Abstract
Introduction
The external quality assessment (EQA) program is designed to objectively evaluate a laboratory's performance. It plays a critical role in ensuring the reliability of laboratory tests for informed decision-making. Laboratory errors caused by poor-quality management practices can lead to patient harm and a loss of trust by clinicians, resulting in the decreased use of diagnostic testing data for clinician decisions. This study aimed to assess the EQA results from laboratories participating in the EQA program for biochemistry, hematology, and serology with the National Institute of Public Health and identify key challenges encountered in implementing the EQA program.
Methods
This study utilized existing data from the biochemistry, hematology, and serology EQA programs enrolled between 2018 and 2023, along with responses from an EQA survey conducted between April 17 and May 19, 2024. Forty-three laboratory heads and quality officers voluntarily completed a self-administered questionnaire via Google Forms. The questionnaire covered staff qualifications, the condition of analyzers, the availability of reagents, frequently unavailable serology reagents, and quality assurance performance. Descriptive statistical analysis with SPSS V 22 was used to determine the frequency, proportion, and mean (SD).
Results
The average percentage of EQA scores for biochemistry increased from 70% (R1) to 85% (R3). However, the EQA matrix in some laboratories still scored below 80%. The average EQA score of serology was stable at over 95% in each round, whereas the average EQA score of hematology remained stable at approximately 83% from R1 (2018) to R2 (2023). The hematology EQA matrix revealed that most laboratories fell below the target threshold of 80%. Additionally, 3 out of the 13 laboratories consistently ran out of hematology supplies, and 4 laboratories reported that the serology analyzers were out of service. Among the 11 responding laboratories, 9.1% always reported stock shortages. A total of 74.4% of laboratories reported assessing staff competency, 76.7% performed IQA before testing, and 83.7% took corrective actions when the EQA results were discordant.
Conclusion
This study revealed that the EQA results for biochemistry and hematology remained low, with hematology results particularly underperforming, which required them to perform corrective actions. The challenges faced during EQA implementation included equipment malfunctions, outdated instruments, reagent shortages, staff competency issues, irregular internal quality control procedures, and failure to take corrective action when the results were inconsistent. Therefore, appropriate reagent stock management and service maintenance should be considered to avoid service interruption. Enforcement mechanisms should be implemented to regulate laboratory staff competency performance, internal quality control, and corrective action.