Well, not necessarily anything, although as usual that depends on the circumstances. Recently I was contacted by an individual who was concerned that their DLCO had decreased from 120% of predicted to 99% of predicted. They also mentioned that their DLCO results have normally ranged from 117% to 140% of predicted over the last 9 months.
More interestingly however, they said that
“the technician told me before I even took the test that anything over 100% for DLCO is essentially a testing error.”
Wow. That statement is wrong on so many levels it’s hard to know where to start but I’ll give it a shot anyway.
First, there are a variety of DLCO reference equations. The ATS/ERS guidelines recommends that PFT Labs pick the reference values that most closely matches their patient population but how this is done is left to individual labs. There are at least a couple dozen DLCO reference equations to choose from and probably about a half dozen of these are in common use in PFT labs around the world.
Because no patient population is ever going to precisely match those of a study this means that DLCO results are going to tend to be above or below 100% of predicted depending on which reference equation the lab is actually using. This also means that if results from otherwise normal subjects are mostly above or mostly below 100% of predicted then the wrong reference equations are being used.
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.