FDA WARNING_LETTER - Middlesboro Appalachian Regional Hospital

On August 18, 2011, an inspection by a representative of the Commonwealth of Kentucky, acting on behalf of the FDA, revealed serious violations of the Mammography Quality Standards Act of 1992 (MQSA) at Middlesboro Appalachian Regional Hospital. The inspection identified two primary deficiencies. First, the facility failed to provide documentation verifying that two radiologic technologists met the continuing experience requirement of performing 200 mammography examinations in 24 months, a repeat Level 2 violation of 21 CFR 900.12(a)(2)(iv). Second, a mammography equipment evaluation by a medical physicist for a specific laser printer was not conducted, a Level 2 violation of 21 CFR 900.12(e)(10). The facility's response on August 31, 2011, was deemed inadequate as it lacked a plan for permanent corrective action. This repeat violation regarding technologist experience has been cited in multiple previous annual MQSA inspections dating back to 2001, indicating serious underlying problems that could compromise mammography quality. The FDA warns that continued non-compliance may lead to additional actions, including an Additional Mammography Review, a Directed Plan of Correction, civil money penalties up to $10,000 per failure, suspension or revocation of the FDA certificate, and fee-based compliance follow-up inspections. The facility is required to respond within fifteen working days, detailing specific corrective and preventative steps, including timeframes, and providing sample records.