Imagine being told that you have invasive cancer, undergoing radical surgery and radiation treatment, and then finding out that your lab results had been switched and you never had cancer. It happened to a woman from Ohio, and allegations of such mistakes are increasing nationwide. Many believe that technological advances, such as smart cards, bar-code identification labels that are placed directly on specimen slides, and computerized physician order entry systems, will do much to reduce some errors. However, the problems run deep.

Last month, a Los Angeles Times article reported on the alarming increase in laboratory errors, as well as allegations that lab-inspection systems are fundamentally flawed.¹ The article quoted quality expert James Westgard from the University of Wisconsin, who says the nation’s lab-inspection system is set up to ensure compliance with regulations, but not to encourage high-quality work. As a result, hospital administrators facing financial pressures strive to meet the minimum standards. “Doing the minimum to get by does not lead to quality,” Westgard says. Moreover, new regulations, such as unannounced laboratory inspections, will not solve the problem, according to Westgard. In fact, he suggests that such inspections could cause more problems because of more pressures on already overworked—and short-handed—lab professionals.

According to the Times article, an increasing number of labs are receiving failing grades from accreditation agencies. Many labs, including some in top medical centers, are faced with losing their accreditation. Part of the problem is the increased workloads in the lab. A hospital administrator quoted in the article admitted that because of inadequate staffing, quality improvement had taken a back seat to the completion of lab tests. However, a completed lab test is worthless—and potentially dangerous—if it is inaccurate.

Until recently, there has not been a successful effort to systematically address lab-quality concerns. However, the Institute for Quality in Laboratory Medicine (IQLM) aims to do just that. Westgard, who received IQLM’s Improved Quality Processes Award last year, recently spoke at the G-2 Lab Institute’s Lab Quality Symposium in Washington, DC. In his presentation, he said that quality-control procedures can prevent conditions that may cause erroneous and misleading results. “If we want to be sure laboratory tests won’t mislead the physician, we must be able to detect conditions of unstable performance. That requires that we perform the right QC to be able to detect medically important errors,” he said.

It is critical that we take a look at the lab-accreditation process, provide whistle-blower protection to those who report lab errors, improve communication with physicians, frequently check the accuracy of testing equipment, and examine and improve all lab processes. This includes designing systems that reduce the potential for human error.

CLP will continue to cover this topic throughout the year. Watch for Gary Tufel’s overview of safety issues in our February issue.

Carol Andrews
candrews@ascendmedia.com

Reference
1. Roche W. Lab mistakes threaten credibility, spur lawsuits. Los Angeles Times. December 2, 2005:A1.