ML12164A741

NRC Form 313A (Aut), Authorized User Training, Experience, and Preceptor Attestation (for Uses Defined Under 35.300)(10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396). (01-2020)

ML12164A741
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Issue date:	01/31/2020
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NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120 (01-2020) EXPIRES: 01/31/2023 AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300)

[10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396]

Name of Proposed Authorized User State or Territory Where Licensed Requested Authorization(s) (check all that apply):

35.300 Use of unsealed byproduct material for which a written directive is required OR 35.300 Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 35.300 Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.300 Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)

• Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.

1. Board Certification

a. Provide a copy of the board certification.

b. For 35.390, provide documentation on supervised case experience. The table in section 3.c. may be used to document this experience.

c. For 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Skip to and complete Part II Preceptor Attestation.

d. For a board certification issued on or before October 24, 2005 that is listed in 10 CFR 35.57(b)(2)(ii), provide the following:

(i) Documentation that the individual performed each use checked above on or before October 24, 2005.

(ii) Dates, duration, and description of continuing education and experience within the past seven years for each use checked above.

e. Stop here.

2. Current 35.300, 35.400, or 35.600 Authorized User Seeking Additional Authorization

a. Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply):

35.390 35.392 35.394 35.490 35.690

b. If currently authorized for a subset of clinical uses under 35.300, provide documentation on additional required supervised case experience. The table in section 3.c. may be used to document this experience. If board certified, provide a copy of the certificate and stop here. If not board certified then provide completed Part II Preceptor Attestation.

NRC FORM 313A (AUT) (01-2020) PAGE 1

NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)

AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)

c. If currently authorized under 35.490 or 35.690 and requesting authorization for 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

3. Training and Experience for Proposed Authorized User

a. Classroom and Laboratory Training 35.390 35.392 35.394 35.396 Clock Dates of Description of Training Location of Training Hours Training*

Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use Radiation biology Total Hours of Training:

b. Supervised Work Experience 35.390 35.392 35.394 35.396 (If more than one supervising individual is necessary to document supervised training, provide multiple copies of this page.)

Supervised Work Experience Total Hours of Experience:

Description of Experience Location of Experience/License or Dates of Confirm Must Include: Permit Number of Facility Experience*

Ordering, receiving, and unpacking radioactive materials Yes safely and performing the related radiation surveys No Performing quality control procedures on instruments Yes used to determine the activity of dosages and performing No checks for proper operation of survey meters Calculating, measuring, and Yes safely preparing patient or human research subject No dosages Using administrative controls to Yes prevent a medical event involving the use of unsealed No byproduct material Using procedures to contain Yes spilled byproduct material safely and using proper No decontamination procedures NRC FORM 313A (AUT) (01-2020) PAGE 2

NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)

AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)

3. Training and Experience for Proposed Authorized User (continued)

b. Supervised Work Experience (continued)

License/Permit Number listing supervising individual as an Supervising Individual authorized user Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)**:

35.390 With experience administering dosages of:

35.392 Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 35.394 Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.396 Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, 35.57 or photon energy of less than 150 keV, for which a written directive is required.

• • Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

c. Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.

Number of Cases Location of Experience/License or Permit Dates of Description of Experience Involving Personal Number of Facility Experience*

Participation Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

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NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)

AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)

3. Training and Experience for Proposed Authorized User (continued)

c. Supervised Clinical Case Experience (continued)

License/Permit Number listing supervising individual as an Supervising Individual authorized user Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)**:

35.390 With experience administering dosages of:

Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 35.392 gigabecquerels (33 millicuries) 35.394 Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.396 Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or 35.57 photon energy of less than 150 keV, for which a written directive is required.

• • Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

d. Provide completed Part II Preceptor Attestation.

PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.

By checking the boxes below, the preceptor is not attesting to the individual's "general clinical competency."

First Section Check one of the following for the requested authorization:

For 35.390:

I attest that has satisfactorily completed the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training Name of Proposed Authorized User and experience, including a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training, as required by 10 CFR 35.390 (b)(1).

For 35.392:

I attest that has satisfactorily completed the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom Name of Proposed Authorized User and laboratory training, as required by 10 CFR 35.392(c)(1), and the supervised work and clinical case experience required in 35.392(c)(2).

For 35.394:

I attest that has satisfactorily completed the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom Name of Proposed Authorized User and laboratory training, as required by 10 CFR 35.394 (c)(1), and the supervised work and clinical case experience required in 35.394(c)(2).

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NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)

AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)

Second Section I attest that has satisfactorily completed the required clinical case Name of Proposed Authorized User experience required in 35.390(b)(1)(ii)G listed below:

Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

Third Section I attest that is able to independently fulfill the radiation safety-related Name of Proposed Authorized User duties as an authorized user for the medical uses authorized under 10 CFR 35.300 for:

Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

Fourth Section For 35.396:

Current 35.490 or 35.690 authorized user:

I attest that is an authorized user under 10 CFR 35.490 or 35.690 Name of Proposed Authorized User or equivalent Agreement State requirements, has satisfactorily completed the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, as required by 10 CFR 35.396 (b)(1), and the supervised work and clinical case experience required by 35.396(b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user under 10 CFR 35.300 for:

Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

OR Board Certification:

I attest that has satisfactorily completed the board certification Name of Proposed Authorized User requirements of 35.396(a)(3), has satisfactorily completed the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training required by 10 CFR 35.396 (b)(1) and the supervised work and clinical case experience required by 35.396(b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user under 10 CFR 35.300 for:

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NRC FORM 313A (AUT) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)

AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)

Fifth Section Complete one of the following for the attestation and signature:

Authorized User I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:

35.390 35.392 35.394 35.396 35.57 for 35.300 uses I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization:

Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required.

OR Residency Program Director:

I affirm that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements below or equivalent Agreement State requirements:

35.390 35.392 35.394 35.396 35.57 for 35.300 uses I affirm that this facility member has experience in administering dosages in the same dosage category or categories for which the individual is requesting authorized user status and concurs with the attestation I am providing as program director.

I affirm that the residency training program is approved by the:

Residency Review Committee of the Accreditation Council for Graduate Medical Education Royal College of Physicians and Surgeons of Canada Council on Post-Graduate Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in:

35.390 35.392 35.394 35.396 Name of Facility: License/Permit Number:

Name of Preceptor or Residency Program Director (Typed or Printed) Telephone Number Date Signature NRC FORM 313A (AUT) (01-2020) PAGE 6