Mobile Mammography is an important tool utilized today by many healthcare organizations to expand access to mammography services, bringing mammography to the patient. Mobile units travel to locations such as corporations, health fairs, tribal lands, prisons, and to health clinics that do not have dedicated mammography equipment. As of November 2017, there are over 300 accredited mobile units operating in the United States; most vans provide full field digital mammography and some provide digital breast tomosynthesis. Breast Tomosynthesis, a newer technology also known as 3D mammography, is a form of mammography that uses computer reconstructions of two-dimensional images to create three-dimensional pictures of the breast, helping improve the visualization of breast tissue.
Under the Mammography Quality Standards Act (MQSA), the regulatory requirements for mobile units are the same as for stationary units, with one additional requirement: 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. Post-move verification tests must be performed by the facility as required by the image receptor manufacturer’s quality control manual.
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. 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. Due to the complexities that arise from multiple management scenarios, FDA would like to clarify who is ultimately responsible for ensuring that mobile mammography units meet the accreditation and certification requirements under the MQSA.
It is ultimately the responsibility of the certified mammography facility (or the mammography facility seeking certification) to ensure that the mobile unit meets all the requirements of the MQSA. It is also the responsibility of the facility to ensure that personnel associated with the mobile unit meet all MQSA personnel requirements, as well as state and local requirements for practicing mammography in each state where the mobile unit is operated.
In determining who is responsible for meeting the requirements, the first question to ask is, “Who holds the MQSA certificate”? To help answer this question, it is important to know the difference between a Mobile Operator and a Mammography Site.
Mobile Operator (MO): A mammography service provider with one or more mobile mammography x-ray units that are transported to different locations to provide mammography services. A mobile operator may own the unit or may lease it from a third party.
Mammography Site (MS): A location where patients obtain mammography services.
To assist facilities that operate a mobile unit or those considering doing so, here is a brief overview of the most common mobile mammography certification scenarios in practice.
Scenario 1: In this scenario, a certified MO provides mammography services to one or more uncertified sites (MS). The MO is the MQSA certified facility. The MO may have one or more mobile units that are accredited by the MO’s accreditation body and operated under a MQSA certificate held by the MO.
- Inspection Location: A location that is agreeable to both the MO and the inspector. All records must be available for review at the time of the inspection, and it is recommended that all of the mobile units are brought to one central location on the day of the inspection for evaluation. By bringing all mobile units to one central location the annual inspection can usually be completed in a single day.
- Inspection Scope: The inspection will cover all the same areas as a fixed-site annual MQSA inspection, including acquiring a phantom image on each mobile unit. Additionally, the inspector must verify that a post-move verification quality control (QC) test(s) was performed after each move of the mobile unit and prior to patient imaging. The travel schedule for each mobile unit should be provided to the inspector to facilitate the records review for the post-move verification QC test(s).
Scenario 2: In this scenario, the mobile unit is tied to a certified fixed-site mammography facility which may also have stationary units (MS-MO). Again, the mobile unit provides services to one or more uncertified sites (MS).
- Inspection Location: Inspection occurs at the certified fixed-site MS-MO and the mobile unit must be present at the fixed-site MS-MO location on the day of the inspection. All records must be available for review at the time of the inspection, including the travel schedule for the mobile unit.
- Inspection Scope: Same as Scenario 1.
Scenario 3: In this scenario, the MO is uncertified and provides the mobile units that are operated under the MQSA certificate of the MS. The mobile unit must be accredited at each certified MS where the unit is used to image patients.
- Inspection Location: Inspection occurs at each certified MS with the mobile unit-onsite on the day of the inspection.
- Inspection Scope: Same as Scenario 1. All records pertaining to the mobile unit will be evaluated during each of the certified MS’s inspections.
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. Facilities can also prepare by maintaining all manufacturer required quality control records, medical physicist survey reports, service records, and MQSA-required personnel records. As with all MQSA inspections, the inspector will provide advanced notice of an inspection, allowing time for the facility to coordinate the schedules of the mobile units with the inspection schedule.
It is important for each facility that operates mobile units to ensure the MQSA certificate is displayed in an area visible to all patients receiving mammography services; this may mean having a copy of the certificate in each mobile van. You can obtain additional copies of your certificate (at no charge) by contacting FDA at 1-800-838-7715 or writing to: MQSA Hotline, P.O. Box 6057, Columbia, MD 21045. Spanish-language certificates are also available. Facilities with State-issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.
Mobile mammography can be a patient-friendly experience that increases access to this valuable tool for breast cancer detection. Thanks to the dedicated efforts of facilities that operate mobile units and MQSA inspectors who make sure they meet the required standards, it’s ok to step on a van to get a mammogram!