State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry.

CONTEXT: Harmonization and standardization of results among different clinical laboratories is necessary for clinical practice guidelines to be established. OBJECTIVE: To evaluate the state of the art in measuring 10 routine chemistry analytes. DESIGN: A specimen prepared as off-the-clot pooled sera and 4 conventionally prepared specimens were sent to participants in the College of American Pathologists Chemistry Survey. Analyte concentrations were assigned by reference measurement procedures. PARTICIPANTS: Approximately 6000 clinical laboratories. RESULTS: For glucose, iron, potassium, and uric acid, more than 87.5% of peer groups meet the desirable bias goals based on biologic variability criteria. The remaining 6 analytes had less than 52% of peer groups that met the desirable bias criteria. CONCLUSIONS: Routine measurement procedures for some analytes had acceptable traceability to reference systems. Conventionally prepared proficiency testing specimens were not adequately commutable with a fresh frozen specimen to be used to evaluate trueness of methods compared with a reference measurement procedure.

Wisconsin State Laboratory of Hygiene's role in clinical laboratory improvement.

The clinical laboratory at the beginning of the 21st century is a highly automated, multi-faceted entity, capable of turning out complex test results on a variety of samples in a relatively short period of time. These test results are used by physicians to diagnose illness, establish treatment strategies, and monitor therapies for patients. They must be of the highest quality and reliability to insure that the course of action taken by the health care provider will lead to the best possible outcome for the patient.