(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.