Wake Forest Baptist Hospital Reviewing Path Lab Deficiencies

More than 9,000 histopathology cases must be reviewed at NC's Wake Forest Baptist Hospital

CEO SUMMARY: In response to information the staff provided to Wake Forest Baptist Hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, CMS describes deficiencies found as “an immediate jeopardy to the health and safety of patients” at the 885-bed hospital. THE DARK REPORT’s analysis shows that a single pathologist may be to blame, highlighting the dangers to labs of leaving critical responsibilities in the hands of a single individual.

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 compliance of Wake Forest Baptist Medical Center (WFBMC) in Winston-Salem, N.C with the federal Medicare conditions of participation (COP) for hospitals.

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 Hospital. 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 may lose 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 Wake Forest Baptist Hospital, 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 of reviewing the cases and preparing them for external review. At least some of these cases involved patients with breast cancer.

CMS told Wake Forest Baptist Hospital that it had until June 12 to correct the pathology lab deficiencies, which included failures in training, equipment maintenance, supply shortages, missing or incomplete documentation, and problems with the laboratory director’s management of the lab.

Those problems date back to 2014, and in some cases possibly earlier, according to reporting by Mark Tosczak of North Carolina Health News.

In the March 26 report, CMS said problems were found in reports on four patients from one pathologist, identified as MD #7 in the report. “For three patients whose cases are described in the report, incorrect breast cancer diagnoses from pathology reports led to unnecessary care in 2016 and 2017,” Tosczak wrote. “Two patients had lumpectomies and radiation treatment. A third had a lumpectomy and chose a more aggressive surgery—double mastectomy.”

A pathology report on a fourth patient resulted in what CMS characterized as being “underdiagnosed” in a report done on breast tissue removed in a biopsy. “Thirteen months later she was diagnosed with breast cancer and subsequently received treatment,” Tosczak added.

Who is at fault?

In its statement of deficiencies, CMS cited multiple times that the Wake Forest Baptist Hospital laboratory director in the department of pathology failed to follow proper procedures. CMS based the findings on its review of procedure manuals, personnel records, and interviews with staff on Feb. 5 through 8.

“The laboratory director delegated responsibilities to another pathologist (surgical pathology director) but failed to ensure the delegated duties were performed as required,” the CMS statement said.

Review of personnel records showed that the histology supervisor did not meet the education requirements to serve as a technical supervisor or general supervisor in a high-complexity histopathology laboratory, the CMS statement said, adding, “The responsibilities for review of records and testing personnel competency assessment could not be delegated to the histology supervisor (assistant manager).”

Commenting on the CMS statement of deficiencies, Elissa Passiment, a laboratory management consultant, said, “The lab director’s lack of compliance led to the major failures cited in the report. Each of the deficiencies cited can either be directly linked to the duties and responsibilities assigned to the laboratory director by the CLIA regulations, or to poorly-qualified personnel, the hiring of whom is also a regulatory responsibility of the laboratory director.”

The medical center’s case illustrates a problem inherent in the CLIA rules, she added. “This case is a prime example of relying only on one person to ensure compliance and quality,” she wrote in an email to THE DARK REPORT. “In my opinion, this has always been a major flaw in the CLIA regulations. Labs should delegate the responsibilities of ensuring compliance and quality to a number of lab staff members.”

What do you believe these developments mean for pathology labs in an era of cost-cutting and staff shortages? Please share your thoughts with us in the comments below.


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