Report: Real Risk of Errors in Patient Tissue Biopsy Processing
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, announced a groundbreaking study in the Journal of Histotechnology that indicates there is a real risk that errors can be made in the processing of patient biopsy tissue in anatomic pathology labs around the world. The Journal reports on the startling outcome of the Stainer Bath Cross Contamination Challenge (SBCCC), developed by Ventana Medical Systems, Inc., that involved 70 pathology labs from six countries across three continents.
The SBCCC demonstrated that human tissue can easily migrate from one biopsy slide to another slide in the traditional tissue sample preparation process used in many of today’s pathology labs, and this cross-contamination can lead to misdiagnosis. Each one of the 70 pathology labs that participated in the SBCCC reported some tissue contamination, ranging from 3 to 3,018 qualified contaminants. Further, the study found up to 36 percent of patient simulator slides contained migrated tissue. Based on millions of patient slides that are processed annually in worldwide using old dip and dunk technologies, the risks for misdiagnosis from tissue cross contamination are substantial.
“The Stainer Bath Cross Contamination Challenge raises serious concerns about patient samples in labs that continue to use traditional batch tissue processing methods,” said Mara G. Aspinall, president, Ventana Medical Systems, Inc. “At Ventana, patient safety is our number 1 priority. The VENTANA SYMPHONY system is based on automated individual slide staining where each slide is stained by itself, with no sharing of reagent through stainer baths. This helps ensure against tissue migration, cross-contamination between patients’ slides, and misdiagnosis, saving resources and potentially patient lives.”
“In the past, laboratories have unfortunately had little choice but to use ‘dip and dunk’ technology. Despite significant efforts of laboratory personnel, the risk of sample cross contamination during this process cannot be avoided,” says Adrian Ralph, VP, Lifecycle Leader, Primary Staining. “Today labs have access to an alternative technology that minimizes this risk and delivers improved patient safety.”
A focus on this issue in the current U.S. Congress is generating greater attention as healthcare professionals, federal legislators, regulators, and others examine how these threats to public health can be reduced or eliminated. A congressional briefing on November 19, 2012, in Washington D.C. highlighted the risks that patients face and how laboratory practitioners, advocacy groups such as National Patient Safety Foundation, and industry are working together to solve those problems.
“I think our systems are designed to respond to risk and error rather than proactively look for ways to anticipate error and the potential risk and harm that it can cause,” says Patricia McGaffigan, National Patient Safety Foundation. “Changing that mindset about anticipating and expecting that error is human and that it will happen, and that our goals for patient safety should be centered around identification of risk and mitigation of those risks, are vital components of transforming healthcare safety.”
Watch the Stainer Bath Cross Contamination Challenge video for details.
More information about patient safety in the lab can be found at SaferPath.org.