Tools, Technologies and Training for Healthcare Laboratories

2025 IFCC Recommendations for IQC

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.

Suffering from Looming Deadline Trauma? (LDT) Regulation

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.

On the Fallacy of Disappearing Bias

 

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.

It's time to talk to your FDA about ED. [enforcement discretion]

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.

Theory versus Practice in Analytical Quality Specifications

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.

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