Cellular Therapeutics Freezer Storage Space Limited By Documentation Issues

Cellular Therapeutics Freezer Storage Space Limited by Documentation Issues.

J. Spradley, C. Rode, K. Birdsey, B. Blunk

Background/Objective:

126 patients were identified as being deceased with over 350 stem cell units in storage.  The inability to dispose of these cells has a significant impact on our program; primarily freezer space availability.

The process of obtaining required documentation for the disposal of cells had not been streamlined, and no one had oversight for the process, resulting in a lack of documentation needed to dispose of cells.

 

Methods:

In June of 2012, a data manager took ownership of the project.  In July of 2012, the Cellular Therapeutics Department Cell Destruction Policy was revised to include the SSDI report as valid documentation necessary for destruction of cells and the new process was implemented.

Per programmatic policy, appropriate documentation is requested as soon as possible after notification of a recipient's death.   Aggressive attempts are made to obtain EITHER:

·         A death certificate

·         OR An SSDI report

If any information is inconsistent, additional corroborating documentation is still necessary to corroborate patient identification.  These documents are scanned and stored on a (secure) shared drive. 

The Cellular Therapeutics (CT) Team then reviews documentation submitted by the data management team.  Appropriate forms are filled out by CT and the documentation is verified by a second CT Team member.   Forms must then be signed by either the Processing Facility Medical Director or the recipient's physician per FACT Guidelines (D 11.1.4).  The Product disposal may then occur per policy.

Results:

Our freezer capacity is 3660 total units (11 freezers of different sizes).  2627 Autologous Units and 705 Allogeneic Units = 3332 total units are currently stored (10/1/13).

Year	Total # of units destroyed
2011	112
2012	35
2013*	127

                                *Through 10/9/2013

With ownership of the new streamlined process, documentation has been received on an additional 52 patients (150 units) are now eligible for destruction, and documentation is pending on an additional 37 patients (104 units).  2013 data represents a 72% increase in cells eligible for destruction over 2012.