Q: We remove autologous bone flaps and store them temporarily for reimplantation into the same patient at a later date. Do the Tissue Storage and Issuance standards apply?
A: Yes. The Joint Commission’s Tissue Storage and Issuance standards apply to the extent they are relevant. For example, the organization must have policies and procedures for identification, tracking, storage, handling, and adverse reactions.
Note: Collection and storage of autologous tissues for reimplantation by the same facility does not require registration with the FDA as a tissue establishment, as long as the facility does not perform additional manufacturing to the tissue and does not send the tissue to an off-site storage facility under different management. The initial removal and subsequent reimplantation are considered to be the "same surgical procedure", even though the storage time preceding the replacement surgery may be a number of days.