Section 0400-20-09-.06 - SPECIFIC REQUIREMENTS FOR THE ISSUANCE OF A CERTIFIED REGISTRATION(1) In addition to the requirements of Rule 0400-20-09-.05, a Certified Registration for human use of an accelerator in medical institutions will be issued only if: (a) The applicant has appointed a medical committee of at least three members to evaluate all proposals for research, diagnostic, and therapeutic use of an accelerator within that institution. Membership of the committee shall include physicians expert in internal medicine, hematology, therapeutic radiology and a person experienced in particle depth dose calculations, and protection against radiation;(b) The applicant possesses facilities for the clinical care of patients; and(c) The physician designated on the application as the responsible individual shall be a radiologist or therapeutic radiologist certified by the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology and has experience in the use of accelerators to treat humans.1(2) In addition to the requirements of Rule 0400-20-09-.05, a Certified Registration for an accelerator which is to be used in research and development will be issued only if: (a) The applicant has appointed a radiological safety officer who will advise and assist on radiological safety problems; and(b) The applicant has established a radiation safety committee (composed of the radiological safety officer and one or more individuals trained or experienced in the safe use of accelerators) which will review and approve, in advance, proposals for such use.(3) In addition to the requirements of Rule 0400-20-09-.05, a Certified Registration for use of an accelerator in industrial radiography will be issued only if the requirements of Chapter 0400-20-08 are satisfied.(4) In addition to the requirements of Rule 0400-20-09-.05, a Certified Registration for the production of radioactive materials by an accelerator will be issued only if: (a) The applicant's staff has experience in the use of accelerators in the production of radioactive materials; and(b) The applicant has appointed a radiological safety officer who will advise and assist on radiological safety problems.(5) In addition to the requirements of Rule 0400-20-09-.05, a Certified Registration for the modification of the structure, chemical composition, bacterial composition of materials, etc. by an accelerator will be issued only if: 1 Certified registrants that desire to utilize physician(s) who do not meet these criteria for minimum training and experience may request a variance excepting the physician from the requirements for a limited time period. The variance request should include:
1. The name of the proposed individual,2. A description of his or her training and experience including information similar to that specified in subparagraph (1)(c) of Rule 0400-20-09-.06,3. Information to substantiate that the physician is currently engaged in the certification process,4. Written endorsement of the technical qualifications of the proposed physician from personal knowledge by a physician certified by the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology. This should be a letter from the proposed physician's Residency Director where the physician in question completed the Residency program in radiology or therapeutic radiology. Upon receipt of acceptable information, the Division will grant a specific variance to subparagraph (1)(c) of Rule 0400-20-09-.06. This variance will be for a time period not to exceed 1 year. The Division will entertain a request to extend this variance for no more than 2 additional 1 year time periods provided the certified registrant can support that the physician remains currently engaged in the certification process.
(a) The applicant's staff has experience in the modification of materials; and(b) The applicant has appointed a radiological safety officer who will advise and assist on the radiological safety problems.Tenn. Comp. R. & Regs. 0400-20-09-.06
Original rule filed February 22, 2012; effective May 22, 2012.Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.