In an advisory posted to its website, the U.S. Food and Drug Administration (FDA) noted that each time a mobile unit is moved to a new location, a post-move verification test must be conducted prior to imaging patients at the new location. The advisory is in adherence with the Mammography Quality Standards Act (MQSA).
The statement also clarified the responsibility of meeting the accreditation and certification requirements of MQSA lies with the certified mammography facility or the one seeking certification. Furthermore, the facility operating the mobile unit is responsible for ensuring all personnel associated with the mobile unit meet MQSA personnel requirements and state and local requirements.
“Just like stationary units, mobile mammography units are required to be accredited by an FDA-approved accrediting body, and the facility operating the mobile unit must have a certificate issued by either the FDA or an FDA-approved state certifying agency,” the statement read. “Sometimes mobile units are owned by a certified mammography facility and at other times these units are leased from a third party. In both cases, the mobile mammography unit must be accredited, and the mobile unit must be operated by a certified facility.”
The FDA also provided MQSA-related recommendations for facilities operating mobile units.
“A facility that operates mobile units can prepare for its MQSA inspection by maintaining a mobile unit travel schedule or log which shows the dates when the mobile unit moved locations and when mammographic exams were performed on the mobile unit; the MQSA Inspector will use this documentation to help verify that post-move verification tests recommended by the image receptor manufacturer were performed after each move and prior to patient imaging,” the statement read.
The full advisory can be read here.