Quality Requirements and Standards
In 2011, Clinical Chemistry published an update on the status of hemoglobin A1c measurement and goals for improvement.Update on HbA1c quality goals and performance requirements. NGSP and CAP have been actively tightening standards in an effort to improve method performance. So, in light of these efforts, has there been improvement? If so, how much? And how much further do methods need to improve, given the clinical use and demands on the test?
Are instruments so good that we don't have to worry about quality anymore? Or are they so bad there's no point trying to differentiate one from another? In light of the events of 2010, a reflection on the state of quality in diagnostics and the laboratory.
In 2010, an assessment study of 27 different glucose meters was conducted. That same year, new papers in the literature advocated for tighter quality requirements. An FDA-sponsored public hearing on glucose meter quality also recommended tighter quality requirements. How will these 27 different glucose meters fare if quality standards are tightened?
On March 16 and 17, 2010, the FDA held a public meeting to discuss concerns about the quality of Blood Glucose Meters. As slides and transcripts have become available of this meeting, Dr. Westgard reviews some of the key points.
The next-to-last installment of an extended discussion of HbA1c methods and the analytical quality necessary for patient care. While we may have found problems with many HbA1c methods at the point of care, are methods any better in the central laboratory?