Note | ||
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General information | |
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Organisation name: | Slovenský register placentárnych krvotvorných buniek- Eurocord-Slovakia (SRPKB) |
Organisation ION: | ION-4398 |
Country: | Slovakia |
Year the registry started operations: |
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Affiliated centre information | Comments | |
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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? | ||
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 |
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The Cord Blood Banks are FACT-NetCord accredited: If yes, which cord blood bank(s)? |
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The registry is able to provide a copy of all the certificates: |
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Affiliated centres comply with WMDA Standards and applicable national regulations: |
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The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: If yes, please specify these requirements: |
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Donor policy | |
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All donors are unpaid volunteers: |
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All donors are informed aboutdonationprocess and associated risks: |
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Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff: |
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The registry has systems in place to protect and control access to donor/patient records: |
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The registry maintains donor anonymity: |
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The registry has detailed donor evaluation and exclusion criteria in place: |
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The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines: |
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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) (in number of days) |
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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: |
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All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: |
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HLA typing for patient specific request is performed in an appropriately accredited laboratory: |
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Sterility testing is performed on the adult donor product: |
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Sterility testing is performed on the cord blood product: |
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Screening questionnaire to exclude communicable disease: |
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Screening questionnaire to exclude donors with 'high risk' lifestyles: |
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Donor reliability identified by a medical doctor: |
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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:
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