中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
12期
1155-1158
,共4页
孙宏勋%赵建宏%顾洪涛%谢永富
孫宏勛%趙建宏%顧洪濤%謝永富
손굉훈%조건굉%고홍도%사영부
实验室,医院%质量控制%参考标准
實驗室,醫院%質量控製%參攷標準
실험실,의원%질량공제%삼고표준
Laboratories,hospital%Quality control%Reference standards
目的 探讨不同实验室间不同检测系统实现统一的生化常规项目室内不精密度范围的可行性.方法 经统一培训的生化专业人员实地走访河北省18家三级甲等医院实验室,调阅其微机系统中的生化常规项目的室内质控信息,根据被调查实验室室内参数设定依据进行分类；记录从2010年4至9月间21项常规项目的累积均值、标准差和变异系数等,以美国CLIA'88规定的可接受范围各项目的允许总误差(TEa)的1/3、1/4和生物学变异导出的允许变异系数(以下简称“允许CVb％”)进行比较.结果 18家实验室中,以半年均值作为靶值的有5家,占27.8％；以初始20 d均值作为靶值的有5家,占27.8％；以厂家质控品赋值作为靶值的有8家,占44.4％.以6个月累计数据确定标准差的有6家,占了调查总数的33.3％,以最初20 d检测数值确定标准差后固定的有8家,占44.4％,以厂家给定的标准差画质控图的有4家,占22.3％.18家医院实验室21项生化常规项目的CV差别很大,LDH的CV相差6.79倍,CK的CV相差76.79倍；累积变异系数满足小于1/3TEa评价要求的,各项目占比从35.5％ ～94.1％不等,满足小于1/4TEa评价要求的,各项目占比从0.0％～91.7％不等,满足小于允许CVb％评价要求的,各项目所占比从0.0％ ～94.1％不等,21项中有16项CV能满足小于1/3TEa,占检测项目的76.2％.未满足小于1/3TEa生化常规项目中,出现的频率排在前5位的有Na、Urea、TBIL、ALT、GLU.结论 河北省生化实验室室内质量控制参数的设定标准尚不统一,75％点位作为我省三级甲等医院室内不精密度标准参考,试行一段时间并改进后,设立全省统一的生化常规项目室内不精密度范围,为实现我国室内质控标准统一提供参考依据.
目的 探討不同實驗室間不同檢測繫統實現統一的生化常規項目室內不精密度範圍的可行性.方法 經統一培訓的生化專業人員實地走訪河北省18傢三級甲等醫院實驗室,調閱其微機繫統中的生化常規項目的室內質控信息,根據被調查實驗室室內參數設定依據進行分類；記錄從2010年4至9月間21項常規項目的纍積均值、標準差和變異繫數等,以美國CLIA'88規定的可接受範圍各項目的允許總誤差(TEa)的1/3、1/4和生物學變異導齣的允許變異繫數(以下簡稱“允許CVb％”)進行比較.結果 18傢實驗室中,以半年均值作為靶值的有5傢,佔27.8％；以初始20 d均值作為靶值的有5傢,佔27.8％；以廠傢質控品賦值作為靶值的有8傢,佔44.4％.以6箇月纍計數據確定標準差的有6傢,佔瞭調查總數的33.3％,以最初20 d檢測數值確定標準差後固定的有8傢,佔44.4％,以廠傢給定的標準差畫質控圖的有4傢,佔22.3％.18傢醫院實驗室21項生化常規項目的CV差彆很大,LDH的CV相差6.79倍,CK的CV相差76.79倍；纍積變異繫數滿足小于1/3TEa評價要求的,各項目佔比從35.5％ ～94.1％不等,滿足小于1/4TEa評價要求的,各項目佔比從0.0％～91.7％不等,滿足小于允許CVb％評價要求的,各項目所佔比從0.0％ ～94.1％不等,21項中有16項CV能滿足小于1/3TEa,佔檢測項目的76.2％.未滿足小于1/3TEa生化常規項目中,齣現的頻率排在前5位的有Na、Urea、TBIL、ALT、GLU.結論 河北省生化實驗室室內質量控製參數的設定標準尚不統一,75％點位作為我省三級甲等醫院室內不精密度標準參攷,試行一段時間併改進後,設立全省統一的生化常規項目室內不精密度範圍,為實現我國室內質控標準統一提供參攷依據.
목적 탐토불동실험실간불동검측계통실현통일적생화상규항목실내불정밀도범위적가행성.방법 경통일배훈적생화전업인원실지주방하북성18가삼급갑등의원실험실,조열기미궤계통중적생화상규항목적실내질공신식,근거피조사실험실실내삼수설정의거진행분류；기록종2010년4지9월간21항상규항목적루적균치、표준차화변이계수등,이미국CLIA'88규정적가접수범위각항목적윤허총오차(TEa)적1/3、1/4화생물학변이도출적윤허변이계수(이하간칭“윤허CVb％”)진행비교.결과 18가실험실중,이반년균치작위파치적유5가,점27.8％；이초시20 d균치작위파치적유5가,점27.8％；이엄가질공품부치작위파치적유8가,점44.4％.이6개월루계수거학정표준차적유6가,점료조사총수적33.3％,이최초20 d검측수치학정표준차후고정적유8가,점44.4％,이엄가급정적표준차화질공도적유4가,점22.3％.18가의원실험실21항생화상규항목적CV차별흔대,LDH적CV상차6.79배,CK적CV상차76.79배；루적변이계수만족소우1/3TEa평개요구적,각항목점비종35.5％ ～94.1％불등,만족소우1/4TEa평개요구적,각항목점비종0.0％～91.7％불등,만족소우윤허CVb％평개요구적,각항목소점비종0.0％ ～94.1％불등,21항중유16항CV능만족소우1/3TEa,점검측항목적76.2％.미만족소우1/3TEa생화상규항목중,출현적빈솔배재전5위적유Na、Urea、TBIL、ALT、GLU.결론 하북성생화실험실실내질량공제삼수적설정표준상불통일,75％점위작위아성삼급갑등의원실내불정밀도표준삼고,시행일단시간병개진후,설립전성통일적생화상규항목실내불정밀도범위,위실현아국실내질공표준통일제공삼고의거.
Objective To explore the feasibility of carrying out the common imprecision range among different biochemical systems in different laboratories.Methods Biochemical professionals visited 18 third-grade class A hospitals in Hebei Province,investigated the internal quality control data of 21 biochemical tests and made classification according to certain parameter criterias.Data were collected from April to September,2010 and calculated for cumulative mean,standard deviation (s) and CV.Data were compared according to 1/3,1/4 of TEa established by CLIA'88 and allowable CVb％ derived from biological variants.Results Among 18 hospitals,5 (27.8％) set their target value by mean value of 6 months,5(27.8％) by continuous 20 days and 8(44.4％) by the given value of the supplier.CVs of 21biochemical tests were quite different among 18 biochemistry laboratories,in which LDH was 6.79 times and CK was 76.79 times different from one another.35.5％-94.1％ biochemical tests met the requirement of CV ＜ 1/3TEa and 0.0％-91.7％ met the requirement of CV ＜ 1/4TEa.0.0％-94.1％ of tests were below allowable CVb％ 16/21 (76.2％) tests could satisfy the requirement of CV ＜ 1/3TEa.The top five tests which didn't meet the requirements were Na,Urea,TBIL,ALT and Glu.Conclusions The internal quality control among biochemistry laboratories in Hebei Province has not been standardized yet.According to the survey data,biochemistry laboratories of third-grade class A hospitals may set 75％ point of imprecision as a reference.After a period of improvement,we will set common imprecision range among biochemistry laborotories in Hebei Province and even in China.
