Technology is advancing by leaps and bounds, and manufacturers release new point-of-care testing (POCT) devices almost daily. As news of a novel technology spreads, requests from hospitals, provider offices, urgent care sites, and other locations increase. Likewise, when the public becomes aware of the possibilities of faster testing, people start to expect that when they visit their provider or any other healthcare site, they’ll be able to get results and necessary treatment immediately. With emerging POCT devices, the days of hospital-based glucose and urine dipstick testing being the only tests available at patient bedside are in the past.
Researching New Technology
There are multiple ways to discover new POCT devices. Clinical laboratory-focused magazines such as CLN, organizations such as AACC and the American Society for Clinical Laboratory Science, and social media sites such as LinkedIn are a few sources that can provide information on the latest POC devices. It’s important for clinical laboratorians to keep up with news about testing devices and kits that might be almost ready for launch, as well as potential new methodologies coming in the future.
Laboratorians must also keep abreast of the need for testing on the clinical side. Investigating a POCT device that won’t answer a clinical question or support better patient outcomes does little good, and the very best technology or device won’t be useful if no one wants to adopt it. For instance, you might have discovered the best device to detect malaria, but if that disease isn’t endemic in your area, healthcare sites won’t bring the device onboard.
Is It Approved for Patient Testing?
Once I'm aware of a new device or test that I might want to implement, it’s important to do as much research as possible, starting with looking into the device’s FDA authorization status and CLIA designation. For use in a clinic, a device must be CLIA waived, while use in a hospital or urgent care site might require a moderate complexity designation. The COVID-19 pandemic added a new complication, which is that both laboratories and near-patient sites are using newly developed tests under FDA emergency use authorization (EUA). This EUA process has an impact on a test’s CLIA designation. If a device is listed for use in a POC setting, it is considered waived; however, if the EUA doesn’t specify that the test can be used at the point-of-care, then the laboratory must validate it as a moderate complexity test.
Things to Consider
Once I’ve decided that the device or test will meet a clinical need, and there are requests for use from clinics, there are multiple considerations to address. Will the device fit into the space available? Is there an electrical plug available, or can one be installed? Is the environment suited for the device (for example, does the device need to be in a “dirty” area)? Is a printer or other ancillary device needed? Does the device have barcode capability built in, or will a separate barcode device be needed? Ensuring all requirements for a device are met is important to having a beneficial outcome.
If It’s Not Connected, I Can’t Use It
If the device is going into a hospital, urgent care, or physician office that is part of a system, I already have POCT connectivity for other devices. Interfacing POCT devices has many benefits: automatic transmission of results to the patient chart, elimination of manual entry errors, lockout of those not trained to use the device, and the ability to track and trend results and quality control (QC). This is one of the first questions I ask of any vendor presenting a new device.
The gold standard is bidirectional connectivity, where information is sent from the device (results, QC data) as well as to the device (operator information, new reagent lot information). This allows me to monitor devices even when they’re located hours away from the office. Many new device manufacturers are developing cloud connections for their devices to monitor results and QC. This is useful for those sites that do not have connectivity for their POCT devices.
What Are the Next Steps?
Once I’ve decided that the device is approved for use and that it meets clinical needs, I start on the implementation. The clinical validation requirements will be different depending on complexity—moderate complexity devices have more requirements before they can be used, while waived devices need only follow manufacturer’s instructions.
For moderate complexity devices, accuracy, precision, reportable range or analytical measurement range (AMR), and patient normal reference range need to be validated. Many manufacturers make validation kits for their devices/kits, and often the same validation kit can be used for both accuracy as well as AMR.
Since I am interfacing with the device, I need to do an IT validation, too. I connect the device to my test systems and run test patients samples to ensure that results are being reported accurately from the device through the middleware to the laboratory information system or electronic medical record. I make sure that the reference ranges and units are correct, and that any comments needed have been transmitted along with the results.
Before taking the device live, all operators who will use the device to test patient samples need training. Often, the vendor can assist with this. If many people need training, I use a train-the-trainer model, where the POCT team trains a few key people in the unit or clinic, who then train the rest of the staff.
Go Live
Once all these steps are complete, the device is ready to use for patient testing. I recommend a celebration and thanking all who helped, including the POCT team, IT team, vendor, and the unit or clinic staff.
Kathleen David, MT (ASCP), is manager of point-of-care testing at TriCore Reference Laboratories in Albuquerque, New Mexico. +Email: [email protected]