AM24-MN-31-O: Cell Therapy: Creative Inventory Management & Discard (Enduring)

CABP CE Eligible

A presentation of how one facility tackled a massive inventory reduction project to discard cell therapy products that had been in LN2 storage for 10 to 25 years. The project involved the hospital legal department, medical director, transplant physicians, Lab Director, Quality and Regulatory Manager, Lab Supervisor and staff, the hospital Mail Department and the Cell Therapy Storage Agreement signed by the donor and recipient. Hundreds of products that had been in long term storage were discarded with patient and physician notification and permission, and two large LN2 freezers were completely emptied. We will share some of the questions that patients asked about discard of their products during the project. We will demonstrate our electronic database, internally developed by our hospital. This database is used to track cell therapy products once collected and cryopreserved, placed in storage, and then later removed for infusion, distribution and/or discard. We will describe the cell therapy product rack numbering system. The inventory management system easily identifies if a cell therapy product is designated for transplant, boost, or backup, just by the rack numbering rank and location. This project eliminated the prior system of inventory management documented on paper. The presentation will include a description of the electronic and paper downtime methods. Two to three speakers will address administrative tasks of developing algorithms for products to evaluate for discard, how we involved the hospital legal department to protect the hospital from liability, creation of discard consent forms, obtaining IT support, hands-on steps involved to label and number canisters and racks, mail certified letters, discard cell therapy products. Lecture will describe how we created and validated the electronic inventory management database; and how we verified the location of each product in electronic and physical inventory. We will describe the audit program we have developed for verifying the inventory management system works. We will emphasize that each facility will need to consult their own legal team and we will present how our hospital accomplished this task and include a list of legal topics for facilities to consider, including addressing whether there are family rights to cell therapy products if a patient dies.