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U.S. Department of Health and Human Services

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Mammography Facility Adverse Event and Action Report - August 7, 2012 (Updated)

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 this action taken against a mammography facility has concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of New Jersey

Facility Name and Address:
Imaging Center of Oradell
680 Kinderkamack Road, Suite 101
Oradell, NJ 07649

Facility ID Number:
238691

Adverse Event:
On January 26, 2012, the State of New Jersey notified the Food and Drug Administration (FDA) that Imaging Center of Oradell failed to perform Full-Field Digital Mammography quality control testing from October 7, 2011 until January 6, 2012. The American College of Radiology (ACR) notified the FDA of this facility’s closure and bankruptcy status effective January 30, 2012. FDA notified the bankruptcy trustee for Imaging Center of Oradell requesting the facility to submit clinical images to the ACR for an Additional Mammography Review (AMR). At the request of the FDA, the ACR performed an AMR of Imaging Center of Oradell. The AMR revealed the quality of mammography at this facility has been compromised.

Action Taken:
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 image quality problems at the facility.

Corrective Action:
The facility completed the PPN on August 7, 2012.

Status of the Facility:
The facility has ceased performing mammography. To request mammography records from Imaging Center of Oradell, patients may call Dignity Films at (908) 686-2916 or fax (908) 686-2919. Operating hours are Thursdays 9:30 AM to 4:00 PM. Dignity Films is located at 1191 Morris Avenue, Suite 105, Union, NJ 07083.