Enhancing the Efficiency of ISO 15189 and ISO 15190 Medical Laboratory Accreditation by e-Accreditation

ISO 15189 and ISO 15190 Medical Laboratory Accreditation by e-Accreditation

Abstract

          The Bureau of Laboratory Quality Standards (BLQS), Department of Medical Sciences, Thailand, has accredited medical laboratories in Thailand according to ISO 15189 and ISO 15190 since 2003. To date, more than 300 medical laboratories have been required to submit paper-based quality documentation for accreditation purposes, resulting in significant time consumption for both document preparation and review. To address these inefficiencies, the BLQS launched an electronic program for accreditation processes, namely e-Accreditation (e-Acc), in 2019. The system aimed to streamline the accreditation process by digitizing all document submissions and reducing administrative burdens. This study evaluated the effectiveness of e-Acc by comparing the average processing time of the manual accreditation process with that of e-Acc during fiscal years 2019−2022. It includes 183 laboratories under the manual accreditation process and 144 laboratories using e-Acc. The study found that laboratory accreditation using the manual system and the e-Acc system, as required in the part managed by the BLQS, averaged 123 and 90 days, respectively (t-Test, p < 0.001). The comparison was divided into three processes (manual/e-Acc) as follows: submission of documents (62/47 days), correction (34/24 days), and granting accreditation (27/19 days) were significantly reduced by 15, 10, and 8 days, respectively, and all statistically significant reductions (t-Test, p < 0.001). These findings demonstrated that e-Acc not only reduced accreditation time across every process but also enhanced the overall efficiency of the accreditation process. Moreover, it aligned with quality improvement initiatives for laboratory accreditation based on the Lean concept, supporting a more agile and responsive laboratory accreditation system that enables it to promptly and effectively meet the needs of service users.