Wake Forest Baptist
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By Mark Tosczak, North Carolina Health News

Wake Forest Baptist Medical Center is reviewing more than 9,000 cases from its pathology lab, seeking to uncover any additional instances of errant cancer diagnoses.

In March, the Winston-Salem-based health system said it had found 10 cases of patients where pathology lab errors “led to a change in diagnosis requiring a change in management.” At least three patients underwent unnecessary surgery and radiation treatment after receiving incorrect diagnoses of breast cancer, while another patient’s breast cancer treatment was delayed.

A 59-page report from the Centers for Medicare & Medicaid Services indicates those 10 patients were discovered based on a review of 1,422 cases. However, the government report says, the hospital had identified a total of 9,291 cases requiring review. As of March 26, the hospital was still working on completing the additional 7,869 reviews.

Wake Forest Baptist didn’t respond on Thursday to questions about how many case reviews it has completed to date and whether any additional affected patients had been identified.

But according to the report, the health system’s chief medical officer, Dr. Russell Howerton, told government inspectors in February that “We’ve internally and externally reviewed and found our care did not meet our standards.”

On Monday, CMS, which manages the federal Medicare program, notified the health system that it had until June 12 to satisfy government inspectors that it had fixed problems in its pathology labs. According to the report, those included shortcomings in training, equipment maintenance and lab supply problems, in addition to missing or incomplete documentation. Those problems date back to 2014, and in some cases possibly earlier.

The report also identifies problems with the diagnosis of four patients by a pathologist, identified as “MD #7.”

Costly errors

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. Two patients had lumpectomies and radiation treatment. A third had a lumpectomy and chose a more aggressive surgery — double mastectomy, the removal of both breasts — but didn’t have radiation treatment.

A fourth patient was “underdiagnosed” in a pathology report done on breast tissue removed in a biopsy. Thirteen months later she was diagnosed with breast cancer and subsequently received treatment.

Those mistakes and others first came to the hospital’s attention in September of last year, when employees reported concerns about 10 of MD #7’s patients to the hospital risk management officials.

After hospital leaders discovered the mistakes, they “attempted to put more qualified individuals in the workflow” and “also made changes to the leadership of the pathology lab,” Howerton told inspectors.

The CMS inspectors interviewed the chair of the pathology department, who the report identifies as “MD #10.” He told them that he had been in that position since August 2017 and that he had been asked to lead the department after the previous department chair “separated” from the health system. He also told inspectors that, around the end of January or beginning of February, the health system had hired a new director of surgical pathology.

Wake Forest Baptist’s website identifies Michael Benjamin Cohen as the interim chair of the pathology department.

The hospital has also, according to the report, put in place a procedure where any positive breast cancer pathology reports are reviewed by a second pathologist. The ultimate goal is to institute the same procedure for all cancers.

The threat of cutting off a hospital’s Medicare funding is relatively common, said Daniel Carter, a health care consultant at Chapel Hill-based Ascendient.

“There are multiple times a year that they happen in North Carolina at hospitals,” he said. The threat of such sanctions is a way the government makes sure that health care providers pay attention to quality, safety and documentation issues. However, he noted, the nature of the violations at Wake Forest Baptist are more unusual.

“This is something where real people are affected,” he said. “That’s what I think makes this more sensationalized.”

Other lab problems

Besides the errors attributed to MD #7, government inspectors in February found other problems with Wake Forest Baptist’s pathology labs.

In interviews with staff and physicians, as well as during physical inspections of the actual labs, they found little documentation of training on, or manufacturer’s recommended maintenance for lab equipment.

“The laboratory director failed to ensure testing personnel were trained prior to testing patients,” the report says, “and failed to ensure policies and procedures were established and followed for monitoring testing personnel competency.”

The report says that based on personnel records, the absence of training records and interviews with lab staff, “the laboratory director failed to ensure that prior to testing patient specimens, 20 of 21 testing personnel received appropriate training and had demonstrated they could perform all testing operations reliably to provide accurate patient test results.”

There were also equipment problems. For example, two devices in the lab require a filter to be changed every three months, the report says. However, “There was no documentation that the filter was changed every three months as specified.” The report also describes maintenance shortcomings with other equipment, too, as well as a failure to monitor water quality, temperature and humidity levels in the lab.

Inspectors additionally found lab supplies well past their expiration date still on the shelves. When inspectors toured the pathology labs in February, they found supplies with expiration dates dating back, in some cases, to 2005. A container of sodium bisulfate that was received in 1998 and opened in 2013 did not have an expiration date.

The inspectors said the laboratory compliance, safety and quality manager told them that the expired supplies were identified during routine audits and noted on safety reports and that the lab was aware of those reports.

It’s not clear if Howerton, the chief medical officer, knew about these issues when he was interviewed by government inspectors on Feb. 5. At the time, he told them “there was no evidence to date that the organization had a problem other than the work by MD #7, ‘who is now gone.’”

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