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General information | |
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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 registry WMDA Qualified or WMDA Accredited? SPECIFY WHICH ONE? | YES / NO |
Is the registry 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 many affiliated collection centres does the registry work with? | |
How many affiliated cord blood banks does the registry work with? | |
How many affiliated transplant centres does the registry work with? | |
How many affiliated IDM Testing Laboratories does the registry work with? | |
How many affiliated HLA/other DNA markers testing laboratories does the registry work with? | |
Would the registry 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 Cord Blood Banks FACT-NetCord accredited? If yes, which cord blood bank(s)? | YES / NO |
Is the Registry able to provide a copy of all the certificates? | YES / NO |
Affiliated centres comply with WMDA Standards and applicable national regulations: | |
We have 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 donors unpaid volunteers? | YES / NO |
Are all donors informed about donation process and associated risks? | YES / NO |
Do donors sign a valid informed consent to donate in the presence of a medical practitioner/health care personnel/registy staff? | YES / NO |
Does your registry have systems in place to protect and control access to donor/patient records: | YES / NO |
Does the registry maintain donor anonymity? | YES / NO |
Does the registry have detailed donor evaluation and exclusion criteria in place? | YES / NO |
Does the registry have 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) | YES On request NO Test method |
ALT/AST: | |
Chagas: | |
CMV IgG: | |
CMV IgM: | |
CMV Total: | |
EBV IgG: | |
EBV IgM: | |
HAV (NAT): | |
HBV (NAT): | |
HBc Ab: | |
HBs Ag: | |
HCV (NAT): | |
HCV Ab: | |
HEV (NAT): | |
HIV (NAT): | |
HIV-1 Ab: | |
HIV-2 Ab: | |
HIV p24 Ag: | |
HTLV-I: | |
HTLV-II: | |
Malaria: | |
HSV: | |
STS: | |
STS FTA-ABS: | |
Toxoplasmosis: | |
VZV: | |
WNV-NAT: | |
Other tests performed: | |
Testing | |
Is the physical and medical exam at donor work up performed by a medical practitioner? | |
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: | |
HLA typing for patient specific request is performed in an appropriately accredited laboratory: | |
Sterility testing is performed on the adult donor product: | |
Sterility testing is performed on the cord blood product: | |
Reporting of Serious Adverse Events | |
Is a Mandatory or a 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 Registry 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: |
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