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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 CBBBayerische Stammzellbank gGmbH
CBB DirectorHans
CBB DirectorKnabe
AddressRobert-Koch-Allee 23
Address82131
AddressGauting
Phone Number++49-89-89 32 66 220
Websitewww.akb.de
Date CBB Started Collecting Cord Blood Units
(month/day/year)
10/01/1998
Number of Public Cord Blood Units4,021
Planned Number of Public Cord Blood Units Stored in 2015200
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationZKRD
2. Cord Blood Units in Inventory
Current Processing MethodLiquid+ red auto
Previous Processing MethodLiquid+ red manual
Year Current Process Method Started2010
Percent of Units Plasma and RBC Reduced (manual)73
Percent of Units Plasma and RBC Reduced (automated)27
3. Accreditations, Licenses and Certifications
FACT-NetcordYes
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityRegierung von Oberbayern and: Paul-Ehrlich-Institut
Audited by National Stem Cell RegistryYes
ISONo
OtherMarketing Authorization (Paul-Ehrlich-Institut), WMDA
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Collection BagDouble needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB
Secondary Bag UsedYes
Transport ConditionsInsulating transport container
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportOther (lower limit +1-35Β°C, higher limit +6-30Β°C)
6. Pre-Processing Evaluation
Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Method for CD34 RemunerationISHAGE guidelines
External Proficiency Testing for QC of FACS LabYes, other
External Proficiency Testing for QC of FACS LabINSTAND
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to Processingup to 48H
7. Processing and Packaging
Pre Freeze Processing Methods- Unit in InventorySEPAX
Pre Freeze Processing Methods- Unit in InventoryVolume reduction with HES-Manual
Pre Freeze Processing Methods- CurrentSEPAX
Additives Currently in UseHES
Current Cryopreservation MethodConventional CRF
Current Cryopreservation MethodOther: Consarctic
Current Cryoprotectant AdditiveOther: HES and autologous plasma
Current CryobagSingle bag (one fraction)
Current CryobagMultiple bags
Current Target Cryopreservation Volume (mL)29.0
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
8. Testing
PCR Performed on IgM+ ResultCMV
Extra Material Currently StoredCord blood DNA
Extra Material Currently StoredCord blood material for DNA extraction
Extra Material Currently StoredPlasma/cord blood
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
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
1.50
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
1
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
90
9. Storage
Type of Storage Container UsedConventional tank liquid phase
Type of Storage Container UsedDouble walled liquid nitrogen
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
Monitoring of StorageLid opening
Monitoring of StorageSystem default
Monitoring of StorageTemperature monitoring
10. HLA Typing
Current Level of HLA Typing at Time of Listing
HLA-A
HR
Current Level of HLA Typing at Time of Listing
HLA-B
HR
Current Level of HLA Typing at Time of Listing
HLA-C
HR
Current Level of HLA Typing at Time of Listing
HLA-DRB1
HR
Current Level of HLA Typing at Time of Listing
HLA-DQB1
HR
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
4
Attached Segment Used for Confirmatory/ Verification TypingNo
Units Listed without Attached Segment and have not been Previously Typed on Attached SegmentNo
Percentage of CBUs that have an Attached Segment90-100%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementYes
11. Reservation and Cancellation Policies
What Point is a CBU Reserved for a PatientReservation request
What Point is a CBU Reserved for a PatientShipment request
What Point is a CBU Reserved for a PatientOther: At time of HLA typing request: CBU marked as requested for another patient
Length of Time a CBU can be Reserved
in days
90
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 ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
>60% / NA
Current Packaging for Shipment to TCMetal canister
Current Packaging for Shipment to TC2 attached segments
Time Between Shipment Request and Sending CBUOther
Time to Prepare a Cord Blood Unit for ShipmentTime dependent on extent of QC-testings to be completed prior to shipment (i.e. confirmatory typing). Without further testings: 0-3 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 Companyaccompagnied transport only (Ontime Courier or members of the fire department Munich); fee for transfer included in fee for CBU
Shape of Transport ContainerOther
Shape of Transport ContainerOnboard transport or transport by train: Little dry shipper in a cage of metal (cylindrical); transport by car: Dry shipper in outer container (cubic or mushroom)
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

RBC red manRBC red manRBC red autRBC red autRBC red aut

15. Infectious Disease Marker (IDM) CURRENTLY performed.



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