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

Related Content

Transpara Deep Learning Software Matches Experienced Radiologists in Mammogram Reading
News | Computer-Aided Detection Software | January 12, 2018
Deep learning and artificial intelligence improves the efficiency and accuracy of reading mammograms, according to...
Fat Distribution in Women and Men Provides Clues to Heart Attack Risk
News | Women's Health | January 11, 2018
January 11, 2018 – It’s not the amount of fat in your body but where it is stored that may increase your risk for hea
Women Prefer Getting Mammograms Every Year
News | Mammography | January 09, 2018
Women prefer to get their mammograms every year, instead of every two years, according to a new study presented at the...
Planmed Clarity 2-D Digital Mammography System Receives FDA Approval
Technology | Mammography | January 08, 2018
The U.S. Food and Drug Administration (FDA) issued an approval letter for the Planmed Clarity 2-D full-field digital...
Overweight Women May Need More Frequent Mammograms
News | Mammography | January 04, 2018
Women with higher body mass index (BMI) face an increased risk of not detecting their breast tumor until it has become...
About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

Feature | Breast Imaging | January 02, 2018 | Kathryn Pearson Peyton, M.D.
Sixty million women undergo regular screening mammography in the United States, but even in the digital age, it is di
Imagio Opto-Acoustic Breast Imaging System Helps Differentiate Tumor Subtypes
News | Oncology Diagnostics | January 02, 2018
Seno Medical Instruments Inc. (Seno Medical) recently reported data from their clinical study demonstrating that its...
Study Finds Link Between Breast Cancer Treatments and Cellular Aging Markers
News | Women's Health | January 02, 2018
January 2, 2018 — A new study found women who had received chemotherapy and/or...
ACR Appropriateness Criteria Adds and Revises Topics for December 2017
News | Clinical Decision Support | December 29, 2017
December 29, 2017 — Radiologists can enhance the quality and effectiveness of care with the newest release of the ACR
Overlay Init