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Terms of reference for the National Focal Point and the Technical Expert for the WHO survey on the availability, safety and quality of blood and components National Focal Point Required attributes • Senior individual within the national blood service/system or very closely linked to it • Good understanding of the expected activities of blood services/systems • In-depth knowledge of the overall high level management and organisation of the national blood service/system • Full authority nationally to ensure that the required information is made available by all elements of the national blood service/system • Sufficient IT knowledge/experience to be able to obtain and collate the required information to complete the survey and to be able to access and complete the survey Role within the survey • To support the Technical Expert in completing the survey • To liaise with WHO to discuss any issues or problems related to the survey • To ensure that the information required to complete the survey is provided by all elements of the national blood service/system, whether government, private or NGO • To ensure that the survey is completed within the timescale set • To overview the completed survey to ensure that the information provided is complete, accurate and reliable • To provide the overall ‘sign-off’ of the completed survey prior to submission to WHO Technical Expert Required attributes • Experienced scientific or technical individual within the national blood service/system or very closely linked to it • In-depth understanding of the expected activities of blood services/systems • In-depth knowledge of the day to day working of the national blood service/system • Relevant knowledge and experience to be able to request the information required to complete the survey from all relevant parties within the national blood service/system • Relevant knowledge and experience to be able to initially assess the information supplied to ensure its credibility and validity in relation to the survey • Good IT knowledge/expertise to be able to access the survey and to collate and enter the required survey information Role within the survey • To identify and contact all relevant individuals who are responsible for providing the information required to complete the survey • To enter the information provided to complete the survey • To assess the credibility of the information supplied • To liaise with the National Focal Point to discuss and monitor progress • To liaise with WHO to discuss any problems or issues arising during the completion of the survey • To ensure the survey is completed within the timescale set WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION Date: 20 January 2022 ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ REGIONAL OFFICE FOR EUROPE Ms Elen Ohov BUREAU RÉGIONAL DE L’EUROPE REGIONALBÜRO FÜR EUROPA Adviser ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО European Union Affairs and International Co- Head office: operation Department UN City, Marmorvej 51, Ministry of Social Affairs DK-2100 Copenhagen Ø, Denmark Suur-Ameerika 1 Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Email: [email protected] 10122 Tallinn Website: http://www.euro.who.int Estonia Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: На Ваш номер: Dear Ms Ohov, Survey on availability, safety and quality of blood components In response to the WHA resolution 63.12 1 on the Availability, safety and quality of blood products, aligning to the 13th WHO Global Programme of Work 2, the WHO Action framework to advance universal access to safe, effective and quality assured blood products 2020 – 2023 3, and following the European Programme of Work – “United Action for Better Health in Europe” 4, the WHO Regional Office for Europe is initiating above mentioned short survey. In 2021 a desk review of blood services and their regulation was conducted within the WHO European Region. A critical finding is that for many Member States the information available on national blood programmes, the overall safety and sufficiency of the blood supply and national regulation is limited in amount, depth, consistency, reliability, and accuracy. In general, the levels of national coordination, complexity, quality, and regulation are all lower in the low- and middle-income member states, and all decreasing going from west to east across the Region. The status of blood as a medicine also varies across the Region, some Member States classing it as a medicine, others do not, whilst some do not include blood in, or may even specifically exclude it from, their classifications of medicines and medicinal products. Even if blood is considered to be a medicine or other licensed product, there is limited information whether regulation by the national regulatory authority takes place and is adequate. The purpose of this survey is to provide WHO with specific, accurate and reliable information on the current structure, organisation, activities and regulation of blood services in WHO Member States in the European Region. It is important that WHO obtains this information to enable it to properly assist and support Member States by making available the appropriate and relevant technical assistance, including resource mobilisation and planning, to be able to meet the commitments of the WHA resolutions on blood safety. 1 https://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R12-en.pdf 2 https://apps.who.int/iris/bitstream/handle/10665/324775/WHO-PRP-18.1-eng.pdf 3 https://apps.who.int/iris/rest/bitstreams/1269101/retrieve 4 https://www.euro.who.int/en/health-topics/health-policy/european-programme-of-work/about-the-european-programme- of-work/european-programme-of-work-20202025-united-action-for-better-health-in-europe2 UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: http://www.euro.who.int Denmark In addition, it is hoped that information will allow WHO to better support Member States who wish to make use of recently developed tools - the WHO Action Framework 2020-2023 and the WHO Global Benchmarking Tool + Blood 5, to assess blood service and regulatory activities, and who may then require technical assistance to further develop these activities. The purpose of this letter is to inform the Ministry of Health of the survey and to request their agreement to participate in it. If the Ministry agrees, please nominate one country focal point and one technical expert and send their names and contact details (email and phone) to the technical officers Ms Dorina Pirgari at [email protected] and Dr Olexandr Polishchuk at [email protected] at the WHO Regional Office for Europe, if possible before 05 February 2022. Terms of references for the national focal point and technical expert for this survey, scope and purpose and survey questionnaire are attached to this letter. On receipt of your official nomination, the focal points will be sent all relevant information regarding the survey and use of the IT tool developed for its completion. Sincerely yours, Dr Natasha Azzopardi Muscat Director, Division of Country Health Policies and Systems Encls: Survey questionnaire Survey scope and purposes Terms of reference for the national focal point and technical expert Copy for information to: Ms Triin Uusberg, Head, European and International Coordination Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Katrin Saarsalu-Layachi, Ambassador Extraordinary and Plenipotentiary, Permanent Representative, Permanent Mission of the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin du Petit-Saconnex 28A, CH-1209 Genève, Switzerland H.E. Mr William Mart Laanemäe, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia 5 https://www.who.int/tools/global-benchmarking-tools/VI-plus-blood –2– QUESTIONNAIRE Description of the current status/ Q No. Element situation Blood Service information 1 Responsibility for the running of the blood service in the country: Government / NGO / Private / Other 2 Organisation and structure of the blood service (organisational structures and organogram) 3 Existence of a national regulatory and licensing system for blood and blood services 4 Existence of a national blood policy 5 Funding of the blood service 6 Existence of system for annual review of activities and outcomes 7 Existence of system for the performance of regular, formal regulatory audits or inspections of the blood service to ensure adherence to national standards and guidelines and maintaining licensing requirements 8 Existence of appropriate national standards/ guidelines for blood service activities which are subject to regular review and update 8.1 • appropriate national donor selection guidelines 8.2 • appropriate national donation collection guidelines 8.3 • appropriate national testing/screening guidelines 8.4 • appropriate national processing and storage guidelines 8.5 • appropriate national guidelines on the appropriate use of blood 9 Existence of hospital transfusion committees and ongoing relationships with the blood service 10 Existence of national vigilance system which includes all adverse events related to blood and components Donors and donations 11 Donor recruitment activities 12 Annual number of donations collected from all sources, first time and repeat 12.1 Number of donors from whom the donations in Q13 were collected 12.2 Approximate annual % of donors who are voluntary non-remunerated donors 12.3 Approximate annual % of donors who are family replacement donors 12.4 Approximate annual % of donors who are paid donors 13 Estimated annual requirements 13.1 Estimated annual requirements for whole blood 13.2 Estimated annual requirements for red cells 13.3 Estimated annual requirements platelets 13.4 Estimated annual requirements for fresh frozen plasma 13.5 Estimated annual requirements for cryoprecipitate 14 Estimated annual requirements for plasma for fractionation (production of PDMPs) 15 Estimated shortfall between collection and requirements for each component type  15.1 Estimated shortfall between collection and requirements for whole blood 15.2 Estimated shortfall between collection and requirements for red cells 15.3 Estimated shortfall between collection and requirements for platelets 15.4 Estimated shortfall between collection and requirements for fresh frozen plasma 15.5 Estimated shortfall between collection and requirements for cryoprecipita 15.6 Estimated shortfall between collection and requirements for plasma for fractionation 16 System for the provision of plasma for production of PDMPs Laboratory activities 17 Immunohaematology investigations performed on donations 18 Infectious disease screening performed on donations 18.1 infectious disease screening algorithm used 18.2 confirmation of screening reactivity confirmed 18.3 management of infectious disease screen reactive donors 19 Validation/evaluation of laboratory systems and reagents before use Blood Service Quality management 20 Existence and role of an effective quality management system 21 Implementation of the QMS across the organisation 22 Performance of internal audits or inspections by the Quality Team National Regulatory Authority information 23 National classification of blood and components as a ‘medicine’ or ‘medicinal product’ 24 Existence of a national regulatory and licensing system for blood and blood services 25 Performance of regular, formal regulatory audits or inspections of the blood service to ensure adherence to national standards and guidelines 26 Existence of national vigilance system which includes all adverse events related to blood and components 27 Appropriate expertise within the NRA to regulate blood services and their activities 28 Existence of a quality management system within the NRA Saatja: PANAGIOTAKI, Katerina <[email protected]> Saadetud: 20.01.2022 17:01 Adressaat: Elen Ohov <[email protected]>; Triin Uusberg <[email protected]>; SM Info <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; KÖHLER, Kristina <[email protected]>; PIRGARI, Dorina <[email protected]>; POLISHCHUK, Olexandr <[email protected]>; LINDHARDT, Lisbeth Sjaelborg <[email protected]> Teema: Survey on availability, safety and quality of blood components Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included.Veuillez vous r¨¦f¨¦rer ¨¤ la correspondance ci-jointe du Bureau r¨¦gional de l'Europe de l'Organisation mondiale de la sant¨¦. Une ou plusieurs annexes peuvent ¨ºtre jointes.Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalb¨¹ro f¨¹r Europa. §³§Þ. §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§à§Ö §á§Ú§ã§î§Þ§à §à§ä §¦§Ó§â§à§á§Ö§Û§ã§Ü§à§Ô§à §â§Ö§Ô§Ú§à§ß§Ñ§Ý§î§ß§à§Ô§à §Ò§ð§â§à §£§ã§Ö§Þ§Ú§â§ß§à§Û §à§â§Ô§Ñ§ß§Ú§Ù§Ñ§è§Ú§Ú §Ù§Õ§â§Ñ§Ó§à§à§ç§â§Ñ§ß§Ö§ß§Ú§ñ (§à§Õ§Ú§ß §Ú§Ý§Ú §ß§Ö§ã§Ü§à§Ý§î§Ü§à §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§í§ç §æ§Ñ§Û§Ý§à§Ó). Katerina Panagiotaki Access to Medicines and Health Products (AMP) WHO Regional Office for Europe Copenhagen, Denmark Office: 3.3.11 Web: Follow WHO on | | | Scope and purpose Title of the survey: Survey assessing the structure, organisation, activities and regulation of blood services in member states Organized/sponsored by The World Health Organization (WHO) Regional Office for Europe Background Blood sufficiency and safety have been included in WHO strategic activities for some years. More recently WHO has developed two specific tools to assist member states in the development of effective and appropriately regulated national blood services:  WHO Action Framework to advance universal access to safe, effective and quality assured blood products 2020 – 2023  WHO Global Benchmarking Tool + Blood (GBT + blood) for evaluation of national regulatory systems of blood products including whole blood, blood components and plasma derived products To support the use of these tools WHO European Region needs to have a clear understanding of the status of blood services, their activities and their regulation in member states. Although the biennial WHO Global Database on Blood Safety1 (GDBS) does provide some information it has become clear that for some member states the quality and reliability of GDBS generated information is variable, and in addition there are some member states which do not respond to the request to complete the GDBS questionnaire. To assist WHO EURO in the use of WHO’s recently developed tools, this survey seeks to provide a reliable and comprehensive dataset of specifically selected blood service related information from each member state. Objectives of the survey: The survey objective is to obtain specific, accurate and reliable information on the current structure, organisation, activities and regulation of blood services in WHO EURO member states. Purpose of the survey To obtain information from which to build a picture of the current status of blood services and their activities across the WHO Euro region. Specifically, this will then enable WHO to assess the blood services and their activities of member states against the WHO Action Framework and the WHO GBT+Blood. Communication for the nominations 1 The World Health Organization (WHO) Global Database on Blood Safety (GDBS) was established in 1998 to address global concerns about the availability, safety and accessibility of blood for transfusion. The objective of this activity is to collect and analyse data from all countries on blood and blood product safety as the basis for effective action to improve blood transfusion services globally All information about the survey as well as questions and answers with regards to the survey conduct should go to Dr Alan Kitchen at [email protected] with a copy to Dr Olexandr Polishchuk at [email protected] and Mrs Dorina Pirgari at [email protected] at the WHO EURO