Should I Repeat My 1:2s QC Rejection?

Author:

Parvin Curtis A1,Kuchipudi Lakshmi1,Yundt-Pacheco John C1

Affiliation:

1. Bio-Rad Laboratories, Quality Systems Division, Plano, TX

Abstract

Abstract BACKGROUND Repeating a QC that is outside 2SD from the mean (1:2s rule) appears to be a common practice. Although this form of repeat sampling is frowned on by many, the comparative power of the approach has not been formally evaluated. METHODS We computed power functions mathematically and by computer simulation for 4 different 1:2s repeat-sampling strategies, as well as the 1:2s rule, the 1:3s rule, and 2 common QC multirules. RESULTS The false-rejection rates for the repeat-sampling strategies were similarly low to those of the 1:3s QC rule. The error detection rates for the repeat-sampling strategies approached those of the 1:2s QC rule for moderate to large out-of-control error conditions. In most cases, the power of the repeat-sampling strategies was superior to the power of the QC multirules we evaluated. The increase in QC utilization rate ranged from 4% to 13% for the repeat-sampling strategies investigated. CONCLUSIONS The repeat-sampling strategies provide an effective tactic to take advantage of the desirable properties of both the 1:2s and 1:3s QC rules. Additionally, the power of the repeat-sampling strategies compares favorably with the power of 2 common QC multirules. These improvements come with a modest increase in the average number of controls tested.

Publisher

Oxford University Press (OUP)

Subject

Biochemistry (medical),Clinical Biochemistry

Reference5 articles.

1. Medical laboratories: particular requirements for quality and competence;International Organization for Standardization (ISO),2007

2. Audit of internal quality control practice and processes in the south-east of England and suggested regional standards;Housley;Ann Clin Biochem,2008

3. Double sampling X̄ charts;Daudin;J Qual Technol,1992

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