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Section 1 General Info
Question | CBB answer |
The information has been reviewed in year : | |
Name of the cord blood bank: | Versiti Michigan |
Number of cord blood units the cord blood bank plans to store for public use (unrelated patients): | 3786 |
Section 2 Cord Blood Units in Inventory
Question | CBB answer |
Current processing method(s): |
Plasma and RBC reduced (automatic) | ☑ |
Plasma reduction only | ☐ |
Plasma and RBC reduced (manual) | ☐ |
RBC reduction only | ☐ |
Total Nucleated Cell Count (x10E7) of your cord blood units stored for Unrelated Patients (Public Use). |
< 125 : | 2357 |
125 - 149 : | 718 |
150 - 199 : | 595 |
200 - 250 : | 103 |
> 250 : | 13 |
Section 3 Cord Blood Collection
Question | CBB answer |
Current practice for collecting cord blood: | In-utero and ex-utero |
Current antiseptic: | Other povidone-Iodine |
Collection bag: | Single needle |
Agitation during collection: | Manual |
Section 4 Conditioning and transport from Collection Centre to cord blood bank
Question | CBB answer |
Secondary bag used by the cord blood bank (sealed, plastic bag or similar to avoid any leakage): | yes |
Transport conditions: |
Insulating transport container | ☑ |
Active refrigeration system | ☐ |
Passive refrigeration system (gel, blocks) | ☑ |
Electronic temperature probe | ☐ |
Non-electronic temperature probe | ☐ |
Qualified transporter | ☑ |
Unqualified transporter | ☐ |
Air transport | ☐ |
Ground transport | ☑ |
Other, Validated 2-8 C transport box | ☐ |
Temperature range for storage and transportation of fresh product: | Temperature between +2 to +8°C |
Section 5 Evaluation
Question | CBB answer |
Pre-processing Evaluation: Current threshold for accepting a cord blood unit for public use in the cord blood bank: |
Net weight in grams (excluding bag and anticoagulant) before processing | 70 - 79.99 grams |
TNC (10E7) before processing | 125 - 149 |
Viability CD45 positive cells (%) | NA- not evaluated pre-processing |
Viability CD45 positive cells (method) | 7AAD |
Viability CD34 positive cells (%) | NA- not evaluated pre-processing |
Viability CD34 positive cells (method) | 7AAD |
Criteria that are completed before accepting a cord blood unit for public use in the cord blood bank: |
Medical History | ☑ |
Collection Report | ☑ |
Informed Consent | ☑ |
Maternal IDM results | ☐ |
Temperature and integrity of the bag | ☑ |
Other, | ☐ |
Used method for CD34 enumeration: | BD Stem Cell Enumeration Kit and software |
The cord blood banks uses external proficiency testing for QC of the cord blood banks FACS lab: | yes |
The cord blood bank performs post processing/pre-freeze CD34 cell count: | yes |
Acceptable time from collection to processing: | 24-48H Collection up to 48 hrs |
Section 6 Processing-Packaging
Question | CBB answer |
The pre-freeze processing method(s) cord blood bank uses at any stage in time: |
AXP | ☐ |
SEPAX | ☑ |
Optipress | ☐ |
Prepacyte | ☐ |
Manual- plasma and red cell reduction | ☑ |
RBC/plasma reduction with HES | ☐ |
Ficoll sedimentation | ☐ |
Centrifugation and volume reduction | ☐ |
No processing | ☐ |
Manual- plasma reduction only | ☐ |
Other, | ☐ |
The current pre-freeze processing method(s): |
AXP | ☐ |
SEPAX | ☑ |
Optipress | ☐ |
Prepacyte | ☐ |
Manual- plasma and red cell reduction | ☑ |
RBC/plasma reduction with HES | ☐ |
Ficoll sedimentation | ☐ |
Centrifugation and volume reduction | ☐ |
No processing | ☐ |
Manual- plasma reduction only | ☐ |
Other, | ☐ |
Additives currently in use in addition to anticoagulants and DMSO during processing: |
HES | ☑ |
Prepacyte | ☐ |
Plasmalyte | ☐ |
Albumin | ☐ |
Isotonic salt solution NaCl (saline) | ☐ |
No additive | ☐ |
Other, | ☐ |
Cryoprotectant additives currently in use: | DMSO- Dextran |
Cryopreservation method currently in use: |
BioArchive | ☐ |
MVE 1850 Vapor freezer | ☐ |
Programmed cryopreservation with Air Liquid program (FREEZAL) | ☐ |
Programmed freezer | ☑ |
Two-step (equilibrium) freezing | ☐ |
Cryobag currently in use: | Single bag (two fractions) |
Currently used packaging when a unit is stored: | Metal canister and overwrap |
Segments currently stored with the unit by the cord blood bank: |
One attached segment | ☐ |
Two or more attached segments | ☑ |
Separate segments detached from the bag, but stored with the CBU | ☐ |
Other samples | ☐ |
None | ☐ |
Section 7 Testing
Question | CBB answer |
Does your cord blood bank currently store extra material? |
Cord blood DNA | ☐ |
Cord blood material for DNA extraction | ☐ |
Plasma/cord blood | ☑ |
Maternal DNA | ☑ |
Maternal material for DNA extraction | ☑ |
Maternal plasma/serum | ☑ |
HLA typing at time of listing: |
HLA-A | High Resolution |
HLA-B | High Resolution |
HLA-C | High Resolution |
HLA-DRB1 | High Resolution |
HLA-DRB2 | High Resolution |
HLA-DPB1 | High Resolution |
Section 8 Storage
Question | CBB answer |
The following type(s) of storage container is currently used by the cord blood bank: |
BioArchive tank | ☐ |
Conventional storage tank-Vapor phase | ☑ |
Conventional tank-Liquid phase | ☐ |
Double walled liquid Nitrogen | ☐ |
Type following type(s) of storage monitoring is currently by the cord blood bank: |
Alarm on individual tanks only | ☑ |
Centralized system-local | ☐ |
Centralized system-remote monitoring | ☑ |
LN2 level | ☑ |
Lid opening | ☑ |
System default | ☐ |
Temperature monitoring | ☑ |
No temperature monitoring | ☐ |
Section 9 Adverse Events Reporting
Question | CBB answer |
Adverse Event Reporting used by the cord blood bank: |
Competent authority | ☑ |
Internal report | ☑ |
National registry | ☑ |
Transplant centre | ☐ |
WMDA | ☐ |