Donors' perspectives on their postdonation information (PDI) event: a qualitative interview study of PDI donors.

BACKGROUND: Postdonation information (PDI) occurs when a donor fails to report a risk that would have resulted in deferral, but at some subsequent point is disclosed. Donors' perspectives on and perceived reasons for their PDIs have not been previously studied. STUDY DESIGN AND METHODS: A qualitative interview study was conducted with PDI, appropriately deferred (and not PDI), and accepted donors from the six REDS-II blood centers. Telephone interviews were conducted with donors using semistructured discussion guides after their most recent donation or donation attempt. Salient themes were identified within and across the three donor categories using interview recordings and notes. RESULTS: Sixty-six donors were interviewed (35 PDIs, 21 appropriately deferred, and 10 accepted). Cases could be grouped into one of three broad clusters according to the apparent primary reason for the PDI event: perceived changes in rules or application of more intensive screening procedures at this visit versus prior visit(s), issues of recall or interpretation of a question, and discrepancies in recollections of timing. CONCLUSIONS: While descriptive and demographic information exists on the numbers and types of PDI events and donors, there has never been a qualitative study exploring donation experiences and possible reasons for their PDIs. This exploratory study based on semistructured interviews of donors identified several potentially actionable areas including the need for screeners to clarify the meaning of and answers to certain questions and helping donors accurately remember the details and dates of deferrable activities.

Demographics of successful, unsuccessful and deferral visits at six blood centers over a 4-year period.

BACKGROUND: Descriptions of donor demographics are of value in formulating recruitment and retention strategies. The demographics of successful (SV), unsuccessful (UV; meaning a nonuseable unit), and deferred (DV) donor visits over a 4-year period were investigated using Retrovirus Epidemiology Donor Study (REDS)-II databases. STUDY DESIGN AND METHODS: Fourteen deferral categories were created that included low hematocrit (Hct) or hemoglobin (Hb), feeling unwell, malaria travel, malaria other, couldn't wait, blood pressure or pulse, medical diagnosis, medication, test results, higher-risk behavior, variant Creutzfeldt-Jakob disease (CJD), CJD, needle exposure or tattoo, and other. Rates per 10,000 donor presentations were determined for each category globally and for six subcategorizations (first-time or repeat donor status, sex, race/ethnicity, age, education, and fixed or mobile donation location). Deferral rates were also calculated on simultaneous stratifications of donor status, sex, and race/ethnicity. RESULTS: Of 5,607,922 donor presentations there were 4,553,145 SVs (81.2%), 302,828 UVs (5.4%), and 751,381 DVs (13.4%). Overall rates of deferral ranged from 0.6 per 10,000 presentations for CJD, human growth hormone, or dura mater exposure to 777 per 10,000 presentations for low Hct or Hb. Deferral rates were remarkably different by first-time or repeat donor status, sex, race/ethnicity, and other demographics. The highest overall deferral rate was 3953 per 10,000 presentations, or nearly 40% in first-time, female, Asian donors, and the lowest rate was 5.6% in repeat, male, white donors. CONCLUSION: Successful donation visits according to demographic characteristics need to be placed within the context of all donor visits. Deferral rates indicate that the burden of donor deferral is high. Efforts to expand the diversity of the donor base through recruitment of minority donors may bring additional challenges because certain deferral reasons were proportionally much higher in these groups.

Donation return time at fixed and mobile donation sites.

BACKGROUND: This study investigated the effect of blood donation environment, fixed or mobile with differing sponsor types, on donation return time. STUDY DESIGN AND METHODS: Data from 2006 through 2009 at six US blood centers participating in the Retrovirus Epidemiology Donor Study-II (REDS-II) were used for analysis. Descriptive statistics stratified by whole blood (WB), plateletpheresis (PP), and double red blood cell (R2) donations were obtained for fixed and mobile locations, including median number of donations and median interdonation interval. A survival analysis estimated median return time at fixed and mobile sites, while controlling for censored return times, demographics, blood center, and mandatory recovery times. RESULTS: Two-thirds (67.9%) of WB donations were made at mobile sites, 97.4% of PP donations were made at fixed sites, and R2 donations were equally distributed between fixed and mobile locations. For donations at fixed sites only or alternating between fixed and mobile sites, the highest median numbers of donations were nine and eight, respectively, and the shortest model-adjusted median return times (controlling for mandatory eligibility times of 56 and 112 days) were 36 and 30 days for WB and R2 donations, respectively. For PP donations, the shortest model-adjusted median return time was 23 days at a fixed location and the longest was 693 days at community locations. CONCLUSION: WB, PP, and R2 donors with the shortest time between donations were associated with fixed locations and those alternating between fixed and mobile locations, even after controlling for differing mandatory recovery times for the different blood donation procedures.

Characteristics of post donation information donors and comparison with appropriately deferred donors.

BACKGROUND: Post donation information (PDI) is the most frequently reported biological product deviation (BPD) related to donor suitability and the health history screening process. PDI occurs when a deferrable health history known by the donor is not disclosed, but is subsequently disclosed at a future donation. STUDY DESIGN AND METHODS: PDI and appropriately deferred (AD) donors were identified at six US blood centers from July 1, 2006, to June 30, 2007. PDI and AD donors were categorized according to travel, medical, blood disease or exposure, and high-risk-sexual and high-risk-nonsexual deferrals. Information was obtained from BPD reports and blood center records. Predictors of PDI were identified using an adjusted logistic regression model controlling for select characteristics. RESULTS: There were 2059 PDI and 36,512 AD donors. PDI donors were significantly more likely to be male, older, and more educated than AD donors. Medical and high-risk-sexual PDI donors were more likely to have more than six intervening donations before disclosure of deferrable history. PDI donors with a deferral reason due to high-risk behaviors (both sexual and nonsexual) were 2.3 and 2.6 times more likely to be PDI than the reference group (travel PDI donors). CONCLUSIONS: No previous studies have described the characteristics of PDI donors or examined how PDI donors are different from AD donors for the same deferral reasons. We found that PDIs are more likely in older, male donors with higher levels of education when compared to AD donors.

Deconstructing the risk for malaria in United States donors deferred for travel to Mexico.

BACKGROUND: More than 66,000 blood donors are deferred annually in the United States due to travel to malaria-endemic areas of Mexico. Mexico accounts for the largest share of malaria travel deferrals, yet it has extremely low risk for malaria transmission throughout most of its national territory, suggesting a suboptimal balance between blood safety and availability. This study sought to determine whether donor deferral requirements might be relaxed for parts of Mexico without compromising blood safety. STUDY DESIGN AND METHODS: Travel destination was recorded from a representative sample of presenting blood donors deferred for malaria travel from six blood centers during 2006. We imputed to these donors reporting Mexican travel a risk for acquiring malaria equivalent to Mexican residents in the destination location, adjusted for length of stay. We extrapolated these results to the overall US blood donor population. RESULTS: Risk for malaria in Mexico varies significantly across endemic areas and is greatest in areas infrequently visited by study donors. More than 70% of blood donor deferrals were triggered by travel to the state of Quintana Roo on the Yucatán Peninsula, an area of very low malaria transmission. Eliminating the travel deferral requirement for all areas except the state of Oaxaca might result in the recovery of almost 65,000 blood donors annually at risk of approximately one contaminated unit collected every 20 years. CONCLUSION: Deferral requirements should be relaxed for presenting donors who traveled to areas within Mexico that confer exceptionally small risks for malaria, such as Quintana Roo.

An objective structured clinical examination to evaluate health historian competencies.

BACKGROUND: Post-donation information events in the blood-collection process account for the majority of errors reported to the FDA. An eight-station objective structured clinical examination (OSCE) based on information reported after donation was developed as a competency examination for health historians. STUDY DESIGN AND METHODS: The OSCE measured two individual skill components: history-taking technique (HXE) and ability to record and interpret a medical history (HXI). Donor historians at the Hoxworth Blood Center, University of Cincinnati Medical Center, were examined (n = 56). RESULTS: In general, staff performance was acceptable, but several areas for improvement were identified. Of particular concern were the deferrals associated with the malaria scenarios. The overall reliability score was greater than 0.8 for the total OSCE and HXI. Using the cut score of 0.9, or 90 percent, 10 subjects would not have passed the exam based on the HXE score and one person would not have demonstrated competency based on the HXI score. CONCLUSION: An OSCE is a reliable, valid, and practical method for assessing continued competency in health historians. This form of competency assessment and subsequent retraining may reduce the incidence of errors in information reported after donation and should be further studied as a suitable national standard for assessing competency.