The application of lean manufacturing principles to a national network of cellular therapy laboratories

Abstract

helps to identify areas that accredited facilities need to improve and that FACT-JACIE needs to target for educational activities. Methods: Post inspection citations reviewed and approved by the FACT CT Accreditation Committee under the 3rd and 4th edition Standards were compiled for analysis. Drill-down analysis of the 4th edition data was performed and then compared to the 3rd edition. Results: A total of 114 inspection reports with 2505 citations were analyzed for the 3rd Edition and compared with 180 reports with 2434 citations for the 4th Edition. Under the 4th edition, the average number of citations in a single program was: 5 clinical, 2 marrow, 6 apheresis & 7 processing. The Quality management (QM) section was the most commonly cited under both editions. However, the percentage of QM citations dropped significantly from the 3rd to 4th edition within all parts of the program. Audits were the most common QM citation (17%) while qualification & validation, accounted for only 3&6% respectively. A significant increase in the number of citations between the 3rd and 4th editions was noted in the donor section (mostly related to informed consent & donor suitability), facility management and process control. Conclusions: QM programs of FACT-accredited facilities improved significantly between the 3rd and 4th editions of the FACT-JACIE Cellular Therapy Standards, possibly due to correction of deficiencies between inspection cycles and heavy emphasis of QM during FACT educational sessions. However, increased issues were noted for process control, in particular relating to donor evaluation and management. Assessment of commonly cited standards can guide future efforts to improve cellular therapy, such as educational sessions and in the development and organization of future editions of the Standards and their associated guidance.