Quality Requirements and Standards
Lenters-Westra and Slingerland have just published a new review of HbA1c POC devices. The good news: now 4 out of 7 methods meet the minimum analytical performance. The bad news: that's still 3 of 7 that don't. There's still a lot of room for improvement.
While the responses to FDA's Draft Guidelines for better Glucose Devices have been almost entirely critical, there is a case to be made for tighter glucose goals, particularly on the analytical side. Here's a summary of the studies that bolster the "pro" side for making changes to how glucose goals are set.
It's becoming clear that the 2014 Draft Guidelines on Glucose Meters have raised the ire of nearly everyone in the laboratory marketplace. Here's an overview of the key opinions.
As with January of every year, there’s an impulse to set goals. Perhaps a worthy goal of 2014 would be to choose the right goals for quality.
An extended version of an essay originally prepared for the September 2013 issue of Clinical Laboratory News. It discusses how "total" our "total error" should be. Back when Total Analytic Error was introduced, it was clear that it concentrated on the analytical step. Over the years, "mission creep" has tempted others to keep expanding the types of errors to be considered.