POC testing roundtable: risks, resources, relationships

Dr. Cotten: I don’t direct point-of-care testing at UNC like I did at my previous employer, Ohio State University Wexner Medical Center. I’ll speak to this question from the OSU perspective. We took the package insert and intended use very seriously with our glucose devices, and that prompted us to develop a comprehensive management plan of how and where the device was being used and the type of specimens used. We developed criteria that were a decision support tool for the users, and that training eventually was incorporated into computer-based learning that was required by all users, and that worked out very well. It was a long journey from inception to effective deployment of the program, but it turned out to be successful.

We did see in certain populations reduced instances of hypoglycemia. We felt like we were now guiding the user to get the right specimen type for the right population. And they developed quality indicators that were monitored monthly and audited. That’s an important component of any point-of-care program; you can’t just let the devices go out in the wild and then not have oversight. As others have said, you can’t do site visits at all your locations with all end users, so you need some way to effectively audit that data. Ohio State did a good job with that.

At UNC, we’re kind of in the same boat. There are point-of-care coordinators who take compliance seriously and work closely to try to round at most locations, as much as possible and at least monthly, and they have QI indicators that are monitored closely by our director who is over point of care. There are the usual struggles and opportunities for improvement.

Dr. Bowman, you said it takes a systematic approach with a lot of commitment not only from nursing but also from clinical advocates. Do you foresee a greater commitment from nurses as these concerns come more to the fore in any institution or health care system?

Dr. Bowman: It will vary but, yes, I do, especially if they understand the risks. This is the age-old conundrum of point-of-care testing: how to balance the lab’s interest in technical needs with the operator’s interest in clinical needs. Education, quality management, and auditing are extremely important, but there’s no substitute for strong leadership, commitment, and partnership. To me, point of care is a lot about developing good relationships.

Dr. Geaghan, how has the field evolved, and what hopeful signs do you see at Stanford?

Dr. Geaghan: More than 10 years ago, I went to a pediatric patient’s room because I was offered the chance to see what an artificial pancreas looks like and how it works, and now it is a reality. It’s about software and integration in a device system that doesn’t need organs or synthetic tissue but is a safe and effective way to integrate the so-called first hybrid close-looped system, which was approved a couple of years ago.

And this field continues to evolve. To me, that’s the most exciting future for this field: to integrate the monitoring, which should be automatic and 24/7, and then adjust basal insulin doses in the patient based on their innate close-looped system. The FDA has been committed to making sure these device systems are safe and effective and has developed guidance for these applications. This could be the future and eliminate fingerstick monitoring someday. But for countries and patients that don’t have access to this, we have to have a parallel track of improving the conventional diabetes blood glucose monitoring.

Inpatients tend to be sicker than ever before, and with the enormous problem of diabetes in the population, the solutions you’re suggesting for the future will play an important role in health care.

Dr. Bowman: But it’s actually the nondiabetic population that may be more at risk from dysglycemia or conditions with hypoglycemia, hyperglycemia, and glycemic variability or swings in glucose levels. Dysglycemia may actually reflect a person’s clinical severity and put sick patients at more risk. And there’s literature that shows that diabetics who are used to the swings may do better, whereas a nondiabetic patient may be more at risk from dysglycemia since they are not conditioned to the swings. So we need to educate people that we’re not dealing just with diabetes. We’re dealing with dysglycemia, and that means that everybody may be at risk.

Labs have tight budgets and a shortage of qualified technologists, which would include point-of-care coordinators. Some systems have had to put in extra appropriations for laboratory personnel just to hold the cohort in place that they need to serve their patients. Dr. Fantz, have these laboratory labor issues and point-of-care coordinating issues affected point-of-care activities as you see them from your perch at Roche, and if so how?

Dr. Fantz: They absolutely do. We’re being asked to develop software solutions that can help manage larger numbers of patients. We’re also seeing from a regulatory standpoint a loosening of the guidelines to allow more people to do point-of-care testing. People who haven’t been trained in laboratory medicine are now becoming experts in their own areas for their institutions for point of care. We’re seeing more test development challenges because concepts that may be intuitive to point-of-care coordinators are challenging to others who have not been traditional users of point-of-care testing, such as troubleshooting, quality control, and operator lockout.

Dr. Cotten, how does the labor problem affect point-of-care testing?

Dr. Cotten: This speaks to the question of where we see point of care going in general. There is a push toward point of care because on paper workflows can be designed around a point-of-care test and on paper there is gained efficiency and cost avoidance, whether it’s OR time or triaging. But the cost or the consequence of that is, as has been said, you’re pushing the end user to a person who is not a laboratorian to do the testing.

If you ask nurses whether they want to run more point-of-care tests, for most the answer is probably going to be no. Yet the trend administratively seems to be developing workflows, whether in a particular unit or in entire buildings, that are based around decentralized point-of-care testing.

I don’t know if point-of-care testing is going to solve the labor problem; I think it’s just going to create a different type of labor problem.

Dr. Bowman: Sometimes you think you’re going to have a savings, but when you look at the monitoring costs and at the clinical workflow, it’s not as big a savings as expected, and it may be more of a burden. So labs have to work with sites to be able to provide the best service they can. But you have to be aware constantly of clinical process and everything that’s involved and, of course, there is the adage: If you have a bad process and you add point-of-care testing, all you have is point-of-care testing and a bad process.

So if you’re thinking about adding point-of-care testing or using it as an adjunct, you have to open up the entire process and you have to get all your stakeholders invested and get the different perspectives. I’m sure we could all give examples of how you introduced a point-of-care test and it just wouldn’t work. And when you looked at it, you saw there was an unworkable clinical process and it was never going to work in that context. In the right setting with the right process, it’s wonderful, and it does add to efficiency and better quality. If you don’t think that out, you could have a bigger problem on your hands.

Dr. Geaghan: I am a fan of the secret-shopper technique. If one has a resident, or whatever the level individual you can put on this, it’s extremely helpful to see what people are doing out on the floor when they are not being watched in terms of ensuring patient safety in this point-of-care testing arena.

Eliminating the need for fingerstick blood testing for people with diabetes is now a reality with some of the new technologies the FDA has authorized, and that, to me, is the most exciting solution. As currently implemented, fingerstick blood testing continues to pose risk for patients as we see from the literature. In that sense, we still have a lot of work to do out there.

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