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  5. Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center

Status of the Facility

Phelps Memorial Health Center has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited, and may provide mammography services.

Facility

Phelps Memorial Health Center
1215 Tibbals St
Holdrege, NE 68949

Facility ID Number

169607

Inspection/Reporting Entity

U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA 

On January 24, 2023, the FDA initiated an Additional Mammography Review (AMR), performed by the facility’s accreditation body, the American College of Radiology (ACR). The AMR included a selection of mammograms performed at the facility from May 19, 2022, through January 13, 2023, that was based on the time period during which the facility performed mammography without first obtaining accreditation from the ACR.

On March 21, 2023, the ACR notified the facility that it failed the AMR. Six (6) out of the thirty (30) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria; some of the deficiencies were severe. Additionally, the ACR notified the facility that it intended to revoke its accreditation. The facility did not appeal the adverse accreditation decision, and the ACR revoked the facility’s accreditation, effective on April 4, 2023.

Based on the information obtained from the ACR concerning the reasons for the revocation of the facility’s accreditation, the FDA determined that the facility’s practice posed a serious risk to human health, and that in order to protect the public health, on April 5, 2023, declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation was reinstated and the facility had complied with all the requirements of the FDA. The FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert patients who had mammograms performed at this facility from April 5, 2021, through March 21, 2023, and their referring health care providers of the mammography quality problems at the facility.

Corrective Action

The facility successfully completed the PPN and was notified of such by the FDA on June 23, 2023. The facility successfully completed an ACR corrective action plan. The ACR reinstated the facility’s accreditation, and on July 20, 2023, the FDA issued an MQSA certificate to the facility so that it could legally perform mammography.

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 http://www.fda.gov/mammography webpage. Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.

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