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Date | Description Action Task |
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| August 21 |
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| 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? | |
| 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 |
The Cord Blood Banks are FACT-NetCord accredited: If yes, which cord blood bank(s)? | YES / NO |
| The Registry is able to provide a copy of all the certificates: | YES / NO |
| Affiliated centres comply with WMDA Standards and applicable national regulations: | YES / NO |
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: If yes, please specify these requirements: | YES / NO |
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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) |
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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: | Additional 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: | YES / NO |
Reporting of Serious Adverse Events 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 Scheme | YES / NO | |
Voluntary National Reporting Scheme | YES / NO | |
WMDA SEAR/SPEAR Reporting Scheme: | YES / NO | |
| 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 |
Quality management | Additional comments | |
| Do you maintain Standard Operating Procedures (SOPs) for your work? | YES / NO | |
Would you be willing to provide these to WMDA or another registry upon request? | YES / NO | |
Would you be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in? | YES / NO | |
| How many years are donor records retained relating to the medical exam and HPC collection process? | ||