Another question from the Cut Your QC webinar:

"Most of my staff are generalists. It can be difficult for them to keep up with all of the details in every department. If we use different QC rules on each assay and instrument, how do we manage their frustration and confusion?"

I get it. The prospect of every assay having a different set of QC rules is daunting. But we're not asking the staff to know the QC settings of every test or instrument. We're just asking them to follow the software alerts.

The only practical way to implement a customized, optimized QC approach is to shift the burden from the staff to the software. Each tech doesn't need to know all the settings of all the tests and instruments. They just need to respond to the charts when and only when the flag goes up.

If we move this burden further upstream, we can embed the correct QC rules into each test. So the software keeps track, does the correct rule interpretations on each test, so that all the control chart interpretations are flagged by the software and the staff simply responds when a flag is raised. The staff doesn't need to do _more_ rule interpretation on the chart than what the software is already doing. 

This obviously requires that the QC software has the capability of setting rules on a test-by-test, instrument-by-instrument basis. 30 years ago that was not possible. Today, however, the major control vendors offer their software with test and rule customization, and most of the major diagnostic manufacturers build that capability into their instruments.

Where this solution breaks down is where the software is too primitive, too backward, to allow individualized QC rules. I have seen this in some of the enterprise-scale hospital information systems, where the QC module is such a severely neglected feature that it represents a step backward in utility. I have also seen a lot of POC devices where there is no flexibility available in QC, just one set of rules for everything. Some instruments from emerging diagnostic manufacturing countries also have this failing.

In short, if the instrument or software is so inflexible there is no customization of rules possible, it's unlikely that the staff can carry that burden. The days of building your own QC monitoring, on paper, or in an external spreadsheet, are mostly behind us. There isn't enough spare time for the staff to add this tool. Instead, the suffering and inefficiency of bad QC is likely to continue until modern software/instruments are adopted.

However, a final note on "frustration and confusion" that laboratory staff may suffer. The most common laboratory practices – using the 1:2s and repeating controls after 2s outliers – are also the most likely things that will cause frustration and confusion. If we apply the Westgard Sigma Rules approach, we can eliminate many outliers, alleviate many frustrations, and eradicate many confusions.
Implementing a new approach takes more effort than the status quo. But once the new system is in place, there will be fewer frustrations and confusions.