Establishment of internal quality control system for automated hematology analyzer according to ISO 15189 / 国际检验医学杂志

ABSTRACT

Objective To establish a proper internal quality control(QC) system for the automated hematology analyzer accord‐ing to the corresponding stipulation by ISO151892012 .Methods The high ,normal and low levels of controls offered by the instru‐ment were used to detect 22 items in whole blood cells routine analysis ,draw the Levey‐Jennings chart ,analyze and evaluate the quality control data for each month or each batch .Results A proper QC system was established ,including quality goals setting , new QC target value and standard deviation calculating and the QC rules choosing .In setting the target value for new batch of con‐trol ,MCV ,HCT and MCHC should adopt the mean values of at least 20 values ,while other items could adopt the mean values of 10 values ;the difference of CV values for some items existed in different QC levels ,different brands or different instruments in the same brand .Therefore ,the quality goals and standard deviation for new batch should be set according to different levels and differ‐ent instruments .Due to the QC characteristics and existence of QC chart drift phenomenon ,therefore MCV ,HCT and MCHC should adopt the 13 s and 22 s rules .For the other items ,the 13 s ,22 s and 10x rules were adoted .Conclusion Under the corresponding stipulations of ISO15189 and by combining with the laboratory practical situation ,a set of applicable internal quality control system is established .