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| 1. General Information | |
|---|---|
| Name of CBB | Canadian Blood Services National Public Cord Blood Bank |
| CBB Director | Heidi |
| CBB Director | Elmoazzen |
| Address | National Public Cord Blood Bank |
| Address | Canadian Blood Services |
| Address | 40 Concourse Gate |
| Address | K2E 8A6 |
| Address | Ottawa |
| Phone Number | 613-560-7218 |
| Website | www.blood.ca/cordblood |
| Date CBB Started Collecting Cord Blood Units (month/day/year) | 09/30/2013 |
| Number of Public Cord Blood Units | 78 |
| Planned Number of Public Cord Blood Units Stored in 2015 | 1,500 |
| Lists on BMDW | Yes |
| Affiliated with National Stem Cell Donor Registry | Yes |
| Registry Affiliation | OneMatch Stem Cell and Marrow Network |
| 2. Cord Blood Units in Inventory | |
| Current Processing Method | Liquid+ red auto |
| Year Current Process Method Started | 2013 |
| Percent of Units Plasma and RBC Reduced (automated) | 100 |
| 3. Accreditations, Licenses and Certifications | |
| FACT-Netcord | No |
| AABB | In the process of accreditation.Yes |
| Competent Authority/ National Health Authority | Yes |
| Name of Competent Authority | Health Canada |
| Audited by National Stem Cell Registry | Yes |
| ISO | No |
| 4. Cord Blood Collection | |
| Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
| Current Antiseptic | Chlorhexidine |
| Collection Bag | Double needle |
| Agitation during Collection | Manual |
| 5. Conditioning/Transport from Collection Site to CBB | |
| Transport Conditions | Unqualified 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 |
| Method for CD34 Remuneration | Other |
| Method for CD34 Remuneration | Stemkit |
| External Proficiency Testing for QC of FACS Lab | Yes, other |
| External Proficiency Testing for QC of FACS Lab | QMPLS |
| 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- 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) | 25 mL Total (includes DMSO/Dextran) |
| Current Packaging for Storage | Overwrap |
| Current Packaging for Storage | Canister |
| Current Packaging for Storage | More than one segment |
| Current Packaging for Storage | Other: 4 attached segments included |
| 8. Testing | |
| 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 | 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 | Not applicable |
| Current Post Processing Threshold for Accepting a CBU for Public Use CFU | Not applicable |
| Current Post Processing Threshold for Accepting a CBU for Public Use Viability | 85 |
| 9. Storage | |
| Type of Storage Container Used | BioArchive |
| Monitoring of Storage | No temperature monitoring |
| Monitoring of Storage | Centralized alarm system local |
| Monitoring of Storage | Centralized system remote monitoring |
| Monitoring of Storage | LN2 level |
| Monitoring of Storage | System default |
| 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 | LR |
| 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 | 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 |
| What Point is a CBU Reserved for a Patient | Other: Verification Typing, Post-Thaw, Miscellaneous Sample Request. All of the selections are scenarios in which a CBU is reserved & unavailable to other patients. |
| Length of Time a CBU can be Reserved in days | Other |
| Length of Time a CBU can be Reserved in days | Reservation times vary, based on type of request |
| 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 | Not applicable |
| 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 | 2 attached segments |
| Time Between Shipment Request and Sending CBU | 0-3 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 | Mushroom |
| 13. Adverse Events Reporting | |
| Who are S(P)EARS Reported To National Registry | Yes |
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