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Mammography Facility Adverse Event and Action Report – January 14, 2020: North Jersey Radiology Center

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated that 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 Against Which There Was An Adverse Action

The State of New Jersey

Facility Name and Address:

North Jersey Radiology Center
410 Centre Street
Nutley, NJ 07110

Facility ID Number:

241797

Adverse Event:

On June 11, 2019, The American College of Radiology (ACR) notified the facility that it was required to undergo an extensive Clinical Image Review (CIR) to determine if corrective actions implemented by the facility following a deficient Limited Additional Mammography Review (AMR), failing to complete a Food and Drug Administration (FDA) ordered Additional Mammography Review, and for completing and FDA Patient and Provider Notification (PPN), had led to improvements in mammography image quality. On September 9, 2019, the ACR notified the facility that the AMR failed with ten (10) out of thirty (30) cases not meeting the ACR’s clinical image quality criteria.

Action Taken:

Based on the failed AMR results, on September 20, 2019, the ACR revoked the facility’s accreditation.

After evaluating the reasons for the accreditation revocation, on September 20, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all of the requirements of the FDA.

Corrective Action:

Based on the serious image quality deficiencies noted during the AMR, the FDA declared the mammography performed at this facility to be a serious risk to human health and therefore 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 December 12, 2019.

Status of the Facility:

The facility is currently not performing mammography.