CEO SUMMARY: For medical directors and pathologists interested in improving their labs’ compliance with CLIA regulations, a report from federal and state inspectors of an inspection of the pathology lab at the Wake Forest Baptist Medical Center offers insights into what issues caught the inspectors’ attention. During their visit in February, the government lab inspectors found multiple, serious diagnostic errors in the medical center’s academic pathology department.
AFTER DISCOVERING SERIOUS DEFICIENCIES in the anatomic pathology laboratory at the 885-bed Wake Forest Baptist Medical Center in February, the federal Centers for Medicare and Medicaid Services notified the medical centers that it could lose its Medicare billing privileges.
Early in February, federal lab inspectors conducted a “complaint inspection” at the hospital in Winston-Salem, N.C. On March 26, CMS sent a 54-page statement of deficiencies and plan of correction to the medical center, previously known as North Carolina Baptist Hospital. In the statement of deficiencies, CMS said it was considering that the hospital could be “terminated as a provider” to the Medicare program. (See TDR, April 16, 2018.)
Wake Forest Baptist Medical Center currently awaits the results of a review of 9,291 histopathology cases, a number that federal inspectors determined were the result of deficiencies in the Pathology Department. As of March 26, only 1,422 cases had been reviewed.
Inspectors from CMS and the CLIA staff of North Carolina’s Division of Health Service Regulation conducted the joint investigation. The primary source of deficiencies were found in histology cases done between June 2014 and August 2017.
To provide context for the problems the medical center faces, THE DARK REPORT asked pathologist Frederick Kiechle, MD, PhD, to review the 54-page statement of deficiencies and offer some of the lessons learned for pathologists in similar settings.
Kiechle, a consultant in clinical pathology in Cooper City, Fla., and the past Medical Director of Clinical Pathology for Pathology Consultants of South Broward, in Hollywood, Fla., suggests all pathologists should know the lessons from the Wake Forest case. The most obvious are: hire qualified and appropriately-trained staff for all supervisory positions, ensure that all staff are committed to producing high-quality clinical results every day, and never compromise patient care.
“Pathologists should be aware that CMS has a list of the top 10 standard deficiencies,” he said. “When I read the CMS statement of deficiencies about what happened in the Pathology Department at Wake Forest Medical Center, it’s clear that many of the deficiencies the lab inspectors uncovered are of the same type as the major deficiencies on that CMS list.
Lists of Major Deficiencies
“Other organizations, such as the College of American Pathologists, have similar lists, and each lab accrediting organization that keeps such a list includes all the major deficiencies the inspectors identified,” noted Kiechle. “In fact, on the first page of the March 26 statement of deficiencies, CMS defines the focus the inspectors have when starting an inspection.
“This is one lesson from the pathology lab problems at Wake Forest,” he added. “It is helpful for medical directors and pathologists to know the specific problems CMS will look for during a lab inspection. For this reason alone, that inspection report itself is instructive.”
An expert in clinical pathology, Kiechle has served as an inspector for labs nationwide. “In my career, I have seen many of these CMS reports and this one stands out as being among the best written reports I’ve ever seen. It tells the story of what CMS’ inspectors did, and it explains exactly why they did what they did.
“Therefore, any pathologist wanting to understand the problems identified in the Wake Forest Baptist Pathology Department and how they happened should read this report,” suggested Kiechle. “Someone running a CLIA-certified pathology laboratory should know: What are the elements of lab operations that stand out as red flags for CMS and other agencies do such inspections?” he said. “What does the director of a pathology laboratory need to know to avoid getting a statement of deficiencies and having inspectors shut down the lab?
“The CMS report states that the problems at Wake Forest primarily are in histology. It noted that the lab failed, the laboratory director failed, and the supervisor failed,” explained Kiechle. “The report states, for example, that the supervisor failed because he or she didn’t have the educational requirements to be a supervisor. That’s a serious and obvious problem and something the head of personnel should know.
“In any lab, one fundamental rule is to understand the requirements for each job and to hire the right people for the right job,” he said. “That’s one of the first messages in this report.
“In some of WFBMC’s lab departments, the wrong people were in the wrong positions and those were important positions,” Kiechle stated. “Two examples that stand out were the supervisor of histopathology and the chairman of the department.
Lack of Requisite Education
“In this case, we see that the supervisor was hired inappropriately because he or she did not have the requisite education or training,” Kiechle said. “As a consequence, all of the subsequent issues arise because he or she didn’t do what a supervisor is supposed to do.
“This is why lab directors always have to ask: Do we have the right person in charge of our laboratory section?” he noted. “This is a no-brainer because the rules and regulations from CLIA are clear about the education and experience required for this position.
“CMS’ inspectors are interested in competency,” he added. “They want to see the lab’s competency records. At Wake Forest, in checking those records, the inspectors found that residents in the grossing section had not been trained appropriately.
“This brings up the question: Were residents grossing specimens properly?” asked Kiechle. “Who can know this, if they were not trained according to the documentation? That’s a serious deficiency.
“When hiring a supervisor or laboratory director, laboratories need to hire someone committed to providing excellence in laboratory services,” he stated. “That someone needs to be an experienced pathologist who understands how to run a highly-efficient and clinically-excellent lab.
Trained Pathologists Depart
“Next, the CMS report said the chairman of the pathology department assigned someone to be the surgical pathologist and then both the chairman and the newly-appointed surgical pathologist left the medical center,” he said.
“The CMS statement of deficiencies makes clear that they put the wrong people in charge, and as a result, the medical center compromised patient care,” he added. “CMS will always be quite interested when patient care is compromised.
“This is perhaps the most important point in the CMS report: If your lab compromises patient care, CMS will be very, very concerned,” noted Kiechle.
“We know the inspectors had four issues that they reported in an earlier report and then they listed 13 issues in the second report. Only four of those issues resulted in wrong diagnoses,” he explained.
No Signs of Cancer
“When you read what happened to patients numbered 1, 2, and 3, those stories were really sad,” he said. “One women had a bilateral mastectomy for no reason at all. She didn’t have any signs of cancer.
“Also, the federal and state lab inspectors found cases that didn’t match with their results, which the medical staff noticed,” Kiechle explained. “It’s significant that the WFBMC medical staff had to say that they had a problem with pathology service and that, after the misdiagnoses in the cases of potential breast cancer, the medical staff and the pathology department agreed to have a second pathologist review all breast biopsy diagnoses for confirmation.
“In other words, the Pathology Department didn’t seem to know what they were doing because they diagnosed cancer when there wasn’t cancer and some patients were treated with radiation when they shouldn’t have been,” he continued. “The CMS report identifies four such cases that led to bad outcomes, but that’s a lot!”
“And all of those bad outcomes seem to go back to pathologist #7, who was the chairman,” he said. “Problems like these really upset CMS inspectors, as they should.
“In addition to the major issues that should jump out at anyone who reads the report, there were other problems that, from a pathology laboratory operations standpoint, were not as severe, but were still important and needed to be addressed,” stated Kiechle.
Failed to Validate Equipment
“For example, the lab failed to validate some new equipment and failed to validate that equipment properly,” he added. “The pathology lab had different stainers and didn’t use the right validation procedures or ignored the manufacturers’ recommendations. The lab had no validation processes in place and it didn’t have any maintenance function checks. These are all red flags that any lab director should notice.”
The CMS inspection report was made public by the local newspaper, the Winston-Salem Journal. Pathologists and lab managers interested in reading the full CMS inspection report of the Wake Forest Baptist Medical Center pathology laboratory can access it using this URL: https://tinyurl.com/path-errors.
Contact Frederick Kiechle, MD, PhD, at 954-680-2163 or firstname.lastname@example.org.