Patient results and laboratory test accuracy

被引:4
作者
Katayev, Alexander [1 ]
Fleming, James K. [1 ]
机构
[1] Lab Corp Amer Holdings, Dept Sci & Technol, Elon, NC 27215 USA
关键词
United States of America; Quality control; Bias; Analytical performance; Laboratory tests; Reference interval;
D O I
10.1108/IJHCQA-09-2012-0092
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Purpose - Traditional quality control materials used for monitoring the clinical laboratory test accuracy might be non-commutable with patient samples and may not detect systematic errors. The aim of this paper is to describe a method to monitor inter-instrument bias using result distributions that are independent of the control's commutability. Design/methodology/approach - Serum calcium data collected within a laboratory network were assessed. A reference interval was calculated using a computerized, indirect Hoffmann's algorithm using all data across a laboratory network without excluding any results. Results outside the reference interval were considered as the zero-bias distribution. Three allowable bias levels were then calculated to determine the corresponding shift in abnormal results for each bias level in both directions from the zero-bias distribution. The observed result distributions in three laboratories within the network were compared for bias performance after one year of the reference interval study. Findings - Performance levels for bias were: minimum allowable <1.27 percent; desirable <0.85 percent; and optimal <0.42 percent. Zero bias result distribution above and below the reference interval for calcium was 3.92 percent and 2.53 percent respectively. All three laboratories performed within the desirable allowable bias level. Originality/value - Bias-monitoring process using patient result distributions allows managers to: assess systematic error between laboratory instruments; improve laboratory quality control; and strengthen patient risk management.
引用
收藏
页码:65 / +
页数:7
相关论文
共 4 条
[1]  
Fraser C, 2001, BIOL VARIATION PRINC
[2]   Establishing Reference Intervals for Clinical Laboratory Test Results Is There a Better Way? [J].
Katayev, Alex ;
Balciza, Claudiu ;
Seccombe, David W. .
AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2010, 133 (02) :180-186
[3]   Establishment of Outcome-Related Analytic Performance Goals [J].
Klee, George G. .
CLINICAL CHEMISTRY, 2010, 56 (05) :714-722
[4]   Commutability Limitations Influence Quality Control Results with Different Reagent Lots [J].
Miller, W. Greg ;
Erek, Aybala ;
Cunningham, Tina D. ;
Oladipo, Olajumoke ;
Scott, Mitchell G. ;
Johnson, Robert E. .
CLINICAL CHEMISTRY, 2011, 57 (01) :76-83