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R 333.5701 Purpose and scope.
Rule 701. (1) This part establishes requirements governing the use of computed tomography (CT) scanners by, or on behalf of, a health practitioner licensed under article 15 of the act, MCL 333.1101 to 333.25211.
(2) This part applies to all registrants who use a CT scanner for the intentional exposure of humans for diagnostic imaging.
(3) A CT scanner is exempt from this part if the scanner meets 1 of the following:
(a) Generates a peak power of 5 kilowatts or less as certified by the manufacturer.
(b) Is used only for attenuation corrections and anatomical markers as part of a positron emission tomography (PET/CT) or single photon emission computed tomography (SPECT/CT) study.
(c) Is used as a simulator solely for treatment planning purposes in conjunction with a megavoltage radiation therapy unit.
(d) Is used solely for intra-operative guidance tomography.
(4) In addition to the requirements of this part, all registrants are subject to applicable parts of these rules and the certificate of need review standards for computed tomography scanner services.
Discussion:
This rule states the purpose and scope of the CT rules. The rules cover most of the CT scanners used in medical facilities but they do not cover CT scanners used in veterinary medicine, industry, research, or those scanners used in radiation therapy to create 3D images. Point-of-care CT scanners, such as dental and ENT CT scanners, are not covered by these rules because their peak power is less than 5 kilowatts. PET/CT, SPECT/CT and therapy CT simulator scanners are also not covered by these rules unless the CT portion is used for diagnostic imaging studies. All CT facilities must meet the Certificate of Need Review Standards for CT Scanner Services and all other applicable parts of the Ionizing Radiation Rules.
Yes. The CT portion of the PET/CT is being utilized independently for a diagnostic imaging study and therefore is covered by Part 15. In this case, the facility must obtain a Certificate of Need for diagnostic CT scans that are not in conjunction with the PET/CT procedure.
June 6, 2016