Harmonization of Laboratory Indicators: International Study Examines Cross-Country Comparability Challenges

Harmonization of Laboratory Indicators: International Study Examines Cross-Country Comparability Challenges

Harmonization of Laboratory Indicators: International Study Examines Cross-Country Comparability Challenges

A publication in Clinical Chemistry and Laboratory Medicine brings together international experts and includes participation from Controllab.

Amid efforts to harmonize data and improve indicator comparability in laboratory medicine, experts in laboratory medicine have examined the challenges involved in standardizing quality indicators used by clinical laboratories across different countries. The analysis was presented in a Letter to the Editor published in the scientific journal Clinical Chemistry and Laboratory Medicine (CCLM), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

The publication brings together representatives from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML), and Controllab.

The authors include Dr. Mario Plebani and Dr. Vincent de Guire, representing the IFCC, as well as Dr. Wilson Shcolnik and Dr. Alex Galoro from SBPC/ML. All are members of the Working Group on Laboratory Errors and Patient Safety (WG LEPS) of the IFCC, coordinated by Dr. Vincent de Guire. Within the group, Controllab is represented by Luiza Bottino.

Analysis of Laboratory Indicators Across Countries

This work is part of a WG LEPS project focused on defining quality specifications for laboratory indicators using a meta-analysis approach. Data from laboratory indicator programs in Brazil, China, Argentina, and Spain were analyzed, along with data from the IFCC itself.

Although international initiatives have established harmonized definitions for quality indicators, the study highlights methodological differences in how these indicators are calculated, aggregated, and reported. Advancing the harmonization of these methods is an important step toward further enhancing the comparability of laboratory indicator programs. One example highlighted is the “Sample Coagulation” indicator.

Comparability and Benchmarking Challenges

According to the authors, this heterogeneity limits international comparability across laboratory indicator programs and may hinder the development of robust global benchmarks. The publication also underscores the need for standardization in stratification criteria, data aggregation methods, and reporting frameworks.

Controllab’s participation in the study reinforces its commitment to quality, methodological innovation, and the strengthening of benchmarking programs aimed at continuous improvement and patient safety on a global scale.

Access the full publication on the website:
https://www.degruyterbrill.com/document/doi/10.1515/cclm-2026-0076/html

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Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

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Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).