IT IS NOT OFTEN THAT WE DEVOTE AN ENTIRE ISSUE TO A SINGLE TOPIC. The last single-topic special issue of THE DARK REPORT was almost exactly one year ago, when we provided the laboratory industry’s most detailed assessment of the Medicare Part B Competitive Bidding Demonstration Project, the details of which had finally been made public on December 5, 2007.
Obviously this Medicare competitive bidding demonstration project was a high-profile news story—one that had the potential to negatively affect the finances of every laboratory in the United States and lead to an erosion in the current high standard of lab testing in this country today.
So why devote this full issue to the topic of Vitamin D testing and the acknowledgement by Quest Diagnostics Incorporated that, for certain periods of time, it had reported inaccurate results on certain patients? After all, it is an extremely rare event because well-run clinical laboratories are consistently good at producing accurate, reliable, reproducible results every day, on every shift, and on every instrument. When questionable test results are produced, well-run labs are generally quick to recognize that fact and take timely action so that the physician gets an accurate result and patient care is not adversely affected by that particular laboratory failure.
The uncommon nature of this lab retest/recall program is precisely the reason that Vitamin D testing is the sole theme of this DARK REPORT. The Vitamin D test recall is an extraordinary event. Anecdotal reports from certain communities indicate that many thousands of physicians may have been sent notices of inaccurate testing on their patients, along with an offer for a retest at no charge. It is also a noteworthy story because it involves the nation’s largest laboratory company—a company that continually reminds Wall Street investors that it is committed to Six Sigma quality.
Every laboratory in this country that offers Vitamin D testing is experiencing strong increases in test volume. Thus, plenty of important laboratory management lessons can be learned by watching how this laboratory company manages its relations with physicians, patients, payers, and the press on the very touchy subject of having inaccurate Vitamin D results on some patients.
This recall/retest campaign by a prominent laboratory is also a reminder to other lab organizations that anything can happen at any moment. It is why contingency plans and disaster preparations should always be kept up to date.