Quality Requirements and Standards
A ground-breaking new study of EQA performance demonstrates the vast distance between real laboratory performance and EFLM optimal, desirable, and minimum goals. A quick review of 25 common chemistry tests shows a gap unlikely to be bridged by today's instrument performance.
A recent paper by Marrington, Sinclair and MacKenzie raises important questions: why do methods that are not fit-for-purpose stay in the marketplace? Given all the institutions and regulations, why is the ability to remove a method from use so weak?
The outcry over LDT regulation misses one key point: Phase 1 takes effect May 6th, 2025. No matter how much we don't like FDA's LDT rules, they're on the books.
The IFCC has issued a new guideline on how to properly implement IQC. Surprisingly, it still supports the use of Westgard Rules and analytical Sigma-metrics. Not surprisingly, a growing emphasis (and confusion?) about the use of measurement uncertainty.
There are some who say bias doesn't exist. There are others who say bias is just a variance. Here, we explore the fantasy world that they live in.