Operational information

This data is publicly available. Parent page : ION-8362

Operational data for Thai National Stem Cell Donor Registry - ION-8362

Organisation Overview
The information has been reviewed in year :2023
Issuing organisation Number (ION)ION-8362
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneAsia/Bangkok (GMT+07:00)
The timezone in which this organisation operates.
Business hours8:30 AM - 4:30 PM
The daily hours in which this organisation operates.
Work scheduleMonday - Friday
The normal work week in which this organisation operates.
Organisation closuresTSCDR closes on major public holidays as gazetted by Office of the Prime Minister of Thailand.
For all organisation closures, please see the WMDA Calendar.
Donor ID exampleDonor ID 902418060 and GRID 8362 0000 9024 1806 026
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 requestIR for HLA*-A, B, C, DRB1, DQB1, DRB3/4/5 HR for HLA*-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1
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 request30 days
Verification Typing
Maximum blood volume allowed30 mL sample type can be requested are EDTA, CPDA and no anticoagulant
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 typingsYes
If yes, procedure to apply for sibling typings Please send email request to tscdr.coordinators@redcross.or.th and do the following; 1) TSCDR accept the request through international registry only. 2) Sibling donor must be informed basic information about blood collection or stem cell collection process before contact to TSCDR staff. 3) Sibling donor has to pay for travel by themselves. 4) For all cost, TSCDR will send invoice to the international registry.
Workup Request
Product dosage limitIn PBSC collection, if donor has adverse reaction and Dose CD34 ≥ 4 x 10^6/kg, do not allow collect in the next day.
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collectionYes
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collectionTSCDR accepts request for donor from countries which are EMIDIS and MatchPoint member via MatchPoint system. National registry which is not EMIDIS and MatchPoint member needs to send a request through email. Individual transplant center which is not a member of registry needs to comply with TSCDR minimum requirements for stem cell transplant center/hospital in order to request for Thai donor.
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 availableNot applicable
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policyYes
Anonymous contact allowedYes
Direct contact allowedNo
Gift exchange allowedYes, not of significant value and anonymous.
Cord blood contact allowedNo

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient On request
ChagasChagas, T. cruzi On requestTrypanosoma cruzi Antibody (Quest diagnostic), Immunoassay
CMV IgGCytomegalovirus (CMV) Antibody testing IgG YesCMIA
CMV IgMCytomegalovirus (CMV) Antibody testing IgM YesCMIA
CMV TotalCytomegalovirus Total No
EBV IgGEpstein-Barr Virus Antibody testing IgG On requestEIA
EBV IgMEpstein-Barr Virus Antibody testing IgM On requestELISA
HAV (NAT)Anti-hepatitis A virus nucleic acid testing On requestRT-PCR
HBV (NAT)Hepatitis B nucleic acid testing YesIndividual NAT
HBc AbHepatitis B core antibody testing YesCMIA
HBs AgHepatitis B Surface antigen testing YesCMIA
HCV (NAT)Hepatitis C nucleic acid testing YesIndividual NAT
HCV AbHepatitis C antibody testing YesCMIA
HEV (NAT)Hepatitis E Virus nucleic acid testing On requestRT-PCR
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing YesIndividual NAT
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing YesCMIA with HIV Ag/Ab combination
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing YesCMIA with HIV Ag/Ab combination
HIV p24Human Immunodeficiency Virus p24 antigen testing YesCMIA with HIV Ag/Ab combination
HTLV-IHuman T-Lymphotropic Virus type I testing YesAnti-HTLVI/II, CMIA
HTLV-IIHuman T-Lymphotropic Virus type II testing YesAnti-HTLVI/II, CMIA
MalariaMalaria On requestMalaria Ag screening, immunochromatography, Remark: On request at VT and mandatory testing at WU.
HSVHerpes Simplex Virus On requestHSV IgG and HSV IgM by ELISA, Multiplex Real-time PCR
STSSerological tests for syphilis YesCMIA
STS FTA-ABSSerological test for syphilis On requestIFA
ToxoplasmosisToxoplasmosis On requestCMIA, IFA, Realtime PCR
VZVVaricella Zoster Virus On requestELFA, EIA, IFA, Real-time PCR, Immunofluorescent assay
WNV-NATWest Nile Virus nucleic acid testing On requestReal-time PCR
Other tests performed No




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:Thai National Stem Cell Donor Registry (TSCDR)
Organisation ION:ION-8362
Country:Thailand
Year the registry started operations:2002

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: 2 1
HPC, Apheresis: 44 29
HPC, Cord: 0 0

License

Organisation is licensed/accredited by the Competent Authority: yes
Comment:
Name of Competent Authority:WMDA Qualified and ISO9001:2015
Date of last inspection:1) WMDA 2018-03-27 2) ISO9001:2015 date of issue 2023-03-22/valid until 2026-03-21
Link to website of Competent Authority:http://masci.or.th/
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 Qualified
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:1 (TSCDR is also donor centre)
The registry audits its donor centres:We have an internal audit once per year
The registry works with the following numer of affiliated collection centres:4
Ther registry audits its collection centres:Every 4 years
The registry works with the following number of affiliated Cord Blood Banks:1 (TSCDR have cord blood bank located at National Blood Centre)
The registry audits its Cord Blood Banks:We have an internal audit once per year
The registry works with the following number of affiliated transplant centres:6
The registry audits its transplant centres:3 years for the first renewal, and every 5 years for the next renewal.
The registry works with the following number of affiliated IDM Testing Laboratories:1 (TSCDR is also IDM testing Laboratory)
The registry audits its IDM Testing Laboratories:We have an internal audit once per year
The registry works with the following number of affiliated HLA/other DNA markers testing laboratories:1 (TSCDR is also HLA Laboratory)
The registry audits its HLA/other DNA markers testing laboratories:We have an internal audit once per year
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:no
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: yes
If yes, what are these requirements?Transplant center and collection center must be audits by TSCDR compliance with WMDA guideline.

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: 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:No
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:No
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:No
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:No

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:More than 30 years

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