Enhancing pre-analytical phase efficiency in a tertiary Parasitology-Mycology Laboratory: A methodological approach

Area of Science:

• Medical Laboratory Science
• Clinical Diagnostics
• Quality Management Systems

Background:

• The pre-analytical phase is critical in medical laboratory workflows, directly influencing analytical and post-analytical phases.
• Errors in the pre-analytical stage can have significant repercussions on overall laboratory accuracy and patient care.

Purpose of the Study:

• To comprehensively analyze the causes of pre-analytical non-conformities.
• To evaluate implemented corrective procedures within a clinical laboratory setting.
• To identify areas for improvement in compliance with ISO 15189:2022 standards.

Main Methods:

• A 30-month evaluation of ISO 15189:2022 compliance using a self-assessment grid.
• Categorization of non-conformities by root cause.
• Pareto analysis to pinpoint significant pre-analytical issues.
• Failure Modes and Effects Analysis (FMEA) to assess associated risks.

Main Results:

• Frequent non-conformities included sample transportation delays, reagent shortages, and identification-prescription errors.
• FMEA identified these issues as high-risk.
• Proposed corrective actions included enhanced transport protocols, automated reagent alerts, improved staff training, and better interdepartmental communication.

Conclusions:

• A holistic approach to managing pre-analytical non-conformities is essential.
• Fostering a culture of quality and shared responsibility improves laboratory efficiency and patient outcomes.
• Continuous monitoring via quality indicators supports ongoing practice improvement.