Kaiser Permanente - 20th Avenue Medical Center – FDA Warning Letter

On September 25, 2012, the FDA issued a Warning Letter to Kaiser Permanente, specifically addressing their facility at 10350 East Dakota Avenue, Denver, CO 80247, following an MQSA inspection (ID # 118869) conducted on August 14, 2012. The inspection revealed a serious problem involving the conduct of mammography.

The identified violation was that the manufacturer-recommended Quality Control (QC) procedures for the monthly monitor viewing conditions for the review workstations (RWS) in the biopsy room at the Kaiser Permanente Franklin facility were not followed. This violates 21 CFR 900.12(e)(6) and (d)(2) of the Mammography Quality Standards Act of 1992 (MQSA).

Kaiser Permanente responded to the noncompliance by letter on September 4, 2012, indicating that a correction addressing the documented issues had been implemented. Despite the correction, the FDA stated that these violations might indicate serious underlying problems that could compromise mammography quality.

The FDA warned that additional actions could be taken, including but not limited to: requiring an Additional Mammography Review, placing the facility under a Directed Plan of Correction, charging for on-site monitoring, requiring patient and physician notification of deficiencies, seeking civil money penalties up to $11,000 per violation, suspending or revoking the