FDA WARNING_LETTER - Saint Mary's Medical Group, Inc. - October 15, 2014

On October 15, 2014, an FDA inspection of Saint Mary's Medical Group, Inc. revealed serious violations of the Mammography Quality Standards Act (MQSA) and its implementing regulations (42 USC 263b and 21 CFR Part 900). Key deficiencies included performing mammography without a valid certificate, failure to provide documentation for radiologic technologist continuing experience and interpreting physician continuing education, and non-adherence to manufacturer-recommended QC procedures for digital unit printer and monitor. Additionally, one of seven reports lacked an acceptable assessment category, infection control procedures were inadequate or not followed, and the MQSA certificate and required personnel qualification documents were not displayed or available. The FDA acknowledged the facility's November 6, 2014, response as seemingly adequate, but warned that further compliance actions, including an Additional Mammography Review, may be taken if clinical image quality issues persist. Potential enforcement actions for unresolved violations include a Directed Plan of Correction, civil money penalties up to $10,000, patient/physician notification, and suspension or revocation of the FDA certificate. The facility was advised to submit further responses detailing corrective and preventive actions with timeframes and sample records.