6 Colo. Code Regs. § 1007-1-2.4

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

Section 6 CCR 1007-1-2.4 - State of Colorado Authorization or Approval Recognized by the Department is Required for Each Category Designated in This Section

2.4.1 Registration of a Facility.

2.4.1.1 Each person possessing or in the process of coming into the possession of a radiation machine facility shall:

(1) Be registered with the Department prior to using a radiation producing machine at the facility;

(2) Before the facility registration expiration date, at least every twelve (12) months, submit a complete application for registration on the applicable Department R-4 series Form, and include all of the information required by the form and any accompanying instructions. The facility shall:

(a) Designate a radiation safety officer who meets the applicable requirements of Appendix 2A to be responsible for overall radiation protection for the facility; and

(b) Document that a written shielding design has been:

(i) Completed in accordance with Parts 6, 8, or 9 of these regulations, as applicable, prior to any radiation machine installation; and

(ii) Retained on file at the facility for the life of the facility.

(c) Pay the radiation machine facility registration fee for radiation control services indicated by Part 12, Category 26. The radiation machine facility registration fee is not required for registration updates required by 2.4.6.5 unless the update is submitted less than thirty (30) days prior to the registrant's expiration date.

2.4.1.2 As prescribed by 6.3.3.4 for a healing arts screening program, registrants shall complete and submit a Healing Arts Screening application including all of the information required by Part 6, Appendix 6F.

2.4.1.3 In addition to the other requirements of 2.4, any research using radiation machines on living humans shall be approved by an Institutional Review Board (IRB).

2.4.2 Registration as a Service Company.

2.4.2.1 Each person who is engaged (or offers to engage) in the business of selling, leasing, transferring, lending, assembling, installing, maintaining, repairing, storing, trading out, disabling or disposing of radiation machines and their related components, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State, shall be registered with the Department prior to performing such activities.

2.4.2.2 Each Service Company shall complete the Form R-60 series application for registration with all of the information required by the Department indicated on the form and all accompanying instructions, together with the fee required by Part 12, Category 22.

2.4.2.3 Each applicant for registration under 2.4.2 shall specify:

(1) The service category for which registration is being requested, including but not limited to:

(a) Selling, leasing, transferring, lending, assembling, installing, maintaining, trading out, disabling or disposing of radiation machines and associated radiation machine components; and

(b) Servicing of radiation machines and associated radiation machine components, to include preventative maintenance, performance adjustment, calibration, or repair.

(2) The name and qualifications of each service technician who will provide service, including:

(a) A management attestation that the technician's training and experience was evaluated and meets the requirements of Appendix 2H; and

(b) A management attestation that each service technician has been instructed in, and demonstrates an understanding of the requirements of:

(i) These regulations; and

(ii) The Federal Performance Standard (21 CFR Chapter I, Subchapter J; and

(3) An attestation that the type of personnel dosimetric monitoring in use meets the requirements of 4.17 and 4.18; and

(4) An attestation that all calibration and testing instruments are adequate to ensure that machine performance and manufacturer's specifications will be met.

(5) Each service company registrant under 2.4.2 shall notify the Department when any service technician is no longer authorized to provide radiation machine services for the registrant.

(a) The registrant will be assessed the acceptance review fee required by Part 12, Category 24 when adding a technician, unless technicians are added during a registration renewal.

2.4.2.4 Service Company registration will be for a one (1) year period.

2.4.3 Registration as a Qualified Expert.

2.4.3.1 Each individual who designs or evaluates protective shielding around a radiation area so the area meets the public exposure requirements of Part 4, shall be registered with the Department as a qualified expert designated QE(R), QE(S) or QE(T).

(1) Each individual who designs or evaluates shielding for a radiation machine regulated by Parts 8 or 9 and not used in the healing arts shall be registered with the department as a QE(S) and meet the requirements of Appendix 2C.

(2) Each individual who designs or evaluates shielding for a radiation machine used in the healing arts as regulated by Part 6, but not used in radiation therapy, shall be registered with the department as a QE(R) and meet the requirements of Appendix 2B

(3) Each individual who designs or evaluates shielding for a radiation machine used in radiation therapy as regulated by Part 24, shall be registered as a QE(T) and meet the requirements of Appendix 2B.

2.4.3.2 Each Qualified Expert shall complete the applicable Form R-68 series application for registration and include all of the information required by the form and any accompanying instructions, together with the fee required by Part 12, Category 22.

2.4.3.3 Qualified Expert registration shall be for a one (1) year period.

2.4.4 Registration as a Qualified Inspector.

2.4.4.1 Each individual who performs a certification evaluation of a radiation machine or an evaluation of a facility shall be registered with the Department as a qualified inspector who meets the criteria established in Appendix 2I.

2.4.4.2 Each individual who performs a certification evaluation on mammography, fluoroscopy or computed tomography machines used in the healing arts or, evaluates the quality assurance programs of digital imaging systems used in the healing arts shall be registered with the department as a qualified inspector with approval in the Registered Medical Physicist category.

(1) Individuals who perform a certification evaluation on Volumetric Dental Imaging Systems shall be registered with the department as a qualified inspector with approval in "Volumetric Dental Imaging Systems".

2.4.4.3 Each individual who performs registered medical physicist duties required by Part 24 shall be registered with the department as a qualified inspector with approval in the radiation therapy Registered Medical Physicist category.

2.4.4.4 Each Qualified Inspector shall complete the applicable Form R-53 series application for registration and include all of the information required by the form and any accompanying instructions, together with the fee required by Part 12.

2.4.4.5 Qualified Inspector registration shall be for a period of one (1) year.

2.4.4.6 Certification evaluation measurements shall be made with instruments that are sufficiently sensitive to determine compliance with these regulations.

(1) The instruments shall be maintained and used in good working order.

(2) The instruments shall be calibrated at least every two (2) years, or in accordance with the manufacturer's recommendation, whichever is more frequent, or after any repair that could affect the calibration of the instrument.

(3) Calibrations shall be NIST-traceable where such traceability is feasible.

(4) Procedures for instrument calibration done by inter-comparison with a suitable and appropriately calibrated instrument must be approved by the department.

(a) The comparison shall be between an instrument that has a current calibration traceable to NIST and an instrument for which a calibration factor is to be determined.

(b) The comparison shall be made using the actual physical quantity to be routinely measured (for example, radiation energy/quality or visible light spectrum) and shall be compared in the same physical geometry.

(c) The procedure(s) for inter-comparison shall be documented and available for review by the department.

(5) In addition to the requirements in 2.4.4.6, instruments used for the certification evaluation report to measure the air kerma or air kerma rate of mammography machines shall be calibrated with an accuracy of ± six (6) percent (95 percent confidence level) in the mammography energy range.

2.4.5 Registration of specific radiation machine operators.

Except as otherwise specified in these regulations, registration with the Department is not required for an individual who holds a current, valid national registry in radiography, nuclear medicine technology, radiation therapy, computed tomography or mammography as issued by the ARRT or NMTCB (with specialty certification in Computed Tomography) or other nationally recognized registry specifically accepted by the Department. Additional requirements may be applicable in accordance with Appendix 2E, Appendix 2G, Appendix 2M, or Appendix 2O. All other non-physician individuals operating x-ray imaging systems on living humans who are not nationally registered or certified by ARRT or NMTCB must meet the requirements specified in the regulations and shall register with the Department, when applicable.

2.4.5.1 Limited Scope Operator.

(1) Each individual operating an x-ray system on living humans in the State of Colorado, shall be registered as a Limited Scope Operator consistent with 2.4.5.1(2), except for:

(a) Those individuals subject to 2.6.1.5, 2.6.1.6, 2.6.1.7, 2.6.1.8, 2.6.1.10, 2.6.1.11, and 2.6.1.12, or

(b) Those individuals having current registration with the American Registry of Radiologic Technologists in radiography.

(2) Registration

(a) The applicant for LSO registration must complete the requirements of 2D.2.1, 2D.2.2 and 2D.2.3 in a structured and documented training program in order to apply for registration as a Limited Scope Operator.

(b) Each Limited Scope Operator shall complete an application with all of the information required by the form and instructions, together with the fee required by Part 12, Category 24.

(i) The Form R-70 series application shall be used to initiate the registration process.

(ii) The Form R-71 series application shall be used to confirm the completion of the requirements of 2D.2.1, 2D.2.2 and 2D.2.3.

(c) Application for registration as a Limited Scope Operator shall be made within one year upon completion of the requirements of 2D.2.1 and within ninety (90) calendar days upon completion of the requirements of 2D.2.2 and 2D.2.3.

(d) If an applicant cannot achieve a passing score per 2D.2.4 within three attempts, the applicant must restart the training required by 2D.2.1, 2D.2.2, and 2D.2.3.

(e) Registrants must meet the requirements of 2D.2.5 in order to renew the Limited Scope Operator registration.

(i) The Form R-90 series application shall be used to renew the registration for a Limited Scope Operator.

2.4.5.2 Computed Tomography Operator

(1) Each individual operating a computed tomography system on living humans shall meet the requirements of Appendix 2E.

2.4.5.3 Bone Densitometry Equipment Operator (BDEO).

(1) Each individual operating a dual-energy x-ray absorptiometry system used on a living human shall be registered as a Bone Densitometry Equipment Operator, except for:

(a) Those individuals registered with the American Registry of Radiologic Technologists as a radiologic technologist, nuclear medicine technologist or radiation therapist; or

(b) Those individuals registered with the Nuclear Medicine Technology Certification Board (NMTCB) as a certified nuclear medicine technologist.

(2) Registration

(a) The applicant must complete the requirements of 2F.2.1, 2F.2.2, and 2F.2.3 in a structured and documented training program in order to apply for registration as a Bone Densitometry Equipment Operator.

(b) Applicants with International Society of Clinical Densitometry (ISCD) certification must, at a minimum, document the completion of the requirements of 2F.2.1.1 through 2F.2.1.3.

(i) ISCD-certified applicants have met the requirements of 2F.2.1.4 through 2F.2.1.9, 2F.2.2 and 2F.2.3 and are exempt from the requirements of 2F.2.4

(c) Application for the Bone Densitometry Equipment Operator registration shall contain all of the information required by the form and instructions, together with the fee required by Part 12, Category 24.

(i) The Form R-80 series application shall be used to initiate the registration process.

(ii) The Form R-81 series application shall be used to confirm the completion of the requirements of 2F.2.1, 2F.2.2 and 2F.2.3.

(d) Application for registration as a Bone Densitometry Equipment Operator shall be made within one year upon completion of the requirements of 2F.2.1 and within ninety (90) calendar days upon completion of the requirements of 2F.2.2 and 2F.2.3

(e) If an applicant cannot achieve a passing score per 2F.2.4 within three attempts, the applicant must restart the training required by 2F.2.1, 2F.2.2 and 2F.2.3.

(f) Bone Densitometry Equipment Operator registration is issued for a period of three years.

(g) Registrants must meet the requirements of 2F.2.5 in order to renew the Bone Densitometry Equipment Operator approval.

2.4.5.4 Mammographer

Any individual performing mammography shall:

(1) Be certified by the ARRT in Mammography (R.T.(R)(M)(ARRT)); and

(2) Meet the qualifications of and maintain the education and experience requirements for MQSA under 21 CFR Part 900.12(a)(2) ; Or

(3) Register as a provisional mammographer, meet the requirements of Appendix 2M, and be considered to be in-training until the requirements of 2.4.5.4(1) and 2.4.5.4(2) are met.

2.4.5.5 Fluoroscopy operator

(1) On or after January 1, 2021, each individual operating a fluoroscopy imaging system on living humans shall be registered with the department as a fluoroscopy operator consistent with 2.4.5.5(2) or 2.4.5.5(3), except for:

(a) A physician who has an active license from the applicable State of Colorado licensure board consistent with the requirements of Section 2.6.1.2; or

(b) A Registered Radiologist Assistant or Radiology Practitioner Assistant (RPA) who meets the requirements of Appendix 2G; or

(c) An individual with a current R.T.(R), R.T.(CV), R.T.(CI), R.T.(VI), or R.T.(T) registration.

(2) Individuals whose training and experience has been evaluated by the department in writing prior toJanuary 1, 2021, as having met the training and experience requirements of Appendix 2O:

(a) Need not complete the training or testing requirements of Appendix 2O.1; and

(b) Shall be required to obtain and maintain registration in accordance with 2.4.5.5(3)(b) through 2.4.5.5(3)(f) on or after January 1, 2021.

(3) Registration

(a) In order to apply for registration as a fluoroscopy operator, the applicant for fluoroscopy operator registration must complete the requirements of Appendix 2O in a structured and documented training program that meets the requirements of ARRT or another program as authorized by the regulations or as approved in writing by the department.

(b) Each fluoroscopy operator shall complete an R-50 series application form with all of the information required, together with the fee required by Part 12, Category 24.

(i) The Form R-50 series application form shall be used to confirm the completion of the requirements of Appendix 2O.

(c) Except for those individuals meeting the requirements of 2.4.5.5(2), application for registration as a fluoroscopy operator shall be made within one year following completion of the training requirements of Appendix 2O.

(d) If an applicant cannot achieve a passing score on the applicable national registration exam per Appendix 2O, section 2O.1.3.1 or 2O.1.3.2 within three attempts, the applicant must restart the training required by Appendix 2O.

(e) A fluoroscopy operator registration is valid for a two year period.

(f) Registrants must meet the requirements of 2O.2 in order to renew the fluoroscopy operator registration.

(i) The Form R-50 series application form shall be used to renew the fluoroscopy operator registration every two years.

(g) Reciprocal recognition of a registration or license specifically authorizing fluoroscopy use and granted by another state or organization shall be submitted to the Department for review and evaluation on an individual case-by-case basis.

(h) Department registered fluoroscopy operators shall operate machines within their respective scope of practice, training, and experience.

2.4.6 General Requirements Applicable to Issuance and Maintenance of Department Registrations.

2.4.6.1 The application to be registered in the State of Colorado shall be submitted on the appropriate Department form(s) and shall contain all information required by the Department as indicated on the form(s) and all accompanying instructions.

2.4.6.2 Upon a determination that an applicant meets the requirements of the regulations, the Department shall issue a Notice of Registration.

2.4.6.3 The Department may incorporate in the Notice of Registration at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's activities as the Department deems appropriate or necessary.

2.4.6.4 Approval to conduct or perform activities in accordance with the registration requirements of these regulations shall be:

(1) For a period of two (2) years, except as otherwise specified by these regulations or the Department; and

(2) Limited to the category or categories of activities specifically designated in the Notice of Registration.

2.4.6.5 The registrant shall notify the Department in writing within thirty (30) calendar days of making any change of information contained in the application for registration and/or the Notice of Registration.

2.4.6.6 Except as provided by 2.4.6.7, each Notice of Registration shall expire at the end of the month in the year stated therein.

2.4.6.7 In any case in which a registrant, not less than thirty (30) calendar days prior to the expiration of the registrant's authorization, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department.

2.4.6.8 The Department will not review or otherwise process a new application or application for renewal for which no fee is received.

(1) All application fees are non-refundable.

2.4.6.9 The Department may deny, withdraw, limit or qualify its approval of any person to perform activities upon determining that such action is necessary in order to prevent undue hazard to health and safety, or for other reasonable cause.

2.4.7 Providing Notice of Registrant's Rights

2.4.7.1 Whenever a business relationship exists between the qualified inspector and a registered service company, a "Notice of Registrant's Rights" Form R-65 shall be provided to the registered facility prior to beginning the service or evaluation, including:

(1) When a qualified inspector is also registered to perform services and servicing;

(2) When a qualified inspector is also a qualified expert; and

(3) When a qualified inspector, a qualified expert and/or a services and servicing provider is a member of the same corporation, partnership or other formal business relationship.

2.4.8 No person, in any advertisement, shall refer to the fact that the person is registered with the Department pursuant to the provisions of 2.4.1, 2.4.2, 2.4.3, 2.4.4, and 2.4.5 and no person shall state or imply that the quality of conduct or performance of any activity under such registration has been approved or endorsed by the Department.

6 CCR 1007-1-2.4

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