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       Headlines - October 8, 2007
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R. Lewis Dark: Lean, Six Sigma and Laboratory Errors

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 commited 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.



More Labs Actively Adopt Quality Management

Lab Quality Confab draws global audience to share improvement breakthroughs, successes

CEO SUMMARY: With almost 300 speakers, attendees, and vendors in attendance from seven countries, Lab Quality Confab was a significant milestone for the global lab industry. On one level, it was a sign that the quality improvement trend has come of age. On another level, it provided ample and powerful evidence that labs using Lean and Six Sigma are actively raising the benchmarks for measuring the quality of laboratory testing services.




Shiel Medical Lab Grows In Tough NYC Market

Flying under the radar screen, lab firm builds market share to achieve yearly sales of $50 million

CEO SUMMARY: There’s a new lab player emerging in the New York metropolitan market. Shiel Medical Laboratory of Brooklyn, New York, is growing steadily and now reports $50 million in annual revenue. It is taking full advantage of the managed care contracting turmoil and adding new clients at a surprising rate. During the first 12 weeks of 2007, Shiel Medical Laboratory says nightly specimen volume increased by 50%.



Lab Briefs:

NEW CEO NAMED AT ROCHE DIAGNOSTICS, VENTANA OFFER EXTENDED

BILL WOULD REPEAL LAB BIDDING DEMO



CDC Convenes Institute To Leverage Lab Testing

“Summit” brought healthcare leaders together to explore how lab testing can play a bigger role

In convening the 2007 Institute “Managing for Better Health,” in Atlanta last week, the Division of Laboratory Systems of the CDC invited a broad spectrum of healthcare experts and policymakers to participate. The ambitious goal was to facilitate discussions involving stakeholders such as employers, payers, policymakers, clinicians, and others to identify ways that laboratory medicine could more effectively leverage outcomes and patient care.



Medicare Soon Won’t Pay Hospitals for Errors

Private payers may be encouraged to adopt similiar policies of no pay for “preventable errors”

CMS issued new rules, effective in October 2008, that it will no longer pay the extra cost of treating patients after preventable errors, infections, or injuries that occur in hospitals. It continues Medicare’s transformation from a “passive payer simply processing claims” to an “active purchaser with a stake in quality and efficiency.” Many experts believe that private payers will follow Medicare’s lead and also cease to reimburse for conditions related to preventable errors.



Laboratory Error Results In Mistaken Mastectomy

NY Dept. of Health determines that lab tech cut corners with tissue samples, causing wrong diagnosis

In New York, because of a laboratory error and wrong diagnosis, a woman underwent a needless double mastectomy. In reporting the case, New York newspapers discovered another case of lab error and both women are suing the labs involved. Each case is a reminder that the public and state healthcare regulators are becoming increasingly intolerant of preventable laboratory errors.


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