key: cord-1019702-02g1f9o4 authors: Dhiman, Yashaswi; Coshic, Poonam; Pandey, Hem Chandra; Khatiwada, Basanta; Singh, Jasmeet; Mehta, Vikas; Gupta, Sanjay title: Deterrents in recruitment of COVID‐19 convalescent plasma donors: Experience from a hospital‐based blood centre in India date: 2021-03-21 journal: Transfus Med DOI: 10.1111/tme.12768 sha: 839ed7d588ebc3bc94f6e56664e3acb5a2291a3a doc_id: 1019702 cord_uid: 02g1f9o4 INTRODUCTION: Recruitment of Covid‐19 convalescent plasma (CCP) donors may present as a challenge due to inexperience and differences in donor profile as compared to whole blood donation. Present study highlights the deterrents to recruiting CCP donors at a hospital based blood centre. MATERIALS AND METHODS: Potential CCP donors were contacted individually by telephone and a group approach through camp organisers from May to July 2020. Recruitment challenges were noted and deferrals of these recruited donors during screening and medical examination was obtained and analysed. RESULTS: Total 1165 potential CCP donors were contacted. Around 47% donors were lost due to challenges related to information storage and retrieval. Fear of health, family pressure, and fear of a new procedure were major reason (27.2%) for unwillingness to donate. The main reasons for deferral among potential donors were multiparity (38%) and being overage/underage (31.6%). Finally, 468 donors were recruited including 408 by individual approach and 60 by a group approach. From these absence of detectable COVID‐19 antibodies were found in 15.4%. Few donors (9.0%) were deferred as they had not completed 28 days post recovery. CONCLUSION: The process of CCP donor recruitment differs from that of whole blood donation and requires an individualised approach with involvement of clinicians in the initial phases of the pandemic. A group approach targeting specific organisations could be adopted for a successful CCP collection program. There is a need to relook into some aspects of donor selection such as consideration of multiparous female donors and overage/underage donors after reviewing scientific evidence. profile and potential benefit led to its use as an off label therapy globally including India. 6 India has a decentralised blood collection system with >3000 centres majority of which are hospital based blood centres. All blood centres operate independently with a provision to transport blood and blood components to other blood centres in case of shortage. Blood collection using cell separators is limited to only a few centres across major cities with plateletpheresis being the most common procedure. During the COVID-19 pandemic, there was a surge in demand of CCP across major cities in India as well, and blood centres were faced with a challenge to convert COVID-19 recovered patients into potential CCP donors. The limited number of recovered COVID-19 patients being pursued by multiple blood centres in the same city made the task of recruiting CCP donors challenging. The lack of donor selection guidelines for CCP donation added to the difficulties in recruiting these donors. The donors were selected following the screening criterion as per Drugs and Cosmetic Act & rule 1945, India and the interim guidance for donor selection in-view of COVID-19 pandemic given by National Blood transfusion council which were specific to whole blood donation. 7 A COVID-19 recovered patient was considered to be eligible for CCP donation when he has completed 28 days post discharge from COVID-19 treating facility or has completed 28-days in-home isolation after being reverse transcriptase-polymerase chain reaction positive and remained asymptomatic during this period. 8 Our experience may highlight some of the differences and challenges in recruiting these plasma donors in comparison to whole blood and platelet donors. This would also help formulate strategies to approach these donors and ease the process of plasma donation in pandemic situations in future. The present report is thus aimed to analyse the challenges in recruitment of potential convalescent plasma donors as well as to understand the reasons for deferral of plasma donors who were willing to donate convalescent plasma. The study involved retrospective collection and analysis of data related to recruitment of CCP donor in a blood centre of tertiary care hospital in Northern India. The blood centre started CCP donor recruitment and collection from May 2020 in view of the progressing pandemic. Ethical clearance was obtained from Institutional Ethics Committee before collection and analysis of donor data. A list of lab-confirmed COVID-19 patients treated and discharged from our hospital along with their contact details was requested from the team responsible for treatment of COVID patients. Patients who had completed 28 days post discharge were identified from the list and were contacted by two staff nurses who are trained to recruit blood donors. On making a contact, the blood centre staff introduced themselves and asked the potential donors a convenient time to talk. If the donor was willing to talk, the staff enquired about their health status and assessed their eligibility to donate. Then they were informed about the need and importance of CCP plasma and its potential application in treatment of COVID-19 patients and were asked for their willingness to donate. If they agreed to donate, they were explained the procedure of plasma collection in brief and the approximate time required for donation. All queries were resolved and basic information like age and parity (in case of female donors) was enquired telephonically before confirming the appointment at blood centre. They were then given an appointment at a suitable time as per their convenience for pre donation screening and health check-up at the blood centre. If the donor was unwilling to donate, the reason for their unwillingness was asked and documented verbatim by the recruiter. Various deterrent and deferral reasons were coded from A to J and also divided into subcategories by one of the authors (Table 1) . These coding were reassessed and verified by another author. In case the potential donor could not be reached through telecommunication due to network related issues or phone being switched off or busy at the time, one more attempt was made to contact them after a period of 2 days. Only two attempts were made, and a negative response was documented. Information related to donors with an incorrect contact details were also documented. On the day of appointment, the donor was asked to fill up a donor history questionnaire followed by a physical examination. An ethylene diamine tetraacetic acid sample was drawn from the donor and the donor was screened for the presence of SARS-COV-2 IgG antibodies using Architect i1000SR immunoassay analyser in addition to a complete blood count, Transfusion transmitted infection markers, blood group, antibody screen for unexpected red cell antibodies and CCP donors who reported directly to the blood centre were also screened and the same post-recruitment procedure as described above was followed. The present study included collation and retrospective analysis of the information collected at the time of recruitment of potential CCP donors focusing on various deterrents as well as the reasons for deferral of plasma donors. The data related to these parameters was collected from the records, and entered into a spreadsheet (Excel, The blood centre in total screened 468 potential plasma donors. These included 408 willing donors who reached the blood centre other than those who were screened and deferred telephonically due to either multiparity or age. These also included 60 voluntary and replacement donors who presented at the blood centre directly through group approach. Of the total telephonically contacted willing donors 38% (171/449) and 31.6% (142/449) donors were deferred due to multiparity and overage (>60 years)/underage (<18 years) respectively. With the start of COVID-19 pandemic a number of potential therapies were explored globally. One such therapy included CCP which was collected from the patients who have recovered from the illness and were supposed to be having protective antibodies against the illness. With publication of various reports describing benefit of using CCP in patients, the demand for the CCP increased exponentially. 9, 10 However, the availability of the product was limited in the initial phases of the pandemic. Blood collection centres across the world were faced with an uphill task to motivate and recruit potential CCP donors to meet the increasing demand. Present study highlights the experience of a hospital-based blood centre from a resource limited country in recruiting potential plasma donors. We observed that the process of motivation and recruitment of a 11 We also observed that there was an apprehension among potential CCP donors regarding their health due to procedure. This emphasises the importance of adopting different strategy to motivate and recruit these donors when general public is facing a taboo of COVID-19 and is living in fear of getting infected while coming to donate in a hospital set up. 12, 13 This calls for an approach where, in addition to motivating donors for CCP donation, efforts should also be made to inform them of the safety of the procedure. Such donors could also be motivated to donate whole blood instead of donating using apheresis as reported by Wong et al 14 It is also evident from the present study that around 50% potential donors were lost due to either inaccurate contact information or a residence out of town similar to CCP recruitment attempt by Wong et al. 14 It may be challenging to maintain the patient information of all the patients to be contacted at a later date especially when the patient needs to be isolated in separate facilities. More than one mode of communication should be registered to avoid loss of donors due to inaccurate/incorrect information. Accurate and complete information of a recovered patient using various tools like a web-based survey will also facilitate triaging of these patients into eligible, soon to be eligible and ineligible donors and then coordinating them to appropriate blood centres near their residential location. 16 However, success of such approaches will need to be tested in technologically limited, resource poor countries. Explaining the eligibility criteria to donors during telecommunication may be a much more efficient way of recruiting CCP donors in countries like ours but would demand more time and manpower. We also observed that there was a significant time duration incentives like masks, sanitizers and transport facility to these donors may also provide some confidence to these donors towards blood centres. This will also prevent black marketing of this precious product as was being reported from various countries. 18 In initial phase of the pandemic lack of clarity regarding selection of CCP donors posed a major challenge. Deferral of multiparous female donors, which is not done routinely for whole blood donors, was also added to the already existing guidelines specifically for CCP donations. The rationale behind this was the evidence that plasma from multiparous female donors was earlier reported to be associated with TRALI due to the presence of anti-HLA and anti-HNA antibodies. 19 While this may not affect the whole blood donor pool in our country where only 3%-10% of blood donation is contributed by female blood, 20 As the pandemic progressed and the number of eligible donors increased, we changed our recruitment strategy and approached various organisations where employees were working throughout, and chances of recruiting donors were good. We could conduct an inhouse voluntary plasma donation camp with around 25 donors donating plasma on a single day. Group approach seems to be another way to recruit plasma donors during the pandemic. However, this approach may be adopted once the pandemic has progressed with sufficient number of recovered donors and may not work in the initial phases. Our approach to recruit CCP donors was limited by the fact that due to limited trained manpower and time we could contact the donors only once. We could neither follow the donors who initially showed their willingness to donate CCP but did not reported to us on the scheduled day of appointment nor were able to ascertain the reasons for their no-show. Donor selection for a new component using a less known technique could be a challenging task especially in countries like ours where awareness for voluntary donation is less and the donor pool itself is limited. However, an individualised approach with involvement of clinical staff could be a feasible approach in the initial phases of the pandemic that is to be conveyed with utmost sensitivity and good will in order to gain their trust and altruistic affection for the ones in need. A group approach in later phases targeting specific organisations could be adopted. A pandemic poses a unique situation, and a flexible evolving system could be a key to a successful CCP collection program. Monitoring transmissibility and mortality of COVID-19 in Europe Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza a (H1N1) 2009 virus infection Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol A meta-analysis of clinical studies conducted during the West Africa Ebola virus disease outbreak confirms the need for randomized control groups Clinical Management Protocol: COVID-19 Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) Department of Health. The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules National guidance to Blood Transfusion services in India in light of COVID-19 Pandemic. India NBTCMoHaFWGo Use of convalescent plasma therapy in two COVID-19 patients with acute respiratory distress syndrome in Korea The emerging role of convalescent plasma in the treatment of COVID-19 What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea Dwindling blood reserves: an ominous downside of COVID-19 pandemic because every drop counts": blood donation during the COVID-19 pandemic Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection Volunteers' motivations: a functional strategy for the recruitment, placement, and retention of volunteers Recruitment strategy for potential COVID-19 convalescent plasma donors Guidance for the procurement of COVID-19 convalescent plasma: differences between high and lowmiddle income countries Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial) Implementation and outcomes of a transfusion-related acute lung injury surveillance programme and study of HLA/HNA alloimmunisation in blood donors Female contribution in blood donation and alternatives: female contribution in blood donation and alternatives: fact & factual. Int Deterrents in recruitment of COVID-19 convalescent plasma donors https://orcid.org/0000-0001-7684-8567Hem Chandra Pandey https://orcid.org/0000-0002-8180-0004