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General information | |
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Organisation name: | Against Leukemia Foundation MDR (ALF) |
Organisation ION: | ION-3918 |
Country: | Poland |
Year the registry started operations: |
Products | Comments | |
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This organisation provides HPC, Marrow: |
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This organisation provides HPC, Apheresis: |
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This organisation provides HPC, Cord Blood: |
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This organisation provides MNC, Apheresis: |
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This organisation provides NC, Whole Blood: |
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This organisation provides other products, if yes please specify: |
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Number of national HPC products provided in 2018: | HPC-Marrow: HPC-Apheresis: HPC-Cord: | |
Number of HPC products exported internationally in 2018: | HPC-Marrow: HPC-Apheresis: HPC-Cord: |
Licences and accreditations | Comments | |
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Organisation is licensed/accredited by the Competent Authority: |
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Name of Competent Authority: | Ministry of Health | |
Date of last inspection: | 2016/03/28 | |
Link to website of Competent Authority: | www.mz.gov.pl | |
Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry can be provided: |
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The registry is WMDA Qualified or WMDA Accredited: If yes, please specify: |
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The registry is accredited by any other organisation: If yes, please fill in the organisation: |
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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 about donation process 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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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: |
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Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify: |
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Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify: |
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Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify: |
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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: | Comments | |
Mandatory National Reporting Scheme: |
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Voluntary National Reporting Scheme: |
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WMDA SEAR/SPEAR Reporting Scheme: |
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Will 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? |
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Quality management | Comments | |
Do the registry maintain Standard Operating Procedures (SOPs) for your work? |
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Would the registry be willing to provide these to WMDA or another registry upon request? |
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Would the registry be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in? |
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How many years are donor records retained relating to the medical exam and HPC collection process? | Until next ct sample collection |