A Total Quality-Control Plan with Right-Sized Statistical Quality-Control.
A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right-sized statistical QC procedure to detect medically important errors. Westgard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements.
Department of Pathology and Laboratory Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI 53705, USA; Westgard QC, Inc, Madison, WI 53717, USA. Electronic address: james@westgard.com.
James O
JO
Westgard
D003951:Diagnostic Errors / Q000517:prevention & control*; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D011786:Quality Control; D018570:Risk Assessment; D017749:Total Quality Management / Q000379:methods*
Hazard identification; Individualized QC plan; Risk assessment; Risk-based QC; Total QC plan; Westgard Sigma Rules