Serious Hazards Of Transfusion Research Articles

SHOT UK Collaborative Reviewing and Reforming IT Processes in Transfusion (SCRIPT) survey: Laboratory information management systems: Are we ready for digital transformation?

To understand the use, functionality and interoperability of laboratory information management systems (LIMS) in UK transfusion laboratories. LIMS are widely used to support safe transfusion practice. LIMS have the potential to reduce the risk of laboratory error using algorithms, flags and alerts that support compliance with best practice guidelines and regulatory standards. Reporting to Serious Hazards of Transfusion (SHOT), the United Kingdom (UK) haemovigilance scheme, has identified cases where the LIMS could have prevented errors but did not. Shared care of patients across different organisations and the development of pathology networks has raised challenges relating to interoperability of IT systems both within, and between, organisations. A survey was distributed to all SHOT-reporting organisations to understand the current state of LIMS in the UK, prevalence of expertise in transfusion IT, and barriers to progress. Survey questions covered LIMS interoperability with other IT systems used in the healthcare setting. A variety of LIMS and version numbers are in use in transfusion laboratories, LIMS are not always updated due to resource constraints. Respondents identified interoperability and improved functionality as the main requirements for transfusion safety. A nationally agreed set of minimum standards for transfusion LIMS is required for safe practice. Adequate resources, training and expertise should be provided to support the effective use and timely updates of LIMS. A single LIMS solution should be in place for transfusion laboratories working within a network and interoperability with other systems should be explored to further improve practice.

Guideline on the investigation and management of acute transfusion reactions.

Guideline on the investigation and management of acute transfusion reactions.

Haemovigilance: Giving it our best SHOT!

Haemovigilance: Giving it our best SHOT!

Serious hazards of transfusion: evaluating the dangers of a wrong patient autologous salvaged blood in cardiac surgery

BackgroundThe past half century has seen the near eradication of transfusion-associated hazards. Intraoperative cell salvage while widely used still poses significant risks and hazards due to human error. We report on a case in which blood collected from a patient with lung cancer was mistakenly administered to a patient undergoing cardiac surgery who should have received his own collected blood. The initial investigation found that the cause of the patient harm was violations of procedures by hospital personnel. A detailed investigation revealed that not only violations were the cause, but also that the underlying causes included haphazard organizational policies, poor communication, workload and staffing deficiencies, human factors and cultural challenges.Case presentationOn August 14, 2019, a 72-year-old male was admitted to our hospital for angina pectoris and multivessel coronary artery disease. Cardiac surgery was performed using an autologous salvage blood collection system, and there were no major problems other than the prolonged operation time. During the night after the surgery, when the patient’s blood pressure dropped, a nurse retrieved a blood bag from the ICU refrigerator that had been collected during the surgery and administered it at the physician's direction, but at this time neither the physician nor the nurse performed the required checking procedures. The blood administered was another patient's blood taken from another surgery the day before; an ABO mismatch transfusion occurred and the patient was diagnosed with DIC. The patient was discharged 65 days later after numerous interventions to support the patient. An accident investigation committee was convened to analyze the root causes and develop countermeasures to prevent a recurrence.ConclusionThis adverse event occurred because the protocol for intraoperative blood salvage management was not clearly defined, and the procedure was different from the standard transfusion practices. We developed a new workflow based on a human factors grounded, systems-wide improvement strategy in which intraoperative blood collection would be administered before the patient leaves the operating room to completely prevent recurrence, instead of simply requiring front-line staff to do a double-check. Implementing strong systems processes can reduce the risk of errors, improve the reliability of the work processes and reduce the likelihood of patient harm occurring in the future.

Safe handovers: Safe patients-why good quality structured handovers in the transfusion laboratory are important.

Effective transfer of information relating to patient care is vital in healthcare. In the UK formal handover is an established and well reported process in the clinical setting but less so in transfusion laboratories. Blood transfusions occur within many hospital specialities and across clinical and laboratory staff shifts, making robust handover critical for safe practice. Failure to adequately transfer information relating to pending or ongoing provision of blood components during shift handover in the laboratory can have an adverse impact on patient care. To identify transfusion errors where laboratory handover was considered a contributory factor. Serious adverse events and reactions reported to the UK haemovigilance scheme, Serious Hazards of Transfusion (SHOT), involving handover in the transfusion laboratory were reviewed for a 6-year period. Laboratory incidents involving handover were mainly associated with incorrect blood component transfused-specific requirements not met (IBCT-SRNM) and delays in provision of blood components transfusion, with 16.6% of these cases involving major haemorrhage situations. Handover was found to be insufficient in most cases, no handover was completed in 29.5% of cases, inadequate written handover accounted for 14.8% cases, and inadequate verbal for 5.7% of cases. Poor handover can lead to laboratory errors, particularly delays in provision of blood components. Embedding effective handover processes in the laboratory and including handover time within the shift working pattern, may help reduce errors and ensure continuity of care. Handover should be considered a task that is built into laboratory routine practices, ensuring effective transfer of information and appropriate follow up actions are taken. SHOT have created a handover template which can be adopted in laboratories to formalise this process.

Guidelines: the same evidence but different conclusions - relaxation of indications for irradiation of cellular blood components?

Guidelines: the same evidence but different conclusions - relaxation of indications for irradiation of cellular blood components?

Skating on Thin Ice: National Audit of TACO Demonstrates Poor Recognition of Risk Factors

BackgroundTransfusion-associated circulatory overload (TACO) is the leading cause of death following transfusion reported by the UK Serious Hazards of Transfusion (SHOT) report in 2016. Risk factors for TACO include older age, heart failure, treatment with diuretics, pre-existing pulmonary or peripheral oedema or positive fluid balance, undiagnosed respiratory symptoms, renal and liver impairment and hypoalbuminaemia. We sought to identify whether patients with risk factors for TACO were identified and managed appropriately and whether those who developed features of TACO were diagnosed, treated and reported accordingly.MethodsHospitals throughout the UK were invited to participate. Inpatients and outpatients aged 60 years and over who had received a red cell transfusion were audited in 153 sites throughout the UK during March and April 2017. Data were collected on: patient demographics, indication for transfusion, rate and volume of transfusion, risk factors for TACO and any subsequent features of TACO.Results80% (122/152) NHS Trusts in England participated: 2428 inpatient and 2075 outpatient transfusion episodes were audited. Mean age of transfused patients was 78 years. Inpatient transfusions were predominantly in general medicine (48%) and general surgery (29%) with 9% occurring on ITU. Outpatient transfusions occurred most commonly in haematology (67.4%) and oncology (16.4%).The most common indication for transfusion was symptomatic anaemia in a stable patient (inpatients, 31%) and chronic transfusion dependent anaemia (outpatients, 46.7%). Excluding patients with active bleeding and haemodynamic instability (20.3% of all transfusions) and exchange transfusions (0.1% of all transfusions), the median number of red cell units transfused per transfusion episode was 2.Only 61% of inpatients and 23% of outpatients had a weight documented pre-transfusion. 32% of inpatients had a completed fluid balance in the 24 hours prior to transfusion. Notably, 84% (2032/2428) of inpatients had an additional risk factor for TACO (over and above age). 1409/2032 (69%) of inpatients at risk had at least one measure taken to reduce risk of TACO. Fewer than 1% (21/2428) of inpatients were documented by their own medical teams as being at risk of TACO.3214 patients had more than 1 unit of red cells transfused and for 13% (433/3214) there was evidence of clinical review after every unit.38% (932/2428) of inpatients and 59% (1228/2075) of outpatients had a complete set of observations, including respiratory rate and oxygen saturations pre transfusion, at 15-20 minutes and following the transfusion.2% (34/2075) of outpatients were admitted within 24 hours of the transfusion; 7/34 (21%) with respiratory symptoms. 135/2428 (6%) inpatients and 13/2075 (0.6%) outpatients developed features indicative of TACO (using SHOT criteria). 13/148 (9%) of these patients were diagnosed with TACO, but none were reported to SHOT as having developed TACO.Overall mortality at a median of 45 days follow up (range 0 to 117 days) was 276/2428 (11%) in inpatients and 7/2075 (0.3%) in outpatients. Transfusion was not thought be implicated in 263/276 inpatient deaths but thought possible in two cases (unknown for 11). Transfusion was not thought to be implicated in any of the 7 deaths occurring in patients who had their transfusion as outpatients.DiscussionThis national audit shows patients with risk factors for TACO were not identified as high risk prior to transfusion. The majority of audited patients had at least 2 risk factors for TACO but <1% were identified as such. Most patients did not have additional measures taken to reduce the risk of TACO, such as careful fluid balance monitoring and a clinical review after each unit. In those developing features of TACO, few were diagnosed by clinical teams and even fewer were reported to SHOT. Despite the under-recognition of TACO, transfusion was not felt to be contributory in any death that occurred during the audit.TACO continues to be an under recognised complication of transfusion. The recent 2016 SHOT report includes a checklist for TACO and subsequent measures to reduce the risk. Improved awareness of TACO among clinical teams is required which will require national and local measures including better education, electronic decision support and better reporting. DisclosuresNo relevant conflicts of interest to declare.

Transfusion-associated circulatory overload (TACO): Significance of appropriate pre-transfusion risk assessment to prevent fatal health outcomes.

Madam, Transfusion of blood products is a life rescuing medical intermediation; however, associated adverse transfusion reactions are major pitfalls. Transfusion-associated circulatory overload (TACO) is life-threatening pulmonary oedema that develops secondary to volume overload. Underlying precipitating factors include ages &gt;60 years or &lt;3 years, low body mass index (BMI), rapid transfusion rate and pre-existing volume overload conditions such as heart disease, renal failure, lung disease or low albumin levels. Sign and Symptoms include dyspnoea, tachypnoea, tachycardia, hypoxia, raised jugular venous pressure, broad pulse pressure and hypertension, that appears during or either six hours posttransfusion [1]. TACO should be discriminated from transfusion-related acute lung injury (TRALI) by high jugular venous pressure, pulmonary arterial pressure to &gt;18mmHg, hypertension, brain natriuretic peptide levels (&gt;1200pg/ml) and response to diuretics. Management of TACO includes immediate discontinuation of transfusion, diuretics, supplementary oxygen, and assisted ventilation if indicated [2]. Serious Hazards of Transfusion (SHOT) in 2018 reported TACO as the most typical reason for transfusion-related deaths. Over the period of 11 years (2007-2018), overall cases raised from six to one hundred and ten, including the increase in mortality from one to five and one significant morbidity from three to thirty-six cases [3]. Interestingly, timely and appropriate preventive actions can reduce this severe reaction to zero. A precise risk assessment before transfusion is recommended by SHOT for TACO elimination, especially if the patient has underlying risk factors. Preventive strategies in such predisposed patients include reviewing the need for transfusion, deferring the transfusion until issue can be resolved, transfuse according to body weight, measure fluid balance, consider prophylactic diuretic, slow transfusion rate and monitoring vital signs including oxygen saturation. Thus, TACO is a serious but avoidable transfusion reaction. Appropriate assessment prior to transfusion in every patient is important to ensure safe blood transfusion practice. Continuous...

National blood system: current status and prospects. Organization of transfusion care in a medical institution

Background. Blood safety is a system of measures to organize equal and timely access of citizens to high-quality and safe components of donated blood in the required quantity, their safe and proper use, as well as the safety of donors and patients.&#x0D; Objective. To describe the state and prospects of the development of national blood system.&#x0D; Materials and methods. Analysis of available regulatory documents and literature sources.&#x0D; Results and discussion. In Ukraine, there is a need to create a sustainable self-sufficient national blood system, which could include both the provision of services by medical institutions and the supervision of their provision. This system should be based on voluntary gratuitous donation. It is also necessary to coordinate and standardize such processes as blood procurement, processing, testing for transfusion-transmission infections, determination of blood group and rhesus, storage, distribution, transportation of blood and its components, monitoring of adverse reactions. The hospital transfusion committee (HTC), the hospital blood bank (HBB) and the transfusion immunological laboratory should be the part of the transfusion service of health care facilities. The functions of HTC are to determine the algorithms for the organization of transfusion care, to establish the rules for the appointment of blood and its components, and to assist in education and training of personnel and more. In turn, the functions of HBB include centralized receiving, accounting, storage and dispensing of blood or its components, control of transportation and storage of blood, introduction of alternative therapeutic transfusion methods, control of clinical efficacy assessment, hemovigilance, control of the records and documents of transfusion assistance. It is recommended to allocate four rooms for HBB: for receiving, storage and distributing blood; for collecting and processing applications; for immunohematological examinations and for the staff. Requirements for the provision of blood transfusion services in a health care facility include the organization of the listed above units, inventory management, guidance on the proper use of blood components, quality management, reporting system, and staff training. The blood centre and health care facility must work together to manage blood supplies. When transporting blood, it is extremely important to adhere to the cold chain from the moment the blood is received from the donor to the transfusion of its components to the recipient. Blood and erythrocyte-containing blood components should be stored at 2-6 °C to prevent hemolysis and microbial contamination. Plasma blood components need to be stored frozen (-30 °C), and platelet-containing – in a thermoshaker at a temperature of 20-24 °C. Depending on the type of preparation, plasma, erythrocyte and platelet preparations may have different clinical efficacy. Before transfusion, the doctor must perform a macroscopic assessment of the suitability of the blood product, determine the blood group and rhesus of the recipient, compare the result with the patient’s medical record, determine the blood group and rhesus of the donor, compare the result with plastic container label, perform blood compatibility tests, perform clinical and biological test. Reports on the serious hazards of transfusion (SHOT) indicate that there are adverse transfusion reactions that cannot be prevented, as well as reactions that can be avoided by improving practice and control, and human-related reactions. An important role in the functioning of the blood system is played by hemovigilance. The advantages of hemovigilance are to identify trends in adverse reactions, to reveal the areas for improvement in transfusion medicine, to stimulate research, to raise awareness of risk factors, and to increase the safety of transfusions for patients.&#x0D; Conclusions. 1. In Ukraine there is a need to create a stable self-sufficient national blood system. 2. It is necessary to coordinate and standardize such processes as procurement, processing, testing for transfusion-transmission infections, determination of blood group and rhesus, storage, distribution, transportation of blood and its components, monitoring of adverse reactions. 3. Hemovigilance plays an important role in the functioning of the blood system.

Missed irradiation of cellular blood components for vulnerable patients: Insights from 10 years of SHOT data.

BackgroundIrradiation of cellular blood components is recommended for patients at risk of transfusion‐associated graft‐vs‐host disease (TA‐GvHD). Prestorage leucodepletion (LD) of blood components is standard in the UK since 1999.Study Design and MethodsAnalysis of 10 years' reports from UK national hemovigilance scheme, Serious Hazards of Transfusion (2010‐2019), where patients failed to receive irradiated components when indicated according to British Society for Haematology guidelines (2011).ResultsThere were 956 incidents of failure to receive irradiated components all due to errors. One hundred and seventy two incidents were excluded from analysis, 125 of 172 (72.7%) because of missing essential information. No cases of TA‐GvHD were reported in this cohort. The 784 patients received 2809 components (number unknown for 67 incidents). Most failures occurred in patients treated with purine analogues (365) or alemtuzumab (69), or with a history of Hodgkin lymphoma (HL) (192). Together these make up 626 of 784 (79.9%). Poor communication is an important cause of errors.ConclusionLeucodepletion appears to reduce the risk for TA‐GvHD. None of 12 cases of TA‐GvHD reported to SHOT prior to introduction of LD occurred in patients with conditions recommended for irradiated components by current guidelines. Irradiation indefinitely for all stages of HL is not based on good evidence and is a difficult guideline to follow. Further research on long‐term immune function in HL is required. Variation between different national guidelines reflects the very limited evidence.

How to verify patient identity and blood product compatibility using an electronic bedside transfusion system.

Transfusion of an incorrect blood component is an important avoidable serious hazard of transfusion resulting from process errors. Our group and others have taken advantage of new technology and developed electronic transfusion systems for safe transfusion practice in a previous studies. They allow the clinical staff to correctly identify the patient and the blood product at the bedside, ensuring the right blood product is given to the right patient. This video is to demonstrate the process and not to promote any specific product. It is a follow up our previous video clip on electronic remote blood issue in a previous study. The process for correct patient identification originates from the wristband, which contains the patient identification details in a 2D barcode and is printed from the electronic patient record system. These details are associated with the blood sample through using a portable printer to produce a label for the sample tube. The patient details are scanned into the blood bank laboratory information system (LIS) and are then printed on a compatibility label by the LIS, which also contains a 2-dimensional barcode, and is then attached to the blood product. Following an initial visual check of these details by the clinical staff, the electronic bedside system requires that both the patient wristband barcode and the blood product compatibility barcode are scanned. This will electronically verify at the patient's bedside that the right unit is to be given to the right patient. This is the final step in ensuring end-to-end electronic control and safe transfusion practice.

Electronic identification systems reduce the number of wrong components transfused.

Errors in hospital transfusion may cause wrong (blood) components to be transfused. This study assessed the value of electronic identification systems (EISs) in reducing wrong component transfusions (WCTs). UK hospitals reporting to Serious Hazards of Transfusion were invited to complete an electronic survey about transfusion including the use of EISs. Further information was requested for WCTs and near-miss WCTs. A response rate of 93 of 222 (42%) hospitals accounted for 38% of UK blood component issues in 2015 and 2016. Thirty-three of 93 (35%) hospitals employ manual procedures and 16 (17%) use EISs throughout the transfusion process; most of the remainder use EISs for blood collection only. Fifty-seven WCTs were identified in approximately two million blood components. The primary error was at blood draw and sample labeling (3), blood collection (15), and administration (2); the remainder were mostly blood bank errors. No WCTs occurred with blood draw and sample labeling or administration with use of EISs. Three WCTs occurred with EISs for blood collection due to incorrect processes for emergency transfusions of group O blood without any adverse effects. Seventeen WCTs occurred with manual processes; one was an ABO-incompatible red blood cell transfusion resulting in renal impairment. Near-miss WCTs were also more frequent with manual procedures than EISs at blood draw and sample labeling and blood collection. This is the first multicenter study to demonstrate a lower incidence of WCTs and near-miss WCTs with EISs compared to manual processes, and highlights some limitations of both manual and EIS procedures.

Human errors in manual techniques for ABO/D grouping are associated with potentially lethal outcomes.

To review if ABO/D grouping errors are more likely to occur with manual intervention compared to automation. Human errors in manual pre-transfusion testing may result in ABO/D-incompatible transfusions and catastrophic outcomes. Accurate ABO/D grouping is a critical part of pre-transfusion testing. This was a retrospective analysis of reports made to Serious Hazards of Transfusion (SHOT) between January 2004 and December 2016 where ABO/D grouping errors led to the transfusion of an incorrect blood component to review if errors are more likely to occur with manual intervention compared to automation. In 148 of 158 (93%) ABO/D grouping errors, manual intervention took place. In the remaining 10, causes were not reported. No errors occurred with full automation. Interpretation errors occurred in 86 of 148 (58%) and 42 of 148 (28%) transcription errors, and in 20 of 148, wrong or no samples were selected. Of 148 errors, 21 (14%) resulted in ABO-incompatible transfusion, with one death in 2004 due to an interpretation error in a manual ABO group. In 30 of 148 (20%), D-positive red cells were given to D-negative recipients, where three women of child-bearing potential became sensitised and developed anti-D. ABO grouping errors have reduced from 18 of 539 (3%) of total reports analysed in 2004 (3·3%) to 3 of 3091 (0·10%) in 2016. Where manual testing cannot be avoided, results should be confirmed using automated techniques as soon as possible, and a back-up process should be available 24/7. SHOT data confirm that manual interventions are prone to human error, especially in transcription and interpretation, and demonstrate a continuing need for appropriate serological knowledge and understanding by transfusion laboratory staff to underpin safety provided by automation and information technology (IT).

Obstetric intra-operative cell salvage: a review of an established cell salvage service with 1170 re-infused cases.

The use of cell salvage during caesarean section has been increasing steadily, although there are concerns relating to cost, a perceived risk of amniotic fluid embolism, and fetal red cell sensitisation. We present observational data from almost a decade of use of intra-operative cell salvage in obstetrics. By the end of this period, we set up cell salvage collection for >98% of all caesarean sections. From 2008 to 2017, 1170 women have had a re-infusion of cell salvaged blood with no clinical safety concerns; the median (IQR [range]) volume was 231 (154-306 [80-1690]) ml. During this time there has been a marked reduction in the number of women who were transfused allogeneic blood, as well as the amount of blood transfused. In total, 647 (55%) women have had alloimmunisation testing, with two positive cases. Quality control data indicate that the quality of blood processed from partial first bowls is no worse than that from full bowls. We discuss the costs of providing this service with regard to: staffing costs; single suction; leucodepletion filters; selectivity in the processing of collected blood; and the use of partial first bowls.

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.

The administration of blood components: a British Society for Haematology Guideline.

The administration of blood components: a British Society for Haematology Guideline.

SHOT conference report 2016: serious hazards oftransfusion-human factors continue to cause mosttransfusion-related incidents.

The Annual SHOT Report for incidents reported in 2015 was published on 7 July at the SHOT symposium. Once again, the majority of reports (77·7%) were associated with mistakes ('human factors'). Pressures and stress in the hospital environment contributed to several error reports. There were 26 deaths where transfusion played a part, one due to haemolysis from anti-Wra (units issued electronically). The incidence of haemolysis due to this antibody has increased in recent years. Transfusion-associated circulatory overload is the most common contributor to death and major morbidity. Reports of delays to transfusion have increased, some caused by the failure of correct patient identification. There were seven ABO-incompatible red cell transfusions (one death) with an additional six to allogeneic stem cell transplant recipients. Near-miss reporting and analysis is useful and demonstrated nearly 300 instances of wrong blood in tube, which could have resulted in ABO-incompatible transfusion had the error not been detected. Errors with anti-D immunoglobulin continue, and preliminary data from the new survey of new anti-D found in pregnancy has shown that sensitisation occurs in some women even with apparently 'ideal' care. For the first time, the SHOT report now incorporates a chapter on donor events.

PILOTING IN ED–EXTRA DIFFICULT OR EASILY DONE

Objectives & BackgroundPatient Identification is fundamental to the success of safe transfusion. ABO incompatible blood transfusion has been classed as a Never Event by the Department of Health.In 2014, 680...

Incidence of transfusion reactions: a multicenter study utilizing systematic active surveillance and expert adjudication.

Prevalence estimates of the serious hazards of transfusion vary widely. We hypothesized that the current reporting infrastructure in the United States fails to capture many transfusion reactions and undertook a multicenter study using active surveillance, data review, and adjudication to test this hypothesis. A retrospective record review was completed for a random sample of 17% of all inpatient transfusion episodes over 6 months at four academic tertiary care hospitals, with an episode defined as all blood products released to a patient in 6 hours. Data were recorded by trained clinical research nurses, and serious reactions were adjudicated by a panel of transfusion medicine experts. Of 4857 transfusion episodes investigated, 1.1% were associated with a serious reaction. Transfusion-associated circulatory overload was the most frequent serious reaction noted, being identified in 1% of transfusion episodes. Despite clinical notes describing a potential transfusion association in 59% of these cases, only 5.1% were reported to the transfusion service. Suspected transfusion-related acute lung injury/possible transfusion-related acute lung injury, anaphylactic, and hypotensive reactions were noted in 0.08, 0.02, and 0.02% of transfusion episodes, respectively. Minor reactions, including febrile nonhemolytic and allergic, were noted in 0.62 and 0.29% of transfusion episodes, respectively, with 30 and 50% reported to the transfusion service. Underreporting of cardiopulmonary transfusion reactions is striking among academic, tertiary care hospitals. Complete and accurate reporting is essential to identify, define, establish pathogenesis, and mitigate/treat transfusion reactions. A better understanding of the failure to report may improve the accuracy of passive reporting systems.

Are the 'rules' for times in set up and duration of red cell transfusion too strict?

To discover if any adverse clinical effects have been reported to the UK haemovigilance scheme, Serious Hazards of Transfusion (SHOT) relating to delays in set up of transfusion or extended transfusion time for red cell units. Current guidance for duration of transfusion is based on outdated studies that do not reflect current UK Blood Service practices. Recent evidence suggests that the '30-min rule' could be extended without adverse effects. Aggregated data from reports to SHOT covering a 5-year period (2010-2014) were reviewed in order to identify adverse clinical outcomes related to delay in set up of a red cell transfusion of more than 30 min after removal from cold storage, or total transfusion time of longer than 5 h. Five years of data from SHOT shows that there were no adverse clinical events related to delays in setting up transfusion or extended transfusion time between 2010 and 2014. There were a total of 382 reports which included 143 delays in set-up, and 239 episodes where transfusion took longer than 5 h. Delays in set up of transfusion and extended transfusion time did not result in any adverse clinical outcomes. Current guidance may be too stringent and lead to increased wastage.