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General

The information has been reviewed in year :
Organisation name:Tobias Registry
Organisation ION:ION-5285
Country:Sweden
Year the registry started operations:1992

Products

comment
Do you provide HPC, Marrow? yes
Do you provide HPC, Apheresis? yes
Do you provide HPC, Cord Blood? yes
Do you provide MNC, Apheresis? yes
Do you provide NC, Whole Blood? yes

Product quantity

Data valid for year2022
Number of products NationalInternational
HPC, Marrow products: 3 13
HPC, Apheresis: 41 105
HPC, Cord: 0 2

License

Organisation is licensed/accredited by the Competent Authority:no
Comment:Not required
Name of Competent Authority:Not applicable
Date of last inspection:Not applicable
Link to website of Competent Authority:Not applicable
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ? yes
Is your registry WMDA Certified, WMDA Qualified or WMDA Accredited?WMDA Accredited
The registry is accredited by any other organisation:no
If yes, by which organisation?

Affiliation

The registry works with the following number of affiliated donor centres:Not applicable
The registry audits its donor centres:
The registry works with the following numer of affiliated collection centres:6
Ther registry audits its collection centres:Yes
The registry works with the following number of affiliated Cord Blood Banks:1
The registry audits its Cord Blood Banks:Not applicable
The registry works with the following number of affiliated transplant centres:6
The registry audits its transplant centres:yes
The registry works with the following number of affiliated IDM Testing Laboratories:6
The registry audits its IDM Testing Laboratories:Yes
The registry works with the following number of affiliated HLA/other DNA markers testing laboratories:2
The registry audits its HLA/other DNA markers testing laboratories:Yes
The registry would be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request: yes
The Cord Blood Banks are FACT-NetCord accredited: yes
If yes, the following Cord Blood Bank(s) are accredited:The Swedish National Cord Blood Bank
The registry is able to provide a copy of all the certificates: yes
Affiliated centres comply with WMDA Standards and applicable national regulations: yes
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: yes
If yes, what are these requirements?JACIE Accreditation

Donor policy

All donors are unpaid volunteers: yes
All donors are informed about donation process and associated risks: yes
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff: yes
The registry has systems in place to protect and control access to donor/patient records: yes
The registry maintains donor anonymity: yes
The registry has detailed donor evaluation and exclusion criteria in place: yes
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines: yes

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient Yes
ChagasChagas, T. cruzi No
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yeswithin 30 days of collection
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yeswithin 30 days of collection
CMV TotalCytomegalovirus Total No
EBV IgGEpstein-Barr Virus Antibody testing IgG On request
EBV IgMEpstein-Barr Virus Antibody testing IgM On request
HAV (NAT)Anti-hepatitis A virus nucleic acid testing No
HBV (NAT)Hepatitis B nucleic acid testing Yeswithin 30 days of collection
HBc AbHepatitis B core antibody testing Yeswithin 30 days of collection
HBs AgHepatitis B Surface antigen testing Yeswithin 30 days of collection
HCV (NAT)Hepatitis C nucleic acid testing Yeswithin 30 days of collection
HCV AbHepatitis C antibody testing Yeswithin 30 days of collection
HEV (NAT)Hepatitis E Virus nucleic acid testing On request
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yeswithin 30 days of collection
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yeswithin 30 days of collection
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yeswithin 30 days of collection
HIV p24Human Immunodeficiency Virus p24 antigen testing Yeswithin 30 days of collection
HTLV-IHuman T-Lymphotropic Virus type I testing Yeswithin 30 days of collection
HTLV-IIHuman T-Lymphotropic Virus type II testing Yeswithin 30 days of collection
MalariaMalaria On request
HSVHerpes Simplex Virus On request
STSSerological tests for syphilis Yeswithin 30 days of collection
STS FTA-ABSSerological test for syphilis No
ToxoplasmosisToxoplasmosis On request
VZVVaricella Zoster Virus On request
WNV-NATWest Nile Virus nucleic acid testing On request
Other tests performed On request

Testing

The physical and medical exam at donor workup is performed by a medical doctor: yes
All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: 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
Sterility testing is performed on the cord blood product: yes
Screening questionnaire to exclude communicable disease: yes
Screening questionnaire to exclude donors with 'high risk' lifestyles: yes
Donor reliability identified by a medical doctor: yes
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:

  • They are pregnant;
  • They are breastfeeding;
  • There is the potential for transmission of inherited conditions;
  • There is evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration Donor travel and exposure history and local infectious disease prevalence;
  • There is presence on the donor’s body of physical signs implying a risk of transmissible disease(s);
  • There is a history of a disease of unknown aetiology;
  • There is a risk of transmission of diseases caused by prions;
  • There is systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated;
  • There is history of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the Cell Product;
  • There is recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist;
  • There is ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.
 yes

Customs regulations

Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify:
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:no Customs paperwork needed
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:Regulation (EC) No 1546/2006 and the recommendations from Transportstyrelsen (TSL 2013-6447)

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:
- Mandatory National Reporting Scheme yes
- Voluntary National Reporting Scheme yes
- WMDA SEAR/SPEAR Reporting Scheme yes
The registry will 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

Quality management

The registry does maintain Standard Operating Procedures for your work: yes
The registry would be willing to provide these to WMDA or another registry upon request: yes
The registry would be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in: yes
Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained:Indefinitely

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