Facility Annual Return

Blood Facilities

(e.g., apheresis, whole blood, pooling events)
Whole Blood units collected (excludes cord blood) the total number of Donation Identification Numbers (DINs) assigned annually*
Does not include changes to expiration date.
DINs are assigned to each collection, pooling or apheresis event. This does not include cell therapy products

Cellular Therapy

(e.g., apheresis, marrow, cord blood, adipose)
Total number of Donation Identification Numbers (DINs) assigned annually*
- For facilities that only perform collections: The total number of Donation Identification Numbers (DINs) assigned annually. DINs are assigned to each collection/pooling event.
- For facilities that only process units: The total number of final ISBT 128 labeled products distributed annually.
- For facilities that both collect and process: Whichever annual total value is greater.

Tissue (Non-Ocular)
Number of tissue products distributed annually that are labeled with ISBT 128*
Facility Only Stores Tissue

Please check if your facility only stores tissue (i.e., Does not collect, recover, process)
(Note: For tissues collected with intent of being processed into cellular therapy product please fill out cellular therapy collections.)

Tissue (Ocular)
Number of ocular tissue products distributed annually that are labeled with ISBT 128*
Facility Only Stores Tissue

Please check if your facility only stores tissue (i.e., Does not collect, recover, process)
(Note: For tissues collected with intent of being processed into cellular therapy product please fill out cellular therapy collections.)

HCT/P Medical Devices
Number of final labeled products produced annually that are labeled with ISBT 128*

Plasma Fractionators
- For facilities that assign Donation Identification Numbers (DINs): The total number of Donation Identification Numbers (DINs) assigned annually.
- For facilities that label final products: The number of final products labeled annually with ISBT 128.
Total DINs assigned annually OR Total final products labeled*

Assisted Reproductive Technology (ART) / Medically Assisted Reproduction (MAR) (Cells and Tissues) Facilities
Number of ART/MAR products distributed annually that are labeled with ISBT 128*

Organ Transplant
Number of final labeled products produced annually that are labeled with ISBT 128*

Fecal Microbiota
Number of final labeled products (treatments) produced annually that are labeled with ISBT 128*

Regenerative Medicine
Number of final labeled products produced annually that are labeled with ISBT 128*

Serum Eye Drops
Number of Donation Identification Numbers (DINs) assigned annually*
DINs are assigned to each collection/pooling event.
Manufacturer Only?

Please check here if you are a Manufacturer only

Facility Info