Pop Quiz: What's an IQCP?

Posted by Sten Westgard, MS

Heads up. There's a new abbreviation in town: IQCP

Can you guess what IQCP means?

1. Information Quality Certified Professional
2. Individualized Quality Control Plan
3. Intelligent Quality Control Plan
4. Incoherent Quality Control Plan
5. Ill-conceived Quality Control Plan

The answer, after the jump...

The answer, of course, is 2. Individualized Quality Control Plan.

Back in December, a memo went out announcing the demise of EQC. But the memo didn't have a name for what was going to replace EQC. Risk analysis and Quality Control Plans were mentioned, as was the new CLSI guideline, EP23-A. But there wasn't one specific term that was explained as the replacement for EQC.

Now we know. IQCP is the new EQC. At some point in the future, CMS will terminate the validity of EQC and all laboratories will have the choice of returning to default QC (2 controls a day) or switching to IQCP.

There's a new memo explaining this change here. It's being call the 12-20-CLIA memo, but that only refers to the official CMS Memo #, not the date of issuance. The memo came out on March 9th. 

There's also a brief brochure extolling the future benefits of IQCP here. This is little more than a list of bullet points for claimed benefits, so I'll just list them here as well:

• Customizes QC Plan for each test in its unique environment
• Optimizes use of eletronic/integrated controls
• Offers laboratories flexibility in achieving QC compliance
• Adaptable for future advancements in technology
• Incorporates other sources of Quality Information
• Strengthens Manufacturer/Laboratory partnerships
• Formalizes risk management data already maintained within the laboratory
• Provides equivalent quality testing to meet the CLIA QC regulations

Sounds great, right? Who could be against IQCP when it's going to accomplish all of this.

You may notice, however, that so far we have had a list of claims, promises and future benefits, without much detail on the actual how this will be done and the practical implementation steps. But that's supposed to come later. CMS will be scheduling training for their inspectors to learn about IQCPs throughout 2012. So don't expect to see IQCPs become mandatory anytime soon. (It's far more likely we won't see real IQCPs for a few years.)

By the way, that last bullet point of that marketing list is the most important. Because IQCP is going to be written into the Interpretive Guidelines of the State Operations Manual (SOM), we won't be seeing any public discussion about it before the rules are written. CMS can write whatever it wants into the SOM without having to hold any hearings, because the SOM isn't a public law like CLIA. It used to be an internal guidance manual for inspectors. Now it's an efficient way to modify rules without the burden of extensive debate. The CLIA Final Rule gave CMS this power through section  §493.1256(d), where the novel concept of "equivalent quality testing" was born.

Essentially, this brochure we're seeing is like a movie trailer. Snippets, highlights, and tantalizing clues of what the new policy will be.

Coming soon to a laboratory near you... IQCP