POC testing roundtable: risks, resources, relationships

March 2019—Infection control and the heavy demands on point-of-care coordinators were among the top concerns that came up in a recent CAP TODAY roundtable on point-of-care glucose testing. Publisher Bob McGonnagle spoke with four POC testing experts: Sharon Geaghan, MD, Cynthia Bowman, MD, Steven Cotten, PhD, and Corinne Fantz, PhD. Here is what they told us.

We have seen many ups and downs in bedside glucose testing. There was at one point a mania for tight glycemic control; more recently, the FDA had concerns about the use of bedside testing devices in critically ill patients. Dr. Geaghan, what is top of mind for you now, and what are your concerns about point-of-care glucose testing and the devices?

Dr. Geaghan, emerita chief of pathology, Lucile Packard Children’s Hospital at Stanford and emerita codirector of Stanford Clinical Laboratories: Two top concerns I have are the infectious risk of point-of-care glucose monitoring and the limitations of conventional glucose monitoring by fingerstick in terms of the quality of diabetes care and outcomes.

Recently, the CDC reported on health-care–associated hepatitis B and C outbreaks reported to the CDC from 2008 to 2017, and before we talk about the numbers it’s important to remember that the long incubation period of these hepatitis infections—up to six months—and their typically asymptomatic course mean the outbreaks have likely been greatly underestimated. And reporting to the CDC is not required when state and local health departments are notified of outbreaks.

With that in mind, there was a fairly stunning summary of outbreaks of hepatitis B, which required more than 10,000 at-risk persons to be notified, and hepatitis C, which required more than 100,000 persons to be notified. The vast majority of these exposures were associated with point-of-care testing. The fact that single identified cases are not even included in this report and the breadth of settings—from home to long-term care to dialysis units to dental offices, and so on—make this a public health issue of great import.

Bedside glucose testing systems product guide

The CAP has gone a long way toward improving care by adding four requirements to its accreditation program checklist targeting some of the risks, specifically requiring single-use devices for capillary sticks, handwashing and changing gloves before and after patients, and disinfecting the glucose monitoring devices.

My second concern is the limitations of conventional glucose monitoring, mainly that it’s not continuous, there aren’t alarms, and very high and very low levels can go unnoted because of intermittent monitoring.

Dr. Cotten, would you like to comment on Dr. Geaghan’s points?

Dr. Cotten, assistant professor, Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine: Decontamination of the device after use is an important aspect of creating an effective point-of-care program, and device manufacturers could probably spend a little more time in creating a device for which decontamination is easily documented. There has been such influence on the accuracy of the glucose measurement that often we forget all the other aspects that go into effective and safe use of the device in a hospital setting.

Dr. Bowman, former laboratory medical director, Baystate Wing Hospital, Palmer, Mass., and Noble Hospital, Westfield, Mass.: I would echo the concern about infection control, but it goes along with being aware of the limitations and the risks associated with these devices, and that’s probably the biggest issue. The devices have gotten better, and we now have a different, less intense approach to glycemic control; we no longer aim for tight glycemic control. But even some people on the FDA advisory committee were not fully aware of the limitations of point-of-care glucose devices and that any hospitalized patient in a dynamic state could manifest the conditions that affect glucose meter accuracy.

Stakeholders, operators, and the laboratory need to be fully involved in educating people about this. Many are not aware of all the variables that go into the accuracy or usefulness of the devices. We need a strong verification process to introduce these concepts and test the actual practice of using glucose meters, but we also need to have a strong, comprehensive quality process that involves education and constant monitoring of their use and looks for outliers and possible inaccuracy.

The FDA is trying to waive a lot of these devices and get vendors involved so that they will qualify to have their devices waived for use with capillary samples, but there are still a lot of variables associated with that use, and we have to be respectful of that. That’s a great opportunity for the laboratory to be a partner in educating people and assisting in the oversight of glucose meters.

Dr. Fantz, director of medical and scientific affairs, Roche Diagnostics point-of-care: I agree with what has been said. We see customers continuing to struggle with the package insert and being able to educate all the providers using the equipment because there are so many operators in an institution. Getting this information out in a coordinated way is one of the things we’ve focused on with education and the training materials we provide to customers.

When the CMS put out the directive warning about the limitations of these devices, it’s not only that some hospitals didn’t know those limitations existed, but also that they had to be able to develop quality monitoring programs and audit performance so that operators do what you intend them to do after they’re trained.

Health systems are becoming enormous and they incorporate not only inpatient testing, but also, as they take over doctors’ offices and clinics and other smaller hospitals and networks, bedside glucose testing. And it strikes me that the laboratory is given a heroic challenge in having to deal with so many hundreds or thousands of people who are engaged in bedside glucose testing to guarantee quality control. The same is true of point-of-care vendors. Dr. Fantz, is this much like swimming in an ocean?

Dr. Fantz: Yes, it is. The demands on the point-of-care coordinator today are overwhelming. People in those positions are struggling to get to all of the sites they oversee on a monthly basis to do the auditing. That’s why we think that the data analytics and software solutions that companies can provide can help, so they’re not in their car traveling from site to site to analyze what’s going on and only getting to the sites once a month or every other month. We do think that digital diagnostics and relying on software solutions to help them do their jobs more effectively is going to be a trend that continues.

Dr. Geaghan: I agree. The manual, old-fashioned visit doesn’t suffice to the degree that’s required.

Dr. Bowman: This is an example of where laboratories or systems need to provide resources for coordinators. Point-of-care testing doesn’t work well unless you have partnerships and clinical advocates. So you need to have a group that understands the issues—and that’s not only nurse operators and other operators but also your providers and administrators—so they can support the efforts.

Dr. Fantz, can you tell us where Roche is on its offerings for digital and IT help in solving this point-of-care dilemma?

Dr. Fantz: We have a connectivity system, the Cobas IT 1000 connectivity solution. It is used to do things like manage your operators. It houses QC and also connects devices that run not just Roche devices but also third-party devices. That’s just one aspect of it.

We are seeing the point-of-care connectivity piece a bit more broadly than other manufacturers. Everybody has their own solution, but what Roche is doing is investing in digital diagnostics more broadly. Roche is making investments in Viewics, which is a lab optimization tool. There is also a tool called Navify workflow solutions for pathologists to pull in information from other areas, not just pathology but radiology, et cetera, and consolidate reports. Eventually you will see all of that flowing together. The solution that works in one area may bleed over into point of care if it’s working for Navify workflow solutions.

Dr. Cotten, what are you doing at UNC to address the concerns that have been expressed?