a physician, dentist, or podiatrist who: (1) meets the requirements in §§ 35.59 and 35.190(a),...

A physician, dentist, or podiatrist who: (1) Meets the requirements in §§ 35.59 and 35.190(a),

35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or

(2) Is identified as an authorized user on—◦ (i) A Commission or Agreement State license that

authorizes the medical use of byproduct material;◦ (ii) A permit issued by a Commission master material

licensee that is authorized to permit the medical use of byproduct material;

◦ (iii) A permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or

◦ (iv) A permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.

Authorized UserAuthorized User

Candidates seeking certification for diagnostic radiology in 2011 and forward must meet the specific training and experience requirements described in 10 CFR 35.290 (c)(1)(i), (c)(1)(ii) and 10 CFR 35.392 (c)(1) and (c)(2), and 10 CFR 35.394 (c)(1), (c)(2) and (c)(3)

Radiation safety, radionuclide handling and quality control and related topics specified in 10 CFR 35.290, 10 CFR 35.392, and 10CFR 35.394 must be covered

ABR RequirementsABR Requirements

NRC Recognized Specialty NRC Recognized Specialty BoardsBoards

http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html

Evaluated and Certified by NRC!

Specialty Boards Recognized By Specialty Boards Recognized By NRCNRChttp://www.nrc.gov/materials/miau/med-use-toolkit/spec-http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.htmlboard-cert.html35.290

◦ CBNC with “for Physicians Residing in the United States” from October 29, 2000 until 2006

◦ CBNC with “for Physicians Trained in the United States” from 2006 forward

◦ ABNM with “United States” from October 20, 2005 forward

◦ AOBR in Diagnostic Radiology from July 1, 2000 forward

◦ AOBNM in Nuclear Medicine from May 18, 2006 forward

◦ ABR in Diagnostic Radiology with “AU Eligible” from June 2006 forward

◦ Any recognized board for 35.390

Specialty Boards Recognized By NRCSpecialty Boards Recognized By NRChttp://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.htmlcert.html

35.392◦ AOBR in Diagnostic Radiology from July 1, 2000

forward◦ ABR in Diagnostic Radiology with “AU Eligible”

from June 2006 forward◦ ABR in Diagnostic Radiology with “AU Eligible”

from June 2011 forward (same as 35.394)35.394

◦ABR in Diagnostic Radiology with “AU Eligible” from June 2011 forward

Specialty Boards Recognized By NRCSpecialty Boards Recognized By NRChttp://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.htmlcert.html

35.390◦ ABNM with “United States” from October 20,

2005 forward ◦ ABR in Radiation Oncology with “AU Eligible”

from June 2007 forward ◦ AOBR in Radiation Oncology from May 1,

2007 forward◦ These also satisfy 35.392 and 35.394

Review of Part 35 Training Review of Part 35 Training RequirementsRequirements35.290: Training for imaging and

localization studies

Review of Part 35 Training Review of Part 35 Training RequirementsRequirements

35.200: Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required. ◦ Includes generators.

35.300: Use of unsealed radioactive material for which a written directive is required.

35.1000: Other medical uses of radioactive material or radiation from radioactive material. (such as SIRS)

Review of Part 35 Training Review of Part 35 Training RequirementsRequirements35.390: Training for use of unsealed radioactive

material for which a written directive is required35.392: 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)* Imaging and localization studies using more than 30 µCi of I-131 must meet these requirements in addition to 35.290.

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)

35.396: Training for the parenteral administration of unsealed radioactive materials requiring a written directive

35.1000: Evaluated as applicable for each use.

Supervisors, Preceptors, and Supervisors, Preceptors, and Written AttestationsWritten AttestationsAll work experience must be

supervised by a qualified AU. This means the supervising AU meets the qualifications described in the appropriate sections of Part 35.

Part 35 requires written attestation in many of the pathways. Preceptor must meet the qualifications described in Part 35.

Can have multiple supervisors and/or preceptors.

No longer need to be board certified.

Training RequirementsTraining Requirements35.290

35.29035.2901.

2.

3.

Recognized board certification Written Attestation

AU under 35.390

700 hours of training and experience, including a minimum of 80 hours of

classroom and laboratory training (see 35.290 for detailed T&E requirements)

Written Attestation

Work experience

eluting generator systems

Training RequirementsTraining Requirements

35.39035.392*, 35.394, 35.396*Includes imaging and localization studies using greater than 30 µCi of I-131

35.39035.390

1. Recognized board certification Written Attestation

Three cases of:

Oral administration of greater than 33 mCi of I-131 (three of these

satisfies the ≤ 33 mCi requirement)

Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which is a written directive is required

Parenteral administration of any other radionuclide, for which a written

directive is required

AND/OR

35.39035.390

2.

700 hours of training and experience, including a minimum of 200 hours of

classroom and laboratory training (see 35.390 for detailed T&E requirements)

Written Attestation

Work experience including 3 cases

35.392 (35.392 (≤ 33 mCi≤ 33 mCi I-131)I-131)

1.

Recognized board certification

Written Attestation

Work experience including 3 cases:

Oral administration of less than or equal to 33 mCi of I-131

Oral administration of greater than 33 mCi of I-131 (three of these satisfies the ≤ 33 mCi

requirement)

35.392 (35.392 (≤ 33 mCi≤ 33 mCi I-131)I-131)

2.

3.

AU under 35.390 or 35.394


Oral administration of less than or equal to 33 mCi of I-131

Oral administration of greater than 33 mCi of I-131 (three of these satisfies the ≤ 33 mCi

requirement)

80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a

written directive

Written Attestation

35.394 (> 33 mCi I-131)35.394 (> 33 mCi I-131)

1. Recognized board certification

Written Attestation


Oral administration of greater than 33 mCi of I-131

35.394 (> 33 mCi I-131)35.394 (> 33 mCi I-131)

2.

3.

AU under 35.390

80 hours of classroom and laboratory training, applicable to the medical use of sodium

iodide I-131 for procedures requiring a written directive


Oral administration of greater than 33 mCi of I-131

Written Attestation

35.396 (other than I-131)35.396 (other than I-131)

1.

Recognized board certification for 35.490 or 35.690

80 hours of classroom and laboratory training, applicable to parenteral administrations, for

which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with

a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide

for which a written directive is required


Written Attestation

35.396 (other than I-131)35.396 (other than I-131)

2.

3.

AU under 35.390

80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or

any photon-emitting radionuclide with a photon energy less than 150 keV, and/or

parenteral administration of any other radionuclide for which a written directive is required

Work experience including 3 cases: Written Attestation

AU under 35.490 or 35.690

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;

CoursesCourses

The work experience must involve:

◦(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

◦(B) Performing quality control procedures on 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;

Training Training

◦(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) 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 elute for radionuclide purity, and processing the elute with reagent kits to prepare labeled radioactive drugs;

40 hour hot lab rotation covers (1st year):

◦ (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

◦ (B) Performing quality control procedures on 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;

Basic Sciences (Thu 3rd year) - 2012-13

◦Physics & Instrumentation 27◦Mathematics 7 (5)◦Chemistry 3 (2)

Total 37 (34)

Physics (Thu 2nd year) - 2012-13

◦Physics & Instrumentation 1 (0)◦Clinical 2◦Radiation Protection 3◦Radiobiology 1

Total: 7 (6)

Core lectures (Fri) – 2012-13

◦Clinical 38◦Radiation Protection 2

Total 40

T&E FormsT&E Forms

Authorized UsersAuthorized UsersAll T&E must be obtained in the last seven

years.There are FOUR forms to document NEW AU

Training and Experience. ◦ RHB 313A(AUD)◦ RHB 313A(AUT)◦ RHB 313A(AUS)◦ RHB 313A(AU)

If the user has been board certified or listed on a license over seven years ago, the user must have had related continuing education and experience since the required T&E was completed.

There is ONE form to document REFRESHER AU Training and Experience.◦ RHB 313A(CE)

RHB 313ARHB 313AAUD for 200.AUT for 300.

◦ I-131 > 30 µCi for imaging and localization studies

AU for 200 and 300

RHB 313A(AU)RHB 313A(AU)Designed for 35.100, 35.200, 35.300 and

35.500

RHB 313A(AU)RHB 313A(AU)

This is the link to the 2008 10 CFR 35.Medical Guide will be referenced here in

the future.


Medical LicenseCheck the box with the appropriate authorization

RHB 313A(AU)RHB 313A(AU)The form will walk you through the

different pathways. Choose the appropriate pathway and complete the required sections.


Supervising Individual Information


Clinical Cases

Supervising Individual Information


End of Part I!


Preceptor Attestation must be completed for 35.100, 35.200, and 35.300 (required for 35.400 and 35.600 on form 313A(AUS)).

Preceptor must still meet the qualifications described in Part 35 for each authorization!

RHB 313A(AU)RHB 313A(AU)There are

multiple sections!

Complete for each requested authorization.

Follow the instructions for each authorization.


Choose the appropriate pathway


Complete the second section if required.

RHB 313A(AU)RHB 313A(AU) Preceptor

Qualification Submit a copy

of the RML if it is not a CA license.

If listed on a broad scope license, provide a copy of the license and a letter from the RSO, verifying the preceptor’s authorizations for the dates training took place.

SummarySummary If you qualified for “greater” authorizations, you

are also qualified for the “lower” authorizations, i.e. qualified for 35.390 = qualified for 35.190, 35.290, 35.392, 35.394, and 35.396.

If you are requesting authorization for imaging and localization studies and wish to use > 30 µCi of I-131, you must also meet the qualifications for 35.392 and complete the T&E form(s) for 35.200 and 35.300.

Preceptor attestation is required for every pathway except current AU

a physician, dentist, or podiatrist who: (1) meets the requirements in §§ 35.59 and 35.190(a),...

Documents