Harmonization in laboratory medicine: Requests, samples, measurements and reports

Area of Science:

• Laboratory Medicine
• Clinical Chemistry
• Analytical Science

Background:

• Standardization and harmonization are crucial for equivalent measurement results in laboratory medicine.
• These terms are often used interchangeably but represent distinct concepts rooted in traceability.
• Current laboratory test results exhibit variability, impacting reliable interpretation and patient care.

Purpose of the Study:

• To clarify the distinct meanings of standardization and harmonization in laboratory medicine.
• To emphasize the importance of achieving equivalence in measurement results for patient outcomes.
• To highlight the expanding scope of harmonization beyond analytical methods to the total testing process.

Main Methods:

• Conceptual analysis of standardization and harmonization principles.
• Review of traceability to the International System of Units (SI) and reference measurement procedures (RMPs).
• Discussion of the total testing process (TTP) elements included in harmonization efforts.

Main Results:

• Standardization involves traceability to SI units via primary reference materials or RMPs.
• Harmonization ensures result equivalence when high-order standards or RMPs are absent.
• Harmonization now encompasses terminology, units, reporting, reference intervals, and test selection.

Conclusions:

• Achieving standardization and harmonization is essential for accurate and actionable laboratory information.
• Expanded harmonization efforts across the total testing process are critical.
• Continued initiatives and professional commitment are needed to ensure comparable laboratory data for better diagnosis and treatment.