Transitioning from ‘blood’ safety to ‘transfusion’ safety: addressing the single biggest risk of transfusion

Transfusion errors occur at all points in the transfusion chain, often occurring at multiple points in the transfusion process for the same patient. Such events have been reported to national haemovigilance programs in almost all countries, over and over again. An incredible number of safety changes have been implemented to improve blood safety, including but not limited to: nucleic acid testing for HIV/HBV/HCV, bacterial culture for platelet concentrates, use of male-only plasma, and the introduction of pathogen reduction strategies. By contrast, very little momentum has developed behind transfusion safety, in hope of improving the safe delivery of blood to patients. This article will review the interventions that have been studied by transfusion medicine services in attempt to improve transfusion safety at every link in the transfusion chain. The most important and indispensable safety step is the introduction of an error tracking system. Such a system should capture all deviations from standard operating procedures, including near-misses that are captured before the blood product is issued. Near-misses are 300-fold more common and represent latent safety concerns requiring urgent attention. The system should be anonymous to ensure that there is no barrier to reporting and no-fault to recognize that the vast majority of errors are due to latent system errors. The errors should be coded by type and location to allow for the ability to query the error database for the purposes of benchmarking and tracking and trending after system changes. Such a system will allow hospital transfusion services to focus their initiatives at the steps in the transfusion chain most in need of repair at their institution. The system changes that have been studied include: confirmatory group testing, computerized physician order entry, prospective screening of transfusion orders before/after issue, controlled patient registration, regional blood bank information systems, positive patient identification at time of sample collection and the start of transfusion (using barcode or RFID technology), controlled release refrigeration devices, patient involvement in the transfusion process, and healthcare professional education. For each area, the specific technologies or examples will be detailed, the reports from the literature will be reviewed, and the obstacles to implementation will be discussed. Now that blood safety has been assured, we need to re-focus our attentions on the single biggest threat to patients: errors in the transfusion chain at the hospital level. We need to ensure that patients get blood only when required, that they get the correct product of the correct blood group, at the right dose, at the appropriate infusion rate, to the correct patient, at the right time. We need to take a rigorous scientific approach to solving transfusion safety to ensure that each process change is properly tested and validated to verify that each newly introduced process is safe and effective.     

The role of the transfusion nurse in the hospital and blood centre

The transfusion process is complex, involving many interlinking chains of events, and a multidisciplinary group of health professionals with different levels of awareness and understanding of transfusion practice. In recent years, many measures have been implemented to increase blood component safety and the clinical transfusion process. Haemovigilance programs report the greatest risks to patients from transfusion in many countries now relate to hospital-based steps in the process. The role of the Transfusion Nurse (TN) is evolving as an integral part of efforts to optimise appropriate use of blood components, reduce procedural risks and improve transfusion practice generally. The TN position is a relatively recent specialist role within hospitals and blood services, and continues to develop with growing experience of areas requiring intervention in the clinical setting, and increasing expectations for improvements in transfusion clinical governance. The role typically includes activities to improve clinician and patient awareness of transfusion issues and practical knowledge of blood product use, and therefore to improve clinical decision-making and enhance blood administration processes, along with responsibilities for education/training, auditing and adverse event follow-up. Within the Blood Service in Australia the role also covers approval and provision of specialised blood products along with many of the hospital-based TN functions. The TN serves as an expert resource and has been fundamental in development of tools, resources and skills in the following areas: - Patient blood management: - Education - Governance - Professional development - Research Benchmarking across organizations has demonstrated that availability and review of comparative data can be a powerful motivator of change. Reviews of the TN role/programmes highlighted their effectiveness and resulted in ongoing support/funding. Skills and attributes such as confidence, persistence, energy, excellent communication/ technical knowledge and clinical experience are key requirements for the roles success. Conclusion The specialist transfusion practitioner/Transfusion Nurse is an integral part of a multidisciplinary team, supporting efforts at institutional and national levels to reduce transfusion risks and improve practice.     

The role of blood transfusion in Sickle Cell Disease

Blood transfusion is used in the treatment and prevention of acute and chronic complications of Sickle Cell Disease. Blood may be administered in the emergency situation as a simple top-up transfusion or as an automated or manual exchange procedure. Elective transfusions may be offered as an one-off procedure, often pre-operatively or as a long-term regime, usually for primary or secondary stroke prevention. The main complications of transfusion in this patient population are alloimmunization, hyperhaemolytic transfusion reactions and iron overload.     

Questioning the benefit of restrictive transfusion practice in older adults

Restrictive transfusion practice is widely promoted, with many international guidelines recommending haemoglobin thresholds of 70 to 80 g/l for adult patients who are asymptomatic. Randomized controlled trials comparing outcomes associated with liberal and restrictive transfusion strategies underpin this approach. Meta‐analyses including trials of adult patients >18 years of age have concluded that restrictive practice is noninferior to liberal transfusion approaches. A restrictive approach to transfusion reduces resource consumption and cost, as well as the hazards associated with unnecessary exposure to blood products. Although adults aged ≥65 years consume over half of the blood supply, there are few randomized controlled transfusion trials exclusive to this cohort. Our 2017 meta‐analysis of a small number of trials focussed on older adults found that higher transfusion haemoglobin thresholds were associated with lower mortality and fewer cardiac complications in this age group. Other studies have also shown that higher transfusion haemoglobin thresholds are beneficial in older adults. This paper presents recent evidence regarding transfusion outcomes in older adults and discusses aspects of the pathophysiology of ageing that impact on the reduced resilience of older patients to anaemic states. This evidence challenges the use of Hb thresholds that apply across the adult lifespan, regardless of age. It proposes that older age be considered as a risk factor in assessing transfusion requirements, and that transfusion practice in older adults may require higher haemoglobin thresholds than for younger adults.     

The impact of a closed-loop electronic blood transfusion system on transfusion errors and staff time in a children's hospital

ObjectivesTo assess the impact of a closed-loop electronic blood transfusion system on transfusion errors and staff time.Materials and methodsBefore and after study in all wards of a children's hospital, involving patients and staff of all the wards. The changes were closed-loop electronic blood transfusion, barcode patient identification, electronic blood transfusion administration records and error pop-up warning. The main outcome measures were percentage of blood transfusion errors, time spent on transfusion tasks.ResultsTransfusion errors were identified in 3.87% of 2556 blood transfusion orders pre-intervention and 0.78% of 2577 orders afterwards (P < 0.01). Phlebotomists, nurses, and physicians may make mistakes, including wrong blood type when apply for blood, wrong patient when blood draw or transfusion, wrong dose when apply for blood and the wrong tube label when blood draw or cross-matching, which are significantly reduced after change (1.09% vs 0.31%, 1.13% vs 0%, 0.31% vs 0%, 1.33% vs.0.78%, P < 0.01). Time spent on blood apply was 5.3 ± 1.2 min, hand over blood bag at the transfusion department was 14.9 ± 1.4 min and blood transfusion was 15.8 ± 2.4 min. Time per transfusion round decreased to 2.6 ± 1.0 min, 6.3 ± 1.6 min and 9.3 ± 2.2 min respectively (P < 0.01).ConclusionsA closed-loop electronic blood transfusion, barcode patient identification and error pop-up warning reduced transfusion errors, and increased confirmation of patient and blood types identity before transfusion. Time spent on blood transfusion tasks reduced.     

Anemia and transfusion of red blood cells

The red cells transfusion is a mainstay in the treatment of anemic patients. These blood transfusions are not without risks. The risk-benefit profile for red cell transfusions to treat anaemia is uncertain, but they may contribute to adverse patient outcomes in some situations. The ability of a patient to tolerate anaemia depends on their clinical condition and the presence of any significant co-morbidity; maintenance of circulating volume is of paramount importance. There is no universal transfusion trigger. Advances in the development and validation of physiological, accessible, practical and reliable markers to guide therapy are expected. To improve patients'' outcomes, further study is required to more fully explore the risk of anemia, optimal hemoglobin level, and the risk and efficacy of RBC transfusion. Future clinical investigations with high priority should determine the efficacy of transfusion in those classified as uncertain scenarios. In the absence of data, it is prudent that transfusion is administered with caution in these clinical scenarios.     

Clinical observation study of massive blood transfusion in a tertiary care hospital in Korea

Purpose

Massive blood transfusios are uncommon. The goal of this study was to propose an ideal ratio for the blood component of massive hemorrhage treatment after review of five years of massive transfusion practice, in order to have the best possible clinical outcomes.

Materials and Methods

We defined a ''massive transfusion'' as receiving 10 or more units of red blood cells in one day. A list of patients receiving a massive transfusion from 2004 to 2008 was generated using the electronic medical records. For each case, we calculated the ratio of blood components and examined its relationship to their survival.

Results

Three hundred thirty four patients underwent massive transfusion during the five years of the study. The overall seven-day hospital mortality for massive transfusion patients was 26.1%. Factors independently predictive of survival were a fresh-frozen plasma (FFP)/packed red blood cell (pRBC) ratio≥1.1 with an odds ratio (OR) of 1.96 (1.03-3.70), and elective admission with an OR of 2.6 (1.52-4.40). The receiver operation characteristic (ROC) curve suggest that a 1 : 1 : 1 ratio of pRBCs to FFP to platelets is the best ratio for survival.

Conclusion

Fixing blood-component ratios during active hemorrhage shows improved outcomes. Thus, the hospital blood bank and physician hypothesized that a fixed blood component ratio would help to reduce mortality and decrease utilization of the overall blood component.     

End-to-end electronic transfusion management in hospital practice

Background Errors occur at all stages of the hospital transfusion process and the resulting morbidity and mortality are well documented. Recent initiatives in the UK and elsewhere to reduce transfusion errors have focussed on implementing recommended manual procedures for good practice, but have only been partially effective. Aims Our approach was to ‘re-engineer’ bedside and laboratory transfusion procedures. Materials and Methods We implemented barcode patient identification, bedside handheld computers and electronically controlled blood fridges to simplify transfusion procedures and improve practice. Results There was an improvement from 11.8% to 100% of staff following the process for correct pre-transfusion bedside patient identification; no ABO incompatible red cell transfusions in 5 years; a reduction in wrong blood component transfused events from 1 in 27,523 to 1 in 67,935; reduced nursing (one nurse rather than 2 and half the time to administer blood) and laboratory workload; and more rapid delivery of urgently required red cell units to patients (from a median of 18 minutes to 45 seconds). The electronic system provided a simple mechanism for compliance with UK/EU regulatory requirements for the traceability of blood, and the documentation of transfusion and training. Feedback from both staff and patients was positive. Discussion The project was taken through pilot stages between 2001 and 2006 through to its full implementation across the acute hospitals in Oxfordshire in 2006/07. Our group wrote a national specification for the electronic transfusion process, but the implementation elsewhere in the UK has been slow. There is the potential to introduce an additional module into the electronic transfusion process to provide ‘decision support’ for doctors ordering blood to minimise inappropriate use of blood as part of a patient blood management programme, and use the same ‘end-to-end electronic’ approach for other clinical procedures such as drug administration. Conclusion The implementation of a hospital electronic transfusion management system was shown to provide improvement in transfusion practice and in the efficiency of the service.     

The impact of training in transfusion medicine

Background Basic training skills and program for all health care providers working in the blood transfusion services is important and essential. All blood transfusion staff should have active participation in a training program that includes teaching all national and international regulations related to blood transfusion administration and guidelines of safe blood and blood products. The blood bank staff (physicians, medical technologists and nurses) should pass proper assessment procedures in order to work in this vita health related services. All staff working in blood transfusion services should receive a proper education and learning skills in this field of medicine. Awareness of blood safety and Good Manufacturing Practice (GMP) in blood transfusion should be greatly increased among them. Methods and Results Sustainable national and international education and training in blood transfusion services are needed and should be considered as a priority. Methods of teaching and training may include courses or workshops consist of a series of lectures, practical sessions, problem based learning and computer based distance learning programs. A proper training and continuous medical education in blood transfusion services have played an important role in minimizing the risk of transfusion related complications in many countries. Conclusions Creating an effective learning and training environment is a real challenge for most developing countries. Transfusion medicine is a branch of medicine which has a great link with almost all medical and surgical specialties. Blood transfusion safety plays an important and significant role in the patient's management. Proper qualified training personnel are the key of delivering safe blood components and the Good Manufacturing Practice (GMP) in blood transfusion services.     

成分输血在25例外科手术患者大出血的应用

目的探讨成分输血在抢救外科手术患者手术中大出血的临床疗效。方法回顾性分析25例大量输血手术患者的临床资料,根据患者病情分为择期手术组和急诊手术组,统计分析患者输注红细胞悬液（CRCs）、新鲜冰冻血浆（FFP）、浓缩血小板（PC）和冷沉淀（Cryo）等成分血的种类和剂量以及输注后的不良反应。结果25例大出血患者经成分输血抢救后出血症状均得到控制,并获得良好的疗效;输注量最大的血液品种是红细胞悬液,两组大量输血手术患者手术前、后实验室检查结果比较无显著性差异（P〉0．05）。结论成分输血在外科手术患者手术中大出血时应用可获得良好的止血效果,为手术继续进行提供了很好的机会,但在各种成分血液用量上有很大差异,应根据患者的出血情况和实验室检查结果输注不同的成分血液。     

Modeling transfusion reactions with kodecytes and enabling ABO-incompatible transfusion with function-spacer-lipid constructs

Background KODE technology uses Function-Spacer-Lipid (FSL) constructs for artificial attachment of blood group antigens onto live cells (kodecytes) and visualisation, thus making it potentially suitable to model both transfusion reactions and determine in vivo cell survival. Additionally, as some FSL constructs are glycolipid-like, the possibility exists that they may also neutralise circulating antibodies, in the same way Lewis glycolipids were historically used to allow Lewis incompatible transfusions. Aims To determine if kodecytes can be used to both mimic and monitor transfusion reactions in an animal model, and also to determine if FSL construct infusions can neutralise circulating antibodies and allow for an incompatible transfusion. Methods Naïve, anti-A positive (immunised), and anti-A positive/FSL-A neutralised mice were given transfusions of murine kodecytes created with FSL-biotin and FSL-A. Levels of surviving kodecytes were determined at multiple time-points via their biotin label. Analysis for anti-A was performed with inkjet printed FSL-A constructs in a micro immunoassay. Results Normal kodecyte survival was observed in control animals. Mice with anti-A predominantly cleared their incompatible A-kodecyte transfusions within 6 min. Mice with anti-A that had been neutralised with an FSL-A infusion had normal survival of their incompatible A-kodecyte transfusions. Re-challenge transfusions of A-kodecytes into mice previously given FSL-A (once the FSL-A had cleared from their circulation) gave two different results. One group cleared the incompatible A-kodecytes within minutes while the other had normal survival, suggesting potential induction of tolerance. Conclusions Kodecytes can be used to model blood group A incompatible transfusions in animals. FSL-A can neutralise anti-A and allow for incompatible A-kodecyte transfusion. The potential exists to extend these research observations into clinical use to allow for transfusion and transplantation across the ABO barrier, or at least mitigate the consequences of accidental ABO incompatibilities.     

Reduction of blood transfusion rates in unilateral total knee arthroplasty by the introduction of a simple blood transfusion protocol

We prospectively studied blood transfusion practices within a single institution before and after the introduction of a blood transfusion protocol in consecutive patients undergoing unilateral total knee arthroplasty. Data were collected on 393 patients (group I) prior to and 295 patients (group II) after the introduction of the protocol. Following the introduction of the protocol, patients with preoperative haemoglobin of less than 11 g/dl were cross-matched prior to surgery. The criterion for postoperative transfusion was postoperative haemoglobin of less than 8.5 g/dl or a symptomatic patient with haemoglobin of greater than 8.5 g/dl. This change in practice reduced the transfusion rates from 31% in group I to 11.9% in group II. It reduced the non-utilisation of blood from 64 to 1%. There were no adverse outcomes related to the introduction of the protocol.     

Intraplacental choriocarcinoma with fetomaternal transfusion

Intraplacental choriocarcinoma is very rare, and is usually found only after maternal and fetal metastatic disease is identified. The purpose of this case report is to review the incidence and findings of intraplacental choriocarcinoma. A term placenta was investigated because the newborn was born with severe anemia (Hb 3.0 g/dL). A 2 cm nodule was noted on the surface of the amniotic membrane and grossly resembled an infarction. The tumor was examined microscopically with immunohistochemical staining for the alpha- and beta-human chorionic gonadotropin (alpha-hCG, beta-hCG) subunits, human placental lactogen (hPL) and Ki-67. Microscopically, the tumor consisted of necrotic areas with proliferation of atypical trophoblastic cells and destruction of the villi and capillaries. The cells were positive for the alpha-hCG, beta-hCG subunits, hPL and Ki-67, consistent with intraplacental choriocarcinoma. The mother and newborn were investigated for the presence of metastatic disease. Computed tomography scans and magnetic resonance imaging of the mother and infant were negative for metastatic disease. Choriocarcinoma, limited only to the placenta with no evidence of metastatic disease is very rare. Primary intraplacental choriocarcinoma may frequently be overlooked or missed, and choriocarcinoma may possibly arise in the placenta more often than in retained or persistent trophoblast following pregnancy.     

Effect of exchange blood transfusion on some indices of skeletal muscle metabolism

After replacement of 85% of the blood volume in healthy dogs and also in animals with transfusion shock the content of the nitrogenous fractions and activity of aspartate and alanine aminotransferases in the skeletal muscles were studied for 7 days. The exchange blood transfusion produced a good therapeutic effect on the animals with transfusion shock. However, the process of flushing of nonprotein substances from the tissues of these animals was much less complete than in healthy animals.Experimental Division, Institute of Hematology and Blood Transfusion, L'vov. (Presented by Academician of the Academy of Medical Sciences of the USSR A. M. Chernukh.) Translated from Byulleten' Éksperimental'noi Biologii i Meditsiny, Vol. 82, No. 12, pp. 1423–1424, December, 1976.     

Blood transfusion services in countries that joined the EU in the last years: Czech Republic

The Czech Republic is a country in the middle of Europe with 10·3 million inhabitants and 80 000 km². It became a European Union (EU) member in 2004. Blood transfusion service is disperse, hospital based. Blood is collected mostly from voluntary non‐remunerated blood donors and the country is self‐sufficient in blood components and plasma for fractionation. Predeposit autologeous programme is popular and covers around 4·5% of red cells needs. Donor population is stable and relatively safe. Total of 21 HIV positive donors have been detected during last 20 years, the incidence of hepatitis in blood donors is decreasing being below 0·10 pro mille for hepatitis B virus and below 0·20 pro mille for hepatitis C virus in 2005. European standards have been accepted and implemented during last 15 years; safety (quality) and general availability being the priorities. Donor selection, blood collection, processing and testing comply with EU directives. Producers of blood components (blood establishments) are under control of the state authority (State Institute for Drug Control). Recommendations based on expert opinion are available for clinical use of blood. Adverse effects of treatment are followed and investigated. Costs of blood components and plasma products are covered by general health insurance.     

地中海贫血患儿输血后血清促红细胞生成素变化

目的检测地中海贫血（地贫）患儿长期输血治疗后血清促红细胞生成素（EPO）含量,探讨其临床价值。方法应用酶联法（ELISA）检测8例长期输血重型β-地贫患儿输血前后血清EPO含量,15例轻度地贫和40例健康对照组儿童血EPO含量。结果重型β-地贫患儿EPO含量明显增高（P〈0.001）,输血前后EPO含量差异无统学意义（P〉0.05）,轻度地贫患儿与健康对照组EPO含量差异无统计学意义（P〉0.05）。结论长期输血重型β-地贫患儿EPO含量增高显著,输血治疗对EPO无影响,轻度地贫患儿EPO含量与健康儿童无差异。     

Blood transfusion services in the countries that joined EU in the last years: Poland

The activity of Polish Blood Transfusion Service (BTS) is based on the Public Blood Transfusion Service Act voted by the Polish Parliament. There are 21 regional blood transfusion centers, one military blood transfusion center and one blood transfusion center (BTC) of the Ministry of Internal Affairs. The Institute of Haematology and Transfusion Medicine (IHTM) is responsible for issuing guidelines for blood transfusion medicine. All BTCs must have an accreditation from the Ministry of Health. In Poland, there is a national system of haemovigilance. Hospitals are obliged to immediately report all post‐transfusion complications and ‘near‐miss’ events. Immunological, viral, bacterial as well as transfusion‐related acute lung injury reactions are supervised by IHTM. Qualification improvement and training of personnel is one of the priorities of Polish BTS.     

Changing educational paradigms in transfusion medicine

Over the past decades, the fields of activity and knowledge in transfusion medicine have evolved into an array of diverse areas and sub-specialities including immunohaematology, blood component production, haemapheresis, pathogen detection, methods of cell and tissue collection and manipulation, cell conservation and banking, transplant immunology and haemostaseology. Physicians in most clinical disciplines require basic or more advanced knowledge in these fields to meet the requirements of modern medicine. Specialist physicians in transfusion medicine are valuable and competent partners for these related disciplines when it comes to safe, effective and tailored haemotherapy. Transfusion medicine is thus an important qualification at the interfaces of analytical laboratory medicine, pharmaceutical production and clinical disciplines such as internal medicine, anaesthesiology or surgery. In the past, blood transmittable diseases like HIV and hepatitis and adverse reactions to blood and cellular products have led to a complex system of regulatory and technical requirements. Good laboratory practice (GLP), good manufacturing practice (GMP), quality management systems and quality control on the pharmaceutical manufacturer’s level are only a few examples of the standards in today’s blood banking. European directives in the field of blood products, stem cell preparations and tissue have harmonized national regulation and led to higher uniform quality standards for biological preparations in a unified Europe, which is the desired outcome, but which also increases the complexity of this field. By contrast, directives 93/16/EEC, 2001/19/ EC, and 2005/36/EC, the directives of the European Parliament and of the Council on the mutual recognition of professional qualifications of European doctors currently in force, do not include transfusion medicine, blood transfusion or immune haematology at all. Other medical specialities, which like our field, are not common to all member states of the European Union, are listed in the above mentioned directives with the minimum length of training and minimal requirements for the qualifications. Bearing in mind the regional particularities of the medical speciality of transfusion medicine – caused by historical developments, rigidified by national legislations and the urgent need for quality standards also on the educatory level – we support a levelled approach in transfusion medicine education. Irrespective of the required day-to-day responsibilities in the blood field, which may range from basic level experience in haemotherapy, over specific knowledge of immunohaematology and clinical haemopathology, as needed for local blood bank management, up to the highest skill level required to direct a complex transfusion service and/or blood bank at an academic medical centre, transparent service quality requires defined minimum educational standards, which could then be adapted to fit specific national requirements. A long-term objective might be to introduce the transfusion medicine specialisation into the above-mentioned EC directives in order to guarantee quality and facilitate mutual recognition of transfusion medicine qualifications throughout Europe.