Lessons for Transfusion Laboratory Staff. from the 2007 SHOT Report SHOT SERIOUS HAZARDS OF TRANSFUSION

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1 Lessons for Transfusion Laboratory Staff from the 2007 SHOT Report SERIOUS HAZARDS OF TRANSFUSION SHOT

2 The Serious Hazards of Transfusion Scheme (SHOT) is a UK-wide confidential enquiry that collects data on adverse events of transfusion of blood and blood components. These are red cells (including autologous and salvaged red cells), platelets, fresh frozen plasma (FFP, including SD-FFP) and cryoprecipitate, and errors associated with the issue of anti-d immunoglobulin. SHOT findings are used to: Aid the production of national clinical and laboratory guidelines for the use of blood. Improve standards of hospital transfusion practice. Educate users on the hazards of transfusion and their prevention. Inform policy within the four UK transfusion services and via the EU Commission. Identify new trends in adverse events and stimulate research. An annual report and a separate summary have been published by SHOT each year since 1998 and several general and specific recommendations made, which aim to improve transfusion safety. Recommendations are aimed at all levels from Chief Medical Officers, through professional bodies, Trust Chief Executive officers, and to each and every member of hospital staff involved in transfusion, as everyone has the opportunity to influence safe practice. What is the most frequent transfusion hazard reported to SHOT? Incorrect blood component transfused (IBCT), remains the most frequent transfusion hazard reported to SHOT. These incidents make up more than 62% of all incidents reported and are all preventable. Sub-categories of IBCT include administration errors, laboratory errors, special requirements not met, inappropriate and unnecessary transfusion and handling/storage errors. Over an 11-year period, from 1996 to the end of 2007, more than 36 million components have been issued from the four UK Blood Services, and there have been 4334 incidents analysed. The appointment of Transfusion Practitioners and the establishment of Hospital Transfusion Teams has resulted in an increased awareness of errors and a continuing increase in reporting, (11.4 cases per 100,000 components issued in 2007 compared to 10.6 per 100,000 in 2006.) The encouraging downward trend in reports of ABO incompatible transfusions since 1999/2000 shows evidence of a growing safety culture in transfusion in the UK. However, there are still a significant number of hospitals (approximately 25% of registered reporters) who have never submitted a haemovigilance report in This figure has remained unchanged in recent years despite the legal requirement to report to MHRA via SABRE and this is of concern from both professional and regulatory viewpoints. page 2

3 What are the figures for transfusion related mortality? There was one death classified as probably related to transfusion in the 2007 report - a probable case of Transfusion Related Acute Lung Injury (TRALI). Three further deaths were reported where the transfusion may have been a contributory factor one acute reaction in a very sick baby, and two haemolytic reactions in patients with multiple co-morbidities. Laboratory errors are a cause for concern and in some cases reflect poor standards of practice There were a total of 96 (29%) IBCT cases in the 2007 report in which the primary error originated in the laboratory. This year all the ABO and D typing errors involved manual techniques or manual interventions in automated methods. Two errors involved misinterpretation of mixed field reactions. All the ABO errors were made while providing blood for urgent cases, and 12/15 wrong blood incidents occurred out of routine working hours. Wrong blood events (n = 15): Three cases where the wrong sample was selected for testing. These errors resulted in group A FFP being transfused to a group B recipient; group A RhD positive red cells to a group A RhD negative female recipient; and group O red cells to a group A recipient. Four errors in ABO grouping, including a group A patient being mistyped as group B and transfused groupb red cells, a group A patient being mistyped as group AB, and a group AB patient being mistyped as group A. Three errors in D typing, resulting in the transfusion of D positive red cells in one case, and D positive platelets in another, to D negative recipients. Three cases of incorrect component selection, including D positive red cells given to a D negative patient, group O red cells selected for a group A patient, and group O FFP selected for a group A recipient. One case where the wrong platelet unit was selected, labelled for and transfused to a patient. One case where a Wrong Blood in Tube error was not detected by the laboratory, compounded by the BMS on duty altering the group on the computer to reflect the results from the incorrect sample. page 3

4 Learning Points Manual processes are more prone to error. During process validation ensure that manual procedures and interventions are kept to a minimum and that appropriate checks are in place at weak, manual points of a process. Competency assessment in ABO/D typing should include detection and interpretation of mixed field reactions. Competency-based training for laboratory staff must include staff who work out of hours, both those staff who do not work regularly in transfusion and those who do, and must apply to locum members of staff. Events in which the blood given was not of the appropriate specification (n = 41) As highlighted in previous SHOT reports, the majority of these cases involved failure to provide irradiated blood components for patients treated with purine analogues or those who have undergone stem cell transplantation putting them at risk of Transfusion Associated Graft versus Host Disease (TAGvHD). 27 cases occurred during routine working hours and nine during out of hours or shift working. In the remaining five cases, the time was not given. Nine cases involved children under one year of age, six further patients were under 16 and 26 were adults. This type of error is not decreasing, and a number of these cases appear to be due to patients being assigned multiple records during hospital visits. Learning Points Transfusion laboratories must have thorough search strategies when looking for patient histories in order to find and reconcile multiple entries for a patient. A laboratory quality system must include process validation. The process of recording special transfusion requirements within the transfusion laboratory should be validated and must be kept as simple as possible. Pre-transfusion testing and procedural errors (n = 20) 12 cases occurred out of routine laboratory working hours. There were five testing errors, where the correct tests were performed but incorrect results obtained, either by poor performance of the test, transcription error or incorrect interpretation. Two of the testing errors, a missed antibody reaction and erroneous selection of an incompatible unit, led to transfusion reactions in patients. There were also two missed weak reactions in manual antibody screens, and a missed specificity in an antibody mixture. The 15 procedural errors included the use of improperly labelled samples, samples that were too old for compatibility testing, failure to test maternal sample when issuing blood to a baby, failure to select antigen negative units in the presence of a known anti-k+c, and one example of electronic issue of red cells where there was no current sample in the laboratory. page 4

5 Learning Points The same standards should apply to pre-transfusion testing both in and outside of laboratory core hours. Laboratories must ensure that robust systems are in place for highlighting outstanding work on a patient, for example positive antibody screen awaiting identification or group and screen not complete. A laboratory quality system, as required by the Blood Safety and Quality Regulations 2005, must include internal incident reporting mechanisms and appropriate, documented corrective and preventative actions. Handling and storage errors (n = 20) Errors continue to occur in the handling and storage of blood. Some of the cases reported were due to problems with satellite blood fridges and in many cases it was difficult to ascertain responsibility for the error. There were two cases reported where a BMS had overridden electronic blood tracking systems to allow the transfusion of expired components. Learning Points The management of satellite fridges should be tightly controlled by a comprehensive written SOP/SLA/technical agreement, clearly specifying responsibilities. Ensure the implementation and monitoring of a comprehensive quality system covering blood component handling and storage to meet the requirements of the Blood Safety and Quality Regulations page 5

6 Key Recommendations for Transfusion Laboratory Staff Laboratories must develop a robust quality system in line with the Blood Safety and Quality Regulations This should include; Task-based training and competency assessment for all staff in the transfusion laboratory. A robust quality incident reporting system which encompasses root cause analysis and CAPA (corrective and preventative actions) Documented change control. Defined communication systems for staff at handover periods and following implementation of change. The National Transfusion Laboratory Collaborative have produced a paper that contains recommendations to improve standards, staffing levels, knowledge, competency and skills within hospital laboratories, and this should be noted and supported. Laboratories must be vigilant in reviewing procedures and systems against current guidelines, and ongoing staff training is essential. Efforts to prevent bacterial contamination of blood components should continue. These include adherence to British Committee for Standards in Haematology (BCSH) guidelines (1999) with regard to the visual inspection of blood components for any irregular appearance immediately prior to issue for transfusion. Clotted Red Cells Bacterially Contaminated Platelets page 6

7 Learning from our mistakes When reporting to SHOT, reporters are asked to identify whether a root cause analysis (RCA) was carried out, whether the event was reviewed locally, and what the outcomes of that review were. There are a range of tools available on the SHOT website and the NPSA website to assist practitioners undertake RCA, develop risk assessment processes, and implement corrective actions. Reporting of serious adverse reactions (SARs) and serious adverse events (SAEs) to the MHRA is mandatory under the terms of the Blood Safety and Quality Regulations SABRE, the on-line reporting system, can be accessed via the SHOT website or via the MHRA website page 7

8 If you would like more information on SHOT please contact; The SHOT Office, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL Tel: Fax: Website: