Qualidade, biossegurança e segurança do paciente no diagnóstico laboratorial: revisão narrativa e proposta de matriz operacional para a prática biomédica em sistemas de saúde de alta demanda

Abstract

Introduction: Laboratory diagnosis is an essential component of contemporary healthcare systems, influencing clinical decision-making, disease screening, therapeutic monitoring, epidemiological surveillance, and patient safety. In high-demand healthcare settings, failures in the pre-analytical, analytical, and post-analytical phases may lead to diagnostic delays, inaccurate results, repeated testing, waste of resources, and direct risks to patient care.

Objective: To analyze, through a narrative review, the importance of quality, biosafety, traceability, and process standardization in laboratory diagnosis, with a focus on biomedical practice and patient safety in high-demand healthcare systems.

Methodology: Narrative review based on scientific literature, technical documents, and guidelines related to laboratory medicine, patient safety, quality control, biosafety, risk management, traceability, the pre-analytical phase, the analytical phase, and the post-analytical phase.

Discussion: The literature indicates that most laboratory errors occur in the pre-analytical phase, especially in patient identification, sample collection, transportation, sample preparation, storage, and communication between healthcare teams and laboratories. Qualified biomedical practice, combined with operational protocols, quality indicators, continuous training, internal and external quality control, biosafety, and effective communication, contributes to risk reduction and strengthens diagnostic reliability.

Conclusion: Laboratory quality should be understood as a strategic component of patient safety. The integration of technical competence, biosafety, traceability, process management, documentary standardization, and continuing education is essential for biomedical practice in high-demand laboratory environments.