Core Values and the Rapid Deployment of a COVID-19 Convalescent Plasma Program

COVID-19 was first diagnosed in November 2019 in Wuhan, Hubei Province, China. 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. CCP donors must meet all allogeneic donor requirements.

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)

Figure 1. OneBlood organizational chart

Figure 2. OneBlood core values

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. Communication and collaboration at the national level with other blood centers, FDA regulators, and national associations was paramount.

Understanding the importance of raising public awareness, the company’s CEO, CMO, and senior vice president of corporate communications and public relations enlisted the support of the mayor of Miami, Florida, who had successfully recovered from COVID-19 and was willing to be the face of CCP donation. This first unit was collected from him on April 2 and transfused to a patient on April 3, 2020, amid significant media fanfare.

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.

OneBlood recognized the critical need to engage all departments across the organization while prioritizing close coordination and clear communication. The adaptability of the medical staff, donor services and collections, biologics manufacturing and distribution, information technology (IT), a dedicated project management office, marketing, public relations, and corporate development allowed those departments to provide crucial support throughout the process. The human resources department helped deploy personnel to support new operations.

Cancellation of elective surgeries negatively affected revenue of blood products; however, as an employee-centric organization, OneBlood made an early business decision to avoid staff furloughs, which proved to be fortuitous, as it allowed redeployment of staff to the new CCP collection process. The agility and execution of this plan allowed OneBlood to be one of the first blood centers in the country to make this therapy available.

Even the initial iteration of OneBlood’s response relied on the agility of the IT team to establish a secure place to direct donor and community inquiries.

Key Collaborations

Although OneBlood collects approximately 900,000 donations annually, early CCP donor recruitment was particularly challenging. A significant pool of eligible donors did not exist, there was no available database of persons recovering from COVID-19 to draw on, and many of the CCP donors were first-time donors to OneBlood.

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. The single largest limiting factor at the outset was identification of qualified donors and access to test results required for donation.

Before OneBlood had finalized a plan to collect CCP, OneBlood physicians, hospital doctors, and blood banks collaborated to identify recovered patients as CCP plasma donors. Those early partnerships were invaluable in providing a consistent source of donors as the program developed. As community knowledge about CCP donation increased, additional donors contacted OneBlood independently.

OneBlood’s in-house donor marketing and corporate communications and public relations departments played a critical role in CCP donor and community education and hospital partnerships. OneBlood’s operations and scope of community impact spans the southeastern United States, from the southern tip of Florida to the Carolinas, through Georgia and Alabama.

Media outlets recognized OneBlood’s role and began requesting information and comments on a range of topics pertaining to CCP. The agility of the marketing and communications teams enabled them to handle inquiries quickly. The materials and information created and distributed were critical to OneBlood’s CCP recruitment effort and are still being leveraged by hospital partners to educate their audiences about CCP.

OneBlood medical directors became the liaisons among hospital physicians, the OneBlood intake team, and biologics manufacturing and distribution. Key champions at the hospitals as well as within the community made it possible to coordinate the various tasks. These recruitment efforts were especially helpful to the smaller hospitals that did not have a large base of recovered patients. Adaptability, collaboration, and frequent and effective communication were vital during these weeks in order to provide potentially lifesaving CCP.

Meeting Demand

Apheresis plasma donations can provide up to four units of plasma per donation and require a much shorter waiting period between whole blood donations (28 days versus 56 days). Within two weeks, OneBlood successfully trained 89 employees on apheresis plasma collection and deployed them to CCP-specific mobile drive collection locations. The training was provided entirely through virtual sessions, instructing staff members simultaneously on new processes and new platforms.

Staff were continuously called upon to draw on OneBlood’s core values: respect, innovation, agility, and execution. Adherence to these values allowed the company to sustain a demanding pace in a high-stress environment.

Typically, blood products collected from allogeneic donors are placed into a common inventory and distributed as needed. CCP was a new product with demand exceeding supply, and there was no time to build up an allogeneic inventory. Hospital orders were filled according to a “first in, first out,” or FIFO, logic.

To meet hospital demand and to encourage people to donate, OneBlood established a “referred” donation pathway that enabled a specific patient to receive plasma from a specifically identified donor for that particular patient. Compatibility and FDA-mandated infectious disease testing (taking approximately 24 hours) needed to be completed before product release. Enabling referred donations meant clinicians and family members were able to coordinate donors to give product to a patient sooner than the FIFO logic would allow.

OneBlood shipped its first unit of CCP to a hospital on April 3, 2020 — 10 days after the FDA released the first CCP guidance and placed OneBlood at the forefront of the country’s blood centers in developing innovative means to collect and distribute CCP. By the end of April, OneBlood had successfully built up an allogeneic supply of CCP that surpassed daily demand (see Figure 3).

Figure 3. CCP supply and demand

Results

Adhering to its core values, OneBlood simultaneously developed internal processes to support an innovative process for donor pre-screening and intake, created unit-tracking procedures, and reinforced its role as an organization that collaborates with and educates the community. It took just more than three weeks for OneBlood to secure an allogeneic supply of CCP to fulfill all pending orders as well as all incoming orders for a single day (see Figure 3).

On May 18, 2020, OneBlood led the country with an innovative decision to implement SARS-CoV-2 antibody testing of all regular blood donations, thus enabling OneBlood to readily identify donors who could provide CCP units based on positive antibody test results and the absence of symptoms in the 14 days before donation (see Figure 4).

Figure 4. OneBlood’s development and deployment timeline

The advantage to this approach is that as the prevalence of COVID-19 increases in the general population, so does the prevalence of CCP positive units from healthy traditional blood donors, thus providing an automatic mechanism to help keep CCP production in pace with the local demands during the pandemic.

Qualified plasma units from these antibody-positive donors are converted to CCP, and the donors are subsequently contacted by OneBlood’s donor marketing team to be recruited specifically to increase CCP donation.

Months after establishing an inventory of CCP, demand from hospitals increased by more than 500 percent between the beginning of June 2020 until the end of July 2020 (see Figure 3). OneBlood remained agile as the organization increased messaging to CCP donors and constantly adjusted operations to incorporate CCP intake and related activities into standard operations.

Conclusion

In a continuously changing environment during the COVID-19 pandemic, OneBlood, tapping into the already established leadership framework and core values, was able to rapidly mobilize all departments and resources as well as collaborate with partner hospitals and the community to respond to this unprecedented need and achieve the ultimate goal of building a stockpile of CCP to serve our hospital and patient community as well as supplement a national reserve of CCP.

The core values of the organization (respect, innovation, execution, and agility) as well as the generosity of donors in the community and the involvement of our hospitals, enabled OneBlood to be at the forefront of the fight against this pandemic.

Acknowledgments

The authors thank OneBlood’s senior leadership for their support and review of this field report. Beyond the creation of this report, the authors would like to recognize and thank OneBlood’s senior team for their leadership through the organization’s response to COVID-19. Without the senior team’s commitment to the mission and the communities OneBlood serves, the CCP program would not have been possible. Additionally, the authors recognize the enormous effort that every OneBlood employee has committed to many times over in the past several months. Without the daily efforts of frontline staff, the CCP program would not have come to fruition.

OneBlood departments include:

• Biologics, Labs, and Supply Chain

• Business Intelligence

• Corporate Communications & Public Relations

• Corporate Development

• Corporate Support Services

• Data Science

• Donor Marketing

• Donor Operations

• Finance

• Human Resources

• Information Technology

• Learning and Development

• Project Management

• Quality Assurance & Regulatory Affairs

• SMT – Scientific, Medical, Technical

References

1. World Health Organization. WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020. WHO; 2020. www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 (Accessed July 18, 2020).

2. Cheng Y, Wong R, Soo YO, Wong, W, et al. Use of Convalescent Plasma Therapy in SARS Patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005; 24(1):44–46. https://doi.org/10.1007/s10096-004-1271-9 .

3. Leider JP, Brunker PA, Ness PM. Convalescent Transfusion for Pandemic Influenza: Preparing Blood Banks for a New Plasma Product? Transfusion. 2010; 50(6):1384–98, https://doi.org/10.1111/j.1537-2995.2010.02590.x

4. Arabi YM, Hajeer AH, Luke T, et al. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016; 22(9):1554–61. https://doi.org/10.3201/eid2209.151164 .

5. U.S. Department of Health and Human Services Food and Drug Administration. FDA Investigational COVID-19 Convalescent Plasma Guidance for Industry. Updated November 16, 2020. www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-covid-19-convalescent-plasma .

6. Convalescent plasma is a biological product subject to licensure under section 351 of the PHS Act. 42 U.S.C. 262(a).

7. Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19. V 9.0, July 15, 2020

8. U.S. Department of Health and Human Services Food and Drug Administration. FDA’s Guidance, Emergency Use Authorization of Medical Products and Related Authorities. January 2017. available from: www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities (Accessed July 18, 2020).

9. Reik R. Cases Spike in Wuhan Mystery Pneumonia Cluster | CIDRAP. E-mail message to Bud Scholl, Lance Reed, John Holder, Michael Rogers, OneBlood Medical Directors, Alicia Prichard, Judith Smith, Martin Grable, Carl Peers, John Murphy. January 5, 2020.

10. U.S. Department of Health and Human Services Food and Drug Administration. FDA Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility. April 2013. www.fda.gov/media/72533/download .