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General information | |||||
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| Organisation name | |||||
| ION of the organisation | |||||
| Country | |||||
| Year the registry started operations | |||||
| Products | |||||
| This organisation provides HPC, Marrow | |||||
| This organisation provides HPC, Apheresis | |||||
| This organisation provides HPC, Cord Blood | |||||
| This organisation provides MNC, Apheresis | |||||
| This organisation provides NC, Whole Blood | |||||
| This organisation provides Other products | |||||
| 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 a National Regulatory the Competent Authority: | |||||
| Name of Competent National Regulatory Authority: | |||||
| Date of last inspection: | |||||
| Link to website of competent authority/national regulatory bodyCompetent Authority: | |||||
| Legal documentation from the national government Competent Authority that your organisation is allowed to operate as a registry can be provided: | |||||
| Is the registry WMDA Qualified or WMDA Accredited? | |||||
| Is the registry accredited by any other organisation?Is your registry or cord blood bank an approved NMDP IND supplier? | |||||
| 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 onecord blood bank(s)? | |||||
| Are the collection centres FACT-JACIE accredited? | |||||
| Is the Registry able to provide a copy of all the certificates? | |||||
| 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: | |||||
| How often does the registry audit affiliated centres? | SPLITSEN | ||||
| Donor policy | |||||
| Are all donors unpaid volunteers? | |||||
| Are all donors informed about donation process and associated risks? | |||||
| Do donors sign a valid informed consent to donate in the presence of a medical practitioner? | |||||
| Does your registry have systems in place to protect and control access to donor/patient records: | |||||
| Does the registry maintain donor anonymity? | |||||
| Does the registry have detailed donor evaluation and exclusion criteria in place? | |||||
| Does the registry have donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines? | |||||
| 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 | Full donor screening for infectious disease risk is performed at the following stage: | Physical exam and relevant donor testing is performed at the following stage: | Infectious disease testing is performed at the following stage: | A sample for additional donor testing can be provided upon request: | |
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 national regulatory agency: | The kits used for donor testing (at work up) for infectious disease are licensed/approved for use on donors by the national regulatory agency? | 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 | |||||
| Mandatory National Reporting Scheme | |||||
| Voluntary National Reporting Scheme | |||||
| WMDA SEAR/SPEAR Reporting Scheme | |||||
| 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? | |||||
| Retention policy | |||||
| Donor records relating to the medical and HPC collection process are retained for: |
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