[Quality controls in medical mycology]

Area of Science:

• Medical Mycology
• Laboratory Quality Management

Context:

• ISO 15189 lacks specific guidance on quality control (QC) frequency and requirements.
• The French Accreditation Committee (COFRAC) provides essential guides for laboratory practices.
• Medical mycology labs require structured internal QC programs for reagents, media, and staff competency.

Purpose:

• To outline the essential components of a Quality Management System (QMS) in medical mycology.
• To emphasize the need for adherence to COFRAC technical guides, specifically LAB GTA 06.
• To detail the requirements for internal and external quality controls in fungal serology and general mycology.

Summary:

• A QMS in medical mycology necessitates systematic monitoring using internal and external quality controls.
• Key elements include reagent testing, use of reference strains, preparation of homemade reagents, and staff competency assessment.
• Quantitative analysis utilizes Levey-Jennings charts, with external QC references and defined corrective actions for out-of-range results.

Impact:

• Ensures accuracy and reliability of diagnostic tests in medical mycology.
• Provides a framework for laboratories to meet accreditation standards and regulatory requirements.
• Improves patient care through dependable mycology test results and effective laboratory management.