In 1999, a groundbreaking report was published by the Institute of Medicine of the National Academies. To Err is Human: Building a Safer Health System brought to public attention the impact that medical errors have on individuals and on our healthcare system, and in many ways it initiated a debate that is still going strong about how to reduce medical errors. The report estimated that up to 98,000 American deaths each year are due to preventable medical errors, and concluded that the majority of errors resulted from systemic problems rather than from poor performance by individuals. It suggested that the issues that need to be addressed are with systems and technologies, more than with the erring humans themselves.
That report started an earnest conversation on broad and specific issues of patient safety and how to improve it. Since the report’s publication, myriad aspects of patient safety have been addressed, and many solutions have been identified and implemented. But in the cancer space, the issue of patient safety has not been fully explored. The safety risks and opportunities for error in cancer diagnostics and treatment are legion and include dangerous drug interactions, delayed diagnosis, patient misidentification, cross-contamination of tissue in the lab, and more.
To address some of these issues, Representative Ron Barber (D-AZ) co-hosted a Congressional Briefing on Capitol Hill last November entitled “A Dialogue on Patient Safety and Cancer” to focus legislators’ attention on this often overlooked topic. The briefing, sponsored by Ventana Medical Systems, Inc., and moderated by Mara Aspinall, Ventana President, included a panel of experts who explored patient safety issues in the cancer community, including challenges and solutions, from the pathology lab to outpatient care. As the chief medical officer at Ventana, I was invited to report on the state of patient safety in today’s clinical anatomic pathology laboratories and to address potential solutions to reduce the risk of the most common errors.
My remarks highlighted the two main patient safety risks in the modern pathology laboratory by presenting two patient cases in which lab errors led to tragic consequences. The first case involved a specimen identification error. A lab specimen was mistaken for that of another patient, leading to misdiagnosis and inappropriate treatment. The second case involved tissue cross-contamination, sometimes referred to as floater contamination. In labs where hematoxylin and eosin (H&E) staining is done through mechanical “dipping and dunking” in shared linear reagent baths, tissue sometimes detaches from slides and re-attaches to that of other patients, again potentially leading to misdiagnosis and inappropriate treatment. Both of these patient safety risks are serious quality assurance issues for today’s anatomic pathology lab.
Other aspects of patient safety and cancer were also addressed in the briefing. Patricia McGaffigan, Interim President of the National Patient Safety Foundation (NPSF), spoke about NPSF’s leadership in addressing critical safety issues, providing a moving account of the unfortunate consequences of delayed diagnosis in a teenager—her own daughter. Maurie Markman, MD, Senior Vice President of Clinical Affairs and National Director of Medical Oncology at Cancer Treatment Centers of America (CTCA), discussed some of the threats to patient safety in a cancer treatment setting and described what his organization has done to address them.
Congress has a record of addressing patient safety issues over the years. In March 2011, Representative Steve Israel (D-NY) introduced a resolution in the House of Representatives supporting the goals of National Patient Safety Awareness Week, an annual observation sponsored by the NPSF. In April 2011, Representative Bruce Braley (D-IA) made a statement on the floor of the House on behalf of then-Representative Gabrielle Giffords. Braley addressed the issue of safely preparing microscope slides for cancer biopsies, noting the need to actively work to eliminate patient identification errors and cross-contamination.
All stakeholders in the medical laboratory community should work together to sustain this momentum, as much remains at stake. With the technology that’s available today, we can ship and track packages across the world with great accuracy. We should be able to do the same thing for specimens within a single pathology laboratory. The technology is there, and the know-how is there; it’s just a matter of changing the standards to say that enough is enough and that we are going to solve these issues once and for all.
Of course, we will never bring error rates to zero, but we need to bring them to a much lower rate than occurs today. All members of the laboratory community can be a part of the larger conversation about how to do that, and destinations such as www.saferpath.org (a Ventana-sponsored website) exist to encourage the dialogue.
With an estimated 3% tissue cross-contamination rate occurring in the 300 million tissue slides processed annually in the United States, there is an urgent need to continue this discussion about how to mitigate these patient safety risks in the lab. Encouragingly, members of Congress are now joining the conversation. This suggests the potential for a public policy-driven solution.
Eric Walk, MD, FCAP, is the Chief Medical Officer for Ventana Medical Systems, Inc. He is board certified in Anatomic and Clinical Pathology and a Fellow of the College of American Pathologists (CAP). Dr. Walk graduated from the University of Virginia Medical School in 1995.
