The COVID-19 pandemic has accelerated the prominence of pharmacies in public health by providing pharmacists the legal authority to perform CLIA-waived testing.
The COVID-19 pandemic has accelerated the prominence of pharmacies in public health by providing pharmacists the legal authority to perform Clinical Laboratory Improvement Amendment (CLIA)-waived testing, which enables greater access to diagnostic testing.
Community pharmacies have experienced a 45% growth in CLIA-waived testing in the past 5 years, making pharmacies the second largest provider of CLIA-waived tests.1 This change is largely due to state and federal action clarifying the authority of pharmacists to provide CLIA-waived SARS-CoV-2 testing during the pandemic.1 There are a wide variety of CLIA-waived tests being performed, including tests for COVID-19, HbA1c, HIV, Hepatitis C, international normalized ration (INR), cholesterol, and pharmacogenetics. These tests can be both convenient and cost-effective for the patient because individuals with a high deductible may be more reluctant to pay the high cost of a physician’s office visit and would be more likely to visit a community pharmacy for testing.
A pilot project examining the feasibility of CLIA-waived point of care testing (POCT) detailed a 3-month trial of hepatitis C antibody (HCV-Ab) testing, in which community pharmacists provided 83 HCV-Ab POC tests.2 Results from this study highlighted that partnering with another organization—in this case, San Francisco Department of Health’s Hepatitis Division—to provide assistance and training was key to success. Two major barriers were found in implementing HCV-AB testing in a community pharmacy setting: patient recruitment for testing and time for pharmacists to administer the tests and provide the results.2
To implement these services, there are several considerations for a pharmacy manager to take into account. Most important is to be familiar with the CLIA and federal regulations governing pharmacy and collaborative drug therapy management because the scope of practice available to pharmacists varies among states. If a state does not address POCT explicitly, collaborative drug therapy management provisions may allow for POCT through collaborative practice agreements with physicians. To make POCT more feasible, consider partnering with other organizations to assist in providing services such as state professional organizations, state agencies, or non-profits. These partners can direct patients to your pharmacy, donate supplies, or even provide funding.
Training staff on how to perform POCT is essential prior to providing these services. Dong et al. reported that further training on communication skills needed to discuss positive test results is vital to success.2 This is especially important with diseases such as Hepatitis C or HIV to alleviate the stigma of discussing how infection may have been acquired. When choosing which testing to provide, evaluate the patient population that visits your pharmacy in order to maximize the benefit of these services. For example, if you serve an elderly population, consider cholesterol or blood glucose testing as your initial offerings.
A survey of community pharmacies to investigate the implementation of POCT found that 74% of pharmacy managers agreed that testing would increase stress levels and result in higher workload burdens.3 Consider staffing, workflow adjustments, and space requirements needed to incorporate POCT compliant with logistics and Health Insurance Portability and Accountability Act (HIPPA) regulations.
Pharmacists from Pennsylvania shared their experience in providing point of care services and Steltenpohl et al. reported that utilizing pharmacist overlap with 2 or more pharmacists working at the same time eased the burden of workflow.4 If pharmacist overlap is not possible, consider an appointment-based model targeting appointment times for the slower points in the workday.4
POCT is already being implemented in community pharmacies across the nation during the pandemic.This has opened the door for pharmacists to widen their scope of practice and increase access to care. Adding POCT as an additional pharmacy service is beneficial to the pharmacy by generating revenue and adding to our repertoire in the name of public health.
More information about Implementing Value-Added Pharmacy Services can be found in
Pharmacy Management: Essentials for All Practice Settings, 5e.
Ashley Woodyard is a PharmD candidate at Touro University California.
Shane P. Desselle, PhD, is a professor of social and behavioral pharmacy at Touro University California.
1. Klepser NS, Klepser DG, Adams JL, Adams AJ, Klepser ME. Impact of COVID-19 on prevalence of community pharmacies as CLIA-Waived facilities. Res Social Adm Pharm. 2021;17(9):1574-1578.
2. Dong BJ, Lopez M, Cocohoba J. Pharmacists performing hepatitis C antibody point-of-care screening in a community pharmacy: A pilot project. J Am Pharm Assoc (2003). 2017;57(4):510-515.e2.
3. Gallimore CE, Porter AL, Barnett SG, Portillo E, Zorek JA. A state-level needs analysis of community pharmacy point-of-care testing. J Am Pharm Assoc (2003). 2021;61(3):e93-e98.
4. Steltenpohl EA, Barry BK, Coley KC, McGivney MS, Olenak JL, Berenbrok LA. Point-of-care testing in community pharmacies: Keys to success from Pennsylvania pharmacists. J Pharm Pract. 2018;31(6):629-635.