[Toward pertinent analytical objectives for haematological parameters].

Area of Science:

• Hematology
• Clinical Chemistry
• Laboratory Medicine

Context:

• Routine hematology labs rely on manufacturer-provided target values for internal quality control (IQC).
• Monitoring the analytical measurement system's performance is crucial for reliable diagnostic results.
• Existing IQC methods may not fully capture system variability for all hematologic parameters.

Purpose:

• To improve the monitoring of analytical measurement systems for 17 key hematologic parameters.
• To establish clearly argued allowable limits for IQC values by integrating multiple data sources.
• To develop a more robust IQC strategy beyond manufacturer-defined targets.

Summary:

• A novel approach was developed to set allowable critical limits for IQC by analyzing internal quality control (IQC) data from multiple levels, lots, analyzers, and passage modes over four months.
• This involved benchmarking against expert recommendations, clinical requirements, and statistical indicators, alongside exploiting interlaboratory comparison reports (SNCS, EuroCell).
• Performance was compared against Ricos objectives to define IQC limits, resulting in limits aligning with Ricos imprecision for 14 parameters and more stringent personalized limits for 3 parameters.

Impact:

• Successfully established clearly argued allowable limits for IQC values, enhancing the reliability of hematologic parameter measurements.
• The proposed method provides a more rigorous framework for internal quality control in hematology laboratories.
• This contributes to improved diagnostic accuracy and patient care through better analytical system performance monitoring.