(P-BC-39) Expanding Inventory by Collecting RBCs from Eligible Therapeutic Testosterone and Hereditary Hemachromatosis Donors

Background/Case Studies: On November 6, 2024 our medium-sized blood center implemented an initiative to distribute RBCs from eligible donors on testosterone therapy or with Hereditary Hemochromatosis. Before this, these donors were charged a fee for therapeutic collection and all products were discarded. This old process was performed by 2 staff members and was not scalable.

Study

Design/Methods: With the FDA’s allowance to collect these donors if eligible and with a prescription, we wanted to increase RBC collections by creating a new type of collection, opening appointments for this at additional locations, streamlining the prescription process, and removing the fee. First, a prescription/enrollment form was developed that had a set algorithm for frequency of donation based on the donor's hemoglobin (HGB): HGB >20.0 g/dL, donor can donate as soon as 3 days later, if HGB 16.0-20.0 g/dL donor can donate as soon as 7 days later, and if HGB13.0-15.9 g/dL donor can donate 30 days later. This set algorithm simplified the eligibility determination of this new donor group. New standard operating procedures and training program were developed which included workflows to ensure the plasma and platelet products were not used for transfusion. A preapproval supplement was filed with the FDA. Phlebotomy staff were trained on the new eligibility and draw process, and component and hospital services staff were trained on the new product workflows. All donors previously drawn therapeutically for a fee were contacted and transitioned over to the new program. Collection data was pulled from our center’s blood establishment computer system.

Results/Findings: Between November 6, 2024 and May 15, 2025, 368 donors have been enrolled into our new program. We are now seeing about 5 new prescription/enrollment forms per day, with 72% of these donors eligible for allogeneic collections. We have collected a total of 413 allogenic RBCs including 165 units of O positive RBCs and 41 units of O negative RBCs. Frequency of O type donors is on track to average 6 collections per year.

	# New Donors	# Usable O Type RBCs	# Usable Non-O Type RBCs
Nov 2024	25	6	5
Dec 2024	27	8	5
Jan 2025	50	14	20
Feb 2025	81	25	31
Mar 2025	70	54	45
Apr 2025	87	76	63

Conclusions: Implementing an allogenic Therapeutic Testosterone and Hereditary Hemochromatosis program has led to an inventory increase of over 413 RBCs, ~50% being type O. The only outreach so far has been to the pre-existing therapeutic donors from our prior program. The organic growth seen is from the physicians of those donors actively enrolling additional donors into our new program. The next phase in our program is to onboard additional urology clinics, men’s health clinics and other providers of testosterone replacement therapy within our service region. As the program continues to scale up and grow, it is expected to contribute a significant percentage to our overall RBC collections.