Digital approaches using metadata and cardiovascular risk: standardization and harmonization of results to ensure accurate laboratory exams

Background: Although analytical procedures in laboratory medicine are largely standardized, information related to the pre- and post-analytical phases remains insufficiently coded and underutilized, despite its potential clinical value. This project aims to standardize data associated with the Total Testing Process (TTP) in order to improve harmonization and comparability of laboratory results, particularly in cardiovascular (CV) risk assessment and management. To address this need, a standardized coding system for pre- and post-analytical quality indicators was developed to enhance result reliability and interoperability across laboratories.

Materials and Methods: An extensive and systematic literature review was conducted to identify laboratory tests relevant to CV risk evaluation, including glucose, aldosterone, renin, lipid profile, and glycated hemoglobin. Based on the available evidence, the most clinically significant pre- and post-analytical variables affecting these tests were identified, categorized, and structured for standardization and harmonization.

Results: Relevant conditions and variables influencing the selected laboratory parameters throughout the TTP were systematically collected and encoded into a standardized alphanumeric coding system designed for easy integration into laboratory information systems and AI-based applications. The coding structure consists of sequential letters and numbers representing specific procedural details, enabling precise traceability of each phase of the testing process. For instance, samples transported for 20 minutes at 20°C and 4°C are coded as T20C20 and T20C04, respectively.

Discussion: The implementation of a standardized coding system for variables affecting the pre- and post-analytical phases is essential to ensure accuracy, reliability, and comparability of laboratory results in CV risk management. The proposed code incorporates key variables such as collection tube type, patient conditions, interfering therapies, transport conditions, and centrifugation procedures. When integrated with the LOINC system, this approach may support comprehensive monitoring of samples throughout the TTP, promoting harmonization of clinically relevant laboratory processes across institutions and improving longitudinal and inter-laboratory comparability of test results.