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  5. Mammography Facility Adverse Event and Action Report - January 21, 2021: Ochiltree County Hospital District
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report - January 21, 2021: Ochiltree County Hospital District

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 Texas

Facility Name and Address

Ochiltree County Hospital District
dba Ochiltree General Hospital
3101 Garrett Drive
Perryton, TX 79070

Facility ID Number

194290

Adverse Event

On August 26, 2020, the State of Texas Certification Agency (STX CA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, to be conducted by this facility’s accreditation body, the State of Texas Accreditation Body (STX AB). The AMR was initiated due to quality control deficiencies discovered during the facility’s annual MQSA inspection, performed on June 10, 2020, by the STX CA.

On September 29, 2020, the STX AB notified the facility and the Food and Drug Administration (FDA), that the AMR revealed serious deficiencies with the clinical image quality, and that the facility failed to meet the STX AB’s clinical image evaluation criteria.

Action Taken

Based on the failed AMR results, the STX CA issued a “Notice of Violation”, and a “Notice of Failure of Mammography System”, to the facility on September 29, 2020. The facility voluntarily suspended mammography operations pending completion of the mandatory corrective actions. The facility’s MQSA certificate, which is required in order to legally provide mammography services, was placed in a revoked/suspended status.

Corrective Action

Based on the serious image quality deficiencies noted during the AMR, the STX CA 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 healthcare providers of the mammography quality problems at the facility.

The facility successfully completed the PPN and was notified of such by the STX CA on December 10, 2020.

Status of the Facility

The State of Texas rescinded the facility’s certificate suspension on December 10, 2020. The facility is currently operational and performing mammography.

 
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