An optimized method for setting Internal Quality Control targets (mean and limits) for multi-instrument Internal...

Area of Science:

• Clinical laboratory science
• Hematology
• Analytical chemistry

Background:

• Internal Quality Control (IQC) procedures require updates to accommodate increased patient volumes and inter-laboratory result comparability.
• Current IQC methods may not adequately address the evolving needs of modern hematology laboratories.

Purpose of the Study:

• To develop and assess a novel strategy for setting Internal Quality Control (IQC) material targets across multiple hematology analyzers.
• To enhance the detection of significant errors in routine hematology analytical processes.

Main Methods:

• A common IQC sample mean and limits were determined using a manufacturer-based peer group.
• A new parameter, SD_intra90 (random error of peer group analyzers), was incorporated to detect bias or imprecision.
• The model was validated over five months on 17 analyzers measuring hemoglobin and red cell count.

Main Results:

• The developed IQC model effectively controls analytical error in a network of laboratories using identical measurement systems.
• The approach demonstrated the ability to detect bias or imprecision using the SD_intra90 parameter.
• The model requires that analyzers exhibit no significant bias when using a common mean.

Conclusions:

• The proposed IQC strategy meets the demands of real-world laboratory practices.
• This model aligns with theoretical principles for reducing patient risk and harmonizing laboratory practices.
• The novel approach offers improved error detection and result comparability in hematology testing.