Health Minister Nelu Tataru has approved changes in the methodology regarding plasma donation by people recovered from COVID-19 to be used to treat critical patients infected with SARS-CoV-2 in an attempt to increase the number of donors.
The Ministry of Health announced on Monday that Tataru approved an order amending the annex to Order 654/2020 approving a methodology for the collection, testing, processing, storage and distribution of plasma from donors recovered from COVID-19 and the monitored use for critically ill COVID-19 patients in intensive care.
According to a press statement, the changes were proposed after consulting with specialists in the anesthesia and intensive care and transfusion boards of the Ministry of Health and the Prof. Dr. C. T. Nicolau National Institute of Transfusion Hematology.
The order contains amendments to the selection of potential whole blood/plasma donors who will be able to be chosen from among the persons who can prove a personal history of SARS CoV-2 infection and the disappearance of the risk of communicating the disease, without applying the requirement that they be previously hospitalised.
At the same time, the minimum requirements for admission as a donor cured of COVID-19 have been modified, as well as the list of requested documents, taking into account the need to harmonise the legislation in force. For example, the eligibility requirement that the donors submit two negative RT-PCT tests has been removed.
The minimum requirements for admission as a recovered donor of COVID-19 will be: signing informed consent to enter the selection procedure for plasma plasmapheresis and/or whole blood donation and for the coded transmission of donation data to the national and European database; producing documents attesting to a personal history of SARS-CoV-2 infection and the cessation of the risk of communicating the disease, compliance with all standard criteria for donation of whole blood or plasma, according to the existing national legislation; there should be an interval between two successive plasma donations of at least 14 days.
The changes are designed to increase the number of recovered COVID-19 people who can donate blood/plasma, as well as the number of critical patients in intensive care who can receive plasma. In addition, the Ministry of Health will contribute data to the data reporting platform of COVID-19 convalescent blood/plasma donors made available to member states by the European Commission - EU CCP Database. The information will be used to improve evidence at EU level on the safety and efficacy of this therapy.
Responsibilities are also set up for submitting information to the EU database.
Collection will be carried out in compliance with current standards in national legislation in the field of blood transfusion for the collection, testing, processing, storage and distribution of blood and blood components, while complying with the principle of unpaid voluntary donation and the technical guide developed by the European Commission on collection, testing, processing, storage, distribution and monitored use of plasma from COVID-19 recovered individuals for COVID-19 treatment.
Donated plasma should only be administered to critically ill patients, at least 18 years of age, who agree on the administration of COVID-19 convalescent plasma by signing informed consent and who meet a number of specific requirements.
According to data with the National Institute of Transfusion Hematology, more than 490 donors have been registered so far, and blood transfusion centres have distributed to hospitals a number of 463 convalescent plasma units.