The Big News from Houston: What's an IQCP again?

Posted by Sten Westgard, MS

The biggest news coming out of the AACC/ASCLS conference in Houston was made by Judy Yost of CMS.

So the new future is IQCP. Remember what that stands for?

• It's Quickly Coming to Pass
• I've Quit Caring about Performance
• It's Quackery, Chaos, and Pablum
• I'm Quietly Compromising my Processes 

Of course, the answer is that the new regulations are Quickly Coming to Pass (at least on the government time scale). And IQCP really stands for Individualized Quality Control Plan.

At the CLSI information session, Judy Yost announced that new regulations regarding Risk Analysis and CLSI's EP23  guideline would be released in September, that inspectors will be trained throughout the rest of this year, and once these regulations are released, there will be a 2-year clock winding down on EQC. As you remember, EQC is out and Risk QC is in.

In the wake of this announcement, other manufacturers have also begun making announcements. Since Point-of-Care (POC) devices have been the main implementers of "Equivocal QC"/EQC protocols, they are starting to warn their customers that change is coming.

• From Abbott I-Stat, their alert on the coming regulatory changes.

• From Bio-Rad, a new white paper explaining their recommended approach to Risk Analysis

So the next shoe is almost about to drop, almost 2 years after CLSI issued the accepted public version of EP23. Stay tuned...