Lean, Six Sigma and Laboratory Errors

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IT IS TOUGH TO IGNORE THE STEADY DRUMBEAT about patient safety. In every sector of healthcare, accrediting bodies, state legislatures, private insurers, and federal health administrators are instituting programs designed to focus providers on eliminating the sources of medical errors and reducing the variability in care provided to patients.

As you will read on pages 17-18, just last week two medical errors committed by national lab companies triggered newspaper headlines and coverage on television news programs. In both cases, simple errors in specimen handling at the laboratory caused a woman to get an inaccurate diagnosis of cancer. Only after undergoing life-changing surgery and other procedures, did these women’s physicians learn about the lab errors. It was the post-surgery pathology review which uncovered the original laboratories’ errors.

These types of errors are unusual and uncommon—but they do occur with some regularity, given the large volume of specimens handled annually by the nation’s laboratories. All lab directors and pathologists know stories about how a lab error caused a patient to receive inappropriate care. Although most of these stories escape the notice of journalists and television news reporters, they do represent an area of lab medicine that does not get the attention it deserves.

However, as more laboratories actively incorporate quality management systems, like Six Sigma and Lean, into their operations and clinical services, they are discovering effective tools that will further drive down the already-low rate of medical errors that occur in laboratories. That was one clear theme at last month’s Lab Quality Confab, where the profession’s first mover and early adopter labs shared their case studies and successes with improvement programs and projects. (See pages 3-5.)

I can foresee the day when laboratories will cease to report the performance of laboratory functions using decimals and percentages and will use either a Six Sigma scale or a defects-per-million figure. Those two measurement terms were a common lingua franca at Lab Quality Confab. By effective use of quality management techniques and methods, laboratories at this conference are achieving a notable reduction in error rates within their lab operations. That is a positive omen for the future of laboratory medicine. It represents early evidence that the laboratory profession can achieve paradigm-shifting gains in quality and reduction of medical errors.

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