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These data are submitted by the cord blood bank to the WMDA in February 2015. The WMDA makes no representations or express or implied warranties regarding any information on this site or obtained through these links; expressly disclaims all legal liability and responsibility for the accuracy, completeness, currency, suitability, validity, or usefulness of such information; and is not and will not be liable for any statements, errors, or omissions in posted information, or for any losses, injuries, or damages that arise or are alleged to arise from such information. Use of any information provided on this site does not and is not intended to create a contractual or other relationship. All information is on an as-is basis. The data cannot be updated.
| 1. General Information | |
|---|---|
| Name of CBB | LifeCord/LifeSouth Community Blood Centers |
| CBB Director | Yesi |
| CBB Director | Sevilla |
| Address | 4039 Newberry Road |
| Address | 32607 |
| Address | Gainesville |
| Phone Number | 1 352 224-1600 |
| Website | www.lifesouthcord.org |
| Date CBB Started Collecting Cord Blood Units (month/day/year) | 06/01/1998 |
| Number of Public Cord Blood Units | 6,216 |
| Planned Number of Public Cord Blood Units Stored in 2015 | 1,000 |
| Lists on BMDW | No |
| Affiliated with National Stem Cell Donor Registry | Yes |
| Registry Affiliation | National Marrow Donor Program (NMDP) |
| 2. Cord Blood Units in Inventory | |
| Current Processing Method | Liquid+ red auto |
| Previous Processing Method | Vapour+ red manual |
| Previous Processing Method | Vapour+ plasma only |
| Year Current Process Method Started | 2012 |
| Percent of Units Plasma and RBC Reduced (manual) | 5 |
| Percent of Units Plasma and RBC Reduced (automated) | 28 |
| Percent of Units RBC Reduced Only | 67 |
| 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 | FDA |
| Audited by National Stem Cell Registry | Yes |
| ISO | No |
| Other | QC Lab - CLIA |
| 4. Cord Blood Collection | |
| Current Collection Practice Is the collection In/Ex -Utero or both? | In-utero |
| 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 +1-35°C, higher limit +6-30°C) |
| 6. Pre-Processing Evaluation | |
| Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
| Completed Prior to Accepting a CBU | Labeling criteria |
| Current Threshold for Accepting a CBU | Viability threshold CD45 |
| Method for CD34 Remuneration | ISHAGE guidelines |
| External Proficiency Testing for QC of FACS Lab | Stem cell technology, CAP |
| 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 | BioArchive |
| Current Cryoprotectant Additive | Ready for use DMSO-Dextran |
| Current Cryobag | Single bag 80:20 |
| Current Target Cryopreservation Volume (mL) | 29.0 |
| Current Packaging for Storage | Overwrap |
| Current Packaging for Storage | Canister |
| Current Packaging for Storage | One attached segment |
| 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 | Plasma/cord blood |
| Extra Material Currently Stored | Maternal DNA |
| 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 | Growth |
| Current Post Processing Threshold for Accepting a CBU for Public Use Viability | 85 |
| 9. Storage | |
| Type of Storage Container Used | BioArchive |
| Type of Storage Container Used | Conventional storage tank vapor phase |
| Type of Storage Container Used | Conventional tank liquid 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 | LR |
| Current Level of HLA Typing at Time of Listing HLA-B | LR |
| 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 | 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 | ?10 |
| 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 | 75-90% |
| 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 | Shipment request |
| Length of Time a CBU can be Reserved in days | Other |
| Length of Time a CBU can be Reserved in days | 30 days prior to shipment date and 30 days post shipment date |
| 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 | 85% |
| 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 | 3 or more segments |
| Current Packaging for Shipment to TC | 2 attached segments |
| 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 | Requesting transplant centre |
| 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. Pictures of cord blood units in the inventory
15. Infectious Disease Marker (IDM) CURRENTLY performed.
Attachments
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Holiday Calendar
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