Enterprise Point of Care

Point-of-care testing in acute care - the Epocal perspective by Richard Epps, Vice President of Sales and Marketing.

The intellectual argument for point-of-care testing remains as strong today as it was a decade ago: better and cheaper medical care will result whenever simple-to-use and cost-effective tools become available to provide blood test results at the time and place that the physician demands them: now and where the patient is.

To better understand the time value of blood test data consider that a large proportion of acute care blood tests performed by the laboratory are not diagnostic tests at all. They are tests that are used to monitor a patient’s physiological status or to manage their therapy. The test results are used as part of a feed-back control loop to effect a treatment adjustment: a change in the level of medication or an adjustment of a piece of equipment. Rapid turnaround time for these monitoring tests is mandatory because the data are used as part of a feedback control loop. Furthermore, with a patient-side testing technology the care-giver can now perform the feed-back control process comprising the steps of blood test data acquisition and therapy adjustment in a single transaction without having to leave the patient side.

The promise of technology developments in biochips and lab-on-a-chip devices of the 1990s caused industry thought leaders to predict that a 50% conversion of all blood testing from the laboratory to the point of care would occur by early in the new millennium. In actuality, the conversion has been far less extensive. In acute care, where there is a demonstrable need for blood tests with fast turnaround time and where the value proposition for point of care is the strongest, there has been only a few percent conversion to patient-side testing, despite the availability of quantitative patient-side testing products.

What then explains the overall slow adoption rate of patient-side blood testing?

Early Obstacles

The hospital’s decision to move diagnostic testing out of the laboratory to the point of care was initially slow for several reasons. First and foremost, the laboratory needed to be convinced that the point-of-care technology provided quality results when the test was performed by a patient-side caregiver. This meant demonstration of precision and accuracy equivalent to lab devices. This also meant demonstration of error-free operation when the test was run by patient-side caregivers in the far more chaotic patient-side environment as compared to testing performed by highly trained technologists in the tightly controlled lab environment. Furthermore, point-of-care devices needed to demonstrate ease of use and robustness; that testing information could be easily captured and managed; new electronic quality control processes had to be understood and approved by the regulatory agencies; clinicians needed to demonstrate that they would comply with internal procedures and not overuse the system; internal politics and spending constraints imposed by tightened healthcare budgets also proved to be barriers.

POCT remains cost prohibitive

Performance obstacles are being overcome, with the best-in-class point-of-care devices showing levels of performance equivalent or even superior to laboratory technology. Today, hospitals generally accept the point-of-care value-proposition: improvement in service and better medical care coming from faster turnaround time for test results. However, the marketplace has clearly demonstrated an unwillingness to pay the large premium being sought by point-of-care vendors for these benefits. The market wants better service, but only at the same or lower total cost. Also, in view of the hospital’s significant internal investment in the re-engineering of blood testing processes from the laboratory to the point-of-care, the hospital needs assurance that the technology that it is adopting will be cost-effective for the long term before it commits to purchase.

Today’s point-of-care products have simply proven much too expensive for broad adoption. The manufacturing cost per test of current products exceeds the total laboratory cost (including the cost of labor for sample transportation and testing), such that point-of-care products must be sold at a large premium relative to existing laboratory costs. Certainly, improvements in patient outcome, if demonstrable and measurable, help to justify the premium costs of existing point of care technologies, but these benefits have been and continue to be difficult to calculate beyond anecdotal evidence, although some examples are beginning to emerge.

Moreover, support functions like data transfer, frequent distribution of reagents from centralized refrigeration storage locations to the patient-side and the management of distributed reagent inventories are predominantly manual processes in today’s technologies. The significant extra cost of supporting the point-of care testing service further adds to the total cost per test

Since the market has rejected the notion of broad adoption at premium pricing, the use of current patient-side testing products has been limited to the particular circumstances of hard-to-service departments, off-shift testing, and deployments in small hospitals with low blood testing volumes when the laboratory has difficulty providing cost-effective service.

Limited menus

As well as being expensive, today’s point-of-care products still only offer a limited menu of quantitative tests. For example, point-of-care immunoassay biomarker products are still mostly qualitative screening tests, and where quantitative products are available the performance is not yet considered to be lab grade. Accordingly, immunoassay at the point-of-care is used as a screening test or as a supplemental to the ‘definitive laboratory test.’ Before there is widespread conversion of laboratory tests to the point-of-care, products must be able to achieve a sufficiently broad menu of tests which provide the medical practitioner with a complete testing solution with lab-grade performance. Until that time the vast majority of acute-care tests will continue to be performed by the lab.

Appropriate test menu, lower acquisition and operating costs and improved system adaptability will be required for broad adoption

To have a viable point-of-care product, the suite of point-of-care tests offered by a vendor should comprise a complete process solution for a target application. For the respiratory therapy application in critical care a point-of-care blood gas test suite is all that is required to enable patient-side testing and ventilator adjustment. For monitoring of a patient on CPB during a cardio-thoracic operation, the perfusionist needs blood gases, electrolytes and hematocrit for a complete solution (with extensions to include glucose and ACT, so that all of the testing can be consolidated into a single device). In the out-patient clinics for the monitoring of patients on warfarin, a patient-side INR test is a complete solution. In the ED, by far the largest user of acute-care tests in hospitals, a much larger test suite is required to offer a complete solution. An ED physician still has to wait for results from the laboratory for those test not provided at the point of care before he can take action on the patient. Because he will derive significantly less value in an incomplete point-of-care offering, he is less likely to use a point-of-care device.

For a comprehensive restructuring of hospital blood testing to the patient side, the new technology needs to be cost-effective when supporting only about 2 requisitions per day, which is the average daily volume of tests per acute-care hospital patient location. This means that the average retail sales price of instrumentation per bedside can be no more than a few thousand dollars.

The bedside testing solution must have automated connectivity, preferably using a wireless data link to an enterprise information system. The test card with blood test reagents, which comprise the variable cost per test, should be able to compete against the marginal cost of an efficient laboratory. Test cards should be able to be stored with the test device at the bedside and bar-coded for automated quality assurance and inventory management, for true bedside capability.

The new technology should be easily capable of forward integration to support new test categories with minimum increase in the cost of the equipment, with the same operator interface so that new training and quality control regimes are not required, and enable effortless integration into the clinical care process.

EPOC^TM: an enterprise point-of-care solution

Coming in with a second generation point-of-care technology Epocal is uniquely positioned to build upon the foundation established by the first generation technologies. Products such as the i-STAT, Piccolo and Triage have demonstrated that blood testing systems designed in a small instrument format can achieve performance at par with the old generation of ‘big iron’ lab solutions. A good beginning, but far from meeting all of the requirements for enterprise-wide deployment. The single largest unmet challenge for the industry has been how to bring down the manufacturing cost per test. Therefore, the central element of the EPOC design solution has addressed cost per test. The EPOC test card’s biosensors are manufactured in a modified smart-card technology, leveraging off of the ultra low cost of the smart card device which is manufactured at quantities of more than 10 billion annually for electronic smart card applications. The EPOC technology achieves the same low manufacturing cost per test of a glucose test strip, but now in a device achieving laboratory grade performance and reliability. Epocal’s strategy to manage down the bedside hardware cost per test has resulted in the replacement of the complex and costly analytical instrumentation of the current technologies with a simple card reader. The EPOC card reader is a minimally featured low-cost device much like the card-swipe at a supermarket checkout. Its primary function is to read the raw signal from the test card, digitize it and convert it into a wireless transmittable format. The wireless raw data stream is then transmitted to a general purpose computer such as a PDA, a lap top or a tablet PC for calculation and display of blood test results. The test record is automatically Wi-Fi uploaded to the hospital LAN for incorporation into the patient’s electronic record.

An EPOC card reader with integral PDA can be configured as a hand-held portable or as a bedside workstation; as a peripheral to a mobile PDA barcode scanner, adding blood testing to the PDA’s existing utility in bedside computing; or as a peripheral to a bedside tablet PC or touch screen display output for results-reporting and trend-monitoring. The modularity in the EPOC design enables essentially the same technology to be configured in multiple different physical formats, each optimized to a specific blood testing environment and process flow.