Transfusion Medicine
|
CONFERENCE REPORT
Bullet points from SHOT: key messages and recommendations from the Annual SHOT Report 2013 P. H. B. Bolton-Maggs Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Manchester, UK Received 7 July 2014; accepted for publication 7 July 2014
INTRODUCTION The Serious Hazards of Transfusion (SHOT) reporting system has been providing invaluable data on adverse events in the UK for 17 years. In 2013, there were 1571 reports, excluding the categories of ‘near miss’ and ‘right blood right patient’. ‘Near miss’ events make up about one-third of all SHOT reports (996 of 2751). If ‘wrong blood in tube’ had not been detected during testing at least 125 patients could have been at risk of ABO-incompatible transfusions. The actual number of ABO-incompatible transfusions reported in 2013 was 12, of which 9 were red cell transfusions. As in previous years, the most common non-error adverse incidents are allergic-type acute transfusion reactions (ATR) (n = 320). Numbers of reported anaphylactic reactions have been 27–41 per year. There were no new bacterial or viral infections reported in 2013. However, 0·03% donors are infected with hepatitis E and transmission to recipients can be demonstrated, which may very rarely cause chronic hepatitis in profoundly immunosuppressed individuals. In 2013, there were 22 deaths where transfusion (n = 17) or delay in transfusion (n = 5) played a part. Transfusion-associated circulatory overload (TACO) contributed to 12 deaths including one woman transfused for iron deficiency. There were 143 instances of major morbidity with TACO the leading cause (43 of 143 or 30·1%). In conclusion, although blood components are now very safe with rare transfusion-transmitted infections, patients must be supervised for acute allergic type, TACO and other transfusion reactions. Integrating human factors training into medical practice would reduce errors which can have serious clinical consequences. Key words: SHOT reporting system, ATR, TACO. The Annual SHOT report for data collected in 2013 was published on 9 July and is available on the website (www.shotuk.org)
Correspondence: Paula H. B. Bolton-Maggs, Medical Director, Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL, UK. Tel.: +44 (0)161 4234208; fax: +44(0)1614234395; e-mail: [email protected]
© 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
together with the summary and other resources including the learning points and recommendations (Bolton-Maggs et al., 2014). Participation by UK NHS hospitals continues to be high with 99·5% registered to report. The total number of reports started in 2013 was 3568, and the flow diagram for the fate of these is shown in Fig. 1. Cumulative data for 17 years of SHOT reporting are shown in Fig. 2 (13 141 reports, 1571 in 2013, excluding the categories of ‘near miss’ and ‘right blood right patient’) [for comment and review for the 2012 report see Roberts (2013b) and Bolton-Maggs (2013)]. ‘Near miss’ events make up about one-third of all SHOT reports (996 of 2751) and their review supplies important lessons. In 2013, there were 643 instances of ‘wrong blood in tube’ samples (64·6% of all near misses) and if these had not been detected (83·5% during testing), at least 125 patients could have received ABO-incompatible transfusions. The actual number of ABO-incompatible transfusions reported in 2013 was 12, of which 9 were red cell transfusions. As in previous years, the most common non-error adverse incidents are allergic-type acute transfusion reactions (ATR) (n = 320). These are idiosyncratic and unpredictable and demonstrate the importance of monitoring patients during the early part of every transfusion. The overall number of ATRs has reduced because since 2012 SHOT no longer collects reports of minor febrile reactions. Review of the number of anaphylactic reactions (27–41 per year) over several years shows no change in the incidence (Fig. 3), and these are about 10% of ATR reports. There were no new infections (bacterial or viral) reported in 2013 and the overall risk of infection from blood components remains very low. However, hepatitis E is an emerging issue; while evidence of infection in donors in a research study was 0·03%, and transmission to recipients can be demonstrated, this is very rarely associated with clinical symptoms except in profoundly immunosuppressed individuals who may develop chronic hepatitis (Hewitt et al., 2014). In 2013, there were 22 deaths where transfusion (17 cases) or delay in transfusion (5 cases) played a part. Two deaths had a high level of imputability: one due to delay in transfusion of a child with sickle cell disease and severe anaemia, and in the other a middle-aged woman who developed post-transfusion purpura (PTP) complicated by intracranial haemorrhage.
doi: 10.1111/tme.12142
198 P. H. B. Bolton-Maggs
incomplete as of 31/12/2013
Error 955
60.8%
withdrawn
SHOT reports started during 2013
1571 Incidents
Completed and included in 2013 Annual SHOT Report
616 39.2%
Total reports analysed in 2013 Annual SHOT Report
reports started in 2012 but completed during 2013
Pathological reactions
Near miss 996 RBRP 184 All errors
Fig. 1. Breakdown of reports to SHOT in 2013. Cumulative to 2012
2013
Unclassifiable complications of transfusion Post-transfusion purpura Patholocigal reaoitcns which may not be preventalb
Transfusion-transmitted infection Transfusion-associated dyspnoea Cell salvage and autologous transfusion Acute transfusion reaction Transfusion-associated graft vs host disease Alloimmunisation
Probably or possibly preventable by improved practice and monitoring
Transfusion-associated circulatory overload Transfusion-related acute lung injury Haemolytic transfusion reaction Avoidable, delayed or undertransfusion Anti-D immunoglobulin errors
Adverse events caused by error
Handling and storage errors Incorrect blood component transfused 0
500
1000
1500
2000
2500
3000
3500
4000
Fig. 2. SHOT cumulative data 1996/1997 to 2013, n = 13 141.
PTP is a rare complication since leucodepletion was initiated in 1999. PTP requires rapid recognition and treatment (with intravenous immunoglobulin and platelets) without waiting for results of investigation. The other deaths in which a transfusion reaction played a part included an ABO-incompatible transfusion to a very sick man where the adverse reaction appeared to be the last straw. Transfusion-associated circulatory overload (TACO) contributed to 12 deaths including one woman transfused for iron deficiency. There were 143 instances of major morbidity (including the need for admission to high dependency units, dialysis or Transfusion Medicine, 2014, 24, 197–203
renal impairment, jaundice and other evidence of intravascular haemolysis) with TACO the leading cause (43 of 143) (30·1%).
HUMAN FACTORS IN HOSPITAL PRACTICE Year on year, the largest group of reports relate to mistakes made in the transfusion process. In 2013, errors contributed to 77·6% of all reports (this includes ‘near miss’ and ‘right blood right patient’ reports where, by definition, no harm was done). Analysis of all reports where a patient received an incorrect blood component shows that the errors in the nine-step © 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
Bullet points from SHOT
199
Fig. 3. Numbers of reports of anaphylaxis 2005–2013.
multidisciplinary transfusion process are frequently multiple (median 3, maximum 5 errors). If each person in the transfusion sequence completed their part correctly, these errors would not occur. Many could be detected before transfusion, especially by the final check at the patient’s side. Most of these errors result in patients failing to receive components suitable for their specific requirements, particularly irradiated components for patients who are immune suppressed. There is a particularly high incidence of this error in haematology departments, where staff should have a better understanding, and there is clearly a need for better training. Cumulative analysis shows that there are now nearly 1000 patients who have not received irradiated components when indicated since the introduction of leucodepletion in 1999. Fortunately, there have been no reports of transfusion-associated graft vs host disease in these patients. The single case in 2012 was caused by an intrauterine transfusion using maternal blood, therefore not leucodepleted, not irradiated and HLA-related. Leucodepletion gives good protection but these observational data are not sufficient for the Blood Services to abandon the recommendation for irradiation. The use of anti-B cell antibodies for immune suppression in solid organ transplantation is widespread, and there is some controversy about the need for irradiation in this group, where the dose of antibody is lower than usually used in haemopoietic stem cell transplantation. The BCSH Transfusion Task Force is supporting a review of the current irradiation guidelines to address this. There were 284 laboratory errors reported in 2013, 84 (29·6%) made at sample receipt and 104 (36·6%) errors in component labelling, availability or in handling and storage. There were 203 instances where information technology (IT) systems played a part in the reported events, particularly where specific requirements were not met (127 of 203) (62·56%). In some cases, computer flags were either not set up or were overridden © 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
demonstrating that IT solutions may not prevent human errors. The specific requirements were proportionally more likely to be missed in paediatric patients (22% of all reports in this group compared with 12% overall). In response to the first report about the tragic events at Mid Staffordshire NHS Foundation Trust (Roberts, 2013a), a Human Factors Reference Group (Keogh, 2012) was set up by Sir Bruce Keogh, Medical Director of NHS England. ‘Human Factors is the science explaining the interrelationship of humans to their environment and to each other’ or ‘enhancing clinical performance through an understanding of the effects of teamwork, tasks, equipment, workspace, culture and organisation on human behaviour and abilities and application of that knowledge in clinical settings’. His report notes ‘the significant role that good handover and communication has to play in delivering safe care’. The errors reported to SHOT often demonstrate failures in communication and handover that lead to adverse incidents, some life-threatening, in transfusion practice. A House of Commons Health Committee Parliamentary Inquiry into patient safety reported in 2009 (House of Commons Health Committee, 2009) making 59 recommendations including human factors training in all medical undergraduate and postgraduate courses, patient safety training covering the role of human factors in training curricula of all healthcare workers and changes to the ways that hospitals assess risks and measure performance by using information about actual harm done to patients. This was a decade after the publication of ‘An organisation with a memory’ (Department of Health, 2000) which encouraged NHS staff to report instances of patient harm (in the context of a more open culture searching for systems failures with the intent of learning from these), and the establishment of the National Reporting and Learning System (NRLS, set up in 2003) together with the National Patient Safety Agency (NPSA). It is estimated that up to 10% of patients admitted to hospital Transfusion Medicine, 2014, 24, 197–203
200 P. H. B. Bolton-Maggs
Fig. 4. The nine steps in the transfusion process.
experience some form of potentially avoidable harm. Data from the NRLS show that of the 1·49 million incidents reported between 1 October 2012 and 30 September 2013, 68% caused ‘no harm’, 25% were ‘low harm’, 6% ‘moderate harm’, and
|
CONFERENCE REPORT
Bullet points from SHOT: key messages and recommendations from the Annual SHOT Report 2013 P. H. B. Bolton-Maggs Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Manchester, UK Received 7 July 2014; accepted for publication 7 July 2014
INTRODUCTION The Serious Hazards of Transfusion (SHOT) reporting system has been providing invaluable data on adverse events in the UK for 17 years. In 2013, there were 1571 reports, excluding the categories of ‘near miss’ and ‘right blood right patient’. ‘Near miss’ events make up about one-third of all SHOT reports (996 of 2751). If ‘wrong blood in tube’ had not been detected during testing at least 125 patients could have been at risk of ABO-incompatible transfusions. The actual number of ABO-incompatible transfusions reported in 2013 was 12, of which 9 were red cell transfusions. As in previous years, the most common non-error adverse incidents are allergic-type acute transfusion reactions (ATR) (n = 320). Numbers of reported anaphylactic reactions have been 27–41 per year. There were no new bacterial or viral infections reported in 2013. However, 0·03% donors are infected with hepatitis E and transmission to recipients can be demonstrated, which may very rarely cause chronic hepatitis in profoundly immunosuppressed individuals. In 2013, there were 22 deaths where transfusion (n = 17) or delay in transfusion (n = 5) played a part. Transfusion-associated circulatory overload (TACO) contributed to 12 deaths including one woman transfused for iron deficiency. There were 143 instances of major morbidity with TACO the leading cause (43 of 143 or 30·1%). In conclusion, although blood components are now very safe with rare transfusion-transmitted infections, patients must be supervised for acute allergic type, TACO and other transfusion reactions. Integrating human factors training into medical practice would reduce errors which can have serious clinical consequences. Key words: SHOT reporting system, ATR, TACO. The Annual SHOT report for data collected in 2013 was published on 9 July and is available on the website (www.shotuk.org)
Correspondence: Paula H. B. Bolton-Maggs, Medical Director, Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL, UK. Tel.: +44 (0)161 4234208; fax: +44(0)1614234395; e-mail: [email protected]
© 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
together with the summary and other resources including the learning points and recommendations (Bolton-Maggs et al., 2014). Participation by UK NHS hospitals continues to be high with 99·5% registered to report. The total number of reports started in 2013 was 3568, and the flow diagram for the fate of these is shown in Fig. 1. Cumulative data for 17 years of SHOT reporting are shown in Fig. 2 (13 141 reports, 1571 in 2013, excluding the categories of ‘near miss’ and ‘right blood right patient’) [for comment and review for the 2012 report see Roberts (2013b) and Bolton-Maggs (2013)]. ‘Near miss’ events make up about one-third of all SHOT reports (996 of 2751) and their review supplies important lessons. In 2013, there were 643 instances of ‘wrong blood in tube’ samples (64·6% of all near misses) and if these had not been detected (83·5% during testing), at least 125 patients could have received ABO-incompatible transfusions. The actual number of ABO-incompatible transfusions reported in 2013 was 12, of which 9 were red cell transfusions. As in previous years, the most common non-error adverse incidents are allergic-type acute transfusion reactions (ATR) (n = 320). These are idiosyncratic and unpredictable and demonstrate the importance of monitoring patients during the early part of every transfusion. The overall number of ATRs has reduced because since 2012 SHOT no longer collects reports of minor febrile reactions. Review of the number of anaphylactic reactions (27–41 per year) over several years shows no change in the incidence (Fig. 3), and these are about 10% of ATR reports. There were no new infections (bacterial or viral) reported in 2013 and the overall risk of infection from blood components remains very low. However, hepatitis E is an emerging issue; while evidence of infection in donors in a research study was 0·03%, and transmission to recipients can be demonstrated, this is very rarely associated with clinical symptoms except in profoundly immunosuppressed individuals who may develop chronic hepatitis (Hewitt et al., 2014). In 2013, there were 22 deaths where transfusion (17 cases) or delay in transfusion (5 cases) played a part. Two deaths had a high level of imputability: one due to delay in transfusion of a child with sickle cell disease and severe anaemia, and in the other a middle-aged woman who developed post-transfusion purpura (PTP) complicated by intracranial haemorrhage.
doi: 10.1111/tme.12142
198 P. H. B. Bolton-Maggs
incomplete as of 31/12/2013
Error 955
60.8%
withdrawn
SHOT reports started during 2013
1571 Incidents
Completed and included in 2013 Annual SHOT Report
616 39.2%
Total reports analysed in 2013 Annual SHOT Report
reports started in 2012 but completed during 2013
Pathological reactions
Near miss 996 RBRP 184 All errors
Fig. 1. Breakdown of reports to SHOT in 2013. Cumulative to 2012
2013
Unclassifiable complications of transfusion Post-transfusion purpura Patholocigal reaoitcns which may not be preventalb
Transfusion-transmitted infection Transfusion-associated dyspnoea Cell salvage and autologous transfusion Acute transfusion reaction Transfusion-associated graft vs host disease Alloimmunisation
Probably or possibly preventable by improved practice and monitoring
Transfusion-associated circulatory overload Transfusion-related acute lung injury Haemolytic transfusion reaction Avoidable, delayed or undertransfusion Anti-D immunoglobulin errors
Adverse events caused by error
Handling and storage errors Incorrect blood component transfused 0
500
1000
1500
2000
2500
3000
3500
4000
Fig. 2. SHOT cumulative data 1996/1997 to 2013, n = 13 141.
PTP is a rare complication since leucodepletion was initiated in 1999. PTP requires rapid recognition and treatment (with intravenous immunoglobulin and platelets) without waiting for results of investigation. The other deaths in which a transfusion reaction played a part included an ABO-incompatible transfusion to a very sick man where the adverse reaction appeared to be the last straw. Transfusion-associated circulatory overload (TACO) contributed to 12 deaths including one woman transfused for iron deficiency. There were 143 instances of major morbidity (including the need for admission to high dependency units, dialysis or Transfusion Medicine, 2014, 24, 197–203
renal impairment, jaundice and other evidence of intravascular haemolysis) with TACO the leading cause (43 of 143) (30·1%).
HUMAN FACTORS IN HOSPITAL PRACTICE Year on year, the largest group of reports relate to mistakes made in the transfusion process. In 2013, errors contributed to 77·6% of all reports (this includes ‘near miss’ and ‘right blood right patient’ reports where, by definition, no harm was done). Analysis of all reports where a patient received an incorrect blood component shows that the errors in the nine-step © 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
Bullet points from SHOT
199
Fig. 3. Numbers of reports of anaphylaxis 2005–2013.
multidisciplinary transfusion process are frequently multiple (median 3, maximum 5 errors). If each person in the transfusion sequence completed their part correctly, these errors would not occur. Many could be detected before transfusion, especially by the final check at the patient’s side. Most of these errors result in patients failing to receive components suitable for their specific requirements, particularly irradiated components for patients who are immune suppressed. There is a particularly high incidence of this error in haematology departments, where staff should have a better understanding, and there is clearly a need for better training. Cumulative analysis shows that there are now nearly 1000 patients who have not received irradiated components when indicated since the introduction of leucodepletion in 1999. Fortunately, there have been no reports of transfusion-associated graft vs host disease in these patients. The single case in 2012 was caused by an intrauterine transfusion using maternal blood, therefore not leucodepleted, not irradiated and HLA-related. Leucodepletion gives good protection but these observational data are not sufficient for the Blood Services to abandon the recommendation for irradiation. The use of anti-B cell antibodies for immune suppression in solid organ transplantation is widespread, and there is some controversy about the need for irradiation in this group, where the dose of antibody is lower than usually used in haemopoietic stem cell transplantation. The BCSH Transfusion Task Force is supporting a review of the current irradiation guidelines to address this. There were 284 laboratory errors reported in 2013, 84 (29·6%) made at sample receipt and 104 (36·6%) errors in component labelling, availability or in handling and storage. There were 203 instances where information technology (IT) systems played a part in the reported events, particularly where specific requirements were not met (127 of 203) (62·56%). In some cases, computer flags were either not set up or were overridden © 2014 The Author Transfusion Medicine © 2014 British Blood Transfusion Society
demonstrating that IT solutions may not prevent human errors. The specific requirements were proportionally more likely to be missed in paediatric patients (22% of all reports in this group compared with 12% overall). In response to the first report about the tragic events at Mid Staffordshire NHS Foundation Trust (Roberts, 2013a), a Human Factors Reference Group (Keogh, 2012) was set up by Sir Bruce Keogh, Medical Director of NHS England. ‘Human Factors is the science explaining the interrelationship of humans to their environment and to each other’ or ‘enhancing clinical performance through an understanding of the effects of teamwork, tasks, equipment, workspace, culture and organisation on human behaviour and abilities and application of that knowledge in clinical settings’. His report notes ‘the significant role that good handover and communication has to play in delivering safe care’. The errors reported to SHOT often demonstrate failures in communication and handover that lead to adverse incidents, some life-threatening, in transfusion practice. A House of Commons Health Committee Parliamentary Inquiry into patient safety reported in 2009 (House of Commons Health Committee, 2009) making 59 recommendations including human factors training in all medical undergraduate and postgraduate courses, patient safety training covering the role of human factors in training curricula of all healthcare workers and changes to the ways that hospitals assess risks and measure performance by using information about actual harm done to patients. This was a decade after the publication of ‘An organisation with a memory’ (Department of Health, 2000) which encouraged NHS staff to report instances of patient harm (in the context of a more open culture searching for systems failures with the intent of learning from these), and the establishment of the National Reporting and Learning System (NRLS, set up in 2003) together with the National Patient Safety Agency (NPSA). It is estimated that up to 10% of patients admitted to hospital Transfusion Medicine, 2014, 24, 197–203
200 P. H. B. Bolton-Maggs
Fig. 4. The nine steps in the transfusion process.
experience some form of potentially avoidable harm. Data from the NRLS show that of the 1·49 million incidents reported between 1 October 2012 and 30 September 2013, 68% caused ‘no harm’, 25% were ‘low harm’, 6% ‘moderate harm’, and
