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The MQSA Program in Action: A Compliance Case History

The Mammography Quality Standards Act (MQSA) signed into law by President George H.W. Bush on October 27, 1992, and its implementing regulations are not just dry legal papers, but are the basis of a vibrant program that helps mammography facilities maintain quality, and, in cases where they can’t, helps them get back to practicing quality mammography. The Division of Mammography Quality Standards (DMQS), which administers the MQSA program at the US Food and Drug Administration (FDA), wants to share with you a real world story of how the MQSA worked to help one facility improve the quality of its mammography and therefore the health of women.

A facility underwent its annual MQSA inspection, conducted by an FDA-trained State inspector, under contract with the MQSA program. This inspection revealed that an MQSA facility had two mammography units; however, one of the mammography units in use had been denied accreditation by one of the FDA-approved bodies who accredit mammography facilities in order for them to receive an MQSA certificate and legally operate. Due to the fact that the facility continued to use an unaccredited mammography unit to image patients, DMQS required the facility to participate in an Additional Mammography Review (AMR), whereby the facility’s accrediting body would have an expert clinical image reviewing radiologist evaluate the quality of 30 randomly selected mammograms performed by the facility using the unaccredited unit.

The AMR revealed serious problems with the facility’s image quality, including major concerns in the areas of positioning, compression, exposure level, contrast, sharpness, and noise. The AMR also revealed concerns with the final interpretations rendered by the facility’s interpreting physicians for some of the clinical images included in the AMR. Based on the AMR results, the accrediting body reported to FDA that it believed that the facility’s mammography practice posed a serious risk to human health. The accrediting body also revoked the facility’s second unit’s accreditation, and after reviewing the AMR results, DMQS concluded that the facility posed a serious risk to human health and placed the facility’s certificate in a “no longer in effect” status. These combined efforts by the accrediting body and FDA ensured that the facility could no longer legally perform mammography until the facility successfully completed all corrective actions required by the accrediting body and the FDA.

Because the facility’s mammography posed a serious risk to human health, the FDA required the facility to notify at-risk patients who had mammograms performed at this facility, and their referring health care providers, of the facility’s serious image quality problems. This notification, which included FDA recommendations to both health care providers and patients, allowed health care providers to discuss appropriate follow-up medical care with their at-risk patients who had received mammography services at a facility where image quality had been compromised.

This Patient and Provider Notification (PPN) action proved to be the largest notification in the history of the MQSA program. Over 12,000 patients and 200 providers were notified of the concerns regarding the facility’s mammography image quality. The facility, guided by the DMQS MQSA compliance officer assigned to the case, worked diligently to ensure the PPN was completed on time through such efforts as holding weekly PPN update-meetings, providing detailed spreadsheets of PPN activity, and reaching out to the local United States Postal Service to arrange an electronic method for viewing returned patient notification letter receipts. The facility successfully completed the FDA- required PPN and the corrective action plan required by the facility’s accrediting body. The facility’s accreditation was reinstated and FDA issued a provisional MQSA certificate which allowed the facility to resume mammography services.

Because the facility’s accreditation had been revoked, the facility was required to undergo a post revocation AMR to ensure the corrective actions employed by the facility were effective. Unfortunately, the facility failed the post revocation clinical image review, suggesting that its corrective action plan had not been sufficient to improve image quality. Consequently, the accrediting body again revoked the facility’s accreditation and the FDA placed the facility’s provisional MQSA certificate in a “no longer in effect” status for a second time. The accrediting body and FDA held a teleconference to discuss the best options to bring the facility into compliance with the MQSA. In the area where the facility was located, there were limited other mammography services available nearby. Due to the facility failing the follow-up image review after implementing their corrective action plan, FDA and the accrediting body decided that the accrediting body would conduct a Scheduled On-Site Survey (SOSS) to assist the facility in addressing its clinical image deficiencies and to help the facility return to practicing quality mammography as soon as possible. This meant that a team of experts including a mammography technologist, an interpreting radiologist, and an expert in mammography facility administration would spend time on-site at the facility, and would develop an extensive corrective action plan based on that facility’s specific needs.

The SOSS included an on-site review of the facility’s clinical image quality control activities, a review of randomly selected clinical images to evaluate image quality, a medical physicist survey of the facility’s mammography equipment, and real-time patient positioning evaluation. The facility communicated to both the MQSA compliance officer and the accrediting body that the SOSS was an extremely positive and helpful educational experience. The facility also noted that during the SOSS, its interpreting physicians became more aware of what constitutes clinical image quality and how to efficiently address quality issues. After the SOSS, the facility submitted its corrective action documentation which was accepted by the accrediting body as complete. The effectiveness of the corrective action was demonstrated by the fact that the facility, which was required to participate in another AMR after the second accreditation revocation and the SOSS, this time was able to pass the post revocation AMR.

The facility had its accreditation reinstated and the FDA issued the facility a 3-year MQSA certificate. Patients once again had access to quality mammography. Although it sometimes requires extensive measures, the provisions of the MQSA, with the help of the dedicated staff at DMQS who administer the program, along with equally dedicated staff at its partners – the accrediting bodies, certifying states, state radiation programs and state and FDA field inspectors – allow us all to help facilities come back into compliance and provide quality mammography to their patients. After all, the quality of mammography directly impacts women and their health, and therefore is the ultimate goal of the MQSA. The facility is currently operating and by all indications is providing patients with quality mammography services.

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