FDA highlights mammography issues at 3 radiology practices, posing ‘serious risk to human health’
The U.S. Food and Drug Administration recently announced Mammography Quality Standards Act issues occurring at a trio of radiology practices in three separate states.
Regulators issued all “adverse event and action reports” on March 5, the first time the FDA has publicly cited a facility for MQSA issues since August. The practices are in Michigan, Texas and California, with 2 of the 3 regaining their accreditation to perform breast screening exams.
Here is a quick rundown of what happened:
‘Serious’ quality deficiencies at Desert Imaging Services
Last year, inspectors with the State of Texas Certifying Agency unearthed “serious imaging quality deficiencies” at Desert Imaging Services, based in El Paso. Local officials requested that the practice voluntarily suspend services, which it obliged, losing its accreditation on Feb. 15, 2023.
“The STX CA declared the mammography performed at this facility to be a serious risk to human health, and the facility’s [state] mammography certificate was placed into a ‘no longer in effect’ status,” the FDA said in its announcement.
Regulators required Desert Imaging to alert patients about the issue, and they also fined the business $18,041. The practice successfully completed all requirements, and state regulators lifted the voluntary accreditation suspension effective Aug. 16. The practice is again accredited and providing mammography services, the FDA said.
Desert Imaging Services did not immediately respond to a Radiology Business request for comment Monday.
Farmbrook Radiology is still unaccredited
The FDA on April 26 of last year initiated an Additional Mammography Review request at Farmbrook Radiology, which was overseen by the American College of Radiology.
ACR did so shortly after, using a sample of mammograms spanning from April 25, 2022, through Nov. 23, 2022. During that time span, the Southfield, Michigan-based radiology practice allegedly did not perform required quality control tests at the frequency specified by its device manufacturer.
The college informed Farmbrook Radiology on June 13 that it had failed the review, with 13 of 30 cases submitted not meeting clinical image evaluation criteria. “Some of the deficiencies were severe,” the FDA said, with ACR revoking its accreditation effective June 18.
“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 …,” an announcement said.
Farmbrook Radiology’s MQSA certificate was declared no longer in effect as of June. The FDA also required the facility to notify patients and referring providers about its quality issues for exams performed between June 29, 2021, through June 29, 2023. The practice reportedly met this requirement and was notified as such by the FDA in September. However, as of March 5, the agency still listed the business as “unaccredited and uncertified to perform mammography.”
Farmbrook Radiology did not immediately respond to a Radiology Business request for comment Monday.
Stockdale Radiology fails quality review
ACR initiated an Additional Mammography Review at Stockdale Radiology on March 7, 2023, at the request of the FDA. The analysis used a sample of images from between Feb. 7, 2022, and Sept. 29, 2022, based on issues that first arose during a November inspection.
The analysis found that 18 of 30 clinical cases submitted did not meet clinical image evaluation criteria, with ACR labeling some of the deficiencies as “severe.” The college subsequently revoked the Bakersfield, California-based practice’s certificate as of April 25.
Stockdale Radiology alerted patients and referring providers about the deficiencies, which impacted mammograms gathered between April 25, 2021, through April 25, 2023. The practice sent out such communications and submitted its corrective action plan to the ACR, with its accreditation reinstated as of Sept. 8.
The practice did not immediately respond to a Radiology Business request for comment Monday.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.