A Texas community hospital temporarily suspended mammography services after a recent review found they may have posed a “serious risk to human health.”
The U.S. Food & Drug Administration first revealed the imaging issue in an update shared on Thursday. During an August 2020 annual review, state accreditors discovered “serious deficiencies” with clinical image quality at Ochiltree General Hospital, located in the Northeast Texas Panhandle city of Perryton.
After those inspection results, officials issued notices of violation and “failure of a mammography system” in September. OGH voluntarily suspended breast imaging operations in order to address the concerns, and the hospital had its Mammography Quality Standards Act certificate temporarily revoked.
“Based on the serious image quality deficiencies noted during the [Additional Mammography Review], the [State of Texas Certification Agency] declared the mammography performed at this facility to be a serious risk to human health,” the FDA wrote Jan. 21, “and therefore required the facility to perform a Patient and Referring Healthcare Provider Notification to alert all at-risk patients and their healthcare providers of the mammography quality problems at the facility.”
Ochiltree General completed the corrective actions last month, and the state rescinded the certificate suspension on Dec. 10, allowing it to resume regular breast imaging operations. Officials with the hospital declined to comment when contacted by Radiology Business Thursday.