CEO SUMMARY: Every day in every laboratory, there is the potential for some aspect of the testing process to go wrong and not be immediately detected. In such circumstances, the lab can then unknowingly report inaccurate test results to physicians and patients. That is why lab managers should have a contingency plan in place that effectively addresses the clinical consequences of such an event, along with the ethical, regulatory, and legal issues that are likely to come into play.
IN SELECTED CITIES AND TOWNS ACROSS THE UNITED STATES, local laboratories are reporting that quite a few physicians and patients in their communities have gotten letters from Quest Diagnostics Incorporated. These letters advise the recipient that Quest Diagnostics may have reported “questionable Vitamin D results” and offer to retest the patient at no charge.
The scope and scale of Quest Diagnostics’ campaign to notify physicians of a problem with previously reported Vitamin D tests and to offer affected patients a new Vitamin D test remains unknown. However, in various cities, competing laboratories report that a significant number of physicians have received these letters.
These labs also report that certain doctors have been advised that as many as one hundred or more of their patients should be advised of the “questionable results,” and come in for a free retest of their Vitamin D levels. These anecdotal reports suggest that, at a minimum, this Vitamin D retest campaign involves numerous physicians and several thousands of patients.
If there is good news in this story, it is the fact that, only on rare occasions, is it possible for an inaccurate Vitamin D result to play a direct role in increasing a patient’s morbidity or mortality.
Physicians Must Trust Labs
On the other hand, a laboratory is only as good as the trust extended to it by physicians, patients, and payers. For that reason, Quest’s campaign to alert physicians about the possibility of inaccurate Vitamin D results, and how it works to restore their trust and confidence, provides a unique case study opportunity for the entire clinical lab industry.
After all, every laboratory, at some time or another, has determined during QA/QC reviews, that certain runs of tests probably produced inaccurate or unreliable results. In these situations, it is common to contact the physicians and patients and arrange to perform that same test again on a new specimen to ensure clinical accuracy. These test “recalls” typically happen within hours or days of the original test report.
But it is an uncommon event for any laboratory to contact referring physicians and acknowledge that, for a period lasting a number of months—or more than a year—results for a specific type of test were likely to be inaccurate, and thus retesting all patients affected during that period time is recommended and should be done. It is this dimension of the Quest recall/retest campaign that may make it a real world example that is studied by lab managers and pathologists for years into the future.
After all, the monster under the bed of every laboratory scientist is this ever-present concern: “Did anything go wrong today in my lab that caused inaccurate results to be reported and went undetected? Did my lab unknowingly report inaccurate results today that could negatively affect patient care?”
U.S. Labs Among World’s Best
It is a testimony to the quality and consis- tent performance of the thousands of clinical laboratories in the United States that only rarely is there public news about a breakdown in laboratory test quality and test result accuracy that is detrimental to patient care. Compared to the healthcare systems of many developed nations, the quality of laboratory services in the United States ranks with the best in the world.
That is why the current Vitamin D recall/retest campaign initiated by Quest Diagnostics Incorporated has the potential to provide valuable lessons to pathol- ogists and lab managers. Quality management methods, including Lean and Six Sigma, give lab managers proven tools to reduce the statistically-predictable rate of errors generated by work processes and lab testing procedures. But there is little practical experience available to guide laboratory managers about what they should do in circumstances where inaccurate test results are produced and unknowingly reported to physicians.
Few Past Examples of Lab Tests Gone “Bad”
WHAT IS THE LARGEST NUMBER OF PATIENTS involved in other laboratory retesting programs known to have occurred? In the public record since 1990, THE DARK REPORT is aware of only a few public campaigns to alert several thousand patients about problems with their laboratory testing and offer to retest at no charge.
One was the Maryland General Hospital lab testing scandal in Baltimore in 2004, when about 4,500 patients were identified as possibly having been given inaccurate infectious disease test results, including HIV and HCV, over a two-year period. Lab managers and staff were aware of the flawed testing process, but it took a med tech whistleblower to alert health regulators, who finally stepped in, closed the laboratory, and initiated a program to locate the patients and have them retested. (See TDRs, April 5, April 26, May 17, 2004.)
Another earlier episode happened in April, 1999, when it was discovered that a phlebotomist employed by SmithKline Beecham Clinical Laboratories (SBCL) and working in a patient service center in Palo Alto, California, had been reusing butterfly needles for a period of several months.
In this case, SBCL executives offered free infectious disease screening tests to any patient who had blood drawn at any service center during a time period when this phlebotomist was working at that particular patient service center, going back to 1994. At the time, it was estimated that about 15,000 patients were eligible for this testing, and a much lower number actually showed up to have themselves tested. (See TDRs, April 26 and June 7, 1999.)
THE DARK REPORT is unaware of any similar cases to the two described above where more than 15,000 patients were involved in some type of lab retest or recall effort.