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 Oklahoma

Facility Name and Address

Wagoner Community Hospital
1200 W Cherokee
Wagoner, OK 74467

Facility ID Number

198473

Adverse Event:

On October 17, 2019, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, to be conducted by the facility’s accreditation body, the American College of Radiology (ACR). The AMR was initiated due to quality control deficiencies noted during the annual MQSA inspection performed on September 16, 2019, by the FDA.

On February 20, 2020, the ACR notified the FDA and the facility that the AMR revealed serious deficiencies with clinical image quality and that the facility failed to meet the ACR’s clinical image evaluation criteria.

Action Taken

Based on the failed AMR results, on March 03, 2020, the ACR revoked the facility’s application for mammography accreditation.

After evaluating the reasons for the revocation of the facility’s accreditation application, on March 04, 2020, the FDA issued a 900.11 ‘Certificate Status’ letter to the facility notifying them that the facility’s MQSA provisional certificate was no longer valid until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 May 27, 2020.

Status of the Facility

The facility’s accreditation was reinstated, and the facility was issued an MQSA certificate. The facility is currently performing mammography.