Impact of non-conformities in the pre-analytical, analytical and post-analytical phases of the clinical laboratory

Abstract

The quality management system in clinical laboratories is fundamental to guarantee accurate, reliable and timely results. The implementation of a quality management system based on ISO standards, especially ISO 9000 and ISO 15189, is essential to minimize errors or nonconformities in the phases of the laboratory process: pre-analytical, analytical and post-analytical. The objective of this work was to determine the impact of nonconformities on the quality and safety of clinical laboratory results. This literature review analyzed the impact of nonconformities in these phases, identifying that the pre-analytical phase represents the highest number of errors in the workflow of the clinical laboratory (83%), followed by the post-analytical (10%) and analytical (7%). It was found that the main nonconformities include hemolysis, coagulated samples, insufficient volumes collected and sample identification errors. In addition, mitigation strategies focused on staff training, process standardization, implementation of technologies such as laboratory information systems (LIS) and strengthening effective communication. Correct quality management can reduce up to 92% of non-conformities, thus ensuring the reliability of results, improving patient safety and optimizing the costs of the healthcare system.