Laboratory Industry Has “Elephant in the Room”

In January, a major lab failure was national news, but the story went unremarked by most lab sources

CEO SUMMARY: In almost every laboratory across the United States and in several countries around the globe, one much-discussed topic in recent weeks has been the Vitamin D testing program deficiencies at Quest Diagnostics Incorporated. Yet, even as rank and file laboratorians actively talked to each other about what this story means, the lab industry’s professional associations, societies, and publications were silent on this matter, with few exceptions.

AS NEWS OF WHAT MAY BECOME KNOWN as the “Vitamin D testing fiasco” made headlines across the nation last month, there was near total silence from the clinical laboratory profession.

First, outside of pathologists and executives employed by Quest Diagnostics Incorporated, no news stories known to THE DARK REPORT carried quotes, opinions, or information credited to a pathologist, laboratory scientist, or laboratory executive. That is a meaningful fact.

Second, even weeks after the national news stories made the American public aware that Quest Diagnostics had reported inaccurate Vitamin D test results on tens of thousands of patients during an 18-month period during 2007 and 2008, this story remained virtually unreported and unmentioned by laboratory associations, professional societies, and laboratory industry publications—with three exceptions.

These three exceptions were THE DARK REPORT, which was first to print the story about Quest Diagnostics’ systemic problems with Vitamin 25(OH) D testing and its voluntary program to notify and offer free retesting to what may be as many as 490,000 patients; Clinical Lab Products (CLP) magazine, which immediately posted the news on its Web site; and Laboratory Economics, which published its analysis of the story in its very next issue.

This raises an interesting question. Why did the national media recognize the significance of a major failure by a respected lab company to report accurate test results to huge numbers of people—even as the lab industry’s usual sources of news, current events and industry gossip chose to not provide this same news story to their members, readers, and audiences?

Ignoring The Big Story

What does it mean when the laboratory profession’s leading institutions go about their business as if nothing happened? Meanwhile, newspapers and television reports are full of headlines such as “Quest Acknowledges Problem with Vitamin D Test” and “Lab Sent Out Number of Flawed Vitamin D Test Results.”

This silence is certainly not an accident nor an oversight. Everywhere THE DARK REPORT has traveled since it broke this news, lab administrators, pathologists, and medical technologists are quite familiar with the fact that Quest Diagnostics admitted it reported inaccurate Vitamin D results to a huge number of patients. In fact, these individuals have many questions and seem interested to learn more details about the nature of the problems, how Quest conducted its root cause analysis, and what it is doing differently to prevent such a systemic failure from recurring again.

Since the rank and file in laboratory medicine are keenly aware of this story and actively discussing it in their own laboratories, why are the industry’s professional societies, associations, and most publications ignoring this unprecedented event in laboratory medicine? After all, keeping members and readers posted on important developments is one reason these organizations get support from laboratory professionals.

Two Common Responses

The deafening silence across this spectrum of the laboratory industry may turn out to be a significant outcome on its own. In polling pathologists, clinical chemists, and medical technologists about why they think their associations and societies have not posted any news bulletins or commentaries about this story, they express puzzlement about the lack of recognition and commentary about this event. Their responses follow two common themes.

Invariably, the first theme most mention is how the public disclosure of major systemic failures at the nation’s largest lab company has the potential to trigger increased regulation that becomes a burden on the entire laboratory. Essentially, they are concerned that the sins of one lab will bring unwelcome consequences on the many.

The second theme, almost as common as the first, is that most lab professionals immediately recognize that those professional associations involved in licensing, inspections, accreditation, proficiency testing, and quality management activities may have much to lose. If laboratory regulators and elected officials were to dig deeper into the acknowledged deficiencies within Quest Diagnostics’ Vitamin D testing program, these regulators may then turn their attention on how the oversight activities of the relevant lab associations failed to either prevent these deficiencies or catch them during the 18 months that Quest acknowledges it had systemic problems.

Out Of Step With Rank & File

This anecdotal survey of the lab industry rank and file seems to indicate that leaders in these professional associations are out of step with their members by not publicly recognizing the events surrounding Quest Diagnostics’ acknowledgement of its Vitamin D testing program deficiencies.

This fits the metaphor of the elephant in the room. The elephant is so big, everyone knows everyone else sees it. Yet still, no one wants to publicly discuss the elephant until someone else goes first. Maybe this silence is because the laboratory industry was not ready to respond to news of a major failure by a major laboratory that affected tens of thousands of doctors and several hundreds of thousands of patients.

This lab failure is not the action of a single phlebotomist found to be reusing butterfly needles on her patients (SmithKline Beecham Clinical Laboratories–1999). Nor is it a rogue laboratory administrator who, for two years, actively suppressed the med- ical technologists in his lab from expressing their concerns about how the failures of a single instrument used in HIV and HCV testing was putting patients at risk. (Maryland General Hospital–2004.)

Rather, the lab industr y finds itself confronting an unexpected reality: the profession’s largest testing organization has failed on a scale never before seen in laboratory medicine. There seems to be no crisis plan at any major professional lab organization which can guide its leadership in making an appropriate public response.

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