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Case study on how an independent pharmacy launched a comprehensive COVID-19 testing program to best serve their patients during the pandemic

Community pharmacists play a key role in diagnosing COVID-19 cases, and more

As healthcare professionals on the frontline of patient care, pharmacists provide necessary medical resources that help keep communities healthy. The staff at Tarrytown Pharmacy understands the importance of this role and has been striving to provide the highest quality healthcare services since the pharmacy opened its doors to the greater Austin community in 1941.

During the earliest days of the COVID-19 pandemic, Tarrytown recognized that accessible, reliable testing would be critical to protecting their patients and community, helping limit the spread of disease. Here, we outline how this independent pharmacy first got their COVID-19 testing program up and running, and how it has evolved since.

Improving community care with point-of-care testing

Tarrytown Pharmacy started providing point-of-care testing — or testing that delivers results without sending samples to a lab — prior to the COVID-19 pandemic. Seth Beltran, PharmD, Tarrytown’s Director of Point of Care Services, explained why the team initially pursued these offerings, highlighting the pharmacists’ central role in helping to deliver comprehensive care. “Being a pharmacist these days means providing a diverse range of services. It’s about more than medication and counting pills. We’re there to educate our patients and provide important services the community needs.”

Tarrytown was initially interested in testing sick patients for common illnesses, such as strep throat and the flu. They then expanded their scope to provide total cholesterol, A1C, and blood glucose screening, helping patients monitor risks related to common chronic conditions like heart disease and diabetes in between doctor visits. In combination with testing, the Tarrytown team has built relationships with local providers so patients can receive a diagnosis and initiate or optimize treatments as quickly as possible.

For pharmacies like Tarrytown to offer point-of-care-testing, they first have to get a CLIA certificate of waiver. Clinical laboratories are CLIA certified to process tests and deliver clinical results. Pharmacies and healthcare providers, as well as non-medical institutions such as schools, have the option to apply for a CLIA certificate of waiver, which allows them to process a subset of simple diagnostic tests. It took Tarrytown a few months to get their waiver in 2016, and Dr. Beltran and his colleagues describe the process as straightforward. The pandemic and increased demand for testing locations has since prompted the Centers for Medicare & Medicaid Services (CMS) to expedite waiver applications for even faster turnaround times [1].

Seth Beltran

“Being a pharmacist these days means providing a diverse range of services. We’re there to educate our patients and provide important services the community needs.”

Seth Beltran, Director of Point of Care Services

Providing accessible and reliable COVID-19 testing

When the pandemic began, the Tarrytown team was ready to step up to meet the needs of their patients. During those early days when so much about COVID-19 was uncertain, Dr. Beltran said his team was motivated to help the community. “It was about trying to make something available that was very important at the time,” said Dr. Beltran. “The pandemic was at the peak, and Tarrytown was really trying to make things better by providing testing, counseling, and clarity during a time of fear. We had a lot of people come together to make this work.”

The Tarrytown staff built a COVID-19 testing model that could grow and adapt with changing test options and community needs. In the summer of 2020, they kicked things off by offering an antigen test. By later that year, they recognized the need for a molecular option. And it wasn’t just the Tarrytown team that wanted to expand their offerings beyond antigen — patients were asking for molecular test options, too, given the fact that they are generally considered more accurate [2]. “If you’re looking for a test, you want a really sensitive test to know for sure if you’re infected and possibly contagious. People wanted a more sensitive, more specific test to confirm their diagnosis. We felt better being able to offer a molecular option,” he continued.

Accula

The Accula system is small, mobile, and easy to use with minimal training required. These features, along with accurate PCR results in approximately 30 minutes, makes the platform a desirable option for busy pharmacies and their patients.

In early 2021, the team began looking for a rapid PCR test that would deliver the convenience of antigen testing with the established reliability of the PCR testing method. So when they first learned of Thermo Fisher Scientific’s Accula SARS-CoV-2 Test for use in CLIA waived settings, the Tarrytown team thought it was “too good to be true.” This rapid PCR platform operates with a small, mobile, easy-to-use dock that plugs into a standard wall outlet to deliver results in approximately 30 minutes.

Tarrytown continues to grow their testing program, now offering a range of COVID-19 tests, including both antigen and molecular platforms. Dr. Beltran says the Accula test is a welcome option for patients at Tarrytown Pharmacy. When learning about the surprising ability to get reliable, same-day PCR results, he shared, “People are shocked. It’s definitely a game changer. People want that option. Time is of the essence.”

With variants leading to fluctuating COVID-19 risk, accurate testing remains important to helping fight the pandemic. After Delta led to a surge in testing demand and cases, Dr. Beltran said pharmacists and patients are applying key lessons learned. “Now with Omicron, we’re getting strategic. We are seeing people gravitate more toward molecular tests. Generally, PCR tests have represented a third of our daily test volume. Recently, it was almost half.”

Tapping pharmacies to test, treat, and educate

As the pandemic increases demand for accessible medical resources and reliable health information, pharmacists are there to provide the key services and guidance patients need to navigate this unprecedented and challenging time. “Pharmacists are educators,” Dr. Beltran said. “We talk to our patients about their options and base our recommendations on evidence and mechanisms. We guide people who don’t know what to do so they can make informed health decisions, and we try to ease their tension.”

Looking ahead, Tarrytown continues to seek opportunities to offer more expanded diagnostic and treatment services to maximize their impact in delivering efficient and coordinated care. They recently gained the ability to administer monoclonal antibody treatments to COVID-19 patients, marking an exciting extension beyond a pharmacist’s traditional scope of practice.

The Tarrytown team is celebrating these new capabilities in the community pharmacy world, and they hope other pharmacy teams are embracing the evolution, too. “The need is there,” said Dr. Beltran. “We need to be able to offer these services, and help people understand their options for treatment and prevention. To get there, it’s going to take a strong commitment to teaching and educating in a judgement-free environment.”

For information on the CLIA certificate of waiver process, visit the CMS website. And to learn more about Thermo Fisher Scientific’s rapid PCR test, go to the Accula SARS-CoV-2 Test webpage or contact us to request a quote.

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Resources

References:
1. https://www.mcknights.com/news/cms-to-expedite-review-of-clia-waivers-for-covid-19-point-of-care-tests/
2. https://www.yalemedicine.org/news/which-covid-test-is-accurate

Disclaimer: This Accula SARS-CoV-2 Test has not been FDA cleared or approved but has been authorized for emergency use by FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The test is authorized for use at the Point of Care (POC),i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detectionof nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstancesexist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and CosmeticAct, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Regulatory and Intended Use: For Use under the Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.

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