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Abstract

Background

Risk management strategies have been proposed for applications in clinical laboratories to reduce patient risks; however, effective and visual risk-monitoring tools are currently lacking in medical laboratories. In this study, we constructed a risk quality control (QC) chart based on risk management strategies.

Methods

We calculated the risk levels of QC materials based on Bayes' theorem by combining the total allowable error, QC results, and the maximum number of unacceptable errors in the laboratory. Then, we constructed a risk QC chart by presenting the Z values and corresponding risk levels of QC materials simultaneously. Finally, we evaluated the risk-monitoring capabilities of the risk QC charts by simulating different long-term errors in the laboratory.

Results

The risk levels of QC materials increased as the QC results moved further away from the set mean. Larger sigma values led to fewer risks obtained for the same QC results. The constructed risk QC charts intuitively showed specific risk levels and could warn lab staff out-of-control, without the need for QC rules to make judgments. The risk levels of erroneous results differed for items with different sigma performance.

Conclusions

Risk-based QC charts allowed visualization of the QC results and specific risk levels simultaneously, providing more intuitive results than those obtained from traditional QC charts.

Keywords

Quality control risk management risk quality control chart

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References

Levey

Jennings

. The use of control charts in the clinical laboratory. 1950. Arch Pathol Lab Med 1992; 116(7): 791–803, discussion 799-803.

Shewhart

. Economic Control of Quality of Manufactured Product. Milwaukee, WI: ASQ Quality Press, 1931.

Henry

Segalove

. The running of standards in clinical chemistry and the use of the control chart. J Clin Pathol 1952; 5(4): 305–311.

Henry

. Use of the control chart in clinical chemistry. Clin Chem 1959; 5(4): 309–319.

Westgard

Groth

Aronsson

, et al. Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection. Clin Chem 1977; 23(10): 1857–1867.

Westgard

. Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control. Clin Lab Med 2017; 37(1): 85–96.

Parvin

. Assessing the impact of the frequency of quality control testing on the quality of reported patient results. Clin Chem 2008; 54(12): 2049–2054.

Wayne

. CLSI Document EP23-A: Laboratory Quality Control Based on Risk Management; Approved Guideline, 2011.

Parvin

. What's new in laboratory statistical quality control guidance? The 4th edition of CLSI C24, statistical quality control for quantitative measurement procedures: principles and definitions. J Appl Lab Med 2017; 1: 581–584.

10.

Yago

. Selecting statistical quality control procedures for limiting the impact of increases in analytical random error on patient safety. Clin Chem 2017; 63(5): 1022–1030.

11.

Yago

Alcover

. Selecting statistical procedures for quality control planning based on risk management. Clin Chem 2016; 62(7): 959–965.

12.

Bayat

. Selecting multi-rule quality control procedures based on patient risk. Clin Chem Lab Med 2017; 55(11): 1702–1708.

13.

Westgard

Bayat

Westgard

. Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers. Clin Chem 2018; 64(2): 289–296.

14.

Njoroge

Nichols

. Risk management in the clinical laboratory. Ann Lab Med 2014; 34(4): 274–278.

15.

Wang

Gong

, et al. Comparative analysis of calculating sigma metrics by a trueness verification proficiency testing-based approach and an internal quality control data inter-laboratory comparison-based approach. J Clin Lab Anal 2019; 33(9): e22989.

16.

Waterhouse

Kunzmann

Torres

, et al. An internal validation approach and quality control on hematopoietic chimerism testing after allogeneic hematopoietic cell transplantation. Clin Chem Lab Med 2013; 51(2): 363–369.

17.

Sidebotham

. Are most randomised trials in anaesthesia and critical care wrong? An analysis using Bayes' theorem. Anaesthesia 2020; 75(10): 1386–1393.

18.

Westgard

. Six Sigma Quality Design and Control. 2nd ed. Madison, WI: Westgard QC, Inc., 2011.

19.

Ialongo

Bernardini

. Long story short: an introduction to the short-term and long-term Six Sigma quality and its importance in laboratory medicine for the management of extra-analytical processes. Clin Chem Lab Med 2018; 56(11): 1838–1845.

20.

Coskun

Serteser

Ünsal

. The short story of the long-term Sigma metric: shift cannot be treated as a linear parameter. Clin Chem Lab Med 2019; 57(9): e211–e213.

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