室间质量评价与临床检验结果互认的可行性研究  

Study on external quality assessment and the feasibility of result inter-accreditation for clinical laboratory

作　　者：曾黎峰[1] 雷良华[1] 万本愿[1,2] 姜青龙[2] 吴时耕[2] 贺葵阳[2] 李胜远[1,2] 

机构地区：[1]江西省人民医院检验科,江西南昌330006 [2]江西省临床检验中心,江西南昌330006

出　　处：《实验与检验医学》2013年第2期121-124,194,共5页Experimental and Laboratory Medicine

基　　金：江西省卫生厅科技项目(编号:20061022)

摘　　要：目的分析江西省二级医院以上实验室的2004年至2011年连续8年的5个检验专业科目的室间质评数据,为检验结果在实验室间的互认提供可行性依据。方法采用统一订购的无生物危害的质控品(包括临床化学17项、血液6项、出凝血4项、乙肝、丙肝标志物和尿液干化学8项)进行实验室能力比对检验(proficiency testing,PT),要求在规定时间内进行测定并回报有效数据。结果三级医院在临床化学17项和临床血液6项检验的8年合并PT合格率强于二级医院,分别为94%对79%和87%对66%(P<0.05),差异有统计学意义;而在临床出凝血4项、HBV/HCV标志物和尿液干化学8项检验方面,二、三级医院的8年合并PT合格率分别为70%对83%、87%对94%、和86%对94%,差异无统计学意义(P>0.05)。结论实验室室间质评可以作为检验结果互认的认定依据。Objective To analyze the data of external quality assessment （EQA） items for clinical laboratory from 2004 to 2011 in all level two and level three hospitals in Jiangxi province, and to provide the evidence for result inter-accreditation of clinical laboratory tests. Methods All level two and level three hospitals were required to participate the EQA program organized by Jiangxi Provincial Center for Clinical Laboratory and to detect 5 items including clinical chemistry, clinical hematology, blood co- agulation, immune markers of hepatitis and urine dry chemistry.All results of EQA from 2004 to 2011 were collected and analyzed statistically by proficiency testing panel （PT） according to state criteria GB/20032301-T-361. The passing rates were calculated with PT scoring, and the coefficients of variation of every test items were compared in all participating laboratories. PT scoring was calculated according to allowable error： PT scored 100 when the test result was in the range of allowable error, while PT scored 0 when test resuh was out of the range of allowable error. The single item was considered passing when the mean PT score of ten samples was more than 80%. Results The passing rates of level three hospitals were higher than those of level two hospitals in tests of clinical chemistry （94% vs 79%, P〈0.05） and clinical hematology （87% vs 66%, P〈0.05）.But there were no statistical sig- nificances in tests of blood coagulation （83% vs 70%, P〉0.05）, immune markers of hepatitis （94% vs 87%, P〉0.05） and urine dry chemistry（94% vs 86%, P〉0.05） between level three hospitals and level two hospitals. Conclusion The scores of EQA items would provide the evidences of result inter-accreditation among different clinical laboratories.

关 键 词：质量控制 能力比对检验 结果互认 临床检验 

分 类 号：R446[医药卫生—诊断学]