Registry Working Group Open Session
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1 Registry Working Group Open Session Chair: Irina Evseeva Chair elect: Annette Rasche Istanbul 20 th of March
2 Agenda Agenda item Time Topic Presenter Welcome and introduction Irina Evseeva New WMDA Standards discussion Pam Robinett Brief on Finance Project Timothy Fox Update on WMDA Handbook Annette Rasche Update on Search Coordinators Annette Rasche Certification Program Update on Forms Committee work Irina Evseeva AOB All
3 Towards new version of the WMDA standards, edition 2017 Advice requested from WMDA working groups Pam Robinett
4 WMDA Standards 17 th Edition proposals Registry mergers: policies and procedures Files transfers: validations Communications restricted to registry-to-registry Verify donor and recipient HLA at work-up Donor withdrawal consent 3 month time limit for results on search requests and associated payment
5 Registries Working Group New WMDA standard related to merging of two registries to one registry If, in case of a complete merging between two registries: The registry must have policies describing the transfer of the donor data There must be a written agreement between the transferring and accepting registry that describes the responsibilities of each entity The transferring registry must have a procedure to review the records of the transferred donor data The accepting registry must have a procedure to check the completeness and accuracy of the transferred donor data The accepting registry must ensure that the transferring registry complies with WMDA standards (according to the level of compliance of the accepting Registry)
6 Registries Working Group New WMDA standard related the transfer of donor/ cord blood file from a registry to another If all or part of a donor file is to be transferred to another registry, but the registry mantains its configuration: When transferring data from the registry to another body (BMDW, mirroring of data, etc) there should be a validated protocol for the transfer, both the transferring unit and the receiving unit must have policies to validate the data.
7 Registries Working Group New standard Where a national registry exist, all communications and all requests should/must go via the national registry. International registries/donor centres should/must not directly communicate with transplant centres in that country, unless specifically stated by the national registry.
8 Registries Working Group New standard At the point of donor work up the registry should have a process to check the HLA details for both patient and donor to ensure the request for this donor is valid.
9 Registries Working Group Revising standard 3.06 CURRENT WORDING: A volunteer donor must be free to withdraw at any time. REVISED WORDING: A volunteer donor must be free to withdraw at any time and must be informed of this ability and if appropriate the point at which this ethically can no longer occur.
10 Registries Working Group New standard The registry should report HLA typing results and/or additional information and/or an aliquot of donor (or maternal if cord blood) sample within a 3 month of the request. If results are provided after expiration of the 3 month period, the requesting registry need not guarantee payment of the services unless the requesting registry has previously confirmed the need for service completion despite the delay.
11 DRWG Open Session The cost of a cure: What is the value of a haematopoietic progenitor cell Donor Registry to a community? Timothy Fox, Anthony Nolan Amy Ronneberg, NMDP
12 Introduction to the research project Objectives Stimulus for the project A changing market, e.g. cost pressure, pricing disparity and real risk to the country registry, donor centre etc. Risks / opportunities posed by EU wide economic overview of the markets of stem cells for the European Commission (cost, pricing, market control) Project Aims Can the value a WMDA registry member provides to its own or other communities be quantified in a way that establishes an indispensable value above and beyond a crude assessment based on the price it charges for the provision of services and products?
13 Three phases of the Project 1. Project initiation and State of the Registry Economy 2. Defining the Registry business model (calculate an indicative / approximate cost of a Haematopoietic Progenitor Cell Unit (HPC Unit), considering all costs? and quantifying added value) 3. Financial benchmarks and cost saving opportunities
14 Phase 1 State of the registry economy Methodology: 16 registry interviews. Qualitative. Three broad questions: i. What will the market be like in 3 to 5 years? ii. Will members still be using the same business model to operate? iii. What do we need to do now as community if anything?
15 What will the market be like in 3 to 5 years? 1. More lives saved 2. The convergence of continuing clinical developments, increasing need for transplants, healthcare expenditure, better HLA typed donors, targeted and more efficient donor recruitment and IT developments will result in increasing competition between registries. 3. The current picture appears to be mixed dependent on the maturity of the registry, but the common theme is one of an increasing threat of protectionist policy in terms of competition.
16 What will the market be like in 3 to 5 years? 4. Real and increasing pressure on current and future funding. The necessary investment needed to improve efficiency, operational infrastructure and donor recruitment in order to compete. Both resulting in price and cost pressures. 5. Not only was it clear that there was a need for this research considering the changes to market over the last few years, but there is a real need to do something about it, quickly.
17 Will members still be using the same business model to operate? Emerging themes from Phase 1 include: 1. Collaboration or competition? 2. Increasing cost pressure and efficiencies may result in changes to registry infrastructure and survival 3. Investment decisions will be challenging in order to develop the registry, for example can or will a registry invest in IT, targeted recruitment, increasing the level of the HLA Typing resolution of existing donors, cord research etc.?
18 Will members still be using the same business model to operate? Emerging themes from Phase 1 include: 4. Review of strategy including, sustainable funding and pricing models 5. Prove value and efficiency. Clarity of funding and cost allocation.
19 What do we need to do now as community if anything? 1. Discuss openly (Internally efficiency, collaboration and sharing but maintain registries to support the diverse populations) 2. Commit to Phase 2: Cost of a Cure 3. Externally Consider the need to raise the profile of WMDA and members 4. Efficiency measures (short term?)
20 Next steps 1. Working Group to discuss Phase 1 findings and the Phase 2 approach. Phase 2 progress review in October Additional contributors required for phase 2 / 3: Contact: timothy.fox@anthonynolan.org: Research project outline Model / tool in development Phase 1 report
21 DRWG Open Session Handbook Committee Update Annette Rasche
22 WMDA Handbook: What s up? Thank you to Bruce Schmaltz! Welcome to Pam Robinett and Volker Rump Determine responsibles for Introduction and Glossary Training on new content management tool: WMDA Confluence platform Recap handbook update cycle for 2016 Version Evaluate idea of conducting a seminar for emerging registries
23 Handbook Project Members Introduction 1. General Organization of Registry Annette Rasche Beth Amer 2. Recruitment of Volunteer Donors Sabine Hildebrand Ann O Leary 3. Donor Search Request Gabi Rall Susie Joran 4. Collection and Transportation Michael Punzel Corina Gonzalez 5. Post Donation Grazia Nicoloso Maria MacWilliams 6. Cord Blood Banking Jacqueline Van Beckhoven Susana G. Gomez 7. Information Technology and data management David Steiner Ian Britton 8. Finance & Administration Volker Rump Carine Mijnarends Glossary
24 Handbook Review Cycle Working Cycle until August Edit Review September/October Cycle Post New Version on WMDA Confluenc e asap Close Edit Review Process End of the year Final Review November
25 DRWG Open Session Search Coordinators Certification Program Annette Rasche
26 Search Coordinators Certification Program: Basic Level Pilot Basic Level Pilot is running successful module 6 just started final exam will be scheduled evaluation by students for each module certificate must be designed, issued and distributed Evaluation of basic level materials is needed experts are welcome! students evaluation will be reflected
27 Search Coordinators Certification Program: Formal Basic Level Basic Level Program will be enrolled in fall Participation for the whole program with exam and certificate at the end or just for certain module(s) Fees proposed by WMDA board: Euro 100, per module for WMDA members Euro 200, per module for non members Euro 600, per year (whole course) for WMDA memb. Euro 1000, per year (whole course) for non members
28 Search Coordinators Certification Program: Advanced Level Pilot Modules 1 and 2. Umbilical cord blood unit selection Module 3. HLA mismatched donor is it always bad? Module 4. Aspects of graft selection Module 5. HLA nomenclature, HLA typing techniques Module 6. Advanced search strategy Modules 7 & 8. Case studies on donor search Module 9. IT tools for case study Speakers needed
29 Search Coordinators Certification Program: General Issues Terms & Conditions have to be defined. Help wanted! Clarification of Copyright issues. Help wanted! Potential collaboration with EBMT
30 DRWG Open Session Forms Committee Update Irina Evseeva, DRWG Chair
31 Thank you to Tom Wiegand! Welcome to Jennifer Wuchter
32 STATUS UPDATE SINCE NOVEMBER % of the forms updated with new WMDA logo Over 50% with content / functionality updates Updates to forms in progress anticipated release by Summer 2015 New forms proposed Proforma Invoice Notification of Donor Abnormal Findings Donor Not Cleared Form Change Control Document Form Functionality Testing
33 STATUS UPDATE SINCE NOVEMBER 2014 Change in Terminology: T Cell, Apheresis vs. MNC, Apheresis Development / Maintenance of Smart Forms Clarification statements being added to forms displaying decimal values
34 Thank you! FORMS COMMITTEE MEMBERS Mats Bengtsson Grazia Nicoloso Claudia Benkoe Gabi Rall Jason Dehn Annette Rasche Raewyn Fisher Jennifer Skinkle Kerri Heinen Ingrid Tistl Judith Maeck Anne Marie van Walraven Susanne Morsch Thomas Wiegand
35 Education Day 2015 Committee members: Betina Sorensen, Sabine Hildebrand, Elizabeth Murphy, Joannis Mytilineos, Michael Punzel, Grazia Nicoloso, Laurie Olesen, Irina Evseeva, Annette Rasche Survey of Education Day 2014: More time for discussions or questions Many suggestions on topics for Education Day 2015 Preliminary title: Registries Around the World Introduce World Café format: Make an interactive Education Day Cover more topics Meet new people Possibility to discuss in small groups and ask experts Encourage participants to bring a cases/problems/questions/challenges to be discussed in the World Cafe
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