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 | CBB Roma Azienda Policlinico Umberto I |
| CBB Director | Gabriella |
| CBB Director | Girelli |
| Address | Via Chieti, 7 |
| Address | 00161 |
| Address | Rome |
| Phone Number | 0039.06.49976549 |
| Date CBB Started Collecting Cord Blood Units (month/day/year) | 06/01/1994 |
| Number of Public Cord Blood Units | 1,185 |
| Planned Number of Public Cord Blood Units Stored in 2015 | 100 |
| Lists on BMDW | Yes |
| Affiliated with National Stem Cell Donor Registry | Yes |
| Registry Affiliation | IBMDR |
| 2. Cord Blood Units in Inventory | |
| Current Processing Method | Liquid+ plasma only |
| Year Current Process Method Started | 2009 |
| Percent of Units Plasma and RBC Reduced (manual) | 20 |
| Percent of Units No Volume Reduction | 80 |
| 3. Accreditations, Licenses and Certifications | |
| FACT-Netcord | No |
| AABB | No |
| Competent Authority/ National Health Authority | Yes |
| Name of Competent Authority | National Blood Center |
| Audited by National Stem Cell Registry | No |
| ISO | Yes |
| 4. Cord Blood Collection | |
| Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
| Current Antiseptic | Chlorhexidine |
| Current Antiseptic | Betadine |
| Collection Bag | Double needle |
| Agitation during Collection | Automatic |
| 5. Conditioning/Transport from Collection Site to CBB | |
| Secondary Bag Used | Yes |
| Transport Conditions | Qualified transporter |
| Transport Conditions | Insulating transport container |
| Transport Conditions | Active refrigeration system |
| Transport Conditions | Electronic temperature probe |
| 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 | ISHAGE guidelines |
| External Proficiency Testing for QC of FACS Lab | Yes |
| External Proficiency Testing for QC of FACS Lab | Missing |
| 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 | No processing |
| Pre Freeze Processing Methods- Unit in Inventory | Other: Manual plasma depletion |
| Pre Freeze Processing Methods- Current | Other: Plasma depletion manual |
| Additives Currently in Use | No additive |
| Current Cryopreservation Method | Conventional CRF |
| Current Cryoprotectant Additive | DMSO |
| Current Cryobag | Single bag (one fraction) |
| Current Target Cryopreservation Volume (mL) | bag ml : 10-30 ; 30-60; 60 |
| Current Packaging for Storage | Canister |
| Current Packaging for Storage | More than one segment |
| Current Packaging for Storage | Other: Not attached vials stored with CBU |
| 8. Testing | |
| PCR Performed on IgM+ Result | CMV |
| PCR Performed on IgM+ Result | Toxoplasmosis |
| PCR Performed on IgM+ Result | EBV |
| Extra Material Currently Stored | Cord blood DNA |
| Extra Material Currently Stored | Plasma/cord blood |
| Extra Material Currently Stored | Maternal DNA |
| Extra Material Currently Stored | Maternal plasma/serum |
| Current Post Processing Threshold for Accepting a CBU for Public Use TNC | 120 |
| Current Post Processing Threshold for Accepting a CBU for Public Use CD34 (10^6) Single Platform | 1.00 |
| 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 | Conventional tank liquid phase |
| Monitoring of Storage | Centralized alarm system local |
| 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 | |
| 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 | EFI 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 | 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 | 50 |
| 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 | Separate segment |
| Time Between Shipment Request and Sending CBU | 1-2 weeks |
| 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 | world courier selected by IBMDR |
| Shape of Transport Container | Mushroom |
| 13. Adverse Events Reporting | |
| Who are S(P)EARS Reported To Competent Authority | Yes |
14. Pictures of cord blood units in the inventory
15. Infectious Disease Marker (IDM) CURRENTLY performed.
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