Evaluation of the performance of the hematology laboratory during the entire testing procedure utilizing sigma metrics and quality indicators in Saudi Arabia 2024

Abstract

Background: In clinical laboratory, the performance of the hematology analyzer should be checked routinely to ensure the desired quality. Clinical laboratories are dynamic and complex organizations that have a critical role in patient diagnosis, treatment, and management. It is crucial to ensure laboratory quality by reducing the extent of errors. Therefore, this study aimed: To evaluate hematology laboratory performance in the entire testing procedure utilizing sigma metrics and quality indicators in Saudi Arabia. Methods: A cross‐sectional study was conducted from January to March 2024. The study included a total of 645 samples. Data on included variables were collected using a checklist. Descriptive statistics were used to present the overall distribution of errors. Binary logistic regression models were applied. Additionally, we evaluate laboratory performance by employing a Sigma scale and calculating the percentage of mistakes. Results: The overall error rate was (26%): (19.7%) pre‐analytical, (0.5%) analytical, and (5.8%) post‐analytical. Of the overall errors, (75.8%), (1.9%), and (22.3%) were pre‐analytical, analytical, and post‐analytical errors, respectively. The overall sigma value of the laboratory was 2.2. The sigma values of the pre‐analytical, analytical, and post‐analytical phases were 2.4, 4.1, and 3.1, respectively. The sample from the inpatient department and collected without adherence to the standard operating procedures (SOPs) had a significantly higher (p < 0.05) rejection rate as compared to the outpatient department and collected with adherence to SOPs, respectively. Furthermore, a correlation was seen between manual recording, inpatient departments, and morning work shifts and longer turnaround times. Conclusion: Based on the current study, the laboratory's performance was very poor (less than three sigma). Thus, the hospital administration should switch from a manual system of ordering tests and releasing results to a computerized system and provide need-based training to all personnel engaged in the collecting and processing of hematological laboratory samples.