' The NRC is taking this action in anticipation of a revision to its regulations governing the medical use of byproduct material. Any board that is interested in being recognized by the NRC should submit a letter certifying that its certification process would meet the draft final training and experience requirements for an authorized medical physicist, authorized nuclear pharmacist, authorized user, and/or a Radiation Safety Officer.
DATES: The solicitation process begins November 2, 2000.
ADDRESSES: Documents related to the proposed rule may be examined through September 22, 2000, at the NRC Public Document Room and electronically at http://ruleforum.llnl.gov. Beginning September 25, 2000, the NRC Public Document Room will be located at 11555 Rockville Pike, Rockville, MD.
FOR FURTHER INFORMATION CONTACT: Sam Jones, Office of Nuclear Material Safety
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and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555- 0001, (301) 415-6198, e-mail SZJ@nrc.gov.
SUPPLEMENTARY INFORMATION:
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Discussion
The NRC is in the final stages of revising its medical use regulations in 10 CFR Part 35, ``Medical Use of Byproduct Material.'' The proposed rule revising Part 35 was published August 13, 1998 (63 FR 43516). It is anticipated that the Commission will publish the final rule in the Federal Register in Spring 2001 with an effective date 6 months after publication. As part of this revision, the regulatory text would not include the names of the specific boards whose diplomates automatically fulfill the training and experience requirements for an authorized medical physicist, authorized nuclear pharmacist, authorized user and a Radiation Safety Officer. Rather, the NRC will recognize certification boards that require individuals to complete the training and experience requirements specified in the regulatory text. This change is being made to eliminate the need for a rulemaking each time a board is added or deleted. Once recognized, the board's name will be placed on the list of recognized boards to be maintained on the NRC website. NRC expects to begin listing the names of boards on an NRC website prior to the effective date of the final rule.
This document serves as notification to all speciality boards of NRC's intent to initiate the recognition process immediately. If any board is interested in being recognized by the NRC, the board should submit a letter to Dr. Donald A. Cool, Director, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001. The letter should list each training and experience section of the rule for which the board believes that their diplomates should be deemed to have met the requirements. Section II and Section III of the SUPPLEMENTARY INFORMATION should assist a board in preparing its letter. Section II lists all training requirements for which NRC plans to recognize board certification as meeting the requirements. Section III is a copy of the draft final regulatory text that lists the training and experience criteria for an authorized medical physicist, authorized nuclear pharmacist, authorized user and a Radiation Safety Officer.
The board's letter should clearly state that an individual must have completed the training and experience required by a particular section prior to receiving board certification. For example, if a board would like to be recognized under 10 CFR 35.390. ``Training for use of unsealed byproduct material for which a written directive is required,'' the letter should state: ``(the name of the organization) has reviewed 10 CFR 35.390 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board.'' The letter should be dated and signed by the chief executive of the board.
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Training Requirements for Which NRC Plans To Recognize Board Certification
The following are the titles of the specific sections in the draft final regulations that contain the specific training and experience requirements for a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist, and authorized user:
35.50 Training for Radiation Safety Officer. 35.51 Training for an authorized medical physicist. 35.55 Training for an authorized nuclear pharmacist. 35.190 Training for uptake, dilution, and excretion studies. 35.290 Training for imaging and localization studies. 35.390 Training for use of unsealed byproduct material for which a written directive is required. 35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries). 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries). 35.490 Training for use of manual brachytherapy sources. 35.491 Training for ophthalmic use of strontium-90. 35.590 Training for use of sealed sources for diagnosis. 35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
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Draft Final Regulatory Text--Training and Experience
This section contains draft final regulatory text for the sections listed under section II. This regulatory text is presented here for use by boards that are interested in being recognized by NRC.
Section 35.50 Training for Radiation Safety Officer
Except as provided in Sec. 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Sec. 35.24 to be an individual who--
(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program consisting of both:
(i) 200 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Radiation biology; and
(E) Radiation dosimetry; and
(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes similar type(s) of use(s) of byproduct material involving the following--
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;
(C) Securing and controlling byproduct material;
(D) Using administrative controls to avoid mistakes in the administration of byproduct material;
(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;
(F) Using emergency procedures to control byproduct material; and
(G) Disposing of byproduct material; and
(2) Has obtained written certification, signed by a preceptor Radiation Safety Officer, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee; or
(c) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has Radiation Safety Officer responsibilities.
Section 35.51 Training for an authorized medical physicist
The licensee shall require the authorized medical physicist to be an individual who--
(a) Is certified by a specialty board whose certification process includes all of the training and experience requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Holds a master's or doctor's degree in physics, biophysics, radiological physics, medical physics, or health physics and has completed 1 year of full-time training in therapeutic radiological physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist at a medical institution
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that includes the tasks listed in Secs. 35.67, 35.433, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, and 35.652, as applicable; and
(2) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written certification must be signed by a preceptor authorized medical physicist who meets the requirements in Sec. 35.51 or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
Section 35.55 Training for an authorized nuclear pharmacist
The licensee shall require the authorized nuclear pharmacist to be a pharmacist who--
(a) Is certified as a nuclear pharmacist by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed 700 hours in a structured educational program consisting of both:
(i) Didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised practical experience in a nuclear pharmacy involving--
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;
(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;
(D) Using administrative controls to avoid medical events in the administration of byproduct material; and
(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and
(2) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.
Section 35.190 Training for uptake, dilution, and excretion studies
Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under Sec. 35.100 to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under Secs. 35.290 or 35.390 or equivalent Agreement State requirements; or
(c)(1) Has completed 60 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies; the training and experience must include--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.190, Sec. 35.290, or Sec. 35.390 or equivalent Agreement State requirements, involving --
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(2) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in Secs. 35.190, 35.290, or 35.390 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Sec. 35.100.
Section 35.290 Training for imaging and localization studies
Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under Sec. 35.200 to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under Sec. 35.390 or equivalent Agreement State requirements; or
(c)(1) Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies; the training and experience must include, at a minimum--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use;
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user, who meets the requirements in Secs. 35.290 or 35.390 or equivalent Agreement State requirements, involving--
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
(2) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in Secs. 35.290 or 35.390 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Secs. 35.100 and 35.200.
Section 35.390 Training for use of unsealed byproduct material for which a written directive is required
Except as provided in Sec. 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under Sec. 35.300 to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material
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requiring a written directive; the training and experience must include--
(i) Classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in Sec. 35.390(b), must have experience in administering dosages in the same dosage category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual requesting authorized user status. The work experience must involve--
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Calibrating instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;
(F) Eluting generator systems, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
(G) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status--
(1) Oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131;
(2) Oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131 \1\;
\1\ Experience with at least 3 cases in Category (G)(2) also satisfies the requirement in Category (G)(1).
(3) Parenteral administration of any beta emitter or a photon- emitting radionuclide with a photon energy less than 150 keV; and/or
(4) Parenteral administration of any other radionuclide; and
(2) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Sec. 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in Sec. 35.390(b), must have experience in administering dosages in the same dosage category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual requesting authorized user status.
Section 35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries)
Except as provided in Sec. 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b), for uses listed in Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, or equivalent Agreement State requirements; or
(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive; the training must include--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Chemistry of byproduct material for medical use; and
(v) Radiation biology; and
(2) Has work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), Sec. 35.392, Sec. 35.394, or equivalent Agreement State requirements. A supervising authorized user who meets the requirements in Sec. 35.390(b), must have experience in administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(1) or (2). The work experience must involve--
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;
(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under Sec. 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirement in Sec. 35.390(b), must have experience in administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(1) or (2).
Section 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries)
Except as provided in Sec. 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (c) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b), for uses listed in Sec. 35.390(b)(1)(ii)(G)(2), or equivalent Agreement State requirements; or
(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive; the training must include--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity;
(iv) Chemistry of byproduct material for medical use; and
(v) Radiation biology; and
(2 ) Has work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), Sec. 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in Sec. 35.390(b), must have experience in administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(2). The work experience must involve--
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(ii) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;
(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
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(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under Sec. 35.300. The written certification must be signed by a preceptor authorized user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in Sec. 35.390(b), must have experience in administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(2).
Section 35.490 Training for use of manual brachytherapy sources
Except as provided in Sec. 35.57, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under Sec. 35.400 to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes--
(i) 200 hours of classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.490 or equivalent Agreement State requirements at a medical institution, involving--
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Checking survey meters for proper operation;
(C) Preparing, implanting, and removing brachytherapy sources;
(D) Maintaining running inventories of material on hand;
(E) Using administrative controls to prevent a medical event involving the use of byproduct material;
(F) Using emergency procedures to control byproduct material; and
(2) Has obtained 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in Sec. 35.490 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in Sec. 35.490 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under Sec. 35.400.
Section 35.491 Training for ophthalmic use of strontium-90
Except as provided in Sec. 35.57, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who--
(a) Is an authorized user under Sec. 35.490 or equivalent Agreement State requirements; or
(b)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy; the training must include--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology; and
(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve--
(i) Examination of each individual to be treated;
(ii) Calculation of the dose to be administered;
(iii) Administration of the dose; and
(iv) Follow up and review of each individual's case history; and
(3) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in Sec. 35.490, Sec. 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (a) and (b) of this section and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.
Section 35.590 Training for use of sealed sources for diagnosis
Except as provided in Sec. 35.57, the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under Sec. 35.500 to be a physician, dentist, or podiatrist who--
(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b) Has had 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device; the training must include--
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Radiation biology; and
(5) Training in the use of the device for the uses requested.
Section 35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
Except as provided in Sec. 35.57, the licensee shall require an authorized user of a sealed source for a use authorized under Sec. 35.600 to be a physician who--
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraph (b) of this section and whose certification has been recognized by the Commission or an Agreement State; or
(b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes--
(i) 200 hours of classroom and laboratory training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Sec. 35.690 or equivalent Agreement State requirements at a medical institution, involving--
(A) Reviewing full calibration measurements and periodic spot- checks;
(B) Preparing treatment plans and calculating treatment doses and times;
(C) Using administrative controls to prevent a medical event involving the use of byproduct material;
(D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
(E) Checking and using survey meters; and
(F) Selecting the proper dose and how it is to be administered; and
(2) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in Sec. 35.690 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written certification that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written certification must be signed by a preceptor authorized user who meets the requirements in Sec. 35.690 or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.
Dated at Rockville, Maryland this 20th day of October, 2000.
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For the Nuclear Regulatory Commission. Josephine M. Piccone, Acting Director, Division of Industrial and Medical Nuclear Safety, NMSS.
[FR Doc. 00-27940Filed11-1-00; 8:45 am]
BILLING CODE 7590-01-P
