Must mammography units that are used exclusively for special interventional purposes (localization, biopsy, or specimen radiography) be accredited? Must a facility that performs mammography only for such special purposes be accredited and certified?
Not at this time. Although these procedures do involve radiography of the breast, special procedures are currently exempted from MQSA regulations. 21 C.F.R. 900.2(aa)(1).
Personnel who are not involved with screening or diagnostic mammography may also be excluded from the application for accreditation. However, an accredited and certified facility that also has a mammography unit dedicated to such special purpose usage should inform the MQSA inspector that such equipment and personnel are used only for these special purposes, and are not used for screening or diagnostic mammography. In some cases, inspectors may have to examine facility records to verify this.
Note that any X-ray units or personnel involved even occasionally in routine screening or diagnostic mammography must meet the MQSA quality standards. These units must be included in the accreditation process and will be covered under the MQSA certificate. 21 C.F.R. 900.11.