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1. General Information | |
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Name of CBB | Cord Blood Bank of Samara Regional Center of Family Planning and Reproduction |
CBB Director | Olga |
CBB Director | Tyumina |
Address | 159 Tashkentskaya St |
Address | 443095 |
Address | Samara |
Phone Number | +7(846)9560511 |
Website | cordbank.ru |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 06/07/2004 |
Number of Public Cord Blood Units | 7,555 |
Planned Number of Public Cord Blood Units Stored in 2015 | 400 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | HPC registry |
2. Cord Blood Units in Inventory | |
Current Processing Method | Liquid+ red manual |
Current Processing Method | Liquid+ red auto |
Year Current Process Method Started | 2004 |
Percent of Units Plasma and RBC Reduced (automated) | 100 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | No |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | Ministry of Healthcare of Samara Region |
Audited by National Stem Cell Registry | Yes |
ISO | Yes |
Other | EFI accreditted lab #05-RU-005.995 |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | In-utero |
Current Antiseptic | Chlorhexidine |
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 | 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 |
External Proficiency Testing for QC of FACS Lab | No |
Post Processing/ Pre Freeze CD34+ Cell Count | Yes |
Time from Collection to Processing | up to 36H |
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 |
Pre Freeze Processing Methods- Current | Volume reduction with HES manual |
Additives Currently in Use | HES |
Current Cryopreservation Method | BioArchive |
Current Cryoprotectant Additive | DMSO |
Current Cryobag | Single bag (one fraction) |
Current Target Cryopreservation Volume (mL) | 30.0 |
Current Packaging for Storage | Overwrap |
Current Packaging for Storage | Canister |
Current Packaging for Storage | One attached segment |
Current Packaging for Storage | Additional separate segments |
8. Testing | |
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 | 150 |
Current Post Processing Threshold for Accepting a CBU for Public Use CD34 (10^6) Single Platform | 1.60 |
Current Post Processing Threshold for Accepting a CBU for Public Use CD34 (10^6) Double Platform | 1.6 |
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 | BioArchive |
Monitoring of Storage | Centralized alarm system local |
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 | IR |
Current Level of HLA Typing at Time of Listing HLA-B | IR |
Current Level of HLA Typing at Time of Listing HLA-C | LR |
Current Level of HLA Typing at Time of Listing HLA-DRB1 | HR |
Current Level of HLA Typing at Time of Listing HLA-DQB1 | LR |
Current Level of HLA Typing at Time of Listing HLA-DPB1 | LR |
Accreditation of HLA Lab | EFI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | 5 |
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 | 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 | 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 | Overwrap |
Current Packaging for Shipment to TC | Protective sleeve |
Current Packaging for Shipment to TC | Separate segment |
Time Between Shipment Request and Sending CBU | 2-3 weeks |
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 | 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 |
14. IDM
15. Images
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