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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 CBBDKMS Cord Blood Bank
CBB DirectorAlexander
CBB DirectorPlatz
AddressEnderstraße 94, Building C
Address01277
AddressDresden
Phone Number+49-351-2509660
Websitewww.dkms-nabelschnurblutbank.de
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/01/1997
Number of Public Cord Blood Units8,428
Planned Number of Public Cord Blood Units Stored in 2015500
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationZKRD Zentrales Knochenmarkspender-Register für die Bundesrepublik Deutschland gemeinnützige GmbH
2. Cord Blood Units in Inventory
Current Processing MethodVolume reduction with SEPAX
Year Current Process Method Started1997
Percent of Units Plasma and RBC Reduced (manual)0
Percent of Units Plasma and RBC Reduced (automated)100
Percent of Units RBC Reduced Only0
Percent of Units No Volume Reduction0
3. Accreditations, Licenses and Certifications
FACT-NetcordYes
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityLandesdirektion Sachsen + Paul-Ehrlich-Institut
Audited by National Stem Cell RegistryYes
ISONo
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticAlcohol
Collection BagSingle needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsPassive refrigeration system
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportRoom temperature
6. Pre-Processing Evaluation
Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Current Threshold for Accepting a CBUViability threshold CD45
Method for CD34 RemunerationISHAGE guidelines
External Proficiency Testing for QC of FACS LabYes, other
External Proficiency Testing for QC of FACS LabInstand e.V., RV No. 217
Time from Collection to Processingup to 48H
7. Processing and Packaging
Pre Freeze Processing Methods- Unit in InventorySEPAX
Pre Freeze Processing Methods- Unit in InventoryOther: Centrifugation + volume reduction
Pre Freeze Processing Methods- CurrentSEPAX
Additives Currently in UseNo additive
Current Cryopreservation MethodConventional CRF
Current Cryopreservation MethodOther: Icecube 14 M-B
Current Cryoprotectant AdditiveDMSO
Current CryobagSingle bag 80:20
Current Target Cryopreservation Volume (mL)25.0
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
8. Testing
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
50
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
0,1
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
1x10^4
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
1x10^4
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
85
9. Storage
Type of Storage Container UsedConventional storage tank vapor phase
Monitoring of StorageCentralized alarm system local
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
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
HR
Accreditation of HLA LabASHI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
3
Attached Segment Used for Confirmatory/ Verification TypingYes
Units Listed without Attached Segment and have not been Previously Typed on Attached SegmentNo
Percentage of CBUs that have an Attached Segment100%
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
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
Viability 85% and TNC should meet minimum dose per kg/recipient´s body weight
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 TCTransport rack
Time Between Shipment Request and Sending CBU1-2 weeks
Fee for Shipment CancellationNo
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 if the TC does not want other courier
Shape of Transport ContainerMushroom
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 autRBC red aut

15. Infectious Disease Marker (IDM) CURRENTLY performed.



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