Improvement Plan for the Pre-Analytical Process of the SEMEDICLAB Laboratory Period 2022

Objective: SEMEDIC is a clinical laboratory that performs tests in the areas of hematology, biochemistry, urinalysis, immunology, coprology, and immunochemistry. This work aims to implement a continuous improvement plan for the pre-analytical process of the SEMEDICLAB laboratory in 2022. Theoretical Framework: The research focuses on pre-analytical errors in clinical laboratories and their impact on the quality of results. It is based on the premise that, despite technological advances and automation, the pre-analytical phase remains a weak link in the clinical analysis process. Method: The present study adopts an observational and descriptive methodology, as it allows for the visualization of the environment in which the research is carried out. It should be noted that no population or sample was considered; it was based on the identification, definition, and standardization of sub-processes of the SEMEDICLAB company process. Clause 5.4 of the ISO 15189:2012 checklist was used to identify the gap between the sub-processes currently completed. Results and Discussion: The causes of the problem in the pre-analytical phase of the workers in the SEMEDICLAB laboratory were described, which were caused by non-compliance or omission of the ISO 15189: 2012 standard, related to clauses 5.4.2. "Information for patients and users," 5.4.4.2. "Instructions for pre-analytical activities," and 5.4.6 "Sample reception," where irregularities were observed. Implications of the research: Research on pre-analytical errors has a direct impact on the quality of patient care, the efficiency of clinical laboratories, and the sustainability of health systems. By identifying the causes of these errors and developing strategies to prevent them, it contributes to improving patient safety and the reliability of laboratory results. Originality/Value: The value of this type of research is multifaceted. Firstly, it contributes to improving the quality of patient care by reducing the incidence of erroneous laboratory results, which in turn reduces the risk of misdiagnosis and inappropriate treatment. Secondly, it optimizes processes in clinical laboratories, increasing efficiency and reducing costs associated with the repetition of tests and error management. Thirdly, this research promotes the development of standards and clinical practice guidelines for the prevention and management of pre-analytical errors, which helps to ensure the quality and safety of laboratory services at the national and international level.