Mammography Facility Adverse Event and Action Report – December 8, 2022: Palo Pinto County Hospital District doing business as Palo Pinto General Hospital
Status of the Facility
Palo Pinto County Hospital District dba Palo Pinto General Hospital is currently unaccredited, does not have a certificate in effect, and may not provide mammography services.
Facility
Palo Pinto County Hospital District dba Palo Pinto General Hospital
400 SW 25th Ave
Mineral Wells, TX 76067
Facility ID Number
129726
Inspection/Reporting Entity
The State of Texas Certifying Agency (STX CA)
Actions Taken by the STX CA
On June 11, 2021, the STX CA initiated an Additional Mammography Review (AMR), to be performed by the facility’s accreditation body, the American College of Radiology (ACR), of mammograms performed at the facility between February 1, 2021, and May 18, 2021, based on quality control violations that were discovered during the facility’s annual MQSA inspection conducted by the State of Texas.
On July 16, 2021, the ACR notified the STX CA and the facility that five (5) out of the six (6) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria; some of the deficiencies were severe. Due to the severity of the deficiencies, the facility was required to participate in an expanded AMR of mammograms performed at the facility from July 16, 2019, to July 16, 2021.
On September 20, 2021, the ACR notified the STX CA that the facility had failed the AMR. Eighteen (18) out of thirty (30) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria; some of the deficiencies were severe. The ACR revoked the facility’s accreditation effective October 4, 2021.
Due to the mammography image quality issues and the seriousness of the results of the AMR, on September 24, 2021, the STX CA requested that the facility voluntarily suspend providing mammography services.
Based on the information obtained from the ACR concerning the reasons for the revocation of the facility's accreditation, the STX CA determined that the facility’s practice posed a serious risk to human health and that in order to protect the public health, on October 4, 2021, suspended the facility’s mammography certificate and declared that the facility was no longer certified. The facility’s accreditation had to be reinstated and the facility had to comply with all the requirements of the ACR, prior to recertification by the STX CA. The STX CA also required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all patients who had mammograms performed at this facility from July 16, 2019, to July 16, 2021, and their referring health care providers, of the mammography quality problems at the facility.
Corrective Action
On December 14, 2021, the STX CA notified the facility it had successfully completed the PPN.
The facility paid a monetary penalty of $13,500 (Current Disciplinary Actions - Radiation Control Program (texas.gov) Search “Mammography”).
In May 2022, the facility notified the STX CA that the facility did not intend to pursue accreditation reinstatement and would not resume mammography services.
Background - MQSA Program
The FDA compiles and makes available to physicians and the general public information that is useful in evaluating the performance of mammography facilities. As of October 2010, the FDA posts individual notices following completion of the adverse actions taken against facilities. This information is useful in evaluating the performance of mammography facilities nationwide and assists providers and patients in making informed decisions. For additional information, please see the Reports (MQSA) webpage.
Additional Resources
For more information, please refer to the MQSA Program webpage. Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.