Evaluation of the Impact of Changing Quality Control Rules and Frequency on the Risk Management Index: Results from the Clinical Routine of a Medical Laboratory

Abstract

Objective: The consideration of the principles of risk management in the analytical process is a current trend. The aim of this study was to evaluate whether the risk management index (RMI) for various laboratory parameters can be influenced by interventions that change the internal quality control (IQC) strategy.

Methods: We selected 10 laboratory parameters associated with cardiovascular disease for the study (myoglobin, N-terminal fragment of the pro B-type natriuretic polypeptide, cardiac troponin T, creatinine kinase, lactate dehydrogenase, glucose, triglycerides, total cholesterol, and low-density lipoprotein and high-density lipoprotein cholesterol). The study-specific interventions included changing the IQC rules and changing the IQC schedule. This was a one-armed intervention study in which changes in the RMI, a measure of patient harm risk, was recorded over time.

Results: Before the intervention, the mean RMI was 1.022 (95% confidence interval [CI], 0.269-1.776). After the intervention, the mean RMI was 0.934 (95% CI, 0.088-1.956). The RMI values before and after the intervention were not significantly different (P =.89).

Conclusion: The study-specific interventions did not lead to an improvement of the RMI in the clinical routines of a medical laboratory. There is a great need to further explore this subject area with interventional studies to clarify how the risk of unintended patient harm can be measurably improved.

Keywords: analytical quality; intervention study; patient harm; quality control; rejection rules; risk management.