Chairperson and committee
Chairperson: Jay Epstein (USA)
Vice Chair: Silvano Wendel (Brazil)
Secretary: Thierry Burnouf (Taiwan)
Treasurer: Martin Smid (Netherlands)
Members at large:
Claude Tayou Tagny (Cameroon)
Nelson Tsuno (Japan)
Salwa Hindawi (Saudi Arabia)
Jean-Claude Faber (Luxembourg)
Susan Stramer (USA)
Membership
The Working Party currently has 68 members representing 31 different countries.
Presently 68 members from 31 countries with 4 new members and one loss (death of Dr. Dana Devine) during the year. Subgroups (No. of participants, chairpersons): “Voluntary versus Replacement Donation” (29, Nelson Tsuno); “Needs versus Demand” (30, Jean Stanley); “Safe Plasma Proteins” (22, Jean-Claude Faber and Thierry Burnouf); “Harmonization of Regulations and Standards” (17, Susan Stramer).
Meetings and Teleconferences
Plenary meeting of the WP: June 23, 2024 at the ISBT Congress in Barcelona
- Invited Presentations:
- Blood Supply in the Dutch Caribbean, Prof. Ashley Duits
- Plasma fractionation infrastructure in Armenia, Dr. Mikayel Ginovyan
- Subgroup reports
- General discussion
Meetings of the Organizing Committee
- May 22, 2024:
- Preparation for the Business Meeting in Barcelona
- Opportunities for Cooperation with other WPs
- November 1, 2024:
- Reflections on the Business Meeting in Barcelona
- Subgroup reports and plans
- January 16, 2025:
- Preparation for the Business Meeting in Milan
- Recruitment of new ICSPP members after exiting by WFH and IPOPI in June 2024.
- Planning for OC elections
Activities during the period
Voluntary versus Replacement Blood Donation
- Literature review on donation topics
- Review of donation incentives included a SWOT analysis.
- Review of motivators and deterrents is ongoing.
- Interviews with countries close to 100% voluntary non-remunerated donation (VNRD) and surveys in those relying on family/replacement donations (FRD).
- Initial work involved interviews in countries with near-complete VNRD. A stakeholder questionnaire, based on member input, received responses from countries like Brazil, Finland, Georgia, Ghana, Indonesia, Japan, Oman, Saudi Arabia, Thailand, Turkey, and Malaysia.
- Data were analyzed using the PESTELE framework. Preliminary findings were presented at the ISBT Congress in Barcelona and a manuscript is in preparation.
- Creation of regional groups to address local issues.
- Groups are being formed for Africa, Latin America, the Middle East, and Asia
- Discussions are ongoing on tools to help countries move from FRD to VNRD. One proposal includes a university student education program.
- Assistance to WHO for review of upcoming WHO blood donation guidelines
Safe Plasma Proteins
ISBT Planning Group for ICSPP Steering Committee (SC) held regular planning and quarterly SC meetings.
- Outreach to World Apheresis Association to join ICSPP
- Progress in Ethiopia:
- Adopted National Blood and Plasma Policy as a development framework.
- WHO-supported training events.
- May 2024 hybrid GMP training for blood establishments.
- November 2024 webinar on “Strengthening Blood Systems through Regulation.”
- February 2025 GMP "train-the-trainer" workshop addressing ICSPP audit findings at six key establishments.
- New initiative with ISBT WP on Cellular Therapies: apheresis for cell products, plasma exchange, and plasma for fractionation.
- Cooperation with AFRICARhE to explore local sourcing of anti-RhD plasma from previously pregnant women for preparing small-scale anti-D immunoglobulin.
- Progress in Senegal:
- Agreement with FIODS to mobilize donors, with potential support from African Society of General Medicine.
Other subgroup activities:
- Revived project with Armauer Hansen Research Institute (AHRI), Addis Ababa, for local IgG production.
- Ongoing VIPS support on facility design.
- Planned Egypt training by Magdy El-Ekaiby.
- Collaboration with WHO on cross-border plasma transfer guidance for PDMPs.
- Advocated continued cryoprecipitate listing on WHO EMLs ; Supported WHO Survey on cryoprecipitate availability and use ; Submitted advocacy letter to EML Secretariat ; Reviewed 2025 EML Applications from WFH.
Need versus Demand
- Literature review on best practices for assessing blood need/demand/supply gaps
- Launched a project to measure gaps:
- Pilot surveys in Ethiopia and Indonesia on maternal hemorrhage
- Phase 1: Retrospective data from national blood service, 2 blood establishments, and 4 hospitals per establishment (2 private, 2 public)
- Phase 2: Prospective data from same sites to validate phase 1
- Reporting forms developed with local input; launch pending staff briefings
Harmonization of Regulations and Standards
- Developed two manuscripts from a global survey (Oct 2023–Mar 2024) on TTID laws, regulations, standards, and practices. Respondents: 74 countries/regions (65 countries + Hong Kong and 8 regions). Data analyzed by World Bank Income level. Key findings:
- 96% of respondents had regulatory authority over collection/processing; 94% nationally.
- All reported screening for HIV, HBV, HCV; most for syphilis. Confirmatory testing common. NAT less frequent in lower-income countries.
- Lower-income countries used fewer advanced methods: component separation, pathogen/leukocyte reduction, routine platelet bacterial testing.
- All countries/regions provided donor education and deferred donors after reactive results.
- Manuscript on laws, regulations and standards for blood/component collection and processing accepted by Vox Sanguinis
- Manuscript on TTID testing and donor vigilance submitted to Vox Sanguinis
Working Party Publications
- Farrugia A, Perry R, Rossi F, von Bonsdorff L, Bowie G, Faber J-C, et al. Generating pathways to domestically sourced plasma-derived medicinal products: Report from a workshop by the International Plasma and Fractionation Association and the Working Party on Global Blood Safety of the International Society of Blood Transfusion. Vox Sang 119(9):1012-1020,2024.
- Burnouf T, Epstein J, Faber J-C, and Smid WM. Response to comments from the International Patient Organization for Primary Immunodeficiencies on “Stepwise options for preparing therapeutic plasma proteins from domestic plasma in low- and middle-income countries.” Vox Sang 119(9):1023-1024,2024.
- Epstein JS, Maryuningsih Y, Faber J-C, Smid WM, and Burnouf T. Inclusion of cryoprecipitate, pathogen-reduced, in the WHO model lists of essential medicines for adults and children;a call for action. Blood Transfusion Medicine 22:481-483, 2024 doi:10.2450/BloodTransfus.687
