Label reconciliation is now required in the eighth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Specifically, Standards CM126.96.36.199, C188.8.131.52, and D7.2.3 state: “A system of label reconciliation shall be used to ensure the final disposition of all labels allocated to a specific product is documented.”
The purpose of this requirement is to prevent cellular therapy product mix-ups. As the FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual states, “The purpose of reconciliation is to ensure that all labels have been accounted for and no mix-up occurred. A system for label reconciliation that documents the number and type of labels received by the Collection/Processing Facility, the number of labels used, and the number of labels passed to the Processing Facility or destroyed shall be used.” The scope includes labels with unique identifiers of final products. It does not include labels for patient demographics or internal tracking numbers if they are not uniquely identifying a product, though these labels must still be controlled.
Print-on-demand systems for labels reduce risks of label mix-ups; however, there are instances in which a batch of labels is printed to facilitate processes. Label reconciliation does not need to be performed in real-time but should at least occur at the end of a process (for example, during cleanup of a processing procedure.)
In addition to the labeling operations requirements outlined in the FACT Coding and Labeling Cellular Therapy Products sections of the Standards (CM7, C7, D7), the following are example methods that may facilitate label reconciliation:
- Keeping labels in a batch record.
- Limiting the number of labels that are printed at a given time, and defining in policies what the use of each label will be.
- Utilizing a form that details the number of labels printed or received, used, passed to another unit, or destroyed. This could be on a collection form or a separate label reconciliation form.
- Affixing unused labels to the relevant form and crossing through or annotating labels that will no longer be used.
- Numbering labels (e.g., for 12 labels, label them 1 of 12, 2 of 12, and so on) to facilitate documentation of which label was used where.