Recommendations for Testing a New Lot of Hematology Control and Establishing an Acceptable Range

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Test the<br> new lot when the instrument is in good working order and quality control results on the old lot are<br> acceptable. The laboratory recovered mean should be within the assay range.</p> <p>For greater control sensitivity each laboratory should establish its own mean and acceptable<br> range and periodically reevaluate the mean. The laboratory range may include values outside of<br> the assay range. Target values not listed on the Assay Sheet may be established by the user if<br> the control is suitable for the method.</p> <ol> <li>Test the new lot in parallel with the old lot 2 to 3 times a day for a minimum of 5, preferably 10<br> days.<br> <ol type="a"> <li>Verify that there are no trends and that the precision is acceptable.</li> <li>Delete obvious outliers (values > 3 SD from the mean). Repeat testing as needed.</li> </ol> <li>Calculate the mean for each measured parameter on the new lot. Calculate indices from the<br> measured parameters.<br> <ol type="a"> <li>A provisional mean may be calculated from 10 data points but recalculate the mean after 20 data points are accumulated.</li> <li>The laboratory mean should be within the assayed range.</li> </ol> <li>Calculate control limits from the laboratory mean and long-term standard deviation. The longterm<br> SD is the average SD from previous lots. The SD for each parameter should be very<br> similar from lot to lot at the same control level. <ol type="a"> <li>Do not use the SD from parallel testing to establish a range. This SD is too narrow for control limits because it is obtained over a short time compared to the shelf life of the control.</li> <li>Typically a range is calculated from 2 to 3 times the SD value. For example if the WBC mean is 10.0 and 1 SD is 0.2, a range based on 2.5 SD is 10.0 + 0.5 (0.2 x 2.5). The range used depends on the clinical needs of the laboratory for error detection.</li> </ol> <li>Calculate and evaluate statistical parameters (mean, standard deviation, coefficient of variation) at least once per month to ensure continued acceptable performance. If the mean has changed significantly, usually more than 1 SD, check calibration and adjust the target mean as needed.</li> </ol> <h3>References:</h3> <ol> <li>Clinical and Laboratory Standards Institute. Statistical Quality Control for Quantitative Measurement Procedures: Principle and Definitions; Approved Guideline-Fourth Edition. CLSI document C24.</li> <li>Clinical and Laboratory Standards Institute. Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition. 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Recommendations for Testing a New Lot of Hematology Control and Establishing an Acceptable Range