What Is CAP’s Role When Lab Has a Serious Medical Error?

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IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed.

And the story doesn’t end there. It is further alleged in court documents that, when a whistleblower in the pathology department reported this incident to hospital executives, administrators apparently refused to investigate the incident.

Meanwhile, according to a whistleblower’s legal filing, the patient has still not been informed that the diagnosis of cancer was wrong and that a healthy organ was surgically removed as a result of the diagnostic error.

News reports and court documents show that the whistleblower notified The Joint Commission, which accredits Kansas University Medical Center and KU Hospital where these events are alleged to have taken place. Upon inquiry by THE DARK REPORT, the College of American Pathologists confirmed that the clinical laboratory at Kansas University Medical Center and KU Hospital is CAP-accredited.

In an email, CAP said that if it were investigating, “Our investigation would not focus on the misdiagnosis specifically. It would focus on ensuring the laboratory is in compliance with our checklist requirements. CAP has checklist requirements that address pathologists’ competency and so we routinely ensure that a laboratory is meeting the requirements in that area and within the quality management area.”

R. Bruce Williams, MD, CAP’s President-Elect, explained that the CAP accreditation means anyone in the KU laboratory could file a complaint with CAP at any time about any issue of concern. He declined to comment on whether an employee at the KU Hospital had notified CAP. Nor would he comment on whether CAP is investigating the alleged misdiagnosis.

“All CAP-accredited labs are required to post a notice in a prominent place in the lab informing employees of the various ways they can make a complaint about a misdiagnosis or any other patient safety or quality issue,” stated Williams. “Also, CAP could start an investigation even without a complaint from a staff member of a lab. If CAP learned of a problem at a lab through the media or some other source unaffiliated with the lab, it would certainly investigate.

No Comment in this Case

We don’t comment on ongoing investigations or on potential investigations,” Williams explained. “We can talk about the processes we follow, but would not discuss individual cases because of confidentiality requirements.

“In this case, we would want to ensure that there is a review board or internal process that the lab has to review a case like this,” Williams said. “There are cases of misdiagnosis. They don’t happen often but when they do, the laboratory involved needs a mechanism to address how that misdiagnosis was made and how to prevent a similar misdiagnosis going forward.”

Contact Amy Daniels at accred@cap.org.

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