The world is becoming a place where even instant gratification isn’t fast enough. While it may be a luxury when dealing with fast food or digital downloads, for medical professionals, being able to have immediate access to test results can often mean the difference between life and death for patients.
“Growth and demand for point-of-care tests (POCT) are coming from several different sources—innovations from industry, advances in technology, demand for rapid accurate results from health care providers, and other trends, such as emergency department overcrowding, necessitating better ways of expediting patient care to improve outcomes,” says Ken Buechler, PhD, co-founder, president, and chief scientific officer, Biosite Inc, San Diego. “Introduction of new tests to the market and publication of data supporting new modalities of diagnosis also drive interest.”
Manufacturers are working to meet this need with an ever-growing selection of POCT systems.
“Every time manufacturers launch a new device, which seems to be on a 5-to-7-year cycle, it has new features, such as becoming faster or having better data management and conductivity features,” says Brian Gunderson, director of product portfolio management for Medical Automation Systems, Charlottesville, Va, who expects that trend to continue. “Companies are taking advantage of the new technology, not only for connectivity and management, but also technology for the testing engines that make it possible to generate results much faster than they have in the past.”
In addition to advancements in technology, POCT plays a role in the shifting dynamics of testing within a hospital. For example, many facilities are closing their traditional stat labs and automating their main or core laboratories in an effort to satisfy the constant demand for faster turnaround time from laboratory tests. One of the primary goals of this type of automation is the reduction of turnaround time for all laboratory tests performed.
“Some of these facilities are making use of point-of-care testing devices to continue to meet turnaround time goals of special needs areas,” says Dave Colard, POC testing coordinator, Saint Luke’s Hospital, Kansas City, Mo. “These special needs areas commonly include intensive care units, surgery, and emergency departments.”
The most employed POCTs are those used to monitor a patient’s glucose levels. In recent years, studies have been published indicating that strictly monitoring the glucose ranges of patients, especially those in the ICU, can dramatically decrease their morbidity and mortality rates.
“What we’re seeing is a lot of institutions implementing tight glycemic control protocols, which is dramatically increasing the amount of glucose testing that’s going on at the patient’s bedside,” Gunderson says. “In some places it’s 20% to 30% growth in volume of that type of testing.”
Within the last few years the American Diabetes Association has adjusted its guidelines for acceptable levels of glucose accordingly. This change reflects the increased importance placed on glycemic control in today’s health care environment.
“What they have found in critical care units is that even a point change from 105 to 107 can delay, pretty drastically, the healing of people,” says Daniel Orr, MTA-MT, laboratory/radiology manager and medical technologist for Olathe Medical Services, Kansas City. Kan. “There are a number of glucose meters out now that nursing staff have been trained on and use to conduct hour-by-hour glucose testing to maintain tight glycemic control of their patients.”
Orr helps manage physician office laboratories (POL) for his health system. One of the clinics regularly hosts “diabetic counseling day,” when patients are encouraged to bring in their personal glucose meters.
“We will actually have the test performed by the patient in front of us to make sure they are using good technique and that they are following the appropriate quality control aspects, as well as to ensure that the meter itself works,” Orr says. “You can use a test, but if it’s not being done properly, then that’s a problem. This way we can do counseling and education on the spot.”
For patients who do not use their own meters, clinicians at the POL will use a POCT, obtaining immediate results that are then shared with the patients. The benefits are the same: immediate feedback and, when necessary, an adjustment to lifestyle and health maintenance.
“Being able to conduct an on-site visit with them, instead of waiting for the next day to get their lab results, means they can do counseling immediately,” Orr says. “What we are finding is that the better you can get the patient to understand their glycemic conditions, the better their life can be, and the less likely they are to have negative outcomes.”
POCT also includes coagulation testing. This arena is growing due to the relatively recent realization that patients who are on blood-thinning medications for extended periods of time can, for reasons that are not yet clear, develop toxic levels of the drug in their systems. Some patients develop severe bleeding disorders without even being aware of them. As a result, a number of companies have developed home-based, POCT coagulation testing.
“This area of testing has been really hard for laboratorians to let go of, because it’s always been one of those really sensitively timed tests, demanding exactly the right sample, quantity, and volume,” Orr says. “About 5 years ago a couple of companies came out with coagulation meters, and a lot of these use an electronic control so patients aren’t having to mess with the lipid controls like they do with their glucose meters.”
Though it is still not commonplace, the last few years have seen a greater demand for the personal version of this type of testing. These meters have not only started to head home with some patients, but the POCT technology is allowing many POLs to put them to use as well.
“What it’s allowed us to do in the physician office is also offer a ‘coagulation clinic day’, where patients come in and are tested, receiving results on the spot,” Orr says.
As with other POCTs, the rapid response has made a significant impact on patient care.
“It used to be the clinician who would draw the blood, send it to the lab, and get results back the next day,” he says. “But if the levels were high, the patient might already have toxic levels by the time the nurse gets ahold of him or her.”
As with glucose testing, these one-on-one sessions make it possible for patients to receive immediate feedback and counseling about their medical conditions. The take-home units are also providing care for those who live in very rural areas, where the closest medical facility might be hours away.
All-in-One, on the Rise
Another burgeoning segment for POCT products is one that allows clinicians to perform a full panel of tests from a single platform.
“These analyzers test for many things, including blood gasses, electrolytes, chemistry, coagulation, hematology, glucose, and cardiac markers,” says Orr, who notes that these systems have been on the market for almost a decade, and are among the first real POC analyzers to go outside the laboratory and to be utilized by a large number of departments. “They are now used in emergency departments, critical care units, operating rooms, NICU—because now they can train individuals to use them and obtain immediate testing results.”
As coronary artery disease and other heart ailments increase, multitaskers in this arena are also in high demand.
“Biosite offers a product that simultaneously tests for CK-MB, myoglobin, troponin I, and BNP,” says Buechler. “It is used as an aid in the diagnosis of myocardial infarction, diagnosis and assessment of severity of heart failure, and the risk stratification of patients with acute coronary syndromes, both in the acute setting and at the physician’s office laboratory.”
Other growing areas include POCT screening for sepsis, kidney injury, and abdominal pain, using a rule-out test for appendicitis and pancreatitis and a rule-in for cardiac issues.
As testing continues to migrate from the clinical lab to hospital floors and specialty units, part of the challenge is inspiring the same level of commitment to quality from the medical staff as is found in laboratory professionals.
“It is a wonderful thing, because the more rapidly you can get diagnostic information to the provider or clinician, then the better your health care is going to be for the patient,” Orr says. “But the biggest negative is simply the fact that you have nonlaboratorians doing the testing—and they’re not trained for it.
“In the laboratory, our focus is on obtaining the appropriate sample and ensuring that the test we are doing works. Quality assurance is everything from a laboratorian standpoint,” he continues. “It’s a little harder to get nonlaboratorians to understand that. I always tell my staff about the importance of things like proper collection, because if you draw the wrong sample it doesn’t matter if you do the test right.”
These concerns are considerable, taking into account the impact regulation violations can have on a lab.
“The laboratory is ultimately responsible for all testing,” Gunderson says. “What we’ve seen is, if the lab embraces point-of-care testing and they get involved with it, helping the rest of the players involved understand what it means and helping them understand the implications to the laboratory, we see better buy-in throughout the hospital. If the laboratory is constantly pushing back, what you see is the devices start showing up at the hospital and the lab doesn’t know about it. Of course, that testing is still under the purview of the laboratory.”
Aiding laboratories with some aspects of quality control are software solutions that extract data from the devices and allow lab and hospital managers to utilize it as necessary.
“Before solutions like ours came along, there was really no way to get the information out of the device, but we make it possible to connect to them, pull that data off, and then allow the lab to manage and oversee the quality control of the data,” Gunderson says . “Our systems can also pass the data along to the laboratory information system, the HIS, or any other system they choose.”
These types of programs also assist the lab with routine processes, such as linearity testing, producing not only the results of those actions, but processing the results for them, so they can see how their devices are performing and how their overall program is functioning.
Improved technology also makes it possible for the devices themselves to regulate who uses them. In this case, it’s not just a matter of getting the data out of the devices, but it is also the ability to send data back to them.
“If a laboratory wants, we can send an operator list to that device and only those operators can perform testing on it,” Gunderson says. “Which gives the laboratory even greater control.”
New generations of hardware are also designed to meet regulations. Many of today’s glucose meters, for example, require that blood completely fill the sample window. Even if the quantity provided is inadequate, the meters will display results, providing no indication that they are inaccurate.
“My desire is to have as much as possible controlled by the instrument; the fewer details they have to remember, the less likely it is they will have bad results,” Colard says.
Laboratorians may credit inexact collection to a failing on the part of nurses and other medical personnel.
“The lab’s perspective is they don’t have the necessary attention to detail, but from the nursing point of view, they’re not just doing tests—they’ve got other patients, and interruptions are common and that’s where these types of errors occur,” Colard says. He also notes the importance of weighing all aspects of testing before transitioning out of the clinical laboratory. “A major consideration when implementing point-of-care testing is who will actually be performing the testing. Who is responsible for training, and ensuring operator compliance, and competency? Who will be responsible for instrument troubleshooting, maintenance, and quality control testing? Shifting this workload from the laboratory to nursing staff may not always be a very good decision.”
On the Horizon
Whatever direction it eventually takes, POCT is set to develop an even larger presence in today’s healthcare facilities. “Point-of-care-testing is definitely poised to continue to grow in importance,” says Biosite’s Buechler. “Offering a more robust immunoassay menu will be critical, as customers want to have all their testing needs met by as few vendors as possible. Robust quality control and remote access features will also be more demanded by customers.”
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Mergers and acquisitions will advance the integration of imaging and diagnostic capabilities, according to Buechler, making it possible for one manufacturer to service patients from the emergency department, to the cath lab, to radiology, to admission, and through discharge. These changes also hold the potential for IT consolidation and improvements, such as EMR and bar codes.
“Over the next 10 years, I think we’re going to start seeing a lot more new types of testing, things that weren’t even imagined 5 years ago or even today,” Gunderson says. “As molecular diagnostics and testing in that area becomes prevalent and very well accepted, you’re going to see a potential for testing that we can’t even dream of today.”
Dana Hinesly is a contributing writer for CLP. For more information, contact .