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Vox Sanguinis International Forum on Hospital Transfusion Services' Response to COVID‐19: Responses

2020; Wiley; Volume: 115; Issue: 6 Linguagem: Inglês

10.1111/vox.12944

1423-0410

Mark H. Yazer, Bryon Jackson, Monica B. Pagano, Naomi Rahimi‐Levene, Victoria Peer, José Luis Bueno, Ryan P. Jackson, Hua Shan, Luiz Amorim‐Filho, Maria Esther Lopes, Carla Boquimpani, Ulrik Sprogøe, Mie Topholm Bruun, Kjell Titlestad, Kylie Rushford, Erica M. Wood, Zoe McQuilten, Vincenzo De Angelis, Michela Delle Donne, Mike Murphy, Julie Staves, Duck Cho, Fumihiko Nakamura, Akira Hangaishi, Jeannie Callum, Yulia Lin, Mostafa Mogaddam, Ahmad Gharehbaghian, Miquel Lozano,

Trauma, Hemostasis, Coagulopathy, Resuscitation

Naomi Rahimi-Levene & Victoria Peer Demographics: Our hospital blood bank accepts samples for pre-transfusion testing from patients who were confirmed or suspected to be infected with novel coronavirus. We do not release products for an individual patient in a cooler. We have a plan to deal with samples with novel pathogens, which was implemented during the 2003 SARS epidemic. Instruction was mandatory for all laboratory personnel explaining the infectivity of the virus and how to use personal protective clothing when handling a suspected or confirmed sample. They were also instructed on how to work in the BSC, where to store the samples and how to dispose of the waste. The utilization of blood components has not changed since the start of the epidemic. But since elective surgical procedures have been postponed due to the epidemic, we expect our usage to go down. No, we do not expect shortages in our hospital, as the national blood service Magen David Adom does not have shortages at this stage. However, if the situation in the country changes and the national blood services will have a shortage in donors, we will be affected by this as they are our only supplier. It is important to have both a national and a local policy for dealing with infected samples, and the staff must be familiar with all aspects of it. It is important to have a national entity that can answer questions arising during the pandemic, as unexpected scenarios may occur. Communication between the blood supplier and the hospital blood banks is cardinal. Especially as there are already look-back issues of donors either in quarantine or infected, whose donated units have already been issued. Locally, in the laboratory it is important to have a plan dividing the staff into shifts that rotate and do not have contact with other in order to avoid neutralizing the whole team if an individual is infected. Magen David Adom, the national blood service, is beginning to collect convalescent plasma from COVID-19 patients tomorrow. The plan is to collect 600 ml for each convalescent. Pathogen reduction will be performed either by the Intercept® Blood System or by the Mirasol® Pathogen Reduction Technology System. The decision is being made at this time. There will be a national policy to whom it will be transfused (Personal Communication, Prof. Eilat Shinar, Director of Magen David Adom National Blood Services). José Luis Bueno Yes, our hospital blood bank accepts samples for pre-transfusion testing from patients who were confirmed or suspected to be infected with novel coronavirus. At our hospital, we are assuming that all the patients and workers are actually infected. We have improved the infection risks (hypoclorite, hand washing, alcoholic dilutions…but for every sample and everybody). Yes, I think so, but nobody had read it before, I guess. Yes, definitely. All workers have been trained according to their risk assessment. It has been dramatically reduced. Our transfusion activity has been reduced to just urgent transfusion. We have begun today a clinical trial to transfuse convalescent plasma from recovered patients/donors to mild–severe new patients. Actually, the first randomized patient has received today a plasma transfusion. We think this new strategy will increase our transfusion activity in the next weeks. No, we do not anticipate blood component shortages. At the beginning of the epidemic in Madrid, we expected a shortage, and we implemented different strategies, but at the end it was not necessary, as lot of donors came during the first days to donate. This, beside the blood component reduction due to routine surgery suspension, took to a reduced need of blood components. Be ready to implement a quick and efficient convalescent plasma programme. Yes, our centre will offer convalescent plasma. Please see our plasma manufacturing protocols in Annex 1. Information on the clinical trial may be obtained by writing directly to the corresponding author. Convalescent donors will be recruited according to the inclusion and exclusion criteria included in the protocol of this clinical trial. (See protocol). Briefly, convalescent donors are cured patients after the COVID-19 infection. To verify their cure, a double-negative RNA RT-PCT (with at least 24 h interval) and a specific antibodies against SARS-CoV-2 will be performed. Also, these donors will fulfil the requirements to be accepted as a general altruistic blood donor, as is defined in the European Guidelines 1 and the Spanish RD 1088/2005. CD will be contacted by phone using the regional or national COVID-19 patient's database. CD candidates will be asked to participate in this trial and will be pre-screened according to the previous inclusion and exclusion criteria. If agree, CD will be appointed to the apheresis collection centre, for: Note: Any apheresis machines and kits able to collect the defined product would be also acceptable. Note: Any other plasma inactivation system validated for transfusion products could also acceptable. (Consider, e.g. Methilene Blue or Amotosalen procedures). Plasmapheresis data, donor tests and labelling will be done using the software Coyote, or any other software designed for managing blood components. PR-HP used in this study is the same product used for the plasma transfusion indications in the clinical practice. These products are collected and manufactured by the Regional Blood Transfusion Centers in Spain and are distributed to hospital transfusion services for their use. The properties, preparation, quality requirements, storage and transport requirements, labelling requirements and warnings for the manufacturing of these products are well described in the chapter 2 of the Guide to the preparation, use and quality assurance of blood components. 18th ed. 1. For an easy consultation of those requirements, we have added this chapter as an annex. at the end of this document. The investigators of this trial do not consider these differences between the two plasma products to be critical, and regarding objectives of this trial both product can be considered as equivalent on the manufacture procedure, being the only critical difference the presence of high title of neutralizing anti SARS-CoV-2 antibodies, in contrast to the plasma coming from healthy donors. Ryan P. Jackson & Hua Shan Demographics: Yes, we accept samples for pre-transfusion testing. Yes. Under our standard operating protocols, universal precautions apply to all specimen handling. There is, however, no specific detail regarding novel pathogens. Our protocols refer transfusion laboratory staff to follow the SHC Lab administration policies and procedures as well. Therefore, our policy for how to handle PUI blood specimens and our COVID-19 response in general were shaped by guidance provided by the SHC Lab Quality programme. At each occurrence or encounter of a future novel pathogen, we will look to the SHC and Lab Quality/Safety leadership for guidance. Yes. During operational staff huddles, the SHC and SHC Lab published guidelines were discussed. SHC Lab Quality also assigned lessons (i.e. readings with required quizzes and signatures at completion) to all AP and Clin Lab staff. All Transfusion Service staff, supervisors and manager were included in these trainings. Overall blood usage has decreased by about 30% since the start of the pandemic. 'With a continued risk to blood product supply, we ask for your quick review of and adherence to transfusion and care guidelines below. The use of restrictive transfusion practices has been shown to be equivalent or better for patient care in many scenarios and should always be practised. During this time of uncertainty, it is imperative to use transfusion judiciously. RBC transfusions: Platelet transfusions: transfusions should be considered for counts below the following thresholds: Plasma transfusions: avoid prophylactic therapy based on INR prior to procedures. Meta-analysis finds that patients with INR ≤2·0 do not have higher bleeding risk compared to normal range INR across a wide variety of minor and major procedures 7. Consultation with transfusion medicine (Pager #12027 staffed 24/7) and haematology (SHC: p#27436 SCH/LPCH #24362) is encouraged with any blood product questions, especially on patients with platelet refractoriness or bleeding.' The Transfusion Service/Blood Bank remains a 'little different' and therefore 'unique' from the rest of laboratory operations within the hospital as biological blood products, besides blood specimens, are handled in our setting. During the COVID-19 pandemic, the first version of the Laboratory 'One-Point Lesson (OPL) regarding specimen handling' for our institution did not quite cover the manual serology of blood specimens, which remains a common practice even during this era of automation, and other blood product manipulations (e.g. modification methods such as separation, aliquoting and washing). In the absence of strong guidance from the CDC, this led to some uncertainty, and personnel became concerned about safety. We were able to abate these concerns and ensure safety through a process of self-assessment, adaptation of some best practices from other institutions and, ultimately, implementation of further guidelines from the CDC. In sum, we think a thorough, independent assessment of the Transfusion Service, Blood Bank and blood collection centre as to the physical environment, methods of specimen or blood product processing, and equipment in use should be initiated early in preparation for 'safe handling' guidance to be issued as quickly as possible to working personnel. We are currently planning to use convalescent plasma from COVID-19 patients in a trial and for compassionate use. The dosing scheme is still being worked out, but eligible patients are expected to get one unit of plasma. Patient eligibility will be determined per FDA IND criteria 8. We plan to exclude patients who are eligible for any other active trials at Stanford (currently, this will mostly pertain to patients who are eligible for remdesivir). Due to practical considerations, we will not seek pathogen inactivation of the plasma at this time. Luiz Amorim-Filho, Maria Esther Lopes & Carla Boquimpani Demographics: Yes. No, we did not have this specific preparedness plan. Now we are developing a comprehensive plan to encompass those situations. Yes. Everyday there is a training session, with a limited number of attendees. Red blood cell concentrates' utilization was reduced by 21·2% since the start of the pandemic in Rio de Janeiro. Platelet utilization is stable; plasma utilization was reduced by 24%. It should be stressed that we only treat patients with primary haematological diseases (leukaemia, lymphoma, myeloma, sickle cell disease, etc.). The reduction in red blood cell and plasma utilization was due to the fact that many outpatients are missing their medical appointments, even if they were scheduled to be transfused. This is especially true for sickle patients in a chronic transfusion programme. Platelets are almost exclusively transfused for inpatients, that is why platelet utilization rate is stable during the pandemic. YES, we anticipate component shortages. Our hospital is part of a complex which includes the main blood centre in Rio de Janeiro city. Since it is very hard to reduce or adapt blood utilization in patients with severe haematological diseases, we concentrated our efforts on alternative strategies to donor recruitment during the pandemic. Namely, replacing mobile drive in universities, companies and churches (all of them closed) by mobile drives in the armed forces locals and in the large private condominiums. More than 1000 people live in each one of these condominiums, and the vast majority are staying at home due to the lockdown recommendation. For our fixed site, we are stimulating blood donation under appointment, in order to comply with social distance measures. Regarding the blood utilization side, the only difference was a more restrictive transfusion policy for sickle cell patients. If we had a blood shortage, we could opt for simple transfusion instead of partial exchange transfusion in some situations (but so far we did not have a blood shortage). The main difficulty is related to our workforce. A large proportion is ill or have had close contact with a confirmed case. In addition, public transport is restricted and our employees face many problems in leaving their homes. A reduction in the number of workers able to go to the hospital was taken into account in our contingency plan. However, the mitigating measures that we established were not sufficient, due to the magnitude of the pandemic and to the number of health professionals directly affected by COVID-19. The lessons we learned about this are that we need to update the plan daily and adapt our activities to the availability of employees—for example suspending the activity of the centralized transfusion team. Yes, we are collecting it for use in other hospitals to where we refer COVID-19 patients. We are selecting donors with an anti-SARS-CoV-2 IgG titre ≥80; these donors must also have a neutralizing antibody titre ≥1:64. The plasma dose is 200–300 ml/patient (a single transfusion). We accept female donors; if they have already become pregnant, we screen their plasma for anti-HLA antibodies. For plasma donors O and A, we are also performing an anti-A (and anti-B, for O plasma) agglutinin titration. We are inactivating pathogens with Amotosalen + UVA irradiation technology (Cerus technology). Ulrik Sprogøe, Mie Topholm Bruun & Kjell Titlestad Demographics: Yes, we accept all samples for pre-transfusion testing, etc. We do not release products for an individual patient in a cooler. As far as we know, it does not, except contingency plans in case of sudden emergencies with patients contaminated with radiation, chemicals or biological agents. A hospital-wide mandatory e-learning programme concerning prober hand washing and other protective measures was introduced by hospital management. First-line medical staff underwent further hands-on training regarding the use of protective equipment, face masks, etc. Utilization of RBC: 3 weeks (16th March – 5th April 2020): −28% Utilization of platelets: 3 weeks (16th March – 5th April 2020): −17% Utilization of plasma: 3 weeks (16th March – 5th April 2020): −44% No, we do not anticipate blood component shortages. No, we do not have any further comments. Yes, patients will receive intravenous infusion with 2 × 300 ml convalescent anti-SARS-CoV-2 plasma. Both units are to be administered within a 24-h period. Units will not be pathogen inactivated. Kylie Rushford, Erica M. Wood & Zoe K. McQuilten Demographics: Yes, samples were accepted. If a cooler of blood products is ordered, our practices are described below. Yes. The current novel pathogen method was reviewed and a separate additional protocol was written for COVID-19. This was distributed to all laboratory staff as part of COVID-19 preparations. Laboratory disinfection protocols and the correct use of PPE were reviewed with laboratory staff. The laboratory staff are required to maintain social distancing, and laboratory workplaces have been modified to implement this. However, this is intended to stop the virus from spreading between staff members, rather than protecting laboratory workers from infection from COVID-19-containing samples. No change to date. Yes, shortages are anticipated as indicated below. The hospital has already cancelled elective surgery as part of the state level and national level response. Locally, we are enforcing single unit red cell transfusions in anaemic, haemodynamically stable non-bleeding patients who do not have an underlying haematological or oncological hypoproliferative disorder. If blood component shortages do occur in the future, our institutional emergency blood management protocol will be activated. This involves notification of the Hospital Incident Commander and Haematology Registrar/Haematologist for clinical input and triaging of product requests for transfusions. Australia also has a National Blood Supply Contingency Plan (available at: https://www.blood.gov.au/nbscp) with which we will comply if it is activated. This outlines responsibilities and actions to be taken by governments, the national blood service, hospitals and laboratories. Organizing our staff in a way to maintain separate teams that do not interact to minimize potential spread of the virus amongst staff and the number of contacts that would need to be isolated if a staff member becomes infected has been a challenge. This is difficult in our 24/7 open-plan laboratories where the Blood Bank, Haematology, Biochemistry and Specimen Reception staff all share a large work space. Social distancing, correct use of PPE and frequent disinfection of work benches have been implemented. We have changed our work practice so that interactions between staff are via written messages or video conferencing whenever possible. Convalescent plasma from COVID-19 patients is not yet available in our jurisdiction. We are developing protocols for its use within clinical trials, and have been participating in dialogue regarding trial design and product specifications through the ISBT Clinical Practice Working Party and our national and international research networks. Our national blood supplier is investigating the feasibility of providing this product. Vincenzo de Angelis & Michela Delle Donne Demographics: Yes, samples were accepted. Coolers are not used. No, regular routine universal precautions are mandatory for any blood sample (potentially infectious). Yes, different online courses and education provided on the website of the hospital. At a national level, a specific online education is provided by National Health Institute (Istituto Superiore di Sanità, Rome). All hospitals in Italy have responded to the emergency (all ICU have been initially occupied by COVID-19 patients) by drastically reducing the non-urgent surgical and medical admittance. This was responsible for a decrease of blood utilization (25%–30% during the central weeks of March). At the beginning of March, there was also a decrease in blood donations but then a rapid increase due to a big pressure on public opinion (by national and Regional MoH, Civil Protection, Blood Donor Associations, National Health Institute…). This was responsible for an unwanted increase of the inventories in blood establishments. Yes, we anticipate blood component shortages. Plan measures (e.g. scheduled donations) to allow regular/constant access of donors to the collection sites; reinforcing alla actions for the control on appropriate use of blood components (PBM, restrictive transfusion triggers, early recall of untransfused units after surgery – not later than 12 h). After the emergency, we need to restructure mechanisms for a better dynamism and a faster adaptation of blood collection programmes to rapid changes in the 'scenario' of blood demand, to avoid either shortage or unnecessary stocks of blood components. Although this is not a programme for Udine University Hospital, many protocols using plasma from patients who recovered from COVID-19 are ongoing or planned in Italy. For reference, see the 'Position paper on the preparation of immune plasma to be used in the treatment of patients with COVID-19' published by SIMTI and SidEM available at http://isbtweb.org/fileadmin/user_upload/Italy.pdf. Mike Murphy & Julie Staves Demographics: Yes, samples were accepted. No changes to the usual practice were made if a cooler of blood products was ordered for a patient with confirmed or suspected COVID-19. Yes. Yes in relation to minimal changes to usual practice. Only change as described above: samples not processed immediately after centrifugation to minimize the risk of contamination by aerosol when opening the sample container. Yes. Red cell and FFP usage has reduced by about 40% because of postponement of elective work. Platelet usage is down approximately 20%. We do not anticipate any blood component shortages. The challenge for us has been to minimize wastage at a time when blood usage has reduced significantly. We have reduced our usual stock levels by about 30%. Try to maintain normal procedures to avoid confusion amongst the many hospital staff involved in some aspect of transfusion. Yes. We will be providing CCP for patients enrolled in clinical trials. Dose is 2 units of plasma within 48 h. Plasma will not be pathogen-inactivated. Duck Cho Demographics: Yes, samples were accepted. Coolers are not issued on any patient. In response to MERS outbreak in 2015, we established a guideline on dealing with samples from patients suspected or confirmed to have been infected with MERS. As for novel pathogens, we have followed the guideline since then. Our hospital has disseminated COVID-19 education materials to the hospital staff and encouraged them to learn the nature of SARS-CoV-2 and its infectivity. No notable disparity has been found. No, we do not anticipate blood component shortages. One patient in our hospital was transfused with blood from a donor exposed to confirmed COVID-19 cases. Fortunately, the Korean government found that the donor donated blood before exposed to the confirmed cases, and therefore, we concluded that the blood from the donor was safe. Although blood from donors with COVID-19 is generally considered safe, we need to be cautious about it before hard evidence comes out and the government body responsible for controlling COVID-19 should ask confirmed or suspected cases about their recent blood donation history. For now, we are not considering the use of convalescent plasma from COVID-19 patients as a therapeutic option. We do not have a system for pathogen inactivation of donated blood in South Korea. Fumihiko Nakamura & Akira Hangaishi Demographics: Yes, samples are accepted. When a cooler is ordered, our process is described below: Yes. Samples from patients with novel pathogens are almost always sent to the National Institute of Infectious Diseases which is adjacent to our hospital. Nosocomial infection of SARS-CoV-2 occurs in many hospitals. However, the risk of SARS-CoV-2 infection can be reduced by appropriate prophylaxis. From this viewpoint, ICT members at our institute alert us by emails as follows, Yes. In comparison to February 2020 (before pandemic), utilization of RBCs, platelets and plasma in April 2020 were reduced by 17%, 47% and 34%, respectively. The trend is probably explained by a marked decline in surgical procedures. A state of emergency was declared in Tokyo on 7 April. We are afraid healthy donors may hesitate to go outside for blood donation. Japan Red Cross reports that blood donation was reduced by approximately 30% after the declaration of emergency. RBCs, platelets and plasma are currently supplied by Japan Red Cross without any difficulty. It may be partly explained by reduction of utilization. If this pandemic continues, blood component shortages may occur in the medium term. We have not yet discussed how to avert or minimize shortages. Currently no, but we would be happy to share any lessons whenever they will be available. No, we are not planning to use convalescent plasma from COVID-19 patients to treat severe forms of the disease. Jeannie Callum & Yulia Lin Demographics: Yes, our hospital does accept samples. When a cooler of blood products is ordered our process is as follows: Yes, prompted by Ebola. Yes, policies and procedures in place and a town hall-type educational forum on the risks to technologists/technicians from handling samples from COVID-19 patients. RBCs 1 February 2019 to 23 April 2019 = 2723 vs. RBCs 1 February 2020 to 23 April 2020 = 2148; PLTs 611 vs. 423 platelet pools/apheresis units; plasma 378 vs. 276 units. Some blood component shortages are anticipated. We have notified physicians to maximize patient blood management (iv iron, epo and tranexamic acid), adhere to 70 g/l threshold in absence of symptoms and prescribe 1 unit at a time in the absence of bleeding for RBCs. We use intravenous iron aggressively for iron deficiency anaemia for chronic blood loss and pregnancy, and perioperatively. We have instructed clinicians to increase the use of tranexamic acid for thrombocytopenic patients and adhere to the 10 × 109/l threshold for hypoproliferative thrombocytopenia. We use PCCs for warfarin reversal exclusively. We do not use cryoprecipitate (fibrinogen concentrate used for all patients, including neonates). Plasma is used primarily for traumas (incidence has dropped during lockdown) and for cardiac surgery (elective cases postponed). We utilize POCT with ROTEM for cardiac surgery-related haemorrhage to allow for targeted transfusion therapy. We have reduced our inventory of RBCs to mitigate the risk of outdating products. We have been keeping the hospital Emergency Blood Management Committee apprised of the National inventory updates from our National Emergency Blood Management Committee. Our National and Provincial Emergency Blood Management Committee plans for shortages were robust and have served us well during the pandemic so far. There has been national cooperation by hospitals to reduce blood use and increase the use of patient blood management to mitigate a shortage. The Canadian public has responded positively with coming out to donate allowing the blood suppliers to maintain inventories across the country. In hindsight, we should have had a plan for the use and evaluation of convalescent plasma developed before the onset of a pandemic given its application in H1N1 influenza, SARS-CoV-1 and MERS. As a result, a protocol was required to be developed in 4 weeks when we could have anticipated its need. We have planned two randomized clinical trials for the use of convalescent plasma (CONCOR-1 and CONCOR-Kids). CONCOR-1 (NCT 04348656) is a randomized, open-label trial of convalescent plasma vs. standard of care in hospitalized, non-intubated adults with acute COVID-19 respiratory illness requiring supplemental oxygen. The trial is planned for a total of 1200 patients from approximately 50 hospitals in Canada and the United States. The dose is a single 500 ml transfusion (slowly over 4 hours) of apheresis plasma collected from a donor after full recovery from PCR-positive confirmed COVID-19 and with detectable anti-SARS-CoV-2 antibodies. No required titre threshold is required for release of the product. The donor must meet all the standard donor criteria set out by the appropriate regulator (Health Canada and the FDA). The primary end-point is the need for intubation for mechanical ventilation or death at 30 days. Other important outcomes will be the length of stay in the intensive care and hospital, serious adverse events, and the change in viral load between baseline and 48 hours. The trial is expected to take 6 months to complete. CONCOR-Kids is a similarly designed trial in children that will run in parallel. Pathogen inactivation will not be used. Donors between 14 and 27 days after complete recovery will be required to test negative for SARS-CoV-2 by PCR nasopharyngeal swab or by blood testing for RNAaemia. At the time of writing, there is currently no plan in Canada to consider an exceptional access programme for convalescent plasma outside of a clinical study. Mostafa Mogaddam & Ahmad Gharehbaghian Demographics: Yes. If a cooler of blood products was ordered for a patient with confirmed or suspected COVID-19, our process is described below. As an extra precaution notice, a warning flag (Patient under observation) shows up once laboratory staff check the patient's information in the computer system. Yes. Since all the elective surgeries were cancelled and only labour and delivery section, ICU and floors prepared for coronavirus suspicion were requesting blood products, patient blood utilization lowered to less than 30% of usual situation. We do anticipate some blood component shortages. Adopting more restrictive transfusion thresholds. Elective surgeries cancelled; therefore, less blood was requested. Try to be informed quickly as much as possible about the nature and characteristics of the organism involved from trusted, reliable international and national sources who are expert in the matter and change your routine policy accordingly. Not in our facility. But our blood supplier Iranian Blood Transfusion Organization (IBTO) is planning to do so. I was told 1–2 units of convalescent plasma. However, the convalescent plasma has been using in some hospitals in Iran. For instance, some large academic medical centres in Tehran, where are dealing with COVID-19 infected patients have been using the convalescent plasma and a specified facility for collecting such plasma from cured patient has been established in Iranian Blood Transfusion Organization in Tehran as well as the other capital cities in each province (31 provinces) across country and they have to follow similar guidelines/standards that have been prepared and distributed by IBTO headquarter. It is worth mentioning that Iran is a large and highly populated country and blood transfusion establishment as part of healthcare system is a national and central coordinated over here, which is called Iranian Blood Transfusion Organization (IBTO). Indeed, every blood transfusion establishment in every capital city of Iran Province collects convalescent plasma and distributes to other main cities, which are located inside province and a diversity of the size of collected plasma in each province is observed.