FDA warns troubled imaging center following similar state alert alleging ‘serious risk to human health’
The U.S. Food and Drug Administration alerted patients about a troubled Illinois imaging center on Friday following a similar warning from the state earlier this summer.
Hoffman Imaging & Medical Center in Hoffman Estates, Illinois, reportedly let its mammography accreditation lapse in October 2019 and continued to deliver exams anyway. Regulators had ordered the facility to notify providers and all at-risk patients imaged between then and March 2021 about their exams but had not complied with the order as of Sept. 10, the FDA said.
“Based on the serious image quality deficiencies noted during the [Additional Mammography Review], the [State of Illinois Certification Agency] declared the mammography performed at this facility to be a serious risk to human health,” the administration said.
State regulators initiated the American College of Radiology review in August 2020, with ACR issuing a failing grade two months later. Illinois health officials also conducted a surprise inspection this past March that unearthed the group’s continued delivery of breast imaging, despite its lack of certification or accreditation. An emergency order followed that same month, and the State of Illinois Certification Agency issued a second stoppage in April 2021 after the medical business changed ownership.
Hoffman Imaging—which has also gone by Hoffman MRI and Hope Imaging and Medical Center Inc.—did not immediately respond to a Radiology Business request for comment Monday. A receptionist said the center has not delivered mammography services for the past six months.
Back in May, Omayr Niazi—a pharmacy technician previously identified as vice president of Hope Imaging—was arrested and charged with aggravated battery, forgery and wire fraud. He allegedly injected a female patient with contrast for a CT scan, but after the agent was administered, the patient had a negative reaction and later called the police. An investigation allegedly found that the 41-year-old VP was neither trained nor certified to perform CT scans and had submitted false credentials and unauthorized reimbursement claims.
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.