Colorado Radiation Regulations, Proposed Revised Part 2 April 9, 2010

Thesechanges are made in Part 2, Registration of Radiation Machines, Facilities and Services, 6CCR-1007-1-2, of the State of ColoradoRules and Regulations Pertaining to Radiation Control.

Section 2.4.2.3(2)(a) is modified.

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

(a)DOCUMENTATION OF tThe training and experience that demonstrate, for each service technician AS REQUIRED BY APPENDIX 2H, sufficient competence to provide the services for which registration is being requested; and

Section 2.4.4.3 is modified.

2.4.4.3Department approval as a registered medical physicist CONSISTENT WITH APPENDIX2B is considered also to be Department approval as a qualified inspector for ANY healing arts facilitYies and/OR machines.

Sections 2.5.1.3 and 2.5.1.4 are modified to make the applicable inspection frequency more clear.

2.5.1.3Each bone densitometry, dental, podiatry or veterinary radiation machine shall be inspected at least every three (3) years, except that:

(3)EACH VOLUMETRIC DENTAL IMAGING SYSTEM SHALL BE INSPECTED ANNUALLY.

2.5.1.4Each HUMAN USE portable hand-held instrument used for any purpose shall be inspected annually.

TABLE 2-1: SUMMARY OF FREQUENCY OF RADIATION MACHINE INSPECTION
Category / Frequency
Each radiation machine, including under reciprocity, unless otherwise provided below: / Every year
Each non-healing-arts fixed industrial radiography or analytical, cabinet, airport or port-of-entry xraymachine or system / Every two years
Each bone densitometry, dental, podiatry or veterinary radiationmachine, except as required below: / Every three years
Pursuant to 2.5.1.3(1), each radiographic x-ray machine or tomographic or computed tomographic system used with a variable setting (kVp, mA or collimation) in non-intraoral dentistry or podiatry / Every year
Pursuant to 2.5.1.3(2), each x-ray machine used in podiatry at more than 30 mA / Every year
PURSUANT TO 2.5.1.3(3), EACH VOLUMETRIC DENTAL IMAGING SYSTEM / EVERY YEAR
Pursuant to 2.5.1.4, each HUMAN USE hand-held x-ray machine / Every year

Sections 2.6.1.9 through 2.6.1.13 are modified to read “meets any applicable requirement of”.

2.6.1.9For radiographic equipment used in the practice of medicine, “adequately trained” shall mean that the individual operator meets the ANY APPLICABLE requirements of the Colorado State Board of Medical Examiners (in particular Rule 700, “State Board of Medical Examiners Rules and Regulations Regarding Education and Training Standards for Unlicensed Personnel Exposing Ionizing Radiation” of 3CCR713-16).

2.6.1.10For radiographic equipment used in chiropractic, “adequately trained” shall mean that the individual operator meets the ANY APPLICABLE requirements of the Colorado State Board of Chiropractic Examiners (in particular Rule 19, “Safety Training for Unlicensed Chiropractic Personnel,” of 3CCR707-1).

2.6.1.11For radiographic equipment used in dentistry, “adequately trained” shall mean that the individual operator meets the ANY APPLICABLErequirements of the Colorado State Board of Dental Examiners (in particular Rule X, “Minimum Standards for Qualifications, Training and Education for Unlicensed Personnel Exposing Patients to Ionizing Radiation,” of 3CCR709-1).

2.6.1.12For radiographic equipment used in podiatry, “adequately trained” shall mean that the individual operator meets the ANY APPLICABLErequirements of the State of Colorado Podiatry Board (in particular Rule 700 of 3CCR712-9).

2.6.1.13For radiographic equipment used in veterinary medicine, “adequately trained” shall mean that the individual operator meets the ANY applicable requirements of the State of Colorado Board of Veterinary Medicine (in particular 4CCR7271).

Appendix 2A, Section 2A.1.4.2 is modified to clarify that a qualified operator is eligible to serve as RSO.

2A.1.4.2Sufficient radiation safety experience, FOR EXAMPLE, AS A QUALIFIED RADIATION MACHINE OPERATOR (at least two years unless otherwise approved by the Department), COMMENSURATE with the type(s) of activity or facility for which the individual is seeking to perform RSO duties as, or under the supervision of, a certified health physicist, certified medical physicist, experienced RSO, or radiation protection professional recognized by the Department;

Appendix 2C, is modified to be clear that it applies to shielding design other than a healing arts facility

PART 2, APPENDIX 2C: QUALIFIED EXPERT FOR SHIELDING DESIGNFOR OTHER THAN A HEALING ARTS FACILITY – QE(S) -ADEQUATERADIATIONSAFETYTRAININGAND EXPERIENCE

As provided by 2.4.3.1(2), each qualified expert for shielding design (other than a registered medical physicist) shall be an individual who:

2C.1Has provided evidence of:

2C.1.1Current certification by a physics specialty board recognized by the Department; and

2C.1.2Written approval from the Department as a qualified expert for shielding design, designated QE(S), pursuant to 2.4.2 as stated in 2.4.2.1;

In Appendix 2D, Section 2D.2.4 and 2D.3.2 are modified to reflect streamlining of Department forms.

2D.2.4Approval by the Department as having passed the ARRTLimitedScopeOperatorSTATEExamination required by 2.4.5.1.

2D.2.4.1The application to be registered in the State of Colorado as a Limited Scope Operator 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.

(1)The applicant shall complete Form R-70, “Application for Registration – Limited Scope Operator Examination” and shall attach forms R-71,R-72, and R-73.

(2)The applicant shall verify didactic training AND CLINICAL EXPERIENCE on Form R-71, “Checklist for RegistrationCLINICAL SUPERVISORY AND COMPETENCY STATEMENT – Limited Scope Operator Examination.”

(3)The applicant shall verify clinical experience on Form R-72, “Clinical Supervisory Statement - Limited Scope Operators.”

(4)The applicant shall verify clinical competency on Form R-73, “Clinical Competency Statement - Limited Scope Operators.”

2D.3.2Be documented by certificate(s) or other attestation(s) of satisfactory completion, SUBMITTED WITH AN UPDATED FORM R-90, “APPLICATION FOR RENEWAL – LIMITED SCOPE OPERATOR”.

In Appendix 2F, Section 2F.2.4 and 2F.3 are modified to reflect streamlining of Department forms,

2F.2.4Approval by the Department as having passed the BoneDensityEquipmentOperatorSTATEExamination required by 2.4.5.3.

2F.2.4.1The application to be registered in the State of Colorado as a Bone Density Equipment Operator 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.

(1)The applicant shall complete:(a)Form R-80, “Application for Registration – Bone Densitometry Equipment Operator”; or(b) Form R-81, “Application for Registration – Bone Densitometry Equipment Operator Examination” and shall attach Forms R-810, R-82, and R-83; and

(2)The applicant shall verify clinical experience on Form R-812, “Clinical Supervisory AND COMPETENCY Statement – Bone Density Equipment Operator”; and

(3)The applicant shall verify clinical competency on Form R-83, “Clinical Competency Statement – Bone Density Equipment Operator.”

2F.3Has maintained a minimum of eighteen (18) hours continuing education every three years, documented by certificate(s) or other attestation(s) of satisfactory completion, SUBMITTED WITH AN UPDATED FORM R-82, “APPLICATION FOR RENEWAL – BONE DENSITY EQUIPMENT OPERATOR”.

STATEMENT OF BASIS AND PURPOSE

AND SPECIFIC STATUTORY AUTHORITY

FOR

AMENDMENTS TO THE COLORADO STATE BOARD OF HEALTH

RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL

6 CCR 1007-1

Part 2, Registration of Radiation Machines, Facilities and Services

April 9, 2010

Basis and Purpose.

The Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes (the Act), Section 25-11-104, requires the State Board of Health to formulate, adopt and promulgate rules and regulations pertaining to radiation control.

Section 2511103 of the Act requires the Colorado Department of Public Health and Environment (Department) to develop and conduct programs for evaluation and control of hazards associated with the use of sources of ionizing radiation, including requiring registration of sources of ionizing radiation such as radiation machines and issuing licenses pertaining to radioactive materials.

Section 2511104 of the Act requires Colorado’s radiation regulations to be modeled after the Suggested State Regulations for Control of Radiation (SSRCR) of the Conference of Radiation Control Program Directors, Inc., except when the Board of Health concludes, on the basis of detailed findings, that a substantial deviation from the SSRCR is warranted.

Part 2, Registration of Radiation Machines, Facilities and Services, for which the most recent modifications will become effective July 1, 2010, applies to all types of radiation machines, all facilities that use radiation machines, and all radiation-machine-related services that require registration in Colorado with the Department.

These amendments incorporate needed and desired minor corrections to Part2. Improvements in wording are made in 2.4.3.2(2)(a) and 2.4.4.3. Sections 2.5.1.3 and 2.5.1.4 are made more clear and explicit. A slight improvement in wording is made in a phrase repeated in 2.6.1.9 through 2.6.1.13. In Appendix 2A, the ability of a qualified operator to be an RSO is made more explicit. Appendix 2C is clarified in the title and cross-reference to 2.4.3.1(2). The Department forms are consolidated and streamlined to more effectively implement Appendices 2D and 2F,.

Specific Statutory Authority. These rules are promulgated pursuant to the provisions of Sections 25-1.5-101(1)(l), 25-1-108(1)(c), and 25-11-104, C.R.S.

Major Factual and Policy Issues Encountered. These revisions do not involve large factual or policy issues. The changes are in response to nuanced stakeholder suggestions for improvement at workshops held in March 2010. These changes improve Part 2.

Alternative Rules Considered and Why Rejected. These changes are minor. Alternate word choices were considered, but rejected.

TheColorado Radiation Advisory Committee approved these modifications unanimously on April 2, 2010.

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