One of the fastest areas of growth in laboratory medicine is point-of-care testing (POCT), with estimated global expenditures exceeding $24.2 billion in 2019 and growth (pre-COVID19 Pandemic estimates) projected at over 7.1% annually between 2020 and 2026. The COVID19 Pandemic testing has, in fact, greatly accelerated this growth, and actual expenditures for total POCT testing during 2020- 2021 are expected to be substantially higher than originally estimated. Although home-based POCT is also increasing, 70% of all POCT takes place in hospitals, doctors’ offices, clinics, and other provider locations, including pharmacies and large retail stores such as Walmart and Target.
POCT is defined by the College of American Pathologists as “tests designed to be used at or near the site where the patient is located, that do not require permanent dedicated space, and that are performed outside the physical facilities of clinical laboratories”.
Why is POCT growing so fast?
Consumers increasingly expect health systems to offer certain services that make their lives easier. These must-haves include a single location for appointments and labs. For example, over one-third of consumers surveyed prioritized a single location for appointments and labs among the top three services they would expect from their healthcare provider[i].
Hence, POCT is now the laboratory service of choice when possible; and it is thus a key component in meeting the goals of value-based medicine: simultaneously improving patient outcomes and reducing healthcare costs. These advantages are further enhanced by continuous technological innovation, improving the quality, convenience, connectivity, speed, and range of applications. This in turn has resulted in an explosion in the number of tests that can be performed outside the laboratory setting.
We are thus in a cycle, where demand is driving technical innovation, which in turn, drives demand.
Other factors driving the popularity of POCT include:
• The rapidly increasing older population, leading to increased incidence of chronic diseases, and more frequent monitoring required.
• The rising incidence of lifestyle diseases (ex: Diabetes) among all ages necessitating frequent checkups.
• The increased demand for home-based POC usage (facilitated by technological innovations) for a larger variety of tests for all ages.
There is a steady growth in the number of tests that can be performed outside of the central laboratory, including[ii]:
Coagulation monitoring (INR, ACT, Heparin; Hemostasis Assessment)
Drugs of Abuse (DOA)
Fecal occult blood
Glucose monitoring; Hemoglobin A1C
Infectious diseases (such as Influenza and Rapid Strep)
Methicillin resistant staph aureus
Molecular (DNA and RNA); PCR
Pregnancy and fertility
Other Chemistries (Magnesium, Lactate, Micro-albumin, Creatinine)
D-dimer for thromboembolism; and, of course,
The Benefits of POCT for Patient Care[iii]
Rapid diagnosis in the physician’s office, ambulance, home, the field, or in the hospital room results in rapid decision making and triage, as well as the assurance of optimal use of professional time. Clinicians empowered to make decisions at the point-of-care can have a significant positive impact on healthcare delivery.
There are other potential benefits depending on the specific situation and testing:
• Less sample volume (pediatric, neonatal, ICU venues)
• Decreased pre-analytic concerns related to processing of specimens (i.e. clotting, centrifugation, preservation)
• Optimized drug treatments
• Reduced hospital admissions
• Reduced hospital stays
However, along with the benefits there are challenges inherent in managing Point of Care testing:
In the core lab, errors occur most frequently in the pre- and post-analytic phases; however, POCT errors occur primarily in the analytic phase of testing. This is related to a lack of understanding or training of non-laboratory staff who are involved in POCT.
Managing POCT for Quality Patient Care[iv]
More than ever, the laboratory must be proactive in monitoring all aspects of POCT, if quality care is to be maintained, including:
• All Point of Care (POC) testing personnel must be properly trained, and have their competency periodically assessed, even if all their testing is waived
• All instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration, and maintenance records monitored;
• Test results must be verified as to accuracy and (if the patient had previously been tested) consistent with a patient’s history
• Reagent storage and handling must be monitored
• Utilization of split sampling and proficiency testing is recommended for monitoring quality, even for this waived testing.
• Mindful that non-laboratory staff may be performing POC testing, laboratories often have a staff tech responsible for monitoring this testing, acting as both a liaison, as well as a technical resource for the POC testing staff.
This is an important responsibility, as feedback from the field to the laboratory is needed to identify potential operational problems, complaints, and the needs of both patients and staff.
In this new era of value-based medicine, the same performance standards now apply to POC testing as to in-house lab tests:
• the need for efficient test utilization;
• the importance of interfacing remote test results with all laboratory testing on that patient (EHR); and
• the need to ensure that all healthcare providers have the same access to these results as they would for in-house testing.
The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself, or anywhere else. Ultimate responsibility lies with the laboratory administration and staff.
The Future of POCT
Growing Acceptance; Growing Use; Growing Importance
• Technical advances are making POCT more comprehensive, more accurate, less expensive, and easier to use.
• 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.
• Moreover, to top it off, there is a chronic shortage of qualified clinical laboratory scientists.
Convenient patient access to healthcare, and real-time laboratory results are now the goals and expectations of our profession.
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.
[i] Leinwand, Paul, Reardon, C., Wij, I, Christian, L. Major shift in consumer behavior is forcing providers to respond to an increasing set of demands and competition. October 21st, 2021. Global Healthcare Resource. https://www.beckershospitalreview.com/uncategorized/major-shift-in-consumer-behavior-is-forcing-providers-to-respond-to-an-increasing-set-of-demands-and-competition.html [ii] Futrell, K. Laboratory Point of Care Testing: A Future Outlook. POCT Progression and the Importance of Connectivity Orchard Software Whitepaper. June 2015. https://www.orchardsoft.com/files/white_paper_lab_poc_testing.pdf [iii] Ibid. [iv]Futrell, K. POCT: POCT Supports New Demands. Changes in healthcare open door for point-of-care testing to improve outcomes. December 9, 2013. https://laboratory-manager.advanceweb.com/Archives/Article-Archives/POCT-POCT-Supports-New-Demands.aspx