Inspection uncovers quality and safety issues at mammography facility—including ‘severe’ problems
The U.S. Food & Drug Administration is alerting patients who’ve received mammography services at one Maryland imaging provider after an inspection revealed a litany of quality issues.
During Capitol Radiology’s annual Mammography Quality Standards inspection, the FDA learned the facility—operating as Laurel Radiology Services—failed to obtain accreditation for its full-field digital mammography unit before imaging patients. On top of that, the Laurel, Maryland, organization bypassed mandatory workstation quality control tests for at least 12 straight weeks, spanning June 16 to Sept. 12, 2020.
Following a request from the administration, the American College of Radiology conducted an additional review and found Capitol’s mammograms fell woefully short of clinical standards, including some “severe” deficiencies, the FDA said in a May 20 update.
As a result, the ACR pulled the company’s accreditation on March 24. The following day, the facility was directed to notify all patients who received a mammogram on June 26, 2018, or later. As of Thursday, Capitol Radiology has not complied.
“Under the MQSA, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States,” the agency said. “This facility did not meet the standards for mammography quality under the MQSA."
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.