2019 Regulatory Survey ION-4398

General information
Organisation name:	Slovenský register placentárnych krvotvorných buniek- Eurocord-Slovakia (SRPKB)
Organisation ION:	ION-4398
Country:	Slovakia
Year the registry started operations:

Products		Comments
This organisation provides HPC, Marrow:	Yes No
This organisation provides HPC, Apheresis:	Yes No
This organisation provides HPC, Cord Blood:	Yes No
This organisation provides MNC, Apheresis:	Yes No
This organisation provides NC, Whole Blood:	Yes No
This organisation provides other products, if yes please specify:	Yes No	Cord Tissue, Placental Tissue
Number of national HPC products provided in 2018:	HPC-Marrow: HPC-Apheresis: HPC-Cord:
Number of HPC products exported internationally in 2018:	HPC-Marrow: HPC-Apheresis: HPC-Cord:

Licences and accreditations		Comments
Organisation is licensed/accredited by the Competent Authority:	Yes No
Name of Competent Authority:	Ministry of Health of Slovak Republic, The State Institute for Drug Control of Slovak Republic
Date of last inspection:	2014/11
Link to website of Competent Authority:	http://www.health.gov.sk/Titulka, http://www.sukl.sk/
Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry can be provided:	Yes No
The registry is WMDA Qualified or WMDA Accredited: If yes, please specify:	WMDA Qualified WMDA Accredited Not WMDA Qualified/Accredited
The registry is accredited by any other organisation: If yes, please fill in the organisation:	Yes No

Affiliated centre information	Comments
How many affiliated donor centres does the registry work with?
How often does the registry audit its donor centres?
How many affiliated collection centres does the registry work with?
How often does the registry audit its collection centres?
How many affiliated cord blood banks does the registry work with?
How often does the registry audit its cord blood banks?
How many affiliated transplant centres does the registry work with?
How often does the registry audit its transplant centres?
How many affiliated IDM Testing Laboratories does the registry work with?
How often does the registry audit its IDM Testing Laboratories?
How many affiliated HLA/other DNA markers testing laboratories does the registry work with?
How often does the registry audit 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: Tip: you can upload the full list here and make it available for the WMDA membership	Yes No
The Cord Blood Banks are FACT-NetCord accredited: If yes, which cord blood bank(s)?	Yes No
The registry is able to provide a copy of all the certificates:	Yes No
Affiliated centres comply with WMDA Standards and applicable national regulations:	Yes No
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: If yes, please specify these requirements:	Yes No

Donor policy
All donors are unpaid volunteers:	Yes No
All donors are informed aboutdonationprocess and associated risks:	Yes No
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff:	Yes No
The registry has systems in place to protect and control access to donor/patient records:	Yes No
The registry maintains donor anonymity:	Yes No
The registry has detailed donor evaluation and exclusion criteria in place:	Yes No
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines:	Yes No

IDM Testing at donor workup (please fill in Yes, On Request, No, Test method)	YES	On request	NO	Test method	Timeframe before stem cell donation date (for donors) or Timeframe when the materials sample is taken for testing (for cords) (in number of days)
ALT/AST:
Chagas:
CMV IgG:
CMV IgM:
CMV Total:
EBV IgG:
EBV IgM:
HAV (NAT):
HBV (NAT):
HBc Ab:
HBs Ag:
HCV (NAT):
HCV Ab:
HEV (NAT):
HIV (NAT):
HIV-1 Ab:
HIV-2 Ab:
HIV p24:
HTLV-I:
HTLV-II:
Malaria:
HSV:
STS:
STS FTA-ABS:
Toxoplasmosis:
VZV:
WNV-NAT:
Other tests performed:

Testing Please indicate whether the following are completed on the donor during the medical examination:		Comments
The physical and medical exam at donor work up is performed by a medical doctor:	Yes No
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:	Yes No
HLA typing for patient specific request is performed in an appropriately accredited laboratory:	Yes No
Sterility testing is performed on the adult donor product:	Yes No
Sterility testing is performed on the cord blood product:	Yes No
Screening questionnaire to exclude communicable disease:	Yes No
Screening questionnaire to exclude donors with 'high risk' lifestyles:	Yes No
Donor reliability identified by a medical doctor:	Yes No
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 No

Customs regulations		Comments
Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify:	Yes No
Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify:	Yes No
Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify:	Yes No
Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify:	Yes 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:		Comments
Mandatory National Reporting Scheme:	Yes No
Voluntary National Reporting Scheme:	Yes No
WMDA SEAR/SPEAR Reporting Scheme:	Yes No
Will the registry 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 No

Quality management		Comments
Do the registry maintain Standard Operating Procedures (SOPs) for your work?	Yes No
Would the registry be willing to provide these to WMDA or another registry upon request?	Yes No
Would the registry be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in?	Yes No
How many years are donor records retained relating to the medical exam and HPC collection process?	30

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