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1. General Information | |
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Name of CBB | University of Colorado Cord Blood Bank |
CBB Director | Brian |
CBB Director | Freed |
Address | 12635 E. Montview Blvd |
Address | Ste. 300 |
Address | 80045 |
Address | Aurora |
Phone Number | 303-724-1306 |
Website | www.clinimmune.org |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 11/12/1996 |
Number of Public Cord Blood Units | 8,092 |
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 | NMDP |
2. Cord Blood Units in Inventory | |
Current Processing Method | Vapour+ red manual |
Current Processing Method | Vapour+ red auto |
Previous Processing Method | Liquid+ red manual |
Previous Processing Method | Liquid- red manual |
Previous Processing Method | Liquid+ red auto |
Previous Processing Method | Liquid- red auto |
Year Current Process Method Started | 2009 |
Percent of Units Plasma and RBC Reduced (manual) | 60 |
Percent of Units Plasma and RBC Reduced (automated) | 40 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | No |
AABB | Yes |
Competent Authority/ National Health Authority | No |
Audited by National Stem Cell Registry | Yes |
ISO | No |
Other | FDA Licensed #1855 FDA registered |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | In-utero |
Current Antiseptic | Chlorhexidine |
Collection Bag | Single needle |
Agitation during Collection | Manual |
5. Conditioning/Transport from Collection Site to CBB | |
Transport Conditions | Qualified transporter |
Transport Conditions | Insulating transport container |
Transport Conditions | Passive refrigeration system |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Air transport |
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 | CAP |
Post Processing/ Pre Freeze CD34+ Cell Count | Yes |
Time from Collection to Processing | Other |
Time from Collection to Processing | Missing |
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 | Conventional CRF |
Current Cryoprotectant Additive | Ready for use DMSO-Dextran |
Current Cryoprotectant Additive | Other: DMSO Dextran compounded on site for each use |
Current Cryobag | Single bag (one fraction) |
Current Cryobag | Other: Some units are too lsrge for one bag and must be frozen in two bags of equal volume |
Current Target Cryopreservation Volume (mL) | 41.9 |
Current Packaging for Storage | Overwrap |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
Current Packaging for Storage | Other: Three viable TNC at 0.5ml - two for post thaw QC - one for FDA reserve sample after release |
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 | 1.25 |
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 | growth |
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 | 85 |
9. Storage | |
Type of Storage Container Used | Conventional storage tank vapor phase |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | Temperature monitoring |
10. HLA Typing | |
Current Level of HLA Typing at Time of Listing HLA-A | LR |
Current Level of HLA Typing at Time of Listing HLA-B | LR |
Current Level of HLA Typing at Time of Listing HLA-C | IR |
Current Level of HLA Typing at Time of Listing HLA-DRB1 | HR |
Current Level of HLA Typing at Time of Listing HLA-DQB1 | |
Current Level of HLA Typing at Time of Listing HLA-DPB1 | |
Accreditation of HLA Lab | ASHI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | ?10 |
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 | 75-90% |
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release Requirement | No |
11. Reservation and Cancellation Policies | |
What Point is a CBU Reserved for a Patient | CBU report request |
Length of Time a CBU can be Reserved in days | Other |
Length of Time a CBU can be Reserved in days | until further notice |
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 |
12. Release and Shipment | |
Hemoglobinopathy Screening Performed Prior to Release | Yes |
Criteria to Ship a CBU Viability and Cell Count | >= 70% post thaw viable cell aliquot |
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 |
Time Between Shipment Request and Sending CBU | 4 days-1 week |
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 | Network Global Logistics for Domestic; World or Quick for INT |
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 |
14.
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Pictures of cord blood units in the inventory
15. Infectious Disease Marker (IDM) CURRENTLY performed.
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Attachments
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Holiday Calendar
Team Calendars | ||
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