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General information | |||
|---|---|---|---|
| Organisation name: | |||
| ION of the organisation: | |||
| 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 other products: | YES / NO | ||
| Please specify, other products provided:Number of adult donor products shipped in the last 3 years: | |||
| 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 | |||
| Are the Cord Blood Banks FACT-NetCord accredited? If yes, which cord blood bank(s)?Are the collection centres FACT-JACIE accredited? | 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 toWMDA 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) | |||
ALT/AST is tested at donor workup: | |||
| Chagas is tested at donor workup: IgM and IgG antibody testing against Trypanosoma cruzi | |||
| CMV IgG is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgG | |||
| CMV IgM is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgM | |||
| CMV Total is tested at donor workup: | |||
| EBV IgG is tested at donor workup: Epstein-Barr Virus Antibody testing IgG | |||
| EBV IgM is tested at donor workup: Epstein-Barr Virus Antibody testing IgM | |||
HAV (NAT) is tested at donor workup: | |||
| HBV (NAT) is tested at donor workup: Hepatitis B nucleic acid testing | |||
| HBc Ab is tested at donor workup: Hepatitis B core antibody testing | |||
| HBs Ag is tested at donor workup: Hepatitis B Surface antigen testing | |||
| HCV (NAT) is tested at donor workup: Hepatitis C nucleic acid testing | |||
| HCV Ab is tested at donor workup: Hepatitis C antibody testing | |||
| HEV (NAT) is tested at donor workup: Hepatitis E nucleic acid testing | |||
| HIV (NAT) is tested at donor workup: Human Immunodeficiency Virus nucleic acid testing | |||
| HIV p24 Ag is tested at donor workup: Human Immunodeficiency Virus p24 antigen testing | |||
| HTLV-I is tested at donor workup: Human T-Lymphotropic Virus type I testing | |||
| HTLV-II is tested at donor workup: Human T-Lymphotropic Virus type II testing | |||
| Malaria is tested at donor workup: Testing against Plasmodium (P): P. malariae, P. falciparum, P. vivax, P. ovale and P. knowlesi | |||
| HSV is tested at donor workup: Herpes Simplex Virus IgG type 1 and IgG type 2 testing | |||
| STS (Serological) is tested at donor workup: Serological tests for syphilis | |||
| STS FTA-ABS (verification test) is tested at donor workup: Serological test for syphilis | |||
Toxoplasmosis is tested at donor workup: | |||
| VZV is tested at donor workup: Varicella Zoster Virus (HHV-3 - Human Herpes Virus type 3) testing | |||
| WNV-NAT is tested at donor workup: West Nile Virus nucleic acid testing | |||
| 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 | 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 process are retained for: |