CBB Survey 2015
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 | Carolinas Cord Blood Bank |
| CBB Director | Joanne |
| CBB Director | Kurtzberg |
| Address | 2400 Pratt St |
| Address | Room 1400 |
| Address | 27705 |
| Address | Durham |
| Phone Number | 919.668.1119 |
| Website | ccbb.duke.edu/ |
| Date CBB Started Collecting Cord Blood Units (month/day/year) | 01/01/1998 |
| Number of Public Cord Blood Units | 27,756 |
| Planned Number of Public Cord Blood Units Stored in 2015 | 2,000 |
| Lists on BMDW | Yes |
| Affiliated with National Stem Cell Donor Registry | Yes |
| Registry Affiliation | NMDP |
| 2. Cord Blood Units in Inventory | |
| Current Processing Method | Liquid+ red auto |
| Previous Processing Method | Liquid+ red manual |
| Year Current Process Method Started | 2008 |
| Percent of Units Plasma and RBC Reduced (manual) | 34 |
| Percent of Units Plasma and RBC Reduced (automated) | 66 |
| 3. Accreditations, Licenses and Certifications | |
| FACT-Netcord | Yes |
| AABB | No |
| Competent Authority/ National Health Authority | Yes |
| Name of Competent Authority | New York State |
| Audited by National Stem Cell Registry | Yes |
| ISO | No |
| Other | In December 2003, the CCBB was approved as member of the National Marrow Donor Program (NMDP) banking network. The CCBB continuously maintains its membership and currently lists all of its available cord blood units with the NMDP. In November 2006, the CCBB was awarded a contract from the Health Resources and Services Administration (HRSA) to participate in the National Cord Blood Inventory (NCBI) of the CW Bill Young Cell Transplantation Program. The CCBB has been funded in Cohorts 1 and 5 of this program. In 2010, the CCBB was granted licensure to collect umbilical cord blood in the State of New York by the New York State Department of Health. The CCBB has maintained continuous licensure since 2010. In June 2012, the CCBB Laboratory received Clinical Laboratory Improvement Amendments (CLIA) accreditation. In June 2012 the CCBB Processing Laboratory received accreditation from the College of American Pathologists (CAP). In October 2012, the CCBB received BLA approval from the Food and Drug Administration (FDA). |
| 4. Cord Blood Collection | |
| Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
| Current Antiseptic | Chlorhexidine |
| Current Antiseptic | Betadine |
| 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 | Insulating transport container |
| Transport Conditions | Air transport |
| Temp. for Storage and Transport | Room temperature |
| 6. Pre-Processing Evaluation | |
| Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
| Method for CD34 Remuneration | Other |
| Method for CD34 Remuneration | Not performed on pre-processing |
| External Proficiency Testing for QC of FACS Lab | CAP |
| Post Processing/ Pre Freeze CD34+ Cell Count | Yes |
| Time from Collection to Processing | 24-48H |
| 7. Processing and Packaging | |
| Pre Freeze Processing Methods- Unit in Inventory | SEPAX |
| Pre Freeze Processing Methods- Unit in Inventory | Other: Manual RBC and plasma reduction with HES |
| Pre Freeze Processing Methods- Current | SEPAX |
| Additives Currently in Use | HES |
| Additives Currently in Use | Other: CPD in collection bag |
| Current Cryopreservation Method | BioArchive |
| Current Cryoprotectant Additive | Ready for use DMSO-Dextran |
| Current Cryobag | Single bag 80:20 |
| Current Target Cryopreservation Volume (mL) | 25.0 |
| Current Packaging for Storage | Overwrap |
| 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 | 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 | 9 |
| 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 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 | 90 |
| 9. Storage | |
| Type of Storage Container Used | BioArchive |
| 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 |
| 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 | |
| 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 | 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 |
| 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 | Yes |
| Criteria to Ship a CBU Viability and Cell Count | >40% CD45 on a segment |
| Criteria to Ship a CBU HLA Identity Testing | Yes |
| Current Packaging for Shipment to TC | Metal canister |
| Current Packaging for Shipment to TC | Overwrap |
| Current Packaging for Shipment to TC | Protective sleeve |
| Current Packaging for Shipment to TC | Transport rack |
| Time Between Shipment Request and Sending CBU | 0-3 days |
| 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 | CBB through NMDP. |
| 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. Pictures of cord blood units in the inventory
15. Infectious Disease Marker (IDM) CURRENTLY performed.
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