Bringing point-of-care testing to the community

The expansion of POCT services to pharmacies increases patient access, but barriers exist

According to CDC, 8 million people have undiagnosed diabetes, 240,000 people have undiagnosed HIV, and 800,000 people have undiagnosed hepatitis C in the United States.1 POCT—medical diagnostic testing performed in close proximity to the patient and outside traditional, clinical laboratory settings—can identify all three of these diseases. The testing can be provided at primary care clinics, community pharmacies, paramedical vehicles, rural and remote areas, and during times of natural disasters or emergencies.

POCT offers many advantages toward improving the quality of, access to, and cost effectiveness of patient care. For example, point-of-care glucose testing (finger stick test) for patients with diabetes requires less-invasive and less-complex sample collection compared with blood testing. It also provides rapid results that can help make more timely treatment decisions. Moreover, in an age when patients expect to receive care that is exceptional yet instantaneous, POCT improves patient satisfaction and removes potential barriers that deter them from receiving follow-up care. Traditional HIV testing, such as ELISA (enzyme-linked immunoassays), needs several days for results, while the rapid HIV tests can produce results in as little as 20 minutes. This can facilitate treatment initiation and progression toward reducing undiagnosed HIV infection around the world.

With the expansion of POCT services to nonlaboratory settings such as pharmacies, patients have improved equity of access to achieve better health outcomes. The ever-changing health care environment can benefit from rapid diagnostic testing to address the increasing population of seniors, prevalence of chronic diseases, demand for patient safety and equitable outcomes, and need to adapt to technology. With a focus on quality care and patient outcomes, POCT can help pharmacists screen, perform simple diagnoses, treat, and link patients back into primary care in a timely manner.

Although there are attractive qualities to POCT, the cost and potential for errors resulting from lack of expertise can be hindrances to implementing such a service. Generally, POCT is more expensive on a unit-cost basis than testing performed in a laboratory; however, other factors of overall cost should be considered, such as labor time and transportation of specimens. In addition, reduced time to diagnosis and treatment initiation can potentially decrease the length of patient stay, thereby lowering the cost of overall patient care. Potential errors associated with POCT services can be alleviated by narrowing the education gap, particularly among student pharmacists, practitioners, and other health care providers. Certification programs are available to help expand POCT initiatives.

According to a recent study,2 more than 85% of pharmacists and student pharmacists are not aware of the Clinical Laboratory Improvement Amendments (CLIA), which is a regulating body responsible for overseeing the certification of clinical laboratories. CLIA offers waivers if a laboratory test can be performed at “minimal level of complexity and low risk of erroneous results.” Pharmacies can obtain a CLIA waiver through their state CMS office. Some examples of CLIA-waived tests include international normalized ratio, Helicobacter pylori, A1C, influenza, and HIV/hepatitis C virus screening. Nonetheless, the varied state laws sometimes hinder whether pharmacists in some states can perform POCT at all; the lack of standardization for POCT across the United States also contributes to the barriers of pharmacist-led POCT across practice settings.

Today, pharmacists can engage in patients’ treatment plans in multiple ways, such as providing medication therapy management and patient education. From the patient’s perspective, the pharmacist is the most accessible and trusted medical professional. The convenience of pharmacies eases implementation of POCT services. POCT allows better patient experiences, improved quality of care, and most importantly, encourages patients to take charge of their medical conditions.



2.     Mich Pharm. 2014;52(2):8–11