Harmonization of laboratory testing - Current achievements and future strategies

Abstract

Harmonization in laboratory testing is more far-reaching than merely analytical harmonization. It includes all aspects of the total testing process from the "pre-pre-analytical" phase through analysis to the "post-post-analytical" phase. Harmonizing the pre-analytical phase requires use of standardized operating procedures for correct test selection, sample collection and handling, while standardized test terminology, and units and traceability to ISO standard 17511 are required to ensure equivalency of measurement results. Use of harmonized reference intervals and decision limits for analytes where platforms share allowable bias requirements will reduce inaccurate clinical interpretation and unnecessary laboratory testing. In the post-analytical phase, harmonized procedures for the management of critical laboratory test results are required to improve service quality and ensure patient safety. Monitoring of the outcomes of harmonization activities is through surveillance by external quality assessment schemes that use commutable materials and auditing of the "pre-pre-analytical" and "post-post-analytical" phases. Successful implementation of harmonization in laboratory testing requires input by all stakeholders, including the clinical laboratory community, diagnostics industry, clinicians, professional societies, IT providers, consumer advocate groups and governmental bodies.

Keywords: Critical laboratory results; Harmonization; Quality indicators; Reference intervals; Standardization.