key: cord-0056546-rpco88vn
authors: Venkatesan, Chapy; Vassallo, Michelle; Massiah-White, Melanie; Brittain, Anne; Puhl, Jonathan; Ardabell, Toni; Sintich, Maureen; Younossi, Zobair M.; Motew, Stephen
title: Rapid Operationalization of a Large-Scale Covid-19 Vaccination Program in an Integrated Community Health System
date: 2021-02-19
journal: NEJM Catal Innov Care Deliv
DOI: 10.1056/cat.21.0005
sha: e736f42d5305edbc544099f3616be731952d4f50
doc_id: 56546
cord_uid: rpco88vn

Inova Health System addressed the challenge of Covid-19 by implementing a seamless vaccination program that allowed them to efficiently and safely deliver >67,000 vaccines over the first 6 weeks.

with approximately one-third requiring critical care and 10% requiring mechanical ventilation. At the beginning of the pandemic, our rate of inpatient mortality was approximately 20%; changes in clinical practice (including stricter criteria for mechanical ventilation and the creation of Covid-19 inpatient units) led to a rapid reduction in mortality during the summer of 2020, to a rate of approximately 5% in January 2021.

In mid-December 2020, the U.S. Food and Drug Administration awarded two companies (Pfizer-BioNTech and Moderna) emergency-use authorizations (EUAs) for Covid-19 vaccines.3 , 4 These EUAs were granted during the escalation of the second wave of Covid-19.5 As a result, our health care system was challenged to implement a vaccination program while maintaining highly efficient and proficient care for our Covid-19 inpatients. Following the EUA approval of the 2-stage Covid-19 vaccines, we rapidly launched an efficient vaccination program through careful planning and rapid changes in management. Inova's vaccination capacity increased from 600 individuals/day to >3,500/day, and we continue to learn and adapt through a dynamic process. By the end of January, we had vaccinated >67,000 individuals qualified through the prioritization templates received from the U.S. Centers for Disease Control and Prevention (CDC), the Virginia Department of Health, and local health departments.5 , 6Figure 1 shows the daily and cumulative number of vaccinations given through January 24, 2021.

Here, we share our experiences, providing suggestions and insights from the launch of our vaccination process, in the hope of assisting others who will face the logistical challenges of largescale vaccination programs.

With the anticipation of forthcoming clinical trial results and manufacturing acceleration associated with Operation Warp Speed, Inova created a Vaccination Implementation Team in October 2020 for the purpose of planning for the immediate delivery of the Covid-19 vaccine, once available. The team was led by a triad of leaders (a clinical nurse/operations leader, a pharmacy lead, and our Chief Quality and Safety Officer) in conjunction with our established emergency management leaders and our Covid-19 Coordination Center. The team was empowered by executive clinical and operational leadership as well as the health system Chief Executive Officer to expeditiously assess and remove barriers to implementation. The guiding imperatives were the safety of our vaccination team and vaccine recipients while offering vaccination for all eligible individuals. The initial work streams carried out by the team included:

1. Process design, including space/geography, personnel, and vaccine handling 2. Prioritization and scheduling

Based on our knowledge that at least one of the vaccines (Pfizer) required ultra-cold storage, and given the benefits of managing operations at one site, we chose a geographically central location with proximity to our largest hospital, core pharmacy, and supply depot. A total of 20,000 square feet was identified on the ground floor of a mixed-use conference and clinical building. Belowgrade access to loading docks and space for -80°C and -20°C freezers facilitated delivery, storage, and preparation of the vaccine.

Multiple simulated walkthroughs by a multidisciplinary team allowed us to preemptively identify traffic bottlenecks and maximize unidirectional traffic flow with intentional direct entry from designated parking and screeningareas."

Multiple simulated walkthroughs by a multidisciplinary team allowed us to preemptively identify traffic bottlenecks and maximize unidirectional traffic flow with intentional direct entry from designated parking and screening areas. Patient flow timing was identified and verified after launch. Socially distanced sites were created in the main space for queuing (3 minutes), administrative check-in (5 minutes), vaccination (7 minutes), post-vaccine observation (15-30 minutes), and exit ( Figure 2 ). Additionally, documentation and record-keeping areas and an on-site pharmacy work area for preparation of vaccines were created within the main space. "

Our emergency management team coordinated the security and traffic management/flow as an essential component of our process. This process included communication and coordination with local law enforcement and emergency medical service providers.

The post-vaccination observation area was identified as the site of a bottleneck caused by the fixed observation time of 15 minutes. This issue was addressed with batched entry, improvements in administrative workflow (as second vaccinations were scheduled with use of iPads), and the eventual expansion of the overall space to accommodate more patients.

It was estimated that a total of 65 core team members would be needed for each shift to maintain day-to-day operations and accommodate maximum vaccine delivery. A full-time, on-site leader team was assigned to troubleshoot and oversee the clinical, pharmacy, and documentation teams. We designed each shift to open with a safety briefing, with assessments of staffing, supplies, flow, and training. This process is modelled after Inova's safety huddle process, which is used systemwide.

A combination of part-time and volunteer workers from our health system were enlisted to assist with operations. Shifts were set as 7 a.m. to 12:30 p.m. and from 1:30 p.m. to 6:00 p.m., including weekend and holidays with slightly limited times. To support operations at full capacity, each shift required 29 nurses or licensed providers for vaccine delivery, 7 pharmacists and pharmacy assistants, and 28 others for check-in and administrative support. Shift assignments were managed with use of commercial scheduling software (Signup.com).

We initially underestimated the number support staff required for efficient traffic flow, cleaning of hard surfaces and reusable items, movement of supplies, and data entry. Although vaccine supplies were initially adequate, reusable and electronic supplies such as clipboards, pens, and tablets needed to be monitored and replenished to keep up with demand.

Inova owns multiple -80°C freezers; 5 of these (capacity, 150,000 doses each) were relocated from our research facility to our central location in a secured area for storage of the Pfizer-BioNTech vaccine. Vaccine shipments are tracked via FedEx and are received at our loading dock by our dock master and pharmacy personnel. The vaccine vials are kept in their original storage trays from the manufacturer.

Estimates of scheduled vaccine recipients are emailed to the lead pharmacists on the day prior to vaccination in order to allow them to determine the number of doses needed. Once each day, a pharmacist moves 80 vials of vaccine from the freezer to the refrigerator to thaw; additional vials are thawed as needed.

Within hours after the initial launch, we realized that broader 'tier' categories and flexibility in expanding the vaccine-eligible groups would allow for optimal efficiency. This change also minimized disruption of health care operations because no one group was disproportionately affected by absences resulting from potential post-vaccine side effects. By adhering to this principle, we were able to expand open appointment slots from 600/day initially to >2,000/ day within 6 days."

Each of six workstations contains everything required for vial and dose preparation. After reconstitution, the doses are placed into a sanitized plastic bin that is marked with the time of expiration (6 hours after reconstitution) and contains the appropriate number of CDC vaccine information cards. The bins are stored in a shelf in the pharmacy area and are sorted carefully. Near the end of the clinic day, vials are prepared only as needed to prevent overproduction and wasted " doses. Empty vials are collected and counted at the end of each day, and they are kept in a secure location to prevent tampering or diversion.

Vaccination stations are manned by clinical staff who are trained to administer vaccines and educate vaccine recipients. A flag-signaling mechanism is used to identify readiness for the next patient (green flag) or the need for support or more vaccines (red flag). At least one pharmacist is always on site to oversee vaccine reconstitution and production. This pharmacist is also able to answer questions about the vaccine, such as side effects, timing with other vaccinations, drug interactions, and vaccine efficacy.

We found that we needed to prepare multiple doses prior to opening the clinic each day to improve efficiency. Attention to timing, the number of doses, and vial reconstitution near the end of the day are important to avoid waste. We did find excess dosages per vial; this information was used to calculate additional supply.7 , 8

We initially created three tiers for the vaccination of all interested team members as quickly as possible. The tiers were intentionally broad and were consistent with established guidelines. The initial tier (with an estimated 14,000 recipients) included all patient-facing clinical caregivers and essential support teams as well as all active medical staff. The second tier (with an estimated 3,000 recipients) included associated partnered direct caregiver groups, including joint ventures, contracted groups, and member practices from our clinically integrated network. The final tier (with an estimated 3,000 recipients) included all remaining team members.

At the onset of planning, we discussed using a vaccination scheduling system to control flow and to spread out team members for vaccination. Initially, we sought to identify and limit scheduling to team members in each tier and then open scheduling to subsequent tiers as we completed each group. Tier criteria were communicated and published internally; we decided not to monitor compliance by using rosters but instead by trusting our team to be conscientious organizational citizens. Appointments for the second vaccine dose are made on site during post-vaccination monitoring. Our recent preliminary analysis suggests that 93% of those who were vaccinated in the early phase of our vaccination program returned for their second dose, mostly within the prescribed window of 17 to 23 days.

What We Learned: Within hours after the initial launch, we realized that broader "tier" categories and flexibility in expanding the vaccine-eligible groups would allow for optimal efficiency. This change also minimized disruption of health care operations because no one group was disproportionately affected by absences resulting from potential post-vaccine side effects. By adhering to this principle, we were able to expand open appointment slots from 600/day initially to >2,000/day within 6 days. We also doubled the number of iPads available for second-appointment scheduling in the post-vaccination monitoring area, from 30 to 60 iPads, to increase throughput.

A separate, multispecialty team of experts provided independent evaluation of vaccine data, safety, and approval. Insights provided by well-respected health system leaders and scientists were invaluable in helping us to establish an additional layer of confidence for our team members and partners. Information from this work group was used to populate our Frequently Asked Questions document (described below) and to develop care guidelines for current and future vaccination recommendations.

Effective communication within the organization was crucial for initial and continued success. Our communication principles include transparency and frequent updates (delivered daily or even hourly as needed). A thorough Frequently Asked Questions document was drafted in multiple languages and was widely disseminated before the launch of vaccination. This document includes the following categories: vaccination prioritization, vaccine information, the organizational approach to the vaccine, vaccine decision-making guides, information about receiving the injection, human resources-related implications, and expectations for leaders and team members. This living document is frequently updated on our organization's intranet.

With capacity that exceeds scheduled appointments, we rely on multiple communication channels to frequently update our teams on the availability, safety, and importance of Covid-19 vaccination. Regular video messages in which Inova's CEO emphasizes the importance of vaccination are distributed through the health system intranet, daily e-mail communications, and social media. Weekly all-system huddle messages, launched as the primary form of communication at the onset of the Covid-19 pandemic, are another key mode of communication.

What We Learned: We found that communication of the process was insufficient and that the combination of messaging and education is critical and requires further optimization. Our current approach is broad and multichannel; going forward, more targeted data-driven endeavors will be required to increase confidence and to engage diverse communities.

Inova's Inclusion Council, the team that guides our commitment to serving diverse teams and communities, was engaged to facilitate culturally appropriate communication, to identify ethnic and racial biases and fears, and to promote recommended and safe vaccination practices through an "inside-out" program. In this program, team members from multiple racial and ethnic backgrounds act as trusted messengers within at-risk communities to increase engagement and establish confidence. " What We Learned: We learned that, to overcome some of the initial barriers in vaccinating all our team members, culturally appropriate communication would be critical. In this context, we hope to widen our regional vaccination endeavors in partnership with local health departments to include next-tier and at-risk populations. Advanced planning is underway for the dissemination of vaccines to satellite and physician offices once the vaccine is available for the general population. Inova's Inclusion Council is intimately involved in this process and provides input about effective communication and distribution of vaccines to our diverse teams and communities.

The next phases of our vaccination program will require expansion to other eligible cohorts. These steps will add to our other challenges related to the overlap between persons who are receiving their first dose of vaccine and those who are receiving their second dose. To deal with these challenges, we will continue to implement improvements in the vaccination process, increase the number locations for delivering vaccines, and optimize the recruitment of staff to deliver vaccines. These improvements will be accomplished via engagement of our process-improvement team and the leverage of technology to optimize patient flow.

Although the vaccine is currently provided by suppliers at zero cost, Inova is absorbing all remaining expenses for our Covid-19 response program. Operational and financial resources from federal and state programs are essential for sustainability and success.

Ultimately, the success of the Covid-19 vaccination program relies on broad population acceptance and participation. Developing widespread trust and acceptance among communities will be a larger hurdle as we refine and expand our operations programs.

All Five Inova Hospitals Earn Highest CMS Five-Star Quality Rating. Inova Health System

ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine under an Emergency Use Authorization

COVID-19 Moderna Vaccine EUA Fact Sheet for Recipients and Caregivers

Phased Allocation of Covid-19 Vaccines. ACIP COVID-19 Vaccines Work Group

Virginia Department of Health. VDH COVID-19 Vaccination Response

FDA Encourages Use of Extra Doses of Pfizer COVID Vaccine Vials