Piloting and implementation of quality assessment and quality control procedures in RBC-Omics: a large multi-center study of red blood cell hemolysis during storage.

BACKGROUND: The major aims of the RBC-Omics study were to evaluate the genomic and metabolomic determinants of spontaneous and stress-induced hemolysis during RBC storage. This study was unique in scale and design to allow evaluation of RBC donations from a sufficient number of donors across the spectrum of race, ethnicity, sex, and donation intensity. Study procedures were carefully piloted, optimized, and controlled to enable high-quality data collection. METHODS: The enrollment goal of 14,000 RBC donors across four centers, with characterization of RBC hemolysis across two testing laboratories, required rigorous piloting and optimization and establishment of a quality assurance (QA) and quality control (QC) program. Optimization of WBC elution from leukoreduction (LR) filters, development and validation of small-volume transfer bags, impact of manufacturing and sample-handling procedures on hemolysis parameters, and testing consistency across laboratories and technicians and over time were part of this quality assurance/quality control program. RESULTS: LR filter elution procedures were optimized for obtaining DNA for analysis. Significant differences between standard and pediatric storage bags led to use of an alternative LR-RBC transfer bag. The impact of sample preparation and freezing methods on metabolomics analyses was evaluated. Proficiency testing monitored and documented testing consistency across laboratories and technicians. CONCLUSION: Piloting and optimization, and establishment of a robust quality assurance/quality control program documented process consistency throughout the study and was essential in executing this large-scale multicenter study. This program supports the validity of the RBC-Omics study results and a sample repository that can be used in future studies.

Blood donation history and eligibility assessment in a community-based sample of men who have sex with men.

BACKGROUND: In 2016, the US Food and Drug Administration changed the regulation from a permanent deferral from donation for men who have sex with men (MSM) to a 1-year deferral since last sexual contact. It is unknown what proportions of MSM try to donate and if they would be willing to answer individual risk-based questions to assess their current eligibility. STUDY DESIGN AND METHODS: The National HIV Behavioral Surveillance surveys periodically measure human immunodeficiency virus (HIV) prevalence and risk behaviors among MSM using a venue-based, time-location sampling method. In the 2014 cycle, that is, before the policy change, investigators in San Francisco and New Orleans added questions about blood donation. Questions inquired into three domains: donation history, policy awareness, and knowledge about HIV testing of donations. RESULTS: There were 404 and 557 respondents in San Francisco and New Orleans, respectively. Nearly one in three MSM in San Francisco (27.4%) and New Orleans (31.4%) tried to donate after their first MSM contact. A majority (63.1% in San Francisco, 58.8% in New Orleans) somewhat or strongly agreed that they would be willing to be asked detailed questions for donation eligibility assessment. CONCLUSIONS: The proportion of MSM who reported trying to donate was similar in the two cities. However, a substantial proportion did not agree to be asked more detailed risk behavior questions to assess eligibility. In these two geographic locations, prominent regional differences were not evident.

Feasibility of routine ferritin testing for donor management: validation of delayed processing and demonstration of within donor reproducibility over time.

BACKGROUND: Understanding the effect of delayed processing of whole blood on plasma ferritin will inform the feasibility of both routine ferritin testing in donors and clinical research study design. STUDY DESIGN AND METHODS: Whole blood tubes drawn from 16 donors were held at 4°C and centrifuged at 24-hour intervals to assess plasma ferritin concentration up to 5 days after draw. Intraindividual variation over time was measured in 21 healthy donors in blood samples collected weekly for 4 weeks and then at 12 weeks. RESULTS: No significant variation in plasma ferritin concentration was observed in blood stored at 4°C for up to 5 days after draw (p = 0.32). The estimated loss of 4.75% ferritin over 5 days was within the reported 5% variation of the assay. Moderate intraindividual variation occurs over time in both sexes, with variability increasing with the mean. No difference was detected between men and women in the regression of standard deviation on mean ferritin (p = 0.43). CONCLUSIONS: Ferritin is stable in whole blood up to 5 days, demonstrating operational feasibility of its use in monitoring donor iron stores. Moderate fluctuations over time occur, but ferritin measurements are sufficiently reliable to determine donor iron status on the day of donation.