Federal health regulators have given Wake Forest Baptist Medical Center a second, indefinite extension to resolve issues in its pathology laboratory that led to three patients erroneously receiving a diagnosis of cancer.
A fourth patient was wrongly told they did not have cancer, leading to a delay in treatment.
Wake Forest Baptist initially was facing a March 25 deadline for the federal Centers for Medicare and Medicaid Services, or CMS, to accept its corrective plan, which was submitted March 13. If the plan isn’t accepted, Wake Forest Baptist could lose its Medicare billing privileges.
On March 23, the CMS agreed to a 12-day extension that would have ended Sunday.
The CMS said on Tuesday that it has again extended the deadline for Wake Forest Baptist to correct deficiencies.
“There is no set termination date. We will likely review the hospital’s progress within a 90-day time frame” that could last until mid-June, the CMS said.
Dr. Kevin High, the president of Wake Forest Baptist Health, said a survey team from N.C. Department of Health Safety Regulation, on behalf of the CMS, completed its initial review of the lab last week.
“Recognizing our progress to date, (CMS) withdrew the previously indicated termination date,” High said.
“As is often the case in such events, (the 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,” he said.
“We welcome the opportunity to work with (them) to continuously improve,” High said. “Wake Forest Baptist continues to be a full participant in the Medicare program, providing the full range of clinical treatment and services.”
Complaints led to agency’s investigation
The corrective plan is aimed at resolving concerns raised during a CMS investigation Feb. 5-8. The investigation was prompted by internal complaints.
Wake Forest Baptist has defined the review period as between June 2014 and August 2017.
According to a 23-page report released March 21 by the CMS, the investigation found at least four cases of erroneous test results on patient tissues.
Because of multiple procedural failures, the hospital was placed in “immediate jeopardy” status — a federal designation that means missteps have caused or are likely to cause injury or death. That status initially meant the hospital could, within 23 days, lose its ability to bill Medicare.
Wake Forest Baptist says billing privileges and Medicare payments continue during the extension period.
Medicare and Medicaid beneficiaries represented about 44 percent of the hospital’s gross receivables in fiscal 2016-17, according to its fiscal 2017 report to bond holders.
CMS officials said on March 24 that the agency “typically stays the deadline or provides an extension” when a corrective plan has been submitted.
“The hospital will receive a letter once we finalize and approve the plan of correction, which typically occurs prior to the termination date,” the CMS said.
Wake Forest Baptist said on March 16 that as many as 10 patients were affected by pathology laboratory results and required a diagnosis change.
The laboratory handles about 25,000 surgical pathology cases a year. The tests involved histopathology, which is defined as the study of changes in tissues caused by disease, such as cancer.
The CMS said Wake Forest Baptist provided assurances that it “will increase oversight over its laboratory.”
The laboratory operational failures included: not following all testing procedure protocols; not properly monitoring water quality, temperature and humidity levels; not discarding expired supplies; and not performing and documenting certain quality-control procedures for hematoxylin and eosin stains as required.
High said in a statement dated March 16 that the hospital became aware of deficiencies in its pathology quality-monitoring process in the fall of 2017.
“We promptly notified all patients affected, as well as the physicians who cared for them,” High said. “We have completed a review of hundreds of similar cases to satisfy ourselves that there are no other patients who have been affected.”
High said the hospital determined that “most, if not all, of the misdiagnoses centered on a single individual who is no longer with Wake Forest Baptist.”
David Meyer, the senior partner with Keystone Planning Group of Durham, a health-care business consultant, said that anytime a hospital receives an immediate jeopardy notice from the CMS it is a serious concern.
“That being said, typically a hospital will be able to develop and implement a corrective action plan that will satisfy CMS such that the billing privileges aren’t actually suspended or terminated.” Meyer said.