1. Results Methods A Five-Year Snapshot of Our Hereditary Hemochromatosis Program: A Work in Progress P Davenport 1, D Echols 1, J Giacoletti 1, L Sutor 1,2, J Chiu 1 1 CarterBloodCare, Bedford, TX, 2 University of Texas Southwestern Medical Center, Dallas, TX Background Conclusions References FDA Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis, August 2001. During the five year period 380 HH patients enrolled in the program. Of these 68% (259) qualified as AL donors. The other 32% (121) were either ineligible or did not wish to donate AL and were drawn as TH only. The AL HH donors presented to donate 2078 times during this period. Of those donation attempts 66% (1375) were successful as AL donations, 11% (231) were unsuccessful attempts by AL HH donors who were deferred at time of donation as a result of eligibility criteria and 23% (476) were mistakenly drawn as TH due to staff error. Over the 5 year period, the AL HH donor group presented to donate an average of 8 times per donor, whereas TH HH donors presented an average 10 times each. A significant number of enrolled AL HH donors (36%) had not donated in over a year or had never donated. Overall, our HH program resulted in an average of 5.5 usable AL donations per AL HH donor over the 5 year period. A financial analysis of our HH program did not recognize a monetary gain for our institution, but 1375 allogeneic units were collected and this number could be improved by reducing staff errors and increasing enrollment of eligible AL HH donors. Carter BloodCare, AABB 2014 Data was gathered from existing records of all AL HH and TH HH donors enrolled in the program, delineating number and type of donations, AL HH donor deferrals, and errors. To assess the cost effectiveness of the program we compared costs (“no-fee” TH phlebotomies and estimated employee time) to benefits realized as a result of the program and future potential. In 2001, the Food and Drug Administration (FDA) issued guidance to the blood industry allowing a variance, if approved, to collect blood from individuals diagnosed with hereditary hemochromatosis (HH) and distribute those donations to hospitals without labeling them with the donor’s condition. Concern exists that blood donation by HH patients would provide indirect compensation for medical treatment and create an incentive to deny health or risk conditions that would preclude cost-free donation, thus requiring payment for therapeutic phlebotomy. To avoid this, FDA requires that no fees be collected from HH donors whether they qualify to donate allogeneic (AL) blood intended for transfusion or are drawn only for therapeutic purposes (TH). Five years after implementing our HH program, we evaluated its efficacy. From phlebotomies performed for all enrolled donors (AL and TH), 42% were usable for transfusion, but the potential would be 56.5% if errors could be eliminated. Because no fees are collected for TH procedures, administrative and material costs cannot be recouped. However, some administrative costs for transfusable units are offset because AL HH donors do not require recruitment and all procedures are conducted at select non-mobile sites.