Search

Gay, bisexual and other men who have sex with men (gbMSM) were ineligible to donate blood in most countries since the 1980's. In Canada the deferral period has been incrementally decreased from lifetime to male-to-male sex in the last 3 months. Now a few countries have removed the deferral altogether. Risk models have been utilised to estimate the probability of an HIV positive donation being released into the blood supply and to inform incremental changes to the length of the deferral period. Here we use public health data to estimate the risk of HIV if the gbMSM deferral criteria were removed in Canada. We calculate the risk reduction among heterosexuals based on responses to standard risk questions routinely asked of donors. We assume gbMSM will donate at the same rate as heterosexual males. We apply the same risk reduction principle to HIV incidence and prevalence among gbMSM in the general population to evaluate the HIV risk without gbMSM time deferral. We model three scenarios where risk reduction is varied by assumptions about incidence and compliance with deferral criteria. The estimates for all scenarios were not significantly different to the currently observed scenario which predicts a residual risk of 0.02 HIV positive per million donations (95% CI: 0.000006–0.09). The models predict that removing the gbMSM deferral criteria would result in HIV residual risk similar to currently observed. [ABSTRACT FROM AUTHOR]

SUMMARY Objectives Blood donors in Canada have been tested for Human T-Cell Lymphotropic Virus ( HTLV) since 1990. We report the epidemiology, risk factors and lookback/traceback of HTLV-positive donors/recipients. Methods The annual HTLV rate was calculated from 1990 to 2010. Residual risk was estimated as the product of incidence and window period. Twenty-nine HTLV-positive donors and 116 matched controls (ratio 1 : 4) were interviewed about risk factors. For HTLV-positive donations, lookback investigations involved identification of all previous donations, and attempting to locate and test recipients. Traceback was initiated when transfusion transmission was queried for HTLV-positive blood recipients. All donors of products that the recipient received were identified, with an attempt to locate and test them. Results The HTLV rate decreased from 9·35 per 100 000 donations in 1990 to 1·11 in 2010. The residual risk of infection was 1 in 7·6 million donations. In logistic regression birth overseas ( OR 18·7), history of sexually transmitted diseases ( OR 32·9), sex with unknown background ( OR 5·4) and blood transfusion ( OR 8·9) were significant predictors. In the lookback study, of 109 HTLV-positive donors, 508 components were transfused, of whom 147 recipients were tested and 18 (12%) were positive. All were transfused prior to the implementation of donor testing. Twenty-three traceback investigations were requested involving 324 transfused untested products,of whom 219 (67·6%) of donors were tested and 13 (6%) were positive for HTLV. Conclusions With testing of the blood supply, the risk from HTLV is very low and while most HTLV-positive donors have risk factors, deferrable risk is rare. [ABSTRACT FROM AUTHOR]

SUMMARY Objectives Using population prevalence data for deferrable diseases/conditions we estimated the Canadian population eligible to donate according to three upper-age limit scenarios. Background The donor selection criteria limit the number of potential blood donors but relaxing the upper age criteria could mitigate this. Methods and Materials Forty deferral criteria were identified and their corresponding prevalence data obtained to estimate the number of people excluded by the criteria. The eligible blood donor population was estimated from national census data taking the age limits, deferral criteria and deferral time-period into account. As more than one disease/condition may co-exist, the estimate was adjusted to avoid over-representation. Results Of about 33 million Canadians aged 17 (18 in Québec) to 65, 15·1 million (45·8%) are eligible to donate blood. This number increases to 15·7 million when including people up to 71 years and to 17·1 million in the absence of an upper age limit. Conclusion As about 1·2 million units are collected from 600 000 donors annually, there are more than enough eligible people to meet the need. However, recruitment of donors is challenging and the absence of an upper age limit allows an additional 2 million people to donate. Other countries may wish to consider modification of the upper age criterion to address the effect of an aging population on the blood supply. [ABSTRACT FROM AUTHOR]

Background In the mid-1980s, confidential unit exclusion (CUE) was implemented to permit donors unwilling to admit risk factors in screening to exclude their donation from transfusion. With changes in donor behaviour, epidemiology of disease and improvements in testing, many blood establishments have stopped using it. We evaluated its benefit in Canada, and reported its utility in predicting transmissible-disease (TD) and high-risk behaviour. Study Design and Methods TD-positive donations and incident cases between 2004 and 2008 were analyzed in CUE-safe and CUE-unsafe designated donations. An anonymous survey of 40 000 donors asked about CUE use and risk factors. Results There were 7104 (0·15%) donations designated CUE-unsafe of 4 775 044 donations. Most TD-positive donations were designated CUE-safe (1023/1030, 99·32%) with only seven (0·68%) designated CUE-unsafe. Of 95 incident cases, all were designated CUE-safe including three NAT-yield cases (1 HIV and 2 HCV). In the survey, some donors found the CUE difficult to understand [10·5% (first-time), 3·2% (repeat)], only half thought that the blood would still be tested [48·9% (first-time), 45·9% (repeat)], and about a fifth believed that collection site staff could see their designation. No survey respondents who used the CUE admitted to risk behaviour, but about 1% of donors who designated CUE-safe had high-risk behaviours. Conclusion The data do not provide any indication of a safety benefit from CUE, but CUE use results in a small but constant loss of apparently safe donations. [ABSTRACT FROM AUTHOR]

Transfusion of a bacterially contaminated blood product can have serious consequences. We undertook an electronic survey of representative Canadian hospitals to determine current clinical and laboratory practices for investigating such reactions, prior to the development of national guidelines. There was considerable variability in symptoms and signs that would trigger investigation of possible contamination. The most frequent laboratory investigations performed were aerobic blood cultures of recipients and the residual component. If there is no residual product in the component bag, 36% of respondents would use a segment to perform testing. Guidelines could be helpful in improving and standardizing these practices. [ABSTRACT FROM AUTHOR]

Focuses on the recommendation by the Bayer Advisory Council on Bioethics regarding donations of blood by people who have been exposed to the bovine spongiform encephalopathy (variant Creutzfeldt-Jakob disease). Decision which would exclude those living in infected areas in the United Kingdom and those who had travelled through the area; Survey in Canada on the effects of the denial of blood donors would have on the blood supply.

The article studies the detection of antibody-negative hepatitis C virus (HCV) and HIV-1 in the blood donations conducted by the Canadian Blood Services (CBS). Nucleic acid testing (NAT) for HCV and HIV-1 is conducted through the use of 24 unit minipools. The antibody was screened through HCV 3.0 enzyme immunoassay. The CBS detected viruses which may have been transfused from NAT testing.

Objectives: Estimate HTLV-1/2 (human T-cell lymphotropic viruses) prevalence in Canadian blood donors and the association of demographic variables with infection and their corresponding risk factors., Methods: First-time blood donors in all Canadian provinces (except Quebec) from 1990 to 2022 were included. Blood samples were tested for HTLV-1/2 by enzyme-linked immunoassay, confirmed by Western blot. Multivariable logistic regression with year, age group, sex, region, neighbourhood material deprivation, and ethnocultural composition indices predicted HTLV-1/2. Since 2005, all HTLV-1/2-positive donors (cases) were invited to participate in a risk factor interview, and 4 non-positive donors (controls per case) were matched for age, sex, and region. Case-control predictors of HTLV-1/2 were analyzed using logistic regression., Results: There were 3,085,554 first-time donors from 1990 to 2022. HTLV-1/2 prevalence remained low (12 per 100,000 in 2022, 95% CI 6.4-23.5). The odds ratios predicting HTLV-1/2 were higher in females (2.0, 95% CI 1.5-2.6), older age groups (50 + ; 6.3, 95% CI 4.3-9.2), British Columbia and Ontario, those materially deprived (1.9, 95% CI 1.2-2.9), and those in ethnocultural neighbourhoods (7.5, 95% CI 3.2-17.3). Most HTLV-1/2 in Ontario was HTLV-1, whereas in British Columbia half were HTLV-2. Forty-three of 149 (28.8%) cases and 172 of 413 (41.6%) controls completed an interview. The strongest predictor of HTLV-1/2 in case-control analysis was birth in a high-prevalence country (OR 39.8, 95% CI 7.8-204.3) but about 50% of HTLV-1 and 90% of HTLV-2 were Canadian-born., Conclusion: HTLV-1/2 prevalence is low in blood donors. High-prevalence country of birth accounts for about half of HTLV-1; HTLV-2 positives are usually Canadian-born. HTLV-1/2 transmission likely occurs overseas and within Canada., (© 2024. The Author(s) under exclusive license to The Canadian Public Health Association.)

Background: The two Canadian blood suppliers, Canadian Blood Services and Héma-Québec, removed the time-based deferral for men who have sex with men and adopted criteria assessing sexual risk behaviors. We report the impact of these changes on the safety and adequacy of the Canadian blood supply., Study Design and Methods: Since 2022, all donors are asked if (1) they have had a new partner and (2) more than one sexual partner in the last 3 months. Donors answering yes to either question are asked if they had anal sex in the last 3 months; if yes, they are deferred for 3 months. We followed HIV rates for the 18 months before and 14 (Héma-Québec) or 18 months (Canadian Blood Services) post-implementation and interviewed HIV-positive whole blood donors. We assessed the number and characteristics of whole blood donors answering yes to the two first questions with or without deferral., Results: There were four HIV-positive donations out of 1,492,355 donations pre-implementation and four out of 1,447,772 post-implementation (0.27/100,000 vs. 0.28/100,000, p = 1.00). Post-implementation, one HIV-positive donor was non-compliant with multiple criteria, no risk factors were identified in the others. 3.2% of donors answered yes to questions (1) and/or (2); 0.17% were deferred for a new partner and/or more than one partner and anal sex. Deferral rates were highest in first time, younger donors, and similar in males and females., Conclusion: Implementation of sexual risk behavior donor screening resulted in unchanged HIV rates to date and a manageable deferral rate., (© 2024 AABB.)

Hepatitis B is transmitted sexually, by blood contact, and vertically from mother to child. Chronic hepatitis B is often seen in immigrants from higher-prevalence countries and their Canadian-born children. We assessed the relationship between hepatitis B and social determinants of health. Included were 1,539,869 first-time Canadian blood donors from April 2005 to December 2022. All donations were tested for hepatitis B markers. Logistic regression was fit with chronic hepatitis B as the dependent variable and age, sex, year, and ethnocultural composition and material deprivation quintiles as independent variables. Chronic hepatitis B prevalence was 47.5/100,000 (95% CI 41.5-53.5, years 2017-2022). Chronic hepatitis B prevalence was elevated in males, older age groups, and those living in more materially deprived and higher ethnocultural neighbourhoods. Of 212,518 donors from 2020 to 2022 with race/ethnicity data, chronic hepatitis B prevalence was highest in East Asians. The findings are consistent with infections in immigrants, acquired in their country of origin, in their Canadian-born children and in those with other risks. As blood donors are a low-risk population unaware of their infection and unlikely to seek testing, our results highlight the ongoing public health challenges of diagnosing chronic hepatitis B and treating it when appropriate.

Background and Objectives: In Canada, the time deferral for gay, bisexual and other men who have sex with men (gbMSM) to donate blood has gradually decreased. In September 2022, this deferral was replaced with sexual behaviour-based screening for all donors. We investigate how data from targeted research programmes addressed knowledge gaps to support this change., Materials and Methods: We conducted a scoping review describing the Canadian literature available before the research programmes relating to (1) behavioural indicators of HIV risk and (2) attitudes to blood donation among gbMSM, current donors and the general population. We summarize the targeted research programmes, their outputs and impact to date., Results: For question 1, five projects met inclusion criteria. For question 2, three articles met inclusion criteria. Knowledge gaps identified were insufficient evidence of HIV incidence in gbMSM who met other donor eligibility criteria and scant data on opinions and views of blood donation and screening criteria for sexual risk behaviours. The research programmes funded 19 projects at 11 different research sites involving over 100 individual researchers/collaborators resulting in 19 peer-reviewed publications to date. Leveraging existing gbMSM cohorts yielded relevant HIV incidence data to inform safety modelling studies. Findings indicated that sexual behaviour-based screening was acceptable to gbMSM and donors, and donor discomfort around specific questions could be mitigated with clear explanations., Conclusion: Targeted research programmes filled critical knowledge gaps and informed a change to gender-neutral, sexual behaviour-based screening for all donors. Findings supported successful implementation of these changes with research-informed staff training., (© 2023 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Background and Objectives: The distribution of rare and specific red cell phenotypes varies between races and ethnicities. Therefore, the most compatible red cell units for patients with haemoglobinopathies and other rare blood requirements are most likely to be found in donors from similar genetic backgrounds. Our blood service introduced a voluntary question asking donors to provide their racial background/ethnicity. Results triggered additional phenotyping and/or genotyping., Materials and Methods: We analysed the results of additional testing performed between January 2021 and June 2022, and rare donors were added to the Rare Blood Donor database. We determined the incidence of various rare phenotypes and blood group alleles based on donor race/ethnicity., Results: Over 95% of donors answered the voluntary question; 715 samples were tested, and 25 donors were added to the Rare Blood Donor database, including five k-, four U-, two Jk(a-b-) and two D- - phenotypes., Conclusion: Asking donors about their race/ethnicity was well received by donors, and the resulting selective testing enabled us to identify individuals with a higher likelihood of being rare blood donors, support patients with rare blood requirements and better understand the incidence of common and rare alleles and red blood cell phenotypes in the Canadian donor population., (© 2023 International Society of Blood Transfusion.)

Background: Canada has incrementally reduced restrictions to blood and plasma donation that impact men who have sex with men, gay, bisexual, and queer men, and some Two Spirit, transgender and non-binary individuals (MSM/2SGBTQ+). Prior to the launch of a pilot program in 2021 enabling some MSM/2SGBTQ + to donate source plasma, we explored the acceptability of the program among individuals who could become eligible to donate in the program., Methods: We invited men identifying as MSM/2SGBTQ + to participate in two consecutive semi-structured interviews to explore their views on blood and plasma donation policy, plasma donation, and the proposed Canadian plasma donation program. Interview transcripts were analyzed thematically and acceptability-related themes were mapped onto the Theoretical Framework of Acceptability., Results: Twenty-seven men identifying as having sex with men participated in 53 interviews. Eighteen themes were mapped onto the seven construct domains of the Theoretical Framework of Acceptability. Underlying all aspects of acceptability was a tension between four primary values influencing participants' views: altruism, equity, supply sufficiency, and evidence-based policy. The program was viewed as welcome progress on a discriminatory policy, with many excited to participate, yet tension with inequitable aspects of the program undermined support for the program and interest to contribute to it. The high demands of the program are unique for MSM/2SGBTQ + and are only tolerable as part of a program that is an incremental and instrumental step to more equitable donation policies., Conclusion: Findings highlight past experiences of exclusion in Canada as a unique and critical part of the context of the donation experience among MSM/2SGBTQ+. Despite the program's goals of greater inclusivity of MSM/2SGBTQ + individuals, the anticipated experience of the program included continued stigmatization and inequities. Future research should seek to understand the experienced views of MSM/2SGBTQ + donors to ensure that as policies change, policies are implemented equitably., (© 2023. The Author(s).)

Background and Objectives: Policies regarding medication use vary between blood centres. We evaluated medication use in eligible Canadian Blood Services whole blood donors to inform possible process improvements and allow comparisons between donors and the general population., Materials and Methods: All donors are asked about medication use in the last 3 days, and medications and their reason for use are documented in our donor computer system. Donor computer records were reviewed from January 1, 2020, to March 31, 2022 to extract information on medications by donor age and sex; medications were grouped into therapeutic classes. Stability of medication use over time was determined in a random sample of 100 donors who made at least two donations in the study period., Results: One-third of successful (eligible) donors were taking medications; of these, 80% were on one or two medications. Five classes of medication accounted for 72% of medication use, and 13 classes account for 93% of use. Use remains relatively stable over time., Conclusion: Medication use is common, with a few classes accounting for most use. Drop-down lists and storage of information from one donation to the next may enhance efficiency., (© 2022 International Society of Blood Transfusion.)

Background and Objectives: Donor criteria for diabetes vary significantly. We describe our evolving policies for donors with diabetes, their contribution to the Canadian blood supply and their rate of syncopal reactions compared to other donors., Materials and Methods: All donors are asked if they have diabetes and have taken medications in the last 3 days. We assessed donors with diabetes on various medications, the number deferred over time, and syncopal reactions in donors with diabetes and other donors in our donor reaction database., Results: Policy changes allowing type 2 diabetic donors on oral hypoglycaemics alone, type 2 diabetic donors on oral medications and insulin and type 1 diabetic donors (all on insulin) to donate resulted in a decrease in deferrals from 450 to 22 donors annually. Of donors being treated with medication for diabetes, 11% are receiving insulin as part of their treatment. Syncopal reaction rates were low and not statistically different between diabetic and non-diabetic donors, although confidence intervals (CIs) are large., Conclusion: Policies decreased deferrals while maintaining safety. A longer observation period would strengthen these observations., (© 2022 International Society of Blood Transfusion.)

Background: To reduce the risk of HIV transmission through transfusion, gay, bisexual and other men who have sex with men (gbMSM) are deferred from donating blood in many countries for varying lengths of time after having sex with another man. In 2021, screening algorithms to identify high-risk sexual behaviours using gender-neutral criteria (i.e., without any question on MSM or time deferral for MSM) were implemented in the United Kingdom based on recommendations in a report from the FAIR (For the Assessment of Individualised Risk) steering group., Objectives: This study examines the potential donation loss expected with these criteria if implemented in Canada., Methods: Responses from blood donors regarding engagement in behaviours such as chemsex and anal sex with a new or multiple partners within 3 months of donation were collected using an on-site paper questionnaire., Results: Applying the FAIR criteria resulted in donation loss of 1.0% (95% CI: 0.8% - 1.1%). Donation loss would be higher amongst younger donors aged 17-25 (2.0%, 95% CI: 1.6% - 2.3%). Overall, 20% of donors reported feeling uncomfortable answering study questions but only 2.0% said it would stop them from donating., Conclusion: Donation loss could be compensated by newly eligible gbMSM and with increased recruitment and encouraging donation from infrequent donors., (© 2022 British Blood Transfusion Society.)

Background: Canadian Blood Services introduced new eligibility criteria that allows some sexually active gay, bisexual, and other men who have sex with men (gbMSM) to donate source plasma, marking a significant change from time-based deferral criteria. We aimed to identify potential barriers and enablers to implementing the new criteria from the perspective of donor center staff., Study Design and Methods: We conducted Theoretical Domains Framework-informed interviews with staff from two source plasma donation centers in Canada., Results: We completed 28 interviews between June 2020 and April 2021. Three themes representing eight domains captured key tensions. Valuing inclusive eligibility criteria: staff support inclusive criteria; many were concerned the new criteria remained discriminatory. Investing in positive donor experiences: staff wished to foster positive donor experiences; however, they worried gbMSM donors would express anger and disappointment regarding the new criteria, staff would experience unease over using stigmatizing criteria and convey nonverbal cues of discomfort, and recurring plasma donors may behave inappropriately. Supporting education, training, and transparency of eligibility criteria: participants believed providing in-person training (i.e., to explain criteria rationale, address discomfort, practice responding to donor questions) and ensuring donors and the public were well-informed of the upcoming changes would improve implementation., Discussion: Participant views emphasize the importance of supporting staff through training and transparent communication to optimize the delivery of world-class equitable care for a new cohort of donors who have previously been excluded from plasma donation. Findings inform which staff supports to consider to improve implementation as policies continue to shift internationally., (© 2022 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background and Objectives: Iron depletion is a side effect of blood donation. Agencies have developed policies to test donors and to extend inter-donation intervals (IDIs) for individuals with low ferritin levels. Ferritin testing, however, has an impact on product availability due to longer IDIs and the effect of test results on donor behaviour. In this paper we apply a model to evaluate the impact of ferritin testing in the Canadian donor population on whole blood donations., Materials and Methods: A discrete event simulation was adopted for the study. The model represents a population of individuals that donate blood, are tested for ferritin levels, and may exit the system. Data for the simulation was derived from operational data, donor research studies from Canadian Blood Services and previously published sources., Results: Red cell collections will decline by at least 3.1% and could decline by as much as 19.2% after ferritin testing is put in place. Requirements for new donors could rise by as much as 36.0%., Conclusion: The impact of ferritin testing on repeat donor behaviour, rather than extensions to the mandated inter-donation interval, is the largest factor influencing declines in whole blood donations. Because behaviour changes following the receipt of a low ferritin result, blood agencies must ensure that donors with low ferritin are motivated to modify their lifestyle and, when healthy, return to the donor pool., (© 2021 International Society of Blood Transfusion.)

Background: In Canada, the deferral for men who have sex with men (MSM) has been progressively reduced from a permanent deferral for MSM since 1977, to 5 years, 1 year, and, most recently, 3 months. We estimated human immunodeficiency virus (HIV) residual risk and compliance with the MSM time deferral after each change., Methods: Four anonymous online compliance surveys were carried out before and after each change. HIV incidence and prevalence were monitored from 2010 to 2021. Residual risk was estimated using the incidence-window period model., Results: Human immunodeficiency virus prevalence, incidence, and residual risk did not change with incrementally shorter MSM deferrals. The residual risk per million donations post 3-month deferral was 0.05 (0.001-0.371). Men with temporally remote MSM history became eligible and, therefore, compliant as the deferral periods decreased (Cochran-Armitage p value = <.0001). However, the percentage of men with MSM history in the last 3 months with the indefinite deferral in place was similar to the percentage noncompliant, while the 3-month deferral was in place. MSM donors did not report high-risk behaviors for which they would otherwise be deferred in any survey. Following the change, an estimated 4467 MSM per year were eligible to donate, an increase from 2501 estimated eligible MSM donors following the change to the 1-year deferral., Conclusion: With progressively shorter MSM deferral periods, HIV residual risk was unchanged. The proportion of male donors with deferrable MSM history remained low, while those with temporally remote MSM history became eligible, increasing the number of eligible MSM donors., (© 2021 AABB.)

Every blood center must determine blood donor eligibility criteria for donors with medical conditions, often based on very limited published data and variable practice. This manuscript briefly outlines possible impacts of donor medical conditions on donor and recipient safety and product quality, and describes the multidisciplinary approach used in Canada to think about donor criteria issues. Many years of experience are distilled into practical considerations in determining criteria, possible sources of information, and factors for successful change implementation, to hopefully assist medical and technical staff engaged in decision-making around donor eligibility., (© 2021 AABB.)

Background: There are several strategies to reduce donor reactions. We report donor participation and reaction rates before and after implementing multiple measures at Canadian Blood Services., Study Design and Methods: We introduced a structured program of 500 mL of water and a salty snack pre-donation and applied muscle tension (AMT) during donation. Donors were not deferred for out of range blood pressure (BP); however, BP was measured in first time donors. Time on the donation chair post-donation was decreased from 5 to 2 min for repeat donors. We assessed participation rates using our quarterly survey of 10,000 recent donors. We extracted vasovagal reactions with loss of consciousness (LOC) from our operational database and compared pre-implementation (Oct 12,018-March 31,2019) and post-implementation (Oct 12,019-March 31,2020) periods., Results: Survey response rates varied from 11% to 16%. The percentage of donors who drank the water and ate the salty snack increased from 58% to 82% and 44% to 70% over 4 quarters; those performing AMT increased from 24% to 41%. Reactions decreased from 19.07 per 10,000 (744 reactions in 390,123 donations) to 14.04 per 10,000 (537 in 382,382 donations) (p < .0001). No first-time donors with high BP (n = 684) but 5 with low BP (n = 718) had reactions, CI were very large., Conclusions: Achieving optimal participation was challenging. After implementation of a donor wellness initiative based on best practice, rates of vasovagal reactions with LOC decreased by 25%. A larger dataset is necessary to assess the safety contribution of BP deferrals when other mitigation measures are in place., (© 2021 AABB.)

Background: Alternative screening questions could permit low-risk men who have sex with men (MSM) to donate blood without a time deferral. We performed a study to determine the proportion of current donors who may be deferred by various questions and their comfort with them., Study Design and Methods: Donors attending collection sites in Canada in January and February 2018 were offered one of two questionnaires but not both. Questionnaire 1 asked about risk behaviors; Questionnaire 2 rated comfort with the questions. Volunteers uncomfortable with questions participated in short qualitative telephone interviews to understand reasons. Quantitative data were analyzed using χ 2 statistics., Results: Of 36 241 donors attending, 31 904 (88%, Period 1) completed Questionnaire 1; of 34 947, a total of 30 278 (87%, Period 2) completed Questionnaire 2; 294 completed an interview. In the past 3 months 3.1% (95% confidence interval [CI], 3.1%-3.6%) had more than one partner; 6.0% (95% CI, 5.7%-6.2%) had a new partner; 6.7% (95% CI, 6.4%-6.9%) were in a nonexclusive relationship; 11.2% (95% CI, 10.9%-11.6%) had at least one of these; 3.7% (95% CI, 3.4%-3.9%) had anal sex; and 62.8% (95% CI, 62.2%-63.3%) had condomless sex. More than 6% were uncomfortable with each question, but more (17.2%; 95% CI, 16.8%-17.7%) were uncomfortable with anal sex. Key reasons for discomfort were questions being too personal and unclear safety benefit., Conclusion: Most donors are comfortable answering alternative questions (except very personal ones) but question the benefit. Implementing alternative questions would result in substantive deferrals. Other policies such as using an MSM capture question to ask additional questions only to MSM should be considered., (© 2020 AABB.)

Background: At Canadian Blood Services, platelet concentrate (PC) shelf life was extended to 7 days with a large-volume, delayed-sampling bacterial screening algorithm. We present the development study and postimplementation results., Study Design and Methods: In the development study, PCs inoculated with five bacteria (various concentrations) were incubated for 7 days with daily sampling for BacT/ALERT cultures and bacterial quantification. After implementation, from August 2017 to December 2019, a total of 223 156 pools and 39 725 apheresis units and 5310 outdated PCs were screened. Since March 2018, cocomponents associated to false-positive results have been released to inventory., Results: In the development study, Klebsiella pneumoniae, Serratia marcescens, and Staphylococcus aureus were detected at concentrations of at least 0.01 colony-forming units (CFUs)/mL at 24 hours postinoculation. However, Staphylococcus epidermidis was detected at concentrations of less than 0.16 CFUs/mL only more than 48 hours postinoculation. After implementation, 776 (0.35%) and 303 (0.77%) initial-positive results and 201 (0.09%) and 16 (0.04%) confirmed-positive results were obtained for pools and apheresis units, respectively, predominantly with Cutibacterium acnes. Other organisms included staphylococci, streptococci, Klebsiella oxytoca and Pseudomonas aeruginosa. One nonfatal reaction involving a 7-day pool contaminated with S. epidermidis occurred. Approximately, 1-in-1000 false-negative screening results were obtained during testing of outdated PCs. Approximately 1000 cocomponents associated with false-positive results were released into inventory. Combined PC outdating at Canadian Blood Services and hospitals was reduced from 18.9% to 13.1%., Conclusion: Screening of 7-day PCs increased bacterial detection mainly of anaerobes and reduced outdating. The incidence of septic transfusion events has decreased approximately threefold. A longer surveillance period is needed to evaluate the value of anaerobic cultures and residual safety risk., (© 2020 AABB.)

Background: Blood donation policy in Canada for gay, bisexual and other men who have had sex with men (gbMSM) has changed progressively in the last decade from indefinite deferral to 3-month deferral from last male-to-male sex. Driven by safety data and overseen by the national regulator, more inclusive policies continue to redress the disparity in donation for gbMSM. At the same time, the need for source plasma to prepare fractionated blood products is growing worldwide. The collection and processing of source plasma ensures greater safety compared to whole blood donation with respect to transfusion-transmitted infection. This greater safety offers an opportunity to evolve policies for gbMSM from time-based to behaviour-based deferral using revised eligibility criteria. However, changing policies does not in itself necessarily guarantee that gbMSM will donate or that staff in donor clinics are ready to support them to do so. In anticipation of a move to behaviour-based donation screening for gbMSM in Canada, we aim to assess the acceptability of and perceived barriers and enablers to source plasma donation using revised screening criteria for gbMSM among key stakeholders to inform policy implementation strategies., Methods: This mixed-methods feasibility study will involve gbMSM and donor centre staff to understand modifiable barriers to implementing more inclusive eligibility criteria. Key informant interviews and surveys will be rooted in the Theoretical Domains Framework to identify modifiable factors associated with source plasma donation motives in gbMSM and training needs in donation centre staff. We will use an integrated knowledge translation approach involving a partnership between researchers, the national blood operator and gbMSM, situating knowledge users as key research team members to ensure their perspectives inform all aspects of the research., Discussion: Our integrated knowledge translation approach will provide a more comprehensive and collaborative understanding of blood operator and gbMSM needs while accelerating the implementation of study findings. Given the historical backdrop of the decades of exclusion of sexually active gbMSM from blood donation, this study has the potential not only to inform a process and policy for gbMSM to donate source plasma, a blood product, but also offers opportunities for new relationships between these knowledge users.

Background: Intravenous immunoglobulin (IVIG) is a fractionated plasma product used to treat a range of autoimmune or inflammatory conditions, as well as immunodeficiency. Demand for this high-cost product is increasing worldwide. Understanding historical changes in IVIG use is important for inventory management and demand forecasting as well as for the development of initiatives aimed at optimizing blood product use., Study Design and Methods: This was a 10-year retrospective cohort study of all patient encounters involving an IVIG transfusion from 2007 to 2016 at a four-site tertiary care hospital in Ontario, Canada. IVIG use was reported, including number of hospital encounters and amounts of IVIG prescribed. An interrupted time series analysis was performed to evaluate temporal changes in product use coinciding with the release of 2009-2010 provincial initiatives to optimize IVIG., Results: A total of 1,658,159.50 g of IVIG was administered from 2007 to 2016. Total annual volume administered initially decreased after implementation of new policies (-2032 g/quarter). The number of IVIG patient encounters also decreased (-49.8 encounters/quarter) but was mirrored by an increase in the total volume administered per patient encounter (+0.88 g/quarter). Use increased 820 g/quarter from 2013 to 2016 but was 21% lower than projected before implementation of provincial policies., Conclusion: Trends in IVIG use show ongoing increases in the number of patients treated with the product. Development and implementation of provincial initiatives to optimize IVIG use coincided with significant short-term changes at a large tertiary care hospital. Novel initiatives aimed at dose minimization and prescription rationalization for this therapy are needed on local as well as larger scales., (© 2019 AABB.)

Background and Objectives: In Canada, transfusion transmission risk of Human T-cell lymphotropic virus -I/II (HTLV) is addressed by universal leucoreduction and universal antibody testing. We aimed to estimate the risk with the current policy, if testing only first-time donors and if testing were stopped., Materials and Methods: Monte Carlo simulation was employed to estimate the proportion of red cell concentrate, random donor platelet and apheresis platelet units that would be released into inventory in each scenario (10 billion donors each). The model estimated the number of HTLV-positive donations not intercepted by testing, randomly assigned the number of HTLV particles/100 leucocytes using proportions from published data and randomly selected a postleucoreduction leucocyte count from quality control data. Units were considered infectious if ≥9 × 10 4 copies of HTLV provirus., Results: With universal leucoreduction in place, the residual risk of releasing an HTLV potentially infectious unit with universal testing was 1 in 1·2 billion units (0, 1 in 55·9 million), with testing only first-time donors 1 in 7·1 million (0, 1 in 1·05 million) and with no testing 1 in 1·0 million (0, 1 in 178 600). The efficacy of leucoreduction was >99·5% (lower bound 95·7%) for all scenarios., Conclusion: With universal leucoreduction in place, switching from universal testing to testing first-time donors would incur very low risk., (© 2018 International Society of Blood Transfusion.)

Background: To reduce the risk of variant Creutzfeldt-Jakob disease (vCJD) transmission via blood transfusion in Canada, potential donors who spent a cumulative time in the United Kingdom, Western Europe or Saudi Arabia are deferred. "Stop dates" for accumulated time were later implemented for 3 months spent in the United Kingdom or France (1980-1996) and for 5 years elsewhere in Western Europe (1980-2007); Saudi Arabia deferral was implemented with the "stop date" (1980-1996). We evaluated the long-term impact of these deferrals and "stop dates", as well as the consistency of donors' answers to post-implementation screening questions., Materials and Methods: The monthly deferral rate was monitored from 2003-2015. Time series methods (ARIMA) were used with interruption when "stop dates" were implemented. A telephone survey of 1,000 donors (250 first-time, 500 repeat deferred donors, 250 non-deferred control donors) assessed travel history (response rate 62%). An anonymous mail survey of 40,000 donors assessed compliance with deferral (response rate 45.3%)., Results: When the "stop date" for UK/France travel was implemented, the deferral rate decreased for first-time (2.1% to 1.1%, p<0.0001) and repeat (0.2% to 0.03%, p<0.0001) donors. The deferral rate increased after Saudi Arabia was included (mean increase of 0.4% first-time, 0.02% repeat, p<0.0001). After the Western Europe "stop date" the deferral rate was unchanged in first-time donors (1.0% to 1.1%, p=0.5) but decreased in repeat donors (0.03% to 0.02%, p<0.002). In the telephone survey, 94% of deferred donors confirmed deferrable travel history. In the anonymous survey 0.3% of donors were non-compliant with the UK/France deferral., Discussion: Donors, particularly first-time ones, continue to be lost due to vCJD travel deferral, but most deferrals are correctly applied and non-compliance is rare. The application of a "stop date" reduced deferrals for UK/France travel, but it may be too early to see the full impact of the "stop date" for Western Europe.

Background: Anti-KEL1(K) is a major cause of hemolytic disease of the fetus and newborn. We utilized data from prenatal testing of patients in Western Canada to determine the frequency of anti-K. In Manitoba, we evaluated the frequency of transfusion as the likely cause for alloimmunization. We reviewed international practices to prevent alloimmunization., Study Design and Methods: Prenatal patients undergo antibody screening using an automated testing platform and uniform testing algorithm. Data on the frequency of antibodies, transfusion history, and donor K typing were extracted from the relevant databases at Canadian Blood Services. National standards were reviewed with the help of local experts., Results: Anti-K was found in 397 of 390,193 patients from 2011 to 2013 (1.02 per 1000) and was the second most frequent antibody after anti-E. In Manitoba, 26 of 75 (35%) anti-K patients had received transfusions in the province since 2001; 14 of the 26 (54%) had received at least one K+ RBC unit and three had received all K- units, while in nine, donor K typing was incomplete. Only eight of the 26 had previous pregnancies, three with K+ partners. International practice varies; however, prophylactic use of matched or K- units is standard in many European countries., Conclusions: Anti-K was found in 0.1% of prenatal patients. Although our data on the history of transfusion are incomplete, they demonstrate that transfusion with a K+ unit is a major cause of alloimmunization. Given advances in phenotyping and genotyping technologies, prophylactic matching should be considered in Canada., (© 2015 AABB.)

Background: To investigate the long-term consequences of repeated plasmapheresis on donor health, their donation histories and demographic data were reviewed to determine the frequency of development of monoclonal (Mc) gammopathies or other gamma globulin abnormalities (OGGAs)., Study Design and Methods: Samples from apheresis plasma donors collected at Canadian Blood Services were tested initially and every 4 months for total protein (TP) followed by serum protein electrophoresis (SPE). Out-of-range samples or those showing abnormal band patterns were forwarded to a hospital laboratory for additional investigation., Results: Of 52,972 donors who donated 471,446 apheresis plasmas over 9 years, 89,490 samples were sent for TP and SPE testing. Of 3005 samples forwarded for further investigation, abnormal immunofixation electrophoresis (IFE) results were found in 209 (0.4%) donors, 85 from first-time (FT) and 124 from repeat (RPT) plasma donors during participation in the program. There were 167 donors with Mc gammopathies (73 FT, 94 RPT) and 42 with OGGAs (12 FT, 30 RPT). FT or RPT donors with Mc gammopathies or OGGAs were significantly older than those with normal SPEs. RPT donors with Mc gammopathies or OGGAs also had a longer donation period than donors with normal SPEs., Conclusions: The incidence of Mc gammopathies (2.41 per 1000 donors) did not significantly increase from 2004 to 2012. Older donors had a higher incidence of Mc gammopathies and longer donation periods than their healthy counterparts. Overall, gammopathy rates were below those reported over the same age range in the general population., (© 2015 AABB.)

Correct donor D typing is critical to prevent recipient alloimmunization. No method can detect all variants, and the immunogenicity of many variants is unknown. Routine ABO and D serologic typings are performed in our laboratory by automated microplate testing. Until 2011, routine confirmation of D- status of first-time donors was performed by the manual tube indirect antiglobulin test (IAT); this was replaced by automated solid-phase testing including weak D testing by IAT. Selected donors are investigated by other methods. We describe four weak D type 67 (RHD*01W.67) donors whose samples tested as D- by automated microplate and manual methods but were later determined to be D+ by automated solid-phase and RHD gene analysis. Solid-phase serologic and molecular typing results of all four donors were identical. It was identified that the donors are of English-Irish descent; two are brothers and the others are cousins. Transfusion of blood from one of these donors likely resulted in alloimmunization to D in one of three recipients tested since no other documented exposures were identified. Lookback studies determined that two other D- recipients were not alloimmunized.

Background: Travel to malaria risk areas such as Mexico is a common source of donor deferral in Canada. On February 21st, 2011 the deferrable regions in Mexico were revised to permit donation if donors travelled to the state of Quintana Roo, Mexico, a popular ocean-side resort area., Materials and Methods: Canadian travel data and malaria deferral rates since 2007 were plotted to examine trends. Deferral records in one centre were accessed from January to April, 2011 to tabulate travel destinations of deferred donors immediately before and after the change., Results: Travel to Mexico and the Caribbean accounts for 63% of general population travel, and travel to Mexico has been increasing (P <0.05). Deferral for short-term malaria risk travel has a strong seasonal trend with peaks in the winter and troughs in the summer. Approximately 36,000 fewer donations were lost following the change, a reduction of 37% from the previous year. Deferrals in one centre increased for Caribbean/Central America after the change (P <0.05) consistent with the seasonal trend, but decreased for Mexico (P <0.05)., Discussion: Deferrals for malaria risk travel are substantial. Careful revision and refinement of risk areas of travel can significantly reduce the burden of deferral.

Background: Various testing strategies may reduce the risk of Chagas disease transmission in nonendemic, low-prevalence countries. Results of the first year of selective testing of at-risk donors at Canadian Blood Services are reported., Study Design and Methods: Since February 2009, platelets were not produced from at-risk donors. Since May 2010, at-risk donors were tested for Trypanosoma cruzi antibodies. Donors testing positive were interviewed about risk factors, and lookback studies were initiated., Results: There were 7255 at-risk donors of 421,979 donors screened (1.72%). Risk factors were born in Latin America (50.6%), mother or maternal grandmother born in Latin America (28%), and 6 months or more travel history or residence in Latin America (19%). Sixteen (16) at-risk donors had T. cruzi repeat-reactive test results of whom 13 confirmed positive. Eleven of 13 were born in Latin America (nine in Paraguay and two in Argentina), and the other two were born in Canada but had short-term travel history and mothers who had been born in Latin America. Ten of the donors spoke German as their first language (all of those born in Paraguay and one born in Canada). There were 148 previous donations (176 components transfused) evaluated by lookback, of which 28% of recipients could be tested. None were positive., Conclusion: Selective testing has mitigated a small risk to the blood supply with very few false-positive results. Most positive donors were born in a risk country, with a concentration of German-speaking immigrants from Paraguay. Residency or travel alone were not clear risk factors., (© 2012 American Association of Blood Banks.)

Background: Hemoglobin (Hgb) determination is an essential part of donor qualification. We assessed and implemented a new spectrophotometer for donor Hgb determination., Study Design and Methods: Precision, accuracy, and ease of use were assessed on a prototype DiaSpect analyzer (DiaSpect Medical, GmBH, Sailauf, Germany). A protocol to qualify the analyzer was developed and executed preimplementation. Samples were developed for periodic quality control (QC). Postimplementation performance was assessed based on QC results and trending of deferral rates., Results: Precision was excellent, with a coefficient of variation of 0.53%-1.14% per sample. The correlation coefficient between capillary DiaSpect and venous laboratory autoanalyzer measurements was 0.736. After 169 out of 223 analyzers failed to qualify on our initial protocol, all were successfully qualified with the use of a modified protocol, adjusted to avoid sources of variability. Because commercial controls proved inadequate, in-house samples were developed for periodic QC. Postimplementation, all analyzers had adequate QC results. Deferral rates decreased from 10.1 to 8.1% (p < 0.0001) for female donors and from 0.8 to 0.6% for male donors (p < 0.0001). The system was faster and easier to use compared with our previous two-step process., Conclusion: We successfully implemented a new spectrophotometer, which resulted in greater efficiency, improved ease of use, and decreased deferrals., (© 2012 American Association of Blood Banks.)

Background: Blood operators have taken measures to reduce transfusion-related acute lung injury (TRALI). We classified suspected TRALI cases reported to Canadian Blood Services from 2001 to 2009 and assessed the impact of TRALI reduction measures., Study Design and Methods: Using Canadian Consensus Conference definitions, cases were reviewed by two experts or, from 2006 to 2009, a TRALI Medical Review Group (TMRG). Detection of HLA antibodies was performed using the Luminex system starting in 2008. Measures implemented from 2007 to 2009 included use of predominantly male plasma, suspension of buffy coat platelets in male plasma, and deferral of females with a pregnancy history from plateletpheresis. The buffy coat production method was implemented from 2005 to 2008., Results: Reporting of all suspected TRALI cases, as well as cases classified as definite or possible, increased from 2001 to 2004, was stable from 2004 to 2007, and declined in 2008 to 2009. The decline was most marked for plasma-associated cases, but occurred for all components. TMRG consensus on classification was achieved in 56% of cases. Cases identified as definitive or possible TRALI were significantly more likely to have donor antibody against a corresponding recipient antigen, compared to other cases., Conclusion: Hemovigilance data demonstrated an initial increase in TRALI cases, likely due to increased adverse event reporting and awareness of TRALI, followed by a decrease in cases related to all components. TRALI prevention measures and possibly the switch to the buffy coat production method may have contributed to the decline. Classification of cases remains challenging., (© 2011 American Association of Blood Banks.)

Background: Bacterial contamination of platelet components (PCs) remains an important cause of transfusion-associated infectious risk. In 2004, Canadian Blood Services (CBS) implemented bacterial testing of PCs using the BacT/ALERT 3D system (bioMérieux). This system has been validated and implemented and continuous monitoring of culture rates allows gathering of data regarding true and false positives as well as false negatives., Study Design and Methods: National data gathered between March 2004 and October 2010 from 12 CBS sites were analyzed to compare bacterial contamination rates across three platelet (PLT) preparation methods: apheresis, buffy coat, and PLT-rich plasma. Data were compared before and after implementation of protocol changes that may affect bacterial detection or contamination rates., Results: Initial positive rates among the three production methods were significantly different, with apheresis PCs being the highest. The rates of confirmed positives among production methods did not differ significantly (p = 0.668). Increasing sample testing volumes from 4 to 6 mL to 8 to 10 mL significantly increased the rate of initial positives, while confirmed positives increased from 0.64 to 1.63 per 10,000, approaching significance (p = 0.055). Changing the skin disinfection method from a two-step to a one-step protocol did not significantly alter the rate of confirmed positives. During the period of data analysis, eight false-negative cases were reported, with five implicated in adverse transfusion reactions., Conclusion: Bacterial testing of PCs and implementation of improved protocols are incrementally effective in reducing the risk of transfusion of bacterially contaminated PLT concentrates; however, the continued occurrence of false-negative results means the risk has not been eliminated., (© 2011 American Association of Blood Banks.)

Background: The Canadian blood supply has been screened for West Nile virus (WNV) since 2003. A strategy for targeted individual-donation nucleic acid testing (ID-NAT) was implemented in 2004 to identify potentially infectious donations that may be missed by minipool (MP) testing. In 2007, Canada experienced a larger epidemic than in previous years providing an opportunity to evaluate the ID-NAT triggering algorithm in higher-risk areas., Study Design and Methods: A specially created database and internal-external communication identified regions for targeted ID-NAT using MP and community triggers. WNV-positive donations identified by ID-NAT were reexamined in MP to assess the efficacy of targeted ID-NAT in identifying potentially infectious donations that may have been missed by MP testing. WNV-positive donation data from 2006 and 2007 were analyzed to examine temporal and geographic trends. A telephone survey about symptoms was carried out after the 2007 season., Results: In total 78 WNV-positive donations were identified (66 true-positives and four false-positives being in 2007). Most positive donations were in the late summer, concentrated in the same western provinces as community cases. Fifty-two donations were identified by ID-NAT and 46% were consistently positive in MP. Of the other 54%, 74% were immunoglobulin (Ig)M- and/or IgG-positive. Fifty-six percent of donors experienced mostly mild symptoms before or after donation (but all said they were well at the time of donation)., Conclusion: WNV-positive donations correspond geographically with the epidemic. MP testing identifies most potentially infectious donations with a smaller potential benefit from targeted ID-NAT. Mild symptoms are common but may not deter donation.

Background: Optimal skin disinfection ensures blood safety. In this study, efficacies of the two-step skin disinfection methods used at Canadian Blood Services (CBS) and two one-step methods produced by different manufacturers were compared., Study Design and Methods: In each of the three phases of the study, two methods were compared by disinfection of the antecubital fossae of study subjects. The two-step methods were compared in Phase I: Method A (isopropyl alcohol scrub and iodine tincture ampule) and Method B (isopropyl alcohol and chlorhexidine scrub and isopropyl alcohol and chlorhexidine ampule). In Phases II and III, Method B was compared to two different one-step swab sticks containing isopropyl alcohol and chlorhexidine (Methods C and D). Contact plates were applied on each of the subjects before and after disinfection and incubated at 37 degrees C for 24 hours followed by colony counting., Results: In 99% of the subjects, colonies per plate were reduced from approximately 60 to less than 10 after disinfection using any method. Method B was superior to Method A (p < 0.05) but was not significantly different from Methods C and D. Method D was implemented for skin disinfection at CBS with no significant effects on blood product contamination. Skin reactions increased from approximately 0.02% to approximately 0.62% after implementation, which were subsequently reduced to approximately 0.04%., Conclusion: In this study, isopropyl alcohol and chlorhexidine disinfectants were more efficacious than isopropyl alcohol and iodine. There was no difference in efficacy between one-step and two-step procedures or between methods of application. A one-step chlorhexidine and isopropyl alcohol kit has been successfully implemented at CBS.

An HLA-matched sibling remains the optimal donor for most patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Marked declines in total fertility rates in Canada over the past 50 years will lead to increasing numbers of patients without sibling donors well into the future. We retrieved transplantation data from a Canadian center and the Canadian Blood and Marrow Transplant Group and total fertility data from the United Nations Department of Economic and Social Affairs. The mean age of adults with acute myelogenous leukemia (AML), who underwent transplantation at The Ottawa Hospital between 1995 and 2004, was 41 +/- 12 years (n = 87). The chance of finding 1 or more HLA-matched sibling donors for a patient with AML treated in 2002 is reflected by the total fertility rate in 1961 (average birth year for patients and sibling donors). The sibling rate for 1961 is the total fertility rate-1.0, or 2.68. The chance of having 1 or more HLA-matched sibling is 53.7% (1-chances of no matched sibling, or 1 - 0.75(2.68)). In 2009, the chance of identifying a matched sibling is only 37.1%, because of declining total fertility rates. Following this trend, this chance will be 24.6% in 2014 and 16.6% in 2024. Greater reliance on alternative donors, such as umbilical cord blood (UCB) and HLA-mismatched donors, can be anticipated. The issue of declining fertility rates appears to be regional, and the impact on transplantation will be more pronounced in Canada than in other developed nations.

Background: The expected donor loss from recent implementation of antibody to hepatitis B core antigen (anti-HBc) testing in Canada was uncertain but potentially significant based on US experience. To reduce donor loss from false-reactive tests, repeat-reactive donors without other evidence of infection were eligible to return. The aim was to evaluate the impact of anti-HBc testing on donor loss and to evaluate the effectiveness of this policy., Study Design and Methods: For each donor in the first year of implementation (April 9, 2005-April 8, 2006) repeat-reactive for the presence of anti-HBc only but eligible to return (screening test for hepatitis B surface antigen-negative, plus not reactive to antibody to hepatitis B surface antigen [anti-HBs] and hepatitis B virus [HBV] DNA supplemental tests), 10 matched donors not reactive to the anti-HBc assay were selected. Return rates over 2 years were compared using conditional logistic regression. Testing outcomes were tabulated., Results: Over the first year of testing, 412,236 donors (951,423 donations) were tested for anti-HBc, and 4,489 donors were repeat-reactive (1.3% of first-time donors, 1.0% of repeat donors). Of these 85.6 percent were also reactive for the presence of anti-HBs and/or HBV DNA supplemental tests leaving less than 15 percent eligible to return, of whom 73 percent returned (vs. 90% of controls, p < 0.001). Of the 300 anti-HBc repeat-reactive returning donors, 74 percent were anti-HBc repeat-reactive again (thus permanently deferred), 19 percent were deferred for other reasons versus 14 percent of controls (p < 0.05), and 7 percent (21 donors) did not react and were eligible to continue donating., Conclusion: Most donors repeat-reactive for the presence of anti-HBc likely have past exposure to HBV. If eligible, most are willing to return, but likely to test anti-HBc repeat-reactive again.

Background: The residual risk of hepatitis B is higher than for other markers such as human immunodeficiency virus and hepatitis C virus in nonendemic countries. Evaluating the potential for further risk reduction requires a better understanding of the relationship between donor selection criteria, immigration from endemic countries, and public health vaccination strategies., Study Design and Methods: Age and sex trends of hepatitis B surface antigen (HBsAg)-positive donors from 1997 to 2006 were analyzed using a Poisson model. All HBsAg-positive donors in 2005/2006 plus four matched control donors for every HBsAg-positive donor who participated were invited to participate in a risk factor interview and predictors of HBsAg positivity identified by logistic regression. A survey of 40,000 donors who did not react for all markers asked about vaccination history and country of birth., Results: Most HBsAg-positive donations were from first-time donors (86%), have been decreasing in donors under the age of 30 (p < 0.01), and were correlated with geographic regions with more donors from higher-prevalence countries (p < 0001). Birth in a higher-prevalence country predicted HBsAg positivity (p < 0.01). Fifty-six percent of donors reported being vaccinated for hepatitis including approximately 80 percent of donors under age 30 who reported being vaccinated as part of regular school programs., Conclusion: HBsAg-positive donations are decreasing in donors under age 30, those most frequently vaccinated through provincial vaccination programs. HBsAg-positive donations largely reflect immigration from high-prevalence countries without other deferrable risk factors, mainly chronic cases that will be detected by current testing. Furthermore, risk of incident infections should decrease with increasing vaccination rates in donors, especially the younger cohort now receiving universal vaccination.

Background: Hepatitis C virus (HCV) rates have decreased steadily in first-time donors in Canada since testing was implemented but reasons are unclear. A description of factors that may have played a role in this decline is reported., Study Design and Methods: Descriptive analysis of first-time blood donors by HCV positivity status and year (1993--2006), sex, and age was carried out. HCV-positive first-time donors and matched controls participated in a confidential scripted telephone interview about risk factors in 1993 through 1994 and in 2005 through 2006, and risk factors independently predicting HCV positivity were determined with multiple logistic regression., Results: HCV-positive donations occurred most frequently in donors born between 1945 and 1964 and decreased in this birth cohort over time (p < 0.01). At present, most first-time donors (74%) are born after 1964. History of intravenous drug use, sex with an intravenous drug user, blood transfusion, and tattoo independently predicted (p < 0.01) HCV positivity in both periods (1993--1994 and 2005--2006)., Conclusion: Most HCV-positive donors were born between 1945 and 1964, and the decline in HCV rates is associated primarily with this birth cohort. The key risk factors predicting HCV positivity did not change over the 13 years of the study. With approximately two-thirds of HCV-positive Canadians in the general population having been tested for HCV, potential donors may be aware of their HCV status and be likely to self-defer. This, and an increasing proportion of first-time donors born after 1964, may contribute to declining HCV rates in first-time donors.

Over the last 20 years, the Canadian Blood Services' (CBS) Donor Health Assessment Questionnaire (DHAQ), used to screen prospective blood donors to determine their eligibility, has grown in complexity and length. Its growth is inextricably linked to the evolution of the environment within which CBS operates from unregulated collection and distribution of labile blood products to a fully regulated environment and to the need to satisfy both Health Canada and US Food and Drug Administration (FDA) requirements. Within this context, the development of the CBS DHAQ has been characterized by addition of questions and items without any periodic reevaluation of the need for retaining existing questions and/or items. In this review, we apply principles from cognitive science relating to how people think when answering questionnaires to the situation of blood donors completing the DHAQ. We show that some items that were added at different times in separate questions, for reasons that were historically relevant, could be now asked more simply with a single question. The historical development of the DHAQ, resulting in the condensing of many items into lists, the use of complex wording, and the sheer number of items included in the questionnaire make accurate retrieval of information from the donor's memory difficult. Thus, we believe that redesigning the DHAQ will improve the quality and accuracy of the donors' answers to screening questions.

Background and Objectives: The upper age limit for allogeneic blood donation varies among countries and blood operators. We assessed the impact of the removal of the upper age limit for donation in Canada from December 2004 to January 2006., Materials and Methods: Starting in December 2004, regular donors were permitted to continue whole blood or apheresis donation past their 71st birthday, provided an annual external medical assessment was performed by their family physician. Regular donors aged from 70 to 74 were sent a letter about the change in criteria, and encouraged to continue donations. Rates of donor adverse reactions and deferrals were calculated for these donors and donors in other age groups., Results: In the 13-month period following implementation of the new criteria, 961 (54%) of regular donors who had received a letter initiated a medical inquiry, and 862 inquiries were completed and returned to Canadian Blood Services. In 98% of cases, the donors' family physician approved ongoing donation. Of the 659 donors who presented to donate, 93% successfully donated. There was only one moderate/severe donor reaction out of 3137 donor attendances for donors aged 71 and older. This rate was not statistically different from the rate in the overall donor population. No donors were deferred for high-risk activities or had positive infectious disease test results., Conclusion: Regular blood donors may safely continue to donate past their 71st birthday. Extra steps in the donation process, such as an external medical inquiry, may not be necessary.

Background: In Canada, both blood suppliers, Héma-Québec (HQ) and Canadian Blood Services (CBS), implemented bacterial testing in apheresis platelets (PLTs) with an automated microbial detection system (BacT/ALERT, bioMérieux)., Study Design and Methods: Validation of the BacT/ALERT Classic and 3D systems involved apheresis PLT spiking with different bacteria at concentrations of 10 and 10(2) colony-forming units per mL. As of February 2006, more than 95 percent of apheresis PLTs were screened for bacterial contamination at HQ and CBS. Between 3.5 and 10 mL of PLTs is inoculated into BacT/ALERT aerobic culture bottles followed by incubation for a maximum of 7 days., Results: During the validation studies, all bacteria were detected at all concentrations and volumes tested. Upon implementation of bacterial screening, the percentage of initial positive samples at CBS and HQ was 0.09 and 0.07 percent, respectively. The rate of indeterminate cultures was significantly higher at CBS than at HQ, whereas the rates for true-positive, false-positive, and false-negative results did not differ significantly. Six confirmed-positive cultures, including three coagulase-negative staphylococci and three Enterobacteriaceae species, were detected and PLT units contaminated with these bacteria were not transfused. The rate of true-positive cultures was significantly lower than that reported by other blood operators. Unfortunately, failed detection of two contaminated units resulted in septic transfusion reactions., Conclusion: Bacterial screening of apheresis PLTs in Canada was successfully implemented, and transfusion of contaminated units was prevented. Rapid bacterial detection systems that could be used before transfusion, however, may further reduce the risk of transfusion reactions.

Background: The donor health assessment questionnaire (DHAQ) plays an important role in ensuring blood safety. The Canadian DHAQ has been developed over many years on an ad hoc basis and has never been evaluated in light of cognitive science principles. In addition, donor attitudes about its mode of administration have not been assessed., Study Design and Methods: Between May and August 2005, a total of 456 donors participated in the study by completing the DHAQ, followed by a short, scripted interview assessing recall (as an indicator of attention to the questions) of 17 specific items queried on the DHAQ and attitudes toward interviewer or self-administration of the DHAQ., Results: Overall, 7.5 percent of donors were able to correctly identify all 17 items. Recall was best for questions asked as individual items (87%-99%) and decreased substantially for items that are part of a list (55%-91%). Position effects were demonstrated, with items at the end of a list being the most frequently forgotten. Twenty percent of repeat donors favored the current practice of interviewer administration of high-risk questions, whereas 80 percent were neutral or favored self-administration., Conclusion: The current format of the Canadian DHAQ is not optimal for donor attention to specific questions asked as part of a list. The majority of repeat donors are ready for a change in the method of administration of the DHAQ. Studies on donor recall may help guide evidence-based changes to the DHAQ.

Background: Targeted hepatitis C virus (HCV) lookback studies have been performed in Canada since 1995. The yield of HCV lookback has not been reassessed since the introduction of improved HCV screening tests., Study Design and Methods: Data were combined from the two Canadian blood suppliers to determine the yield of targeted HCV lookback performed on donors found to be HCV-positive by antibody screening and/or nucleic acid testing (NAT) from the introduction of NAT in 1999 until January 1, 2005., Results: Lookback was performed on 498 donations from 176 HCV-seropositive and two NAT-only-positive donors; 494 components had been transfused, and 160 components were traced to living recipients who underwent HCV testing. Seventy-two percent of recipients of components derived from donations given before the introduction of second-generation enzyme immunoassay (EIA) testing were HCV-seropositive. Four recipients of components derived from donations tested by second- or third-generation EIA, with or without NAT, were HCV-seropositive. Two of these recipients tested HCV-seropositive before transfusion, and a third was probably infected by transfusions before the introduction of HCV testing. The fourth recipient likely received a noninfectious transfusion, since five other recipients of components from subsequent donations made by this donor were seronegative., Conclusion: When previous donations had been tested by second- or third-generation EIA, the yield of HCV lookback was likely zero. Because HCV infection is relatively common in the general population and patients in Canada do not undergo pretransfusion testing, coincident infections in recipients may be erroneously attributed to transfusion. The regulatory requirement for HCV lookback should be reassessed.