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Physician Leadership Journal ; 8(3):82-86, 2021.
Article in English | ProQuest Central | ID: covidwho-1812872


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.

Transfusion ; 61(5): 1542-1550, 2021 05.
Article in English | MEDLINE | ID: covidwho-1096956


BACKGROUND: The COVID-19 pandemic has placed additional stressors on physician lives. In this study, we report findings from a survey conducted among attending physician (AP) members of the American Society for Apheresis (ASFA) to elucidate the status of their well-being during the COVID-19 pandemic as well as resources provided or actions taken by their institutions and themselves personally to maintain or improve their well-being. STUDY DESIGN AND METHODS: A 17-question, voluntary, IRB-approved survey regarding well-being was distributed to the ASFA AP members between August 26, 2020 and September 16, 2020. The descriptive analyses were reported as number and frequency of respondents for each question. Non-parametric chi-square tests, ANOVA, and paired t-tests were performed to determine differences in categorical variables, changes in well-being scores, and compare time points, respectively. RESULTS: Based on the responses of 70 attending level physicians representing the United States (U.S., 53, 75.7%) and outside the U.S. (17, 24.3%), the following were observed: (1) COVID-19 negatively affects the well-being of a sub-population of APs, (2) neither institutional nor individual measures to improve well-being completely resolved the problem of decreased AP well-being during the pandemic, and (3) personal actions may be superior to institutional resources. CONCLUSION: There is a widespread decline in AP well-being during the COVID-19 pandemic that was not adequately improved by institutional or personal resources/actions taken. Institutions and physicians must work together to implement strategies including resources and actions that could further improve AP physician well-being during a public health crisis.

Blood Component Removal , COVID-19/epidemiology , Pandemics , Physicians , Public Health , SARS-CoV-2 , Surveys and Questionnaires , Adult , Female , Humans , Male , United States/epidemiology