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Organisation name: DKMS BMST Foundation India Organisation ION: ION-9935 Country: India Year the registry started operations: November 2015
comment Do you provide HPC, Marrow?
Do you provide HPC, Apheresis?
Do you provide HPC, Cord Blood?
Do you provide MNC, Apheresis?
Do you provide NC, Whole Blood?
Data valid for year 2020 Number of products National International HPC, Marrow products:
0 HPC, Apheresis:
3 HPC, Cord:
Organisation is licensed/accredited by the Competent Authority: no Comment: Not applicable in India Name of Competent Authority: Date of last inspection: Link to website of Competent Authority: 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: no If yes, by which organisation?
The registry works with the following number of affiliated donor centres: Not applicable The registry audits its donor centres: Not applicable The registry works with the following numer of affiliated collection centres: 3 Ther registry audits its collection centres: Initial evaluation before starting operation. Regular evaluation is about to be implemented. The registry works with the following number of affiliated Cord Blood Banks: Not applicable The registry audits its Cord Blood Banks: Not applicable The registry works with the following number of affiliated transplant centres: via ION-4596 The registry audits its transplant centres: via ION-4596 The registry works with the following number of affiliated IDM Testing Laboratories: 2 The registry audits its IDM Testing Laboratories: No. IDM laboratory is accredited by NABL The registry works with the following number of affiliated HLA/other DNA markers testing laboratories: 1 The registry audits its HLA/other DNA markers testing laboratories: No. HLA laboratory is accredited by EFI and ASHI. 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: no 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? Comply as per national regulations- Drugs and Cosmetics Rules, 1945
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
Days between test
ALT/ASTALT/AST ratio, De-Ritis-Quotient
Yes Biochemistry <30 days ChagasChagas, T. cruzi
- CMV IgGCytomegalovirus (CMV) Antibody testing IgG
Yes ELISA <30 days CMV IgMCytomegalovirus (CMV) Antibody testing IgM
Yes ELISA <30 days CMV TotalCytomegalovirus Total
On request ELISA <30 days EBV IgGEpstein-Barr Virus Antibody testing IgG
Yes ELISA <30 days EBV IgMEpstein-Barr Virus Antibody testing IgM
Yes ELISA <30 days HAV (NAT)Anti-hepatitis A virus nucleic acid testing
- HBV (NAT)Hepatitis B nucleic acid testing
Yes PCR/TMA <30 days HBc AbHepatitis B core antibody testing
Yes ELISA / CLIA <30 days HBs AgHepatitis B Surface antigen testing
Yes ELISA / CLIA <30days HCV (NAT)Hepatitis C nucleic acid testing
Yes PCR/TMA <30 days HCV AbHepatitis C antibody testing
Yes ELISA /CLIA <30 days HEV (NAT)Hepatitis E Virus nucleic acid testing
- HIV (NAT)Human Immunodeficiency Virus nucleic acid testing
Yes PCR/TMA <30 days HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing
Yes ELISA /CLIA <30 days HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing
Yes ELISA / CLIA <30 days HIV p24Human Immunodeficiency Virus p24 antigen testing
No HTLV-IHuman T-Lymphotropic Virus type I testing
Yes ELISA <30 days HTLV-IIHuman T-Lymphotropic Virus type II testing
Yes ELISA <30 days MalariaMalaria
Yes Quantitative Buffy Coat (QBC) <30 days HSVHerpes Simplex Virus
- STSSerological tests for syphilis
Yes TPHA <30 days STS FTA-ABSSerological test for syphilis
On request FTA <30 days ToxoplasmosisToxoplasmosis
Yes ELISA <30 days VZVVaricella Zoster Virus
- WNV-NATWest Nile Virus nucleic acid testing
No Other tests performed
Yes irregular AB <30 days
The party providing the cell product must exclude donors when:
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: no 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 :
Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify: Transplant centre has to provide 12-B form (Permit for the import of small quantities of drugs for personal use), entry letter for the courier, workup forms and information about person who will meet the courier at the airport. Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify: Basic paperwork, Statement of Necessity, Authorization and Declaration Letter 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:
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 - 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
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: 5 years
The party providing the cell product must exclude donors when: