Quality control of multichannel haematology analysers: critique of current methods and the need for performance goals
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1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota 55905.
Insights
New performance goals for multichannel hematology analyzers were established by the National Committee of Clinical Laboratory Standards. These goals aid in evaluating quality control strategies for complete blood-cell counts when ideal standards are unavailable.
Area of Science:
- Clinical Laboratory Science
- Hematology
- Analytical Chemistry
Background:
- Automated complete blood-cell counts lack ideal calibration standards and reference methods.
- Current quality control strategies for hematology analyzers vary widely.
- Comparing the effectiveness and cost-efficiency of different quality control methods is challenging.
Purpose of the Study:
- To establish consensus-based performance goals for internal quality control of multichannel hematology analyzers.
- To provide objective criteria for evaluating existing quality control strategies.
- To guide laboratories in selecting the most effective and cost-efficient quality control methods.
Main Methods:
- Consensus development by the Subcommittee on Quantitative Cellular Hematology of the National Committee of Clinical Laboratory Standards (NCCLS).
- Determination of achievable tolerance limits for analytical variations in key hematological parameters.
- Focus on measurements including hemoglobin concentration, erythrocyte count, leukocyte count, platelet count, and mean cell volume.
Main Results:
- Performance goals were established for critical hematology parameters.
- These goals represent expert consensus on achievable tolerance limits for analytical variation.
- The developed goals facilitate comparison of different quality control strategies.
Conclusions:
- The established performance goals offer a framework for assessing quality control effectiveness in hematology laboratories.
- These goals can aid in selecting optimal and cost-effective quality control strategies.
- The findings address the need for standardized quality control evaluation in automated hematology.
Abstract:
Performance goals for internal quality control of multichannel haematology analysers have been developed by consensus in the Subcommittee on Quantitative Cellular Haematology of the National Committee of Clinical Laboratory Standards (NCCLS). Conventional methods of quality control (i.e. use of standards for machine calibration and control samples to detect drift) are not feasible for the automated complete blood-cell count because standards and generally accepted reference methods for cell enumeration are not currently available. In the absence of an ideal system, a host of different quality control strategies are utilized with fresh whole blood, stabilized blood preparations, commercial surrogate materials, and statistical functions of measurements on patient specimens. All have their theoretical strengths and weaknesses which, up to now, have been difficult to quantify and to compare experimentally between methods and between laboratories. Performance goals, or what have been judged by a consensus of experts to be achievable tolerance limits for the various sources of analytical variations, were determined for the following measurements: haemoglobin concentration, erythrocyte count, leukocyte count, platelet count, and mean cell volume. These performance goals can be used to compare the effectiveness of the various quality control strategies now used and to determine which strategy would perform best and be most cost-effective in a particular laboratory situation.