Mammography Facility Adverse Event and Action Report - April 23, 2015

Background
As part of the Mammography Quality Standards Act (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.

In order to provide this information in the timeliest manner, we now post the following information in “real time,” as actions taken against mammography facilities are concluded:

Mammography Facility and Adverse Action

The State of Pennsylvania

Facility Name and Address:
Lancaster Breast Imaging
2170 Noll Dr., Ste. 200
Lancaster, PA 17603

Facility ID Number: 239076

Adverse Event: On January 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 December 24, 2014 and December 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.

Action Taken: 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.

Corrective Action: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.

Status of the Facility: The facility is performing mammography.