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 at required times, and proper records of these tests are saved. 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 apparent violations. FDA makes the final determination on the operation of these facilities. Along these lines, DEP inspectors report on whether the personnel at these facilities have the certifications and education mandated for the jobs they are doing. But, it is the Department of Health and Department of State in Pennsylvania which determine the qualifications needed to perform these jobs, 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 health tests. Most violations found during inspections are classified as minor, as noted below, and in very few cases have the violations been found to compromise in any way the quality of care being offered. Patients with concerns should consult their health care provider.
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 even required. They are, however, 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 what corrective action was 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 provide the FDA and DEP with a written response in 15 days on how the violation has been corrected.
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 even these confirmed violations, while serious, if corrected promptly do not mean the quality of any tests were compromised. In fact, in Pennsylvania during a recent 30-month period, none of the twelve Level 1 violations found in 1,021 inspections resulted in an FDA finding indicating the quality of any mammograms had been compromised.
While there is always room for improvement, DEPís inspections show that Pennsylvania women and their families can have a great deal of confidence that their mammography facility is operating at a high level of proficiency, and meeting rigorous federal quality standards.