Accreditation Bodies (ABs) are entities approved by the Food and Drug Administration (FDA) to evaluate and accredit mammography facilities based upon quality standards specified in the Mammography Quality Standards Act (MQSA). Only facilities that are accredited by ABs, or undergoing accreditation by ABs, may receive certificates from FDA or an FDA-approved State Certifying Agency (CA) to legally perform mammography.
Under the MQSA, each AB must require facilities it accredits to meet standards that are equal to the quality standards established by FDA under Title 42, Section 263b(f) of the United States Code to ensure the safety and accuracy of mammography. All ABs have either adopted the MQSA standards by reference or have developed standards that are equal to or exceed the quality standards established by FDA. Each AB has incorporated the standards into its accreditation processes.
Currently, there are four FDA-approved ABs:
- The American College of Radiology
- State of Arkansas
- State of Iowa
- State of Texas
FDA approves ABs for a period of seven years. At the end of the term of approval, an AB must apply to FDA for renewal of its status as an FDA-approved AB, as described in the MQSA regulations. All four ABs are currently approved through April 28, 2020.
Facilities are accredited when they first open and every three years thereafter. In order to become accredited, facilities must apply to an AB and meet its quality standards. Facilities must complete an accreditation application that includes submitting information on personnel, mammography equipment, and quality control and quality assurance aspects of their practices. In addition, as part of the accreditation process, mammography facilities must submit mammograms and phantom images to their ABs for review. A phantom is a test object that has embedded items that simulate mammographic signs of breast cancer, such as calcifications and masses. The submitted mammograms are evaluated on the eight attributes listed in the MQSA regulations: positioning, exposure level, contrast, sharpness, noise, artifacts and examination identification. Each phantom image is evaluated against standards approved by the FDA. Once a facility passes accreditation for the first time, or has its accreditation renewed on a three year cycle, it is issued a three year certificate from FDA or a State CA.
The MQSA regulations require ABs to conduct oversight activities to monitor and assess facility compliance with the standards established by the AB for accreditation. Those activities include onsite visits to facilities and clinical image reviews of mammograms from randomly chosen facilities. The onsite facility visits are either randomly selected or selected based on problems identified through MQSA inspections, serious complaints, or a previous history of noncompliance. .
The ABs, FDA and State CAs work closely together to address image quality issues at mammography facilities. They utilize tools such as Additional Mammography Reviews (AMRs), Patient Provider Notifications (PPNs) and Corrective Action Plans (CAPs). If the quality of mammography at a facility is believed to have been compromised, the AB conducts an AMR. An AMR is a review of up to 30 mammograms. If the AMR reveals problems with mammography that are deemed a serious risk to human health, FDA (or State CA) will require that the facility conduct a PPN, whereby the facility is required to notify patients and their referring healthcare providers of the image quality issues found at the facility and appropriate steps to take. If a facility’s image quality does not meet the quality standards, but the issues do not constitute a serious risk to human health, the AB will require the facility to complete a CAP. The CAP includes actions to ensure that deficiencies found during the clinical image review are corrected and the AB’s quality standards are met. A facility may be directed to complete a CAP after an image review for accreditation, an AMR, a random review or an onsite visit. Once the corrective action is completed, the AB conducts follow-up image quality assessment to ensure its effectiveness.
On an annual basis, FDA assesses the performance of the ABs themselves, evaluating them on resources, reporting and record keeping processes; accreditation review and decision making processes; and policies and procedures. FDA’s performance assessment of the ABs is sent to Congress in an annual report. The ABs themselves undergo rigorous assessment and oversight, and they in turn play many roles in assessing facility performance and ensuring quality mammography is available to women throughout the country. They are indeed one of FDA’s critical partners in administering the MQSA.
* As of January 1, 2016