Blood donations are used worldwide foremergent, life-saving, and non-emergent blood transfusions. Worldwide, eachcountry relies on one or several regulatory bodies to determine the safety and qualityof blood collection and donation and availability of blood products. Theseagencies must follow the current legislation while keeping up to date withevidenced based research.
Ireland utilizes the Irish Blood Transfusion Service,who directly reports to the Ministry of Health and works under the HealthProducts Regulatory Authority to oversee the collection, quality assurance anddistribution of blood products. Other organisations provide guidance andsupport, such as the European Blood Alliance (EBA) and the World HealthOrganization (WHO) (1,2). According to the Irish Blood TransfusionService (IBTS): “Approximately 70,000 patients will have transfusions in Irishhospitals this year” and although thousands of blood donations are needed on aweekly basis, only 3% of the Irish population eligible to give blood donate (3).Whole blood is donated and then processed into other products to be distributedand used clinically with concentrated red blood cells as the primary product (3).In 2016, the IBTS reported processing 129,073 whole blood donations which was a2.92% reduction from the previous year (3). Concentrated red cells, the primaryproduct from whole blood donations was prepared into 113,894 units, however116,936 were ultimately distributed, with the difference in numbers coming fromthe previous year’s stock (3).
Blood shortages pose a serious problem for thevarious hospitals and clinical settings in Ireland. In 2016 alone, the IBTSpublished six press releases documenting a plea for blood donors due to bloodshortages. Many countries, including Ireland, China, the United States, Canadaand the United Kingdom, have difficulties sustaining adequate blood donationsand the reasons are multivariate and include aging populations, emergence ofnew transfusion transmitted infections (TTIs) such as the Zika virus and lackof evidence based guidelines for deferral criteria (4,5,6, 7,8). Much of theeffort of various blood transfusion services are put toward recruitingincreasing numbers of donors to maintain adequate blood supply such as runningrecruitment campaigns (9). Blood shortages may be due to the percentage ofprospective donors who are deferred from donating due to various conditions (10).
According to IBTS Head of Corporate Affairs, the overall deferral rate forblood donations in Ireland was 19.23% for 2017. Despite evidence based guidelinesset out by the World Health Organization, many countries have differingdeferral guidelines (5,11). The EBA has a position statement “one size doesn’tfit all” that can explain this.
This includes the understanding that differentcountries may have vastly different rates of infectious diseases that can betransmitted by transfusion such as HIV. However, they make the differingstatement that many countries have hugely variable deferral times or cut-offlimits for factors that ideally should have a fixed value (12). For example,Canadian Blood Services requires men to have a minimum haemoglobin level of 130g/L, whereas IBTS requires men to have a minimum level of 135 g/L (13,14). Deferrals for blood donation presenta burden to both the potential donor and the blood transfusion service as it isnot time efficient for the clinic, and may cause the potential donor to notreturn to donate again (15,16). Many blood transfusion services have strategicplans in place for donor recruitment and many of those include changingdeferral criteria (3,10,17,18). 2.
0 Research Objectives: The purposeof this study is to compare the guidelines for deferral to blood donation amongEuropean and North American countries and to determine if there is a higherrate of blood shortages in countries with stricter deferral guidelines forblood donation. An additional aim of the study is to describe the method bywhich each country’s blood transfusion service determines when to put out acrisis call for blood shortage to the public. 2.1 Hypothesis: 1) Therewill be less blood donations, adjusted for population size, in countries withblood transfusion services with stricter deferral guidelines. 2) Agreater number of blood shortage calls to the public will occur in countrieswith stricter deferral guidelines. 3.0 Research design A geographical ecological study will be used tocompare the guidelines for deferral to blood donation with blood shortage callsto the public as the purpose of this study is to make large-scale comparisonsbased on routinely collected data. This study design will be a cost-effectiveand time-efficient method to collect data from freely available sources.
Althoughthere may be confounding variables, particularly impacting blood shortage callsto the public such as differences in each population’s need for blood, thesevariables will be described as needed. 4.0 Study population and Sample People ineligible to donate blood secondary todeferral in following areas: European Blood Alliance Members (27 countries,including Republic of Ireland), American Red Cross (United States of America),Canadian Blood Services (Canada).
North America and European countries arebeing considered because these are countries with dedicated blood transfusionservices for which there is annual data on deferral criteria, deferral rates,and number of blood donations required and acquired. 5.0 Data Collection Deferral criteria that is often cited asimpacting rates of blood donation and that differs from country to country willbe analysed (9). These criteria will be extrapolated from freely availablepublications circulated by WHO including the WHO Global Status on Blood Safetyand Availability and the WHO Guidelines on Assessing Donor Suitability forBlood Donation. These criteria will include: i) Travel to countries with knowntransfusion transmitted infections (TTI), ii) Sexual behaviour in populationswith risk of TTI, iii) Hemoglobin levels, iv) Deferrals related to use ofmedical/pharmaceutical products, v) Risk of possibly transmissible diseases(e.g. allergy, pre-malignancies, etc), and vi) time between donations.
Deferral guidelines are publishedon each blood transfusion service website, with the data on deferral rate andblood donations collected by year published in an annual report. Number of blood donations received,processed and distributed per year since 2007 published in Annual Reports foreach Blood Transfusion Service will also be analyzed and compared with the needfor blood based on country population. This date range was chosen as mosttransfusion services must only show publications to the public for up to tenyears from present. Press releases and publications for blood shortage calls tothe public for countries of note will also be investigated. Countrieswith incomplete data will not be included. 6.0 Data Analysis Regression analysis will be usedto compare the relationship between the rate of blood shortage and the differingparameters of deferral criteria for each country.
In order to investigate howthe multiple deferral criteria may be related to lower numbers of blooddonations collected, stratified analyses will be conducted.