Quality indicators and specifications for key processes in clinical laboratories: a preliminary experience.

BACKGROUND The aim of this study was to identify process indicators for the three phases of laboratory activity and their corresponding quality specifications in our setting (primary care centers, and second- and third-level hospitals that provide public healthcare services in Catalonia). METHODS Every 2 months, working group members met to present data obtained for quality indicators for the current processes in their laboratories. The results collected were for indicators recorded monthly from 2005 and for indicators recorded less frequently from 2004. The medians of the results obtained in all laboratories were calculated and the values obtained were established as the current specifications for the corresponding indicators. RESULTS The laboratories participating in this working group use 12 indicators for the key processes (three for preanalytical steps, four for analytical steps and five for postanalytical steps). The preanalytical indicators are erroneous request, erroneous sample, and samples not taken, with specifications of 4.1%, 5.0% and 1.7%, respectively. A new indicator for the analytical step is the percentage of external controls exceeding the specification (0.8%); specifications for the other three well-recognized indicators (imprecision, bias and total error) are not the subject of this study. For the postanalytical phase, the indicators (and specifications) include duplicate hard copies of reports sent to centers or clinical units (1.6%), failure in critical value reporting (0.5%), reports exceeding delivery time (0.7%), reports from referred tests that exceed delivery time (8.9%), and incidents related to the data processing network between centers (25 events per year). CONCLUSIONS The process indicators reflect the state-of-the-art of the laboratories comprising our working group. Current performance for the analytical phase is satisfactory because it is entirely in the hands of the laboratory, while the main problems in extra-analytical phases reside in activities performed outside the laboratory (sample collection and transport, as well as non-electronic report delivery).