Errors in laboratory diagnostic tests can (and do) lead to inappropriate clinical decisions by health care providers regarding investigations, care, and therapy and produce negative consequences for patients, including unfavorable safety and/or efficacy outcomes. Errors in diagnostic testing occur in the following:

At BioCision, we understand that the majority of laboratory diagnostic errors occur during the pre-analytical phase, the importance of standardization and have published on this matter. We have made it our mission to raise awareness and to develop products that address the need for consistency in specimen collection, handling, and storage. All of our products (CoolRack®, CoolSink™, ThermalTray™, CoolBox™, CoolCell®, CoolSystem™) are designed to decrease specimen variability and thus to improve the validity of diagnostic test results.

So what are “pre-analytical errors” ? This subset of errors can include:

  • Mishandling procedures during the collection
  • Sample handling
  • Transportation
  • Sample preparation
  • Storage of specimens

Unfortunately, only 80% of pre-analytical errors are detected and corrected by laboratory professionals or health care providers before inappropriate action is taken based on the inaccurate or unreliable test results.  Approximately 6% of pre-analytical errors result in inappropriate care or inappropriate therapy.  In addition to the potentially unfavorable effects on patient outcomes, pre-analytical errors come with an enormous cost and potential legal consequences. For example, the estimated cost of preanalytical errors at an average German hospital is $460,000/year (Frost & Sullivan 2011 on behalf of BD). Thus, preventing or intercepting pre-analytical phase errors has become an important issue in laboratory diagnostic testing. Fortunately, SPIDA is developing guidelines, quality assurance metrics, and tools to improve in vitro diagnostic testing. SPIDIA as detailed in a previous post, is the large-scale integrated project that has brought together a consortium of 16 leading academic institutions, international organizations, and life sciences companies.

Recently significant updates on the total quality management of the pre-analytical phase of diagnostic testing have been published [1]. This article discusses errors and variability in laboratory diagnostics, governance of variability, models for analysis of workflows, quality indicators, automation, and laboratory accreditation. Since most pre-analytical errors result from system flaws and insufficient auditing processes, rather than human error, it is likely that standardization and monitoring of pre-analytical variables could prevent or allow interception of many diagnostic test errors. Standardization and monitoring of preanalytical variables is also expected to increase diagnostic reliability and efficiency, and reduce operational costs.

Ref 1: Lippi et al., 2012 Clin Chem Lab Med 2011;49:1113-26