摘要
目的分析2010至2011年上海市医院实验室常规化学项目飞行检查结果,为上海市医疗机构检验结果互认工作提供依据。方法收集2010至2011年上海市二级甲等以上医院实验室参加由上海市临床检验中心组织的2次飞行检查常规化学项目结果,计算实验室的合格率,并分别比较20个常规化学项目的全部参加实验室、三级医院、二级甲等医院和通过认可实验室检测结果间的离散度,用基于允许误差和生物学变异的分析变异质量标准评价每个项目的达标情况。结果上海二级甲等以上医院实验室间离散度分析,电解质[钾(K)、钠(Na)、氯(Cl)]3项和尿酸(UA)<3.0%,且Na≤1.6%;白蛋白(Alb)、钙(Ca)、肌酐(Cr)、总胆固醇(TC)、葡萄糖(Glu)、总蛋白(TP)均<5.0%;磷(P)、甘油三酯(TG)、尿素(Urea)和丙氨酸氨基转移酶(ALT)≤7.9%;天门冬氨酸氨基转移酶(AST)、γ-谷氨酰基转移酶(GGT)、乳酸脱氢酶(LDH)、肌酸激酶(CK)和总胆红素(TBil)离散度≤11.4%;高密度脂蛋白胆固醇(HDL-C)最大,术17.9%。认可实验室的Alb、ALT、AST、Ca、TC、TG、TP和CK检测质量相对优于其他组;全部医院、二级甲等医院、三级医院和认可实验室组间的均值基本无差异。ALT、CK和TG是20项常规化学检测中可达到较高质量标准的项目;其次为AST、K、TBil、UA和Urea;然后为Alb、Ca、Cr、Glu、P、TC和TP;Na、Cl、HDL-C、LDH和GGT为达到最低质量标准的项目。结论通过开展实验室全面质量管理,建立检测项目参考体系,开展中国人群基础数据研究,加强质控管理,以此为基础,逐步达到检测结果的互认,为临床提供可靠的诊疗依据。
Objective To analyze the on-spot inspection results of routine clinical chemistry items in Shanghai clinical laboratories from 2010 to 2011, and to provide the reference for result inter-accreditation of clinical laboratory tests in Shanghai. Methods Shanghai Center for Clinical Laboratory organized 2 on-spot inspections from 2010 to 2011, which required above Level 2 Grade A hospitals to participate. The results of routine clinical chemistry items were collected and analyzed statistically. The passing rates were calculated, and the coefficients of variation of 20 routine clinical chemistry items were compared in the whole participating laboratories, Level 3 hospitals, Level 2 Grade A hospitals and accredited laboratories. The calculation was based on allowable error and analytical variation of its biological variation. Results The coefficients of variation among above Level 2 Grade A hospitals were as follows： 3 electrolyte items [ potassium （ K）, sodium （Na） and chlorine （C1） ] and uric acid （UA） were both 〈 3.0%, and Na was 〈1.6% ; albumin （Alb）, calcium （Ca）, creatinine （Cr）, total cholesterol （TC）, glucose （Glu） and total protein （TP） were all 〈 5.0% ; phosphonium （ P）, triglyceride （ TG）, urea and alanine aminotransferase （ALT） were ≤ 7. 9% ; aspartate aminotransferase （ AST）, gamma-glutamyltransferase （ GGT ）, lactic dehydrogenase （ LDH ）, ereatine kinase （CK） and total bilirubin （TBiI） were ≤ 11.4% ;high-density lipoprotein cholesterol （HDL-C） was 17.9%. The results were better in the accredited laboratories than the others with respect to Alb, ALT, AST, Ca, TC, TG, TP and CK. The means had no significant difference among the whole participating laboratories, Level 3 hospitals, Level 2 Grade A hospitals and accredited laboratories. ALT, CK and TG met the relatively high quality requirement in the 20 routine clinical chemistry items. The follows were AST, K, TBil, UA and urea, and Alb, Ca, Cr, Glu, P, TC and TP. Na, C1, HDL-C, LDH and GGT met the minimum required quality goal. Conclusions The comprehensive quality management, establishment of reference systems and research based on Chinese population can promote qualitycontrol, get result inter-accreditation gradually and finally provide diagnostic reference for clinical application.
出处
《检验医学》
CAS
2012年第12期995-1001,共7页
Laboratory Medicine
关键词
结果互认
飞行检查
常规化学
Result inter-accreditation
On-spot inspection
Routine clinical chemistry
