北京地区142家医疗机构互认实验室临床化学和临床免疫及临床检验专业室内质量控制现况调查

Investigation and analysis of internal quality control on clinical chemistry, clinical immunology and clinical hematology of mutual recognition laboratories in 142 medical institutions in Beijing

目的：了解北京地区医疗机构互认实验室临床化学、临床免疫及临床检验专业的室内质量控制现状。方法采用问卷调查及现场调查相结合的方式，使用参考方法定值的新鲜冰冻血清和全血标本，对北京地区142家互认实验室临床化学、临床免疫，临床检验专业的室内质量控制的现状进行调查，并对结果进行分析。结果发放临床化学、临床免疫和临床检验专业调查问卷各142份，分别有120、97和101家实验室回报了问卷，信息回馈率分别为84．5％、68．3％、71．1％，各专业有效回馈率均为100％。问卷调查结果显示：各专业＞50％实验室设置了质量控制目标且大多为误差检出概率（Ped）95％，假失控概率（Pfr）5％；约70％实验室不同的检测项目使用相同的质控方案；使用最多的质控规则是12 s／13 s／22 s。现场调查结果显示，以临床化学专业为例，采用基于生物学变异的适当标准和WS／T 403－2012确定分析质量要求，发现在现有质量控制方法下，多数检测项目不能满足实验室所设置的质量控制目标要求，即Ped 95％，Pfr 5％。结论实验室需考虑实际情况，评估自身能达到的质量水平，为实验室设置合理的质量标准，制定适宜的个性化质量控制计划。

Objective To investigate the internal quality control （ IQC ） on clinical chemistry , clinical immunology and clinical hematology in mutual recognition laboratories in medical institutions in Beijing.Methods By means of questionnaire survey and on -site investigation, fresh frozen serum and whole blood samples with assigned values by reference method were measured to investigate the status of IQC on clinical chemistry , clinical immunology and clinical hematology in 142 mutual recognition laboratories in medical institutions of Beijing,and results were analyzed.Results 142 copies of questionnaireson clinical chemistry, clinical immunology and clinical hematology were send out and 120, 97, and 101 laboratories returned the questionnaires respectively .The information feedback rate was 84.5%, 68.3% and 71.1%respectively .All the questionnaires were effective .Questionnaires survey results showed that more than 50%laboratories set up quality control goals and the most of the goals were probability for error detection （ Ped） 95%, probability for false rejection（Pfr）5%;About 70% laboratories usecd the same quality control plan for different tests ;The most frequently used quality control rules are 12s/13s/22s.On-site investigation showed that ,take the results of clinical chemistry for example , based on the desirable biological variation and WS/T 403 -2012 , most of the tests can＇t meet the quality control goalsunder the existing quality controlcondition.Conclusion Clinical laboratories should consider their actual situations , assess their own qualitylevels that they can reach , set reasonable quality standards for themselves , and make appropriateindividualized quality control plan.