Blood Banking and Transfusion Medicine Challenges

Blood Banking and Transfusion Medicine Challenges

SARS-CoV-2 (also known as COVID-19) has been an unprecedented challenge in many parts of the medical field with blood banking being no exception. COVID-19 has had a distinctly negative effect on our blood collection nationwide forcing blood banks, blood centers, and the US government to adopt new policies to adapt to a decreased blood supply as well as to protect our donors from COVID-19. These policies can be seen distinctly in patient blood management and blood bank operations. We are also faced with developing policies and procedures for a nontraditional therapy, convalescent plasma; its efficacy and safety is still not completely elucidated as of yet.

Keywords: COVID-19, Blood banking, Transfusion medicine, Blood shortage, Blood wastage, FDA donation policies, Convalescent plasma

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Key points

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COVID-19 has had a negative impact on blood collection.

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The Centers for Disease Control, blood centers, and American Red Cross have developed new policies to protect donors and the blood supply.

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Blood management has become more important with decreasing supply as well as management of blood bank personnel.

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Convalescent plasma, although touted as a possible treatment, has limited literature on its efficacy.

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Introduction

Within 3 months of the first diagnosed case, the outbreak of acute respiratory disease caused by the novel coronavirus (SARS-CoV-2), also known as COVID-19, rapidly grew into a global pandemic. The eruption of this virus, reportedly, may have been linked to a seafood and wildlife market in Wuhan, Hubei Province, China.1 , 2 Person-to-person spread is thought to occur via respiratory droplet contact (≤6 feet), skin contacts, and even the transmission through air while speaking. Despite the extraordinary universal attempts to limit the spread of this virus, new cases are diagnosed on a daily basis throughout the world and have dramatically affected, among other health care disciplines, the blood bank and transfusion medicine. Because of the growing prevalence and highly infectious nature of COVID-19, new policies and guidelines have started to develop in transfusion medicine practices. In this article the authors address the myriad of ways that COVID-19 has affected blood banking and transfusion medicine, including the safety of both blood donors and blood product recipients, the management and distribution of blood products during a pandemic, and the use of blood product–derived therapeutics.

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Clinical manifestations of COVID-19

Common symptoms of COVID-19 infection, which typically appear within 2 to 14 days after exposure, include fever, sore throat, cough, shortness of breath, chills, muscle pain, headache, and sensory changes such as loss of smell or taste. Nausea, vomiting, diarrhea, skin rash, delirium, and dizziness have also been reported.3 , 4 In advanced cases, mild-to-severe lower respiratory tract infection can be seen and may progress to critical status, as a result of the cytokine storm, requiring intubation and mechanical ventilation. Acute respiratory failure and a widespread thromboembolic disease are also common in these critical cases.5 , 6 However, conservative estimates of 30% to as high as 96% of infected individuals may manifest mild to no symptoms, posing huge challenges in containing this pandemic crisis and protecting blood donors.7

In one of the earlier studies of COVID-19 patients, Guan and colleagues8 reported that in addition to the usual viral route of respiratory droplets, the virus could be transmitted by saliva, urine, and stool.9 Extracted data of 1099 patients with laboratory-confirmed COVID-19–related acute respiratory distress syndrome (ARDS) showed a predominant male gender (58%), median age of 47 years with most common symptoms of fever (88%) and cough (68%). The median incubation period was found to be 3 days with a range of 0 to 24 days. Only 1.2% of patients reported to have a direct contact with wildlife and 31% had been to Wuhan city, whereas the majority (72%) had contact with people from Wuhan city. At time of admission, ground-glass opacity was the typical (56.4%) radiological finding on chest computed tomography (CT). Interestingly, a significant number of severe cases were diagnosed by clinical symptoms and real-time reverse transcriptase polymerase chain reaction (RT-PCR) with normal radiological findings. Multivariate analysis revealed that severe pneumonia was an independent factor associated with either intensive care unit (ICU) admission, mechanical ventilation, or death (hazard ratio, 9.80; 95% confidence interval, 4.06–23.67).8

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COVID-19 diagnosis

Ideally, testing every blood donor for COVID-19 would be the best practice; however, at least for the time being, this task cannot realistically be accomplished. To date, 7 recognized types of coronavirus strains that can infect humans have been identified, including Alpha coronavirus (229E and NL63) and Beta coronavirus (OC43 and HKU1). The rare but more severe types are called MERS-CoV, which lead to Middle East respiratory syndrome (MERS), and SARS-CoV, responsible for severe acute respiratory syndrome (SARS) endemic.10

Laboratory confirmation of COVID-19 infection is based on detection of unique sequences of viral RNA by RT-PCR. Sputum samples provide better detection than throat samples, whereas lower respiratory tract samples are superior to those from the upper respiratory tract.11 The presence of SARS-CoV-2 RNA in the blood is a marker of severe illness based on 113 studies.12 Additional laboratory findings in COVID-19 infection include lymphopenia (83%); neutrophilia; and elevated levels of serum alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, C-reactive protein (CRP), ferritin, and D-dimer.13 Substantial increase in CRP, ferritin, and D-dimer levels were found to be associated with severe infection.14 In addition, significant association has been recognized between lymphopenia and high levels of D-dimer with mortality.15 , 16

Bilateral air-space consolidation is typically seen on chest radiograph; however, findings may be unremarkable early in the disease. Chest CT images usually demonstrate bilateral, peripheral ground glass opacities, which is nonspecific to COVID-19 infection.

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Management of COVID-19

An effective COVID-19 vaccine would be the ultimate solution for all of the concerns surrounding blood bank industry. However, currently there is no vaccine available to protect against SARS-CoV-2. Likewise, no prophylactic therapy has yet been proved to be effective in patients who have been exposed to SARS-CoV-2 nor a clearly successful treatment of those who develop the infection.17 Patients who are confirmed positive for COVID-19 and present with mild symptoms are usually managed by self-isolation at home for up to 14 days, which is also the minimal deferral period recommended by many blood centers.7, 8, 9, 10 In advanced cases, hospitalization may be required for clinical observation and supportive management with fluid and oxygen resuscitations, anticoagulation, empirical antibiotics in case of a secondary infection, and nonsteroidal antiinflammatory agents in some cases. Critical cases may require ICU admission for possible intubation and mechanical ventilation. Corticosteroids and immunosuppressive agents are usually not recommended except when required for other indications or in a cytokine storm. Extracorporeal membrane oxygenation can be considered but is associated with a high mortality rate.

Complications of COVID-19 infection include pneumonia, respiratory failure, ARDS, sepsis and septic shock, cardiomyopathy and arrhythmia, acute kidney injury, bacterial infections, thromboembolism, gastrointestinal bleeding, polyneuropathy, and death.

The only means we have for reducing infection in the general population and protecting blood donors relies on recommended infection control. Measures, such as proper hand and environmental hygiene, and appropriate use of personal protective equipment along with maintaining the social distancing (at least 6 feet) are necessary to prevent COVID-19 spreading. Early detection, triage, and isolation of potentially infectious patients are also important considerations. A combination of these measures is the basis of current blood donation protocols, which will hopefully protect and maintain our blood supply.

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Blood donation and blood products

There are multiple Federal Drug Administration (FDA) criteria a blood donor must meet before donating blood products. These parameters range from physical requirements, such as age, weight, temperature, blood pressure, and pulse, to a background check of the donor’s sexual, medical, and travel history. Any discrepancies or issues that arise during the interview process and the physical examination could temporarily or permanently defer the donor from the blood donation system.18

Following the start of the COVID-19 outbreak in the United States, additional screening questions and requirements were implemented. Although not standardized across all blood collection organizations, the American Red Cross implemented new deferral policies in February 2020 before regional and national shutdown. All donors with a recent travel history to China, Hong Kong, Macau, Iran, Italy, and South Korea were deferred for 28 days. Donors diagnosed or suspected to have COVID-19 or had contact with a COVID-19–positive patient were also deferred for 28 days despite the absence of any data or evidence as of yet that SARS-CoV-2 can be transmitted through blood products.19

Several measures were adopted by all blood donation centers and blood drives to prevent transmission of SARS-CoV-2. Measures included temperature screening for all donors and staff before entry into the donation centers, social distancing (>6 feet) when possible, disinfecting machines and surfaces between donations, having donors and staff wear face masks, use of hand sanitizer before and during the donation process, and increased spacing between beds. These preventative practices echoed the Centers of Disease Control (CDC) guidelines and were similarly implemented in other blood donation centers.20, 21, 22, 23

As these policies were put into place, blood donations began to decrease as the COVID-19 pandemic grew and blood drive cancellation increased. Regionally, one of the hospitals affected was University of Washington Medical Center, which reported a blood supply shortfall as early as February 29, 2020.24 Nationally blood collections dropped and in a press release by the American Red Cross on March 17, 2020, approximately 2700 Red Cross blood drives were canceled across the country, resulting in 86,000 fewer donations. Evidently, more than 80% of their usual blood supply comes from these blood drives.25 Of note, as per the American Association of Blood Banks (AABB), 33,000 units of blood are needed daily to meet patient need before the pandemic.26

As a result, hospitals needed to develop strategies to adapt to these blood supply shortages. Mitigation strategies that were proposed included additional criteria for transfusion orders review with more stringent guidelines. Splitting platelet units into 2 doses each were also considered to minimize platelet shortage. Hospitals increasingly adopted these measures over the course of a few weeks starting in March 2020.27