The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran

Background: The COVID-19 pandemic has affected blood inventory and donation worldwide. The Islamic Republic of Iran was among the first countries to report the COVID-19 pandemic and it faced a significant blood shortage during the first weeks of the pandemic. Aims: We aimed to evaluate the impact of COVID-19 pandemic on the number, type, and safety of blood donations, comparing the periods before and during the pandemic. Methods: This retrospective study evaluated data from all volunteers who attended the blood transfusion centres in the Islamic Republic of Iran from March to December 2020 (during the COVID-19 pandemic) and during the same period in 2019, i.e. pre-pandemic. Data on the number of blood collections, confirmed transfusion transmissible infection marker test results, and donor demographic information were collected from the Iranian Blood Transfusion Organization integrated donor database. Results: Total blood donations decreased by 8.38%. The number of first-time, lapsed, and female blood donors increased by 4.41%, 0.17%, and 0.90% respectively. Regular blood donation decreased by 4.58%. The distribution of the 3 main blood products, red cell concentrate, frozen fresh plasma and platelets, decreased by 7.86%. All changes were statistically significant. The prevalence rates of hepatitis C virus and hepatitis B surface antigen increased significantly during the pandemic. Conclusion: COVID-19 had a negative effect on blood safety and availability in the Islamic Republic of Iran. To improve blood supply and enhance regular blood donation, the Iranian Blood Transfusion Organization needs to reassure blood donors of the safety and hygiene measures being observed at blood collection sites.

Eastern Mediterranean Health Journal [2022; Vol.28, Issue 11]

Eastern Mediterranean Health Journal is the official health journal published by the Eastern Mediterranean Regional Office of the World Health Organization. It is a forum for the presentation and promotion of new policies and initiatives in health services; and for the exchange of ideas concepts epidemiological data research findings and other information with special reference to the Eastern Mediterranean Region. It addresses all members of the health profession medical and other health educational institutes interested NGOs WHO Collaborating Centres and individuals within and outside the Region.

المجلة الصحية لشرق المتوسط هى المجلة الرسمية التى تصدرعن المكتب الاقليمى لشرق المتوسط بمنظمة الصحة العالمية. وهى منبر لتقديم السياسات والمبادرات الجديدة فى الصحة العامة والخدمات الصحية والترويج لها، و لتبادل الاراء و المفاهيم والمعطيات الوبائية ونتائج الابحاث وغير ذلك من المعلومات، و خاصة ما يتعلق منها باقليم شرق المتوسط. وهى موجهة الى كل اعضاء المهن الصحية، والكليات الطبية وسائر المعاهد التعليمية، و كذا المنظمات غير الحكومية المعنية، والمراكز المتعاونة مع منظمة الصحة العالمية والافراد المهتمين بالصحة فى الاقليم و خارجه

La Revue de Santé de la Méditerranée Orientale est une revue de santé officielle publiée par le Bureau régional de l’Organisation mondiale de la Santé pour la Méditerranée orientale. Elle offre une tribune pour la présentation et la promotion de nouvelles politiques et initiatives dans le domaine de la santé publique et des services de santé ainsi qu’à l’échange d’idées de concepts de données épidémiologiques de résultats de recherches et d’autres informations se rapportant plus particulièrement à la Région de la Méditerranée orientale. Elle s’adresse à tous les professionnels de la santé aux membres des instituts médicaux et autres instituts de formation médico-sanitaire aux ONG Centres collaborateurs de l’OMS et personnes concernés au sein et hors de la Région.

The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran.

Background: The COVID-19 pandemic has affected blood inventory and donation worldwide. The Islamic Republic of Iran was among the first countries to report the COVID-19 pandemic and it faced a significant blood shortage during the first weeks of the pandemic. Aims: We aimed to evaluate the impact of COVID-19 pandemic on the number, type, and safety of blood donations, comparing the periods before and during the pandemic. Methods: This retrospective study evaluated data from all volunteers who attended the blood transfusion centres in the Islamic Republic of Iran from March to December 2020 (during the COVID-19 pandemic) and during the same period in 2019, i.e. pre-pandemic. Data on the number of blood collections, confirmed transfusion transmissible infection marker test results, and donor demographic information were collected from the Iranian Blood Transfusion Organization integrated donor database. Results: Total blood donations decreased by 8.38%. The number of first-time, lapsed, and female blood donors increased by 4.41%, 0.17%, and 0.90% respectively. Regular blood donation decreased by 4.58%. The distribution of the 3 main blood products, red cell concentrate, frozen fresh plasma and platelets, decreased by 7.86%. All changes were statistically significant. The prevalence rates of hepatitis C virus and hepatitis B surface antigen increased significantly during the pandemic. Conclusion: COVID-19 had a negative effect on blood safety and availability in the Islamic Republic of Iran. To improve blood supply and enhance regular blood donation, the Iranian Blood Transfusion Organization needs to reassure blood donors of the safety and hygiene measures being observed at blood collection sites.

Severe acute respiratory syndrome coronavirus-2: implications for blood safety and sufficiency.

BACKGROUND AND OBJECTIVE: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus, first identified in China at the end of 2019 and has now caused a worldwide pandemic. In this review, we provide an overview of the implications of SARS-CoV-2 for blood safety and sufficiency. MATERIAL AND METHOD: We searched the PubMed database, the preprint sites bioRxiv and medRxiv, the websites of the World Health Organization, European Centre for Disease Prevention and Control, the US Communicable Diseases Center and monitored ProMed updates. RESULTS: An estimated 15%-46% of SARS-CoV-2 infections are asymptomatic. The reported mean incubation period is 3 to 7 days with a range of 1-14 days. The blood phase of SARS-CoV-2 appears to be brief and low level, with RNAaemia detectable in only a small proportion of patients, typically associated with more severe disease and not demonstrated to be infectious virus. An asymptomatic blood phase has not been demonstrated. Given these characteristics of SARS-CoV-2 infection and the absence of reported transfusion transmission (TT), the TT risk is currently theoretical. To mitigate any potential TT risk, but more importantly to prevent respiratory transmission in donor centres, blood centres can implement donor deferral policies based on travel, disease status or potential risk of exposure. CONCLUSION: The TT risk of SARS-CoV-2 appears to be low. The biggest risk to blood services in the current COVID-19 pandemic is to maintain the sufficiency of the blood supply while minimizing respiratory transmission of SARS-CoV-19 to donors and staff while donating blood.

Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Blood Safety.

Since the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), it has spread rapidly around the world and caused a serious global social crisis. During the epidemic, the blood collection and supply industry have been greatly impacted, due to the sharply dropped blood donors and transfusion transmission risk of SARS-CoV-2. Many infected individuals are asymptomatic and they may donate blood without awareness of the infection or before symptoms appear. In addition, viral RNAs have been detected in the blood of some patients infected with SARS-CoV-2. Although no infectious SARS-CoV-2 virus was found in the blood nor the blood components, there is a risk of transmission through blood transfusion which may endanger blood safety, especially during the pandemic period. This review briefly introduces the biological characteristics, epidemiology of SARS-CoV-2, with a particular focus on SARS-CoV-2 infection and blood safety.

Impact of COVID-19 on blood donor deferral patterns during the COVID-19 pandemic: A retrospective analysis.

BACKGROUND AND OBJECTIVES: Blood donor deferral is an essential tool for blood safety. The ongoing COVID-19 pandemic has adversely affected blood transfusion services all over the world. But its impact on donor deferral rate and the pattern is unclear in light of the new donor deferral policy due to the COVID-19 pandemic. MATERIALS AND METHODS: This retrospective study was divided into pre-COVID and COVID (15 March 2019-14 March 2021). All the deferred donors were divided into six different categories: (1) medical causes, (2) surgical causes, (3) drugs and vaccination, (4) risk of transfusion-transmitted diseases, (5) miscellaneous causes and (6) flu-like symptoms. In addition, COVID-related deferrals were also incorporated. All these above categories along with the donor demography were analysed by SPSS software version 25. RESULTS: The donor deferral rate was 17.03% and 12.74% during the pre-COVID and COVID periods, respectively. During the pre-COVID period, Category 3 deferrals and during COVID period, Category 6 deferrals were significantly higher. A reversal in pattern with increased blood pressure (40.2% vs. 24.04%) over-riding low haemoglobin (34.77% vs. 55.5%) was noted in the Category 1 deferral during the COVID period. Category 1 deferral was more in middle-aged adults as compared to young and old adults (p < 0.05). Among middle-aged adults, deferral due to flu-like symptoms was also significantly more during the COVID period (p < 0.05). CONCLUSION: COVID-19 significantly affected the donor pool and changed the pattern of donor deferral. Understanding donor deferral patterns may help in identifying targeted donor populations and planning donor recruitment strategies in future pandemic crises.

The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P): A research program striving to improve blood donor safety and optimize transfusion outcomes across the lifespan.

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. STUDY DESIGN AND METHODS: The US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program. RESULTS: The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). CONCLUSIONS: The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.

SARS-CoV-2 and post-donation information: a one-year experience of the French haemovigilance network.

BACKGROUND: There is growing evidence to support the hypothesis that SARS-CoV-2 is probably not transmissible by blood transfusion. In this study, we use the data gathered over one year by the French haemovigilance network on post-donation information related to SARS-CoV-2, and virological investigations on corresponding plasma to explore viral transmission by transfusion. MATERIALS AND METHODS: Whenever a donor reported COVID-19 symptoms and/or a positive SARS-CoV-2 nasopharyngeal (NP) PCR test, information regarding diagnosis and symptoms was collected using a specific questionnaire, and repository plasmas were screened using the SARS-COV-2 R-GENE® assay (Biomérieux). RNA sequencing (Sanger and deep sequencing) and virus isolation on Vero E6 cells were applied in plasma from donors testing positive. RESULTS: We investigated 1,092 SARS-CoV-2-related post-donation information (PDI) reports. PDI donors were younger than the global donor population and donated more often in the Paris region. Sixty-eight percent reported a positive NP real-time (RT)-PCR or antigenic testing and 22% of these also had symptoms at the time of testing. Thirty-seven (3.4%) donations tested positive for SARS-CoV-2 RNA, 11 (30%) were confirmed by another molecular assay, and 7 (19%) by sequencing, confirming low viral level. Most RNAemic blood donors donated in southern regions and in Paris. There was no difference in demographic data or duration parameter between RNAemic and non-RNAemic donors. Duration parameter was determined as the time elapsed between donation and: i) the onset of symptoms; ii) a positive NP RT-PCR; and iii) PDI. Cell culture experiments did not show any infectivity related to RNAemic plasmas. DISCUSSION: SARS-CoV-2 RNA can be detected in a small fraction of blood donors with PDI, reporting very low levels of RNA. The corresponding plasma is probably not infectious. These findings highlight the value of haemovigilance and PDI to guide blood safety strategies.

Effect of the first year of COVID-19 pandemic on the collection and use of blood components in Colombia monitored through the national haemovigilance system.

OBJECTIVE: This work aimed to establish the effects of the COVID-19 pandemic on blood collection and blood product usage at the end of the first year. BACKGROUND: The arrival of SARS-CoV-2 to Colombia on March 6, 2020, triggered closure of borders and mandatory lockdown from March 23, 2020. METHODS/MATERIALS: The Colombian National Institute of Health administers the National database of confirmed cases of SARS-CoV-2 and the National Haemovigilance System. We examined positive SARS-CoV-2 cases identified between March 6, 2020, and March 6, 2021, using positive RT-PCR testing (72.8%) or reactive antigen (27.2%). We also analysed accepted and deferred donors' information provided by 100% of blood banks and transfused patients notified by 83% of health care facilities nationwide, between March 1, 2019, to February 28, 2021. RESULTS: Colombia registered 2 273 245 SARS-CoV-2 cases. From these, 60 412 people died from COVID-19 (2.7%) and 2 172 418 individuals recovered (95.6%). There were 11 659 216 SARS-CoV-2 processed samples nationwide. People between the ages of 20 and 39 years concentrated 44.4% of the SARS-CoV-2 cases. There were 773 569 blood donations, mainly from a 20-39-year-old population (60.5%). The pandemic caused a reduction of 155 393 blood donations (16.7%) and 51 823 total deferrals (33.7%). An 18.4% drop in volunteer donors and a 37.3% increase in donations from family/replacements members were observed. There were 399 453 transfused patients and 1 179 895 blood components administered (-8.7% and - 13.9% compared to March 2019-February 2020). CONCLUSION: Mandatory lockdowns in Colombia decreased blood collection and usage, resulting in a reduction of blood components transfused to individual patients.

Investigation of Bacterial Infections Among Patients Treated With Umbilical Cord Blood-Derived Products Marketed as Stem Cell Therapies.

Importance: The number of clinics marketing stem cell products for joint diseases, chronic pain, and most recently, COVID-19, has increased despite warnings from the US Food and Drug Administration that stem cell products for these and other indications have not been proven safe or effective. Objective: To examine bacterial infections in 20 patients who received umbilical cord blood-derived products marketed as stem cell treatment. Design, Setting, and Participants: This case series is a national public health investigation including case-finding, medical record review and abstraction, and laboratory investigation, including sterility testing of products and whole-genome sequencing of patient and product isolates. Participants included patients who developed bacterial infections following administration of umbilical cord blood-derived products marketed as stem cell treatment during August 2017 to September 2018. Data analysis was performed from March 2019 to September 2021. Exposures: Umbilical cord blood-derived products marketed as stem cell treatment. Main Outcomes and Measures: Data were collected on patient infections and exposures. The Centers for Disease Control and Prevention performed sterility testing on undistributed and distributed vials of product marketed as stem cell treatment and performed whole-genome sequencing to compare patient and product bacterial isolates. Results: Culture-confirmed bacterial infections were identified in 20 patients (median [range] age, 63 [2-89] years; 13 male patients [65%]) from 8 US states who sought stem cell treatment for conditions including pain, osteoarthritis, rheumatoid arthritis, and injury; all but 1 required hospitalization. The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. A patient isolate from Arizona matched isolates obtained from products administered to patients in Florida, and patient isolates from Texas matched undistributed product sent from the company in California. Conclusions and Relevance: Unapproved stem cell products can expose patients to serious risks without proven benefit. Sequencing results suggest a common source of extensive contamination, likely occurring during the processing of cord blood into product. Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections.

Why Does the Precautionary Principle Suffice for Blood Regulation?

Traditional approaches to blood regulation emphasise the precautionary principle and pursue zero-risk for viral transmission; these traditional approaches have usually followed tragedy, such as the HIV and hepatitis C infections that followed the use of factor VIII concentrates. However, a much more haphazard haemovigilance system operates for general adverse events. Such imprecise assessment of hazards prevents sound benefit-risk assessment, and for blood products this is further confounded by the fact that their efficacy has attracted little systematic study. The ongoing COVID-19 pandemic has now prompted the proposal of a convalescent plasma (CP) blood product. Clearly, mere freedom from infectious agents will not suffice in assessing CP, and an objective measure of efficacy, so as to permit formal benefit-risk analysis, is essential. This is both a scientific and an ethical demand, as has been the case for other experimental COVID-19 treatments. With special reference to COVID-19 CP, the well-recognized adverse events of transfusion-associated lung injury (TRALI) and transfusion-associated circulatory overload (TACO) will be important. Furthermore, not only efficacy but also product quality attributes (e.g., antibody titre) will have to be defined. Both of these are outside the traditional regulatory philosophy for blood products and are needed to truly assess the benefit-risk of this putative therapeutic product.

SARS-CoV-2 asymptomatic and symptomatic patients and risk for transfusion transmission.

Oral swabs, sputum, and blood samples from 18 asymptomatic and symptomatic patients with SARS-CoV-2 infection were examined using RT-PCR testing in order to assess the risk of transfusion-related transmission. In asymptomatic patients as well as patients with flu-like symptoms and fever, no SARS-CoV-2 RNA could be detected in the blood or serum despite a clearly positive result in all throat swabs. As patients with symptoms of infectious disease will not be admitted to blood donation, the risk for transfusion transmission of SARS-CoV-2 seems to be negligible.

Impact of the early coronavirus disease 2019 pandemic on blood utilization in the United States: A time-series analysis of data reported to the National Healthcare Safety Network Hemovigilance Module.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has disrupted healthcare services worldwide. However, little has been reported regarding the impact on blood utilization. We quantified the impact of COVID-19 on blood utilization and discards among facilities reporting to the National Healthcare Safety Network Hemovigilance Module. METHODS: Facilities continuously reporting data, during January 2016-June 2020, on transfused and discarded blood components, stratified by component type (red blood cells [RBC], platelets, and plasma), were included. Interrupted time-series analysis with generalized estimating equations, adjusting for facility surgical volume and seasonality, was used to quantify changes in blood utilization and discards relative to a Centers for Medicare & Medicaid Services notification delaying nonessential medical procedures (March 2020). RESULTS: Seventy-two facilities included in the analyses, on average, transfused 44,548 and discarded 2,202 blood components monthly. Following the March 2020 notification and after multivariable adjustment, RBC and platelet utilization declined, -9.9% (p < .001) and -13.6% (p = .014), respectively. Discards increased for RBCs (30.2%, p = .047) and platelets (60.4%, p = .002). No statistically significant change in plasma was found. Following these abrupt changes, blood utilization and discards rebounded toward baseline with RBC utilization increasing by 5.7% (p < .001), and platelet and RBC discards decreasing -16.4% (<0.001) and -12.7 (p = .001), respectively. CONCLUSION: Following notification delaying elective surgical procedures, blood utilization declined substantially while blood discards increased, resulting in substantial wastage of blood products. Ongoing and future pandemic response efforts should consider the impact of interventions on blood supply and demand to ensure blood availability.

Patient blood management and blood conservation - Complimentary concepts and solutions for blood establishments and clinical services in South Africa and beyond.

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.

Methylene blue photochemical treatment as a reliable SARS-CoV-2 plasma virus inactivation method for blood safety and convalescent plasma therapy for COVID-19.

BACKGROUND: In 2020, a new coronavirus, SARS-CoV-2, quickly spread worldwide within a few months. Although coronaviruses typically infect the upper or lower respiratory tract, the virus RNA can be detected in plasma. The risk of transmitting coronavirus via transfusion of blood products remains. As more asymptomatic infections are identified in COVID-19 cases, blood safety has become particularly important. Methylene blue (MB) photochemical technology has been proven to inactivate lipid-enveloped viruses with high efficiency and safety. The present study aimed to investigate the SARS-CoV-2 inactivation effects of MB in plasma. METHODS: The SARS-CoV-2 virus strain was isolated from Zhejiang University. The live virus was harvested from cultured VERO-E6 cells, and mixed with MB in plasma. The MB final concentrations were 0, 1, 2, and 4 µM. The "BX-1 AIDS treatment instrument" was used at room temperature, the illumination adjusted to 55,000 ± 0.5 million Lux, and the plasma was irradiated for 0, 2, 5, 10, 20, and 40 mins using light at a single wavelength of 630 nm. Virus load changes were measured using quantitative reverse transcription- PCR. RESULTS: BX-1 could effectively eliminate SARS-CoV-2 within 2 mins in plasma, and the virus titer declined to 4.5 log10 TCID50 (median tissue culture infectious dose)/mL. CONCLUSION: BX-1 is based on MB photochemical technology, which was designed to inactivate HIV-1 virus in plasma. It was proven to be safe and reliable in clinical trials of HIV treatment. In this study, we showed that BX-1 could also be applied to inactivate SARS-CoV-2. During the current outbreak, this technique it has great potential for ensuring the safety of blood transfusions, for plasma transfusion therapy in recovering patients, and for preparing inactivated vaccines.