CBB Survey 2015

These data are submitted by the cord blood bank to the WMDA in February 2015. The WMDA makes no representations or express or implied warranties regarding any information on this site or obtained through these links; expressly disclaims all legal liability and responsibility for the accuracy, completeness, currency, suitability, validity, or usefulness of such information; and is not and will not be liable for any statements, errors, or omissions in posted information, or for any losses, injuries, or damages that arise or are alleged to arise from such information. Use of any information provided on this site does not and is not intended to create a contractual or other relationship. All information is on an as-is basis. The data cannot be updated.


1. General Information
Name of CBBCord Blood Bank Czech Republic
CBB DirectorIvan
CBB DirectorFales
Addressinstitute of hematology and Blood Transfusion
AddressU Nemocnice 1
Address128 20
AddressPrague
Phone Number+420 22443 6058
Websitewww.bpk.cz / www.uhkt.cz
Date CBB Started Collecting Cord Blood Units
(month/day/year)
04/11/1996
Number of Public Cord Blood Units4,130
Planned Number of Public Cord Blood Units Stored in 2015100
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationCzech Stem Cells Registry
2. Cord Blood Units in Inventory
Year Current Process Method Started1996
Percent of Units No Volume Reduction100
3. Accreditations, Licenses and Certifications
FACT-NetcordNo
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityState Institute of Drug Control
Audited by National Stem Cell RegistryYes
ISONo
OtherJCI from 2007
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
Both
Collection BagDouble needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsActive refrigeration system
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportTemperature between +2 to +8Β°C
6. Pre-Processing Evaluation
Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Completed Prior to Accepting a CBURisk behaviour evaluation report, current pregnancy evaluation report
Method for CD34 RemunerationISHAGE guidelines
External Proficiency Testing for QC of FACS LabUKNEQAS
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to Processingup to 48H
7. Processing and Packaging
Pre Freeze Processing Methods- Unit in InventoryNo processing
Pre Freeze Processing Methods- CurrentNo processing
Additives Currently in UseNo additive
Current Cryopreservation MethodConventional CRF
Current Cryoprotectant AdditiveDMSO
Current CryobagMultiple bags
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
8. Testing
Extra Material Currently StoredCord blood DNA
Extra Material Currently StoredCord blood material for DNA extraction
Extra Material Currently StoredMaternal material for DNA extraction
Extra Material Currently StoredMaternal plasma/serum
Current Post Processing Threshold for Accepting a CBU for Public Use
TNC
120
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Double Platform
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU-GM
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
NA
9. Storage
Type of Storage Container UsedConventional storage tank vapor phase
Type of Storage Container UsedConventional tank liquid phase
Monitoring of StorageAlarm on individual tanks only
Monitoring of StorageCentralized alarm system local
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
Monitoring of StorageLid opening
Monitoring of StorageTemperature monitoring
10. HLA Typing
Current Level of HLA Typing at Time of Listing
HLA-A
IR
Current Level of HLA Typing at Time of Listing
HLA-B
IR
Current Level of HLA Typing at Time of Listing
HLA-C
IR
Current Level of HLA Typing at Time of Listing
HLA-DRB1
IR
Current Level of HLA Typing at Time of Listing
HLA-DQB1
IR
Current Level of HLA Typing at Time of Listing
HLA-DPB1

Accreditation of HLA LabEFI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
7
Attached Segment Used for Confirmatory/ Verification TypingYes
Units Listed without Attached Segment and have not been Previously Typed on Attached SegmentYes
Percentage of CBUs that have an Attached Segment50-75%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementYes
11. Reservation and Cancellation Policies
What Point is a CBU Reserved for a PatientHLA typing request
What Point is a CBU Reserved for a PatientReservation request
What Point is a CBU Reserved for a PatientShipment request
Length of Time a CBU can be Reserved
in days
60
Reservation FeeNo
Reservation Cancellation Fee in Absence of Shipment RequestNo
Can Reservation be ExtendedYes
Is a Unit Report Provided on a Unit that is Reserved for Another PatientNo
Is TC Informed when CBU is ReleasedYes
12. Release and Shipment
Hemoglobinopathy Screening Performed Prior to ReleaseNo
Criteria to Ship a CBU
Viability and Cell Count
NA
Criteria to Ship a CBU
HLA Identity Testing
Yes
Current Packaging for Shipment to TCMetal canister
Current Packaging for Shipment to TCOne attached segment
Current Packaging for Shipment to TCProtective sleeve
Current Packaging for Shipment to TCSeparate segment
Time Between Shipment Request and Sending CBUOther
Time to Prepare a Cord Blood Unit for Shipmentin urgent cases less than 4 days
Fee for Shipment CancellationYes
Dry Shippers Validated to Maintain Temperature of at least -150 for 48 hours Beyond Expected ArrivalYes
Electronic Temperature Data Logger on All Dry ShippersYes
Who Selects Transport CompanyCBB
Who Selects Transport CompanyWorld Courier
Shape of Transport ContainerCubic
13. Adverse Events Reporting
Who are S(P)EARS Reported To
Competent Authority
Yes
Who are S(P)EARS Reported To
Internal Report
Yes
Who are S(P)EARS Reported To
National Registry
Yes
Who are S(P)EARS Reported To
Transplant Center
Yes
Who are S(P)EARS Reported To
WMDA
Yes

14. Pictures of cord blood units in the inventory


15. Infectious Disease Marker (IDM) CURRENTLY performed.



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