Impact of changes to donor hemoglobin criteria on the rate of donor deferral

Abstract

BACKGROUND The Food and Drug Administration's requirements for “Blood and Blood Components Intended for Transfusion or Further Manufacturing Use” (Final Rule) effective May 2016 changed eligibility criteria for blood donors. A multivariate analysis was performed to measure its impact on donor deferral rates. STUDY DESIGN AND METHODS Four blood centers submitted data for similar 6‐month periods before and after implementation of the Final Rule. Data included presenting donors, units collected, deferrals, intended products from deferred donors, deferral reasons, presenting donor demographics, donor hemoglobin (Hgb), hematocrit (HCT), pulse, blood pressure (BP), temperature, and other reasons for deferral. Data were aggregated and periods compared. RESULTS After Final Rule implementation, successful donations decreased by 1.3% (83.1%‐81.9%), despite a 0.2% increase in presenting donors. The rate of Hgb/HCT, pulse, and deferrals increased, while deferrals for other reasons decreased. Male Hgb/HCT deferral rates increased 1.2% (4213 total). Black male donors' Hgb/HCT deferral rate increased (2.7%‐5.2%) but was counterbalanced by an overall 3.7% decrease in black female Hgb/HCT deferrals. While Hgb/HCT deferrals of black donors remained stable overall (17.0% vs. 16.2%), this trend was not observed by all centers. Deferrals for pulse increased (0.2%), as did BP deferrals (0.2%). CONCLUSION Although there was a small increase in presenting donors after implementation of the Final Rule, there was a decrease in successful donations. While it appeared that deferral in black donors was unchanged, this trend was not observed across all centers. Pulse and BP deferrals rose dissimilarly among centers, according to individual procedures.

Supplemental findings of the 2017 National Blood Collection and Utilization Survey

“…However, if deferrals because of pulse and/or blood pressure are combined with deferrals because of “other medical reasons,” the 2017 total is 811,000, a 61% increase. This increase is unlikely to be explained just by increases in deferrals because of pulse and/or blood pressure; a previous study of four blood centers reported only a 0.2% increase in deferrals because of an abnormal pulse and 0.2% increase in deferrals because of an abnormal blood pressure after implementation of the updated donor eligibility regulations . The NBCUS does not ask the specific reasons for deferrals because of “other, non‐medical reasons”, so the causes of the increase in this category from 2015 to 2017 are unknown.…”

“…This increase is likely partially explained by the 2016 change in donor eligibility criteria. Minimum hemoglobin levels for male donors increased from 12.5 to 13.0 g/dL and definitions for eligible pulse and blood pressure were established . Additionally, per new recommendations, for donors with pulse or blood pressure outside the acceptable ranges, a physician must evaluate the donor prior to donation.…”

“…For example, persons with sickle cell disease can require frequent transfusions and are at a high risk of developing alloantibodies; recruiting donors from racially diverse populations for blood antigen matching can reduce the risk of alloimmunization . New thresholds which have increased the minimum Hgb for male donors may have resulted in more deferrals of black males compared to other races, likely because healthy black males have been reported to have lower Hgb level than white males . Strategic planning tools to increase African‐American blood donation are available, but additional studies to determine effective methods to increase donations among minorities are needed …”

“…Minimum hemoglobin levels for male donors increased from 12.5 to 13.0 g/ dL and definitions for eligible pulse and blood pressure were established. 35 Additionally, per new recommendations, for donors with pulse or blood pressure outside the acceptable ranges, a physician must evaluate the donor prior to donation. Total deferrals for low hemoglobin increased by 14% (trends by sex are not possible because 2015 data was not stratified by sex).…”

“…This increase is unlikely to be explained just by increases in deferrals because of pulse and/or blood pressure; a previous study of four blood centers reported only a 0.2% increase in deferrals because of an abnormal pulse and 0.2% increase in deferrals because of an abnormal blood pressure after implementation of the updated donor eligibility regulations. 35 The NBCUS does not ask the specific reasons for deferrals because of "other, non-medical reasons", so the causes of the increase in this category from 2015 to 2017 are unknown. The reasons for the increase in total reported deferrals are unclear, but trends in deferrals will be followed in future surveys.…”