International haemovigilance: what have we learned and what do we need to do next?

The International Haemovigilance Network (IHN) defines haemovigilance as ‘a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow‐up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence’. IHN, the International Society of Blood Transfusion and World Health Organization work together to support both developing and established haemovigilance systems. Haemovigilance systems provide valuable data on a range of adverse events related to blood donation and clinical transfusion, from donor syncopal events to transfusion‐transmitted infections, immunological complications and the impact of human errors. Harmonised definitions for most adverse reactions have been developed and validated internationally. Definitions of pulmonary complications are again under review. Haemovigilance data have resulted in changes in policy, products and practice, and can complement and inform clinical audit and research, leading to improved blood donor safety, optimised product use and better clinical outcomes after transfusion. However, more work is needed. Not all countries have haemovigilance systems in place. More robust data and careful analysis are required to improve the understanding of the causes, occurrence and clinical outcomes of these events. Wider dissemination of results will facilitate health policy development internationally, and implementation of haemovigilance recommendations will support further important progress in blood safety.     

6 Years of shot reporting--its influence on UK blood safety.

Recognition of the importance of systematic surveillance of adverse effects of transfusion has led to the development of haemovigilance schemes [Faber JC. Haemovigilance around the world. Vox Sang 2002;83(suppl.1):71], of which the Serious Hazards of Transfusion (SHOT) scheme, launched in 1996, was one of the first. Over 90% of UK hospitals now participate in the scheme; in 6 years of reporting, SHOT analysed 1630 events of which 64% were errors in the transfusion process, leading to 193 instances of ABO incompatible transfusion. Transfusion related acute lung injury, bacterial contamination of platelets and transfusion-associated graft-versus-host disease were also identified as important preventable causes of mortality and morbidity. Data from SHOT has provided evidence to support the development of blood safety strategies in the UK.     

Conference report: International Haemovigilance Seminar and the SHOT Annual Symposium, 10–12 July 2018

The Annual SHOT Report was published on July 12 at the Annual Symposium. This was preceded by a 2‐day meeting of the International Haemovigilance Network (IHN). The IHN meeting provides an opportunity for haemovigilance experts to network with one another and share presentations, which this year included those from China and Taiwan. Reviews of pulmonary complications were highlighted since the definitions of both transfusion‐related acute lung injury and transfusion‐associated circulatory overload are undergoing revision. The seminar provided an opportunity to present some UK data to an international group (the INTERVAL donor study, the value of big data and work on genomics and human factors). SHOT reports for incidents reported in 2017 demonstrate that, overall, 85·5% are caused by errors. Key recommendations from SHOT are: (i) All staff involved in transfusion must be trained in and know ABO group compatibility. Clinical staff must not just rely on the laboratory staff to get this right. (ii) IT systems have the potential to increase transfusion safety by minimising human factors and should be considered for all transfusion steps. (iii) A formal risk assessment for transfusion‐associated circulatory overload should be undertaken wherever possible.     

A comparison of complication rates based on published haemovigilance data

Haemovigilance is defined as the collection of information on complications of transfusion, the analysis of the data, and suggestions for improvement in the transfusion service. A national haemovigilance system is of value in identifying possible areas in need of improvement in the national transfusion system. Haemovigilance becomes even more important if the system is used to compare the situation in one country with the situation in other countries, e.g. if the countries differ significantly in products used. The current study focuses on immunological transfusion complications, especially TRALI, as published in haemovigilance reports from Denmark, Norway, Sweden and the UK. RESULTS: In Norway immunological transfusion reactions occurred 96.7 times per 100 000 red cell (RBC) transfusion, 231.1 times per 100 000 thrombocyte (Trc) concentrate transfusion and five times per 100.000 transfusions of solvent detergent treated plasma (SD plasma). Denmark and the UK have similar rates of transfusion reactions to RBC and fresh frozen plasma (FFP), but quite different for Trc (0.5 vs. 4.9 per 100 000). In 49% of reported TRALI the causative product is FFP, but no case of TRALI after SD plasma transfusion has been reported. DISCUSSION: When considering all reports for immunological complications in Norway, the most striking is the very small number of reports related to SD plasma. Comparing data from Denmark and the UK shows a big difference in reactions caused by thrombocyte concentrates that may reflect different production methods in the two countries. TRALI is most often caused by FFP, but has never been reported after SD plasma transfusion. Heamovigilance data can be valuable in choosing the safest products available.     

Problem of bacterial contamination in platelet concentrates

Bacterial contamination of blood is being recognized more frequently now and is one of the serious complications of transfusion. Use of integrally attached collection systems and strict standards for skin preparation, collection and storage of blood and components have reduced but not eliminated the risk of bacterial contamination. As bacteraemia may be part of acute or sub acute infections, strict donor selection is warranted. The longer the storage time, the greater is the number of organisms and amount of endotoxin present in the unit and associated with transfusion reactions. Importance of haemovigilance system and awareness among clinicians on the potential complications will go a long way in reducing patient morbidity. New approaches for detection of bacterial contamination, pathogen reduction and developments in the field of platelet biology will increase blood safety.     

A comparison of complication rates based on published haemovigilance data

Haemovigilance is defined asthe collection of information on complicationsof transfusion, the analysisof the data, and suggestions for improvementin the transfusion service. Anational haemovigilance system is ofvalue in identifying possible areas inneed of improvement in the nationaltransfusion system. Haemovigilancebecomes even more important if thesystemis used to compare the situationin one country with the situation inother countries, e.g. if the countriesdiffer significantly in products used.The current study focuses on immunologicaltransfusion complications, especiallyTRALI, as published inhaemovigilance reports from Denmark,Norway, Sweden and the UK.

Results:

In Norway immunologicaltransfusion reactions occurred 96.7times per 100 000 red cell (RBC)transfusion, 231.1 times per 100 000thrombocyte (Trc) concentrate transfusionand five times per 100.000 transfusionsof solvent detergent treatedplasma (SD plasma). Denmark and theUK have similar rates of transfusionreactions to RBC and fresh frozenplasma (FFP), but quite different forTrc (0.5 vs. 4.9 per100 000). In 49% of reported TRALIthe causative product is FFP, butno case of TRALI after SD plasmatransfusion has been reported.

Discussion:

When considering all reportsfor immunological complicationsin Norway, the most striking is the verysmall number of reports related to SDplasma. Comparing data from Denmarkand the UK shows a big differencein reactions caused by thrombocyteconcentrates that may reflect differentproduction methods in the twocountries. TRALI is most often causedby FFP, but has never been reported afterSD plasma transfusion. Heamovigilancedata can be valuable in choosingthe safest products available.

     

Effect of pathogen inactivation on the storage lesion in red cells and platelet concentrates

A primary function of blood transfusion services is to ensure the safety of the community’s blood supply. Multilayer strategies of safety need to be incorporated into the processing of blood components in order to minimize untoward transfusion events related to infections or the blood storage lesion. While there have been considerable technical advances over the past few decades to advance blood component safety, there is a need for continued improvement.One significant problem area is transfusion transmitted bacterial infections. In infectious disease, blood borne bacteria are the major cause of morbidity in transfusion medicine. Proactive implementation of pathogen inactivation technologies, PIT can help to eliminate bacterial contamination of blood. This is accomplished by inactivation of various known and emerging bacterial pathogens, which have been identified through their nucleic acid sequences. The current PIT has additional positive impacts on transfusion safety by reducing adverse clinical events associated with viable residual leukocytes in the blood. Given the valuable benefits of pathogen inactivation, there is a practicable need to advance this technology.In order for a particular pathogen inactivation strategy to gain widespread acceptance, it must satisfy a number of important criteria. The technology shall be:

• (1) 

  Effective to eliminate pathogens.

• (2) 

  Uncomplicated and cost-effective to implement in the preparation of blood components.

• (3) 

  Minimally toxic while maintaining the quality of blood storage products for transfusion purposes.

• (4) 

  Safe.

Currently, PIT is not suitable for all blood components. Future advances in PIT for whole blood and red cell components should expand the application of this technology across a broader range of blood products.Based on available laboratory and clinical data, current pathogen inactivation procedures appear to leave the cell components sufficiently viable to achieve an effective transfusion. Novel technologies continue to evolve for the inactivation of pathogens in the blood supply. We need to ensure these procedures do not worsen the storage lesion causing potential harm to patients. Quality research and development supporting multi-centre clinical trials are necessary. One purpose of such trials is to determine whether this new generation of procedures for processing blood yields bioequivalency regarding the quality of the products. Validated haematological assays should be utilized to test the extent of the blood storage lesion. Post-marketing surveillance involving active haemovigilance is necessary regarding possible adverse outcomes of transfusion.     

Patient blood management and the importance of the Transfusion Practitioner role to embed this into practice

Patient blood management (PBM) is a widely established international initiative, with a multidisciplinary approach to reduce transfusion. The Transfusion Practitioner¹ (TP) role is well embedded in the United Kingdom (UK) and Australia. The value of the TP in changing both culture and practice to implement an all‐inclusive PBM approach to care will be discussed. The TP role was born from both a safety and haemovigilance culture, where the greatest identified risk to the patient undergoing a transfusion was human error. From this initial trigger for improved safety, the TP role has evolved to a multifaceted, highly specialised role, involved in both PBM and transfusion processes. As the transfusion paradigm shifted from product to patient, the TP role evolved to include PBM, with an emphasis on the patients and the impact transfusion has on them. A multidisciplinary team is required to drive both PBM and transfusion; the TP is recognised as a critical link in the multidisciplinary team. They are seen as a driving force for change, bridging the gap between the laboratory and clinical arenas. The TP plays a vital role in helping establish and embed PBM that improves patient and safety outcomes.     

Status of blood transfusion in World Health Organization-Eastern Mediterranean Region (WHO-EMR): Successes and challenges

Background

Blood products are used for patient treatment and survival in the cases of major surgery, hematological disorders or cancer therapy. Presently the main blood components are not yet replaceable by artificial products and all activities related to blood transfusion is highly dependent on the healthcare development of each country. The World Health Organization Eastern Mediterranean Region (WHO-EMR) comprises of 21 member states with variable socio-economic status effective on blood transfusion activities. The fundamental motivation behind this research was to accumulate some data of blood practices in this region and to have an appropriate image of the WHO-EMR region.

基于Cov-AHP-模糊综合评价法构建输血病历质量评价模型

目的 基于协方差-层次分析(covariance-analytic hierarchy process,Cov-AHP)-模糊综合评价法构建一种临床输血病历质量评价模型.方法 通过专家组打分,建立临床输血病历质量评价指标体系.采用协方差-层次分析法(Cov-AHP)对评价指标进行赋权,建立临床输血病历质量评价模型.并收...     

Administration of blood transfusions to adults in general hospital settings: a review of the literature

The Serious Hazards of Transfusion (SHOT) haemovigilance scheme for the United Kingdom and Republic of Ireland has clearly indicated that there are avoidable risks to which recipients of blood transfusion are exposed. Sometimes errors in practice have led to serious and even fatal consequences, particularly when a haemolytic response occurs due to an incompatible transfusion. Despite the risks, blood transfusion is an important and frequently life-saving therapy and its use in clinical practice is common. This paper discusses recently published national guidelines for the care of recipients of blood transfusion in the light of a review of the literature relevant to the administration of blood transfusions to adults in general hospital settings. Recommendations for practitioners, managers and teachers are offered in relation to preventing errors and to patient care associated with blood transfusion in the context of contemporary emphasis upon evidence based care.     

Three years of haemovigilance in a general university hospital

The aim of this study is to describe a newly implemented haemovigilance system in a general university hospital. We present a series of short cases, highlighting particular aspects of the reports, and an overview of all reported incidents between 1999 and 2001. Incidents related to transfusion of blood products were reported by the clinicians using a standard preformatted form, giving a synopsis of the incident. After analysis, we distinguished, on the one hand, transfusion reactions, that are transfusions which engendered signs or symptoms, and, on the other hand, the incidents where management errors and/or dysfunctions took place. Over 3 years, 233 incidents were reported, corresponding to 4.2 events for 1000 blood products delivered. Of the 233, 198 (85%) were acute transfusion reactions and 35 (15%) were management errors and/or dysfunctions. Platelet units gave rise to statistically (P < 0.001) more transfusion reactions (10.7 per thousand ) than red blood cells (3.5 per thousand ) and fresh frozen plasma (0.8 per thousand ), particularly febrile nonhaemolytic transfusion reactions and allergic reactions. A detailed analysis of some of the transfusion incident reports revealed complex deviations and/or failures of the procedures in place in the hospital, allowing the implementation of corrective and preventive measures. Thus, the haemovigilance system in place in the 'Centre Hospitalier Universitaire Vaudois, CHUV' appears to constitute an excellent instrument for monitoring the security of blood transfusion.     

Pre-operative autologous blood donation and transfusion-related adverse reactions: A 14-year experience at a university hospital

Objective

The objective of this study was to determine the rate of adverse reactions to pre-operative autologous blood donation (PAD) transfusion in a single institution over a 14-year period.

Transfusing safely: a 2006 guide for nurses

Transfusion is a 'vein-to-vein' process. The blood supply in Australia is extremely safe in terms of viral risk, although a 'zero risk' blood transfusion is never possible. Safe transfusion practice continues to rely on highly-trained and experienced staff undertaking procedures correctly, in robust hospital systems within a safety and quality framework that includes an adverse event reporting system. Such a reporting system should work to enhance any hospital system where weaknesses or deficiencies are found. Further information on national guidelines and other aspects of transfusion in Australia can be found at: www.anzsbt.org.au/publications and www.transfusion.com.au. A transfusion administration checklist for nurses can be downloaded from: http://www.transfusion.com.au/Resourc eLibrary/resource_safety_2 .asp     

The French Haemovigilance System: organization and results for 2003.

In 1993 by law, in France, haemovigilance became a national system of surveillance and alert, from blood collection to the follow-up of the recipients, gathering and analysing all adverse events of blood transfusion in order to prevent their recurrences. In 2003, 2911 incidents with strong imputability have been specially analysed, among them seven confirmed cases of bacterial contamination, 137 incorrect blood components transfused with 12 cases of ABO incompatibility, 15 adverse reactions diagnosed as TRALI and 12 deaths. The analysis of information provided by haemovigilance has led to the implementation of new guidelines.     

Comparative analysis of national regulations concerning blood safety across Europe

In October 2001, representatives of 17 European countries (Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Italy, Macedonia, Romania, Slovenia, Spain, Turkey and UK) met in Sarajevo at a course organized by the European School of Transfusion Medicine to discuss their countries' regulations concerning different aspects of the safety of blood transfusion. Results are summarized in tables to facilitate comparisons. Most countries (13/17) have specific transfusion laws and 9/17 have hospital-based systems as opposed to national organizations. Quality assurance is common among investigated countries (14/17). Voluntary associations are responsible for donor promotion in the majority of countries (13/17). Exclusively, voluntary non-remunerated donors are found in 5/17 countries, whereas in the remaining ones, incentives, family replacement and remuneration are mechanisms stimulating blood donation. Medical doctors using official selection criteria are checking donor suitability in virtually all countries, which also perform main microbiological testing. Regulations on good clinical use of blood and derivatives are present in most countries but applied only in some. Although the data presented need to be interpreted with some caution, this preliminary analysis shows that, although some significant differences still exist, the majority of countries studied are moving in the same direction to ensure safety of their blood supply.     

Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk

While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic.     

Serious hazards of transfusion – conference report: celebration of 20 years of UK haemovigilance

The Annual SHOT Report for incidents in 2016 was published on July 12 and celebrated of 20 years of UK haemovigilance. Components are very safe, related in part to risk‐reduction measures triggered by SHOT reporting. Transfusion‐related acute lung injury is now very rare (all plasma components are provided from male donors), and infection transmission is also uncommon – a single transmission of hepatitis E in 2016 and no bacterial transmissions. Human factors (errors) account for 87% of all reports. Deaths and major morbidity most often result from transfusion‐associated circulatory overload. Wrong transfusions and deaths from ABO‐incompatible transfusion can be reduced by correct bedside checks. It is notable that information technology systems may not be safe. Standardisation is required for flags and alerts. SHOT key recommendations include: assess patients for transfusion‐associated circulatory overload prior to transfusion. Be like a pilot – use a bedside checklist when setting up the transfusion.     

Patient blood management: The best approach to transfusion medicine risk management

In advanced health systems it is increasingly important to offer effective medical services that have high quality and safety standards. We present an overview of the direct hazards and the indirect hazards associated with blood transfusions. Our aim is to focus on the potential medico-legal impacts of these hazards in the context of clinical risk management, incorporating the accumulating evidence from Patient Blood Management programs. The direct or deterministic hazards of transfusion refer to scenarios where the mechanisms for post transfusion damage are clearly traceable to the blood transfused in a 1:1 cause and effect manner. The indirect hazards can be defined as probabilistic and are associated with transfusion through epidemiological studies. The implementation of Patient Blood Management programs demonstrates that the use of a blood transfusion is not always necessary or unavoidable but can be considered modifiable. Review of the literature confirms that transfusion should not be the default option to manage anemia or blood loss. Instead, accumulating evidence demonstrates that a patient-centred, proactive approach to managing a patient’s own blood is the new standard of care. It thus follows, an adverse transfusion event, where the transfusion was avoidable through the application of patient blood management, may constitute a profile for medical professional medical negligence.In an effort to maximise patient safety, transfusion medicine practice culture needs to shift towards a patient blood management approach, with hospitals implementing it as an important tool to minimize the risks of allogeneic blood transfusion.