ACCREDITATION AND REGULATION
We are accredited by UKAS and regulated by HTA.
LABORATORY SERVICES
The stem cell laboratory (SCL) carries out the analysis, processing and storage of cells collected from bone marrow and peripheral blood stem cells intended for autologous or allogeneic transplant.
The list of processes performed includes:
- Peripheral blood stem cell (PBSC) harvest, processing and storage (HPC-A)
- Bone marrow harvest (BMH), processing and storage (HPC-M)
- Preparation of T cell therapeutic (TC-T) aliquots, formerly called donor lymphocyte infusions (DLI)
- Flow cytometry - immunophenotyping for CD34 and lymphocyte subsets CD3, CD4, CD8 and CD19
- Manipulations that can be arranged include:
- Reduction of product volume
- Depletion of red blood cells
- Concentration of mononuclear cells
Products are cryopreserved in vacuum-packed double bags with 8-10% DMSO cryoprotectant using passive freeze method in a -80°C freezer. Reference sample from cryopreserved cells are frozen and stored in cryovials for further testing if required.
Products are stored exclusively in vapour phase liquid nitrogen vessels, and are monitored (24/7) to ensure maintenance of temperatures between the range of -140 to -190°C
TURNAROUND TIMES
The median turnaround time for CD34 and CD3 analysis by flow cytometry of PBSC, BMHs and DLIs is approximately 90 mins from the time the sample arrives in the laboratory.
COMPLETION OF BOOKING AND REQUEST FORMS
It is important that you provide us with a completed forms by the requesting consultant or transplant coordinator for harvesting and processing including cryopreservation.
The request form should contain the following:
| Booking form |
Request form |
|---|
- Patient’s forename and surname
- Date of birth
- Hospital L number (if known)
- Blood Group
- Weight (kg) of recipient / donor
- Target dose
- Type of processing
- Registry number (VUD only)
- Donor and recipient consent
|
- Patient’s forename and surname
- Date of birth
- Hospital L number (if known)
- Weight (kg) of recipient
- Product volume
- Anticoagulant volume
- Plasma volume
- Plasma anticoagulant volume
|
MANDATORY TESTING
It is a regulatory requirement that all patient or donor material processed has undergone HIV 1 & 2, HBV, HCV, HTLV1 and 2, and syphilis testing within the 30 days prior to collection. This testing is carried out by our in-house microbiology laboratory team.
TRANSPORTATION OF PRODUCTS TO THE STEM CELL LABORATORY
Products must be transported within blood transport boxes with cold packs (not freezer packs). A tracking form and inner container document must also be included. The stem cell laboratory team will advise on the procedures.
REINFUSION OF CELLS
Requests for issue of fresh and/ or cryopreserved cells for either autologous or allogeneic infusion must be in writing and the recipient consent section must be signed.
Requests must stipulate the date and time of infusion and which bags of stored products are to be infused.
STORAGE AND DISPOSAL
An audit of cryopreserved material is conducted annually. When materials are nearing the end of the agreed storage time, the requesting clinician will be asked to review if cells are still required.
