The quality processing determines several criteria, which can be influenced by:

          providing sterility; preserving the maximum amount of the stem cells; and the human factor.

The sterility

          As we already mentioned, sterility is critical for harvesting the umbilical cord blood, the contamination mostly comes from the birth canal. The majority of laboratories use technology that ensures that the contamination risk in comparison with the harvesting is negligible. However, also here there could be differences. In our laboratories the maximum level of cleanness is provided. The laboratory rooms themselves are equipped with overpressure filtering devices, where cleanness level B is reached. The umbilical cord blood is processed in laminar stands, where, by further filtration and laminar airflow, the maximum achievable level of cleanness A is reached (it corresponds to the cleanness of microchip production areas). This technology naturally undergoes regular control by the producer and by the Ministry of the Health, which gave the licence to this laboratory.

          The so-called closed system of the processing further decreases the contamination risk. Our control system has not recorded any contamination at the umbilical cord blood harvesting yet. The harvesting causes all the contamination, which is performed in comparison to the processing in real „battle field” conditions.

          In case of potential, mainly viral contamination it is important whether or not foreign biological material has been used at the processing. By utilisation of some methods, for instance, human albumin is used. It is prepared from the plasma mixture of thousands of donors, and though the plasma of each donor is thoroughly tested for known viruses, we cannot exclude the possible contamination by a presently unknown virus. It is not just a theoretical problem. A similar situation happened several years ago, when many patient treated with transfusions and blood derivatives (for instance haemophilic patients) got infected with the, at that time unknown, HIV virus. Therefore we use such methods of processing that don’t deploy any foreign biological material either of animal or of human origin. Otherwise we would be faced with the risk that we unintentionally contaminate the hundreds of transplants.

The processing methods

          Many workplaces, with the goal to decrease storage costs, isolate the stem cells from the umbilical cord blood, by which they reduce the volume of the stored material. The problem of these methods is that all of them decrease the number of the preserved stem cells, some of them almost by 20%. Additionally, some separating methods impend the risk of total removal of until now not fully known stem cells. Therefore we use the method of whole blood processing, which is used for instance the biggest umbilical cord blood registry in New York, which preserves umbilical cord blood from voluntary donors.

          The technical equipment of our laboratories is at the highest possible level. All the equipment used in laboratories are manufactured by renowned world-wide producers and, as with all our material, they are certified by states authorities.

The human factor

          University education is a pre-condition for all our laboratory employees. For the common practice of the transplant preparing, which is routine work, it is not important, but in unexpected situations, which can arise from time to time, they are more flexible and react more correctly. Not even employee selection guarantees their infallibility, so it is very important to have system for mistake cancellation before they take effect, and a system of control.

Our processing system is based on the principle of decreasing the probability of a mistake occurring by utilising a parallel connection of the independent control in real time. If, in the classic control system, the employee misses a mistake with the probability of 1:1000 and the following output control does not reveal the mistake with the probability 1:1000, thus the probability, that the mistake will happen and will not be detected by control is only 1:1 000000, however the problem is that the classic output control usually detects the mistake, but it does not ensure its removal. Therefore the damage to the product remains in the ratio 1:1000, which corresponds with the probability of the mistake. As the autologous transplant is not a product that you can scrap and replace with others, this classic method is not suitable for the preparation of the unrepeatable auto-transplant. The probability that the transplant will be damaged will not be decreased in any case by input control.

Our system, apart from the classic approach, includes also another one. Although transplant preparation can be carried out by only one person, our method requires 2 persons, where both employees control each other and reveal the colleagues mistakes prior to the possible damage of the transplant. If then the certain mistake occurs with the probability of 1:1000 and the second employee miss it with the probability of 1:1000 the total probability of transplant damage is only 1:1 000000. The processing of one transplant by 2 persons does not shorten the processing time markedly but it decreases the probability of the transplant damage. We do not introduce further standard methods like the irreplaceable way of labelling, the automated barcode system, the system of quality control here, because they are the common part of the modern laboratory practice and they should be obvious everywhere.

Therefore ask about:


• The level of the cleanness in laboratories
• Using the foreign biological material at the processing
• A way of processing which preserves all cells, or the usage of separation
• The personnel qualifications
• The way of lowering the effect of the human factor failure on the transplant quality