Quality Assurance Improvement during Accreditation Process of a French Cord Blood Bank: FACT No Fiction.
Authors: Maddens Stephane , Petitprost Eric , Bardey Isabelle , Lamy Christian , Garnache Francine , Saas Philippe , Chabod Jacqueline , Lapierre Valerie 
Published: October 2019

Abstract
The Cord Blood Banks (CBB) wishing to be affiliated to NETCORD must demonstrate that they adopted the Fact-Netcord standards for collection, processing, quality control testing, storage, selection and release for their cord blood units (CBU). The best way to provide these assurances is to obtain FACT accreditation label. The Besancon Cord Blood Bank initiated this quality approach in January 2004 and was inspected on-site in June 2004.Initial internal audits revealed major deficiencies in specific Quality Management areas and the lack of an efficient documentation system together with adequate standard operating procedures and documented validation studies for each step of the process. Adequate labelling, conformity with good transport practices and post-transplantation clinical data recovery were also areas to be improved. Moreover, in order to clarify the different pathways of material, cell products, staff, or wastes, several building works modifications had to be undertaken. Several major improvements were performed during those six months of Fact accreditation project. The Assurance Quality Information System was significantly upgraded to control all the major elements of assurance quality (staff formation, material, premises, alarms, cleaning, records, and quality control testing) by implementing a computerised Oracle-based application. Morover, all documentation was implemented on an intranet network and is now easily accessible to all the staff wherever in the facility. In order to improve the volume of CBU, a weigh-and-mix machine used for blood donor harvesting procedure was tailored for specific CBU collection. To improve the conditions of transport we set up special containers with controlled temperature continuously monitored. Finally, major validation study was performed on a short period, aiming at demonstrating efficiency and reproducibility of the overall CBU process. In brief, eligible mothers, who give their informed consent, are accepted for CB donation after a medical interview. Collection is performed with the placenta in utero. The delay between collection and processing must not exceed 24hrs. CBU volumes are reduced using Sepax© (Biosafe, Switzerland) technology for long-term storage in a Bioarchive© (Thermogenesis, CA, USA). Quality controls include testing maternal blood samples for infectious markers (HIV, HCV, HBV, HTLV, syphilis) and the presence of IGg- and IgM-antibodies against toxoplasmosis, EBV and CMV on the day of birth and after a quarantine period of at least 60 days. No active infectious disease is mandatory. A baby’s clinical examination is performed at the same time point. Microbiological tests on the CBU must be negative. In addition, our CBB requires a minimal collection volume of 80 ml and a minimum of 2 x 106 CD34 cells for CBU qualification. We implemented a systematic cord blood haemoglobin analysis and tested systematically cord blood plasma for viral infection by genomic detection. Finally, our bank obtained its FACT accreditation on May 2nd 2005, validating our strategy. This achievement had a great impact on CBB staff, desiring to maintain and improve their know how. On June 30th 2005, 5045 CBU were registered at French marrow registry and 273 (5%) were transplanted, 142 (52%) in France and 131 (48%) in other countries. This high 5% transplantation rate may be due to the stringent initial quality controls requirements.