Posted by Sten Westgard, MS
Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.
But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?
The answer depends on how legalistic you want to get. In the US, the IQCP policies and requirements will have the force of law. When CMS issues the final guidance on how to inspect and interpret IQCPs in 2016, every US lab that wants to use risk analysis to change QC frequency must comply with those IQCP regulations.
However, outside of the US, the IQCP regulations have NO legal weight at all. They are, at best, an example of how to do risk analysis in the laboratory, and possibly not even a useful one at that. While some ISO standards recommend doing risk assessment, the specific (or, in the case of IQCP, vague) format dictated by CMS is not the only game in town. There are plenty of other ways to assess risk, some techniques that are far more established, that have time-tested ways to prioritize failure modes, reduce risks, and monitor quality.
If a laboratory outside the US is curious about risk assessment, I would advise consulting the ISO standards first, then possibly the CLSI EP23[tm] guideline next. Remember, the chain of birth for these policies starts with ISO, then goes down through EP23[tm], and finally emerges as a watered-down memo from CMS.
I also believe that laboratories outside the US should understand that IQCP is really a US workaround to solve a problem with EQC and reduced QC frequency. Back when the CLIA regulations were first issued, CMS allowed point-of-care devices to run QC less frequently on a "temporary" basis, until they could get more applicable regulations established. This "final rule" was postponed and postponed until it was quietly shelved. In the absence of CLIA regulations on QC frequency, CMS and other organizations tried to justify reduced QC frequency with the "EQC options" - (you may recall we referred to it as "Equivocal QC"). EQC turned out not only to be wholly unscientific and indefensible, it was deeply unpopular with labs, manufacturers, and regulators. EQC is still in place right now, and IQCPs were developed as a way to replace that policy. Through the magic of risk assessment, labs will have the power (and liability) to decide that they only need to run QC once a week or once a month. All that residual risk will get passed on to the patient.
Outside the US, there are more professional standards that make running QC only once a week or once a month seem ridiculous. Many labs beyond our borders consider that kind of operation to be reckless. They will keep running QC on a safer frequency, one that allows them to detect medically important errors within reasonable time.
There are plenty of things that the US does that everyone else in the world knows not to emulate. IQCP can be added to that list. Risk Management is a good thing, but the particular incarnation of risk assessment as found in IQCP has a lot of flaws. If you're working in a laboratory outside the US, why make the same mistakes as US labs and regulators, when you are not bound by our regulations? Go ahead and embrace Risk Assessment, but don't feel compelled to use IQCP as your blueprint.