Should biological quality control be replaced?

I’ve been thinking about quality control and quality improvement lately. Mostly this has been about how to go about determining whether the lab has a quality problem with testing and what statistics should be used for this purpose but I was reminded recently about an issue concerning biological quality control that came up a couple months ago on the AARC diagnostics forum. Specifically, one of the participants noted that some of their technicians had refused to perform biological QC on the basis that it violated their HIPAA rights to the privacy of their medical information. Further discussion noted that this was actually a correct interpretation of the HIPAA regulations and that no PFT lab can “force” its technicians to perform biological QC.

I will be the first to admit that I’d never thought about it this way, and I’ve been mulling it over ever since. I’ve performed PFT testing on myself both for formal biological QC and as a quick way to check the operation of a test system for decades but I never thought of my PFT results as being part of my medical information. That’s probably an indication of my own short-sightedness however, and I also realize that over the years I’ve run across a number of testing issues I’d taken for granted up until somebody pointed out a problem with them.

My attitude towards my PFT results may also be due to the fact that I don’t have any notable lung disease. My lab has had technicians who have been asthmatic however, and this has never been a factor in whether they were hired or not (other than not letting them perform methacholine challenges). They’ve usually performed bio-QC on themselves and at the time they seemed to regard it as a way to check on the status of their asthma. In retrospect however, I have to wonder if they were ever concerned that I would use their health status and test information against them in their annual evaluation, or even that the hospital would re-consider their employment because the costs of their health insurance might be higher. Although I don’t think the hospitals I’ve worked for ever thought along these lines, like it or not there are many businesses where this is a factor.

Yesterday I asked myself what would happen if all PFT labs were required to completely end biological quality control because of HIPAA requirements? It didn’t take a lot of thought to realize that there are a number of mechanical test simulators in the marketplace that could do quite well at replacing the biological part of quality control. As importantly, the more I’ve thought about it the more I’ve come to think that biological QC probably isn’t the right way to go about QC in the first place.

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QC and the DLCO Simulator

I’ll start by saying that I am not associated with Hans Rudolph Incorporated in any way. I just think they make a bunch of good products, and more specifically in this case, a DLCO simulator.

For as long as I can remember I have always had intermittent problems with DLCO testing and I suspect that every PFT Lab has had them at some time. One of my current concerns has to do with how our test system’s software is calculating exhaled CO and CH4 concentrations from calibration data, but I’ve had other concerns at other times too. One way around to verify that your test system is actually performing the way it should is biological QC but a more precise way is to use a DLCO simulator.

Every PFT Lab should be performing biological QC (self-testing) regularly (and if you aren’t, why aren’t you?). This is the simplest way to check a test system but it does have limited accuracy. My personal experience for DLCO tests is that there was usually a range of about 1.5 ml/min/mmHg (roughly 5%) within the results from a single testing session and 2.5 ml/min/mmHg within session-averaged results over the course of a year. This is good enough to get a general sense of how well a test system is working but not precise enough to pinpoint specific problems. Used correctly a DLCO simulator can produce highly reproducible and accurate test results.

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