Responding to Patient Safety Threats in the Lab
A public-private solution is needed to address and solve the serious risks to patient safety inherent in today’s pathology laboratory.
Few would argue that patient safety in a healthcare venue should be of paramount concern. Recognizing that, the federal government is spending $1 billion to address patient safety risks such as medication errors, slips and falls and inaccuracies in charting. Still, there’s one little-known setting where patient safety can be compromised on a daily basis—a place where risk should be unacceptable, given the potential for catastrophic results: the pathology lab.
In North America’s 3,000 anatomic pathology labs, the hematoxylin and eosin (H&E) stain is the most widely used stain to support diagnosis, and the predominant technology for preparing human tissue for a pathologist’s review and diagnosis is universally referred to as “dip and dunk.” This automated process dips racks of suspended slides into a series of open reagent baths, staining the tissue to make concerning cells more readily visible to the trained eye of the pathologist. But an unintended consequence of this conventional process is raising fresh concern among health professionals, laboratory scientists, leading industry associations and even members of Congress. As slides are dipped and dunked, an estimated 20 million of them, or 8 percent of tissue slides processed in the U.S. annually, are cross-contaminated with material from other slides. In these cases, tissue detaches from one slide, migrates through the bath and reattaches to another slide, making it possible for cells from one patient to be mistaken for those of another. The unfortunate outcome is that some patients may be mistakenly told they have cancer, or erroneously informed that they are cancer-free due to loss of tissue. Such process-driven mistakes variously lead to delayed treatment, mistreatment, increased healthcare costs, litigation and unnecessary patient distress.
“We would never trust a traffic light that was known to function properly only 92 percent of the time,” says Eric Walk, chief medical officer for Ventana Medical Systems, Inc., a member of the Roche Group. “That error rate is simply unacceptable.”
Walk is part of a team of clinicians and researchers that has examined this issue ever since some of this troubling data started to surface. In fact, their exploration has yielded a host of technological advancements that are pushing dip and dunk toward obsolescence. Among these applications is the SYMPHONY staining system, manufactured by Ventana Medical Systems. This fully automated, one-touch H&E slide processing system eliminates the assembly line of reagent baths and the risk of tissue migration by staining the slides individually with fresh reagents, inside a closed cabinet. Finished slides are automatically coverslipped, making them ready for immediate presentation to the pathologist.
John Carpenter, an anatomic pathologist at Cytolab Pathology Services in Lynnwood, Wash., cites the cost of contamination as an additional concern. In cases when a pathologist is able to confirm that there is a tissue contaminant, “the additional analytical time and need for additional tissue sections decreases the productivity of the entire lab,” says Carpenter. “For cases in which microscopy alone cannot distinguish contamination from patient tissue,” he continued, “use of molecular identity testing, or even re-biopsy, may be needed. Molecular testing is time-consuming and of substantial cost, while re-biopsy exposes the patient to additional procedure-related risks and is not always possible.”
In addition to the educational outreach being conducted by new technology providers, growing numbers of laboratory professionals are speaking out in an effort to raise awareness of this lab patient safety issue. The potential for misdiagnosis because of cross-contamination is one of those issues that medical laboratorians say keeps them up at night, which is spurring some professional groups to action.
“Making sure we have the right result for the right patient is the cornerstone component of our work in the lab,” says Elissa Passiment, executive vice president of the American Society for Clinical Laboratory Science, one of the nation’s leading membership groups representing laboratory scientists. “If there are problems in this diagnostics process, or if it is compromised in any way, we have to make darn sure that everyone knows about it.”
Passiment suggests that today’s histology labs are facing many of the same issues chemistry labs faced 25 years ago, when chemists and laboratory scientists began to speak out about the rising threat of specimen contamination in chemistry analyzers.
“When quality control was at risk, people on the front lines started to complain, and complain loudly,” which she said ultimately resulted in a slate of needed changes lead by a series of technological advancements. Passiment is pleased to report that the contamination problems that rocked chemistry labs in the mid-1980s are virtually non-existent today. “Remember what they say about the squeaky wheel,” she says.
It appears that a page from that chemistry labs’ playbook of a quarter-century ago has been instructive for addressing challenges in histology today, with an increasing number of medical laboratorians being provided with an opportunity to take action. A website—www.saferpath.org—has even been created to serve as an educational resource for hospital and laboratory personnel on pathology lab safety concerns and possible solutions.
With the federal government’s billion-dollar investment in patient safety, it is not surprising that Congress has shown an interest in this aspect of lab operations. One member of Congress publicly addressed the issue in a statement last year, in the course of showcasing the important work of the nation’s medical laboratory professionals.
Speaking on behalf of Representative Gabrielle Giffords of Arizona, Rep. Bruce Braley of Iowa informed his House colleagues that “laboratory professionals require state-of-the-art technological support” given the critical nature of their work. “Actively working to eliminate patient identification errors and cross-contamination, the nation’s top lab professionals have replaced outdated slide preparation processes with smart solutions that offer confidence in their ability to deliver the right patient results,” Braley said.
Some government officials have been aware of such lab patient safety issues for years. As far back as 2007, the New York Department of Health was warning laboratories in the state of the existence of problems and requiring immediate remedial action. “As a precautionary measure in light of recent serious errors, laboratories must conduct a full risk assessment for potential errors in the handling of primary specimens,” the Health Department wrote in an urgent memorandum, “and ensure the verification of specimen identity,” further noting that labs must be prepared to provide evidence of how they had complied with these guidelines.
As pathologists, histotechnologists, lab managers and patient safety officers consider the necessary strategies to address the serious risks to patient safety inherent in today’s conventional H&E lab, it is clear that a public-private solution is at hand. With technological innovations coming from lab equipment providers, policy reforms being debated in the public sector and demand for greater accuracy coming from C-suiters and healthcare consumers alike, the healthcare industry is moving steadily closer to the day when every anatomic pathology lab can be absolutely confident of the right result, for the right patient, at the right time.