MOST OF YOU ARE FAMILIAR with how. Edwards Deming and Japanese manufacturers demonstrated the power of understanding customer expectations and organizing one's business to deliver products and services which meet and exceed those expectations.

For the past four decades, one thing that many of the world's most successful organizations have in common is an exceptional ability to meet and exceed the expectations of their customers. It is not a coincidence that, about the time that The Joint Commission joined the Leapfrog Group earlier in this decade, it raised the profile of patient satisfaction surveys as a component of the hospital accreditation process. (See TDR, January 28, 2002.)

In recent years, as laboratories and hospitals in this country adopted Deming-based qualitymanagementmethods, pathologists and labmanagers in those organizations have begun to regularly consider patient expectations and satisfaction. Another aspect of Deming-based quality management methods, such as Lean and Six Sigma, is the use of errors-per-million-events as a way to measure performance and as a guide to eliminating the source of waste, defects, and errors.

Working in a complementary fashion, these quality management methods are going to cause the analytical science of laboratorymedicine tomore directly intersect with the expectations of patients and physicians. As this occurs, it will demand additional rigor from the analytical phase of lab medicine.

Our editor provides an example of why this will happen on pages 10-16 of this issue of THE DARK REPORT. One day this spring, he had blood collected, properly processed, and sent 24 times to nine different laboratories to be tested for Vitamin 25 (OH) D. Of course, our expectation as laboratory professionals- as are the expectations of doctors and patients-is that the same blood should produce essentially the same result when tested by an accepted methodology. This should be true within the same lab, as well as across all labs testing the same patient's blood.

However, that is not what happened to our editor's blood. One methodology- the FDA-cleared immunoassay-did deliver a tight spread of results. By contrast, the home brew tandem mass spec method produced a much wider spread of results. My view is that our editor's unique real-world experiment demonstrates why the lab testing professionmust strive to improve in ways that fully meet the expectations of physicians and patients.

Plain Talk about Current "Health Reform" Effort

Media coverage and public discourse fail to evaluate various options to improve healthcare

CEO SUMMARY: It appears that a determined effort to reshape and restructure the entire American healthcare systemis unfolding in Congress. Missing in public discourse about this vital topic is informed, intelligent discussion about the types of alternative healthcare delivery models and options that might successfully address problems in the current U.S. healthcare system, without a total makeover of healthcare as it exists today. This is a big stakes issue for the entire laboratory testing industry.

Using Lean at Henry Ford Transforms Pathology TAT

Henry Ford Production System and Lean methods used to unlock major improvements in pathology

CEO SUMMARY: Long-standing work flow traditions in anatomic pathology provide fertile ground for improvement with Lean and similar process improvement methods. That was the case at Henry Ford Health System, where empowered teams in the pathology laboratory employed the principles of single-piece/small batch work flow, "pull", and standard work. The outcomes were reduced defects, improved productivity, and a reduction in average turnaround time in specimen processing of up to 50%!

Our Editor Gets His Vitamin D Test Results From 9 Different Labs

Do different Vitamin D methods confuse doctors?

CEO SUMMARY: Editor-In-Chief Robert L. Michel gave blood for the cause and it's another laboratory industry first! To understand what doctors and patients see as national labs use different methodologies and reference ranges to report Vitamin 25(OH) D results, his blood was tested 24 times by nine laboratories. The results were unveiled at the Executive War College last May in New Orleans. These results are published here, along with comments from the All-Star Vitamin D Panel experts who discussed reasons why doctors might be confused and might misinterpret Vitamin D lab test results.

New Lab Player Launches In Breast Cancer Market

Its proprietary assay evaluates 70 genes to predict odds of breast cancer recurrence

CEO SUMMARY: Having opened its CLIA-licensed laboratory in Huntington Beach, California, Agendia, Inc., becomes the newest competitor to enter the market for breast cancer testing. Its proprietary assay looks at 70 genes to assess the risk of recurrence. The company expects to collaborate with local pathologists, as its test requires fresh tissue and can provide a diagnostic answer for untreated patients, including both ER-positive and ER-negative patients. Agendia executives are pursuing Medicare coverage for the assay.

INTELLIGENCE: Late & Latent

RAPID A/NOVEL H1N1 FLU TESTS HAVE LOW DETECTION RATES

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