COVID-19 vaccine distribution: A high reliability organization approach

The development of vaccines capable of combating the novel coronavirus disease (COVID-19) represented a pivotal turning point in what has been an extraordinarily difficult period. Global efforts have shifted from reactionary responses to preventative measures through mass vaccine production, distribution, and administration. Importantly, experts estimated that 70% or more of the population would need to be vaccinated in order to reach “herd immunity,” or the point at which an adequate proportion of the population has become immune to a disease thereby reducing likelihood of infection for those who lack protection [1]. Healthcare systems in the United States (U.S.) experienced immense pressure to rapidly achieve this goal. However, such systems have struggled to organize the staff, supplies, training (e.g., handling and administering vaccines), and logistics (e.g., vaccine storage and transport) needed to safely execute this mission. Notably, equitable delivery across socioeconomic class, geographic region, and age group needed to remain a top priority. Unfortunately, the continuous emergence of new and more transmissible COVID-19 variants, against which existing vaccines may be less efficacious, as well as the issue of general willingness to receive the vaccine threatened to slow this progress [2]. Considering these complex and interactive barriers, healthcare systems may benefit from sharing vaccine distribution strategies to facilitate the collective goal of mitigating the global effects of this and future pandemics.

Against this backdrop, the purpose of this commentary is to describe the way in which the Southeast Louisiana Veterans Health Care System (SLVHCS) utilized a High Reliability Organization (HRO) approach, a framework introduced by The Joint Commission and adopted across the Veterans Health Administration nationally, to address aforementioned barriers and successfully distribute over 96,600 COVID-19 vaccines and boosters. SLVHCS, located in New Orleans, provides health care services to over 50,000 Veterans across 23 parishes in southeast Louisiana. The HRO pillars upon which the facility is structured are Leadership Commitment, Culture of Safety, and Robust Process Improvement [3]. These guiding pillars have been necessary for effective response throughout the COVID-19 pandemic and served as the foundation for the facility’s strong mass vaccination program. SLVHCS’s vaccination program was further bolstered by direct application of the five HRO principles: deference to expertise, sensitivity to operations, preoccupation with failure, reluctance to simplify, and commitment to resilience [3]. Herein, we will outline the SLVHCS vaccine distribution strategy, with attention to how the HRO framework guided decision making at each juncture.

A great deal of organization is needed to effectively, rapidly, and safely administer vaccines to tens of thousands of individuals. At SLVHCS, this process began in November 2020 after being designated as an early vaccination site. Over time specific operations have changed, but throughout we have relied on the three pillars of a high reliability organization. In late 2020, leadership made an intentional and visible commitment to treat COVID-19 vaccination as a critical, life-saving effort, and to provide the resources (e.g., supplies, equipment, overtime for staffing, etc.) necessary to succeed. SLVHCS’s cultural focus on safety meant that patient safety, employee safety, and infection control staff were involved in every step of the planning process in these early stages. Further, in the spirit of robust process improvement, emphasis was placed on continuous learning to ensure that our operations were responsive to changing guidance as time went on. Through these guiding HRO pillars, SLVHCS set the stage for success and vaccination of the patient population was achieved through application of the HRO principles. Although these principles are displayed individually they are highly interrelated, as can be observed through the ways in which challenges are addressed and how the vaccination process changed over time.

• •Deference to Expertise - Upon being designated as an early vaccination site in November 2020, we recognized that we would need to invite a huge variety of subject matter experts to the table to ensure that each element of the plan was adequately evaluated and implemented. Leadership embraced the HRO principle of deference to expertise by recruiting individuals from multiple professions to form a COVID-19 Vaccine Planning Committee, which would oversee the processes for vaccine ordering, receipt, storage, preparation, and administration, as well as operation of a mass vaccination center. This team was comprised of clinicians, such as physicians, nurses, and pharmacists, as well as non-clinical team members including engineering, safety, environmental management, logistics, and medical administration services. This expert group carried out multiple high-fidelity simulations of the vaccination process between 2020 and 2021 as demand for vaccines changed. In addition, leadership continued to encourage communication of updates in COVID-19 risks, safety protocols, and vaccine/booster availability through morning huddles with facility leadership and with frontline staff through email communications.
• •Sensitivity to Operations - Organizing a high-volume vaccine distribution site with minimal disruption to regular operations would prove challenging for any healthcare system. SLVHCS Leadership utilized the HRO principle “sensitivity to operations” to support early coordinated efforts by involving frontline supervisors and staff when designing staffing models, patient flow, supply and equipment needs, and training materials for the vaccination center. Involving supervisors and staff in such decision-making ensured minimal disruption to ongoing medical center functions and facilitated continuity of operations within the vaccination center. By mid-2021 initial vaccine demand had decreased. Being sensitive to operations, the vaccination center was relocated from its original location (i.e., the patient gym) to a smaller space, thereby reducing the number of staff needed to maintain functionality.
• •Preoccupation with Failure – Preoccupation with failure underpinned SLVHCS’s overall approach to COVID-19 vaccination. Months before vaccines were delivered to the facility in 2020, the team employed proactive risk assessments to identify ways that processes could fail. This information was then used to design more risk-resistant processes. For example, freezer failure presented a real risk to the safe storage of vaccines. Therefore, pharmacy and engineering worked together to develop a detailed freezer failure communication and response strategy. Further, long wait times were identified as a possible deterrent to vaccination, so the team shifted resources to develop a high-volume call center that allowed 100% scheduling of appointments to ensure steady patient flow that would not overwhelm capacity. Finally, SLVHCS knew that many individuals were unsure about receiving the vaccine. Recognizing that advice from trusted medical professionals was important to vaccine acceptance, SLVHCS launched a proactive outreach campaign before even receiving the first shipment. This campaign involved Veteran Patient Aligned Care Teams (primary care PACTs) calling each of their patients to discuss vaccination, answer questions, and record the patient’s interest in the medical record. This strategy prompted Veterans to think about vaccination early, ensured access to accurate information, and gave the vaccination center a better idea of anticipated interest. This process continued into 2021 and 2022 to facilitate scheduling of COVID-19 boosters, as well as to inform Veterans of the location change of the vaccination center.
• •Reluctance to Simplify – Healthcare is complex, and SLVHCS recognized that sometimes simple solutions would not sufficiently address complex issues. Although the strong initial outreach campaign in 2020 and 2021 led to early high-volume vaccine acceptance, some Veterans remained unvaccinated. The planning committee evaluated root causes for lack of vaccination among its patients and identified vaccine hesitancy and rural location as two significant barriers. To address vaccine hesitancy, the facility provided clinicians with tools for engaging Veterans in non-confrontational discussions about the relative risks and benefits of vaccination. These conversations were especially important at SLVHCS, where almost half of the patient population identifies as non-White, with 41% identifying as Black/African American, a population with both historical distrust of medical systems, and current COVID-19 vaccine hesitancy [4]. Further, many Veterans reside in rural and underserved areas throughout the state, impeding access to vaccines. Leadership embraced the HRO principle of reluctance to simplify by coordinating vaccination efforts at numerous VA community-based outpatient clinics, which facilitated immunizations for rural-dwelling and low-income Veterans. Additionally, by late 2021 all SLVHCS COVID-19 vaccination locations added flu vaccine availability. Although this increased the complexity of vaccination center operations, it facilitated broad vaccination and promoted Veteran health.
• •Commitment to Resilience – As with any interdisciplinary operation, there were unanticipated problems. Through the lens of a HRO, these events were not viewed punitively, but rather were seen as a chance to improve. Indeed, in keeping with the HRO principle of commitment to resilience, vaccination center staff took an exhaustive approach to analyzing adverse events and near misses. For example, vaccine waste was analyzed to identify underlying causes and to enact plans to prevent reoccurrence. Further, following the FDA and CDC recommended pause of the Johnson & Johnson vaccine in April 2021, SLVHCS once again prioritized patient safety and embraced the HRO principle of commitment to resilience. The COVID-19 high volume call center was enlisted to contact Veterans who had received the Johnson & Johnson vaccine to inform them of the purpose of the pause and potential adverse side effects. Providing Veterans with the opportunity to discuss issues surrounding the recommended pause ensured provider to patient transparency and reduced uncertainty.

In sum, SLVHCS’s use of HRO principles proved instrumental in achieving swift, organized, and effective distribution of COVID-19 vaccines, thereby improving the health and well-being of Veterans and their families. Through teamwork, constant commitment to improving processes, and unwavering attention to patient safety, SLVHCS was able to administer vaccines and boosters to over 96,600 Veterans, spouses, caregivers, and government employees. This resulted in a vaccination rate of 80.76% among all SLVHCS Veterans, compared to a rate of 55% across Louisiana [5]. Additionally, among Veterans identifying as Black or African American, SLVHCS achieved a vaccination rate of 81.55%, compared with a rate of 64% among individuals identifying as Black across Louisiana [6]. Thus, employing HRO principles helped us reach our goals related to broad and equitable vaccination. These same strategies may be helpful in organizing healthcare system responses to the current pandemic or future crises. Indeed, HRO principles can be flexibly applied across settings and thus constitute extremely useful scaffolding for facilities attempting to solve a novel problem. When resources are thin and stress is high, such a framework may be the difference between success and failure.

1. Authors’ Contributions

All authors attest they meet the ICMJE criteria for authorship.

2. Disclosure

The contents of this presentation do not represent the views of the Department of Veterans Affairs or the United States Government.

Funding

Claire Houtsma is supported by the U.S. Department of Veterans Affairs (Clinical Science Research and Development Service) under Career Development Award-1 IK1 CX002370-01A1. Amanda M. Raines is supported by the United States Department of Veterans Affairs (Clinical Science Research and Development Service) under Career Development Award-2 IK2CX001978-02.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Data availability

Data will be made available on request.