Traceability of the samples
Omnigen is accredited with ISO 9001 for the overall quality procedures, and specifically for the laboratory procedures with ISO 17025.
What we define as traceability?
Traceability is the ability of tracking / monitoring and archiving all tissues and cells from the donor to the recipient and vice versa, during the whole process (collection of each sample, processing, storage and distribution).
Identification & Traceability of the Samples
The data of the samples on which the physician will be based in case of transplantation are qualitative and quantitative.
- Date of Processing.
- Unique Sample/Client Code. In the case of twins or triplets, different samples of newborns are recognized with the same sample code assigned by the computerized system by adding A, B or C for each one.
- The dilution factor and the sample volume after the process contribute to the resulted number of cells (WBCf and MNCf).
- Records of the virological tests from peripheral maternal blood.
- Data of cryopreservation
- Barcode and Unique coding of the samples
- Quantity of blood received.
- Number of Cells (WBCi and MNCi) before processing.
- Number of Cells (WBCf and MNCf) after processing.
- Number of Cells, sustainability and total viable CD34 + / CD45 + cells.