6 Colo. Code Regs. § 1007-1-6.3

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-6.3 - General and administrative requirements

6.3.1 Administrative Controls.

6.3.1.1 Each radiation machine used in the healing arts in the State of Colorado shall be registered with the Department as required by Part 2, Section 2.4 and inspected as prescribed in Part 2, Section 2.5.

6.3.1.2 Each radiation machine used on humans shall meet the Federal Performance Standards, Subchapter J - Radiological Health, 21 CFR 1020.30 through 1020.33.

(1) Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR 1020.30 through 1020.33) shall be maintained in compliance with applicable requirements of that standard.

(2) Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable requirement of 21 CFR Part 1020 or Part 6.

(3) The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may have the system modified provided the modification does not result in the failure of the system or component to comply with the applicable requirements of Part 6 and any modification is completed by a registered service company in accordance with 6.3.3.1(5).

(a) The owner who causes such modification need not submit the reports required by Part 6, provided the owner records the date and the details of the modification in the system and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with Part 6.

(b) Registered service companies shall submit to the Department, records of modifications of the x-ray system, as required by these regulations.

(4) Limited exemption from this requirement may be granted by the Department for a radiation machine manufactured prior to August 4, 1974, provided the registrant demonstrates that such exemption will not result in undue risk.

6.3.1.3 The registrant or the registrant's agent shall use approved providers of services, consistent with Part 2, Section 2.6., including but not limited to operation of equipment, inspection of radiation machines and facilities, and assembly, installation, service and/or calibration of radiation machines.

6.3.1.4 An x-ray imaging system that is found to be non-compliant with the requirements of these regulations 30 days beyond initial discovery, may continue to be used for up to 90 days provided:

(1) The system has not been determined to be unsafe for routine use in accordance with Appendix 6D;

(2) Continued use poses no significant radiation risk to patients, members of the public or employees;

(3) Does not significantly result in degraded image quality; and

(4) The registrant obtains in writing, an authorization for continued use from the Department.

6.3.1.5 An x-ray imaging system that is determined as provided in Appendix 6D to be unsafe for human, animal, or other use shall not be operated for diagnostic or therapeutic purposes.

6.3.1.6 A radiation machine in the healing arts shall be operated:

(1) By a physician, chiropractor, dentist, podiatrist or veterinarian who has a current active State of Colorado license to practice the healing arts and has met the applicable requirements of Part 2 of the regulations; or

(2) By an individual authorized by and licensed in accordance with State of Colorado statutes to engage in the healing arts and has met the applicable requirements of Part 2 of the regulations; and

(a) Whose license, licensing body, or licensing regulations and requirements authorize such operation; and

(b) Such operation is within the standard and acceptable scope of practice for the licensed individual; or

(3) By an individual who is under the general supervision of a licensed individual authorized in 6.3.1.6(1) or 6.3.1.6(2), where:

(a) The individual operator being supervised has met the applicable training requirements of Part 2; and

(b) Such supervision by a licensed individual is consistent with the individual's license, licensing body, regulations, and the standard and acceptable scope of practice for the supervising individual; or

(4) By an operator who is under the personal supervision of a licensed individual authorized in 6.3.1.6(1), and where:

(a) The operator being supervised has met the applicable training requirements of Part 2, Appendix 2O; and

(b) Such operation is within the standard and acceptable scope of practice of the operator being supervised.

6.3.1.7 Exposure under Part 6 of any living human being to the useful beam of an x-ray system shall be solely for healing arts purposes, or for the purposeful exposure of a living human research subject in accordance with Part 2, section 2.4.1.3, and only after such exposure has been authorized by:

(1) A physician, chiropractor, dentist, or podiatrist who has a current active State of Colorado license to practice in the healing arts; or

(2) An individual authorized by and licensed in accordance with State of Colorado statutes to engage in the healing arts, and:

(a) Whose license, licensing body, or licensing regulations and requirements permit authorizing such exposure; and

(b) Such exposure is within the standard and acceptable scope of practice for the licensed individual.

6 CCR 1007-1-6.3

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