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  1. Reports (MQSA)

Mammography Facility Adverse Event and Action Report - May 27, 2016: Women's Imaging Center

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 of an Adverse Action

The State of Hawaii

Facility Name and Address:

Women's Imaging Center
Hawaii Radiologic Associates, Ltd
82 Pu'uhonu Pl. 102
Hilo, Hawaii 96720

Facility ID Number:
115600

Adverse Event:
On December 21, 2015, the American College of Radiology (ACR), on behalf of the Food and Drug Administration (FDA), initiated an Additional Mammography Review (AMR) of mammograms performed by this facility to determine if the overall quality of mammography at the facility had been compromised due to the facility’s continued use of an unaccredited mammography unit to image patients as identified during its last MQSA inspection on July 17, 2015.

On February 25, 2016, the ACR notified the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the deficiencies posed a serious risk to human health.

Action Taken:
The ACR revoked the facility’s accreditation effective March 7, 2016.

After evaluating the reasons for the revocation, on March 8, 2016, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all requirements under the MQSA.

Corrective Action:
Based on the serious image quality deficiencies noted during the AMR, the FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients and their providers of the mammography quality problems at the facility.

The facility successfully completed the PPN and was notified of such by the FDA on May 17, 2016.

Status of the Facility:
The facility has had its accreditation reinstated, has a valid MQSA certificate, and is currently performing mammography.