Vol. 22 • Issue 12 • Page 32
One of the fastest areas of growth is point-of-care (POC) testing, estimated to be increasing at 10-12% annually, compared to a 6-7% annual increase in other clinical lab testing.1 Although home-based point-of-care testing (POCT) is also increasing, 70% of POCT takes place in hospitals, doctors’ offices and other ðprovider ðlocations, and this growth is predicted to continue.2
The compelling concept behind POCT is that lab testing can take place conveniently near the patient, increasing the speed of results and the likelihood of a faster diagnosis in support of more immediate clinical management decisions. Used appropriately, POCT can be a key component in ðmeeting the goals put forth by the Affordable Care Act (ACA) of simultaneously improving patient outcomes and reducing healthcare costs. As healthcare facilities become more involved in the business of population health management, there are areas where POC tests, because of their ready availability and affordability, can fill in the gaps.
One of the primary goals for the successful reform of our healthcare system is to have patients more involved in their own health. POCT promotes this goal by providing rapid results that providers can use to immediately inform patients of their condition or progress and modify their treatment on-site with a face-to-face opportunity to ensure understanding and discussion of future goals – thus more directly involving the patient in their own care.
History & Evolution
Initially, POC tests were designed as “copies” of traditional laboratory testing methods that were simply transferred to a POC location or put into small footprints to allow for testing outside of the main laboratory. As POC testing progressed, assays have been designed specifically for POC and the testing modality performance expectations are now similar to traditional laboratory testing, requiring the same high standards.
Historically, POC has been difficult for the laboratory to oversee, causing concern over proper usage. However, with the changes taking place in healthcare, this perspective is changing. Rather than inferior testing or a nuisance, POC testing is increasingly seen as a complementary or alternate type of testing that meets specific care needs and is an integrated part of clinical laboratory services, either under the direction of the central laboratory or with consultation by the laboratory.1 There is often a laboratory POC testing coordinator who is responsible for documentation and training of all testing personnel, choosing test methodologies, and oversight of QC, QA, and proficiency testing programs.2
POC Testing: Where, Who, and What?
POC tests are performed in many non-ðlaboratory sites, such as urgent care offices, the ER, at the patient bedside, in the patient home, in direct access clinics, reference labs, nursing homes, or ambulatory coagulation clinics. Each of these environments has different testing needs, variability in staff available for testing, different data processing procedures, and different regulatory requirements.
POCT has become much more widely available for critical care assays, chemistries (including electrolytes and lipids), blood gases, hematology and coagulation, toxicology, cardiac markers, CRP, Hgb A1c, homocysteine, and glucose self-testing. It is widely used in the diagnosis of stroke, cardiac events, and some types of cancer. Additionally, POC tests are available for urinalysis, pregnancy, ovulation, FOB, food pathogen screening, sepsis, and other infectious diseases (e.g., MRSA, herpes simplex, avian flu, West Nile virus and typhoid).
Testing may be performed by nurses, MAs, EMTs, paramedics, pharmacists, or any combination of trained healthcare workers. In fact, as the ACA adds tens of millions of people to the insurance pool and the shortage of primary care providers continues, retail stores such as CVS and Walgreens are providing a supportive role for the primary care arena that entails the extensive use of POCT, making it more accessible for patients.
POC Benefits
The ACA pushes healthcare to shift from curative to preventive medicine, focusing on early detection and management of chronic disease, along with a more patient-centered approach to care. POCT will have a positive impact, as it offers the clear advantage of on-site testing and same-day treatment, making it more convenient and expedient for patients.
Healthcare is becoming more mobile and patients are being encouraged to become more involved in their own health. For this to become a reality – for people to actually fit monitoring their health status into their daily lives and become tuned-in to their personal health plan – the ability to monitor lab tests must be convenient. POCT supports this effort. Value-based healthcare entities need to focus on oversight of their population’s health, and POCT can provide an alternative avenue to collect lab results that improves patient satisfaction.
Operational benefits of POCT may include rapid decision making and triage, as well as the assurance of optimal use of professional time. POCT sets the stage for rapid diagnosis in the physician’s office, ambulance, home, the field, or in the hospital room. Clinicians become empowered to make decisions at the point-of-care and this can have significant positive impact on healthcare delivery and address some of the challenges of health disparities.
Challenges
To use POC lab testing to its maximum potential, there are a number of challenges that have to be addressed and one of those is embracing the unavoidable changes under way in healthcare. Often, laboratorians tend to avoid remote POCT because of the difficulties in monitoring performance from afar. However, with the pressures of healthcare reform to achieve quality and service while reducing costs, in certain areas, POCT can be an opportunity to achieve these goals.
Management of POCT can be challenging for a number of reasons:
• a higher number of operating personnel to train
• multiple sites
• documentation of training, QC, QA, and PT activities
• error management
Another POC hurdle is that it can often be difficult to get a clear picture of the cost-benefit ratio. The cost-per-test may actually be higher for a POC test (as compared to the same test in a centralized lab), but if the total patient episode of care cost is reduced, this better meets the patient needs and improves patient outcomes while lowering overall costs.
For certain POC tests, other concerns may include:
• only adequate for screening; needs follow up with confirmatory testing
• may not be FDA approved for all uses that the similar test in the lab is approved for (e.g., PT/INR approved for Coumadin monitoring but not for diagnosis of other coagulation disorders)
• less precise testing may result in the need for further testing
• poor quality control and/or improperly trained workers can mean even less accurate tests
• use in settings where the POC tests have not been properly validated (e.g., handheld glucose meters in intensive care units for patients on tight glycemic control)
Laboratorians need to embrace the concept of being more involved in a patient-centric healthcare model and willingly become the POC managers and educators that ensure testing is performed optimally and that POC tests are used appropriately with a focus on safeguarding patient safety.
POC – EHR Integration
The seamless real-time capture of POC test results in the EHR enhances the use and rapidity of POCT and is foundational to its growth in all environments. Results can be shared instantaneously with all members of the medical team, enhancing immediate patient assessment and treatment as well as making POC data available for analysis.
Consolidation of POC test results in the common repository of orders and observations makes the data available for further access by caregivers and allows POC test results to be evaluated in conjunction with other laboratory test results. New healthcare models need analytics to support the responsibility of population health management; this will include POC tests, particularly as POCT increases in scope and value.
The Future: Convenient, Real-Time Access
As we move into improving population health, the monitoring of patients with chronic disease can be a big aspect in reducing costs. Typically, POCT can offer faster TAT and diagnosis and better patient satisfaction as compared to traditional testing. Mergers and reorganizations taking place in healthcare have resulted in fewer full-service laboratories and play a role in the increase of POCT as a means of maintaining access to commonly ordered lab tests.1
Technical advances are making POCT more accurate, less expensive, and easier to use. In fact, many new POC devices are beginning to include QA and documentation features. Demand will continue to increase as economic needs for rapid patient turnaround and reduced hospital length-of-stay intensify. Add to that an increasing need for medical support at remote, diverse sites and outpatient centers, and for underserved populations. And to top it off, there is a continual decrease in qualified clinical laboratory scientists.
Healthcare is becoming more convenient for patients and real-time lab results will become the expectation; POCT should be considered as part of the continuum of the clinical laboratory’s contribution to healthcare and a fundamental responsibility of the laboratory – regarded with the same expectations of quality throughout the total testing process. POCT can be a critical factor in streamlining and improving laboratory services.
Kim Futrell is products marketing manager, Orchard Software Corp.
References
1. CAP Point-of-Care Testing Toolkit. Accessed at : www.cap.org/apps/cap.portal?_nfpb= true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=committees%2Fpointofcare%2Fpoc_toolkit_definition.html&_state=maximized&_pageLabel=cntvwr
2. Scalise D. Point-of-Care Testing. H&HN. Accessed at: www.hhnmag.com/hhnmag/jsp/articledisplay.jsp?dcrpath=HHNMAG/PubsNewsArticle/0