OUTSIDE-THE-BOX COVID-19 TESTING STRATEGIES

Mobile community-based testing sites, pharmacy testing, trailer testing sites, at-home kits and 3D-printed swabs for test kits are some out-of-the-box COVID-19 testing/sample collection strategies being implemented in Ohio. These and other findings are outlined below.

1. Mobile Community-Based Testing

• The Ohio State University Wexner Medical Center is implementing a drive-thru testing site in vulnerable community areas in Columbus, Ohio.

• Its latest mobile testing site intersects 43219 and 423211 zip codes where residents have been determined to be more vulnerable to COVID-19 due to housing characteristics, socioeconomic status, chronic health conditions, and race as well as limited access to care and testing.
• Citizens need to register in advance via phone call to be scheduled for testing.
• The site has the capacity to test up to 100 patients per day.
•  Test results are shared with patients via phone, mail or online.

Mobile Community-Based Testing Model

• While the Ohio State University Wexner Medical Center has not released the budget or timeline plan for its mobile community-based testing initiative, research organization Verily has provided templates for implementing this model.
• Verily’s community-based testing program is called Project Baseline and has been implemented in various US states including Ohio, New York, California, and Washington among others.
• According to Verily, a site launch may take roughly 4 days to set up.
•  Day 0 includes establishing site location, supplies and partnerships while Day 1 consists of setup, dry runs, and patient scheduling.
•  Day 2 consists of opening to accommodate 25% of participants which is increased to 50% of participants on Day 3.
•  Day 4 would finally see the testing site running at 100% capacity and maintaining a steady state of operations.
•  Personnel needed include a Site Lead, Clinical Lead, Participant Data Specialist , Appointment Verifier, Participant Identifier, Swabbers, and Security & Traffic Controller (see p.7 for personnel allocations and responsibilities).
•  Key users of community-based testing models such as Project Baseline include local, state, and federal health authorities.
• Verily provides additional information on best practices for setting up a Project Baseline community testing site in its Testing Site Operations Overview.

• Its Site Lead Guide provides information on setting up IT as well as clinical and non-clinical supplies for the testing site.
• Its Clinical Lead Guide details daily responsibilities of medical staff, clinical training, best practices for personal protective equipment (PPE), and process for sample collection and relocation.

2. Community Pharmacy COVID-19 Testing

• The Ohio Board of Pharmacy allowed pharmacists to administer COVID-19 tests and sample collection in May 2020.

• The Ohio Department of Health mapped out locations for COVID-19 testing centers including both retail and community pharmacies.
•  CVS was one of the first pharmacies to offer COVID-19 testing at over 30 locations in Northeast Ohio.
• The pharmacy chain employs a drive-thru testing model where patients are required to stay inside their vehicles and given a self-swab kit through a pharmacy window.

• Samples are sent to a partner third-party laboratory which processes and returns results in about three days.
• The testing sites aim to ultimately process up to 1.5 million tests per month.

Community Pharmacy COVID-19 Testing Model

• The National Community Pharmacists Association lists 5 types of pharmacy testing scenarios.
• Pharmacies can host a public health department pod on its premises to conduct drive-thru mass testing of patients supervised by public health officials.
• A pharmacy can also partner with a private testing company for drive-thru mass testing, the model used by CVS.
• Pharmacies can also collaborate with an ordering physician to collect samples and then ship them to a state-approved laboratory for processing.
• On the other hand, pharmacies can also sell home testing kits to patients who will ship samples to the laboratory themselves.
• Lastly, pharmacies can conduct point-of-care testing where serologic test is used to detect antibodies and results are reviewed afterwards with patients.
•  Prescribe Wellness also suggests an appointment-based model for pharmacy testing sites to maximize use of PPE and other resources.
• If the pharmacy decides to set up a testing site outdoors, Prescribe Wellness describes a one-time setup, one-time cleanup model for the day (see 29:57 of Part 2: Operationalizing a COVID-19 Testing Clinic).

• Personnel for a pharmacy drive-thru testing site include traffic personnel aside from pharmacists administering testing kits to patients.
• While there is no definite timeline for launching a pharmacy testing site, CVS reported that it operationalized 1,000 pharmacy test sites “in weeks” after launching a pilot testing site in mid-March.
• Key users of pharmacy testing sites include public health agencies and officials.

• As of July 2020, the Ohio Pharmacists Association stated that it is working to equip pharmacists with necessary logistical information and resources to help set up COVID-19 community pharmacy testing.
•  OmniSYS is also offering a free COVID-19 Pharmacist Training to help pharmacists operationalize COVID-19 testing at pharmacy sites.
• Access to OmniSYS’ resources may be requested here but will take at least 3 days due to high volume of requests.
• In an interview with Pharmacy Times, McKesson Health Mart’s chief pharmacist Nancy Lyons discusses how pharmacies can begin COVID-19 testing.
• Lyons said, “So really it starts with just taking a step back and looking at the operational processes that are necessary to ensure patients and their employees are safe, and then looking at those clinical guidelines and seeing how all of that can come together… Then it’s really just executing it, like any other pharmacy process that they’re already familiar with, with just a little bit more specificity of some of the protections that are necessary.”

3. Trailer COVID-19 Testing

•  Cincinnati.com reported that trailers were set up for COVID-19 testing and sample collection in March 2020.
• The trailers were initially parked outside 4 emergency departments ran by St. Elizabeth Healthcare.
• Trailers of various kinds have been typically set up near emergency-room doors of hospitals in the area.

•  Napa Valley Register.com reports similar pop-up mobile trailers for COVID-19 testing and sample collection.
• Temporary trailers were fitted as mobile COVID-19 testing clinics and wheeled to different areas according to schedule.

• The article reports that workers as well as families came to the trailer to be tested.
• Testing is free as most insurance plans cover the procedure.
• Trailers were also designated for testing of first responders, healthcare workers, and community members who may have been exposed or exhibit symptoms.
• The mobile trailer can accommodate over 100 tests per day.

Trailer Testing Site Model

• The US Department of Health and Human Services (HHS) published a guide to setting up a drive-through testing site with a trailer clinic.

• According to the document, several personnel with areas of expertise are needed including an infectious disease physician, infection prevention experts and infection control nurses.
• A laboratorian is also necessary to collect, process, and transport collected specimens.
•  Healthcare workers trained in sample collection, handling and patient data tracking are necessary.
•  Medical Reserve Corps units or trained volunteers may also be needed to assist staffing.
•  Equipment needed include label printers, lab fridge, clean/dirty tables, heat source, computer and phones, PPEs, dry erase board and other supplies.
• Key users include hospitals, medical facilities and private labs needing overflow areas for ER.
• HHS’ document provides a complete overview of guidelines including access and security considerations, messaging, sample setup diagram (p.4) and sample patient flow (p.5).

4. At-Home Testing Kits

• The US Food and Drug Administration (FDA) approved an at-home COVID-19 test kit in early July.
• The FDA granted emergency approval to Kroger Health’s test home collection kit.

•  Ohio is among the first to receive at-home test kits for COVID-19 along with Colorado, Georgia, New Mexico and Virginia among other states.
• The test kit will initially be available to any Kroger employee or associate.
• The company said it plans to offer the home collection kits to other companies and organizations in the next few weeks.
• Patients can order the kit at Kroger’s website and receive it within 24-48 hours.
• A healthcare professional will connect with the patient via telehealth two-way video chat to supervise the sample collection.
• The collected specimen is afterwards sent to a laboratory for processing.
• Depending on the test result, patients may receive a call from a healthcare professional for further guidance.
• Regarding the test’s accuracy, a Kroger official remarked, “There is a low probability of the test producing a false positive or false negative.”
• Kroger Health stated it aims to process up to 60,000 tests per week.

5. 3D-Printed Testing Kits

• FormLabs Ohio delivered 15,000 3D-printed swabs to Ohio State University in April in collaboration with the Ohio Department of Health.
• The swabs are made of bio-compatible resin printed by the company’s 200 3D printers.
• FormLabs hopes its product will speed up testing in Ohio amidst device shortages for sample collection.
• The company aims to produce at least 200,000 swabs to be used in test kits in hospitals.
• The Wexner Medical Center also collaborated with the Ohio State College of Engineering and College of Dentistry to 3D-print over 50,000 swabs for COVID-19 testing in April.

• The medical center also developed a viral transport media to stabilize collected specimen en route to processing.
• Swabs and transport media for sample collection are in critical shortage in Ohio as well as in other states.
• Dr. Andrew Thomas, chief clinical officer of the Wexner Medical Center, said, “Because of this new viral transport media, thousands of people will be tested for COVID-19 who otherwise would have had no other option.”

Research Strategy

We have provided 3 major out-of-the-box COVID-19 testing strategies as well as 2 additional examples of sample collection. As Ohio’s testing plans primarily utilized hospitals and commercial lab buildings, we chose strategies that did not take place in these settings.
While all examples were implemented in Ohio, none provided budget and timeline details. This information was not publicly available from the organizations implementing the testing initiatives such as the Ohio State University Wexner Medical Center, CVS Pharmacy or Carbon Health. No press releases detailing project budget or timeline were found in their websites. Official sources and industry associations such as the HHS and the Ohio Pharmacists Association also had no information regarding budget or timeline considerations of these testing strategies. Media coverage from sources such as News5 Cleveland, Cincinnati.com and The Lantern also did not offer any public information about project budget or timelines.
While we were able to determine timeline data from parallel organizations such as Verily’s Project Baseline, this information proved to be arbitrary to the publishing sources. Therefore, we gathered all relevant information regarding time to implement, personnel requirements, metrics of success/effectivity, etc. from parallel organizations as available. We also included testing site strategy guides from resources such as OmniSYS and HHS as additional helpful information to the project.