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NRC Form 313A (AUD Authorized User Training and Experience and Preceptor At
ICR 200707-3150-007 · OMB 3150-0203 · Object 3697401.
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NRC FORM 313A (AUD) U.S. NUCLEAR REGULATORY COMMISSION (10-2006) AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.190, 35.290, and 35.590] APPROVED BY OMB: NO. 3150-0120 EXPIRES: MM/DD/YYYY State or Territory Where Licensed Name of Proposed Authorized User Requested Authorization(s) (check all that apply) 35.100 Uptake, dilution, and excretion studies 35.200 Imaging and localization studies 35.500 Sealed sources for diagnosis (specify device ) 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. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part II Preceptor Attestation. 2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization a. Authorized user on Materials License State requirements seeking authorization for 35.290. meeting 10 CFR 35.390 or equivalent Agreement b. Supervised Work Experience. (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.) Description of Experience Location of Experience/License or Permit Number of Facility Clock Hours Dates of Experience* Eluting generator systems appropriate for the 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 Total Hours of Experience: Supervising Individual License/Permit Number listing supervising individual as an authorized user Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply). 35.290 NRC FORM 313A (AUD) (10-2006) 35.390 + generator experience in 32.290(c)(1)(ii)(G) PRINTED ON RECYCLED PAPER PAGE 1 NRC FORM 313A (AUD) (10-2006) U.S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 3. Training and Experience for Proposed Authorized User a. Classroom and Laboratory Training. Description of Training Location of Training Clock Hours Dates of Training* Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use (not required for 35.590) Radiation biology Total Hours of Training: b. Supervised Work Experience (completion of this table is not required for 35.590). (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.) Description of Experience Location of Experience/License or Permit Number of Facility Clock Hours Dates of Experience* Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters Calculating, measuring, and safely preparing patient or human research subject dosages PAGE 2 NRC FORM 313A (AUD) (10-2006) U.S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 3. Training and Experience for Proposed Authorized User (continued) b. Supervised Work Experience. (continued) Description of Experience Location of Experience/License or Permit Number of Facility Clock Hours Dates of Experience* Using administrative controls to prevent a medical event involving the use of unsealed byproduct material Using procedures to contain spilled byproduct material safely and using proper decontamination procedures Administering dosages of radioactive drugs to patients or human research subjects Eluting generator systems appropriate for the 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 Total Hours of Experience: Supervising Individual License/Permit Number listing supervising individual as an authorized user Supervisor meets the requirements below, or equivalent Agreement State requirements (check one). 35.190 35.290 35.390 35.390 + generator experience in 35.290(c)(1)(ii)(G) c. For 35.590 only, provide documentation of training on use of the device. Device Type of Training Location and Dates d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor Attestation. PAGE 3 NRC FORM 313A (AUD) (10-2006) U.S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (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. (Not required to meet training requirements in 35.590) First Section Check one of the following for each use requested: For 35.190 Board Certification has satisfactorily completed the requirements in I attest that Name of Proposed Authorized User 10 CFR 35.190(a)(1) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100. OR Training and Experience has satisfactorily completed the 60 hours of training and I attest that Name of Proposed Authorized User experience, including a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35.190(c)(1), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100. For 35.290 Board Certification has satisfactorily completed the requirements in I attest that Name of Proposed Authorized User 10 CFR 35.290(a)(1) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200. OR Training and Experience has satisfactorily completed the 700 hours of training I attest that Name of Proposed Authorized User and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290(c)(1), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200. Second Section Complete the following for preceptor attestation and signature: I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for: 35.190 35.290 Name of Preceptor 35.390 Signature 35.390 + generator experience Telephone Number Date License/Permit Number/Facility Name PAGE 4
| File Type | application/pdf |
| File Title | c:\temp\ffcxc4.wpf |
| Author | cxc7 |
| File Modified | 2007-07-24 |
| File Created | 2007-07-24 |