News | Mammography | May 19, 2016

Arizona Imaging Center Completes Patient Notification of Mammography Issues

ACR revoked the facility’s accreditation in January due to serious image quality problems

Lake Havasu Imaging Center, mammography quality problem, ACR accreditation, MQSA

May 19, 2016 — In late March, Lake Havasu Imaging Center in Lake Havasu City, Ariz., announced completion of a Patient and Referring Healthcare Provider Notification (PPN) action mandated by the American College of Radiology (ACR). ACR issued the mandate due to serious mammography image quality problems identified during a review of clinical images submitted for accreditation renewal. 

The original Additional Mammography Review (AMR) of Lake Havasu Imaging Center was initiated by the ACR on Nov. 2, 2015. On Jan. 6, 2016, the ACR notified the facility and the U.S. Food and Drug Administration (FDA) that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the ACR believed the deficiencies posed a serious risk to human health.

The ACR revoked the facility’s accreditation effective Jan. 19. After evaluating the information leading up to the ACR’s revocation decision, on Jan. 21, the FDA determined that the facility’s Mammography Quality Standards Act (MQSA) certificate should be placed in a "No longer in effect status" until such time as the facility's accreditation was reinstated and the facility complied with all requirements under the MQSA.

Despite completion of the PPN, the facility is currently not performing mammography.

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