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Instructions for completion

General information


Organisation name:
Organisation ION:
Country:
Year the registry started operations:
Products
This organisation provides HPC, Marrow:YES / NO
This organisation provides HPC, Apheresis:YES / NO
This organisation provides HPC, Cord Blood:YES / NO
This organisation provides MNC, Apheresis:YES / NO
This organisation provides NC, Whole Blood:YES / NO
This organisation provides other products:YES / NO
Please specify, other products provided:
Number of national HPC products provided in 2017:
Number of HPC products exported internationally in 2017:


Licences and accreditations
Organisation is licensed/accredited by the Competent Authority:YES / NO
Name of Competent Authority:
Date of last inspection:
Link to website of Competent Authority:
Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry can be provided:YES / NO
Is the
The registry is WMDA Qualified or WMDA Accredited
?
: SPECIFY WHICH ONE?YES / NO
Is the

The registry is accredited by any other organisation

?

:

If yes, which organisation?

YES / NO


Affiliated centre information
How many affiliated donor centres does the registry work with?
How often does the registry audit its donor centres?
How many affiliated collection centres does the registry work with?
How often does the registry audit its collection centres?
How many affiliated cord blood banks does the registry work with?
How often does the registry audit its cord blood banks?
How many affiliated transplant centres does the registry work with?
How often does the registry audit its transplant centres?
How many affiliated IDM Testing Laboratories does the registry work with?
How often does the registry audit its IDM Testing Laboratories?
How many affiliated HLA/other DNA markers testing laboratories does the registry work with?
Would

How often does the registry audit its HLA/other DNA markers testing laboratories?

The registry would be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request

?

:

Tip: you can upload the full list here and make it available for the WMDA membership

YES / NO
Are the

The Cord Blood Banks are FACT-NetCord accredited

?

:

If yes, which cord blood bank(s)?

YES / NO
Is the
The Registry is able to provide a copy of all the certificates
?
:YES / NO
Affiliated centres comply with WMDA Standards and applicable national regulations:
We have

The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:

If yes, please specify these requirements:

YES / NO

How often does the registry audit affiliated centres? SPLITSEN



Donor policy
Are all

All donors are unpaid volunteers
?
:YES / NO
Are all
All donors are informed about donation process and associated risks
?
:YES / NO
Do d
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registy staff
?
:YES / NO
Does your
The registry
have
has systems in place to protect and control access to donor/patient records:YES / NO
Does the
The registry
maintain
maintains donor anonymity
?
:YES / NO
Does the
The registry
have
has detailed donor evaluation and exclusion criteria in place
?
:YES / NO
Does the
The registry
have
has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines
?
:YES / NO
IDM Testing at donor workup (please fill in Yes, On Request, No

...

IDM Testing at donor workup (please fill in Yes, On Request, No
, Test method)YESOn requestNOTest method

Timeframe before stem cell donation date (for donors) or

Timeframe when the materials sample is taken for testing (for cords)

ALT/AST:

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Chagas:
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CMV IgG:
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CMV IgM:
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CMV Total:
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EBV IgG:
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EBV IgM:
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HAV (NAT):

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HBV (NAT):
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HBc Ab:
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HBs Ag: 
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HCV (NAT):
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HCV Ab:
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HEV (NAT):
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HIV (NAT):
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HIV-1 Ab:
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HIV-2 Ab:
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HIV p24:
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HTLV-I: 
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HTLV-II:
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Malaria:
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HSV:
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STS:
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STS FTA-ABS:
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Toxoplasmosis:

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VZV:
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WNV-NAT:
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Other tests performed:
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Testing
Is the

The physical and medical exam at donor work up is performed by a medical

practitioner?

doctor:

YES / NO
All donor testing (at work up) for infectious disease is
performed 
in
performed in a laboratory certified/licensed by a Competent Authority:YES / NO
HLA typing for patient specific request is performed in an appropriately accredited laboratory:YES / NO
Sterility testing is performed on the adult donor product:YES / NO
Sterility testing is performed on the cord blood product:YES / NO

Reporting of Serious Adverse Events

Is a Mandatory or a

Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in:


Additional comments
Mandatory National Reporting SchemeYES / NO

Voluntary National Reporting Scheme

available?If yes, please specify which one:

YES / NO
Is a

WMDA SEAR/SPEAR Reporting Scheme

available:If yes, please specify which one

:

YES / NO
Wil the

The Registry will notify the receiving Registry within 24 hours of receiving information relating to any serious adverse event that could be considered to affect the patient receiving the product?YES / NO
Retention policy
Donor records relating to the medical and HPC collection process are retained for: