Quality Requirements and Standards
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.
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.
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.
May 6th 2024 will forever be etched into the history of regulation. It's the date that the FDA issued its Final Rule on Laboratory-Developed Tests (LDTs). This is the introduction to this momentous, some might say monstrous, occurrence.
As Yogi Bera once said, "In theory, there is no difference between theory and practice - in practice, there is." So is it true with mu.