Search

Blood Transfusion Services are striving to continually improve the efficacy and quality of their blood products whilst also simultaneously diversifying into novel cellular products. For this to be successful the relationships between the various arms of the organisation must be strong and interlinked. As new technologies impact on the products that blood transfusion services supply it should be noted that the interaction between the service and its donor base is also affected by advancing technologies. Social media has fundamentally altered the way in which the public can access information and news, as such blood services must engage and interact appropriately with these new forms of media. As a reflection of these challenges the Scotblood 2015 programme was focussed on service and product improvement, donor engagement and people centred transfusion. This commentary comprises summaries of the presentations, based in part on the abstracts provided by the speakers., (Copyright © 2016. Published by Elsevier Ltd.)

The risk of uncertain results in infectious agents' tests is recognized in blood establishments, being particularly evident during the blood donor selection. The current risk-based approaches require risk assessment and "risk-based thinking". Accordingly, the blood establishment should consider the effect of uncertainty in all the technical decisions taken in a screening laboratory. Since the post-transfusion safety is one of the blood establishments' goals, the risk of post-transfusion infection should be evaluated and actions taken to decrease the chance of blood donations validation use false negative results. This article reviews and discusses the sources of uncertainty of infectious agents' reported results in blood establishments. It describes a set of sources of uncertainty that should be considered in screening immunoassay's decisions. The infectious agents' uncertainty concern is critical for reporting reliable results., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

This brief paper is based on the Coimbra 'conference presentation by the moderator', prior to the two main lectures on pathogen reduction treatment [PRT] of plasma. Being an educationist and teacher in core and having a great interest to simplify the message convey to conference' participants and readers I decided to maintain the slide format of the presentation. To highlight most effectively the role played by pathogen reduction to supplement the multilayer-strategy already in place, emphasizes were placed by going back to basic focusing on: where we were, where we are now and where we are going!. The unresolved problems of viral safety of blood components and criteria of universal acceptability of PRT are highlighted so is the need for further DDR strategies both in incremental and innovative ways. Finally the issue of who would benefit from implementation of PRT is described based on published data and also providing some visionary foresights for the long term benefits of PRT in both optimizing the safety of blood supply and helping at least in health care containment. I hope this new approach will be useful to readers, providing at least some conceptual and technical supports in understanding the role of PRT in optimizing the safety of blood supply., (Copyright © 2015. Published by Elsevier Ltd.)

The European Union regulation for blood establishments does not require the evaluation of measurement uncertainty in virology screening tests, which is required by ISO 15189 guideline following GUM principles. GUM modular approaches have been discussed by medical laboratory researchers but no consensus has been achieved regarding practical application. Meanwhile, the application of empirical approaches fulfilling GUM principles has gained support. Blood establishments' screening tests accredited by ISO 15189 need to select an appropriate model even GUM models are intended uniquely for quantitative examination procedures. Alternative (to GUM) models focused on probability have been proposed in medical laboratories' diagnostic tests. This article reviews, discusses and proposes models for diagnostic accuracy in blood establishments' screening tests. The output of these models is an alternative to VIM's measurement uncertainty concept. Example applications are provided for an anti-HCV test where calculations were performed using a commercial spreadsheet. The results show that these models satisfy ISO 15189 principles and that the estimation of clinical sensitivity, clinical specificity, binary results agreement and area under the ROC curve are alternatives to the measurement uncertainty concept., (Copyright © 2014. Published by Elsevier Ltd.)

Blood establishments routinely perform screening immunoassays to assess safety of the blood components. As with any other screening test, results have an inherent uncertainty. In blood establishments the major concern is the chance of false negatives, due to its possible impact on patients' health. This article briefly reviews GUM and diagnostic accuracy models for screening immunoassays, recommending a scheme to support the screening laboratories' staffs on the selection of a model considering the intended use of the screening results (i.e., post-transfusion safety). The discussion is grounded on a "risk-based thinking", risk being considered from the blood donor selection to the screening immunoassays. A combination of GUM and diagnostic accuracy models to evaluate measurement uncertainty in blood establishments is recommended., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Despite recent advances in the understanding and treatment of coagulopathy, the management of the bleeding patient remains as a major challenge. Traditionally, the main task of the blood bank has been to guarantee the supply of high quality blood and blood components/products to the hospital. Decisions regarding the use of blood components have always been the clinicians' responsibility, with little active involvement of the transfusion service. In the last years, many hospitals have implemented the use of "acute transfusion packages" for massively bleeding patients and point-of-care (POC) instruments such as TEG and RoTEM for monitoring coagulation status in this patient group. This, in addition to the implementation of patient blood management programs in the hospitals, has led to an increasing involvement of transfusion medicine specialists in transfusion decision making, especially regarding strategies for monitoring and treatment of the massively bleeding patient. This new trend may contribute to a more optimal management and monitoring of the bleeding patient, as POC testing may be used as an early predictor for blood usage. The blood bank should optimise the use of POC testing to provide accurate information in a cost-effective way., (Copyright © 2014. Published by Elsevier Ltd.)

The voluntary, non-remunerated blood donation organization is the important part of the International Red Cross movement. Historically the Red Cross Blood Program was established in Oslo with the main objectives to recruit new donors, support the blood banks with recruiting materials and to support in recruiting efforts made by local Red Cross branches. Currently the continual education of the recruited skilled personals, at all levels, is considered to be an essential part of such a program. The 2013 coincide with the 12th anniversary of Norwegian educational program in Quality in Transfusion Medicine. This report focuses on the historical background on the Red Cross Quality Course in Transfusion Medicine, as well as the progress made so far and looking into future perspectives., (Copyright © 2014. Published by Elsevier Ltd.)

In most countries whole blood transfusions have been replaced by component therapy. This has allowed for both better usage of the blood donations and better quality during storage. While this strategy was initially motivated by the commercial need for plasma the plasma reduction also reduced the levels of low grade proteases and sialidase, hence minimizing the cellular storage lesion/microvesiculation during prolonged storage. Plasma reduction also reduces transfusion reactions associated with plasma. During special military conditions, however, blood transfusion is urgently needed without corresponding access to blood components, in particular platelets. Accordingly, new focus on whole blood has aroused and added a new challenge to the blood transfusion services. This special issue of "what is happening" highlights the planed efforts by Swedish and Norwegian groups in the developments of military walking blood bank, which is applicable to civil blood services., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Amongst the presentations featured at Scotblood 2011 were advances in diagnostic tests for antibodies to red blood cells, the establishment of an islet isolation laboratory, and the development of a clinical product for corneal stem cell transplantation. In addition, the conference comprised presentations on state-of-the-art in collection, storage, and clinical utility of haemopoietic progenitor cells. It also included a session on blood banking systems dedicated to an SNBTS colleague, the late Russell Graham. Finally, the keynote lecture was delivered by Prof. John Forsythe on behalf of the Safety of Blood, Tissues and Organs (SaBTO) members, while the Iain Cook Memorial Lecture was delivered by the recently retired SNBTS R&D director, Prof. Chris Prowse., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

This exercise focused on performance of NBS quality monitoring establishments with respect to enumeration of low leucocyte and other quality indexes of platelet concentration. Paired identical leucodepleted platelet samples, spiked with WBC (20 cells/microl) in 'vacuette' or 'pouch' were assessed by participants (n = 20) on days 1, 2 and 5. For low WBC counting, all laboratories gave estimates within acceptable range (+/-25%) and good agreement between storage and assay methods was observed on days 1 and 2. Day 5 results showed greater variability. Under improved performance criteria (+/-15%), only one laboratory under-estimated at days 1 and 2. Similarly, other parameters demonstrated good agreement between storage methods on days 1 and 2. At day 5, mean results were often significantly different to previous days. Improved performance target (+/-15%) will allow identification of non-conformers.

Background: WBC counting, an essential part of quality monitoring of WBC-reduced blood components, is carried out logistically within 48-72 h of collection. The between-laboratory variability and effects of 24-48 h storage were investigated using three major counting technologies., Study Design and Methods: Samples of RBC and platelets with WBC in the range 0-50/microl were transported by courier. WBC counting was performed on days 1 and 2, by IMAGN 2000, flow cytometry and Nageotte, initially using local protocols and then using a national flow protocol. Up to 15 laboratories participated in each exercise., Results: For "real failed leucodepleted" red cell products, higher levels of variability were observed for flow and Nageotte, as compared to IMAGN. For spiked RBC samples at critical decision making point (3-20 WBC/microl), between-laboratory the coefficients of variation (CVs) were low for IMAGN and were the highest for Nageotte. Flow cytometry CVs were generally high but improved subsequent to standardisation of sampling and the gating strategy. A similar pattern in the variability of results was observed for platelet concentrates. Sign tests using all samples (carried out for each method in each exercise; 25 in total) demonstrated no overall tendency for larger WBC counts to be recorded on day 1 when compared to day 2, although this difference was significant (p < 0.001) in certain cases depending on the nature of the spiked product., Conclusions: We conclude that while a good performance is achieved using validated automated technologies for low residual leucocyte counting, the unification of reagents and standardisation of sampling and gating strategies are essential in obtaining interchangeable results. Unfixed RBC and platelet samples can generally be stored for 48 h before WBC counting.

Red blood cell storage in the blood bank makes millions of units of available for transfusion to civilian and military recipients every year. From glass bottles to plastic bags, from anticoagulants to complex additives, from whole blood to leukocyte filtered packed red blood cells: huge strides have been made in the field of blood component processing and storage in the blood bank during the last century. Still, refrigerated preservation of packed red blood cells under blood bank conditions results in the progressive accumulation of a wide series of biochemical and morphological changes to the stored erythrocytes, collectively referred to as the storage lesion(s). Approximately ten years ago, retrospective clinical evidence had suggested that such lesion(s) may be clinically relevant and mediate some of the untoward transfusion-related effects observed especially in some categories of recipients at risk ( e.g. massively or chronically transfused recipients). Since then, randomized clinical trials have failed to prospectively detect any signal related to red cell storage duration and increased morbidity and mortality in several categories of recipients, at the limits of the statistical power of these studies. While a good part of the transfusion community has immediately adopted the take-home message “if it isn’t broken, don’t fix it” ( i.e. no change to the standard of practice should be pursued), decision makers have been further questioning whether there may be room for further improvements in this field. Provocatively, we argue that consensus has yet to be unanimously reached on what makes a good quality marker of the red cell storage lesion and transfusion safety/efficacy. In other words, if it is true that “you can’t manage what you can’t measure”, then future advancements in the field of transfusion medicine will necessarily rely on state of the art analytical omics technologies of well-defined quality parameters. Heavily borrowing from Douglas Adam's imaginary repertoire from the world famous “Hitchhiker's guide to the galaxy”, we briefly summarize how some of the principles for intergalactic hitchhikers may indeed apply to inform navigation through the complex universe of red cell storage quality, safety and efficacy. [ABSTRACT FROM AUTHOR]

Abstract: Considerable progress has been made in the last decade in producing purer, safer, leucocyte and plasma reduced platelet concentrates (PC) with an extended shelf life. The development of different pathogen inactivation technologies (PIT) has made a substantial contribution to this trend. Preceding platelet PIT (INTERCEPT Blood System/Cerus Corporation, Concord, CA, USA; MIRASOL/Caridian BCT, Lakewood, CO, USA) are based on adding a photosensitive compound to PC. The mixture is then activated by UV light in the UVB and/or UVA spectral regions. A novel procedure, THERAFLEX UV-Platelets (MacoPharma, Mouvaux, France), was recently developed that uses short-wave ultraviolet light (UVC), without addition of any photoactive agent. This technology has proven to be highly effective in sterilising bacteria (the major cause of morbidity/mortality after platelet transfusion) as well as inactivating other transfusion transmitted DNA/RNA containing pathogens and residual leucocytes. Any PIT reflects a balance between the efficacy of pathogen inactivation and preservation of platelet quality and function. A broad spectrum of in vitro tests have become available for the assessment of platelet storage lesion (PSL), aiming to better predict clinical outcome and untoward effects of platelet therapy. Recent paired studies on the release of platelet-derived cytokines, as new platelet performance indicators, revealed a parallel increase in both THERAFLEX UV-treated and control PC throughout storage, supporting the notion that the bioavailability of platelet function is not grossly affected by UVC treatment. This is corroborated by some newer technologies for proteomic analysis, showing that the THERAFLEX UV-Platelets system results in limited disruption of integrin-regulating extracellular disulfide bonds and minimal protein alterations when compared to UVB and gamma irradiation. Moreover, standard in vitro parameters reflecting activation, metabolic activity and function of platelets are useful indicators of the overall performance of processing and storage and may be used as surrogate markers of platelet quality in vivo. However, there is some doubt as to what degree each marker alone or in combination reflects the true clinical outcome of transfused platelets. Therefore, an appropriate clinical programme has been initiated. The preclinical evaluation demonstrated tolerability and immunological safety of THERAFLEX UV-Platelets using an animal model. Additionally, the system has successfully completed two autologous Phase I trials on recovery and survival. Preliminary results suggest that the recovery and survival rates are consistent with other pathogen reduced platelet products that are licensed and in use. The method is currently under evaluation for safety and tolerability of UVC-treated platelets in healthy volunteers. Presently the THERAFLEX UV-Platelets system is the simplest and purest PIT easily adaptable to the existing blood bank setting. In the future, extension of the application range of the THERAFLEX UV-Platelets system is expected, in order to make this new technology compatible with a broad spectrum of collection and processing platforms, and with other blood products. [Copyright &y& Elsevier]

Background: Sickle cell trait donations can block leukodepletion (LD) filters or fail to LD, but the variables affecting blockage are unclear.Study Design and Methods: To identify critical variables for further study, the relationship was investigated between filter blockage and donor characteristics, processing conditions, PLT and coagulation system activation, and microvesicle formation in donations with (n = 63) and without (n = 40) sickle trait. With eight filter types whole blood was LD either at ambient temperature on Day 0 or after overnight 4 degrees C hold. Markers of PLT activation (CD62P and CD63 expression and soluble CD62P) and coagulation activation (activated FXII and prothrombin fragment 1 + 2 [F1 + 2]), RBC microvesicles, blood gases, and residual WBCs were measured.Results: All Day 0 filtrations blocked (n = 7). On Day 1, no filter tested was 100 percent successful, with most achieving an approximate 50 percent success rate. Two filters blocked consistently and an additional filter did not block, but resulted in 50 percent of units with high residual WBC counts (30 x 10(6)-394 x 10(6)/unit). Day 1 filtration was not improved if performed at 4 degrees C. Donor RBC variables and prefiltration measures varied little between blocked and successful filtrations except pO2, where 9 of 17 blockages had a pO2 of less than 5.0 kPa, compared with 0 of 13 completed filtrations. F1 + 2 levels increased after filtration in sickle trait units, a consequence of slow flow rate.Conclusion: Filter blockage in sickle trait donors cannot be predicted by donor characteristics or filter type and is not related to PLT or coagulation activation, but can be reduced by storing units at 4 degrees C before filtration. [ABSTRACT FROM AUTHOR]

Supply of blood for urgent substitution is a strategic logistical problem for the military medical services across the world. The limited shelf life of blood- derived bioproductsin the liquid state and the need for special transport and use conditions, apart from donor and donations availability are among the causes for concern. To solve these problems many national health-care authorities implemented the national emergency blood crisis policy, to get a large amount of blood at any time at any place in the case of disaster, terrorist attack or war. The civil therapeutic problems in immunohematolgy cases can also be solved by stocks of fresh and cryopreserved homologous or autologous blood for patients with rare RBCs antigens or HLA / HPA platelet refractoriness with no chance to use common blood. The short shelf life of fresh platelets limits their efficient inventory management and availability during a massive transfusion protocol. Building an inventory of frozen blood components can mitigate the risk of insufficient availability. Since the beginning of the century in the Czech Republic, used, like other countries, the use of of cryopreserved blood-derived bioproducts has become the current method used to overcome the shortages of a timely supply. The Military University Hospital, Prague, and its bank of cryopreserved blood have been operating under this policy since 2006. There is currently a stock of frozen RBCs for military reserve, for a national blood crisis and, also, a stock of rare RBC units. For crisis management there are also stored, frozen PLTs, which are used in the treatment of heavily bleeding polytrauma patients. Both the containment and research development mitigation policy programs are in place for civil / military emergency situations. Even pathogen reduced frozen PLTs and frozen RBCs were successfully investigated for clinical use if demands arose. Currently, it is possible to meet operational demand while reducing the number of resupply transports and loss of products due to expiration. A lesson has been learned from the current containment, reseach and mitigation programs of efficient blood supply management with cryopreserved blood and blood derived bioproducts. [ABSTRACT FROM AUTHOR]

If regular artificial tears are ineffective for treatment of ocular surface disorders (including extreme dry eye syndrome), serum eye drops (SEDs) may provide a way to relieve the symptoms. However, not all patients are eligible to donate blood to produce autologous SEDs. Therefore, the use of allogeneic SEDs (obtained from voluntary blood donors) should be explored as an alternative for autologous SEDs. The Dutch blood bank organization is currently looking into the possibilities to provide allogeneic SEDs, as (GMP) regulations become stricter, making it for hospitals more difficult to provide autologous SEDs. To demonstrate effectiveness of both autologous and allogeneic SEDs, a clinical trial is planned. The current status of SEDs in The Netherlands is described. This paper is based on summary of the presentation given at the DGTI meeting in Dresden. [ABSTRACT FROM AUTHOR]

Iron deficiency anemia is one of the widespread forms of anemia worldwide with important consequences on public health in general and in the management of the hospital blood supply in particular. In this context we decided to “de novo”organize a new hospital service specifically dedicated to iron therapy to correctly diagnose iron deficiency anemia and support patients with the latest generation of i.v. iron formulation. We describe the organizational and educational solutions we adopted to start the new service. The initial results in terms of safety, increase in Hb value, and RBC units saved were encouraging and it has led us to expand the categories of patients to be supported. [ABSTRACT FROM AUTHOR]

Abstract: The annual scientific meeting of the Scotblood National Blood Transfusion Service, (SNBTS), continues to enjoy success. Scotblood 2013 focused on the contemporary issues affecting the various essential areas of blood transfusion and transfusion medicine. Presentations ranged from the challenges of recruiting young donors, forecasting future blood demand and celebrating the success of the better blood transfusion program. The meeting also discussed potential future developments in regenerative medicine particularly the potential of mesenchymal stromal cells and discussion of the ongoing Bloodpharma project, the ultimate aim of developing cultured red blood cells. This commentary comprises summaries of the presentations, based in part on the abstracts provided by the speakers. The Scotblood Conference began with the welcoming introduction by SNBTS Director Mrs. Mary Morgan, during which she updated the ongoing developments within SNBTS over the last year. Mrs. Morgan described how SNBTS met the challenges and obstacles that have been prevalent in all Blood Transfusion Services, whilst also meeting the transfusion needs of the people of Scotland. Mrs. Morgan then introduced the keynote speaker Dr. Aileen Keel CBE, Deputy Chief Medical Officer of Scotland. Dr. Keel’s presentation was entitled “Twenty years in the Scottish Government-edited highlights” in which she described the various challenges that have presented themselves to her throughout her career. Dr. Keel highlighted how the various risks in the blood transfusion field (from HCV, HIV through to nvCJD) have arisen and then reduced to miniscule levels through hard work and perseverance. The highlights of the conference are summarised below. [Copyright &y& Elsevier]

Abstract: The current status of potential adverse reactions associated with the use of apheresis technology is reviewed, focussing on three main areas: adverse events related to component collection, progenitor cells collection and therapeutic apheresis. Based on available information it is believed that apheresis technologies are safe and increasingly used in transfusion medicine, including in auto-transfusion and different types of therapy. Occasionally, however, for various donor/patient and operational reasons, mild or moderate adverse reactions do occur. The majority of these reactions are related to vascular access and anticoagulants used, which can be mostly eliminated with calcium/magnesium administration. The reactions associated with therapeutic apheresis are more frequent (6.75%) than the multi-components and stem cell collections. Most of these reactions are generally mild and only 0.89% has been classified as severe. A national registry of donor adverse reactions as well as a planned haemovigilance system may prove helpful in identifying the potential causes which might be associated with either to donor/donation and/or with a particular technology or procedure. [Copyright &y& Elsevier]

Canadian Blood Services (CBS), Canada’s national blood transfusion service, has for many years sponsored an annual conference, for the education and awareness of interested participants, showcasing the latest evidence-based understanding of both basic science and clinical issues in transfusion medicine and science. The 15th iteration of this symposium took place September 9, 2017 and focused on some of the vital aspects of red blood cells (RBC), in line with the” 3Rs” concept, namely the provision of the Right red blood cell (RBC) product to the Right patient at the Right time. Presentations touched upon: the evolution of blood banking in North America; the monocyte monolayer assay as a predictor of post-transfusion hemolysis; hemoglobin-based oxygen carriers; RBC alloimmunization; serological approaches to complex RBC antibody problems; randomized clinical trials related to the age of stored RBC; RBC genotyping; pathophysiology, prevention and treatment of hemolytic disease of the fetus and newborn (HDFN); and testing and timing in perinatal serology. This commentary provides summaries of all speakers’ presentations annotated with relevant references. Special thanks are due to all contributors for their praiseworthy approaches in sharing their experiences and knowledge on this interesting scientific/clinical and management theme. [ABSTRACT FROM AUTHOR]