Quality Requirements and Standards
Traceability, Standardization, Harmonization Comparability. Even within the laboratory, these are not terms and concepts that excite most of us. But as the world gets smaller, as health records get more connected and as medical practices converge, reliable, comparable test results are going to matter more and more. Whether we want to get involved or not, we are already in the struggle for standardization.
The public assumes that the FDA is the gatekeeper for safety, and that everything with an FDA clearance is therefore safe and effective. Even some laboratories and other healthcare professionals make this assumption. But a recent report from the Institute of Medicine and an editorial in the NY Times are revealing a cold truth about the 510(k) process...
Laboratories are blessed today with a wealth of information about quality requirements, from CLIA, Rilibak, RCPA and of course the Ricos et al biological database. But all those choices can be overwhelming. Often we are asked, "What's the best quality requirement?" or "What's the right quality requirement for my lab?" Here's some advice on what goals to choose.
A new study from Lenters-Westra, Slingerland et al was published in early 2011. The title says it all: One in Five Laboratories Using Various Hemoglobin A1c Methods Do Not Meet the Criteria for Optimal Diabetes Care Management. What were the findings and what does this mean for HbA1c methods?
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?