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Mammography Facility Adverse Event and Action Report - November 27, 2015: Richard D. Adelman, M.D.

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 Subject to an Adverse Action
The State of North Carolina
Facility Name and Address:

Richard D. Adelman, M.D.
7320 Six Forks Road
Suite 260
Raleigh, NC 27615

Facility ID Number:

216093

Adverse Event:

On April 7, 2014, the American College of Radiology (ACR) conducted a Validation On-Site Survey at this facility, a process performed by accreditation bodies to determine whether or not randomly selected facilities are meeting the accreditation body’s standards for clinical image quality. Thirteen (13) out of fifteen (15) clinical exams reviewed during the Validation On-site Survey did not meet the ACR’s clinical image quality standards. The facility was required to undergo further clinical image evaluation through an Additional Mammography Review (AMR). On August 25, 2014, the ACR notified the facility that deficiencies were noted in the clinical image quality factors of the mammography images reviewed under the AMR. In order to more fully evaluate the facility’s clinical image quality, the ACR required the facility to undergo a more extensive AMR. The facility was notified on October 24, 2014, that ten (10) out of thirty (30) clinical cases reviewed for the more extensive AMR did not meet the ACR clinical image quality standards; some of the noted deficiencies were severe.

Action Taken:

The ACR revoked the facility’s accreditation on November 5, 2014. After reviewing the information leading up to the ACR’s accreditation revocation decision, on November 18, 2015, the Food and Drug Administration (FDA) determined the facility’s MQSA certificate should be placed in a “no longer in effect” status until the facility complied with all requirements of the MQSA.

Corrective Action:

Based on the serious image quality deficiencies noted during the Validation On-Site Survey, and the results of the AMRs, the FDA required the facility to perform a Patient and Referring Health care Provider Notification (PPN) to alert all at-risk patients of the mammography image quality problems at the facility. Health care providers were not notified under this PPN action because Dr. Adelman attested to being the only referring health care provider for all patients who received mammography services at Richard D. Adelman, M.D.

The facility successfully completed the PPN and was notified of such by the FDA on November 19, 2015.

Status of the Facility:

The facility has voluntarily ceased performing mammography and is no longer MQSA certified.
 

Page Last Updated: 11/30/2015
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