By Sarah Litel-Smith, FACT Accreditation Coordinator
We have noticed an uptick in the number of questions regarding storage in the collection facility. There appears to be a misconception that collection facilities do not store products if the processing facility or a courier picks up the product. However, a product is considered to be in storage when it is not under the immediate control of qualified personnel. For example, a product placed in a transport container waiting to be picked up, even for a short time, is considered to be in storage.
All apheresis collection facilities must have policies or procedures that, regardless of the amount of time the product is stored, address cellular therapy product storage and define every step of the product from the time of collection to the time of release to the courier or processing personnel.
Policies and procedures must address the following in relation to storage:
- Defined storage areas and container,
- How the integrity and potency of the cellular therapy products are maintained,
- The security of the facility,
- Facility control of temperature and humidity for storage overnight or longer,
- Storage duration, and actions to take if conditions are not met,
- Product expiration date and time,
- Mechanisms to prevent product release until release criteria are met, and
- Transport or shipping temperature range and duration.