Discovery of Pathology Errors Shows Quality Flaws

MOST PATHOLOGISTS WOULD AGREE THAT PATIENTS AND THEIR PHYSICIANS have every right to expect a timely, accurate lab test result. Stated differently, patients and physicians implicitly trust that a pathology laboratory in the United States will not make errors in specimen processing (technical component) and diagnosis (professional component).

For these reasons, the recent federal Centers for Medicare and Medicaid Services (CMS) decision to issue the most severe sanctions against Wake Forest Baptist Medical Center (WFBMC) for deficiencies in its pathology laboratory that could cause immediate “jeopardy to patient health and safety” should be a wake-up call to the anatomic pathology profession.

Laboratories and banks don’t have much in common, except that they succeed only as long as customers trust them. Once customers have reason to believe a bank is in financial distress, they are likely to withdraw their funds in a run that could cause the bank to fail.

As with banks, laboratories must maintain public trust, and they do so by producing accurate and high-quality test results. Look no further than the example of Theranos to confirm that fact. Once credible news articles revealed systemic quality and accuracy failures at Theranos, it collapsed financially and multiple federal agencies commenced civil and criminal investigations.

The administrators at Wake Forest Baptist Medical Center now must assure the public that they have identified and corrected all the problems that caused multiple pathology errors which occurred since at least last year and possibly going back to 2014. In addition to the public fallout the medical center faces, Wake Forest Health administrators can expect malpractice lawsuits from patients whose erroneous pathology results caused them to get care that was inappropriate and life-changing.

One message to take away from this episode is that clinical laboratories and pathology groups should devote all necessary resources to ensuring the quality of all processes in their laboratories. Adoption of a quality management system is a productive first step. Encouraging a culture of continuous improvement, and a system of prevention are proven ways to drive out errors, improve quality and customer satisfaction, and help the lab remain financially sound.