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1. General Information | |
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Name of CBB | DKMS Cord Blood Bank |
CBB Director | Alexander |
CBB Director | Platz |
Address | Enderstraße 94, Building C |
Address | 01277 |
Address | Dresden |
Phone Number | +49-351-2509660 |
Website | www.dkms-nabelschnurblutbank.de |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 01/01/1997 |
Number of Public Cord Blood Units | 8,428 |
Planned Number of Public Cord Blood Units Stored in 2015 | 500 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | ZKRD Zentrales Knochenmarkspender-Register für die Bundesrepublik Deutschland gemeinnützige GmbH |
2. Cord Blood Units in Inventory | |
Current Processing Method | Vapour+ red autoVolume reduction with SEPAX |
Year Current Process Method Started | 1997 |
Percent of Units Plasma and RBC Reduced (manual) | 0 |
Percent of Units Plasma and RBC Reduced (automated) | 100 |
Percent of Units RBC Reduced Only | 0 |
Percent of Units No Volume Reduction | 0 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | Yes |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | Landesdirektion Sachsen + Paul-Ehrlich-Institut |
Audited by National Stem Cell Registry | Yes |
ISO | No |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | In-utero |
Current Antiseptic | Alcohol |
Collection Bag | Single needle |
Agitation during Collection | Manual |
5. Conditioning/Transport from Collection Site to CBB | |
Secondary Bag Used | Yes |
Transport Conditions | Qualified transporter |
Transport Conditions | Insulating transport container |
Transport Conditions | Passive refrigeration system |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Ground transport |
Temp. for Storage and Transport | Room temperature |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
Current Threshold for Accepting a CBU | Viability threshold CD45 |
Method for CD34 Remuneration | ISHAGE guidelines |
External Proficiency Testing for QC of FACS Lab | Yes, other |
External Proficiency Testing for QC of FACS Lab | Instand e.V., RV No. 217 |
Time from Collection to Processing | up to 48H |
7. Processing and Packaging | |
Pre Freeze Processing Methods- Unit in Inventory | SEPAX |
Pre Freeze Processing Methods- Unit in Inventory | Other: Centrifugation + volume reduction |
Pre Freeze Processing Methods- Current | SEPAX |
Additives Currently in Use | No additive |
Current Cryopreservation Method | Conventional CRF |
Current Cryopreservation Method | Other: Icecube 14 M-B |
Current Cryoprotectant Additive | DMSO |
Current Cryobag | Single bag 80:20 |
Current Target Cryopreservation Volume (mL) | 25.0 |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
8. Testing | |
Extra Material Currently Stored | Cord blood material for DNA extraction |
Extra Material Currently Stored | Plasma/cord blood |
Extra Material Currently Stored | Maternal material for DNA extraction |
Extra Material Currently Stored | Maternal 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 Used | Conventional storage tank vapor phase |
Monitoring of Storage | Centralized alarm system local |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | System default |
Monitoring of Storage | Temperature 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 Lab | ASHI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | 3 |
Attached Segment Used for Confirmatory/ Verification Typing | Yes |
Units Listed without Attached Segment and have not been Previously Typed on Attached Segment | No |
Percentage of CBUs that have an Attached Segment | 90-100% |
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release Requirement | Yes |
11. Reservation and Cancellation Policies | |
What Point is a CBU Reserved for a Patient | HLA typing request |
What Point is a CBU Reserved for a Patient | Reservation request |
What Point is a CBU Reserved for a Patient | Shipment request |
Length of Time a CBU can be Reserved in days | 90 |
Reservation Fee | No |
Reservation Cancellation Fee in Absence of Shipment Request | No |
Can Reservation be Extended | Yes |
Is a Unit Report Provided on a Unit that is Reserved for Another Patient | No |
Is TC Informed when CBU is Released | Yes |
12. Release and Shipment | |
Hemoglobinopathy Screening Performed Prior to Release | Yes |
Criteria to Ship a CBU Viability and Cell Count | 85Viability 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 TC | Metal canister |
Current Packaging for Shipment to TC | One attached segment |
Current Packaging for Shipment to TC | Transport rack |
Time Between Shipment Request and Sending CBU | 1-2 weeks |
Fee for Shipment Cancellation | No |
Dry Shippers Validated to Maintain Temperature of at least -150 for 48 hours Beyond Expected Arrival | Yes |
Electronic Temperature Data Logger on All Dry Shippers | Yes |
Who Selects Transport Company | CBB |
Who Selects Transport Company | World Courier if the TC does not want other courier |
Shape of Transport Container | 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 |
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