OCD FY2000: Mammography Quality
The goal of the Mammography Quality Standards Act (MQSA) is to enhance the detection of breast disease through high quality mammography services. Under the law, mammography facilities must be certified by the FDA and accredited by a non-profit body; this includes meeting Federally established quality standards and undergoing annual inspections. For detailed information on the items below, visit FDA’s Mammography Program. The site includes a search engine that enables users to search by subject matter.
To assure mammography quality, mammography facilities undergo annual inspections by FDA credentialed inspectors. Nearly 10,000 inspections take place each year. Fiscal Year 2000 was the first full year of inspections under the MQSA Final Regulations. More than half of the facilities [53%] had no adverse findings during their inspections this year. About 10% of facilities had nothing worse than minor (Level 3) findings, while 33% had moderate (Level 2) findings as their most significant result. Finally, about 4% had serious (Level 1) findings during their inspection. The Level 1 and Level 2 percentages were higher and the Level 3 and "no findings" percentages were lower than in the previous year. The increase in significant findings is related to the newly effective final regulations and was expected as mammography facilities accommodate to the new, and stricter, requirements. The percentage of facilities with significant inspection findings decreased as Fiscal Year 2000 went on and we view this as a positive sign. We are confident that mammography facilities will improve their performance as they become more familiar with the requirements of the final regulations.
- Digital Mammography
FDA approved the first Full Field Digital Mammography (FFDM) system for commercial use in January 2000. The new technology promises to enhance mammography by reducing the need for some women to have additional exposures, while allowing interpreting physicians to quickly and easily manipulate the images. While the accreditation bodies are developing a process for accrediting FFDM units, at this time digital units are exempt from MQSA accreditation requirements. For a facility to lawfully use the FFDM system, it must submit a successful application with required information to FDA, including personnel and equipment requirements.
- States as Certifiers (SAC) Demonstration Project
This project successfully transferred certain key MQSA responsibilities to the States of Illinois and Iowa. The program authorizes qualified States to certify mammography facilities within their jurisdiction, conduct inspections, and enforce the MQSA quality standards, under FDA oversight. The proposed rule to fully implement the program nationally was published in March 2000, comments were evaluated, and final regulations are expected in 2001.
MQSA Policy Guidance Help System (PGHS)
- In Fiscal Year 2000, all MQSA regulatory guidance materials and documents were compiled into one system -- PGHS. Mammography facilities and other interested parties now have access to a comprehensive online resource accessible via MQSA’s web page on the internet. Previously, this information was only available in ten separate documents with no way to search through all of the information at once. PGHS users can search for answers to specific questions through an indexed list of topics and key words. For example, by selecting a particular subject, such as "revocation of accreditation" or "accreditation and certification," the user will see the regulatory citation, any relevant guidance documents, and any other appropriate information and references.
The Nationwide Evaluation of X-ray Trends (NEXT) – see Radiological Health
The Technical Electronic Products Radiation Safety Standards Committee (TEPRSCC)–see Regulatory Science and Standards