REVIEW OF LABORATORY MANAGEMENT AND QUALITY IMPROVEMENT: CURRENT SCOPE, EMERGING TRENDS, AND FUTURE DIRECTIONS

Abstract

Clinical laboratories generate a substantial proportion of the data used in medical decision making. In the past, "quality" in the laboratory mostly meant instrument quality control but over the past decades the understanding has changed, and quality is now understood to span the total testing process, from pre-analytical phase to post-analytical phase. This review aims to describe where laboratory management and quality improvement stand today and what new trends are appearing and how they can be implemented in lowand middle-income countries (LMICs). This is a narrative review, and literature was gathered from peerreviewed journals, systematic reviews, and guidance documents from bodies such as ISO, CAP, CLIA, WHO and IFCC. Modern laboratory quality management combines accreditation (ISO 15189, CAP, CLIA), quality indicators, internal quality control (IQC) and external quality assessment (EQA), risk management, and improvement tools like Lean and Six Sigma. Digital tools, including laboratory information systems, and artificial intelligence, are becoming more common but are not yet accessible to every part of the world, and the evidence for some of the newer technologies is still limited. Resource-limited settings face additional challenges, but programs like SLIPTA and SLMTA show that stepwise progress is possible even without full accreditation. Additionally, cybersecurity is becoming a bigger concern as laboratories become more digital. Laboratory quality management needs to emphasize especially in connecting quality measures to real patient outcomes, and in making sure new technologies are properly tested before wide use.