6 Colo. Code Regs. § 1007-1-6.11

Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-6.11 - Use of dual-energy x-ray absorptiometry (DXA) bone densitometry systems
6.11.1 In addition to the provisions of 6.3 and 6.4, the requirements of 6.11 apply to all facilities using DXA machines.
6.11.2 DXA Systems shall be:
6.11.2.1 Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;
6.11.2.2 Registered in accordance with Part 2 of these regulations; and
6.11.2.3 At a minimum, maintained and operated in accordance with the manufacturer's specifications
6.11.3 Operator requirements.
6.11.3.1 Each operator of a bone densitometry machine shall meet the adequate radiation safety training and experience requirements of Part 2, Section 2.4.5.3, and Part 2, Appendix 2F.
6.11.4 During operation of any DXA system:
6.11.4.1 In the absence of a radiation survey performed by or under the supervision of a RMP the operator, ancillary personnel, and members of the general public shall be positioned at least 2 meters (at least 6 feet) from the patient, x-ray tube, and useful beam during the examination.
6.11.5 Quality assurance.
6.11.5.1 In addition to the applicable requirements in 6.3.5.1, a facility performing DXA shall:
(1) Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Dosimetry or the American College of Radiology.
6.11.6 Records.
6.11.6.1 The registrant shall keep the following records for a minimum of 3 years:
(1) The maintenance and QC tests as prescribed by 6.11.2.3 and 6.11.5.1.

6 CCR 1007-1-6.11

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022
47 CR 06, March 25, 2024, effective 4/14/2024