An optimized quality control procedure for hematology analyzers with the use of retained patient specimens.

The authors propose guidelines for the use of retained patient specimens for the quality control of multichannel hematology analyzers. They demonstrate that control limits for patient specimen replicates may be derived from the long-term standard deviations (s) of commercial whole blood controls. They then use computer stimulation of the Coulter multichannel hematology instrument to determine power functions of various procedures using retained specimens. These power functions show that the use of three patient specimens and +/- 2 s limits are optimal for the detection of systematic error. They recommend that three different, previously analyzed normal range specimens be periodically analyzed, e.g., at eight-hour intervals. The differences between the current and original measurements should then be calculated and compared with their +/- 2 s limits. If at least two of the three differences for any directly measured parameter exceed the +/- 2 s limits, there will be a high probability of significant analytic error. Because the power functions of the derived red blood cell parameters, hematocrit, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration demonstrate relatively low error detection capabilities, the authors recommend that these parameters not be monitored with the retained patient specimen procedure.