State-of-the-art Approach to Goal Setting.

Four external quality assurance programs combined their data to calculate the minimum acceptable quality specifications for laboratory testing. Other sources of quality specifications may be too stringent for the current market, or too lenient given the clinical demands on the test result, but these state-of-the-art goals may be practical and useful. Two main approaches were used: (1) defining the 95% percentile and comparing with other quality specifications, and (2) using an iterative approach to increase the quality specification until 90% of laboratories could achieve 75% of their results within the specification. 72 out of 82 analytes followed procedure 2.

Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers.

BACKGROUND: Four Spanish scientific societies organizing external quality assessment programs (EQAP) formed a working group to promote the use of common minimum quality specifications for clinical tests. Laboratories that do not meet the minimum specifications are encouraged to make immediate review of the analytical procedure affected and to implement corrective actions if necessary. METHODS: The philosophy was to use the 95th percentile of results sent to EQAP (expressed in terms of percentage deviation from the target value) obtained for all results (except the outliers) during a cycle of 1 year. The target value for a number of analytes of the basic biochemistry program was established as the overall mean. However, because of the substantial discrepancies between routine methods for basic hematology, hormones, proteins, therapeutic drugs and tumor markers, the target in these cases was the peer group mean. RESULTS: The resulting specifications were quite similar to those established in the US (CLIA), and Germany (Richtlinie). CONCLUSIONS: The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities.