Estimating the cost of quality of errors in the analytical phase.

BACKGROUND Cost of quality (COQ) can be defined as the difference between the current cost of providing laboratory services and the cost that would be incurred if there were no errors in the measurement process. Errors due to analytical imprecision and bias are not traditionally included in COQ. The objective of this study was to develop methods to estimate the COQ due to errors in the analytical phase. METHODS We consider 2 types of error events: errors in patient results and run failures due to violation of a quality control (QC) rule. We provide a general and a simplified model for estimating the cost of analytical errors in patient results and a separate model for estimating costs due to QC failures. RESULTS An example calculation is provided. The COQ for 12 mass spectrometry assays using the simplified cost model for estimating analytical errors and the cost model for run failures is presented. CONCLUSIONS The models provide a way to estimate COQ associated with analytical error, which have not been previously incorporated into clinical laboratory standards or published literature. Estimating COQ and using those data to prioritize improvement efforts can be challenging for laboratories but are important for value-driven patient care.