ICSH guidance for internal quality control policy for blood cell counters

Area of Science:

• Clinical laboratory science
• Hematology
• Quality control

Background:

• Internal quality control (IQC) is crucial for accurate blood cell counting.
• Existing guidance and practices for IQC policies demonstrate significant global variation.
• The International Council for Standardization in Haematology (ICSH) has reviewed current practices.

Purpose of the Study:

• To describe the ICSH guidance for internal quality control (IQC) policy for blood cell counters.
• To identify and address the diversity in IQC guidance and laboratory practices worldwide.
• To propose a harmonized approach for IQC in diagnostic laboratories.

Main Methods:

• Review of published guidance from regulatory bodies.
• Questionnaire survey distributed to six major blood cell counter manufacturers.
• Survey of 191 diagnostic laboratories across China, Ireland, Spain, and the UK regarding their IQC practices and use of commercial IQC materials.

Main Results:

• Significant diversity exists globally in regulatory guidance for IQC methods, clinical levels, control frequency, and material sources.
• Clinical laboratories exhibit variability in IQC methods, target value derivation, action limits, and control material frequency.
• Current practices reveal inconsistencies in the application of IQC for blood cell counters.

Conclusions:

• The diversity in IQC guidance and practice poses challenges for diagnostic laboratories.
• A harmonized approach is needed to standardize and improve IQC policies and practices for blood cell counters.
• This guidance document aims to provide a framework for consistent and effective IQC implementation.