Quality Requirements and Standards
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.
A recent advisory report on the NHS, chaired by Dr. Don Berwick, has valuable lessons for all healthcare systems: Sometimes we can hit a goal, but miss the point. But while the report acknowledges this truth, it also says the opposite can be true as well: sometimes we can set a goal we'll never be able to hit, and that, too, can be harmful to our healthcare system. So we bring the issue to laboratory quality requirements: do we have goals that are too hard (or too easy) to hit?