6 Colo. Code Regs. § 1007-1-2.6

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

Section 6 CCR 1007-1-2.6 - Facility Registrant Responsibilities

2.6.1 The registrant shall allow only individuals who are adequately trained in radiation safety to operate the machine and perform a radiographic examination. Training shall include instruction on the specific x-ray system to be used and review of the applicable and critical requirements of the operator manual.

2.6.1.1 The facility registrant shall evaluate and document the qualifications of each individual permitted to operate any radiation machine at the facility.

(1) Each operator shall meet all radiation safety training and experience requirements of the respective State of Colorado professional licensure board, as applicable, and any applicable requirements of this Part 2.

(2) The registrant shall maintain a list of all operators of any radiation machine used by the facility registrant.

(a) For fluoroscopy equipment used in examination of a living human, a list of operators and individuals providing supervision of operators shall be maintained.

(b) The list of all operators and supervisors shall be updated at least annually as part of the radiation safety program required by Part 4, Section 4.5.

(3) Records of evaluations shall:

(a) Include current certifications and qualifications;

(b) Be updated annually by the facility; and

(c) Be produced for examination upon request during any inspection conducted under the requirements of these regulations.

2.6.1.2 A physician, chiropractor, dentist, podiatrist, or veterinarian who meets the applicable requirements of Part 6, Section 6.3.1.6(1) and these regulations, is considered to have demonstrated adequate training in radiation safety and the safe and effective use of the radiation machine (consistent with 2.6.1.5) and may operate radiation machines as part of a medical, chiropractic, dental, podiatric or veterinary practice, respectively.

2.6.1.3 For a radiologist assistant "adequately trained" shall mean that the individual is qualified as provided in Appendix 2G.

2.6.1.4 For any radiographic x-ray system used on a living human (consistent with 2.6.1.2, 2.6.1.3 and 2.6.1.5 through 2.6.1.14), "adequately trained" shall mean that the individual meets the requirements of Appendix 2D.

(1) Limited-scope x-ray machine operator approval is limited to imaging procedures for x-ray examination of the skull, chest, hip/pelvis and spine/sacrum, upper extremities and lower extremities, and abdomen.

(2) A limited-scope x-ray machine operator shall not perform radiologic procedures involving the administration or utilization of contrast media, bone densitometry, fluoroscopic, mammography, computed tomography, or radiation therapy procedures.

2.6.1.5 For fluoroscopy equipment used in examination of a living human, "adequately trained" shall mean that, in addition to meeting all applicable requirements in 2.4.5.5, 2.6.1.1 through 2.6.1.4, and Appendix 2O:

(1) Each individual who either supervises a fluoroscopy procedure or operates a fluoroscopy imaging system shall have adequate training in its safe operation. This training shall be documented and include the following:

(a) Basic properties of radiation;

(b) Biological effects of x-ray;

(c) Principles and safe operation of the specific fluoroscopic x-ray system(s) to be used;

(d) Dose management including dose reduction techniques, monitoring, and recording;

(e) Applicable requirements of these regulations.

After January 1, 2022, the training required by 2.6.1.5 shall also include:

(f) Radiation protection methods for patients and staff;

(g) Units of measurement and dose, including DAP (dose-area product) values and air kerma;

(h) Factors affecting fluoroscopic outputs;

(i) High level control options; and

(j) Fluoroscopic and fluorographic (radiation) outputs of each mode of operation on the system(s) to be used clinically.

2.6.1.6 For mammography equipment used in radiography of the human breast, "adequately trained" shall mean that the individual operator meets the requirements of 2.4.5.4(1) and 2.4.5.4(2).

(1) Registered provisional mammographers may operate machines and perform radiographic examinations under supervision while in-training as specified in Appendix 2M.

2.6.1.7 For any computed tomography (CT) system used on a living human (excluding Volumetric Dental Imaging Systems, CBCT systems, and systems used for digital breast tomosynthesis) "adequately trained" shall mean that the individual operator meets the requirements of Appendix 2E.

2.6.1.8 For any bone densitometry equipment used in examination of a living human, "adequately trained" shall mean that the individual operator meets the requirements of Appendix 2F.

2.6.1.9 For radiographic equipment used in the practice of medicine, "adequately trained" shall mean that the individual operator meets all applicable requirements of the Colorado medical board.

2.6.1.10 For radiographic equipment used in chiropractic, "adequately trained" shall mean that the individual operator meets all applicable requirements of the Colorado Board of Chiropractic Examiners and Rule 19 of 3 CCR 707-1.

2.6.1.11 For radiographic equipment used in dentistry, including Volumetric Dental Imaging Systems, "adequately trained" shall mean that the individual operator meets all applicable requirements of the Colorado Dental Board and Rule X of 3 CCR 709-1.

2.6.1.12 For radiographic equipment used in podiatry, "adequately trained" shall mean that the individual operator meets all applicable requirements of the Colorado Podiatry Board and 3 CCR 712-1.

2.6.1.13 For radiographic equipment used in veterinary medicine, "adequately trained" shall mean that the individual operator meets all applicable requirements of the Colorado Board of Veterinary Medicine and 4 CCR 727-1.

2.6.1.14 An individual, enrolled in an ARRT-recognized program or graduated from such a program, may operate radiation machines so long as the individual works under the direct supervision of a radiologic technologist or other qualified trainer and has documentation of having completed education and experience equal to that specified in the program.

(1) A graduate from an ARRT-recognized program is granted ninety (90) calendar days from the date of graduation to schedule, take and pass the ARRT radiologic technology registry examination.

(2) During the 90-day period allowed by 2.6.1.14(1), the graduate is considered to satisfy Appendix 2D requirements.

(3) A student or graduate who fails to pass the registry examination has not met the requirements of Appendix 2D and shall not operate any radiation machine system on a living human unless otherwise authorized by the Department.

2.6.1.15 For radiation machines used in non-healing-arts applications, "adequately trained" shall mean that the individual operator meets the requirements of Appendix 2N.

(1) For industrial radiography, the requirements in Part 5 apply, as stated in 2N.1.

(2) The requirements of 2N.2 apply to all non-healing-arts applications subject to Part 8 (including but not limited to analytical, forensic, morgue, and homeland security uses) but not subject to Part 5.

2.6.1.16 For assembly, installation and repair of radiation machines, "adequately trained" shall mean that the individual service technician meets the requirements of Appendix 2H.

2.6.1.17 Department recognition of training as adequate pursuant to 2.6.1.3 through 2.6.1.16 shall pertain only to the areas of training and experience specifically identified in these regulations.

2.6.1.18 The Department may, upon application or upon its own initiative, accept as being adequate:

(1) Documented combinations of radiation safety training and experience; or

(2) Equivalent approval by another state or agency.

2.6.2 The facility registrant shall ensure that all required certification and compliance evaluations are performed as required by 2.5.2 in accordance with the instructions that accompany Form R 59-1, "X-ray Machine Certification Evaluation Report" and Form R 59-2, "X-ray Facility Compliance Evaluation Report."

2.6.2.1 Upon receipt of a Form R 59-1 signed by a registered qualified inspector, the facility shall complete the certification evaluation process with that qualified inspector unless department approval is granted or required to have the certification evaluation done by a different qualified inspector.

2.6.3 For each radiation machine finding of noncompliance (Form R 59-1), the facility registrant shall:

2.6.3.1 Correct any failure of a radiation machine or imaging system to meet the requirements of these regulations or manufacturer's required specifications, within thirty (30) calendar days or as otherwise specified by the Department, in particular as identified on Form R 59-1, "X ray Machine Certification Evaluation Report."

2.6.3.2 Not use a radiation machine that has been determined to be unsafe for use, as determined by the criteria in Part 6, Appendix 6D, until subsequent certification by a Department-approved qualified inspector or the Department.

2.6.3.3 Permit only a person who has provided evidence of current registration with the Department in accordance with 2.4.2 to provide radiation machine servicing or services.

2.6.3.4 Notify the qualified inspector who issued the Certification Evaluation Report when the radiation machine violations have been corrected.

(1) A copy of the Certification Evaluation Report, Form R 59-1, with the service repair certification signed and dated by the person providing service, shall be provided to the qualified inspector who initiated the certification evaluation..

(2) A copy of any service report shall be provided to the qualified inspector upon request as evidence of completed corrective action.

2.6.3.5 Retain documentation that each indicated violation has been corrected to bring the machine into compliance in accordance with Section 2.6.6.

2.6.4 For each finding of facility noncompliance (Form R 59-2), the registrant shall:

2.6.4.1 Correct any violation within thirty (30) calendar days of each finding of facility noncompliance (Form R 59-2) or as otherwise specified by the Department.

2.6.4.2 Provide documentation to the Department to confirm that each indicated violation has been corrected to bring the facility into compliance.

(1) For any item identified for correction on Form R 59-2, "X-ray Facility Compliance Evaluation Report", provide a copy of the Form R 59-2 with the "Registrant's Certification of Correction" section signed and dated by the registrant or registrant's agent.

2.6.5 Except as otherwise specified in Part 6 and Part 24 of these regulations, each registrant shall follow all applicable manufacturer's recommended equipment maintenance and quality assurance procedures.

2.6.6 Record Retention and Reports.

2.6.6.1 The registrant shall maintain each diagnostic image in a medical record for each patient as specified by the applicable State of Colorado professional licensure board; absent an applicable board specification, record retention shall be for a period not less than ten (10) years or any period of minority or incompetency.

2.6.6.2 The registrant shall maintain for the duration of the registration, records of each shielding design, and each radiation survey required by 6.9.4.1, performed for the facility.

(1) Upon any transfer of ownership, such shielding design(s) and survey records shall also be transferred to the new owner.

2.6.6.3 The registrant shall maintain for the duration of the registration, until a machine is retired from service, the operator and service manual(s) provided by the manufacturer, if available.

(1) If the operator manual is not obtainable from the manufacturer, such a manual of written operating procedures shall be developed and maintained by the registrant, including:

(a) A description, including purpose and function, of each control panel knob, button, and meter;

(b) Techniques for collimation and centering of the beam to the image receptor;

(c) The function of all locks and detents; and

(d) Emergency shutdown instructions.

2.6.6.4 The registrant shall maintain for inspection for a period of three (3) years for each x-ray imaging or image processing system (six years for a facility or machine inspected only every three years) records of:

(1) Operator certifications;

(2) Operator training;

(3) Service and repair reports;

(4) Radiation machine disposition

(5) Radiation machine inspection certification evaluation reports;

(6) Facility compliance evaluation reports; and

(7) Notices of violation.

2.6.7 For each certification label issued by a qualified inspector, facility registrants shall pay the label fee required by Part 12, Category 25. Facility registrants who fail to pay the label fee may be subject to review, audit, and non-routine inspection fees in accordance with Section 2.9.

6 CCR 1007-1-2.6

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