基层输血科自制室内质控品的方法与可行性探讨  

Discussion on the method and feasibility of homemade internal quality control products in blood transfusion department conditions

作　　者：袁晓阳[1] 马晓露[1] 陈洁[1] 

机构地区：[1]大连医科大学附属第一医院检验科,辽宁大连116011

出　　处：《中国输血杂志》2015年第4期398-401,共4页Chinese Journal of Blood Transfusion

摘　　要：目的探讨如何利用基层输血科现有实验室条件,选则自制质控品对ABO血型正反鉴定、Rh D血型鉴定、不规则抗体筛查和交叉配血试验进行室内质量控制。方法回顾性分析我院输血科2013年7月—2014年7月13次自制质控品的可靠性和特异性,评价自制质控品的临床应用效果。自制单独血浆与红细胞质控品,经亲和力、抗体效价检测、凝集强度和稳定性等验证后,按照自行设计的室内质控模式,进行ABO血型鉴定、Rh D血型、交叉配血试验及不规则抗体筛查等试验。结果各检测项目共有1 780个室内质控结果,其中1次(0.06%)属于"警告",2次(0.11%)属于"失控";失控中随机误差1次(50%),系统误差1次(50%)。随机误差和系统误差各占质控总数的比例为0.06%。结论本院输血科自制的室内质控品,其有效性、特异性、稳定性和可靠性,符合《ISO15189医学实验室认可准则》中对IQC的基本要求,可以有效控制输血差错事故的发生。Objective To investigate how to make internal quality control products,taking advantage of the existing blood specimen resources and laboratory conditions,in order to conduct internal quality control( IQC) on positive and reverse ABO blood group typing,Rh D blood typing,irregular antibody screening and crossmatching test. Methods Retrospective analysis was conducted on the parameters of reliability and specificity of 13 homemade quality control products manufactured in our blood transfusion department from July 2013 to July 2014. The clinical effect of the homemade products was estimated. After determination of the affinity and detection of antibody titer,agglutination intensity and stability,homemade single plasma and red blood cell quality control products were used to conduct internal quality control( IQC) on positive and reverse ABO blood typing,Rh D blood typing,irregular antibody screening and cross matching test,according to the design of internal quality control mode. Results Each laboratory test produced 1780 internal quality control results,including one "warning"case( 0. 06%) and two "out of control "cases(0. 11%). Among the "out of control"cases,random error occurred once(50%),systematic error occurred once(50%). Of the total number of quality control products,0. 06% contributed to random and systematic errors,respectively.Conclusion The validity,specificity,stability and reliability of our homemade internal quality control products can meet the basic requirements in the ISO15189 medical laboratory accreditation criteria for IQC. In addition,the products can effectively avoid blood transfusion errors or accidents.

关 键 词：质控品 室内质量控制(IQC) 输血相容性检测 

分 类 号：R457.11[医药卫生—治疗学]