MQSA Inspection Resources

Inspections

MQSA requires each facility conducting mammography in the United States (except those of the Department of Veterans Affairs) to:

• meet quality standards for personnel, equipment, maximum allowable radiation dose, quality assurance, medical audit and outcome analysis, medical recordkeeping and reporting requirements;
• be accredited by a Food and Drug Administration (FDA)-approved accreditation body (AB) (currently, the American College of Radiology [ACR] and the States of Arkansas and Texas);
• be certified to perform mammography by the FDA, or an FDA approved State certification body (each certified facility must prominently display its certificate where it can be viewed by mammography patients); and
• maintain its certified status by:
  • maintaining its accreditation,
  • having an annual survey performed by a qualified medical physicist,
  • undergoing an annual inspection conducted by an MQSA inspector,
  • paying an inspection fee (and, where applicable, re-inspection fees), and
  • correcting any deficiencies found during these processes.

NOTE: The Centers for Medicare and Medicaid Services accepts MQSA certification as evidence of compliance with mammography quality standards. Only facilities with a current MQSA certificate will be eligible to receive Medicare/Medicaid payment for screening and diagnostic mammography.

During each inspection, MQSA inspectors assess a facility's compliance with MQSA quality standards. Facilities must correct all deficiencies found. Inspections will not cover any new regulation before its effective date. To reduce the inspection time, the scope of the standard inspection questions has been limited to items that the FDA believes have the most direct bearing on facility performance and mammographic quality. However, the facility remains responsible for meeting all requirements of the regulations. Concurrent with the MQSA inspection, States may inspect for some items that are required by their laws and regulations. However, these items will not affect the facility's compliance with MQSA or the associated MQSA inspection fee. Under MQSA, each facility location will be inspected at least annually for the following:

• Equipment performance
• Quality Assurance (QA) records
• Quality Control (QC) records and tests
• Technologist tests
• Medical physicist's annual survey report
• Mammography equipment evaluations, if applicable
• Personnel qualification records
• Mammography medical reports and lay summaries
• Medical audit and outcome analysis records.

For more information on MQSA inspections, including Preparing for MQSA Inspections, Inspection News, and Inspection Fees, click on the appropriate link on the lefthand side.