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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 = more...

Sexual dysfunction is extremely common in cancer survivors. Cancer survivors are living longer, and survivorship issues like sexual functioning are now a part of routine cancer care. Oncology providers need to be as comfortable assessing and addressing these issues as they would any other aspect relating to cancer care. Providers should know how to perform an evaluation for sexual dysfunction, understand basic treatment options, and have appropriate referrals available to ensure that the patient's needs are met. This review provides an overview of sexual dysfunction pertaining to women who are survivors of cancer and articulates areas needing further research. more...

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. more...

The NCCN Guidelines for Survivorship are intended to help healthcare professionals working with cancer survivors to ensure that each survivor’s complex and varied needs are addressed. The Guidelines provide screening, evaluation, and treatment recommendations for consequences of adult-onset cancer and its treatment; recommendations to help promote healthful lifestyle behaviors, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes the recommendations regarding employment and return to work for cancer survivors that were added in the 2021 version of the NCCN Guidelines. more...

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 more...

Background The use of pre-/post-exposure prophylaxis (PrEP/PEP) may interfere with routine HIV screening. As a result, blood services worldwide have adopted a variety of deferral policies to mitigate increased residual risk. In this study, we evaluated the operational impact of modifying the donor health questionnaire (DHQ) to include explicit questions to assess PrEP/PEP exposure. Study design and methods We conducted a retrospective study between June 2019 and October 2020 of all blood donors attempting to donate at Canadian Blood Services. Sixteen-months post-implementation, we summarized self-reported PrEP/PEP rates and their indications for use. We also assessed deferral rates and the sensitivity of using existing risk questions to defer people exposed to PrEP/PEP. Results Of 1,122,075 donations, 89 people (eight per 100,000 donations) reported PrEP (64%)/PEP (34%) use in the last 4 months. People exposed to PrEP were more likely to be men (94%) and taking PrEP for lifestyle reasons (87%). In contrast, indications for PEP use included occupational exposure (50%) and sexual assault (27%). Most donors who answered affirmatively to PrEP/PEP exposure were deferred (96%). If potential donors were not directly asked about their PrEP/PEP use, the majority would not have been deferred for any other reasons (PrEP 32/57 (56%) and PEP 15/30 (50%)). Conclusion Not all blood services have adopted direct questions to identify PrEP/PEP exposure; some rely on existing DHQ questions. In Canada, despite DHQ questions such as medication use in the last 3-days, more than half of people exposed to PrEP/PEP would not have been identified and deferred. more...

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. more...

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for consequences of adult-onset cancer and its treatment, with the goal of helping healthcare professionals who work with survivors, including those in primary care. The guidelines also provide recommendations to help clinicians promote physical activity, weight management, and proper immunizations in survivors and facilitate care coordination to ensure that all of the survivors’ needs are addressed. These NCCN Guidelines Insights summarize additions and changes made to the guidelines in 2020 regarding cardiovascular disease risk assessment and screening for subsequent primary malignancies. more...

Background and Objectives: Efficiency in mitigating HIV transmission risk by transfusion may vary internationally. We compared HIV prevalence and incidence in blood donors across different jurisdictions in relation to those rates in the general population and differences in deferral practices. Materials and Methods: Data from 2007 to 2016 were collected in Australia, Brazil (São Paulo), Canada, England, France, Italy, Ireland, Japan, the Netherlands, New Zealand, Norway, Spain (Basque Country), USA (Vitalant) and Wales. For each country/region, the number of HIV antibody-positive donations and nucleic acid testing (NAT)-only-positive donations was broken down according to first-time or repeat donor status, along with the relevant denominators. Results: There is a modest correlation between HIV prevalence among first-time donors and HIV prevalence in the general population. However, rates of HIV-positive donations in repeat donors, a proxy for incidence, do not correlate with incidence rates in the general population. Rates in donors from Italy and Basque Country, where deferral criteria for men having sex with men are less stringent, are higher compared with most other jurisdictions. Rates of NAT-only-positive donations are extremely low and do not differ significantly after adjustment for multiple comparisons. Conclusion: Donor HIV rates are only weakly associated with those observed in the general population. Countries with less stringent deferral criteria have higher HIV rates in their donor population, but the rates remain very low. more...

The ACR Incidental Findings Committee (IFC) presents recommendations for managing adnexal masses incidentally detected on CT and MRI. These recommendations represent an update of those provided in our previous JACR 2013 white paper. The Adnexal Subcommittee, which included six radiologists with subspecialty expertise in abdominal imaging or ultrasound and one gynecologist, developed this algorithm. The recommendations draw from published evidence and expert opinion and were finalized by iterative consensus. Algorithm branches successively categorize adnexal masses based on patient characteristics (eg, pre- versus postmenopausal) and imaging features. They terminate with a management recommendation. The algorithm addresses most, but not all, pathologies and clinical scenarios. Our goal is to improve quality of care by providing guidance on how to manage incidentally detected adnexal masses. more...

BACKGROUND: This study examined the impact of age and sex of first-time donors who had not experienced an adverse event or deferral on their likelihood of and time to return. STUDY DESIGN AND METHODS: On behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative, international blood collection agencies (BCAs) were invited to provide data on first-time whole blood donors in 2014, including initial presentation date, collection site type, age, sex, blood type, return to donate within 24 months (yes/no), and subsequent presentation date. RESULTS: Eight BCAs contributed 706,789 records. The overall odds of returning to donate were slightly lower in female versus male donors, and the overall age trend was U-shaped with younger and older donors having higher odds for returning relative to middle-aged donors. However, variations by BCA were observed. Specifically, in three BCAs, women had higher odds of returning to donate than men. Further, while across seven BCAs the smallest cohort of older first-time donors returned at a higher rate and returned more quickly than middle-aged first-time donors, the behavior of younger donors varied substantially between BCAs. CONCLUSION: While older first-time donors are more likely to return and return more quickly than middle-aged donors they make up only a small proportion of first-time donors, whereas the larger group of younger donors exhibits less clear patterns of return compared to middle-aged donors. Further research is needed to determine whether targeting the recruitment of older donors or bolstering retention of middle-aged donors would be most effective in maintaining the blood supply. more...

Summary The COVID-19 pandemic has major implications for blood transfusion. There are uncertain patterns of demand, and transfusion institutions need to plan for reductions in donations and loss of crucial staff because of sickness and public health restrictions. We systematically searched for relevant studies addressing the transfusion chain—from donor, through collection and processing, to patients—to provide a synthesis of the published literature and guidance during times of potential or actual shortage. A reduction in donor numbers has largely been matched by reductions in demand for transfusion. Contingency planning includes prioritisation policies for patients in the event of predicted shortage. A range of strategies maintain ongoing equitable access to blood for transfusion during the pandemic, in addition to providing new therapies such as convalescent plasma. Sharing experience and developing expert consensus on the basis of evolving publications will help transfusion services and hospitals in countries at different stages in the pandemic. more...

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for consequences of cancer and cancer treatment to aid healthcare professionals who work with survivors of adult-onset cancer. Guidance is also provided to help promote physical activity, weight management, and proper immunizations in survivors and to facilitate care coordination to ensure that all needs are addressed. These NCCN Insights summarize some of the topics discussed by the NCCN Survivorship Panel during the 2019 update of the guidelines, including the survivorship population addressed, ways to improve care coordination, and pain management. more...

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. more...

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 χ2 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. more...

BACKGROUND The deferral for men who have sex with men (MSM) was reduced from a permanent deferral for MSM if even one time since 1977 to progressively shorter time deferrals of 5 years and 1 year in Canada. We assessed compliance with these deferrals and the impact on safety at Canadian Blood Services. STUDY DESIGN AND METHODS Three anonymous online compliance surveys of male whole blood donors were carried out before and after implementation of successive changes. HIV rates and incidence were monitored from January 1, 2011, to August 14, 2018. RESULTS Participation rates in the consecutive surveys were 49.7% before implementation, 36.3% after 5 years and 36.3% after 1 year. There was no difference before versus after implementation in male donors with MSM history in the past year (0.21%, 0.19%, 0.24%; p = 0.70). The percentage of eligible MSM donors increased (0.13%, 0.66%, 1.21%; p < 0.0001), with approximately 2500 eligible MSM donors with the 1-year deferral in place. HIV rates were less than 0.6 per 100,000 donations and unchanged after each policy change (p = 0.14 for trend). Incidence remained unchanged at 0.22 per 100,000 person-years before implementation, 0.54 per 100,000 after 5-year deferral, and no incident cases after 1-year deferral (p = 0.55). CONCLUSION Progressively shorter time deferrals had no impact on noncompliance of MSM with a male partner in the past year. Contrary to modeling predictions, shorter time deferrals had no impact on HIV rates or incidence. There was a modest increase in eligible MSM in the donor pool after each shorter time deferral. These results support the safety of reducing deferral periods for MSM. more...

Background Some countries impose an upper age limit on whole blood and double RBC donation while others do not. We evaluated the safety of blood donation in older individuals (≥71 years), and their contribution to the blood supply of five countries. Study design and methods Twelve blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from four countries with no upper age limit for whole blood and double RBC donation (Canada, New Zealand, England, and the United States) or an upper age limit of 80 (Australia) provided 2016 data on donors and donations, deferral rates, and vasovagal reactions by donor age and sex. Donors under age 24 were included in the number of total donors and donations, but not in deferral and reaction rate comparisons. Results Older donors accounted for 1.0% (New Zealand) to 4.3% (United States) of donors, and 1.5% (New Zealand) to 5.6% (United States) of donations; most were between ages 71 and 76. The deferral rate was higher in older compared to 24- to 70-year-old males, but very similar between older and younger females. In contrast, vasovagal reaction rates were either lower (male donors) or similar (female donor for reactions with loss of consciousness) in older compared to 24- to 70-year-old donors. Conclusions Exclusion solely based on older age appears to be unwarranted based on safety concerns such as donor reactions. Healthy older individuals can continue to safely donate and make a significant contribution to the blood supply past arbitrary age limits. more...

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 × 104 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. more...

BACKGROUND In December 2014, a multinational collaboration of hemovigilance experts from the International Society of Blood Transfusion (ISBT), the International Hemovigilance Network, and AABB published harmonized definitions of complications related to blood donation titled "Standard for Surveillance of Complications Related to Blood Donation." Both mandatory and optional terms were included. The definitions are endorsed by the Alliance of Blood Operators and the European Blood Alliance. STUDY DESIGN AND METHODS The objective of this study was to validate harmonized donor hemovigilance definitions with potential users. In June 2016, 30 real-world cases were sent to potential users around the world along with the definitions, an answer sheet, and instructions on how to complete the validation exercise. RESULTS Overall, 54 responses from 25 countries were received, including over 400 comments. The results were presented for feedback at both ISBT and AABB meetings. Case diagnoses were consistent across most responders. Exceptions were rare adverse events, nonstandard presentations, or incomplete information. In general, the application of optional definitions, including severity grading and imputability, had the most variability. CONCLUSION The use of standardized terms in the donor setting serves to increase focus on donor safety, facilitate conversation, foster exchange of information, and frame questions for future research. Overall, the definitions provide adequate coverage of donor reactions; however, some terms require clarification. Severity grading and imputability and other optional terms need clear and objective definitions and instructions on when and how to use them. Additional feedback and final recommendations are summarized in this report. more...

BACKGROUND We assessed donor return rates, donation frequency, and factors related to the evolution of ferritin levels 2 years after entering donors into a large operational study of ferritin testing. STUDY DESIGN AND METHODS Ferritin testing was done on donors from representative clinics (n = 12,595). Low-ferritin donors ( more...

Background The upper age limit for blood donation differs in various countries, due to concerns about donor safety. In recent years, many countries have reviewed their policies regarding the upper age limits for donation. Evaluation of the impact of changing population and donor demographics may assist in better planning to meet future patient needs for blood. Aims We review current policies, evidence of the safety of donation in older individuals, and the contribution that older donors can make to the blood supply. Methods We reviewed policies in countries that are part of the Biomedical Excellence for Safer Transfusion Collaborative, and published studies on the safety of donation. We evaluated the contribution that older donors make to the blood supply at Canadian Blood Services. Results The upper age limit for regular whole blood donors ranges from 69–70 to 80; blood centres in several countries have recently removed the upper age limit, while many blood centres in the US have long had no upper age limit for donation. Data demonstrate that healthy older individuals can safely donate. Approximately 1·5% of all whole blood donations at Canadian Blood Services are made by donors past their 71st birthday. Summary/Conclusions There are more healthy older individuals than ever before. Many donors would like to continue donating into their eighth decade, and perhaps beyond. There is increasing evidence that donation is safe in older individuals, and that they can make a significant contribution to the blood supply. more...

Many cancer survivors experience menopausal symptoms, including female survivors taking aromatase inhibitors or with a history of oophorectomy or chemotherapy, and male survivors who received or are receiving androgen-ablative therapies. Sexual dysfunction is also common in cancer survivors. Sexual dysfunction and menopause-related symptoms can increase distress and have a significant negative impact on quality of life. This portion of the NCCN Guidelines for Survivorship provide recommendations for screening, evaluation, and treatment of sexual dysfunction and menopausal symptoms to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period. more...

BACKGROUND Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein. STUDY DESIGN AND METHODS In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as “true-positives” when the same bacterium was isolated in initial and confirmatory cultures or “false-negatives” when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases. RESULTS During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria. CONCLUSION The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention. more...

Traditionally, the physical, psychological, and psychosocial long-term needs of cancer survivors have received little attention compared with screening for cancer recurrence and secondary cancers. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Survivorship offer recommendations for various survivorship concerns, and those for improving menopausal symptoms were presented at the NCCN 22nd Annual Conference. Key considerations in managing menopausal symptoms in cancer survivors were reviewed, with chemotherapy-induced amenorrhea, fertility concerns, and both hormonal and nonhormonal therapeutic options featured. more...

BACKGROUND: Determination of blood donor hemoglobin (Hb) levels is a pre-requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low-Hb deferral rates. METHODS: An online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative-binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut-offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post-versus pre-donation Hb measurement and geographical location (Asian vs. rest), with low-Hb deferral rates. RESULTS: Data were included from 38 blood services. Low-Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33-0.84) and men (RR 0.53, 95%CI 0.31-0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23-0.94). Finally, being located in Asia was associated with higher low-Hb deferral rates; RR 9.10 (95%CI 3.89-21.27) for women and 6.76 (95%CI 2.45-18.68) for men. CONCLUSION: Differences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low-Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care. more...

Background Alloimmunisation and haemolytic transfusion reactions (HTRs) can occur in patients with sickle cell disease (SCD) despite providing phenotype-matched red blood cell (RBC) transfusions. Variant RBC antigen gene alleles/polymorphisms can lead to discrepancies in serological phenotyping. We evaluated differences between RBC antigen genotyping and phenotyping methods and retrospectively assessed if partial antigen expression may lead to increased risk of alloimmunisation and HTRs in SCD patients at a tertiary centre in Canada. Methods RBC antigen phenotyping and genotyping were performed by a reference laboratory on consenting SCD patients. Patient demographic, clinical and transfusion-related data were obtained from a local transfusion registry and chart review after research ethics board approval. Results A total of 106 SCD patients were enrolled, and 91% (n = 96) showed additional clinically relevant genotyping information when compared to serological phenotyping alone. FY*02N.01 (FY*B GATA-1) (n = 95; 90%) and RH variant alleles (n = 52, 49%; majority accompanied by FY*02N.01) were common, the latter with putative partial antigen expression in 25 patients. Variability in genotype-phenotype antigen prediction occurred mostly in the Rh system, notably with the e antigen (kappa: 0.17). Fifteen (14.2%) patients had a history of alloimmunisation, with five having HTR documented; no differences in clinical outcomes were found in patients with partial antigen expression. Genotype/extended-phenotype matching strategies may have prevented alloimmunisation events. Conclusion We show a high frequency of variant alleles/polymorphisms in the SCD population, where genotyping may complement serological phenotyping. Genotyping SCD patients before transfusion may prevent alloimmunisation and HTRs, and knowledge of the FY*02N.01 variant allele increases feasibility of finding compatible blood. more...

Purpose: Women with breast cancer have complex and unique gynecologic needs that are challenging to effectively and comprehensively meet in a traditional gynecology visit format. Group medical visits are an effective and well-received model of care in other disease settings and can provide comprehensive health education as an adjunct to one-on-one evaluation and treatment. There are limited data regarding the use of this type of health care delivery in providing gynecology-focused care to women affected by breast cancer. Methods: A group medical visit model was created for gynecology providers to see new breast cancer patient consults. From May 2012 to February 2014, 148 patients (3–6 per group) participated in a 1-hour informational session followed by a 15- to 30-minute individual visit with a physician that included history, physical examination and evaluation. We surveyed 101 women who attended these visits to evaluate a group model for providing gynecologic care and educational support to women with breast cancer. Results: Of those who responded to the survey question, 100% agreed or somewhat agreed that their expectations for an initial intake visit were met during the group visit; 81% agreed or somewhat agreed that they felt a group visit was preferable to an individual introductory visit. More than 95% agreed or somewhat agreed that the information was understandable and their questions were answered during the visit. Only 5 respondents expressed dissatisfaction with the additional time commitment for this type of visit. Conclusions: The majority of women surveyed expressed satisfaction with their experience with a group visit format. The women who participated preferred this format compared to an individual intake appointment when establishing gynecology care after breast cancer diagnosis/treatment, regardless of age, menopausal status, cancer stage or hormone receptor status. While further studies are warranted to directly compare and further assess satisfaction and efficacy, gynecologists may consider using a group model to provide comprehensive education and care to this patient population. more...

Iron deficiency is a global problem in women of child-bearing age and is associated with adverse maternal and newborn outcomes. Repeated blood donations deplete iron stores and decrease hemoglobin levels. However, the clinical impact of iatrogenic iron deficiency on mothers and neonates due to blood donation is uncertain. The objective of this study was to assess the association between repeated blood donations in female donors of child-bearing age and the associated risk of adverse maternal and neonatal outcomes. We undertook an observational cohort study of all women who delivered a live or stillborn infant in Ontario, Canada, between 1 January 2010 and 31 March 2012 using birth record data from the Better Outcomes RegistryNetwork, Canadian Blood Services, and the Institute of Clinical Evaluative Sciences. Only a woman's first pregnancy within the study time frame was included for analysis. We excluded women18 years or50 years of age at the time of delivery and multiple birth pregnancies. Data on all female donors who made whole blood donations between 1 January 2007 and 31 March 2012 were obtained from Canadian Blood Services. The primary newborn outcome was diagnosis of a small-for-gestational-age neonate (less than 10th centile). Secondary outcomes were preterm birth, stillbirth, APGAR4 at 5 minutes, cord pH7, neonatal death, maternal transfusion, infection, preeclampsia, gestational hypertension, gestational diabetes, placental abruption, and maternal death. Regression models evaluated the effect of repeated donation and the time interval between donations and conception on neonatal and maternal outcomes while adjusting for important clinical and demographic risk factors. A total of 260 037 women delivered live or stillborn singleton infants between 1 January 2010 and 31 March 2012. A total of 7919 (3.0%) women were blood donors, with a mean of 2.43 ± 2.10 lifetime donations. Mean maternal age at the time of delivery for nondonors and donors was 30.30 ± 5.38 and 29.74 ± 4.94 years, respectively. Small for gestational age occurred in 23 706 (9.4%) of neonates born to nondonors and 526 (6.6%) of neonates born to donors. There was a reduction in the risk of small for gestational age with increasing number of lifetime donations (adjusted odds ratio 0.89 [0.86-0.92] per additional donation). For the prespecified secondary outcomes, we observed a reduction in the risk of low birth weight (adjusted odds ratio 0.95 [0.91-0.98] per additional donation). There was no association with other secondary neonatal or maternal outcomes except for maternal hypertension. Proximity of donation to conception had no effect on risk of a small-for-gestational age neonate. Our data suggest that there is no increased risk of deleterious neonatal and maternal outcomes associated with repeated blood donations prior to pregnancy. Although possibly a result of a healthy donor effect, our findings are reassuring to female donors and their children as well as to clinicians and blood system stakeholders seeking to inform policy decisions. more...

Background Exposure to blood products during pregnancy carries a potential risk of transfusion transmission of infectious agents. Blood agencies have historically sought optimal deferral and testing strategies to protect blood supplies in part to ensure the protection of pregnant women and their unborn infants. The Zika virus outbreak of 2016 has heightened attention to these concerns. In the current context of the recent Zika outbreak, and also more broadly, data are needed to shed light on the likelihood of exposure to blood products throughout pregnancy to inform policy. Study design and methods Hospital administrative data from a large tertiary care center were examined for outpatient and nondelivery inpatient transfusion events in pregnant women between January 1, 2007, and December 31, 2013. Those pregnancies resulting in miscarriage were excluded from analysis. Results A total of 45,179 pregnancies resulting in delivery of a live or stillborn infant were documented at The Ottawa Hospital during the study period. Our findings indicate that 0.124%, or 1240 in 1,000,000, expectant mothers received transfusion at some point during their pregnancies with 0.04%, or 400 per 1,000,000, expectant mothers receiving a transfusion in the first trimester. Conclusion Data from a large tertiary care center suggest that the risk of maternal and fetal exposure to blood products by transfusion during any stage of pregnancy is very low. Such a low likelihood of transfusion should be taken into consideration when developing donor deferral policies designed to protect women against transfusion-associated infection transmission during pregnancy and could inform evaluations of the risk of prenatal transfusion transmission of the Zika virus. more...

BACKGROUND We assessed risk groups for iron deficiency and the feasibility and efficacy of ferritin testing in a large blood center. STUDY DESIGN AND METHODS Donors were informed of possible testing in the predonation pamphlet. Plasma ferritin was measured on retention samples (n = 12,595) from representative clinics. Low-ferritin donors ( more...

BACKGROUND RhIG prophylaxis for D– pregnant women prevents hemolytic disease of the newborn and typically depends on results of serologic D typing. Interpretation and follow-up of weak D serology is variable. Recent recommendations promote genotyping for RHD status determination in those with weak D serology. Canadian Blood Services performs comprehensive serologic prenatal testing in four provinces. Genotyping is used to determine D typing in patients with weak D. STUDY DESIGN AND METHODS A serologic algorithm identified which patients require genotyping for RHD determination. Genotyping was performed on one of two commercially available platforms. RESULTS Only 0.4% of D– patients met criteria for genotyping. Sixty-one percent were weak D Type 1, 2, or 3. Thirty percent had a partial or weak D other than Type 1, 2, or 3. Eleven had variants which remained unresolved. Seventeen were D+ and four were D–. CONCLUSIONS Genotyping of patients with weak D serology led to an identified genotype in most patients. RhIG administration was avoided in 66% who were weak D Type 1, 2, or 3 or were D+. The use of a serologic algorithm to select patients for RHD genotyping identifies a majority of patients with weak D types not at risk for alloimmunization. This approach limits the number of genotyping investigations and the cost of providing classification for weak D types. more...

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. more...

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common physical and psychosocial consequences of cancer and cancer treatment to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period. This portion of the guidelines describes recommendations regarding the management of anthracycline-induced cardiotoxicity and lymphedema. In addition, recommendations regarding immunizations and the prevention of infections in cancer survivors are included. more...

BACKGROUND The deferral for men who have sex with men (MSM) changed from a permanent deferral since 1977 to a 5-year deferral on July 22, 2013, in Canada. We assessed the impact on safety and adequacy of the blood supply at Canadian Blood Services. STUDY DESIGN AND METHODS Human immunodeficiency virus (HIV) rates were monitored from January 1, 2010, to July 21, 2015. Risk factors were assessed in notification interviews. Anonymous online surveys of male whole blood donors assessed compliance before and after implementation. RESULTS HIV rates were 0.2, 0.5, and 0.51 per 100,000 donations in 2010 to 2012; they were 0.54 and 0.22 in the first and second years after implementation (p = 0.8). Of four male HIV-positive donors after implementation, three denied risk factors and one knew he had HIV. Before implementation 9669 of 19,437 (49.7%) donors participated in the survey, and after implementation, 6881 of 18,934 (36.3%). Before implementation 0.67% of male donors were noncompliant, and after implementation, 0.44%. There was no difference before versus after implementation in male donors with MSM history in the past 5 years (0.37% vs. 0.43%, p = 0.54). After implementation, eligible MSM donors increased (0.42% vs. 0.66%, p = 0.04), with approximately 500 more donors in 2014. CONCLUSION Implementation of a 5-year deferral for MSM had no impact on HIV rates in 2 years of postimplementation monitoring. Donor compliance improved after implementation due to MSM donors who were previously ineligible becoming eligible. There was no change in the percentage of male donors with recent male partners but there was a modest increase in eligible MSM in the donor pool. more...

A downward trend in preoperative autologous donation (PAD) continues in Europe and the Americas, with many jurisdictions only funding medically necessary collections at present. This is the result of decreasing real and perceived residual risks of allogeneic transfusion-transmitted disease and the declining need for transfusion due to patient blood management, which have also led to escalating logistical and cost constraints for PAD programs. We outline collection trends in North America, Europe, and Latin America and review the benefits, risks, effectiveness, and safety of PAD. Important elements of informed consent follow from these points. Evidence-based medical criteria for PAD and autologous transfusion are discussed as are methods to optimize autologous collection timing to regenerate donated red cells. Recommendations for identification of patients whose risk-to-benefit ratio suggests substantial benefit compared with other autologous blood salvage and anemia management alternatives conclude the review. more...

Mandatory predonation reading materials inform donors about risk factors for transmissible disease, possible complications of donation and changes to the donation process. We aimed to assess the attention to predonation reading materials and factors which may affect attention.A national survey in 2008 of 18,108 blood donors asked about self-assessed attention to reading the materials. In face-to-face interviews, 441 donors completed additional questions about reading the materials and a literacy test. Qualitative interviews of 27 donors assessed their approach to reading.In the national survey, most of the first-time donors said they read all or most of the materials (90.9% first-time vs. 57.6% repeat donors, P0.001) and 66% vs. 23.1% reported reading them carefully (P0.001). In face-to-face interviews comparing those who read materials carefully, skimmed or did not read, most knew that donors are informed of positive transmissible disease test results (97.1%, 95.5, 98.0 P0.05), but fewer recalled seeing the definition of sex (77.2%, 56.9, 24.2 P0.001). Literacy was poor (30.5% frustration level, 60.3% instructional, 9.2% independent) but similar when those who read materials carefully, skimmed or did not read were compared (P0.05). Qualitative interviews showed that donors are reluctant to read any more than necessary and decide based on perceived importance or relevance.Attention to predonation reading materials tends to be better among first-time donors. The effectiveness is limited by low motivation to read, especially for repeat donors, as well as poor literacy. more...

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. more...

Background Advancements in treatment have resulted in a growing number of women now living with or affected by breast cancer. This patient population has complex and unique gynecologic needs. Two thirds of breast cancers are hormone positive and these patients will often be given Tamoxifen or aromatase inhibitors which have specific gynecologic effects. Additionally, oophorectomy may be done as part of breast cancer treatment. Chemotherapy may induce menopause with the need for safe and effective treatments for menopausal symptoms. Gynecologists have a very important role in providing care to women affected by breast cancer. Group visits are increasingly used to provide education and care in the setting of chronic disease, including breast cancer. There is limited data regarding the use of this type of healthcare delivery in providing gynecologic focused care to this complex and growing patient population. Methods This is a cross-sectional study measuring patient expectations and satisfaction with the practice of group visits as a model for providing gynecological health information to women affected by breast cancer. From July 2010 through February 2014 we surveyed women who participated in a two hour new patient visit that involved a one hour information session followed by an approximately 30 minute individual exam with a gynecologist. The goals were to measure the role of a small group format and an individual’s sense of satisfaction with their gynecology clinic experience. Demographic data was collected to determine if there were any correlations with satisfaction and women’s age, stage of disease, hormone receptor and menopausal status. Results A total of 104 women participated during the study period. Over 80% of participants in group visits felt that their expectations were met during the visit. Eight five percent felt they had a better knowledge of treatments for gynecologic side effects from cancer treatments. When assessing disease and demographic factors that might be associated with satisfaction, we found that women with hormone receptor positive breast cancer and those with treatment induced menopause were more likely to prefer group visits than women with hormone receptor negative breast cancer or natural menopause. Women with stage 3-4 disease preferred the group education visit experience more than women with stage 1-2 disease. Conclusion There is a need to provide comprehensive gynecologic care and education to the expanding population of women impacted by breast cancer. Our data suggests that group visits are an effective and well-received strategy for providing gynecologic care to this niche patient practice. Incorporating a group visit model into a practice is a cost-effective educational modality to providing sources of information and support. Based on our observed differences in satisfaction and preference for group visits by stage of disease, menopause status and hormone receptivity, we recommend investigations grouping similar patients to further improve unique patient education and satisfaction. Citation Format: Sally R Greenwald, Sarah Watson, Tami S Rowen, Mindy Goldman. Group visits to provide gynecologic care for women affected by breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-10-06. more...

Iron is an essential nutrient, and blood donation leads to significant iron loss. Iron stores can be estimated by measurement of ferritin levels. Several studies of donor ferritin levels have provided data on the frequency and risk factors for iron deficiency in various countries. Iron deficiency is common, particularly in female donors, and donation frequency is an important risk factor for iron deficiency in both males and females. The significance of iron deficiency alone on donor health, and the optimal strategy to integrate ferritin testing into routine operations in large blood centres remain to be determined. more...