Pathologist’s Error and Hospital’s Cover-up Lead to CMS Investigation

Former pathology chair, surgeon, academic hospital named in lawsuit

CEO SUMMARY: In the latest chapter of an explosive case at the University of Kansas Medical Center that includes claims of a cancer misdiagnosis, an unnecessary surgery, and a cover-up that involves the former chair of pathology, the patient has sued for fraud, negligence, and civil conspiracy. After a whistle-blowing pathologist filed an earlier lawsuit, Medicare did its own investigation and found deficiencies in care delivery that left patients at the University of Kansas Medical Center at risk.

AMONG MANY SIGNIFICANT DEVELOPMENT in a case of misdiagnosis and a cover-up involving the now-former chair of pathology at University of Kansas Medical Center (KUMC), one of the most explosive is that the federal Centers for Medicare and Medicaid Services had done its own investigation in the case.

As a result of its investigation into this medical error and the actions of hospital staff following an unnecessary surgery, CMS stated that the actions of the pathologist, the surgeon, and other hospital staff were deficient and “placed all patients receiving services at [the] hospital at risk for receiving care that does not meet acceptable quality and standards.”

The disclosure of CMS involvement comes one year after a pathologist, Lowell Tilzer, MD, filed a whistleblower lawsuit charging that the chair of the department of pathology at KUMC had misdiagnosed a patient’s illness, causing a surgeon to remove the patient’s organs unnecessarily. The lawsuit then said the pathology chair and the surgeon covered up the misdiagnosis.

The fact that CMS investigated the claims in Tilzer’s lawsuit was disclosed in a lawsuit the patient, Wendy Ann Noon Berner, filed Aug. 1. Berner’s lawsuit restated many of the statements in Tilzer’s lawsuit, including the charges that after being notified of the diagnostic error and the patient’s unnecessary surgery, “KUMC’s and KU Hospital’s administrators resisted [the whistleblower’s] efforts to thoroughly investigate the matter and conduct a review known as a ‘root cause analysis;’ and KUMC and KU Hospital did not take corrective action.” THE DARK REPORT covered these developments last year. (See TDR, July 25 and Sept. 26, 2016.)

For laboratory professionals, this case is a public example of how the healthcare system can harm a patient in a life-changing manner and then fail to be accountable to that patient.

In addition, this case highlights the flaws in the system of hospital and laboratory accreditation and regulation. If not for a single principled pathologist in the department who recognized the diagnostic error and how the patient was harmed—but who was not told about the error—then this flagrant cover-up might have succeeded.

Told post-surgery that she was cancer-free, Berner would not have learned that her life-changing surgery was unnecessary. But now she must live without essential organs, needlessly removed.

Also, if not for Tilzer and now Berner, this major medical error and the alleged cover-up by the diagnosing pathologist, the surgeon, and the hospital administration, would never have come to the attention of the hospital’s accrediting bodies and government regulators. A patient choosing a hospital would be unaware of this diagnostic error and the actions of physicians and administrators to hide the error from the patient, regulators, and the public.

Using court documents, THE DARK REPORT provides an overview of the alleged original diagnostic error by the former chair of pathology at KUMC and the subsequent events as described in Berner’s lawsuit.

On Aug. 1, Berner filed her lawsuit in Wyandotte County District Court, claiming fraud, negligence, and civil conspiracy. Named as defendants are the pathologist and former chair of the KUMC pathology department, Meenakshi Singh, MD; the surgeon, Timothy M. Schmitt, MD; Kansas City Hospital Authority, the University of Kansas Medical Center, and the University of Kansas Physicians. In addition to the misdiagnosis and needless surgery, the lawsuit alleged that Singh amended the patient’s medical record to conceal the misdiagnosis. As a result of not informing Berner about the misdiagnosis, the patient got suspicious and started investigating the case, the lawsuit charges. That’s when she read about the misdiagnosis in a Kansas City newspaper last summer.

After Tilzer filed a lawsuit on July 1, 2016, in which he outlined the steps that led to the alleged misdiagnosis, Singh, hospital CEO Bob Page, and others sought to cover up the misdiagnosis, court records show. Tilzer also alleged that Page reprimanded and attempted to intimidate him during a meeting in Page’s office.

In his lawsuit, Tilzer charged that Singh, who at the time was the head of pathology at KU Medical Center, misdiagnosed an unnamed patient as having cancer. That misdiagnosis led to the surgical removal of part of the patient’s pancreas, records show.

That lawsuit raised troubling questions for the hospital because Tilzer was the former chair of pathology at the hospital, and he was challenging the misdiagnosis of Singh, who was the department chair when the patient was misdiagnosed as having pancreatic cancer. Tilzer later withdrew his lawsuit.

In the most recent lawsuit, Berner fills in the details in the case, explaining that Singh reviewed three fine needle aspirate samples from Berner’s pancreas and “misdiagnosed one or more of the FNA samples as cancerous, including her primary misdiagnosis of pancreatic neuroendocrine tumor.”

Based on that misdiagnosis, Berner, who was 44 at the time, was informed that this type of cancer is 94% lethal within five years of diagnosis, the lawsuit says, adding that Schmitt told her surgery was necessary for her survival.

Life-Altering Surgery

Schmitt explained that Berner needed a Whipple procedure but did not explain the possible complications, such as life-long medical complications, the loss of some or all of the essential functions of her pancreas, temporary or permanent loss of digestive functions and enzyme production, the inability to produce insulin, the development of diabetes, and the need to take high-cost medications for life, the lawsuit charges.

On Sept. 1, 2015, Schmitt performed a modified Whipple procedure and open cholecystectomy and also removed her appendix, a portion of her small intestine, and her bile duct, the court records show. “The modified Whipple procedure is a major surgical operation involving the removal of the head of the pancreas, the duodenum, the proximal jejunum, gall-bladder, and part of the stomach,” the lawsuit says.

During a post-surgery examination of Berner’s tissue samples, a board-certified pathologist established that the plaintiff’s pancreas was not cancerous and was “essentially normal,” the lawsuit says.

Tissue ‘Essentially Normal’

“The 9/4/15 surgical pathology report concluded: “[n]egative for tumor in the entirely submitted specimen. After the post-surgery examination determined that Plaintiff’s pancreas was not cancerous, the pre-surgery tissue sample was re-examined by the same board-certified pathologist. The post-surgery re-examination of the pre-surgery tissue sample established that the pre-surgery sample was not cancerous, and that Dr. Singh misdiagnosed the pre-surgery tissue sample. The removed portion of plaintiff’s pancreas was normal. The entire Whipple procedure on 9/1/15 was unnecessary,” court documents show.

After learning the results of the post-surgery examination, Singh told Schmitt the results of the FNA that she used as the basis for diagnosis of neuroendocrine tumor of the pancreas was inaccurate.

In his whistleblower complaint last year, Tilzer alleged that Singh did not recognize the difference between acinar cells and islet cells. She then covered up her misdiagnosis by placing an addendum to her original report stating the original cancer diagnosis and the normal removed organ matched, thereby concealing her original misdiagnosis and perpetuating Berner’s mistaken belief that her pancreas was cancerous, the lawsuit explains.

After being hospitalized for eight days, Berner was discharged on Sept. 9, 2015, five days after the post-surgery examination. At this time, she was not yet informed of the misdiagnosis and still had a diagnosis of primary pancreatic neuroendocrine tumor, the lawsuit charges.

On Sept. 18, nine days after Berner’s discharge, Singh added an addendum to the medical record, say court documents.

At this point, Singh and Schmitt took additional steps to conceal the misdiagnosis, the documents show. “For example, according to Tilzer’s whistleblower petition, Singh—who was the chair of the Pathology Department—did not report her misdiagnosis to KU Hospital’s chief medical officer, Risk Management Committee, or risk manager. Upon information and belief, Schmitt also failed to report the critical misdiagnosis,” the lawsuit says.

On Sept. 17, 2015, Berner met with Schmitt for a follow-up appointment. “Schmitt stated to plaintiff, ‘Good news, no cancer.’ Understandably, plaintiff interpreted Schmitt’s statement to mean that Schmitt successfully removed the cancerous portion of her pancreas containing the neuroendocrine tumor previously identified by Singh,” the lawsuit says.

Later that month, Berner was hospitalized due to complications from the surgery and heard startling news from an emergency room doctor. “Oh, I heard about you. You had an extended Whipple procedure and had your appendix out,” the doctor told her, the lawsuit alleges.

In Case of Pathologist’s Misdiagnosis at KUMC, Timeline of Events Begins in September 2015

THE FOLLOWING IS A TIMELINE OF EVENTS in the case of patient Wendy Ann Noon Berner, who filed a lawsuit against the University of Kansas Hospital Authority, Kansas University Medical Center, KU Hospital and others, charging a misdiagnosis, needless surgery, and a cover up. The source for all statements in this timeline are the lawsuits filed in this case.

August 2015: Pathologist Meenakshi Singh, MD, who is Chair of Pathology at Kansas University Medical Center, diagnosed Berner with pancreatic neuroendocrine tumor.

Sept. 1, 2015: Patient undergoes a modified Whipple procedure and open cholecystectomy, during which her appendix, a portion of her small intestine, and her bile duct are removed.

Sept. 4, 2015: Pathologists conduct a post-surgery review of removed organs and find no evidence of cancer.

September 2015: Pathologist Lowell Tilzer, MD, informed KU Hospital’s chief medical officer and risk management officer that a root-cause analysis was needed.

September 2015: CMO said Singh’s diagnosis was correct because two other pathologists signed off on her report. In fact, Singh had added those pathologists’ names in the record.

Sept. 17, 2015: Patient meets with surgeon Timothy Schmitt, MD, for post-surgery follow up and is told, “Good news. No Cancer.” Berner interprets this statement to mean surgery successfully removed cancerous tumor.

Sept. 27-30, 2015: Patient returns to KUMC due to complications from surgery and is startled to learn from an ER physician that during surgery on Sept. 1, her surgeon had removed her appendix.

Oct. 8, 2015: In follow-up visit Berner asks Schmitt why her appendix was removed. Schmitt replies that it had to come out because it forms the same type of tumors the pancreas had.

Early 2016: During a QI review, staff of KUMC/KUHospital reviewed the three FNA samples and classified them as “major misinterpretations” and determined that the misinterpretation led to unneeded surgery.

Early 2016: Singh lobbied supervisor of cytopathology to edit the QI document to minimize or eliminate references to “major misinterpretation” and to the fact that an unneeded surgery occurred.

April 1, 2016: Tilzer reported to the Joint Commission about the misdiagnosis and failure to correct the medical record.

April 5, 2016: Berner has another complication and needs hernia repair. Schmitt’s surgical note states that the patient has “a history of neuroendocrine tumor of the pancreas.”

April 6, 2016: Tilzer meets with director of risk management about the need for a root-cause analysis.

May 31, 2016: KU Hospital President Bob Page reprimands and attempts to intimidate Tilzer, and describes Tilzer’s report to the Joint Commission as despicable behavior.

July 1, 2016: Tilzer files whistleblower lawsuit.

Aug. 1, 2017: Wendy Ann Noon Berner files lawsuit against University of Kansas Hospital Authority, Kansas University Medical Center, KU Hospital, The University of Kansas Physicians, Meenakshi Singh, MD, and Timothy M. Schmitt, MD.

Shocking News

This news shocked Berner because Schmitt had never mentioned removing her appendix, court papers show. On Oct. 8, 2015, Berner asked Schmitt about her appendix. “Schmitt said, ‘Oh, I must have forgotten to tell you. I had to take that out because they form the same kind of tumors that your pancreas had,” the lawsuit says.

In April 2016, Berner had another complication from surgery and needed an insicionnal hernia repair, the lawsuit states. In documenting the repair, Schmitt described Berner as “having a history of neuroendocrine tumor of the pancreas,” the lawsuit states, adding, “This was not a clerical or charting error; it was a continuation of the efforts to cover-up the misdiagnosis and the unnecessary surgery.”

Early in 2016, staff at KUMC/KU Hospital reviewed the three FNAs during a quality improvement session. “In doing so, KUMC/KU Hospital classified them as ‘major misinterpretations,’ and determined that the misinterpretations led to an unneeded, major surgery,” the lawsuit says.

Lab’s Review of the Case

At this point, Singh lobbied the supervisor of cytopathology to edit the QI document to minimize or eliminate references to the ‘major misinterpretations,’ and to minimize or eliminate the fact that an unneeded, major surgery occurred, the court papers show. “Singh also instructed others to alter meeting minutes referencing her misdiagnosis, and the necessity of conducting a ‘root cause analysis,’” the records show.

In September 2015, Tilzer told the KU Hospital’s chief medical officer and risk management officer that a root cause analysis was needed. At the time, the CMO stated that Singh’s original diagnosis was correct because two other pathologists had signed the report, the lawsuit says.

As was reported earlier, the pathologists did not agree with the original diagnosis, and their names were simply added to the electronic medical record. The CMO thus perpetuated the cover up, the lawsuit says, and a root cause analysis was never done.

After Singh requested that the medical records be altered and, after the hospital failed to conduct a root cause analysis, Tilzer reported the case to The Joint Commission. Court papers say he explained the misdiagnosis, the cover up, and that no effort was made to correct Berner’s medical records or inform the patient of the misdiagnosis.

Attempt to Intimidate

Following Tilzer’s report to The Joint Commission, Page reprimanded and attempted to intimidate him, the lawsuit explains. On the day Tilzer filed his whistleblower petition, Page sent an email to all KU medical staff, and perpetuated the KU defendants’ efforts to conceal the misdiagnosis and cover-up, the lawsuit says.

The lawsuit quotes from the email Page sent as follows:

“The hospital received word today (Friday, July 1st) that pathologist Dr. Lowell Tilzer had filed a ‘whistleblower’ lawsuit against us. The suit alleges a misdiagnosis was made on a cancer patient by a physician, leading to unnecessary surgery. The suit further alleges the hospital ignored Dr. Tilzer’s calls for a review of the case and never informed the patient of the misdiagnosis. In short, this is simply not true.”

Page’s statements were patently false, the lawsuit says.

The CMS Investigation

In July 2016, the Kansas City Regional Office of CMS began investigating Tilzer’s allegations. That month, Schmitt asked Berner to sign an affidavit to insulate the defendants from liability, the lawsuit says.

In the affidavit, Schmitt asked Berner to lie about the timing of when he deceptively told her, ‘Good news, no cancer,’ without informing her of the misdiagnosis, that she never had a cancerous pancreatic neuroendocrine tumor, and that she underwent an unnecessary surgery involving lifelong complications, the lawsuit says. The affidavit also failed to mention Schmitt’s efforts to conceal the problems from Berner, records show.

At this point, Berner became suspicious and learned from a news article about Tilzer’s whistleblower petition filed in July 2016, stating that she was misdiagnosed with cancer, that her medical records were incorrect, that she never had a cancerous pancreatic neuroendocrine tumor, and that she underwent an unnecessary surgery involving lifelong complications. After requesting a copy of her own medical records, Berner saw multiple references to the incorrect misdiagnosis, and saw that she had history for a pancreatic neuroendocrine tumor, the lawsuit says.

Following its review, CMS found that “the hospital’s medical staff failed to ensure the quality of care provided to [plaintiff] in that the surgeon and other hospital staff failed to inform the patient during her hospitalization that she did not have cancer and that her appendix had been removed during surgery; failed to update [plaintiff’s] medical record to remove the diagnosis of cancer, and failed to completely and thoroughly investigate the incident,” the lawsuit says.

CMS also found that the governing body of the hospital “failed to ensure the hospital promoted and protected the rights of [plaintiff] by failing to keep her fully informed of her diagnosis, a misread lab, and her surgical procedure.”

In addition, CMS said the hospital’s governing body, “failed to ensure that the Medical Staff Committee appointed a qualified pathologist to a position by not ensuring that she met the special qualifications listed on the application for privileges,” and that the hospital’s “deficient practices placed all patients receiving services at [the] hospital at risk for receiving care that does not meet acceptable quality and standards.”

KUMC Issues Statement About the Berner Lawsuit

IN A STATEMENT TO DAN MARGOLIES of KCUR Radio, a spokesman for the University of Kansas Health System said the hospital was constrained in what it could say about Berner’s case. “Ensuring the health and well-being of every patient at the University of Kansas Health System is our top priority,” said spokesperson Dennis McCulloch. “We need to be respectful of patient privacy and confidentiality, and because of that we are limited in what we can say on this matter. That said, we do believe that our physicians and staff acted appropriately and with the best interests of our patient in mind.”

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