COVID-19 has presented seemingly insurmountable obstacles since it arrived in the United States over a year ago. After infecting millions of people and claiming the lives of hundreds of thousands more, a glimmer of hope arrived at the loading docks of hospitals around the country in December 2020.1 Following billions of dollars in research resources and a fast-tracked US FDA Emergency Use Authorization approval, the first COVID-19 vaccines presented a new challenge—how to safely and effectively operationalize a vaccine clinic with never-before-seen supply chain constraints.2
UC Davis is a 650-bed hospital that endeavored to open its first COVID-19 vaccination clinic during the vaccine rollout in December. We encountered a shortage of available information on clinic structures, staffing, and vaccine distribution. We hope that sharing tools and strategies in procurement and distribution as well as workflow and management of COVID-19 vaccine clinics based on our experience provides meaningful education on this subject for this pandemic, should the need arise for rapid implementation of a vaccination clinic in the future.
Create an Implementation Team
The first step to safely and effectively setting up a COVID-19 vaccination clinic is establishing an interdisciplinary team to address the development of infrastructure, management strategies, and policies and procedures. This is key to maximizing a facility’s vaccination capability safely and effectively. Implementation teams should consist of members of varying disciplines including but not limited to: administrative staff, nurses, medical assistants, front office staff, pharmacists, information technology (infrastructure and EMR teams), technicians, and those responsible for environmental services, physical operations, and parking.
Staff should be assigned defined roles in executing each of the following priorities and responsibilities:
Leave no discipline out of the planning, plan for mitigating disparities by using outbound calls to patients, consider hiring temporary staff.
Establish the Clinic Site
Clinic location is a crucial factor in determining workflows and limitations, which will be unique to each site. Give attention to regulatory standards, the daily volume of expected personnel and patients while allowing for social distancing, storage, and the security of drugs and supplies.
The first step in establishing a clinic site is to organize the clinic’s design. Structure your clinic with a unidirectional flow of patients while accommodating for social distancing practices during the pre-vaccine questionnaire, vaccine administration, and post-vaccine monitoring stages of the patient visit. Each stage should be conducted in a different physical area and in a rolling fashion. Administer pre-vaccination questionnaires during the period that patients are waiting for an open vaccine station. After vaccination, staff should escort patients to a third waiting area for their 15 to 30 minutes of monitoring.
Continuing with clinic design, each clinic site should accommodate a pharmacy preparation and supply station. Place stations close to the refrigerator(s) for ease of access to vaccine vials. Stations should contain labeling supplies or a labeling machine used to generate custom labels, as well as all supplies necessary for reconstitution when needed.
Select a site that can accommodate the expected patient volume and maintain social distancing, break patient visits up into stages to increase the rate of patient flow.
Workflow and Staff Training
There are many factors to consider when establishing clinic workflow, including but not limited to:
Once workflow is established, a rapid implementation can potentially leave inadequate time to onboard new staff for the clinic. In order to combat this, utilize flowcharts and detailed job aids as training tools for pharmacy staff. These aids should include proper handling, labeling, temperature excursion protocols, and packaging practices. All team members should be well-versed in the process to support medication security and safety, inventory control, and reconstitution when necessary.
Staffing approaches will vary by facility. Options include per diem staff and offering extra shifts, whether unpaid or paid, to current employees. Considerations before implementation include creating training materials or classes for employees, establishing a communication strategy, and developing an escalation plan for when problems arise.
Determine early in the planning process whether doses will be drawn up within or outside of the central pharmacy, consider how involved pharmacy staff members will be in preparing and maintaining the vaccine supply, create a detailed job description to send to employees for review and reference.
Once vaccine shipments arrive at a facility, first check and record the temperature using the digital data logger included for shipping. Vaccine vials should then be placed immediately into the appropriate freezer or refrigerator and secured using locks and keys. Store the keys in a nearby automated dispensing cabinet or other secure location for accessibility.
Inventory can be managed using a combination of scheduled and rolling policies. Throughout the day, pharmacy staff should complete an inventory assessment designed to record the clinic location and capture the total number of unopened vials of each vaccine product, the total number of wasted doses, and ancillary supplies left on site. The inventory management team in turn can access the survey results in order to adjust delivery quantities and repletion of stock as needed.
At the close of business, a more structured approach should be taken. A formal timeout can be performed by all staff one hour prior to the close of the clinic in which all doses are drawn up for immediate use and closely compared to the number of scheduled appointments remaining. Timing of this formal review may vary by site, as it should be determined by each clinic’s workflow. If more doses are needed than what is prepared, the pharmacy staff members should draw up additional doses and directly allocate them to the station in need. In cases where opened vials contain leftover doses after all scheduled appointments are completed, the clinics can turn to their established short list of eligible patients, who can arrive within 15 to 30 minutes to be vaccinated. This interdisciplinary communication strategy is paramount to preventing waste.
Other mitigation strategies include delivery to a different clinic site (if open later), delivery to the ER for use in eligible ambulatory patients, and hospital overhead paging to seek employees in need of vaccination.
Devise a plan for real-time and retrospective inventory management, utilize technology to aid regulatory compliance with labeling and transportation, track and replenish ancillary supplies like vaccine supply, have a structured process to manage doses and open vials at the end of the clinic day, prepare a short list of eligible patients nearby the clinic, think ahead about how the site will accommodate vaccine storage and security.
Temperature Excursion Plans
Whenever storing and handling vaccines, it is important to create a rigorous temperature excursion plan to combat unexpected refrigerator or freezer failures. One clinic leader should be designated at each site as the primary contact for temperature excursions, in addition to affixing a protocol document at the front of the equipment. Each site should simulate temperature excursions to determine the effectiveness of the procedure and timeliness of the responses from both the health system facilities management team and leaders. Access to secondary refrigerators or electric refrigerated coolers can be denoted in each emergency temperature excursion plan as a method to preserve the drug. Should temperatures deviate out of recommended values, clinics should establish individual excursion protocols and call patients from an established list to receive the vaccines and prevent waste.
Temperature excursion plans must be customized for each site and detail the site contact, how to enter the clinic after hours, and the emergency plan for storage of vaccines. Furthermore, temperature excursion simulations need to be conducted to test the plan’s effectiveness.
Any distribution process, no matter how well structured and safeguarded, will have limitations. Sites implementing vaccine clinics should anticipate challenges in relation to storage limitations, resources to accommodate an in-house versus outsourced courier process, and the radius of distribution from the centralized location. Anticipating and allowing for flexibility when necessary helps adapt to the supply chain challenges associated with not knowing the exact amount of vaccines in a given shipment or whether additional doses are present in the vials. This can lead to unexpected supply shortages as the supplies (eg, syringes, needles) shipped with the vaccines match only the expected number of doses (6 for Pfizer, 10 for Moderna) per vial.
To establish a robust COVID-19 vaccination clinic, institutions need an organized, multidisciplinary approach, and the ability to adapt to an ever-changing landscape of vaccine supply. The type of vaccine, logistic and human support of the clinic, board of pharmacy regulations, and patient throughput are important considerations when designing a COVID-19 vaccine clinic. An individualized approach is necessary to ensure vaccine-specific requirements are considered. Furthermore, supply chain management must play a key role in the planning, designing, and implementation of a successful vaccination clinic. Remember that perfect can be the enemy of good, as the ultimate goal is to ensure that as many people as possible, from all patient populations, are vaccinated safely. See the SIDEBAR on page 20 for a case study on COVID-19 vaccination clinics.
Domini M. Hood, PharmD is a PGY-2 medication-use safety & policy resident at UC Davis Medical Center in Sacramento, California. Domini received her doctor of pharmacy degree from Creighton University and completed her PGY-1 in acute care at Froedtert & the Medical College of Wisconsin.
Timothy Cutler, PharmD, is the assistant chief pharmacist at UC Davis Health in Sacramento, California. He currently oversees the clinical ambulatory care division and is a clinical professor at the UCSF School of Pharmacy.
Erin T. St. Angelo, PharmD, MS, is a pharmacy manager of pharmacy supply chain at UC Davis Health system in Sacramento, California. Erin received her doctorate of pharmacy degree from the University of California, San Francisco and completed her PGY-1/PGY-2 with specialization in health-system pharmacy administration at Northwestern Memorial Hospital in Chicago.
Ashley Trask, PharmD, is the medication safety officer and pharmacy manager of medication safety, policy, and regulatory compliance at UC Davis Health in Sacramento, California. She developed and leads the UC Davis Health Pharmacy Peer Responder Team and is a core team member of UC Davis Health Peer Responder network. Ashley also serves as a residency program director at UCDH. She received her doctor of pharmacy degree from the University of Florida College of Pharmacy and completed her PGY-1 acute care pharmacy practice residency at UC Davis Medical Center.
Chad Hatfield, PharmD, MHA, BCPS, is the Chief Pharmacy Officer for UC Davis Health and Assistant Dean at UCSF School of Pharmacy, in San Francisco, California.
Austin Green is a PGY-1 Ambulatory Care/HIV Pharmacy Practice Resident at UC Davis Health in Sacramento, California. Austin received his bachelor of combined science in chemistry and biology from Texas Christian University and went on to receive his PharmD from the University of Texas at Austin and his MPH from the University of Texas Health Science Center at Houston.
Not long after the vaccine rollout began in California, the message from government officials and health system leadership was clear—vaccinate as many people as possible, as quickly as possible. Already dramatically affected by the raging COVID-19 surge and the subsequent complications, UC Davis was tasked with establishing an infrastructure to establish these clinics without any experience in deploying mass vaccination sites.
At UC Davis, we began implementing vaccine clinics by first forming an interdisciplinary team to operationalize each clinic site. In our experience, nursing primarily oversaw the flow of patients, creating protocols for vaccine administration, as well as scheduling, while pharmacy managed the procurement, delivery, storage, and preparation of vaccines for use.
We initially received vaccine allocations intended for both county employees and patients cared for by the health system network. As our vaccine clinic operation grew, permission was granted to utilize our stock to vaccinate all qualifying people, regardless of allocations, to better maximize daily vaccinations. As new batches of vaccines were received, all doses were designated for immediate use as opposed to saving quantities for second doses.
Throughout the process of establishing our clinics, we prioritized the onboarding of staff. We offered stipends to all members of the pharmacy department to staff the clinic, control inventory, reconstitute the vaccine, and review policies and procedures. Learners were also leveraged to support the clinic. A rapid onboarding for pharmacy staff members participating in key activities was developed in the form of a job aid which included vaccine handling, labeling practices, and suggested best practices. Each job aid was customized for the specific site’s processes and expectations. The job aid was distributed to all employees via email as well as printed and housed onsite for reference. This tool was critical in helping to ensure that all staff was quickly informed about policies and procedures, as well as their role in the workflow.
Our facility received shipments of both the Pfizer and Moderna vaccines. In our central pharmacy, we designated one ultra-cold freezer to maintain the Pfizer vaccine at the recommended temperatures of -80°C to -60°C, and one routine freezer to store the Moderna vaccine at the recommended temperatures of -25°C to -15°C.3,4
Due to the strain already upon pharmacy from COVID-19, we could not accommodate drawing up vaccine doses for the clinics in our central pharmacy IV room. Instead, we trained a group of pharmacy technician supervisors, present on a rotating schedule seven days a week, to prepare vaccine shipments for transport directly to the clinics. These technician supervisors were then responsible for preparing batches of vaccine vials once or twice daily to replenish the clinics’ stock as requested.
Prior to transport to our clinics, vaccines were removed from the freezer and thawed, then bagged and labeled with appropriate product-specific BUDs. Our team bagged in batches of five or ten as the vaccines thawed. We then used a labeling system to create custom labels with appropriate product-specific BUDs that prepopulated when printed. Each site was also allocated a machine that could be used to create labels with the new BUD when the vials were moved from refrigeration to room temperature.
Vials were then transported to each site in an electric refrigerated cooler; this workflow allowed individual doses to be drawn up into syringes at each clinic to minimize waste. The location and number of vials in each stage of the distribution process were tracked using a customized vaccine tracker software system.
Various practices for after-hours vaccine storage were implemented depending on the resources available at the site. In one clinic, a limited number of vaccines were secured in refrigerators on site with safeguards in place. Another clinic utilized an ADC to control inventory and ensure security by limiting access. In the other two clinics, the refrigerators are physically locked, and the key is stored in a location known only to clinic leaders and pharmacy staff.
Onsite, we had members of the pharmacy department to support medication security and safety, inventory control, and reconstitution when necessary. In some cases, certified pharmacy staff were also used to immunize patients. Vials were exclusively handled by pharmacy staff until their delivery to vaccination stations. A formal inventory was completed twice daily at a minimum, and vials were counted by two people each time a new batch was couriered to the site.
During the clinic day, pharmacy staff members were instructed to check with the onsite scheduler or access the clinic schedule to determine patient flow and vaccine demand for the next several hours. Pharmacy staff members removed vials from the refrigerator and brought them to room temperature at their station under continuous supervision. They then affixed the vials with product-specific labels with the pre-populated appropriate BUD, reconstituted if needed, and manually distributed the vials to the stations. As more vials were needed, vaccinators signaled the pharmacy station.
Additionally, we conducted a formal inventory audit at the end of each day to prevent waste, including developing a “short-list” of eligible patients to be contacted in the event of an excess of prepared vaccines.
Having quickly, yet thoroughly, trained staff and establishing a set workflow was key to rapidly implementing and managing our clinics. This, combined with flexibility in anticipation of challenges, has allowed us to successfully vaccinate patients quickly and efficiently during this unprecedented time.