CMS Report, News Stories Describe Pathology Issues

Pathology lab at Wake Forest Baptist MC had turnover in leadership, other internal problems

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CEO SUMMARY: In response to information the pathology lab staff provided to the hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, the Wake Forest Baptist Medical Center is taking corrective action to fix serious deficiencies in its anatomic pathology laboratory. In reports issued in February and March, CMS described these deficiencies as “an immediate jeopardy to the health and safety of patients” at the 885-bed hospital.

FOLLOWING A REVIEW of 1,422 pathology lab cases, the Wake Forest Baptist Medical Center (WFBMC) found 10 cases in which patient care was compromised, according to a 54-page report from the federal Centers for Medicare and Medicaid Services. In addition, the CMS report shows that the medical center needs to review a total of 9,291 pathology cases.

Last week, CMS announced that the medical center had taken steps to correct deficiencies that CMS found during an inspection of the medical center’s pathology lab conducted over four days, from Feb. 5 to 8. The deficiencies were cited as an immediate threat to patient safety and resulted in CMS saying it would stop Medicare payments in March.

The corrective steps prevented CMS from revoking the medical center’s participation in the Medicare program. CMS also told the medical center 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.

On Feb. 8, CMS issued a 23-page list of deficiencies. Six weeks later, on March 26, CMS issued a revised list of deficiencies that identified the need for the medical center to review the 9,291 cases.

‘Did Not Meet Standards’

In the March 26 report, CMS quoted Russell M. Howerton, MD, the Chief Medical Officer of Wake Forest Baptist Health, as saying that hospital administrators were concerned about problems in the pathology lab. “We’ve internally and externally reviewed and found our care did not meet our standards,” Howerton told CMS.

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.

Change in Leadership

In an interview with CMS inspectors on Feb. 5, Howerton said of the pathology lab, “We’ve had a work flow/work force imbalance.” Problems in the lab led to a change in leadership, he told CMS. “We are deep in the midst of a complex and deep review to see if we have a quality issue.”

“The interview revealed the organization had not reached a ‘summative conclusion’ and they had disclosure meetings with all patients involved, they had ‘attempted to put more qualified individuals into the workflow,’ new leadership, and upregulated the process of dual reads (already had dual reads on all outside cases),” the CMS report said.

As of April 10, the medical center had taken corrective steps to prevent CMS from stopping Medicare payments to the medical center, CMS said in an announcement. Federal officials said the North Carolina Baptist Hospital (also known as Wake Forest Baptist Medical Center) would continue as a provider of services under the Medicare program.

In its report on Feb. 8, CMS listed failures that federal inspectors identified in the lab’s histopathology section; personnel competence assessment policies; procedure manual, test systems, equipment, instruments, and reagents; and in how the laboratory director managed the lab. Based on the severity of the deficiencies, the immediate jeopardy situation was not abated and the laboratory was placed on a 23-days revocation track, CMS said.

After the federal Department of Health and Human Services issued a Retraction of Termination Notice on April 10, the medical center announced the next day (April 11) that CMS rescinded its decision to revoke the medical center from the Medicare program. The pathology lab at the 885-bed medical center does some 25,000 surgical pathology cases annually.

On March 9, CMS sent the medical center a notice saying it would stop payment for services in a “Public Notice for Involuntary Termination of Medicare/ Medicaid Provider Agreement,” as follows: “Notice is hereby given that effective March 25, 2018, the agreement between North Carolina Baptist Hospital … and the Secretary of Health and Human Services, as a provider of Hospital Services in the Health Insurance for the Aged and Disabled Program (Medicare) is to be terminated.”

Statement of Deficiencies

In its statement of deficiencies, CMS said, “The laboratory failed to identify and correct problems in the subspecialty of histopathology. The laboratory failed to ensure the procedure manual was complete for all testing performed.” The lab also failed to ensure equipment and procedures were validated prior to use for patient testing; failed to perform manufacturers’ specified maintenance as required, failed to monitor water quality, temperature, and humidity, as required; failed to perform and document quality control for H&E (hematoxylin and eosin) stains as required; and failed to discard expired supplies, CMS said.

The statement of deficiencies appeared to show that the most serious deficiencies involved the failures of the laboratory director. “The laboratory director failed to provide overall management and direction of the laboratory,” the CMS statement said. The laboratory director failed to ensure delegated duties were performed as required, failed to ensure testing personnel were trained prior to testing patients, and failed to ensure policies and procedures were established and followed for monitoring testing personnel competency, CMS said.

Duties and Responsibilities

Commenting on the CMS statement of deficiencies, Elissa Passiment, a lab 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.”

For pathology laboratories, the most competent laboratory directors should have a range of experience, she added. “The best type of person to be laboratory director is one who has been appropriately educated and trained in quality management systems, good laboratory procedures and practices, and management leadership,” she wrote.

CMS Cited Multiple Times Laboratory Director in Pathology Lab Failed to Follow Procedures

IN ITS STATEMENT OF DEFICIENCIES, the federal Centers for Medicare and Medicaid Services cited multiple times that the 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 of deficiencies 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).”

In addition, the pathologist serving as surgical pathology director “at the time of the delegation” was no longer employed at the pathology lab as of September 2017. But, the documentation of the delegation was not updated to reflect the specific responsibilities delegated “to current designees,” CMS added.

The lab director also failed to ensure that 20 of 21 testing personnel received appropriate training and had shown they could reliably perform all testing operations. For one laboratorian, identified as TP #2 and hired on Dec. 29, 2017, there was no documentation of training available for review and yet this laboratorian was doing grossing of pathology specimens in the operating room pathology lab, CMS reported.

What’s more, there were no training records for review for all 19 residents who perform grossing of pathology specimens in the OR pathology laboratory, CMS added.

Contact Elissa Passiment at 732-995-2103 or


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