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These data are submitted by the = cord blood bank to the WMDA in February 2015. The WMDA makes no representat= ions or express or implied warranties regarding any information on this sit= e or obtained through these links; expressly disclaims all legal liability = and responsibility for the accuracy, completeness, currency, suitability, v= alidity, or usefulness of such information; and is not and will not be liab= le for any statements, errors, or omissions in posted information, or for a= ny losses, injuries, or damages that arise or are alleged to arise from suc= h information. Use of any information provided on this site does not and is= not intended to create a contractual or other relationship. All informatio= n 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 C=
ord Blood Units (month/day= /year) |
06/01/1998 |
Number of Public Cord Blood U= nits | 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= td> | Vapour+ red manual |
Previous Processing Method= td> | 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 R= eduction | 0 |
3. Accreditations, Licenses and Certifications= th> | |
FACT-Netcord | Yes |
AABB | No |
Competent Authority/ Nationa= l Health Authority | Yes |
Name of Competent Authority<= /td> | FDA |
Audited by National Stem Cel= l Registry | Yes |
ISO | No |
Other | QC Lab - CLIA |
4. Cord Blood Collection | |
Current Collection Practice<= br>Is the collection In/Ex -U= tero or both? | In-utero |
Collection Bag | Single needle |
Agitation during Collection<= /td> | Manual |
5. Conditioning/Transport from Collection Site t= o 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 Transp= ort | Other (lower limit +1-35=C2=B0C, higher limit +6= -30=C2=B0C) |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting= a CBU | Medical history, collection report, informed con= sent |
Completed Prior to Accepting= a CBU | Labeling criteria |
Current Threshold for Accept= ing 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 Proc= essing | up to 48H |
7. Processing and Packaging | |
Pre Freeze Processing Method= s- Unit in Inventory | SEPAX |
Pre Freeze Processing Method= s- Unit in Inventory | Volume reduction with HES-Manual |
Pre Freeze Processing Method= s- Current | SEPAX |
Additives Currently in Use= td> | HES |
Current Cryopreservation Met= hod | BioArchive |
Current Cryoprotectant Addit= ive | Ready for use DMSO-Dextran |
Current Cryobag | Single bag 80:20 |
Current Target Cryopreservat= ion Volume (mL) | 29.0 |
Current Packaging for Storag= e | Overwrap |
Current Packaging for Storag= e | Canister |
Current Packaging for Storag= e | One attached segment |
Current Packaging for Storag= e | More than one segment |
8. Testing | |
Extra Material Currently Sto= red | Cord blood DNA |
Extra Material Currently Sto= red | Cord blood material for DNA extraction |
Extra Material Currently Sto= red | Plasma/cord blood |
Extra Material Currently Sto= red | Maternal DNA |
Extra Material Currently Sto= red | Maternal material for DNA extraction |
Extra Material Currently Sto= red | Maternal plasma/serum |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use TNC |
50 |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use CD34 (10^6) Single Platform |
1.25 |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use CD34 (10^6) Double Platform |
NA |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use CFU-GM |
Growth |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use CFU |
Growth |
Current Post Processing Thre=
shold for Accepting a CBU for Public Use Viability |
85 |
9. Storage | |
Type of Storage Container Us= ed | BioArchive |
Type of Storage Container Us= ed | Conventional storage tank vapor phase |
Type of Storage Container Us= ed | 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 <= /span> |
LR |
Current Level of HLA Typing =
at Time of Listing HLA-B <= /span> |
LR |
Current Level of HLA Typing =
at Time of Listing HLA-C <= /span> |
LR |
Current Level of HLA Typing =
at Time of Listing HLA-DRB= 1 |
HR |
Current Level of HLA Typing =
at Time of Listing HLA-DQB= 1 |
HR |
Current Level of HLA Typing =
at Time of Listing HLA-DPB= 1 |
HR |
Accreditation of HLA Lab | ASHI accredited lab |
Average Turnaround Time for =
Extended HLA Typing Results in days |
?10 |
Attached Segment Used for Co= nfirmatory/ Verification Typing | Yes |
Units Listed without Attache= d Segment and have not been Previously Typed on Attached Segment | No |
Percentage of CBUs that have= an Attached Segment | 75-90% |
Confirmatory/ Verification T= yping 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<= /td> | Yes |
Is a Unit Report Provided on= a Unit that is Reserved for Another Patient | No |
Is TC Informed when CBU is R= eleased | Yes |
12. Release and Shipment | |
Hemoglobinopathy Screening P= erformed Prior to Release | Yes |
Criteria to Ship a CBU |
85% |
Current Packaging for Shipme= nt to TC | Metal canister |
Current Packaging for Shipme= nt to TC | One attached segment |
Current Packaging for Shipme= nt to TC | Overwrap |
Current Packaging for Shipme= nt to TC | Protective sleeve |
Current Packaging for Shipme= nt to TC | 3 or more segments |
Current Packaging for Shipme= nt to TC | 2 attached segments |
Time Between Shipment Reques= t and Sending CBU | 4 days-1 week |
Fee for Shipment Cancellatio= n | No |
Dry Shippers Validated to Ma= intain Temperature of at least -150 for 48 hours Beyond Expected Arrival | Yes |
Electronic Temperature Data = Logger on All Dry Shippers | Yes |
Who Selects Transport Compan= y | 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 = td> | Yes |
Who are S(P)EARS Reported To=
National Registry = |
Yes |