Source: https://dshs.state.tx.us/radiation/mammography/laws-rules.aspx
Timestamp: 2020-08-05 10:04:27
Document Index: 426002456

Matched Legal Cases: ['§289', '§289', '§289', '§289', '§289', '§289', '§289', '§289']

Mammography Laws and Rules - Radiation Control Program
Laws and Rules - Mammography Program
On March 19, 2020, DSHS Radiation Control began receiving information that some medical facilities are limiting access to vendors due to restrictions they have implemented because of COVID-19. Those prohibitions include restricting or barring access to licensed medical physicists who conduct required machine testing, which would result in a delay in conducting physics surveys.
The current Texas regulations on mammography, fluoroscopy, computed tomography, and other x-ray devices require testing at a specified interval. DSHS also aligns its practices to guidance offered by federal regulatory agencies such as the U.S. Food and Drug Administration.
DSHS supports facilities’ efforts to protect public health and offers the following guidance for registrants to ensure a continuity of radiation safety during COVID-19-related restrictions. This is a fluid situation and subject to change.
The U.S. Food and Drug Administration has a policy for mammography devices that allows facilities to notify their state inspector or state certifying agency and request permission in writing to defer the current survey until the extenuating circumstance(s) is no longer applicable. The policy requires facilities to make the notification before the expiration of their current physics survey.
In its request, the facility must include the date the survey expires, explain in writing the reason for the requested deferral, and propose a schedule showing the date by which the deferred physics survey will be completed. As the date when COVID-19 restrictions will end and the resources available for testing at the end of restrictions may be unknown at this time, the facility may satisfy this requirement by describing the efforts they plan to take in the three months immediately following the survey expiration. The department understands this proposed schedule may need to be amended.
Quality assurance testing will still need to be performed by the facility for as long as they continue to perform imaging procedures. In situations where the mammography device requires repair before being used, the facility will direct patients to a facility with properly working mammography devices until the repairs and testing can be completed.
Mammography facilities should notify Trae Windham at trae.windham@dshs.texas.gov to request permission to defer the current survey.
Fluoroscopy, Computed Tomography, and Other X-Ray Devices
If the physics survey is delayed due to circumstances related to COVID-19, the facility is required to document the issue and determine a schedule to have the required testing completed. This documentation should start before the current physics survey expires. If the proposed schedule needs to be amended, the facility should update their documentation. This documentation should be made available to department inspection staff upon request. In situations where the x-ray device requires repair before being used, the facility will direct patients to a facility with properly working x-ray devices until the repairs and testing can be completed.
Questions can be sent to RadiationXRayInspections@dshs.texas.gov
Mammography Rules - Title 25, Texas Administrative Code
Rules Covering Mammography
(PDF, 65KB) “Notice to Employees” RC Form 203-1 (standalone document) 10/01/11
§289.226 (HTML)
§289.226 (PDF, 217KB) Registration of Radiation Machine Use and Services 12/17/13
§289.230 (HTML)
§289.230 (PDF, 378KB) Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography 04/29/12
§289.231 (HTML)
§289.231 (PDF, 280KB) General Provisions and Standards for Protection Against Machine-Produced Radiation 12/29/11
Texas Mammography Accreditation Rules - Title 25, Texas Administrative Code
(In addition to the mammography rules listed above, facilities accredited with State of Texas must follow the rules listed below.)
Rules Covering Texas Mammography Accreditation
§289.234 (HTML)
§289.234 (PDF, 113KB) Mammography Accreditation 04/29/12