The transition to accreditation of Digital Breast Tomosynthesis (DBT) units has brought to light instances of facilities failing to obtain accreditation for each of their DBT units. The FDA is encountering situations where facilities have operated unaccredited DBT units, or DBT units without Certificate Extension from the FDA when the extension program was in effect.
Effective April 9, 2018, all accrediting bodies (ABs) received FDA approval for their DBT accreditation standards and processes, and began to undertake the responsibility of accrediting all DBT units. For DBT units being put into use on or after April 9, 2018, or units which were in place earlier but never received Certificate Extension, a facility must first apply to its AB for accreditation of the DBT unit before using the unit to image patients. Each individual DBT unit must meet this requirement. No DBT unit may be used to image patients unless it has been accredited by an AB (or the DBT unit is already under a Certificate Extension granted by the FDA prior to April 6, 2018, as discussed in the next paragraph).
Facilities that received Certificate Extension from the FDA for their DBT units, prior to the FDA terminating that program, need to check with their AB, as the States of Arkansas and Iowa ABs require DBT accreditation applications immediately, while the State of Texas AB and the American College of Radiology are gradually transitioning from Certificate Extension to accreditation when each DBT’s associated Full Field Digital Mammography (FFDM) unit reaches its accreditation renewal date. But if a DBT unit did not receive or apply for Certificate Extension prior to April 6, 2018, that unit needs to be accredited by an AB immediately, before it may be used to image patients. Again, the use of any unaccredited mammography unit, including a DBT unit that is not accredited or covered under an approved Certificate Extension, is a violation of the MQSA, which can lead to an inspection citation, and possibly other compliance actions such as an Additional Mammography Review and loss of certification. If you are unsure of your DBT unit’s accreditation or Certificate Extension status, immediately check with your AB.
Facilities need to remember that, although they are physically housed within a single mammography device, DBT and FFDM are two separate mammographic modalities. Under MQSA, that one device is considered two mammography units (an FFDM unit and a DBT unit), each of which must be accredited and must undergo annual MQSA inspection. Also, for example, if both modalities were new to an individual who is subject to the MQSA personnel qualification requirements, eight hours of training would be required for each of the two modalities (DBT and FFDM).
The procedure for accreditation of DBT units also varies with the specific manufacturer/unit, and how the DBT unit is used in clinical practice (e.g., whether both FFDM and DBT are performed with the unit). Our previous MQSA Insights article on DBT accreditation outlines the necessary quality control tests, personnel training requirements, and some other aspects of the DBT accreditation process. To learn about specific requirements, or for any further questions, please contact your AB.
The ABs are the best source of information about the transition to DBT accreditation and the specifics of their DBT accreditation requirements and processes; their useful links are provided below: