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General information | |
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organisation name | Ossium Health |
ION of the organisation | ION-8941 |
Products | |
This organisation provides HPC, Marrow | Yes |
This organisation provides HPC, Apheresis | No |
This organisation provides HPC, Cord Blood | No |
This organisation provides MNC, Apheresis | No |
This organisation provides NC, Whole Blood | No |
This organisation provides Other products | No |
Other products provided: | |
Number of adult donor products shipped in the last 3 years: | |
Domestic shipments: | |
International shipments: | |
Licences and accreditations | |
organisation is licensed/accredited by a national regulatory body/accrediting agency: | Yes |
Name of Competent Authority/national regulatory body: | US FDA |
Date of last inspection: | May 20, 2024 |
Link to website of competent authority/national regulatory body: | https://www.fda.gov/ |
Legal documentation from the national government that your organisation is allowed to operate as a registry can be provided: | Not applicable |
Serious adverse events and reactions are reported and investigated: | |
Affiliated centres | |
This organisation has affiliated Donor Centres | Not applicable |
This organisation has affiliated Collection Centres | Not applicable |
This organisation has affiliated Cord Blood Banks | Not applicable |
This organisation has affiliated Transplant Centres | Not applicable |
This organisation has affiliated IDM Testing Laboratories | Not applicable |
This organisation has affiliated HLA/other DNA markers Testing Laboratories | Yes |
There is a full list of affiliated centres with their license / accreditation status available: | Not available |
The full list of affiliated centres list can be obtained: | |
Affiliated centres are required to be licensed by a national regulatory body and/or have an internationally recognised accreditation (e.g. European Federation of Immunogentics (EFI), NetCord-FACT, JACIE) | Not applicable |
Affiliated centres comply with WMDA standards and applicable national regulations: | Not applicable |
We have requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: | Not applicable |
We audit affiliated centres for compliance with applicable standards, national regulations and your organisation’s requirements: | Not applicable |
If Yes, the frequency of audits is : | |
Donor policy | |
Volunteer donors are unpaid: | Yes |
Donors are informed about donation process and associated risks: | Yes |
Donors sign a valid informed consent to donate: | Yes |
We have systems in place to protect and control access to donor/patient records: | Yes |
Our organisation maintains donor anonymity: | Yes |
Detailed donor evaluation and exclusion criteria in place? | Yes |
Detailed donor evaluation and exclusion criteria meet the WMDA guidelines? | Yes |
IDM Testing | |
CMV IgG is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgG | Yes |
CMV IgM is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgM | Yes |
CMV Total is tested at donor workup: | Yes |
EBV IgG is tested at donor workup: Epstein-Barr Virus Antibody testing IgG | Yes |
EBV IgM is tested at donor workup: Epstein-Barr Virus Antibody testing IgM | |
HBV (NAT) is tested at donor workup: Hepatitis B nucleic acid testing | Yes |
HBc Ab is tested at donor workup: Hepatitis B core antibody testing | Yes |
HBs Ag is tested at donor workup: Hepatitis B Surface antigen testing | |
HCV (NAT) is tested at donor workup: Hepatitis C nucleic acid testing | Yes |
HCV Ab is tested at donor workup: Hepatitis C antibody testing | |
HIV–1 Ab is tested at donor workup: Human Immunodeficiency Virus HIV-1 antibody testing | Yes |
HIV–2 Ab is tested at donor workup: Human Immunodeficiency Virus HIV-2 antibody testing | Yes |
HIV (NAT) is tested at donor workup: Human Immunodeficiency Virus nucleic acid testing | Yes |
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 | Yes |
HTLV-II is tested at donor workup: Human T-Lymphotropic Virus type II testing | Yes |
STS (Serological) is tested at donor workup: Serological tests for syphilis | Yes |
STS FTA-ABS (verification test) is tested at donor workup: Serological test for syphilis | |
WNV-NAT is tested at donor workup: West Nile Virus nucleic acid testing | Yes |
Other tests performed: | Trypanosoma cruzi (Chagas), Toxoplasmosis (Toxo) |
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: | |
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a national regulatory agency: | Yes |
The kits used for donor testing (at work up) for infectious disease are licensed/approved for use on donors by the national regulatory agency? | Yes |
HLA typing for patient specific request is performed in an appropriately accredited laboratory: | Yes |
Sterility testing is performed on the adult donor product: | Yes |
Retention policy | |
Donor records relating to the medical and HPC collection process are retained for: |