When DEP inspects a mammography facility, it follows procedures outlined in its contract with the U.S. Food and Drug Administration (FDA). These procedures include making sure the equipment used to perform mammograms is functioning properly; it has been tested and calibrated as required; and proper records are retained. DEP inspectors also check to make sure individuals operating the equipment and reading the test results meet the certification and education requirements set by the FDA.
While DEP carries out these inspections, the FDA has ultimate responsibility for the certification and operation of mammography facilities. Inspection reports and data are electronically transmitted to the FDA by DEP inspectors. Officials from this federal agency review these reports and follow-up where necessary on any identified violations. FDA makes the final determination on the operation of these facilities. The Department of Health and the Department of State in Pennsylvania determine the qualifications needed to perform mammography job functions, and the requirements which must be fulfilled to meet these qualifications.
DEP has found the vast majority of mammography facilities in Pennsylvania meet the key requirements of the federal Mammography Quality Standards Act (MQSA), which sets the requirements for administering these important cancer detection procedures.
Inspectors may note three levels of apparent violations during an inspection. These violations are noted as apparent because they must be verified by the FDA review. The least significant violations are classified as Level 3. These violations typically involve incomplete record keeping and failure to have in place systems for tracking and recording minor violations and when they were corrected. Level 3 violations do not indicate the quality of mammography services may be compromised, and a written response to the FDA describing corrective actions is not required; however, they are reviewed during the next inspection. Level 2 violations indicate the facility meets all key MQSA requirements but fails to meet one or more MQSA standards that may compromise quality. Level 2 violations require immediate corrective action and written notice to the FDA and DEP within 30 days as to the corrective actions taken. Level 1 violations also indicate a failure to meet a key MQSA requirement that may compromise the quality of mammography services but are more serious in nature. Facilities with Level 1 violations must begin correcting the problem immediately, and they must provide the FDA and DEP with a written response within 15 days as to the corrective actions taken.
It is important to note that Level 1 and 2 violations may compromise quality, but do not necessarily do so. The FDA must first confirm these violations, and while potentially serious, does not mean the quality of tests were compromised if corrected promptly.