Quality Requirements and Standards
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 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.
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.
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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.