Sigma Metric Analysis
Now that we know how to translate the manufacturer's performance claims into Six Sigma metrics, let's take a hard look at some real-world data. With a performance study supplied by a "near-patient" chemistry anlayzer, we find out just how good (and how bad) performance of tests are when they're at the POC.
A study in the September 2009 issue of Point of Care examined three different devices that measured lipid profiles and compared them to reference methods. Using that data, we evaluate performance on a Sigma-scale and determine the implications for laboratory QC.
Continuing in our series on translating method validation studies into Six Sigma metrics, we examine a Roche Integra 400+ chemistry analyzer, with data provided by St. Joseph Hospital in Houston, Texas.
A remarkable study by Lenters-Westra and Slingerland in early 2010 found that 6 out of 8 HbA1c POC methods did not meet generally accepted analytical performance standards. What happens when one of those failed methods asks for a "do-over"?
Working with CAP Today's recent survey of High Volume Hematology Analyzers, we convert the manufacturer precision claims into Six Sigma estimates. Want to see how the instruments shape up?