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Donor policy | |
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All donors are unpaid volunteers: | YES / NO |
All donors are informed about donation process and associated risks: | YES / NO |
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff: | YES / NO |
The registry has systems in place to protect and control access to donor/patient records: | YES / NO |
The registry maintains donor anonymity: | YES / NO |
The registry has detailed donor evaluation and exclusion criteria in place: | YES / NO |
The registry 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, Test method) | YES | On request | NO | Test method | Timeframe before stem cell donation date (for donors) or Timeframe when the materials sample is taken for testing (for cords) |
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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: | |||||
HTLV-I: | |||||
HTLV-II: | |||||
Malaria: | |||||
HSV: | |||||
STS: | |||||
STS FTA-ABS: | |||||
Toxoplasmosis: | |||||
VZV: | |||||
WNV-NAT: | |||||
Other tests performed: |
Testing Please indicate whether the following are completed on the donor during the medical examination: | Comments | |
The physical and medical exam at donor work up is performed by a medical doctor: | YES / NO | |
All donor testing (at work up) for infectious disease is 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 | |
Screening questionnaire to exclude communicable disease: | YES / NO | |
Screening questionnaire to exclude donors with 'high risk' lifestyles: | YES / NO | |
Donor reliability identified by a medical doctor: | YES / NO | |
Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC: The party providing the Cell Product must exclude Donors when:
| YES / NO |
Customs regulations | Comments | |
Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify: | YES / NO | |
Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify: | YES / NO | |
Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify: | YES / NO | |
Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify: | YES / NO |
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