ML12164A736
| ML12164A736 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/2020 |
| From: | NRC/OCIO/GEMSD/IMSB |
| To: | |
| References | |
| Download: ML12164A736 (6) | |
Text
NRC FORM 313A (AUS) 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 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690]
Name of Proposed Authorized User State or Territory Where Licensed 35.400 Manual brachytherapy sources 35.600 Teletherapy unit(s)
Requested Authorization(s) 35.400 Ophthalmic use of strontium-90 35.600 Gamma stereotactic radiosurgery unit(s)
(check all that apply) 35.600 Remote afterloader unit(s)
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 obtained 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 35.690, go to the table in 3.e. and describe training provider and dates of training for each type of use for which authorization is sought.
- c. For a board certification issued on or before October 24, 2005, that is listed in 10 CFR 35.57(b)(2)(iii),
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.
- d. Stop here.
- 2. Current 35.600 Authorized User Requesting Additional Authorization for 35.600 Use(s) Checked Above
- a. Go to the table in section 3.e. to document training for new device.
- b. If board certified, provide a copy of the certificate and stop here. If not board certified, provide completed Part II Preceptor Attestation.
- 3. Training and Experience for Proposed Authorized User
- a. Classroom and Laboratory Training 35.490 35.491 35.690 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 Radiation biology Total Hours of Training:
NRC FORM 313A (AUS) (01-2020) PAGE 1
NRC FORM 313A (AUS) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
- 3. Training and Experience for Proposed Authorized User (continued)
- b. Supervised Work and Clinical Experience for 10 CFR 35.490 (If more than one supervising individual is necessary to document supervised work experience, 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 Yes unpacking radioactive materials safely and performing the related No radiation surveys Checking survey meters for Yes proper operation No Preparing, implanting, and safely Yes removing brachytherapy sources No Maintaining running inventories Yes of material on hand No Using administrative controls to Yes prevent a medical event involving the use of byproduct No material Yes Using emergency procedures to control byproduct material No Clinical experience in radiation Location of Experience/License or Dates of oncology as part of an approved Permit Number of Facility Experience*
formal training program Approved by:
Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Council on Postdoctoral Training of the American Osteopathic Association Supervising Individual License/Permit Number listing supervising individual as an Authorized User NRC FORM 313A (AUS) (01-2020) PAGE 2
NRC FORM 313A (AUS) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
- 3. Training and Experience for Proposed Authorized User (continued)
- c. Supervised Clinical Experience for 10 CFR 35.491 Location of Experience/License or Clock Dates of Description of Experience Permit Number of Facility Hours Experience*
Use of strontium-90 for ophthalmic treatment, including:
examination of each individual to be treated; calculation of the dose to be administered; administration of the dose; and follow up and review of each individual's case history Supervising Individual License/Permit Number listing supervising individual as an Authorized User
- d. Supervised Work and Clinical Experience for 10 CFR 35.690 Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s)
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*
Reviewing full calibration Yes measurements and periodic spot-checks No Preparing treatment plans and Yes calculating treatment doses and times No Using administrative controls to Yes prevent a medical event involving the use of byproduct No material Implementing emergency Yes procedures to be followed in the event of the abnormal operation No of the medical unit or console Checking and using survey Yes meters No Selecting the proper dose and Yes how it is to be administered No NRC FORM 313A (AUS) (01-2020) PAGE 3
NRC FORM 313A (AUS) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
- 3. Training and Experience for Proposed Authorized User (continued)
- d. Supervised Work and Clinical Experience for 10 CFR 35.690 (continued)
Clinical experience in radiation Location of Experience/License or Dates of oncology as part of an approved Permit Number of Facility Experience*
formal training program Approved by:
Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Council on Postdoctoral Training of the American Osteopathic Association Supervising Individual License/Permit Number listing supervising individual as an Authorized User
- e. For 35.600, describe training provider and dates of training for each type of use for which authorization is sought.
Description Training Provider and Dates of Training Gamma Stereotactic Remote Afterloader Teletherapy Radiosurgery Device operation Safety procedures for the device use Clinical use of the device Supervising Individual. (If training provided by Supervising License/Permit Number listing supervising individual as an Individual (If more than one supervising individual is necessary Authorized User to document supervised work experience, provide multiple copies of this page.)
Authorized for the following types of use:
Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s)
- f. Provide completed Part II Preceptor Attestation.
NRC FORM 313A (AUS) (01-2020) PAGE 4
NRC FORM 313A (AUS) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
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 attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individual's "general clinical competency."
First Section Check one of the following for each requested authorization:
For 35.490:
I attest that has satisfactorily completed the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of Name of Proposed Authorized User classroom and laboratory training, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, and 3 years of supervised clinical experience in radiation oncology, as required by 10 CFR 35.490(b)(1) and (b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400.
For 35.491:
I attest that has satisfactorily completed the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of Name of Proposed Authorized User classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy, has used strontium-90 for ophthalmic treatment of 5 individuals, as required by 10 CFR 35.491(b), and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
Second Section For 35.690:
I attest that has satisfactorily completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom Name of Proposed Authorized User and laboratory training, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, and 3 years of supervised clinical experience in radiation therapy, as required by 10 CFR 35.690(b)(1) and (b)(2).
AND Third Section For 35.690: (continued)
I attest that has received training required in 35.690(c) for device Name of Proposed Authorized User operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought, as checked below.
Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s)
AND NRC FORM 313A (AUS) (01-2020) PAGE 5
NRC FORM 313A (AUS) U. S. NUCLEAR REGULATORY COMMISSION (01-2020)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
Fourth Section I attest that is able to independently fulfill the radiation safety-Name of Proposed Authorized User related duties as an authorized user for:
Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s)
Fifth Section Complete one of the following for attestation and signature:
Authorized User:
I meet the requirements in 10 CFR 35.490, 35.491, 35.690, or equivalent Agreement State requirements, as an authorized user for:
35.400 Manual brachytherapy sources 35.600 Teletherapy unit(s) 35.400 Ophthalmic use of strontium-90 35.600 Gamma stereotactic radiosurgery unit(s) 35.600 Remote afterloader unit(s) 35.57 for 35.400 and/or 35.600 uses, as applicable OR Residency Program Director (for 35.490 and/or 35.690 only):
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 for:
35.400 Manual brachytherapy sources 35.57 for 35.400 uses 35.600 Teletherapy unit(s) 35.57 for teletherapy unit(s) 35.600 Remote afterloader unit(s) 35.57 for remote afterloader unit(s) 35.600 gamma stereotactic radiosurgery unit(s) 35.57 gamma stereotactic radiosurgery unit(s)
I affirm that this faculty member 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 Postdoctoral Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in:
35.490 35.690 Name of Facility:
License/Permit Number:
Name of Preceptor or Residency Program Director (Typed or printed) Telephone Number Date Signature NRC FORM 313A (AUS) (01-2020) PAGE 6