ML19016A335

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Instructions for AMP T&E for Use by Applicants January 11, 2019
ML19016A335
Person / Time
Issue date: 02/07/2019
From:
Office of Nuclear Material Safety and Safeguards
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ml19016a042 List:
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Download: ML19016A335 (4)


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ML19016A335 Instructions for submitting training and experience information for an authorized medical physicist or an ophthalmic physicist NRC Medical Use Applicants, Licensees, and Master Materials Permittees This instruction describes the training and experience information that applicants, licensees and Master Material License (MML) permittees should submit for each authorized medical physicist (AMP) or ophthalmic physicist in Item 7, Individual(s) Responsible for Radiation Safety Program and Their Training and Experience of NRC Form 313, Application for a Materials License. These instructions are effective until the Office of Management and Budget (OMB) approves the revisions to the NRC Form 313 A series.

Usually, applicants, licensees, and permittees use the NRC Form 313 A series to provide training and experience information. However, OMB has not yet approved the revisions to the revised NRC Form 313 A series that comports with the final rule, Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, 83 FR 33046 (July 16, 2018). Therefore, these forms should not be used by medical use applicants, licensees, or permittees in submissions to either the NRC or an MML. The current NRC Form 313 A series of forms should also not be used because they do not comport with the final rule.

Applicants, licensees, and permittees should follow the instructions provided below to provide training and experience information to the NRC and MMLs. These instructions are from pages 30 through 49 of Guidance for the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, which is available at https://www.nrc.gov/docs/ML1817/ML18176A377.pdf. These instructions comport with the training and experience requirements in 10 CFR Part 35 that went into effect on January 14, 2019.

Authorized Medical Physicist Provide the following:

Name of the proposed AMP.

AND For an individual previously identified as an AMP on an NRC or Agreement State license or permit:

Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was specifically named an AMP for the uses requested.

2 AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.

OR For an individual qualifying under 10 CFR 35.57(a)(4):

Documentation that the medical physicist used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for medical uses at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; AND Documentation that the medical physicist used these materials for the same medical uses as requested.

AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.

OR For an individual qualifying under 10 CFR 35.51(a):

Copy of the certification(s) of the specialty board(s) whose certification process has been recognized1 under 10 CFR 35.51(a);

AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which he or she is requesting AMP status, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.

OR For an individual qualifying under 10 CFR 35.57(a)(3):

Copy of the certification issued by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or 1 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://nrc.gov/materials/miau/med-use-toolkit.html.

3 radiological physics, or by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005; AND Documentation that the medical physicist performed the same medical uses as requested on or before October 24, 2005.

AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.

OR For an individual qualifying under 10 CFR 35.51(b):

Description of the training and experience demonstrating that the proposed AMP is qualified by training and experience identified in 10 CFR 35.51(b)(1) for the uses requested; AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the licensee seeks approval of an individual as AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system; AND Written attestation, signed by a preceptor AMP2, that the proposed AMP has satisfactorily completed the training and experience required in 10 CFR 35.51(b)(1), as well as the training in 10 CFR 35.51(c) for the types of use specified, and is able to independently fulfill the radiation safety-related duties as an AMP for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.

Ophthalmic Physicist Provide the following:

Name of the proposed Ophthalmic Physicist; AND Documentation of a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; 2 Document that the preceptor AMP meets the criteria to sign the attestation.

4 AND Documentation of successful completion of 1 year of full time training in medical physics and an additional year of full time work experience in medical physics; AND Documentation of training in:

The creating, modifying, and completing of written directives; Procedures for administrations requiring a written directive; and Performing the calibration measurements of brachytherapy sources as detailed in

§ 35.432.