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1. General Information | |
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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 +1-35Β°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 | 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.
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Pictures of cord blood units in the inventory
15. Infectious Disease Marker (IDM) CURRENTLY performed.
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Attachments
Attachments |
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Holiday Calendar
Team Calendars | ||
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