Harmonization in laboratory medicine: the complete picture

Area of Science:

• Laboratory Medicine
• Clinical Pathology
• Healthcare Standardization

Background:

• Lack of interchangeable laboratory results and consensus in clinical practice necessitates standardization and harmonization.
• Current focus on measurement procedures is insufficient; harmonization must encompass broader aspects of laboratory testing.

Purpose of the Study:

• To provide insight into laboratory harmonization, emphasizing the need for a complete picture.
• To highlight the drivers and scope of harmonization in laboratory medicine.

Main Methods:

• Review of existing literature and projects on standardization and harmonization in laboratory medicine.
• Analysis of drivers and components of a comprehensive harmonization approach.

Main Results:

• Harmonization extends beyond analytical methods to include terminology, units, report formats, reference intervals, and interpretation criteria.
• Key drivers include patient safety, laboratory consolidation, accreditation, clinical governance, and IT advancements.

Conclusions:

• A three-tier approach (local, national, international) is essential for effective harmonization.
• Comprehensive harmonization, including all aspects of laboratory testing, is critical for improving healthcare outcomes, exemplified by bone turnover marker initiatives.