Operational information

This data is publicly available. Parent page : ION-9738

Operational data for Finnish Stem Cell Registry - ION-9738

Organisation Overview
The information has been reviewed in year :
Issuing organisation Number (ION)ION-9738
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneEurope/Minsk (GMT+02:00)
The timezone in which this organisation operates.
Business hours08:00 - 16:00
The daily hours in which this organisation operates.
Work scheduleMonday - Friday
The normal work week in which this organisation operates.
Organisation closures
For all organisation closures, please see the WMDA Calendar.
Donor ID exampleFI12345D
ID to be expected on paperwork, samples, and products.
Preliminary Search
Requires preliminary search request formNo
If yes, form required can be found on the Documents Page.
Extended Typing
Typing options available for requestHR, IR, LR
Please note special requirements listed
Requires organisation specific typing request formNo
If yes, form required can be found on the Documents Page.
Number of days donor is reserved for a patient after a request2 months
Verification Typing
Maximum blood volume allowed40 ml
Requires organisation specific typing request formNo
If yes, form required can be found on the Documents Page.
IDM testing performed at verificationYes
Number of days donor is reserved for a patient after a request2 months
Sibling Typing
Registry is willing to arrange sibling typingsYes
If yes, procedure to apply for sibling typings The request for sibling typing service can be done by sending an email to the Finnish Stem Cell Registry (stemcellregistry@bloodservice.fi). The email shall include: name of the patient and the sibling, patient's registry, sibling's contact information (address, phone number, email), typing request and billing information (contact person, address, phone number, email)
Workup Request
Product dosage limit
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collectionNo
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collectionYes, patient physician needs to provide patient report on status and treatment plan
Must provide additional information to organisation.
Requires organisation specific work up forms No
If yes, form(s) required can be found on the Documents Page.
Workup IDM completed 30 days prior to collectionYes
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 availableYes
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policyYes, see our policy (SOP) below
Anonymous contact allowedYes, after 1 year post-transplantation
Direct contact allowedNo
Gift exchange allowedNo
Cord blood contact allowedNo

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient -
ChagasChagas, T. cruzi -
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yes
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yes
CMV TotalCytomegalovirus Total Yes
EBV IgGEpstein-Barr Virus Antibody testing IgG Yes
EBV IgMEpstein-Barr Virus Antibody testing IgM Yes
HAV (NAT)Anti-hepatitis A virus nucleic acid testing -
HBV (NAT)Hepatitis B nucleic acid testing Yes
HBc AbHepatitis B core antibody testing Yes
HBs AgHepatitis B Surface antigen testing Yes
HCV (NAT)Hepatitis C nucleic acid testing Yes
HCV AbHepatitis C antibody testing Yes
HEV (NAT)Hepatitis E Virus nucleic acid testing -
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yes
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yes
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yes
HIV p24Human Immunodeficiency Virus p24 antigen testing Yes
HTLV-IHuman T-Lymphotropic Virus type I testing Yes
HTLV-IIHuman T-Lymphotropic Virus type II testing Yes
MalariaMalaria -
HSVHerpes Simplex Virus -
STSSerological tests for syphilis Yes
STS FTA-ABSSerological test for syphilis -
ToxoplasmosisToxoplasmosis -
VZVVaricella Zoster Virus -
WNV-NATWest Nile Virus nucleic acid testing On request
Other tests performed -

Regulatory information

The data provided on this page is updated by the organisations.
The WMDA makes no representations or express or implied warranties regarding any information on this page.
Use of any information provided on this site does not and is not intended to create a contractual or other relationship.

General

The information has been reviewed in year :2024
Organisation name:ION-9738
Organisation ION:Finnish Stem Cell Registry
Country:Finland
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? no

Product quantity

Data valid for year2023
Number of products NationalInternational
HPC, Marrow products: 6 3
HPC, Apheresis: 26 30
HPC, Cord: 0 1

License

Organisation is licensed/accredited by the Health Authority: yes
Comment:
Name of Health Authority:Finnish Medicine Agency, FIMEA
Date of last inspection:2021/10/26
Link to website of Health Authority:www.fimea.fi
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ? yes
The registry is accredited by any other organisation:no
If yes, by which organisation?

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


Regulatory information section 2

Relevant documents will be uploaded by the organisation to the documents page.

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 needed to import cell products into the country of the affiliated transplant centres?
Are there any customs regulations to follow or customs paperwork required needed to export cell products from the country of the affiliated organisation?
Are there any import national regulations to follow or paperwork required needed to import the cell products into the country of the affiliated transplant centre?
Are there any export regulations to follow or paperwork required needed to export cell products from the country of the affiliated organisation?

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
- 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 organisation does maintain Standard Operating Procedures for its work: yes
Please indicate if your organisation/country has any specific requirements that should be communicated in advance to the requesting entity (e.g., financial sanctions, specific regulatory forms, etc.) :
Donor records relating to the medical exam and cell product collection process are the following number(s) of year(s) retained:30 years

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