Development and Implementation of a Standard Format for Clinical Laboratory Test Results

Abstract

Objectives: Surprisingly, laboratory results, the principal output of clinical laboratories, are not standardized. Thus, laboratories frequently report results with identical meaning in different formats. For example, laboratories report a positive pregnancy test as "+,""P,"or "Positive."To assess the feasibility of a widespread implementation of a result standard, we (1) developed a standard result format for common laboratory tests and (2) implemented a feedback system for clinical laboratories to view their unstandardized results. Methods: In the largest integrated health care system in America, 130 facilities had the opportunity to collaboratively develop the standard. For 15 weeks, clinical laboratories received a weekly report of their unstandardized results. At the study's conclusion, laboratories were compared with themselves and their peers by metrics that reflected their unstandardized results. Results: We rereviewed 156 million test results and observed a 51% decline in the rate of unstandardized results. The number of facilities with fewer than 23 unstandardized results per 100,000 (Six Sigma σ > 5) increased by 58% (52 to 82 facilities; β = 1.79; P