CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dr. Rhyner (Beckman Coulter): The preservative tube issue is complex. The preservatives themselves can play with urine chemistry results, and that’s the heart of the issue. As to the approval and what will be accepted from the regulatory agencies, it’s not all the manufacturer’s decision. The FDA has a lot to say about what it considers to be interfering substances. That’s where I would leave it from my perspective: It’s something we want to expand, but we need to work closely with the regulatory agency because the agency has a definitive point of view.
Dr. Nakashima, does that mean you would have to set up some of this as a laboratory-developed test?
Dr. Nakashima (Cleveland Clinic): Yes, that is what we’ve had to do at some sites.
We had so many issues because you can never really tell what happened to a urine sample. You either run it in one hour or you hope someone refrigerated it, and that’s just too much variability. We could either reject all these samples or use preservatives, so that’s why we’ve made that move.
An LDT application may be easy for the Cleveland Clinic but not for a lot of other labs. Carl, can you comment on this?
Carl Trippiedi (Sysmex): Matt mentioned it was a complex situation and I’m going to add another layer of complexity—the tube manufacturers, because they use different preservatives and different manufacturing techniques, it does become a challenge. But we know and understand what the market needs and that is to be able to use a preservative tube. So where tube manufacturers are developing their own standards and their own validations, our industry will need to continue working with both the regulatory bodies and with the collection tube manufacturers to find a resolution.
Carl and Matt, can you comment on data handling in integrated urinalysis systems? Are you happy with the data handling to date? Could it be improved? What couple of things could make everyone’s life easier from the data reporting point of view?
Carl Trippiedi (Sysmex): Data handling is improving. With our new UN system, we do have a single point for data handling and that’s the urinalysis data manager. The UDM is a single interface to a lab information system through an LIS vendor. As much as the data can be analyzed and reported in one place at one time, it is best for the customer. That’s what customers have told us is a product requirement—one we’re trying to meet.
Dr. Rhyner (Beckman Coulter): One nice attraction of a fully integrated workcell is you get the chemistry and the cross peer results. There are opportunities to do more networking. There’s greater opportunity, as Carl said, to connect more fully with the LIS. In terms of what the data is, in the future it can get much better at more certainty around the particle classifications that can be reported, and perhaps new types, new particles could be expanded. Urinalysis is a lot different than it was when it was all manual review, but there’s still progress to be made. It’s probably not as advanced as some other parts of the laboratory.
Dr. Nakashima, what can you tell us about data handling?
Dr. Nakashima (Cleveland Clinic): We do use an integrated workcell and it transmits data pretty well to our LIS. We’re also now going through the pain of an LIS conversion.
There’s always the issue of whether you want the perfect final answer to be transmitted or if you want kind of raw data or if you have middleware to handle that. I haven’t done enough of this hands on to have an opinion about which of those things is best, but things can always be better.
Dr. Nakashima, could a better, quicker use of urinalysis lead to improved antibiotic stewardship?
Dr. Nakashima (Cleveland Clinic): The chem strip can be negative in someone who does have a UTI, so unless we were to find a new marker, I don’t think that would be entirely possible. It is if someone is nitrate positive; then they know what to do with that.
Any comments in closing?
Dr. Rhyner (Beckman Coulter): Urinalysis is a field that has the potential to do more than it does today. Interesting solutions will come to market and you will see more near patient care as the diagnostics field expands.
Carl Trippiedi (Sysmex): I agree, and I would add that clinical laboratories need an efficient way to continue to turn out results. By utilizing data and reflexing, labs will become more efficient with the newer-generation analyzers that are now on the market.
Dr. Nakashima (Cleveland Clinic): I agree with both. Anything that can reduce manual work is welcome in any part of the laboratory. A dream for the future would be to have a smaller-scale automated instrument, which I know would be difficult. But I hope the companies will keep that in mind going forward.