...
1. General Information | |
---|---|
Name of CBB | Bayerische Stammzellbank gGmbH |
CBB Director | Hans |
CBB Director | Knabe |
Address | Robert-Koch-Allee 23 |
Address | 82131 |
Address | Gauting |
Phone Number | ++49-89-89 32 66 220 |
Website | www.akb.de |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 10/01/1998 |
Number of Public Cord Blood Units | 4,021 |
Planned Number of Public Cord Blood Units Stored in 2015 | 200 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | ZKRD |
2. Cord Blood Units in Inventory | |
Current Processing Method | Liquid+ red auto |
Previous Processing Method | Liquid+ red manual |
Year Current Process Method Started | 2010 |
Percent of Units Plasma and RBC Reduced (manual) | 73 |
Percent of Units Plasma and RBC Reduced (automated) | 27 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | Yes |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | Regierung von Oberbayern and: Paul-Ehrlich-Institut |
Audited by National Stem Cell Registry | Yes |
ISO | No |
Other | Marketing Authorization (Paul-Ehrlich-Institut), WMDA |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | In-utero |
Collection Bag | Double needle |
Agitation during Collection | Manual |
5. Conditioning/Transport from Collection Site to CBB | |
Secondary Bag Used | Yes |
Transport Conditions | Insulating transport container |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Ground transport |
Temp. for Storage and Transport | Other (lower limit +1-35Β°C, higher limit +6-30Β°C) |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
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 |
Post Processing/ Pre Freeze CD34+ Cell Count | Yes |
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 | Volume reduction with HES-Manual |
Pre Freeze Processing Methods- Current | SEPAX |
Additives Currently in Use | HES |
Current Cryopreservation Method | Conventional CRF |
Current Cryopreservation Method | Other: Consarctic |
Current Cryoprotectant Additive | Other: HES and autologous plasma |
Current Cryobag | Single bag (one fraction) |
Current Cryobag | Multiple bags |
Current Target Cryopreservation Volume (mL) | 29.0 |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
8. Testing | |
PCR Performed on IgM+ Result | CMV |
Extra Material Currently Stored | Cord blood DNA |
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 | 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 Used | Conventional tank liquid phase |
Type of Storage Container Used | Double walled liquid nitrogen |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | Lid opening |
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 | |
Accreditation of HLA Lab | EFI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | 4 |
Attached Segment Used for Confirmatory/ Verification Typing | No |
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 | Reservation request |
What Point is a CBU Reserved for a Patient | Shipment request |
What Point is a CBU Reserved for a Patient | Other: 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 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 | >60% / NA |
Current Packaging for Shipment to TC | Metal canister |
Current Packaging for Shipment to TC | 2 attached segments |
Time Between Shipment Request and Sending CBU | Other |
Time to Prepare a Cord Blood Unit for Shipment | Time 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 Cancellation | Yes |
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 | accompagnied transport only (Ontime Courier or members of the fire department Munich); fee for transfer included in fee for CBU |
Shape of Transport Container | Other |
Shape of Transport Container | Onboard 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
15. Infectious Disease Marker (IDM) CURRENTLY performed.
...
Attachments
Attachments |
---|
...
Holiday Calendar
Team Calendars | ||
---|---|---|
|