Federal health regulators reportedly granted Winston-Salem, N.C.-based Wake Forest Baptist Medical Center an indefinite extension to resolve issues in its pathology laboratory that led to at least four patients receiving incorrect cancer diagnoses, the Winston-Salem Journal reports.
Here are six things to know about the situation.
1. CMS conducted an investigation of the hospital and its pathology lab from Feb. 5 through Feb. 8 following several complaints. On March 21, CMS released a 23-page report, which discovered at least four cases of erroneous test results on patient tissues. Three patients were mistakenly diagnosed with cancer, while a fourth patient was incorrectly diagnosed as cancer-free, according to the report.
2. CMS placed the hospital on "immediate jeopardy" status, a federal designation indicating Wake Forest Baptist's missteps caused or were likely to cause injury or death. The status initially meant the hospital would lose its ability to bill Medicare within 23 days of the status change.
3. Wake Forest Baptist said in a March 16 statement the hospital became aware of the deficiencies in its pathology lab's quality-monitoring process in fall 2017, and "promptly notified all patients affected, as well as the physicians who cared for them." Officials also determined "most, if not all, of the misdiagnoses centered on a single individual who is no longer with Wake Forest Baptist."
Officials said in the same March 16 statement as many as 10 patients were affected by the incident.
4. Wake Forest initially faced a March 25 deadline to have CMS accept its corrective action plan, which the hospital submitted March 13. CMS later granted a 12-day extension March 23, which would have ended April 1.
5. On April 3, CMS extended Wake Forest Baptist's deadline for the second time, stating, "There is no set termination date. We will likely review the hospital's progress within a 90-day time frame," which may last until mid-June, the report states.
Kevin High, MD, president of Wake Forest Baptist Health, told the publication, "Recognizing our progress to date, [CMS] withdrew the previously indicated termination date. As is often the case in such events, [state health officials] are planning to return within the next few months to further review and confirm adherence to processes and procedures put in place to ensure the quality of care and safety of our patients."
6. Wake Forest Baptist's billing privileges and Medicare payments will continue through the extension period, according to the report.
To access the full report, click here.