The promotion of clinical image quality is a primary goal of the Mammography Quality Standards Act (MQSA). In fact, there is a requirement in the MQSA regulations that “[c]linical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility’s accreditation body” (21 CFR 900.12(i)). When performing clinical image reviews, FDA‐approved accreditation bodies (AB) must include in the review the eight image quality attributes listed at 21 CFR 900.4(c)(2) .
As we have noted in a previous MQSA Insights article, one of the most consequential of these attributes is patient positioning; poor positioning is a factor in most deficiencies and failures of clinical images. The regulations also require that all interpreting physicians interpreting mammograms for the facility shall “[f]ollow the facility procedures for corrective action when the images they are asked to interpret are of poor quality” (21 CFR 900.12(d)(1)(ii)(A)).
Furthermore, “[t]he lead interpreting physician [. . .] shall ensure that records concerning [. . .] quality control (including [. . .] corrective actions [. . .] ) [. . .] are properly maintained and updated” (21 CFR 900.12(d)(2)). This is among the important responsibilities of the Lead Interpreting Physician (LIP) under MQSA. Additionally, 21 CFR 900.2(x) states that the LIP has the general responsibility for ensuring that a facility’s quality assurance (QA) program meets all of the requirements of 21 CFR 900.12(d)-(f). These subsections address the establishment and maintenance of a QA program and maintenance of associated records; quality control (QC) testing of equipment and corrective action as needed; performance of physicist surveys and mammography equipment evaluations; and a mammography medical outcomes audit. Some of the responsibilities for parts of this QA program are assigned to other qualified individuals, such as the QC technologist and the medical physicist, but the LIP is the operator responsible, on behalf of the facility, to make sure that all quality assurance requirements found in 21 CFR 900.12(d) through (f) are met, including that tests and surveys are performed at the required frequencies, corrective actions are taken when warranted by test results, and records are kept.
Some of these existing MQSA requirements related to QA and image quality have generally not been verified or highlighted by inspectors during annual facility inspections. Conversely, some items which have been inspected annually have very rarely identified violations. Therefore, the Division of Mammography Quality Standards is introducing the Enhancing Quality Using the Inspection Program or EQUIP initiative. The EQUIP initiative will begin to be introduced on October 27, 2016, to mark the beginning of the 25th year since the passage of MQSA. As part of EQUIP, in order to emphasize the need for ongoing facility review of clinical image quality, FDA is adding three inspection questions and removing two. Remember, even if questions are removed from the inspection process, the regulations that create the requirements for inspection questions intended to assess compliance still have the force of law and facilities must continue to comply with all the MQSA regulations even if compliance is not generally checked via questions at the time of inspection.
The three new inspection questions will focus on the three regulations quoted above. The first new inspection question assesses for facility procedures to ensure that clinical images continue to comply with AB standards (including image quality attributes such as positioning), and include regular reviews of sample images from each technologist and each interpreting physician (IP). The second new inspection question assesses for corrective procedures when clinical images are of poor quality, including a mechanism for providing ongoing IP feedback to technologists or other designated personnel. The third new inspection question assesses for the procedure for LIP oversight of QA/QC records—including overseeing the frequency of performance of all required tests—and determining whether corrective actions were taken when needed.
During year one of inspections containing the new EQUIP questions, which will begin January 1, 2017, deficiencies identified by the three new questions will be noted on MQSA inspection reports, but no citations will be generated by the inspection software during the year following the January 1, 2017, start date. Inspectors will discuss the three new questions introduced in the EQUIP initiative with facility personnel and point out to the facility that, should procedures assessed by the inspection questions still not be in place by the time of the next annual MQSA inspection and beyond, Level 2 violation citations will be issued. This stepwise introduction will give facilities and inspectors time to become familiar with the three new inspection questions and refresh facilities’ understanding of the underlying requirements the questions are intended to aid in assessing. FDA has posted Frequently Asked Questions for Facilities about the EQUIP initiative and intends to update those FAQs after approximately 3‐6 months of inspector experience and facility feedback.
The addition of the three new questions to the inspection process under the EQUIP initiative is intended to continue MQSA’s emphasis on the significance of clinical image quality, which is one of the most important determinants of the accuracy of mammography. The changes will help “EQUIP” facilities to continue to provide quality mammography.