COMPLETION OF THE 1ST PHASE INVENTORY CHECK OF BIOLOGICAL MATERIAL SAMPLES STORED ORIGINALLY BY FORMER SERVICE PROVIDER

Warsaw, 8^th September 2020

This information is addressed to the customers of former service provider in connection with which we have been authorized as a contact point for the customers of former service provider.

PBKM S.A.-parent company of FamiCord Group (“FamiCord”) is the largest family stem cells bank in Europe.

Samples of almost all families being customers of former service provider were transferred in accordance with technical and medical requirements in year 2019 and 2020 from various European locations to the state-of-the-art facility in Warsaw.

In order to ensure the most accurate information concerning the samples we have initiated manual checking of all inventory. This process started in May  2019 and was completed in July 2020.

Overall we have checked the biological material located in 58 storage containers (out of which 55 were provided by former service provider). It is important to mention that the biological material collected from one child could have been divided into up to 8 different cryopreserved parts (subunits). Each of those subunits could be of different type of package, size and located in different storage containers. Each sample had to be scanned and matched with the customers’ records in our database. All of that made our work extremely difficult and time consuming. It was the largest project of its kind in the world.

After checking over 800.000 subunits, we can confirm with certain reservation the overall acceptable condition of the inventory. We have found however some issues with less than 0,3% of subunits. Most of the issues which have been identified are the following: traces of the biological material on outers surface of the package, signs of mechanical damage of the package, lack of testing aliquots with the main sample. All of these issues are pretty typical results of not fully proper quality control and/or cryopreservation methods used by former service provider. The whole inventory was accumulated for almost 20 years of activity of former service provider and during that period different methodologies of freezing, coding and labelling were used by the company.

The quality of electronic records and samples-related information provided by former service provider was very poor. Nevertheless we managed to correct most of these errors manually. We have found over 150.000 data (coding) errors which we thoroughly checked. The errors we identified include among others: the code of the subunit in the data was different from the code scanned from the subunit, the wrong location of subunits, additional numbers/signs or missing numbers/signs in the code, typos. Those electronic errors, however, had not affected the storage conditions of the samples but the may have hindered finding and use of the samples when needed

In order to perform the process of verification timely and accurately we have created dedicated teams led by lab professionals. In total over 100 people were involved not mentioning dedicated call center and IT staff. The whole process was supervised by quality control specialists and was video recorded.

In conclusion, we are able to answer the families with much bigger confidence than a year ago whether and where we have their samples stored. We are also able to release the sample for transplantation when it is needed.

In order to check whether your biological material is stored in FamiCord Group laboratory in Warsaw, Poland, please see: https://famicordcryobank.ch/contact-for-clients-of-the-former-service-provider/check-your-sample and wait for the confirmation from FamiCord.

A certain number of samples remain with unconfirmed status. If customers have filled out the form, please be patient. At the same time, we also see the need to continue the inventory checking process, this time in a way that allows the more accurate determination of the status of the samples, which have not been confirmed yet. This process (named “2^nd phase inventory check”) will be focused on additional verification of the codes with our documentation or scanned versions of it and can take additional time not less than several months.

FamiCord Team