CORE VALUES AND THE RAPID DEPLOYMENT OF A COVID-19 CONVALESCENT PLASMA PROGRAM

ABSTRACT

The World Health Organization (WHO) declared the outbreak of COVID-19 to be a pandemic on March 11, 2020.1 The use of convalescent plasma (CP) has been studied in outbreaks of other respiratory infections;2-4 the U.S. Food and Drug Administration (FDA) subsequently issued guidance to allow for administration of CP to patients with COVID-19.5 Blood centers collect COVID-19 convalescent plasma (CCP) from individuals who have recovered from COVID-19. Initially, the FDA had not approved the use of CCP,6 it was regulated as an investigational product that had to be administered in clinical trials.5-8 IMPLEMENTATION In direct response to the FDA's convalescent plasma guidance released March 24, 2020, the leadership structure (see Figure 1), mission (see Table 1), and core values of OneBlood (see Figure 2), allowed the blood center to quickly assemble a team and create a CCP donor intake process.9 Senior leadership closely monitored the effort that initially involved a core group of staff members who specialize in process management, in addition to the CEO, CMO, and a physician scientist consultant as the project leaders. Concurrent with immense hospital demand, the public's willingness to donate, and the ongoing evolution of the FDA's CCP donor eligibility requirements, blood centers needed to establish the following * Processes for donor intake in adherence with the evolving eligibility requirements of the Centers for Disease Control and Prevention and the FDA. * IRB approval and informed consent for CCP collection and donation. * Accessible and physically suitable points of collection for CCP donations. * Software upgrades to enable a system that is a 510 (k) cleared medical device.10 * Distribution strategies to equitably deploy CCP to hospitals. * Extensive public communications strategies across multiple media outlets to raise awareness for widely varied audiences. Testing for SARS-CoV-2 became widely available in the southeastern United States in mid-March 2020. Because of the early FDA guidance requiring CCP donors to have an initial positive viral test, be symptom free for at least 14 days, and have a follow-up negative test result, or be deferred from donation until 28 days from the last day of symptoms, a conservative estimate placed the donors' earliest eligibility date to be the first week of April 2020.