CLSI Publishes Guideline for Verification of Comparability of Patient Results Within One Health Care System.

WAYNE, Pa. -- Clinical and Laboratory Standards Institute has recently published a new document, Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (C54-A), which provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system. Patients may get laboratory testing at multiple locations within a health care system. Comparable results within this health care system, using the different measurement systems, and/or multiple instruments within one location (eg, backup instruments, point-of-care [POC] instruments) are necessary to provide optimal patient care. The document reviews the salient issues surrounding verification of comparability of patient results among measurement procedures, and provides a practical, statistically valid approach that laboratories of varying size and resources can use to satisfy this quality requirement.

Christopher M. Lehman, MD, University of Utah Health Sciences Center and Chairholder of the subcommittee that developed the document says, "Laboratories struggle with finding a balance between statistical validity and resource utilization when designing comparability experiments. C54-A provides an intuitive, streamlined, statistically valid approach for evaluating instrument or assay comparability that minimizes the number of patient samples required for comparison testing."

The document provides a simple approach for the assessment of patient laboratory result comparability across a maximum of 10 instruments. It assumes that a more comprehensive validation of quantitative measurement system comparability was undertaken when the measurement systems were initially introduced into the laboratory. The approach described can also be used to verify comparability of patients' results in situations following reagent or calibrator lot changes, instrument component changes or maintenance procedures, alerts from quality control (QC) or external quality assessment (EQA) (proficiency testing [PT]) events, or other special cause event.

This document defines a health care system as a system of physician offices, clinics, hospitals, and reference laboratories, under one administrative entity, where a patient may present for laboratory testing, and whose results may be reviewed by any health care provider within the system for the purpose of providing medical care.

For additional information on CLSI or for further information regarding this release, visit the CLSI website at www.clsi.org or call +610.688.0100.

CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.