Donor vigilance: progress and challenges

Background Internationally, there is increased interest in reporting, treating and attempting to reduce complications of blood donation. Donor haemovigilance is the systematic monitoring of adverse reactions and incidents in the whole chain of blood donor care, with a view to improving quality and safety for blood donors. International Developments Several studies have described the risk factors for vasovagal reactions – female donors, young age, first-time status, low body weight, etc. A water drink before donation, use of applied muscle tension and social support during donation have been found effective in reducing minor vasovagal reactions and/or increasing the likelihood of donors returning for subsequent donations. Haematomas and other venepuncture-related complications are frequent and are the predominant cause of long-term morbidity from complications of blood donation. International surveillance data on donor complications are captured in ‘ISTARE’ International Surveillance database for Transfusion-associated Adverse Reactions and Events, which is being developed by the International Hemovigilance Network. Experience in The Netherlands: Better Monitoring of Donor Complications, Where Next? All donor complications and procedural problems are routinely recorded in the computer system eProgesa. Since 2009, the results have been monitored. An improved coding list was introduced in 2010 in order to record more details and cover new procedures such as Rhesus immunizations. The overall rate of donor complications increased from 0·64 in 2009 to 0·80 per 1000 whole blood collections (second half of 2010) and from 1·34 to 1·40 per 1000 plasmaphereses; there were no changes in donor demographics or procedures to explain this, so better recording is presumed. The recorded complications and procedural problems are regularly presented in team leaders’ and regional directors’ meetings. The data have been used to analyse the effect of a procedural modification: increasing the concentration of citrate solution used in plasmapheresis. The rate of terminating procedures because of citrate reactions was 0·14 per 1000 collections [95% confidence interval (CI) 0·018–0·27] before and 0·09 (95% CI 0·018–0·17) after the modification, signifying no relevant change. It is hoped that in 2012 a revised donor information brochure with instructions on avoiding vasovagal reactions will be piloted and subsequently tested. Nevertheless, only immediate and short-term complications can be effectively addressed by the recording and analysis of complications. Longer term issues such as whole blood donor iron status are the subject of research in our country and abroad. Conclusion In our country as well as elsewhere, recording and monitoring the incidence of complications of blood donation has become the norm. Knowledge of risk factors and evidence-based interventions will enable blood establishments worldwide to reduce donor complications. As yet, longer term complications are not well addressed.     

Hemovigilance in Honduras

Abstract: The Honduras Red Cross Blood Program has worked actively to implement a hemovigilance process which gathers information regarding the donors and the donation process as well as serious untoward effects in transfusion recipients. This review will go over the different epidemiological and statistical indicators that are used routinely to follow trends in donor complications and to anticipate any risks to the blood supply (both in terms of new/reemerging infectious diseases or factors that might affect donor availability).     

Faint and pre-faint reactions in whole blood donors: predictive value of pre-donation measurements

Background A small proportion of blood donors have adverse reactions. The purpose of this study was to determine predictors of faint and significant hypotensive reactions that could serve as targets for interventions to reduce reactions, thus improving the blood donation experience for those at higher risk of reactions and reducing the risk of serious adverse events. Methods The records of 422,231 allogeneic whole blood donations from a 9-month period were assessed for adverse reactions. Incidents related to needle insertion, such as hematoma were excluded. Demographic, biometric, and clinical measurements were collected. Reactions were analyzed by multivariate logistic regression analysis comparing donors with any adverse reaction to donors without reactions and by stratified rates according to reaction severity. Results The overall reaction prevalence was 1·43%. Of the reactions, 63%, 29% and 8% were classified as mild, moderate and severe, respectively. Markers of reactions were: age, gender, race, blood volume, blood pressure, pulse and body mass index. Compared to donors without reactions, the strongest predictor of a reaction was a donor's blood volume <3500 ml (OR 2·9, 95% CI 2·57–3·23). Age and first time status were also associated with a significantly higher risk of reaction with 17–18 years olds (OR 2·8, 95% CI 2·59–2·98) and 19–24 year olds (OR 2·39, 95% CI 2·23–2·56) at higher risk compared to 25–65 year olds, and first time donors at higher risk compared to repeat donors (OR 2·2, 95% CI 2·07–2·33). Using a lower weight limit of 50 kg does not prevent donors from giving more than 15% of their blood volume. Conclusion The results of this study are helpful in identifying donors at risk for adverse reactions and in understanding the contributors to reactions. Donor blood volume was a strong predictor of reaction. Selecting donors using blood volume, not weight, should reduce the frequency of reactions.     

Blood donor profiling using donation patterns

To have a better insight in the donor career, blood establishments need to have a reliable donor profiling system. Keeping track of the regularity of donating behaviour is crucial. Yet, different viewpoints exist on what is to be understood with the term regular donor. The article will present and compare two useful approaches of donor profiling. The first approach distinguishes different donor groups by using the total number of donations. This method uses the total number of donations to create donor groups. These donor groups are then studied in order to try to define factors that accurately describe differences between them. Up till now, the concrete number of donations that is used as a cut-off value to create donor group varies widely among studies, as do the names allocated to describe the groups. The second approach uses donation frequency, thus donations made within a certain time frame, to allocate donors into different groups. Not only the number of donations is important, but donation frequency as well. Recently, a European wide project on blood donor management, called DOMAINE (Donor Management in Europe) has created a new set of donor types by using both the total number of donations but also the different donation patterns. The newly defined donor types are mutually exclusive and present donors in different stages of their donor career. The donor types range from first-time, regular, returning, lapsing and inactive donor, to the last type, the stopped donor. This classification provides blood banks with relevant information on the current ‘activity’ status of their donors. A blood donor profiling system based on the number of blood donations has the clear advantage of getting a quick insight in the career of the donor. However, only focusing on the number of donations leaves out important information about the current activity status of the donor. By using both the total number of donations as well as donation patterns, a more clear-cut classification of donor types is possible. In the short run, this may require a more time-consuming and/or costly method of keeping track of donations, yet it has the advantage of keeping better track of donor activity and employability. It is a useful addition to donor profiling based solely on the total number of donations. Knowing the composition of the donor base and understanding accompanying donor behaviour allows for immediate directed retention, and if necessary, recruitment activities.     

Development of a supersensitive polymerase chain reaction method for human T lymphotropic virus type II (HTLV-II) and detection of HTLV-II proviral DNA from blood donors in Japan

A supersensitive polymerase chain reaction procedure was developed to detect human T-lymphotropic virus type II (HTLV-II) proviral genome. Six primer pairs covering the various regions of HTLV-II were compared and selected on the basis of specificity and sensitivity. Among them, one primer pair of the pol region of HTLV-II (II pol) was able to amplify and detect even 0.1 fg of the cloned plasmid HTLV-II DNA (seven copies) by regular ethidium bromide staining on polyacrylamide gel. By using this procedure, we screened 189 HTLV-I seropositive blood donors from Yamaguchi and Fukuoka Red Cross Blood Centers, Japan. There were four positive samples detectable with the HTLV-II-specific pol primer pair, as well as with the HTLV-I tax primer pair. The amplified DNAs of two specimens were cloned and sequenced. The sequences of the HTLV-I tax region from both specimens were identical to that of HTLV-I. On the other hand, those of the HTLV-II pol region were identical to that of HTLV-II, except for one base substitution in a clone from one subject. These results indicate that dual infection of HTLV-I and HTLV-II in the same persons occurs among Japanese blood donors.     

On-site training in applied muscle tension to reduce vasovagal reactions to blood donation

Vasovagal reactions significantly complicate the blood collection process and, more importantly, discourage people who might otherwise donate blood many times from returning. Applied muscle tension is a simple behavioral technique that may reduce vasovagal reactions by maintaining blood pressure. It has been successfully used to treat patients with blood and injury phobias, but has not been applied in the more general, time-limited context of blood collection clinics. Thirty-seven inexperienced blood donors (maximum number of prior donations = 2) attending mobile blood collection clinics were asked to practice applied tension after watching a 2-min instructional video presented on a notebook computer. They were compared with 94 untreated donors with similar donation experience and 47 more experienced blood donors. Treatment reduced the number of symptoms reported on a postdonation questionnaire. It also significantly reduced the amount of medical treatment required (chair reclining) among those who practiced applied tension for the entire period they were in the donation chair.     

High-resolution HLA-A,HLA-B,and HLA-DRB1 haplotype frequencies from the French Bone Marrow Donor Registry

We have estimated human leukocyte antigen (HLA) haplotype frequencies using the maximum likelihood mode, which accommodates typing ambiguities. The results of the frequency distribution of the 7015 haplotypes obtained are presented here. These include a total of 114 HLA-A, 185 HLA-B, and 76 HLA-DRB1 unique alleles at each locus. Across all populations, although the most common individual HLA alleles were HLA-A¹02:01 (29.0%), HLA-B¹07:02 (11.4%), and HLA-DRB1¹07:01 (15.9%), the most frequent haplotype was found to be HLA-A¹01:01∼B¹08:01∼DRB1¹03:01.     

Dealing with donor issues in therapeutic cell donation

The number of allogeneic stem cell transplantations increases annually and hence does the need for therapeutic cell donations in parallel. These donation procedures harbour immediate, short-term and late adverse reactions. Most of these events are mild to moderate; however, fatalities have been reported. Avoiding as many adverse events as possible is paramount. Donor follow up as proposed by the Worldwide Network for Blood and Marrow Transplantation and the development of donor eligibility criteria for all donors are important measures to better understand the risk of therapeutic cell donation and to increase donor safety.     

广州地区ALT不合格献血者再次献血血液筛查结果分析

目的探讨ALT筛查在无偿献血血液安全中的作用。方法采用回顾性调查方法。追踪广州地区2007—2008年ALT单项检测首次不合格的献血者再次献血时的血液筛查结果，并进行比较分析。结果2007—2008年广州地区9122位ALT单项检测首次不合格的献血者中，1005人（11％）再次来献血，其中，五项传染病指标全部标合格者747人（74．3％），258人（25．7％）不合格，其中ALT单项仍为阳性者240人，为不合格总人数的93％，有18人（7％）献血者传染病指标转为不合格，其中ALT阴性而其他四项指标不合格者15人，ALT合并其他传染病指标不合格者3人。结论ALT筛查在一定程度上能够减少肝炎病毒窗口期或隐匿性感染的漏检．在其他更敏感和特异的检测方法引入我国血液筛查之前，ALT筛查对降低输血传染病残留风险仍具有不可忽视的作用。     

Methods for estimating structure of trace reactions of neurons in medial geniculate body

The trace reactions of neurons in the medial geniculate body during the action of various auditory signals were investigated in anesthetized cats. Using the traditional peristimulus histogram (PSTH) method to analyze the impulse activity, trace reactions were found in some neurons that possessed a definite time structure with a varying degree of periodicity. Prolonged, diffuse changes in the level of activity were demonstrated in another group of neurons. The trace reactions of the second group of neurons were evaluated by averaging for a multitude of responses the individual PSTHs obtained for each response using the procedure of eliminating time shifts. Elimination in this way of the physiological variation in the time of reaction onset made it possible to establish the presence of a time structure in the trace reactions of a number of neurons in the second group.Translated from Fiziologicheskil Zhurnal SSSR imeni I. M. Sechenova, Vol. 71, No. 12, pp. 1531–1539, December, 1985.     

Introduction of a program for voluntary blood donations in Iran (blood transfusion status in Iran)

Background A national and well-coordinated system is very effective for blood self sufficiency of a country; this system might be committed to follow all requirements and standards. It should manifest itself strong and well-established in reality and practice so that all potential donors trust it and contribute. Iranian Blood Transfusion Organization (IBTO) is an example of a centralized network with 200 centers in 31 provinces which could only be decentralized in some aspects of blood donor recruitment based on the cultural and regional attributes of the people there. Methods The mission of IBTO is to provide and ensure a safe and adequate blood supply in Iran. Selection of low risk donors in pre-donation consultation and interview sessions based on behavioral, medical and demographic factors has improved the transfusion safety even before specific lab screening tests have been conducted; Standardization of criteria for donor eligibility and exclusion, and donor screening procedures are all priorities and most importantly the collection of all blood donations just from voluntary nonremunerated (VNR) blood donors. In fact, a lot of efforts concentrated on recruitment of VNR donors and to this end the Blood Donor Recruitment and Retention Office was established. A variety of measures were made to increase the number of voluntary regular donors including technical efforts, information dissemination activities, demographic studies, campaigns, awareness raising programs, publicity, publications, commemorative ceremonies and the like. Results The annual donation index in Iran has greatly increased from 0.39 in 1974 to 25.3 in 2010–2011. Accordingly we have been witness to increasing trend of blood donation reaching about 2 million blood units in 2011, all of which obtained from voluntary non-remunerated blood donors with the annual index of 26 per 1000 population. Conclusions It shows that every country based on its needs should establish a very effective and safe program to raise the number of its voluntary blood donors and to this end centralization of activities monitored by a headquarters and implementation of an efficient recruitment plan by which all aspects are covered and monitored: ranging from stages prior to donor selection including campaigns and activities to motivate populations to embark on donation, donor selection, screening, retention, statistical audit, continuous evaluation of donation sites, ease of access to donation centers, demographic attributes, donor reactions, to post donation era to ensure high return rate and so on so forth. All in all, availability and affordability are the issues which should be always guaranteed.     

Lecture: Blood Donation Program in the Asia Pacific Region

As part of the Asia Pacific Blood Network (APBN) comparison of practice program, member countries review blood donor management practices to understand emerging trends in the region, and identify good practice opportunities which may benefit other members. Our membership includes Australia, Beijing, Hong Kong, Japan, New Zealand, Singapore, South Korea, Taiwan and Thailand. From 2006, we have jointly collected information for a range of donor related measures, including age and sex distribution of donors, criteria for donation, donation volumes and frequencies, transfusion transmitted disease rates, additional donor health screening initiatives and donor deferrals. Analysis of the donor management information both among member countries, and for individual countries over a period of 4 years, provides a useful window into some of the donor characteristics for our region. Whilst there are significant variations in population size of countries, there are shared trends in donor patterns subsequent to local disasters, reasons for donor deferrals, and the need for continued focus on relevant and effective donor retention and recruitment strategies. We continue to see lower red cell utilisation rates in Asia, in general a younger donor population with higher representation of male donors, and low haemoglobin as the single most common reason for donor deferral for most members. APBN members are actively pursuing opportunities for shared donor management approaches, and the progress with these strategies in addition to an overview of regional donor measure is provided.     

Biovigilance initiatives

Background Haemovigilance systems have been in existence for over 10 years, having been established after recognition of the impact from the AIDS epidemic, and other potential risks, on the safety of blood transfusion. Haemovigilance systems now have been implemented globally in most developed countries, with some exceptions including the USA, to monitor the adverse events and incidents associated with blood donations and transfusions. ‘Biovigilance’ extends this term beyond blood to incorporate monitoring of events associated with tissue, organs and cellular components. In the USA, with the absence of either national haemovigilance or broader biovigilance systems, there has been growing interest in development of a national biovigilance programme. Methods The AABB has established a multiorganizational task force, made up of both public and private organizations, to help build a biovigilance network with three separate components addressing safety for transfusion recipients, blood donors and organ/tissue. These systems are being developed through various public–private partnerships with funding from both government and private sectors. The Transfusion Recipient System is being developed by AABB in collaboration with the Centers for Disease Control and Prevention (CDC), as a module in CDC's National Healthcare Safety Network (NHSN). The blood donor system is a collaborative effort with the Department of Health and Human Services, Office of Public Health and Safety and AABB member blood donor programmes. Under a cooperative agreement with the CDC, the United Network for Organ Sharing and other partners are developing a system to increase recognition of adverse events associated with organ and tissues, the Transplantation Transmission Sentinel Network (TTSN). Results These systems have many features in common. They are designed to be voluntary, non-punitive and confidential in order to encourage participation, and are expected to generate data in order to prompt policy changes, standards and procedural interventions to improve patient safety and outcomes. However, the systems also are slightly different in configuration and source of development. For example, for a sentinel network such as TTSN, the additional intention is to improve communications between organ and tissue agencies and to notify healthcare providers when there is a risk associated with a particular donor. Conclusions These biovigilance initiatives are being developed simultaneously through a unique public–private partnership. Furthest along in development are the transfusion recipient NHSN module and the TTSN; both are targeted for pilot testing by the spring of 2008. The blood donor system is still in the concept stage. Although global haemovigilance efforts are more advanced in comparison to the USA, the extent of progress in biovigilance efforts is varied. The safety of solid organs is almost universally not being addressed. However, efforts are currently underway to establish systems to ensure that the safety and quality of blood, tissues and cells are monitored and information shared.     

Haplo-Cord Transplantation Using CD34+ Cells from a Third-Party Donor to Speed Engraftment in High-Risk Patients with Hematologic Disorders

Among the strategies to optimize engraftment of cord blood (CB) stem cell transplantation (SCT), single CB with the coinfusion of CD34⁺ stem cells from an HLA-mismatched auxiliary donor (haplo-cord) provides a valid alternative for adult patients without a suitable donor. A total of 132 high-risk adult patients with hematological malignancies from 3 Spanish institutions underwent myeloablative haplo-cord SCT. The median age was 37 years and median weight was 70 kg; 37% had active disease. The median number of postprocessing CB total nucleated and CD34⁺ cells was 2.4 × 10⁷/kg (interquartile range [IQR], 1.8 to 2.9) and 1.4 × 10⁵/kg (IQR, .9 to 2), respectively. Neutrophil engraftment occurred in a median of 11.5 days (IQR, 10.5 to 16.5) and platelet engraftment at 36 days (IQR, 25.5 to 77). Graft failure was 2% overall and only 9% for CB. Cumulative incidence of acute graft-versus-host disease (GHVD) grades II to IV was 21% and cumulative incidence of chronic GVHD was 21%. Median follow-up was 60 months (range, 3.5 to 163). Overall survival was 43.5%, event-free survival was 38.3%, nonrelapse mortality was 35%, and relapse was 20% at 5 years. Myeloablative haplo-cord SCT results in fast engraftment of neutrophils and platelets, low incidences of acute and chronic GVHD, and favorable long-term outcomes using single CB units with relatively low cell content. Moreover, CB cell dose had no impact on CB engraftment and survival in this study. Therefore, haplo-cord SCT expands donor availability while reducing CB cell dose requirements.