The CMS may revoke Wake Forest Baptist Health's ability to bill Medicare after several patients received erroneous cancer diagnoses due to poor lab oversight.
The provider wrongly diagnosed three patients with cancer and mistakenly told a fourth patient that he or she did not have cancer, according to a CMS notice to the hospital. The errors resulted in unnecessary treatment for three patients and a delay in diagnosis for a fourth patient, the CMS said.
"The complaint investigation resulted in identification of an immediate jeopardy to the health and safety of patients as evidenced by the (hospital) staff's failure to provide oversight and ensure laboratory specimens were appropriately processed with accurate results for medical interventions," the CMS said in the notice.
Unless the hospital in Winston-Salem, N.C., and federal agency can agree on a corrective action plan, the Medicare program will not make payment for hospital services to patients who are admitted after March 25.Wake Forest Baptist received around $63 million in payments from Medicare during fiscal 2017.
Dr. Kevin High, president of the Wake Forest Baptist, said the hospital became aware of deficiencies in its pathology quality monitoring process last fall.
He said Wake Forest Baptist promptly notified all patients affected, as well as the physicians who cared for them. It has also completed a review of hundreds of similar cases and found no other patients were affected.
Wake Forest Baptist's laboratory tests about 25,000 surgical pathology cases per year, according to the CMS.
The hospital has found that most, if not all, of the misdiagnoses stemmed from a single person who is no longer with the hospital, High said.
Additional quality processes and laboratory equipment optimization, as well as staff training and education is needed High said, adding that these actions are well underway and many have been completed.
High said Wake Forest Baptist is working with the CMS to address the issues.
A spokeswoman for the CMS confirmed a corrective action plan has been submitted and is under review.