The X-Ray Certification Unit of the Colorado Department of Public Health and Environment continues to recognize regulatory barriers and provide exemptions in an effort to streamline and facilitate responses to the ongoing COVID-19 pandemic. In addition to the previously provided extensions for Certification Evaluations, CDPHE is providing exemptions to the requirement for registration of temporary health care facility alternative care sites that have a need to use radiation producing machines and for select facility shielding design requirements. The requirements of 6 CCR 1007-1 Part 2 Section 2.4.1 require that facilities must be registered with CDPHE prior to using a radiation producing machine. The department is providing an exemption to this requirement for registered health care facilities to relocate all or a portion of their registered portable and mobile radiation producing machines to alternative care sites and use those devices without registration.
Additionally, 6 CCR 1007-1 Part 6 Section 6.3.2 provides an exemption from certain shielding design requirements for portable and mobile radiation producing machines that are used infrequently within a facility. This exemption is contingent upon the facility implementing As Low As Reasonably Achievable (ALARA) policies and procedures which ensure that no occupational or public dose limits are exceeded. The department is extending this exemption to all portable and mobile radiation producing machines being used in temporary health care facility alternative care sites regardless of the frequency of use. These alternative care sites are still required to establish, implement, and follow procedures and policies consistent with the ALARA concept for the protection of patients, operators, staff, and members of the public.
This will allow for these health care facilities to maximize flexibility related to the use of these devices and allow for a concentrated focus on addressing health care needs as a result of COVID-19.
These exemptions are effective immediately and shall remain in effect until further notice from the department.
Additionally, the following is a summary of the COVID-19 related exemptions already provided by the X-ray certification unit in regard to radiation producing machines:
For those radiation machines and facilities that require an initial certification evaluation within 90 days of use as per Section 188.8.131.52 the department is providing an additional 90 days for the completion of the initial evaluation. Please note, the requirements of 184.108.40.206 and 220.127.116.11 still remain in force and an evaluation of those machines prior to being used to perform any human examination is still required.
Radiation machines and facilities (excluding mammography, defer to FDA) that are due for a certification evaluation, per Section 2.5 of the Regulations, during the months of March 2020 through June 2022 (previous extension was through June 2021) shall be granted a 6 month extension to complete that evaluation.
Please feel free to contact the X-ray Certification Unit with any questions at 303-692-3448 or email@example.com
All non-federal facilities using x-ray machines for any purpose must:
Have their machine initially and periodically inspected by a registered qualified inspector. Inspection frequency varies from 1 to 3 years and is specified in Table 2-1 of Part 2, Section 18.104.22.168 of the regulations depending on the machine type/use.
Initially and annually register with the x-ray certification unit at the Colorado Department of Public Health and Environment.
Renew, register or update your x-ray facility information
Opening a new office or location that uses x-ray machines. (We charge a $50 fee at the time of your new registration.)
Renewing or updating your annual x-ray facility registration. (We send out a $50 facility registration fee February of each year.)
Installing a new x-ray machine or adding a new x-ray imaging suite or location.
There are other changes to your registration information such as a change in address, change in ownership, or change in the radiation safety officer. Notifications of registration information must be made within 30 days.
Remove an x-ray machine from service
No longer in service at your facility.
Disabled in storage.
Transferred, sold, or traded in.
Disposed of or recycled.
Find a registered service company, qualified expert or inspector to provide services to your X-ray facility
Colorado registered qualified inspectors
- All registered qualified inspectors for verification.
- Qualified inspectors, all categories.
- Qualified inspectors for dental machines.
- Qualified inspectors for industrial machines.
- Qualified inspectors for veterinary machines.
- List of approved registered medical physicist.
- List of approved registered medical physicist in mammography.
Facilities intending to perform healing arts screening
Means the exposure of any human being using an x-ray imaging system for healthcare purposes when such a test is not specifically ordered by a licensed practitioner of the healing arts. The formal definition is found in Part 6 of the regulations.
May include using x-ray systems or imaging for body fat analysis, computed tomography cardiac, lung or colon screening, screening using fluoroscopy, or certain research.
Healing arts application instructions.
Entities coming from out of state to perform healing arts screening on a temporary basis should contact us as additional requirements may apply.
Radiation monitoring waiver requests
Not be using fluoroscopy, computed tomography (excluding dental cone beam computed tomography), or radiation therapy X-ray systems.
Demonstrate that worker exposure is not likely to exceed 10 percent of the occupational dose limits of the regulations by providing either:
Six months of recent personnel dosimetry data.
A review from a qualified expert.
Review the radiation safety program each year to ensure no changes were made that would increase the radiation exposure levels for workers such as significantly more X-ray machine use, adding or relocating X-ray machines, or remodeling of an X-ray room, all of which may void a waiver.
Customer technical assistance for questions concerning x-ray and mammography