The COVID-19 pandemic has accelerated the importance of pharmacies to public health by providing pharmacists with the legal authority to perform CLIA-exempt tests.
The COVID-19 pandemic has accelerated the importance of pharmacies to public health by providing pharmacists with the legal authority to perform tests exempt from the Clinical Laboratory Improvement Amendment (CLIA), which allows better access to diagnostic tests.
Community pharmacies have seen a 45% growth in non-CLIA tests over the past 5 years, making pharmacies the second largest provider of non-CLIA tests.1 This change is largely due to state and federal action clarifying the power of pharmacists to provide CLIA-exempt SARS-CoV-2 tests during the pandemic.1 There are a wide variety of tests exempt from CLIA, including tests for COVID-19, HbA1c, HIV, hepatitis C, International Standardized Ration (INR), cholesterol, and pharmacogenetics. These tests can be both convenient and cost effective for the patient, as people with a high deductible may be more reluctant to pay the high cost of a doctor visit and would be more likely to visit a community pharmacy to perform. tests.
A pilot project examining the feasibility of CLIA-exempt point-of-care testing (POCT) detailed a 3-month trial of the hepatitis C antibody test (HCV-Ab), in which community pharmacists provided 83 tests POC HCV-Ab.2 The results of this study highlighted that partnering with another organization, in this case the Hepatitis Division of the San Francisco Department of Health, to provide assistance and training, was key to success. Two major obstacles were found in the implementation of the HCV-AB test in a community pharmacy setting: recruiting patients for the test and the time given to pharmacists to administer the tests and provide the results.2
To implement these services, a pharmacy manager must take into account several considerations. Most important is to become familiar with CLIA and federal regulations governing pharmacy and collaborative management of drug therapy, as the scope of practice available to pharmacists varies by state. If a state does not explicitly address POCT, collaborative pharmacotherapy management arrangements may enable POCT through collaborative practice agreements with physicians. To make the POCT more achievable, consider partnering with other organizations to help provide services such as state professional organizations, state agencies, or nonprofits. These partners can refer patients to your pharmacy, donate supplies, or even provide funds.
Training of staff on how to perform POCT is essential before providing these services. Dong et al. reported that additional training in the communication skills needed to discuss positive test results is critical to success.2 This is especially important with diseases such as hepatitis C or HIV to lessen the stigma of discussing how the infection may have been acquired. When choosing which tests to provide, assess the patient population that visits your pharmacy to maximize the benefits of these services. For example, if you serve an elderly population, consider cholesterol or blood sugar tests as your initial offerings.
A survey of community pharmacies to investigate the implementation of the POCT found that 74% of pharmacy managers agreed that testing would increase stress levels and result in a higher workload.3 Consider staffing, workflow adjustments, and space requirements needed to incorporate POCT in line with logistics and Health Insurance Portability and Accountability Act (HIPPA) regulations.
Pharmacists in Pennsylvania shared their experience in providing point-of-care services and Steltenpohl et al. reported that using the pharmacist overlap with 2 or more pharmacists working at the same time alleviated the workflow burden.4 If overlap of pharmacists is not possible, consider an appointment-based model targeting appointment times for the slowest points of the workday.4
The POCT is already being implemented in community pharmacies across the country during the pandemic. This has enabled pharmacists to broaden their scope of practice and improve access to care. Adding POCT as an additional pharmacy service is beneficial for the pharmacy by generating revenue and adding to our directory on behalf of public health.
More information on Implement value-added pharmacy services can be found in
Pharmacy management: essential elements for all practice settings, 5e.
Ashley woodyard is a PharmD candidate at the University of Touro in California.
Shane P. Desselle, PhD, is professor of social and behavioral pharmacy at the University of Touro in California.
1. Klepser NS, Klepser DG, Adams JL, Adams AJ, Klepser ME. Impact of COVID-19 on the prevalence of community pharmacies as CLIA-exempt establishments. Res Social Adm Pharm. 2021; 17 (9): 1574-1578.
2. Dong BJ, Lopez M, Cocohoba J. Pharmacists performing point-of-care hepatitis C antibody 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 for point-of-service testing of community pharmacies. 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 the success of Pennsylvania pharmacists. J Pharm Pract. 2018; 31 (6): 629-635.