Registry Working Group Open Session

Registry

Working

Group

Open

Session

Chair:

Irina

Evseeva

Chair

‐

elect:

Annette

Rasche

Istanbul

20th _{of March 2015}

Agenda

Agenda 

item

Time Topic Presenter

1

10.00 – 10.05 Welcome and introduction Irina Evseeva

2

10.05 – 10.25 New WMDA Standards discussion Pam Robinett

3

10.25 – 10.35 Brief on Finance Project Timothy Fox

4

10.35 – 10.40 Update on WMDA Handbook Annette Rasche

5

10.40 – 10.45 Update on Search Coordinators 

Certification Program

Annette Rasche

6

10.45 – 10.50 Update on Forms Committee work Irina Evseeva

6

Towards

new

version

of

the

WMDA

standards,

edition

2017

Advice

requested

from

WMDA

working

groups

WMDA Standards 17

_{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

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 

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 

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, 

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 

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 

Registries

Working

Group

New

standard

“10.07.1 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 

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

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?

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

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? 

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.

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 

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.?

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.

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

Next

steps

1. Working Group to discuss Phase 1 findings and the Phase 

2 approach. Phase 2 progress review in October 2015

2. Additional contributors required for phase 2 / 3:

Contact:   [email protected]:

• Research project outline

• Model / tool in development

DRWG

Open

Session

Handbook

Committee

Update

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

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

Handbook Review

Cycle

until August September/October

November

DRWG

Open

Session

Search

Coordinators

Certification

Program

Search

Coordinators

Certification

Program: Basic

Level

Pilot

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!

Search

Coordinators

Certification

Program:

Formal Basic

Level

• 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

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

Search

Coordinators

Certification

Program: General

Issues

•

Terms & Conditions have to be defined.

Help

wanted!

•

Clarification of Copyright issues.

Help

wanted!

DRWG

Open

Session

Forms

Committee

Update

Thank

you

to

Tom

Wiegand!

STATUS

UPDATE

SINCE

NOVEMBER

2014

• 100% 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

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  

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

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