Operational information

November 2023:

  1. Shipping donor’s blood samples for confirmatory typing is possible to all countries of the world with the exception of Syria, Cuba and North Korea. Shipping times depend on the specific country receiving the parcel with blood samples.
  2. Donor’s medical examination at the stage of confirmatory typing is carried out in Russia. 
  3. Work-up and donor’s product collection *: 

a) performed in Russia if courier can deliver the donor’s product from Russia to the transplant center; 
b) performed outside Russia if courier is unable to deliver the donor’s product from Russia to the transplant center.
* In each case the decision is made jointly with the requesting registry taking into account the specific situation.

Contacts for requesting centers: e-mail: karelianbmd.donation@yahoo.com;  karelian.bmd@onego.ru
tel: +7 905 299 91 8; fax: +7 8142 765 897

This data is publicly available. Parent page : ION-8256

Operational data for Karelian Registry of unrelated hematopoietic stem cell donors - ION-8256

Organisation Overview
The information has been reviewed in year :2023-2024
Issuing organisation Number (ION)ION-8256
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneEurope/Moscow (GMT+03:00)
The timezone in which this organisation operates.
Business hours9 - 18
The daily hours in which this organisation operates.
Work scheduleMonday - Friday
The normal work week in which this organisation operates.
Organisation closuresJan, 1st
For all organisation closures, please see the WMDA Calendar.
Donor ID example82560000KAR00412827
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, LR, ER HLA-A, B, C, DR, DQ, DP
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 request90 days
Verification Typing
Maximum blood volume allowed50 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 request90 days
Sibling Typing
Registry is willing to arrange sibling typingsNot applicable
If yes, procedure to apply for sibling typings
Workup Request
Product dosage limit20 ml/kg (BM); 5 x 10^6 CD34+ cells/kg (PBSC)
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 collectionPatient physician needs to provide the report of patient status and treatment plan. For export of the blood samples for verification typing, you will have to fill in a special agreement, which you can find in the membership documents session. Blood samples can be shipped on Monday, Tuesday and Wednesday.
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 policyPossible
Anonymous contact allowedYes. As far as possible
Direct contact allowedYes. 3 years after transplant
Gift exchange allowedYes, but gift must not be of substantial or monetary value
Cord blood contact allowedNo

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient Yes7-10
ChagasChagas, T. cruzi On request
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yes7-10
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yes7-10
CMV TotalCytomegalovirus Total Yes7-10
EBV IgGEpstein-Barr Virus Antibody testing IgG Yes7-10
EBV IgMEpstein-Barr Virus Antibody testing IgM Yes7-10
HAV (NAT)Anti-hepatitis A virus nucleic acid testing Yes7-10
HBV (NAT)Hepatitis B nucleic acid testing Yes7-10
HBc AbHepatitis B core antibody testing Yes7-10
HBs AgHepatitis B Surface antigen testing Yes7-10
HCV (NAT)Hepatitis C nucleic acid testing Yes7-10
HCV AbHepatitis C antibody testing Yes7-10
HEV (NAT)Hepatitis E Virus nucleic acid testing On request7-10
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yes7-10
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yes7-10
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yes7-10
HIV p24Human Immunodeficiency Virus p24 antigen testing Yes7-10
HTLV-IHuman T-Lymphotropic Virus type I testing On request7-10
HTLV-IIHuman T-Lymphotropic Virus type II testing On request7-10
MalariaMalaria On request7-10
HSVHerpes Simplex Virus Yes7-10
STSSerological tests for syphilis Yes7-10
STS FTA-ABSSerological test for syphilis On request7-10
ToxoplasmosisToxoplasmosis Yes7-10
VZVVaricella Zoster Virus On request7-10
WNV-NATWest Nile Virus nucleic acid testing On request7-10
Other tests performed On request7-10


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 :2023
Organisation name:Karelian Registry of Hematopoietic Stem Cells
Organisation ION:ION-8256
Country:Russian Federation
Year the registry started operations:2001

Products

comment
Do you provide HPC, Marrow? yes
Do you provide HPC, Apheresis? yes
Do you provide HPC, Cord Blood? no
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: 0 0
HPC, Apheresis: 3 1
HPC, Cord: 0 0

License

Organisation is licensed/accredited by the Competent Authority: yes
Comment:
Name of Competent Authority:The Ministry of health of the Republic of Karelia
Date of last inspection:2016/03/22
Link to website of Competent Authority:http://mzsocial-rk.ru/
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?
Is your registry WMDA Certified, WMDA Qualified or WMDA Accredited?Not WMDA Qualified/Accredited
The registry is accredited by any other organisation:
If yes, by which organisation?

Affiliation

The registry works with the following number of affiliated donor centres:
The registry audits its donor centres:
The registry works with the following numer of affiliated collection centres:3
Ther registry audits its collection centres:
The registry works with the following number of affiliated Cord Blood Banks:
The registry audits its Cord Blood Banks:
The registry works with the following number of affiliated transplant centres:
The registry audits its transplant centres:
The registry works with the following number of affiliated IDM Testing Laboratories:2
The registry audits its IDM Testing Laboratories:
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:
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:
If yes, the following Cord Blood Bank(s) are accredited:
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:no
If yes, what are these requirements?

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


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:
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:Request for PBSC/BM, license for the PBSC/BM collection, donor consent, agreement between the registry and the transplant center, proforma invoice
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:Request for PBSC/BM, license for the PBSC/BM collection, donor consent, agreement between the registry and the transplant center, proforma invoice
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:Request for PBSC/BM, license for the PBSC/BM collection, donor consent, agreement between the registry and the transplant center
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:Request for PBSC/BM, license for the PBSC/BM collection, donor consent, agreement between the registry and the transplant center

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 Schemeno
- 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:30 years

  • No labels