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Operational information
This data is publicly available. Parent page : ION-8941
Operational data for Ossium Health - ION-8941 | |
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Organisation Overview | |
The information has been reviewed in year : | 2024 |
Issuing organisation Number (ION) | ION-8941 The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA. |
Time zone | America/Los_Angeles (GMT-08:00) The timezone in which this organisation operates. |
Business hours | 9:00 am - 5:00 pm The daily hours in which this organisation operates. |
Work schedule | Monday - Friday The normal work week in which this organisation operates. |
Organisation closures | Labor Day (September 2, 2024), Thanksgiving Day (November 28, 2024), Day After Thanksgiving (November 29, 2024), Christmas Eve (December 24, 2024), Christmas Day (December 25, 2024), New Year's Day (January 1, 2025), Martin Luther King Day (January 20, 2025), Presidents Day (February 17, 2025), Memorial Day (May 26, 2025), Juneteenth (June 19, 2025), Independence Day (July 4, 2025) For all organisation closures, please see the WMDA Calendar. |
Donor ID example | 8941 2024 000 00552 134 ID to be expected on paperwork, samples, and products. |
Preliminary Search | |
Requires preliminary search request form | No If yes, form required can be found on the Documents Page. |
Extended Typing | |
Typing options available for request | HR-A, B, C, DRB1 performed on all donors Please note special requirements listed |
Requires organisation specific typing request form | No If yes, form required can be found on the Documents Page. |
Number of days donor is reserved for a patient after a request | 30 days |
Verification Typing | |
Maximum blood volume allowed | Not applicable |
Requires organisation specific typing request form | No If yes, form required can be found on the Documents Page. |
IDM testing performed at verification | Not applicable |
Number of days donor is reserved for a patient after a request | Not applicable |
Sibling Typing | |
Registry is willing to arrange sibling typings | Not applicable |
If yes, procedure to apply for sibling typings | Not applicable |
Workup Request | |
Product dosage limit | Product dosage determined by physician Number of donor cells allowed based on recipient weight. |
Requires patient to meet certain standards in order to proceed with collection | Not applicable Organisation may or may not allow donor collections for some patients. |
Patient physician must report the following in order to proceed with collection | Not applicable Must provide additional information to organisation. |
Requires organisation specific work up forms | Not applicable If yes, form(s) required can be found on the Documents Page. |
Workup IDM completed 30 days prior to collection | Yes Donor IDM results must be performed within 30 days of collection date to be valid and allow the collection to proceed. |
Medical Health Questionnaire example available | Not applicable If yes, the example can be found on the Documents Page. |
Post-Transplant | |
Subsequent donation policy | Not applicable |
Anonymous contact allowed | Not applicable |
Direct contact allowed | Not applicable |
Gift exchange allowed | Not applicable |
Cord blood contact allowed | Not applicable |
Regulatory information
This data is publicly available. Parent page : ION-8941
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 | Yes |
HCV (NAT) is tested at donor workup: Hepatitis C nucleic acid testing | Yes |
HCV Ab is tested at donor workup: Hepatitis C antibody testing | Yes |
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: | Indefinitely |