Tools, Technologies and Training for Healthcare Laboratories

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.

So long, Specifications! Gear up for Goals

The biggest change in the Prague conference on quality may be a shifting of goalposts.

Specification too strict? Trying lowering your standards

 It's becoming something of a trend in Europe: lowering standards, postponing implementation of standards, and inventing new reasons why the rules don't apply.

Precision QC - the latest adjectivization of Quality Control

Another year, another new model. Almost regularly as the planet circles the sun does a new model emerge in the literature. The latest is called "Precision QC." Have we been practicing "Imprecision QC" for the last 60 years? Do we need to recreate the QC wheel again?