临床生化室室内质量控制性能评价及全面质量控制策略的建立

目的按照每个项目的质量要求，评估生化实验室室内质量控制性能，为每一个检测项目建立个性化全面质量控制策略。方法依据每个项目总允许误差（TEa）以及2010年2月至2010年7月参加罗氏质量控制和卫生部临床检验中心室间质评实验数据确定实验室的不精密（CV％）和不准确度（bias），计算每个项目操作点，利用标准操作规范图（OPSpecs）设计室内质量控制的方法，评估当前使用室内·质量控制规则（1。N=2，R=1）是否满足质量控制性能要求；最后根据评估结果建立全面质量控制（TQC）策略。结果各操作点在OPSpecs上显示：碱性磷酸酶、谷丙转氨酶、谷草转氨酶等20个项目对当前采用的质控规则有高的误差检出率（Ped），Ped〉90％，假失控率（Pfr）〈1％，而总胆红素、直接胆红素及栽脂蛋白B只有改变质控规则（1／2／R，N=2，R=1）才能满足高Ped要求（Ped〉90％，Pfr=1％），其TQC策略重点是应用统计质量控制；钠和钙改变质控规则为（12．5S，N=2，R=1）时仅有中等Ped（Ped=50％～90％，Pfr=4％），其全面的质控策略应强调统计质量控制、方法改进、误差的防范相结合；而尿素、肌酐、清蛋白及氯的Ped比较低（Ped＜50％），TQC策略的重点就应该放在方法改进和误差防范。结论要达到相同质量控制性能，质量要求不同项目其质量控制策略可能会不一样，为每一项目建立全面质控策略是非常必要的。

Performance assessment of quality control and Establishment of total quality control strategies in clinical biochemistry

Objective To assess the intern quality control performance characteristics and establish the total quality control strategies that are appropriate for the quality requirement and select medically useful quality control procedures for individual test. Methods According to the allowable total error such as given by CLIA＇88,and the imprecision and inaccuracy of every test method were collected from the data of ROCHE quality control service （QCS） and national center for clinical laboratory proficiency testing event. Normalized operating point was calculated,which is observed imprecision and inaccuracy expressed as a percentage of the al- lowable total error. Results The operating point of Normalized OPSpecs charts shown that there was a high error detection rate （Ped〉90 %, Pfr〈1% ） with the current quality control rules （ ls~, N = 2, R ~ 1 ） including ALP. AST. ALT. AMY and other 20 i- tems, but TBIL,DBIL and APOB, only changed the rules （ 1/22s/R4s, N = 2, R = 1）, its quality control performance is high error detecti0n（Ped~90 %, Pfr： 1 ~）, the TQC strategy should depend on statistical QC as the primary component. The performance of items（Na and Ca ） with rules （ 12.5 s, N = 2, R = 1 ） is moderate （Ped： 50 % - 90 %, Pfr： 4 % ）, the TQC strategy should emphasize statistical QC,method improvement,and error prevention. The performance of items（UREA.Cr.C1.Alb） is very low（Ped〈50%）, the TQC strategy should place a high priority on method improvement and error prevention. Conclusion QC practices tend towards a uniXorm or average quality control system that is applied to all testing processes ;it is necessary to establish a total quality control strategy for every test based on the quality required and the performance observed.