Pressing questions in POC glucose testing

“We recently had a meeting with our representatives from intensive care, the emergency department, surgery, and so forth to work on our definition of what a critically ill patient is,” she says.

While this specific circumstance is unusual, this kind of collaboration grows out of an underlying effort to make the process of evaluating POC test requests one that is multidisciplinary and evidence based.

“You need to make certain you have the right people at the table,” Dr. Perry says. “If you have the right people and then you interact with them, you’ll come to a good result.”

An example of a good POC testing outcome, in Dr. Perry’s view, started with a patient.

“We had one child at Children’s who really got tired of getting a venipuncture,” she said in the POC session at CAP ’14. “He commented, ‘I poke my finger every day for my glucose three or four times, and now when I come here for my hemoglobin A1c I have to do a venipuncture. How come?’ And you know, kids are smart. Being at a pediatric hospital, it’s amazing. They know about blood and blood draws. So we did something to address that.”

Clinicians had a concern too—to have the A1c results while their patients were still in the clinic. The first plan was to have children get drawn at the phlebotomy outpatient area before going to the clinic. But that was not a foolproof solution because results did not always get to the physician’s office in time, and sometimes patients needed other laboratory work, which meant a second trip to the phlebotomist in the same day.

To address the issue, they brought in a POC testing device for A1c, first to the central lab “to make sure that analytically it was good and to make sure that it was easy to use, easy to perform,” Dr. Perry said. “We found that it met all those criteria.” The next step was to put the same point-of-care device into the endocrinology clinic and train a select few endocrinology nurses.

“Now the kids could either have it done in the central lab, if they had other laboratory tests done, or in the clinic,” and having it in the clinic solved the problem, she said. “What happens is the kids can get a point-of-care test for the hemoglobin A1c, the result is back while the child is in the clinic, and the doctors can look at them and say, ‘You know what, your A1c is 10, Johnny. Quit eating so much pizza, drinking so much pop. You’re not in compliance.’ As opposed to calling him three or four days later.”

Patients and clinicians were happy with the change, and the lab was satisfied with the accuracy of the device. But harder outcomes, such as whether patients’ A1c or overall diabetes is better controlled, or whether their hospital admission rates have dropped, are yet to come, Dr. Perry said. She and her colleagues are working to evaluate that now. The medical literature on the outcomes correlated with POC testing is fairly sparse, she noted, and she urged measuring outcomes as a routine part of evaluating the success or failure of a proposed POC test.

“If you’re bringing a new point-of-care test online, go all the way from drawing the blood and performing the test to the outcome and looking at what you’re going to see,” she said. “Did this change the process of the patient experience? Did we get somebody through the ED faster? Did we get someone through radiology faster because now we have a bedside creatinine test that they can do right before their scan rather than going to the lab, getting a creatinine, waiting for that?”

In his CAP ’14 talk, Dr. Bosler detailed the Cleveland Clinic’s Point of Care Compliance Council. When he became medical director of POC testing in 2009, the council was active in the health system’s main campus. He and his colleagues expanded oversight to Cleveland Clinic’s eight regional hospitals in Northeast Ohio, as well as its outpatient clinics. The idea is to have a central, multidisciplinary body that assesses requests for new POC tests according to established criteria.

“There’s a lot of baggage that comes with point-of-care testing, but at its base it’s not either all positive or all negative,” Dr. Bosler said. “Each new opportunity for point-of-care testing requires assessment of the individual application in order to determine whether it is bringing value to the end goal, which is to improve patient care.”

The central question, he said, is whether the benefits of a POC test outweigh the risks. That involves looking at the clinical application, the perceived value to patient care, the anticipated volume, the number of users and their credentials, the number of sites, and the setting of the testing. Other factors to evaluate are the differential in quality of the POC test method versus the central laboratory, the CLIA status, and the costs.

Clinicians frequently misunderstand the financials associated with bringing in a new POC test, Dr. Bosler tells CAP TODAY.

“They might, for example, look at the cost of test strips and compare it with the charge-master price for a given test and say, ‘Look, it’s so much cheaper.’ But when comparing the full cost of the point-of-care test to the full cost of the automated line, it is really difficult to make the case that the POC test is cheaper on a test-by-test basis, unless you can make the case that having the result earlier will make a difference in patient outcome or efficiency,” he says.

“Point-of-care testing quality management also can be complex, if you have high volume, and a high number of instruments, and a broad number of users that you need to manage centrally with a quality coordinator. And if you don’t have interfacing capabilities, that drives a lot of manual processes. The clinical team may not be thinking about those efforts and costs.”

This is just one area that is regularly elucidated through the systematic process of evaluating POC test requests through the Cleveland Clinic council, Dr. Bosler said in his talk. But that exchange of perspectives will not occur if the laboratory alone is making the call.

“This really should not be done as the laboratory making decisions in a vacuum,” he said. “We need to have a cross-functional team because to impact a system of care, the decision process must involve cross-functional representation of the system.”

At the Cleveland Clinic, that means representatives from quality and patient safety, pathology and laboratory medicine, inpatient and outpatient nursing directors, and more. There are two reasons why that inclusive approach is essential, Dr. Bosler explained.

“One is that cross-functional representation provides better input to start with; it yields better decision-making. And secondly, cross-functional input, once those decisions are made, really helps to drive the execution and compliance with those decisions.… An important concept is that engaged leaders will be a powerful ally in alignment of priorities, resources, and compliance efforts.”

As an example of the process in action, Dr. Bosler told of rheumatology’s seeking to use synovial fluid crystal analysis at the point of care. This was a high-risk setting, the council judged, because it was at multiple sites, with low volume, performed by physicians who may be less likely to comply with policies and procedures, and highly complex, and it involved a manual method with manual resulting.

The council approved the POC testing program, but not before designing a compliance program and coming to terms with the rheumatologists in a detailed service level agreement. The document spelled out what would be done by laboratory medicine, and what would be the responsibilities of the rheumatology department and its testing staff with regard to documentation, competency and proficiency requirements, inspections, maintenance, and reporting. The council held the lever of withdrawing its authorization for the POC program if the rheumatologists didn’t follow through on the agreement.

“This is a tool that we can use to provide both role clarity—so it’s very, very clear from this document what the responsibilities of the rheumatologist and the rheumatology department are—but then also accountability, because we can point back to it and say this is what we agreed you would be doing,” Dr. Bosler said. “So if either party is sort of lapsing on this, we can draw back to the document.”

In addition to evaluating POC testing’s quality outcomes and taking a collaborative approach to assessing new POC test requests, it is essential to ensure that POC testing is done in a way that minimizes the risk of disease transmission, said Stanford’s Dr. Geaghan. She discussed several hepatitis B and C outbreaks that have been traced to POC glucose meters and related equipment, and outlined steps hospitals can take to improve patient safety.

Only single-use lancet devices should be used, she said, and meters must be disinfected after every use. According to the CDC, the POC glucose meter should be restricted to a single patient, if possible. Meters should be properly stored to eliminate their inadvertent use for other patients. Nurses and other health professionals administering the tests should change their gloves and wash their hands between each testing event, and single-use packaging of glucose test strips also should be considered.

“It’s our responsibility to protect our patients and use best practices,” Dr. Geaghan said.

The best single action hospitals and clinics and other facilities can take, in her view, is to do an unannounced observational audit.

The goal of patient safety and many others in POC testing can best be achieved through a collaborative process, Dr. Bosler says. He brings this story back to where it began with the federal government’s impending regulations on glucose meter use among critically ill patients.

“It’s the process of building relationships that over time helps you,” he says. “Just the process of defining a critically ill patient is a primary example that requires a multidisciplinary approach. And it’s easier to have those conversations because of the infrastructure that’s been set up, and the communications that were set up, through our point-of-care council. Not necessarily that all the people who would be involved are attending regularly, but there’s a network of interested parties to start with.”

Kevin B. O’Reilly is CAP TODAY senior editor.