NC Hospital Reviewing Path Lab Deficiencies

Wake Forest Baptist must review more than 9,000 histopathology cases going back 38 months

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CEO SUMMARY: Discovery of multiple diagnostic errors occurring in an anatomic pathology department triggered a complaint investigation and a 54-page report from the federal Centers for Medicare and Medicaid Services. The report shows that Wake Forest Baptist Medical Center is reviewing more than 9,000 pathology cases to identify incorrect cancer diagnoses. Last month, the medical center found 10 cases of patients in which errors in the pathology lab caused inaccurate diagnoses.

EVERY MEDICAL DIRECTOR of a CLIA-licensed lab understands that each day brings the risk of two types of unwelcome events. One is a Medicare program inspection that identifies deficiencies that might rise to the level of posing immediate jeopardy to patient safety. The second is the lab’s discovery that diagnostic errors have compromised patient care.

News stories report that both events happened in recent weeks at 885-bed Wake Forest Baptist Medical Center (WFBMC) in Winston-Salem, N.C. Between Feb. 5 and Feb 8, 2018, officials from the federal Centers for Medicare and Medicaid Services (CMS), and members of North Carolina’s Division of Health Service Regulation (DHSR) CLIA staff conducted a joint complaint investigation to determine the facility’s compliance with the federal Medicare conditions of participation (COP) for hospitals.

From that inspection and subsequent disclosures, regulators determined that the primary source of deficiencies were in histopathology. For a period reported as June 2014 through August 2017, the hospital is reviewing 9,291 histopathology cases. As of March 26, only 1,422 cases had been reviewed. A statement in the CMS report indicates that the hospital is in “a review process and was re-reviewing ‘100%’ of the breast cancer cases.”

Based on the February inspection, CMS sent a 54-page statement of deficiencies and plan of correction, dated March 26, to North Carolina Baptist Hospital, the previous name of Wake Forest Baptist Medical Center. CMS then sent a notice to the medical center that, effective March 26, the medical center “is to be terminated as a provider” to the Medicare program.

As of press time, WFBMC has until April 19 to submit a corrective plan acceptable to CMS and it has until June 12 to resolve the issues with the anatomic pathology lab. Otherwise the hospital would face suspension of inpatient Medicare billing privileges.

Big News Story

The possibility that the hospital loses its ability to bill Medicare has made this a significant story. What has added to the public interest in the news about WFBMC’s problems are the reports of patients who were misdiagnosed. Patients whose cancer was missed did not get appropriate treatment while patients diagnosed with a cancer they did not have underwent unnecessary surgery or other forms of therapy.

To help pathologists and lab administrators understand the role of the pathology laboratory in the problems at WFBMC, this story outlines what was reported about issues involving the pathology department.

Medical center administrators were notified about issues in the pathology department in the fall of 2017. The CMS report stated, “Interviews on 02/05/2018 at 1505, 02/06/2018 at 1050 with the Director of Risk Management, revealed in September of 2017, risk management was made aware of concerns regarding 10 patients of MD #7 [which news stories report to be a pathologist].

“Interview revealed the concerns were brought to the director’s attention as a result of several complaints by employees from the laboratory,” the report said.

This fact is significant. It is reasonable to assume that some staff in the pathology laboratory recognized an issue that they thought managers in the pathology department were not addressing. For this reason, the employees reported this information to the hospital’s risk manager.

The CMS report stated that the risk manager began the process to review the cases and prepare those cases for external review. At least some of these cases involved patients with breast cancer.

“Risk management’s review of the 10 patients’ case files revealed four of the 10 patients’ plans of care would be affected with an incorrect diagnosis,” the CMS report said. Physicians were notified. As of the CMS inspection in February, “The interview revealed the investigation is still ongoing and all updated results were going to the Medical Review Committee who report to the Medical Executive Committee,” said the report.

Who Complained to CMS?

Since CMS wrote that the reason for the February visit was a joint complaint investigation, a fair question would be, “Who complained to CMS? Could it have been one or more of the laboratory staff who reported these problems to the hospital’s risk manager in September and felt that follow-up action was moving too slowly, thus exposing patients with inaccurate diagnoses to further harm?”

Hospitals and health systems that become aware of medical errors, including misdiagnosis of a patient, are sensitive to the potential of malpractice lawsuits that result in multimillion dollar settlements against the institution and the negative publicity that results when a case of misdiagnosed cancer becomes news.

Another relevant fact is the hospital stated that it believed one individual was responsible for the situation. Reporter Richard Craver of the Winston-Salem Journal wrote that medical center President Kevin High, MD, “has not identified hospital officials responsible for the erroneous laboratory results.” The hospital determined that “most, if not all, of the misdiagnoses centered on a single individual who is no longer with Wake Forest Baptist,” Craver reported.

Unaddressed Issue

A hint at the identity of this pathologist is contained in the CMS report, which said, “Interview on 02/05/2018 at 1245 and on 02/08/2018 at 1415 with MD #10, the Chair of the Pathology Department, revealed he had been in his position since August of 2017. Interview revealed he was asked to chair after the previous Chair (MD #7) separated from the organization.”

If this is true, it provides more insight into the problems within the pathology department at WFBMC. If staff members had evidence to believe that the chair of pathology was misdiagnosing certain types of cancers, what options did staff have to use the lab’s internal procedures to call attention to this situation?

The former chair’s departure in August 2017, and the lab staff’s meeting with the hospital risk manager in September 2017, might be interpreted as evidence that—even after the departure of that pathologist—some employees within the pathology department thought that not enough was being done to notify patients identified as having been given a wrong diagnosis—and where timely intervention could minimize negative consequences to those patients.

The CMS deficiency report and the news stories about the problems at Wake Forest Baptist Medical Center show that fundamental problems went unaddressed for about three years. Did the June 2014 through August 2017 time period—when the 9,000 cancer cases under review were diagnosed—coincide with the former chair of pathology’s time at the medical center? If so, what took lab staff so long to take their concerns to the hospital administration?

These events trigger another interesting and relevant question: What was the role of the pathology lab’s CLIA accreditor during the time that problems were known to some lab staff? The website lists the College of American Pathologists as an accreditor. Did someone from the pathology lab notify CAP? When onsite, during that three-year period, did CAP inspectors identify any of the deficiencies CMS reported in its February inspection?

If these assumptions are close to the truth, then it appears serious, ongoing issues happened at the WFBMC pathology lab, at least between 2014 and 2017.

Statement from President of Wake Forest Health System

IN A STATEMENT RELEASED APRIL 11, Wake Forest Health System President Kevin P. High, MD, said, “Wake Forest Baptist and the entire Wake Forest Baptist Health system continue to fully participate as a provider of medical services under the Medicare program.

“CMS made its decision after surveyors returned to Wake Forest Baptist last month and found corrective actions in place and evidence of ongoing monitoring and improvement. The surveyors recommended rescission,” High added.

“Physicians and patient advocates at Wake Forest Baptist continue to provide information and care to those concerned about their diagnoses following biopsy or surgical removal of tissue, and other teams continue to work on improvements to ensure the quality of care and safety of our patients,” he wrote. “We expect a CMS survey team to return within the next few months to confirm compliance with the processes and procedures that have been put in place.”


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