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 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 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 firstname.lastname@example.org
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