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Authorized User

Authorized User. 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—

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Authorized User

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  1. Authorized User 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.

  2. ABR Requirements • 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

  3. NRC Recognized Specialty Boards http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html Evaluated and Certified by NRC!

  4. Specialty Boards Recognized By NRChttp://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html • 35.290 • 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

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

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

  7. Review of Part 35 Training Requirements • 35.290: Training for imaging and localization studies

  8. Review of Part 35 Training Requirements • 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)

  9. Review of Part 35 Training Requirements • 35.390: Training for use of unsealed radioactive material for which a written directive is required • 35.392: 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.

  10. Supervisors, Preceptors, and Written Attestations • All 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.

  11. Training Requirements 35.290

  12. 35.290 Recognized board certification Written Attestation Work experience eluting generator systems 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

  13. Training Requirements 35.390 35.392*, 35.394, 35.396 *Includes imaging and localization studies using greater than 30 µCi of I-131

  14. 35.390 Recognized board certification Written Attestation 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 Three cases of: AND/OR • Parenteral administration of any • other radionuclide, for which a written • directive is required

  15. 35.390 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) Work experience including 3 cases Written Attestation

  16. 35.392 (≤ 33 mCiI-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)

  17. 35.392 (≤ 33 mCiI-131) 2. 3. AU under 35.390 or 35.394 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 less than or equal to 33 mCi of I-131 Work experience including 3 cases: Oral administration of greater than 33 mCi of I-131 (three of these satisfies the ≤ 33 mCi requirement) Written Attestation

  18. 35.394 (> 33 mCi I-131) Recognized board certification Written Attestation Work experience including 3 cases: Oral administration of greater than 33 mCi of I-131

  19. 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 Work experience including 3 cases: Written Attestation Oral administration of greater than 33 mCi of I-131

  20. 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 Work experience including 3 cases: Written Attestation

  21. 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 AU under 35.490 or 35.690 Work experience including 3 cases: Written Attestation

  22. Courses 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;

  23. Training 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;

  24. (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;

  25. 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;

  26. Basic Sciences (Thu 3rd year) - 2012-13 • Physics & Instrumentation 27 • Mathematics 7 (5) • Chemistry 3 (2) Total 37 (34)

  27. Physics (Thu 2nd year) - 2012-13 • Physics & Instrumentation 1 (0) • Clinical 2 • Radiation Protection 3 • Radiobiology 1 Total: 7 (6)

  28. Core lectures (Fri) – 2012-13 • Clinical 38 • Radiation Protection 2 Total 40

  29. T&E Forms

  30. Authorized Users • All 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)

  31. RHB 313A • AUD for 200. • AUT for 300. • I-131 > 30 µCi for imaging and localization studies • AU for 200 and 300

  32. RHB 313A(AU) • Designed for 35.100, 35.200, 35.300 and 35.500

  33. RHB 313A(AU) • This is the link to the 2008 10 CFR 35. • Medical Guide will be referenced here in the future.

  34. RHB 313A(AU) • Medical License • Check the box with the appropriate authorization

  35. RHB 313A(AU) • The form will walk you through the different pathways. Choose the appropriate pathway and complete the required sections.

  36. RHB 313A(AU)

  37. RHB 313A(AU)

  38. RHB 313A(AU)

  39. RHB 313A(AU)

  40. RHB 313A(AU) • Supervising Individual Information

  41. RHB 313A(AU) • Clinical Cases • Supervising Individual Information

  42. RHB 313A(AU) • End of Part I!

  43. RHB 313A(AU) • 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!

  44. RHB 313A(AU) • There are multiple sections! • Complete for each requested authorization. • Follow the instructions for each authorization.

  45. RHB 313A(AU) • Choose the appropriate pathway

  46. RHB 313A(AU) • Complete the second section if required.

  47. 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.

  48. Summary • 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

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