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

Abstract

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 < .001). Conclusions This study demonstrated significant improvement in the standardization of clinical laboratory results in a relatively short time. The laboratory community should create and promulgate a standardized result format.