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1. General Information | |
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Name of CBB | Cord Blood Bank Czech Republic |
CBB Director | Ivan |
CBB Director | Fales |
Address | institute of hematology and Blood Transfusion |
Address | U Nemocnice 1 |
Address | 128 20 |
Address | Prague |
Phone Number | +420 22443 6058 |
Website | www.bpk.cz / www.uhkt.cz |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 04/11/1996 |
Number of Public Cord Blood Units | 4,130 |
Planned Number of Public Cord Blood Units Stored in 2015 | 100 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | Czech Stem Cells Registry |
2. Cord Blood Units in Inventory | |
Year Current Process Method Started | 1996 |
Percent of Units No Volume Reduction | 100 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | No |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | State Institute of Drug Control |
Audited by National Stem Cell Registry | Yes |
ISO | No |
Other | JCI from 2007 |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
Collection Bag | Double 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 | Active refrigeration system |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Ground transport |
Temp. for Storage and Transport | Temperature between +2 to +8Β°C |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
Completed Prior to Accepting a CBU | Risk behaviour evaluation report, current pregnancy evaluation report |
Method for CD34 Remuneration | ISHAGE guidelines |
External Proficiency Testing for QC of FACS Lab | UKNEQAS |
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 | No processing |
Pre Freeze Processing Methods- Current | No processing |
Additives Currently in Use | No additive |
Current Cryopreservation Method | Conventional CRF |
Current Cryoprotectant Additive | DMSO |
Current Cryobag | Multiple bags |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
8. Testing | |
Extra Material Currently Stored | Cord blood DNA |
Extra Material Currently Stored | Cord blood material for DNA extraction |
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 | 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 Used | Conventional storage tank vapor phase |
Type of Storage Container Used | Conventional tank liquid phase |
Monitoring of Storage | Alarm on individual tanks only |
Monitoring of Storage | Centralized alarm system local |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | Lid opening |
Monitoring of Storage | Temperature 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 Lab | EFI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | 7 |
Attached Segment Used for Confirmatory/ Verification Typing | Yes |
Units Listed without Attached Segment and have not been Previously Typed on Attached Segment | Yes |
Percentage of CBUs that have an Attached Segment | 50-75% |
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 | 60 |
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 | No |
Criteria to Ship a CBU Viability and Cell Count | NA |
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 | Protective sleeve |
Current Packaging for Shipment to TC | Separate segment |
Time Between Shipment Request and Sending CBU | Other |
Time to Prepare a Cord Blood Unit for Shipment | in urgent cases less than 4 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 | World Courier |
Shape of Transport Container | Cubic |
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. IDM
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