Optimizing Quality Assurance in Medical Laboratories: Evaluating the Impact of Standardized Protocols on Diagnostic Accuracy and Patient Care Outcomes

Abstract

Heterogeneity in the diagnostic accuracy and the process of patient care enhancement resulting from lack of standard quality assurance (QA) raises a challenge in Saudi Arabian medical laboratories thus affecting the healthcare service delivery and the vision of Saudi vision 2030. The purpose of this research was to measure the effectiveness/s of the practice of the standardized QA protocols in regard to the diagnostic accuracy, operational efficiency, and patient care. A cross-sectional desional study was done among public and private medical laboratories which were willing to participate in the study. Information was obtained through site visits, assessment of various laboratory records and interviews with the laboratory personnel and computer aided analysis of the Laboratory Information Management System (LIMS). Diagnostic accuracy, sensitivity, specificity, error rates, time to result, and patient care data were collected pre- and post implementation of the standardization. Comparison of pre- and post-intervention means was assessed using paired t-tests, Individual differences were identified using ANOVA, Logistic regression analysis was used to identify the strongest predictors. The consistency of protocols increased diagnostic yields from 88.3% ± 4.5 to 94.7% ± 2.8(t = -10.61, p < 0.001), sensitivity from 85.2% ± 5.3 to 92.8% ± 3.1 (t = -10.02, p < 0.001), and specificity from 91.4% ± Diagnostic error incidence reduced to about half from the initial 4.2% ± 1.7 to the final 2.1% ± 1.1 (κ=0.00; p<0.001). Implementing this self-track design successfully shortened the median turnaround time by 33.3% (P < 0.001), and the number of treatments received by the dogs decreased by 47.8% (P < 0.001). The logistic regression analysis of the factors associated with treatment delays revealed that diagnostic errors (odds ratio = 2.31, p < 0.001) and longer turnaround time (odds ratio = 1.78, p = 0.002) were significant predictors of delay The odds ratio for protocol compliance was 0.45, p < 0.001. Therefore, the implementation of scientific and universally recognizable QA standards greatly improved the results achieved by the laboratory, and, thus, contributed to the further development of healthcare services.