Clinical and Laboratory Standards Institute (CLSI) recently published Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2). This document provides guidance for risk management activities that include risk analysis (failure modes and effects analysis [FMEA]), fault trees, and risk monitoring (failure reporting, analysis, and corrective action systems [FRACAS]). These techniques will aid in identifying, understanding, and managing sources of failure based on best practices, using risk analysis methods.

Jan S. Krouwer, PhD, Krouwer Consulting, and chairholder of the committee that developed the document, says, “This updated version of EP18 is much more complete and includes FRACAS, which is a technique used to prevent the recurrence of observed errors. In addition, the original version of EP18 was intended for unit-use devices. The current version is for any diagnostic assay.”

FMEA and FRACAS are the recommended quality tools to be used by manufacturers and clinical laboratory users to identify potential causes of risks, which is the objective of a quality management system.

Dr. Krouwer says, “Harm traced to laboratory tests is often caused by rare events that are not dealt with by most evaluations. EP18 provides a risk management approach to preventing harmful events using a step-by-step explanation of techniques for manufacturers and the clinical laboratory as adapted from other industries.”

This document is intended primarily for in vitro diagnostic manufacturers. However, it is also intended as an important reference for clinical laboratory directors and supervisors who wish to learn about risk management techniques and processes.

James H. Nichols, PhD, DABCC, FACB, Baystate Medical Center, and a volunteer who worked on the subcommittee developing the document, explains that the most beneficial part of this document for laboratories are the tables in the appendix. “The appendix shows examples of potential preanalytical, analytical, and postanalytical sources of error. Laboratories can apply this information to any device to determine the most significant risks, and focus efforts on developing a quality assurance program on eliminating those errors.”

Source: CLSI