CEO Summary: In a thinly-populated region the size of Texas and New Mexico combined, an integrated clinical care program based on point-of- care testing (POCT) has delivered impressive gains in health outcomes. For rural residents, mortality rates from cardiovascular disease have fallen by 50%. There were comparable declines in hospital length of stay and the rate of readmissions. A reliable test result and speed to answer from POC testing is a major factor in these improved outcomes.
IS POINT-OF-CARE TESTING (POCT) ready for prime time as a front line tool for the diagnosis of patients—whether in physicians’ offices or in hospitals? A compelling case study in the state of South Australia suggests that the answer is “yes”!
One visionary clinician (not a pathologist, by the way) saw the potential for point-of-care testing to be a game-changer in both hospital and clinic settings, but only if the POCT program was well organized and tightly managed.
Over the past decade, the deliberate placement and use of POC testing devices has contributed to a 50% reduction in mortality from acute coronary disease for rural patients in South Australia.
The story starts in the late-1990s, when Phillip Tideman, M.D., a cardiologist at Flinders Medical Centre in Adelaide, Australia, was wrestling with two important issues in cardiac care in South Australia. He saw that point-of-care testing could be the answer for both dilemmas.
The first dilemma Tideman faced was how to switch the emergency center at his tertiary-care hospital in Adelaide to troponin assays in place of the then-standard CK-MB assay for detecting myocardial necrosis. “By the late 1990s, troponin assays had become the gold standard,” said Tideman. “But at that time, the hospital laboratory could only run troponin assays on a dedicated machine that was not part of the express laboratory service, and the lab staff ran the assays only once a day.
“When dealing with acute coronary syndromes, results are needed immediately,” he added. Faced with waiting for the once-a-day troponin run, most physicians continued to rely on the CK-MB assay.
At the same time that Tideman was pondering how to make the switch to troponins at this Adelaide hospital, he was also consulting with rural hospitals in an effort to improve survival rates for their cardiac patients. “Most of the data would suggest that an individual had twice the risk of dying from coronary heart disease if he or she lived in country areas compared with metropolitan areas,” observed Tideman.
Tideman explained that South Australia has a highly centralized population, with two-thirds of its 1.6 million people located in Adelaide. The other 500,000 people are scattered across the 985,000 square kilometers of farming and pastoral areas.
The size of this rural area is immense. In the United States, it would take the combined area of Texas and New Mexico to equal the geography encompassed by the state of South Australia. Only 11 of the 66 hospitals serving these rural areas had an on-site laboratory. These labs mostly operate on a Monday-Friday schedule, with on-call staff for nights and weekends.
Not Every Hospital Had A Lab
For the hospitals without laboratories, the only way to get blood chemistry tests done was to send specimens to the tertiary care centers in Adelaide or to a lab at one of the 11 laboratory-equipped peripheral hospitals.
“At this time, it was typical to transport blood specimens 200 kilometers (124 miles) or more—sometimes a lot more,” recalled Tideman. “Some remote centers were transporting a sample as much as 1,000 kilometers (620 miles)! The specimens traveled overland by bus, taxi, or private car.
“If the specimens arrived at a peripheral hospital at night or on the weekend, laboratory staff would have to be called in,” commented Tideman. “Turnaround times were at best six hours, but often as long as 24 hours. With so much time between the blood draw and running the test, some routine laboratory test results, such as potassium levels, were unreliable.”
Tideman recognized how point-of-care testing could contribute to improved outcomes for cardiac patients. He enlisted laboratory scientist Rosy Tirimacco, B.Sc., to help him develop a cardiac network to improve patient care in the rural areas.
They created iCCnet SA, or Integrated Cardiovascular Clinical Network for South Australia. Tideman was Clinical Director and Tirimacco became Operations and Research Manager.
“When we talked to the doctors about what services they needed, they identified better and faster pathology laboratory testing as one of the main things required to improve patient care,” said Tirimacco.
As part of the cardiac network protocols, Tideman and Tirimacco introduced a point-of-care platform to do troponin assays in the rural hospitals. With a troponin assay result in hand, a physician could more definitively determine which patients were high risk and immediately transport those patients to tertiary hospitals in Adelaide for advanced care.
POC Testing In The ER
Further, Tideman and Tirimacco recognized that the same POC test platform could be used to introduce troponin assays in the emergency room at the tertiary hospitals. Instead of waiting for the daily troponin assay run, ER physicians could have results in 12 minutes, allowing them to quickly distinguish a heart attack from other sources of chest pain.
They began their work in mid-2000. The first of the point-of-care devices, the Roche Cardiac Reader, was placed in rural hospitals in 2001. “This device is an optical reader that measures troponin-T in a blood drop on a disposable strip. It takes away the interpretive error and gives the clinician a negative result, a borderline result, or a semi-quantitative positive result,” explained Tirimacco.
“When dealing with acute cardiac syndromes, clinicians need results immediately, 24 hours a day, seven days a week,” said Tideman. “Point-of-care testing was the answer
to that clinical need.”
Tideman and Tirimacco traveled around South Australia, training nursing staff to use the devices. An interactive consulting service was established that allowed rural medical providers to contact network staff by phone and fax, and more recently, through video-conference. If a nurse had a problem with the testing device, a laboratory scientist could help troubleshoot; if a physician had questions about cardiac patient care, a cardiologist could consult.
The team met some resistance when they placed the point-of-care devices in hospitals that had onsite laboratories. “We got a fair bit of angst from traditional laboratory professionals,” stated Tideman, “although they did admit that they couldn’t provide the turnaround time that a POC test device could. There was irritation expressed, but they had no will or motivation to solve the problem that we were asking these laboratory professionals to solve. So we solved it ourselves.”
Back in Adelaide, the team used the point-of-care device to introduce troponin assays in the emergency department at Flinders Medical Center. To make an effective business case for using troponin assays instead of the CK-MB assay, Tideman says he had to offer the physicians a way to get the results as quickly as the CK-MB results.
“When dealing with acute cardiac syndromes, clinicians need results immediately, 24 hours a day, seven days a week,” said Tideman. “Point-of-care testing was the answer to that clinical need.”
Knowing that quality control would be a concern, Tirimacco was careful to establish high standards at the outset of the point-of-care testing program. “Being a laboratory scientist, I was aware of the quality issues around this type of testing,” says Tirimacco. “We insisted on internal and external quality controls. We essentially transposed the protocols that happen in the laboratory to the ward areas of our hospitals.”
POC Testing Succeeded
Within the central hospital, use of the point-of-care platform for troponin testing proved successful. Physicians regularly rely on the troponin test as part of their diagnostic protocols. The central laboratory now offers troponin assay runs as needed, rather than just once a day, although the point-of-care devices are still used when physicians evaluate a chest-pain presentation and need fast results.
It is in South Australia’s rural areas where the impact of iCCnet SA has been most significant. In rural hospitals, the combination of point-of-care troponin assays and 24-hour interactive consultation services dramatically improved outcomes. For rural cardiac patients, there were substantial reductions in mortality rates, as well as length of stay and re-admittance rates.
“In our rural hospitals there is both the demand and the need for point-of-care testing,” noted Tideman. “Without point-of-care testing, in our country areas we could never deliver evidence-based acute cardiology.”
“The inpatient mortality rate in our study population is now half what it used to be!” stated Tideman. “Currently it is the same in country and metropolitan areas, whereas previously it was double in country areas versus city. “As a consequence of using POCT testing, the number of transports has doubled,” he continued, “but now all of the patients who are transported are high risk. We see a reduced length of stay and reduced time to angiography.”
Expansion of POCT Menu
iCCnet SA’s point-of-care testing program has proven so effective that the test menu was expanded. Increasingly, rural hospitals in South Australia have a set of four or five POC devices that can do a range of cardiac markers, basic hematology, bio-chemistry, and blood gasses, as well as coagulation studies. Results are reported in a format similar to results from the hospital labs, or are reported in a format that gives the normal ranges for the test as performed on the point-of-care device.
Quality control has not been a problem, Tirimacco says. In addition to internal quality controls and calibration, the rural hospitals periodically send matched samples to the peripheral hospital labs or labs in the Adelaide hospitals to check for accuracy of their devices. So far, the devices have performed extremely well, with only minor variations in results.
Demand for POC Testing
“In our rural hospitals there is both the demand and the need for point-of-care testing,” noted Tideman. “Without point-of-care testing, in our country areas we could never deliver evidence-based acute cardiology.”
“I think we’ll see more and more acute care tests move into the point-of-care arena,” says Tirimacco, “mostly because of the faster turnaround times that support better patient outcomes. POCT supplements those tests that will always be performed in the central laboratory.”
THE DARK REPORT notes that iCCnet SA’s successful use of point-of-care testing has several insights and useful lessons for the laboratory medicine profession. First, it provides an invaluable case study, since this program now has almost 10 years of operational and clinical history. It offers a well-documented road map on how to design, deploy, and sustain an effective point-of-care testing program.
Second, the lower mortality rates from cardiovascular disease for rural residents living in South Australia resulted from how iCCnet SA encouraged adoption of evidence-based medicine guidelines in tandem with use of point-of-care testing for cardiology patients. It shows the importance of pathologists and laboratory scientists taking a more interactive and collaborative role with clinicians as a way to deliver more value from laboratory medicine.
Third, this case study provides a reminder of why champions and innovators are important. It was Phillip Tideman, M.D.’s vision that led to the creation of the iCCnet SA program. It was the commitment and enthusiasm shared by
Tideman and Tirimacco that inspired other clinicians to participate in a new way of assessing cardiology patients—even though it required clinicians to change long-standing clinical practices and embrace the use of point-of-care testing.
Adoption Of POCT
While the unique geography of South Australia encouraged the adoption of point-of-care testing there, use of the technology elsewhere will follow as the cost of POCT comes down. Pathology labs can choose to see POCT as a threat to business as usual, or they can see it as an opportunity to promote, manage and profit from adoption of this rapidly- improving diagnostics testing technology.
With a 10-year track record and a documented ability to improve patient outcomes in a cost-effective manner, ICCnet SA’s successful use of point-of-care testing provides a useful template. It demonstrates one way that laboratory testing can be leveraged to boost outcomes and add value to the healthcare system.
For example, both the United States and Canada have large regions that are thinly-populated. It is likely that ICCnet SA’s approach to using point-of-care testing to support an integrated clinical care program could deliver similar improvements to patient care in these regions as was achieved in South Australia.
Fast, Accurate Answer
Because the capabilities of POC testing devices are improving continually, it can be expected that use of POCT will expand in coming years. Both physicians and patients welcome a fast, accurate answer at the point of care, because it improves the accuracy of the physicians’ diagnosis while allowing the patient to start therapy without having to wait overnight or longer for a central laboratory to report back all the test results.
Successful Use of Point-of-Care Testing Earns Funds from Government Health Program
DURING THE FIRST FIVE YEARS that the Integrated Cardiac Care Network for South Australia (iCCnet SA) operated, funding for point-of-care testing was a struggle. The project was launched with A$40,000 scavenged from leftovers in the Cardiology Department’s budget. It kept going with a grant from the commonwealth that the team secured 18 months later.
“It took a long time to get anyone in the health service sufficiently interested in what we were doing to fund us,” noted Phillip Tideman, M.D., the cardiologist who organized iCCnet SA. “They weren’t prepared to come onboard until we had some results. About five years ago, when it became clear that project was saving lives and reducing costs, funding came easier, allowing the team to expand the program.
Establishing A Budget
“iCCnet SA now operates on a yearly administrative budget of about A$500,000, which covers network staff and office expenses,” he explained. “Testing costs come out of the individual hospitals’ budgets.”
This year, the South Australian health department decided that it wanted a single, state-wide pathology/lab testing service. That might have spelled disaster for the carefully-constructed POCT program that Tideman and Tirimacco had nurtured. But Tideman was able to negotiate an agreement to integrate his project with the new statewide service as part of a state-wide point-of-care service.
Tideman sees this as a major victory. Though the state government runs both the pathology service and the cardiac network, competition between the two was as fierce as if they were for-profit entities. “We have been told in the past that, because we are not pathologists, we have no role in expanding POCT services. We enjoy proving them wrong and letting the outcomes speak for themselves,” he said.
POCT Is Feasible
“What happened over the last ten years is that the laboratory-based biochemists and pathologists have seen that what we’ve accomplished with POCT is feasible,” observed Tideman. “On the business side of things, there has always been resistance and a great deal of angst from the central laboratories about whether we are stepping on their territory.”
“We overcame that because we deliver a POCT service that they can’t match since they are no longer clinically integrated,” he continued. “The force of consumer and clinician demand has brought them to the table, and we were able to negotiate this new agreement from a position of strength. We had the support of the clinicians and they didn’t.
View POC Test Results
A major advantage of the integrated arrangement, he adds, is that they will have an interface able to upload the results from their point-of-care testing instruments to the central clinical and laboratory information systems operated by the state health service. This will allow physicians anywhere in the system to view the point-of-care test results just as they would the test results performed by the central labs. Previously, the results were only available through the cardiac network database.
Making POCT Work In Clinical Settings
TO WORK WELL, the point-of-care testing platform must be utilized as one part of an integrated system that oversees quality control and provides consultation about results.
“You could put point-of-care testing out there and make no difference whatsoever,” says Phillip Tideman, M.D., Clinical Director of iCCnet SA. “Point-of-care testing has to be part of an integrated clinical network, in which the POC instruments are part of a unified system that ensures evidence-based care, quality results and constant monitoring. That system must be collaborative, so users in the field feel free to offer feedback and suggestions on how to improve performance.
“If you tried to impose this from above, it wouldn’t work. It’s hard to get engagement from the doctors and the nurses unless they feel they own it too,” concluded Tideman.
iCCnet SA @-a-glance
Point of Care Test Instruments
Roche Ccardiac Reader, Cobas h232, Coaguchek XS, Coaguchek XS Plus, Roche Inform 11 (soon to be implemented)
Abbott Diagnostics i-STAT
Abaxis Piccolo
Haemocue – Hb and WCC
Menu-of-Point of Care Tests
Troponin T, NT-proBNP, D-Dimer, CK-MB, INR, Sodium, Potassium, Chloride, Glucose, Lactate, Creatinine, pH, pCO2, PO2, Ionised Calcium, Urea, Haematocrit, Haemoglobin, TCO2, HCO3, Base Excess, Anion Gap, sO2, Cholesterol, HDL, TRIG, ALB, ALP, ALT, Amylase, AST, Bilirubin, GGT, TP, White Cell Count, Glucose
Number of POC Testing Sites
- 66 Hospital sites currently running POCT through ICCnet
- 3 Aboriginal Health Centres
- 33 Clinic Sites
- 1,800 Operators Trained (estimate)