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  5. Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit

Status of the Facility

The Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit (MUSC Hollings Cancer Center-Mobile) is currently unaccredited and does not have a certificate that is in effect and cannot legally provide mammography services.

Facility

MUSC Hollings Cancer Center Mobile Health - MOBILE
86 Jonathan Lucas Street, MSC 955
Room 344
Charleston, S 29425

Facility ID Number

222314

Inspection/Reporting Entity

The State of South Carolina Certifying Agency

Additional Mammography Review

On September 30, 2020, the State of South Carolina Certifying Agency (SSC CA) initiated an Additional Mammography Review (AMR) of mammograms performed by MUSC Hollings Cancer Center-Mobile, to be conducted by the facility's accreditation body, the American College of Radiology (ACR). The State initiated the AMR performed by the SSC CA because of quality control issues found during the annual Mammography Quality Standards Act (MQSA) inspection on September 1, 2020.

On January 7, 2021, the ACR notified the SSC CA that the AMR revealed serious deficiencies with the facility's clinical image quality, and the facility failed to meet the ACR's clinical image evaluation criteria.

Actions Taken by the State of South Carolina

On February 24, 2021, the SSC CA issued an Administrative Order (AO) of Emergency Suspension under state law to the facility. The AO was posted on the website of the South Carolina Department of Health and Environmental Control (SC DHEC), as reported in the January 5, 2022, Summary Sheet of the South Carolina Board of Health and Environmental Control. The facility's SC DHEC Mammography Facility Certificate was suspended, and the facility could not legally provide mammography services (between February 24, 2021 and November 10, 2021).

The MUSC Hollings Cancer Center-Mobile, as a registrant of SC DHEC, and in response to the AMR results and SC DHEC Mammography Facility Certificate suspension, was issued a Consent Order letter on November 10, 2021, and agreed to pay a Civil Money Penalty fine of $70,000. The registrant agreed to adhere to a follow-up inspection at the registrant's expense, and for the first 12 months following the issuance of the order, the registrant will provide SC DHEC with copies of all quality assurance and quality control testing documentation on a monthly basis, by the 15th day of the following month. Additionally, the registrant also agreed to provide meeting minutes from its Quality Control (QC) and Quality Assurance (QA) teams on a quarterly basis.

Corrective Action

Based on the serious image quality deficiencies noted during the AMR, the SSC CA declared the mammography performed at MUSC Hollings Cancer Center-Mobile to be a serious risk to human health. The SSC CA, therefore, 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 November 20, 2018, to October 22, 2019, and their health care providers of mammography quality problems at the facility. MUSC Hollings Cancer Center-Mobile complied with the order and successfully completed the PPN.

On November 11, 2021, after successful completion of the PPN and reinstatement of the facility's accreditation, SC DHEC granted MUSC Hollings Cancer Center-Mobile a provisional SC DHEC Mammography Facility Certificate so that the facility could legally perform mammography to acquire the images needed to complete the accreditation reinstatement process. The ACR conducted the AMR of mammograms performed at MUSC Hollings Cancer Center-Mobile, and the review to support accreditation reinstatement identified mammograms that did not meet the ACR's clinical image evaluation criteria. The facility's certificate expired on May 10, 2022. The facility must complete a detailed extensive Corrective Action Plan (CAP) for continued improvement, including additional personnel training and equipment evaluations, before it can submit another accreditation reinstatement application.

Background - MQSA Program

The U.S. Food and Drug Administration (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.

 
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