News | April 24, 2015

FDA Reaches Agreement with Pennsylvania Mammography Facility on Reporting Violation

Facility still performing mammography following failure to send mammogram lay summary reports to patients in December 2014

April 24, 2015 — The U.S. Food and Drug Administration (FDA) reports that it has reached an agreement with Lancaster Breast Imaging of Lancaster, Pennsylvania, in regards to a Mammography Quality Standards Act (MQSA) violation self-reported by the facility. Lancaster Breast Imaging is still performing mammography to date.

On Jan. 30, 2015, the Lancaster Breast Imaging facility self-reported to the Pennsylvania Bureau of Radiation Protection (PA BRP) Regional Office that 47 patients did not receive their lay summary reports within 30 days. The facility discovered that patients imaged between Dec. 24, 2014 and Dec. 26, 2014, did not receive their lay summary letters within 30 days. All of the referring physicians received the mammography results within the 30-day period.

On March 12, 2015, the facility met with the PA BRP Regional Office to discuss the violations and the parties agreed to a $6,950.00 fine. Both parties entered into a Consent Order and Agreement. The enforcement document details the FDA MQSA regulations, violations and corrective actions to be taken by the facility.

The facility was instructed to revise its patient notification procedure, document that staff received communication concerning the changes, perform an annual audit of policy compliance, and verbally inform patients that they will receive a letter and steps to follow if the letter is not received.

As part of the MQSA, Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.

For more information: www.fda.gov

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