Q: Can POC Cut their QC?

"Can this approach [Cut Your QC] be used on QC for Point of Care devices? Are rules built into these devices that can't be modified like standard central lab instruments?"

This is another question from our Cut Your QC webinar, now available as an on-demand recording. https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQ

The questioner sadly anticipates the answer. Most POC devices that build in QC into their devices do so with one fixed approach. Often it is an approach that uses wide limits that allow most results through. More frequently, POC devices don't have any "traditional" QC controls, but some function checks. There is nothing to cut. You can only accept the QC as it is, and if it's not doing the appropriate job, the only alternative you have is to get a different device. 

There's an additional sad fact: many POC devices take the IQCP approach to QC. Through a sketchy kind of "risk" review, they reduce their QC to once a month. [I call this the Lunar approach. Great if you're a werewolf, I suppose, but not an actual scientific approach.] If a POC device is basing QC on the phase of the moon, there's nothing left to cut. It's already skeletal, almost vestigial.

Finally, to make this into a worst-case scenario, there are a great number of POC devices that are terrible. Their CVs are too high. The wear and tear on them introduces all kinds of problems. They may have significant differences between the values they generate and similar results coming from the core lab instruments (meaning: significant bias). The staff who use the devices are often not laboratory professionals, but other clinical staff that have no training in instrumentation or QC. An objective Sigma metric would reveal their failings. [This may be one of the reasons these devices reduce QC to once a month; it makes it near impossible to gather enough data to assess the method]

In other words, even though many POC devices deserve the scrutiny, analytical Sigma metrics are rarely calculated for them. The results would probably indicate that QC needs to be increased, not cut. And since the devices do not have the capability to increase or alter their QC, the results of the calculations may only generate depression, not enlightenment.

*Please note, I am painting here with a broad brush. Not every POC device is terrible. There are a few good, even great, devices out there. But they are the minority.