X-Ray machine facilities

The X-Ray Certification Unit of the Colorado Department of Public Health and Environment is working to identify regulatory barriers and provide exemptions in an effort to streamline and facilitate responses to the 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 6.6.1.2 the department is providing an additional 90 days for the completion of the initial evaluation. Please note, the requirements of 2.5.1.5 and 2.5.1.6 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 that are due for a certification evaluation, as per Section 2.5 of the Regulations, during the months of March, April, May and June of 2020 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 cdphe.hmxraycomments@state.co.us

 

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 2.5.1.3 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.
Changes to x-ray facilities also require notification to us through completion of the proper form(s) specified below.
 
Facilities that use radiation machines to expose humans or animals for medical or veterinary purposes are considered Healing Arts facilities. All other uses are considered Non-Healing Arts. Both facilities use the same registration form.
 

Renew, register or update your x-ray facility information

  • Renewing your annual x-ray facility registration (fee required).
  • Opening a new office or location that uses x-ray machines.
  • 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.
When completing the R-4 Registration form you must make sure your entries are accurate. The information you input will be the information imported into the x-ray database. Incorrect entries could result in future compliance issues.
Once you submit the registration form, a copy will be emailed to the radiation safety officer specified on the form (or on file with us).
 

Remove an x-ray machine from service

Complete when x-ray machines are:
  • No longer in service at your facility.
  • Disabled in storage.
  • Transferred, sold, or traded in.
  • Disposed of or recycled.
Failure to notify us in a timely manner of x-ray machines no longer in use may require continued registration notifications that may result in monetary penalties.

Find a registered service company, qualified expert or inspector to provide services to your X-ray facility

You must keep copies of all facility and machine certification evaluations, radiation machine purchase and repair documents, and all correspondence with us about your registration.
 
Before installing an x-ray machine in new or existing facilities, contact a Colorado approved qualified expert to learn if a shielding evaluation is required.
 
Colorado registered qualified inspectors
Once installed, your x-ray machine must be initially certified by a Colorado-approved qualified inspector,and periodically after that at the frequency required by Section 2.5.2 of the regulations.
Select a Colorado registered service company to perform the installation of your machine. All sales, installation and servicing of your x-ray machines must be performed by registered service companies.

Facilities intending to perform healing arts screening

Complete the form and submit to the x-ray certification unit.
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.
  • Requirements:
  • 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

Some facilities using X-ray machines may request a waiver to stop or propose an alternative to using radiation monitoring (dosimetry) badges to monitor the occupational radiation exposure of individual employees.
 
The facility must:
  • 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.
    or

    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.
  • Requirements:

Reciprocity request

Contact

Customer technical assistance for questions concerning x-ray and mammography
Phone: 303-692-3448
Fax: 303-691-7841
cdphe.hmxraycomments@state.co.us