By Annette M. Boyle
IOWA CITY, IA — Years ago, “point of care” testing meant a physician took a sample of blood or tissue and looked at it under a microscope while the patient waited—and waited. Handheld devices with sophisticated technology now permit testing with just a drop of blood and a couple of minutes.
From the perspective of Michael Icardi, MD, the VA’s national director of Pathology and Laboratory Medicine Services, the transformation of testing promised by these devices has just begun.
“We’re moving the goal posts. It’s not just about providing point of care service, but enabling patient self-testing in the near future. One of the limitations has been getting a patient to provide specimens to do labs. If they can do that where they live, everything opens up,” Icardi told U.S. Medicine.
In the long view, he envisions a system that relies on cell phone technology for testing that can be conducted at a veteran’s convenience. “How close are we to that? Microfluidic systems that work with cell phones are already in use,” Icardi said. A British system uses a sticker placed on a cell phone screen to enable the underlying system to do the analysis, perform quality assurance and transfer data to an electronic health record.
As an intermediary step, Icardi expects handheld devices to become more common in pharmacies. “A veteran will be able to stop in the pharmacy to pick up a prescription and get a pregnancy test or hematocrit right there. We’ll be able to look at the results and talk to the patient via telehealth and bring the results into the VA system.” Already, he noted, veterans can receive immunizations at Walgreen pharmacies and have their records transferred to the VA.
VA facilities today use handheld testing devices to speed results and treatment. “We’ve been using cartridges that enable quick tests of glucose for at least 15 years,” Icardi said. “Now, they offer a wide variety of tests that can be performed at the point of care.”
The VA uses both the i-STAT and Piccolo Box systems from Abbott Laboratories as well as other point of care devices. Both offer a variety of cartridges which are read by the system’s housing. The test performed depends on the cartridge used. The microfluidic systems perform the same tests that are otherwise done in a lab, but on a microscopic scale. They require just tiny amounts of blood and use minute amounts of reagent, which makes testing much cheaper, Icardi said.
While the systems are used in some VA laboratories, they are particularly valuable in facilities that lack in-house labs, he noted. VA medical centers and other larger healthcare facilities have vacuum tube systems that can send samples to an in-house lab and get results rapidly, but many CBOCs need to transport samples to external labs and wait for reports.
That can create delays that reduce the quality and timeliness of treatment, particularly if a veteran has to wait for an extended time to get a follow up appointment or has trouble getting to appointments. Being able to assess blood glucose control with the patient in the office, for instance, allows a clinician to make treatment decisions and provide appropriate education in one visit, reducing the time and cost for both the VA and the patient and enabling the veteran to achieve better control of his diabetes more quickly.
Delivering test results during an office visit has two additional benefits, Icardi said. “We have reports of increased compliance with treatment from immediate feedback from coagulation, diabetic and drug treatment programs.”
In addition, the quick turnaround eliminates the uncertainty and additional visits that might be necessitated by an abnormal value reporting. “A point of care test that has a spurious critical value can be followed up immediately. If you are sending samples to a main lab, those abnormal results will be detected late in the day or after hours and will need to be followed up then,” often by an on-call physician rather than the person who saw the patient.
While point of care testing systems are particularly useful in facilities far from laboratories, Icardi noted that “they are used pretty much in every facility.”
That includes some sophisticated settings. “They are fairly ubiquitous in hospital clinics. In many cases, they are used by smaller labs as lab analyzers themselves. This was cutting edge 10 years ago, but it’s now pretty standard,” he added.
At the VA, the devices are commonly used for tests that are approved for waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, known as waived tests. Generally, these tests are “simple and have a low risk for erroneous results,” according to the Centers for Disease Control and Prevention. The CDC notes, however, that errors can still occur with waived tests, particularly if the manufacturer’s instructions are not carefully followed or testing personnel lack training on the system.
To ensure the highest level of accuracy, the VA has used ancillary testing coordinators for 20 years. These specialized lab technicians assist with and supervise all the testing done in clinics, ensure that the personnel have the competencies they are supposed have, monitor that protocols are being followed, and perform troubleshooting at sites, according to Icardi.
“The net result,” he said, “is that the VA is able to offer point of care testing that’s more complex in clinics and maintain high quality.”
In addition, the VA requires everyone who uses the testing equipment to prove proficiency. “Typically, you don’t need to do that for a waived test,” Icardi noted, “and it seldom happens in the private sector, where many waived labs just get a certificate from the state and have little supervision.”
The VA’s oversight and support for point of care testing reduces the likelihood of bad lab results. As Icardi pointed out, if the equipment is run by someone without training, it might not be working properly and they may not know. That’s a risk the VA does not take.
The attention to training and support provided by ancillary testing coordinators “keep the quality of care uniform throughout the system,” Icardi said, “whether it’s provided at a small local clinic or major hospital.”
Consequently, healthcare providers can rely on the results from the point of care devices and use them to make clinical decisions, discuss recommendations with patients and take next steps—all in one visit. For veterans, physicians and the VA, that’s a win-win-win—fewer appointments needed, less time lost waiting for lab results, rapid verification of patient health status and quick adjustments when necessary.