5 Things we Know Now about IQCPs

Posted by Sten Westgard, MS

On August 16th of this year, CMS issued a new memo about IQCPs. If you recall, IQCP stands for  Individualized Quality Control Plan, and it's part of the new Risk QC being proposed by CMS as a replacement for EQC. The CLSI guideline EP23, which came out about two years ago, laid out the broad outlines of this new policy, but we have been waiting for the government regulations to spell out the specifics of implementation and interpretation.

So here are five key things we know now:

1. It's really coming. The CMS memo lays out a timeline that explains a 2-year process of phasing out EQC and replacing it with IQCP.
   • Week of September 15, 2013: IQCP Training of RO CLIA surveyors
   • Week of November 18, 2013: IQCP training of SA CLIA surveyors
   • January 1st, 2014: IQCP Education and Transition Period Begins
   • January 1st, 2016: IQCP Education and Transition Period Ends [EQC expires]
     
2. We still don't know all the details and it's not really here yet. Obviously, we've got more than two years ahead of us before all labs must switch from EQC to IQCP. The State Operations Manual (SOM), which contained all the devilish details for EQC, has not yet been updated to contain the new devilish details for IQCP. So while the memo lists more details than we've seen to date, the IQCP remained to be fully fleshed out.


3. There's no grandfathering. Unlike the "Final" CLIA Final Rule, no method gets an EQC "pass" [when the Final Rule came into effect, older methods didn't need to go through method validation; only newer methods did]. Everything using EQC will have to be re-established through Risk Assessment for IQCPs. There will not be a simple switch where a group of POC devices that were chugging along with EQC will get to slap an "IQCP" label on top of their current EQC SOP and keep operating the same way. Every device that was using EQC will need to go through a Risk Assessment process, before it can develop an IQCP which may or may not allow reduced QC frequency. Here's the quotation from the memo:
   

   "We do not anticipate grandfathering test systems under the current EQC policies and procedures. However, historical data accumulated during the EQC evaluation protocol and its ongoing usage could (and likely should) be used in the development of the laboratory's IQCP."

4. Manufacturers will not be able to do this for you. Call this the "EP22 - Catch 22." When EP23 and Risk QC was originally proposed, an accompanying guidline EP22 was supposed to be developed, which would allow manufacturers to develop a standard way of presenting Risk information. That would then allow labs to take that information and use it in their Risk Assessments. In other words, EP22 handed off to EP23 and the whole thing was going to be easier. Unfortunately, along the way, EP22 committed suicide by committee, so EP23 was left all alone. Now, CMS appears to be saying that laboratories, and specifically laboratory managers, will not be allowed to simply take a manufacturer's "Risk Assessment" document and sign off on it.Here's the key quote:
   

   "Note: Manufacturer-provided tools and templates, if available, may be helpful for laboratories implementing IQCP; however, laboratories will need to supplement these materials with laboratory-specific information as part of the Risk Assessment. The manufacturer information is not sufficient in and of itself." [In other words, you can't just accept a manufacturer's "Our Device is Low Risk" brochure as gospel. You need to actively make a Risk Assessment of the device when it is operating in your own laboratory.]

5. The Risk of Risk QC is all on the Laboratory Director. As with EQC, the CMS regulations are quick to point out that the practice of reduced QC may be compliant, but it may not be clinically appropriate or even legal:
   

   "The laboratory director must consider the laboratory's clinical and legal responsibility for providing accurate and reliable patient test results (§493.1407 or §493.1445) prior to implementing a QCP that is less stringent than the specified Analytic Systems control regulations..."

It's a strange world we find ourselves in, a bit new (Risk) and a bit familiar (some of the same EQC warnings and weaknesses). That particular provision sounds like a warning: You can implement Risk QC and be in compliance with CMS, but you may not pass a clinical or legal challenge.

We'll know more soon as the regulations slowly dribble out over the rest of the year. This memo answered some questions, but raised others.

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