Getting Vitamin D Right for the Doctor and Patient

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MOST OF YOU ARE FAMILIAR with how W. 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 quality management methods, pathologists and lab managers 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 laboratory medicine to more 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 profession must strive to improve in ways that fully meet the expectations of physicians and patients.

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