Improved compliance with good clinical laboratory practices as a result of an intervention

Abstract

Introduction: Good clinical laboratory practices are essential to ensure reliable, high-quality results in pediatric diagnostic analyses. In Cuba, their implementation is mandatory according to national regulations (D3-2021), but there are challenges in their adoption.

Objective: To evaluate compliance of good practices in the Clinical Laboratory of the Eduardo Agramonte Piña Pediatric Hospital in Camagüey.

Methods: An intervention study was conducted from January 2022 to March 2024 to evaluate compliance with good practices in the hospital's Clinical Laboratory. The study population consisted of the organization (documentation, staff, equipment, and other resources). The data was collected and processed using a standardized computerized tool that includes 10 sections with 227 requirements. Four sections were selected, some of which could be managed at the laboratory level (documentation management, resource management, analytical process management, and complaints and claims management). After the assessment, nonconformities were identified, an action plan was implemented, and compliance was reassessed. The results were compared.

Results: In the initial assessment, compliance with good clinical laboratory practices was 41% (non-compliant), with deficiencies in the documentation of all sections. After applying corrective actions, it reached 66% (partial compliance).

Conclusions: As a result of the intervention study, compliance with good laboratory practices improved, especially in traceability and error reduction, impacting the quality of pediatric services.