Serious Adverse Events (SAEs) in Blood Transfusion Practice. Jackie Sweeney National Haemovigilance Office

Transcription

1 Serious Adverse Events (SAEs) in Blood Transfusion Practice Jackie Sweeney National Haemovigilance Office 1

2 HSE Report into an SAE- Missed Opportunities? Report into care of Savita Halappanavar Key causal factors: 1. Inadequate assessment and monitoring of the patient 2. Failure to consider all management options 3. Non- adherence to guidelines (which could have prompted effective diagnosis and care of patient) Contributory Factors: Complexity and seriousness of patient s condition Lack of clear guidelines for handover/ communication of information (HSE Final Report: Incident 50278,2013) Many of these findings apply to blood transfusion practice and are reported by haemovigilance systems

3 Serious Adverse Events (SAEs) Approximately 10 % of hospital patients encounter possible and avoidable harm during their stay Need to measure effect of SAEs in terms of harm to patients Single largest category of haemovigilance reports are SAEs Majority due to human error, and in many cases there are multiple causes (Bolton- Maggs,2014) 3

4 SAEs accepted by the NHO 2013 (n=246) Non-mandatory SAE (hospitals) Mandatory SAE (hospitals) Mandatory SAE (Blood Establishments)

5 SAEs 2013 (n=113)

6 SAEs: NHO Table Avoidable transfusions Incorrect component/ product transfused Other Total Percentage of SAEs for reporting year 42 % 51% Table 2: Other SAEs 2013 Description Component transfused at incorrect rate Inappropriate/unnecessary administration of anti D Ig Sampling errors 4 Incorrect administration set used 2 Clots in pack 2 Testing errors 1 Over transfusion 1 Delay in transfusion 1 Total 26 n 8 7

7 Transfusion: What s s the evidence? Studies show: Research challenging assumed benefits of transfusion Increased postoperative mortality rates in cardiac patients receiving a transfusion compared to those who did not: caveat there were confounding factors (Surgenor et al,2009) A liberal transfusion strategy, compared to restrictive strategy, did not decrease rates of death or mobility or morbidity in elderly patients at high cardiovascular risk (Carson et al, 2011) Other studies: Myocardial Ischemia and Transfusion (MINT) trial (n=110) Liberal transfusion strategy was linked towards fewer major cardiac events and deaths than a restrictive strategy. Authors noted results should be interpreted with caution (further research needed)

8 Transfusion: What s s the evidence? UK National Comparative Audit of Platelet use in Haematology (2010) reported 28% platelet transfusions considered inappropriate based on national guidelines Causes of avoidable transfusions: -Lack of knowledge -Inappropriate management e.g. iron deficiency anaemia -Poor communication e.g. handover, wrong blood results (SHOT,2013) 8

9 Comment: UK National Comparative Audit of red cell usage in adult medical patients noted 20% of reports suggested that the patient s anaemia that could have been managed without transfusion Study at US hospital found most common errors: 1. Inappropriate requests for transfusion 2. Sampling and labelling errors (Maskens et al, 2014) Blood is a scarce and costly resource (Shander et al, 2012) and while appropriate transfusions are safe and can save lives they are not without risk i.e. serious adverse reactions/events (Napolitano and Corwin,2004: Vincent et al, 2007, Addison,2014) More recent evaluation of transfusions have resulted in recommendations to reduce/ avoid unnecessary transfusions and consider alternatives (Shander et al, 2012; Society for Advancement of Blood Management,

10 Patient Blood Management (PBM) Definition: a multi-disciplinary evidence based approach to optimising the care of patients who might need a transfusion Promotes appropriate blood usage including transfusion alternatives: to avoid inappropriate blood use putting patients at risk and wasting resources Key: education and patient consent for transfusion improved patient outcomes 10

11 PBM Adopted by the World Health Organisation (2010) as a principle to improve transfusion safety (Shander et al,2012, Spahn et al, 2012) Established in parts of the US, the Netherlands, Austria and Western Australia, where the National Blood Authority has developed guidelines ( Launched in UK (replaces Better Blood Transfusion) National Guidance published in

12 PBM 3 Key strategies (pillars): 1. Optimise patient s own RBC mass 2. Minimise blood loss (Shander et al, 2009) 3. Harness and optimise physiological tolerance of anaemia

13 Patient Blood Management Leahy et al, Transfusion,2014)

14 How to implement PBM? Should be included of HTC committee terms of reference Need a champion (named person/team) Education: clinical staff and patients No decision without me (UK Dept of Health,2010) Competency assessment Developing material and using national resources: hospital.blood.co.uk

15 PBM : Implementation Policies for patients with abnormal haemostasis e.g. on anticoagulant therapy, use of antifibrinolytic drugs Transfusion triggers (based on national/ international guidelines) Laboratory staff should be able to query requests that do not appear to comply with transfusion triggers/ lack an clinical explanation Audit/benchmark requests against transfusion triggers Scorecard for teams/clinicians not adhering to guidelines/transfusion triggers Key performance indicators (KPIs) Benchmark blood use between departments/ against similar hospitals - can be a valuable tool to highlight high-risk areas (Mukhtar et al,2008) NHO can provide data on hospitals by category Participation in national surveillance /audits controls / audit e.g. UK National Comparative Audit Programme (anti D Ig use, transfusion of sickle cell patients, PBM)

16 PBM: Implementation Consider alternatives e.g. cell salvage Minimise blood loss and intra operative bleeding e.g. use of Transexamic acid, better surgical techniques (bloodless surgery) Use of volume expanders Pre operative assessment clinics Anaemia clinics: diagnosis and correction of anaemia: iron, erythropoietin-stimulating agents Collect smaller blood samples less frequently from patients Size matters! Transfuse less e.g. don t use two when one will do (reassess patient after transfusion of one unit) (Leahy et al, 2014)

17 Who should be involved in PBM? Hospital Management: Role: Compliance with legislation/regulatory requirements Support initiatives (effecting cost savings) Provision of information that may affect service e.g. Hospital reconfiguration Consultant for Transfusion Practice/ Haematologists/ Consultant Physicians: Role: champion, guidelines, transfusion alternatives promotion of IT systems supporting PBM developing policies/guidelines, Point of Care (POC) testing advise on guidelines to manage anaemia & maintain haemeostasis 17

18 Who should be involved in PBM? Haemovigilance Officers: Role: Provision of education, investigation of SAEs/SARs & reporting to national bodies Support & conduct audits Networking to promote PBM Some organizations have developed roles that combine that of the PBM coordinator with the HVO, others work separately with with distinct responsibilities (Miller et al, 2015) Surgeons/ anaesthetists: Implementation of blood saving techniques Reduce/eliminate avoidable transfusions Optimisation of pre-operative Hb, point of care testing (ROTEM,TEG) Hospital Transfusion Committee:(HTC) Role : Lead PBM programme and engage staff and patients IT Departments Role: to set up alerts, computerised physician order entry Others: Patient advocates Clinical governance, risk & quality managers

19 What are the benefits of PBM? Lower morbidity and mortality rates (Shander et al,2012) Treatment of preoperative anaemia by transfusion is associated with risks that can increase morbidity & mortality rates in surgical patients (Shander and Goodnough,2009: Vamvakas and Blajchman,2009) Helps to ensure availability of blood components for those patients with no alternative to transfusion Reduced healthcare costs e.g. prolonged hospital stays, medication, nursing time and equipment, and readmission costs = savings ( Kotze et al, 2012)

20 PBM: What s s the evidence? PBM introduced to large hospital (2009) Between hospital services increased by 22% But transfusions decreased ; - RCC 26% - Plasma 38% - Platelets 16 % - Single unit transfusions % -Two unit transfusions 48-37% (Leahy et al, 2014) Another study reported 32% reduction in transfused components following education campaign and strict adherence to guidelines (Maskens et al, 2014) 20

21 NHO Review of SAEs ( ) 2012) 991 SAEs reported All reports cited at least one root cause (RC) 991 SAEs citing 1746 different causes and subsequent corrective and preventative actions (CAPA) proposed Human failure accounted for Root Cause n % Failure to adhere to policies & procedures Verification Slip Knowledge /qualifications Co-ordination/communication factors Carrying out task incorrectly Unclassifiable 11 1 Patient related 5 0 Monitoring 23 2 Other 54 4 Totals % (n=1453) Common causes : active failures also known care delivery problems such as: -failure to adhere to polices/procedures -lack of verification

22 Root causes due to systems error Root Cause n % Lack of policies/procedures Materials Other Design Management priorities Culture 15 5 Construction 1 0 Totals % % (n=293) due to system failure (latent conditions highlighted during RCA and not linked to direct provision of care but contributed to the error) Remember: systems do not always prevent errors e.g. number of SAEs where flags on laboratory information systems were overridden (Bolton-Maggs,2014)

23 Corrective/Preventative Actions (CAPA) (n=719/991) At least 1 CAPA identified in 22% 23% 719 reports. Retraining/ education most common. Others: -changes in policies/ procedures 12% 1% 9% 12% Retraining /education of staff Changes in Procedure Communication/Memos Development/revision of policies Audit Multiple follow-up actions Other 21% -introduction of more robust communication methods e.g. online ordering system from the supply centre -formal Handover procedures during staff shift changes -technological solutions for component management and checking (BloodTrack ) help avoid errors linked to mislabelling & patient misidentification

24 CAPA For SAES attributed to human error, remedial training was the most frequent CAPA If retraining is undertaken, certain conditions should be met with emphasis on critical steps Where training was previously undertaken, need to examine reason why procedures were not followed e.g. inattention to detail or distracted from task (Medicine Health Regulatory Agency,2012, Lundy et al, 2007) Note: not all CAPAs are of equal strength: Some more robust such as, change in a process (reducing recurrence). Others less likely to bring about change e.g. revision of policy, retraining (Wu et al, JAMA,2008)

25 CAPA Comment: More system changes reported (n=555) than system errors (n=293) suggesting suboptimal systems contributed despite human error being cited as root cause Research suggests many root analyses inadequate.obstacles: -inadequate data, resources, feedback -resistance from colleagues /other healthcare professionals -lack of management support Difficult to develop CAPA: repeated SAEs despite CAPA (Wu et al, JAMA,2008)

26 CAPA At a local level, procedures should be scrutinised for any trends, or system failures that may have contributed to the error, and actions to prevent recurrence Feedback should be targeted to errors specific to a department (clinical area, Maskens et al,2014) As human failure (including slip errors, lack of attention to details, or working on automatic pilot ) is repeatedly identified as error causes should consider ergonomics and reconfiguration of the steps in the transfusion process (Bolton-Maggs,2014) 26

27 Initiatives: Clinical Human Factors Group Established by Martin Bromilow Wife died following routine surgery Collaboration of healthcare professionals, managers and service users together with experts in human factors to promote change www. 27

28 Human Factors Reference Group Set up in UK following events at Mid Staffordshire NHS Foundation Trust scandal (Roberts,2013) Aim: to improve clinical performance by understanding the effects of teamwork, tasks, equipment, workspace, culture and organisation on human behaviour and abilities and application of that knowledge in clinical settings (Keogh,2012) Examines why latent conditions compromise the ability of staff to do the right thing, even though they know what the right thing is Many processes and policies complex, or appear to make it difficult for busy staff to perform their work resulting in the temptation to take shortcuts or workarounds

29 Human Factors Reference Group Metaphor: withdrawing money from ATM: had to be adapted following introduction as people left their card/money in the ATM Need to take this concept into healthcare: standardised infusion pumps : make easy to do the right thing (Reid, Foundation Trust Network, Accessed: November 2014) Transfusion: standardised transfusion record? Role of National Transfusion Committee 29

30 Human Factors Reference Group Essential to have good handover and communication Frequently cited in NHO reports Importance of correct patient identity especially at critical points: sampling and administration (Bolton-Maggs,2014)? Review transfusion process: ergonomics promotes equipment design, environment in conjunction with strengths and abilities e.g. is there an area to label patient samples at the bedside? SHOT: key messages and recommendations from the Annual SHOT Report 2013 (Transfusion Medicin,2014)

31 High risk steps: Human interventions Aide-memoire developed by SHOT Ask the patient to state name and date of birth Check identification of component against patient wristband Check prescription: has component been prescribed? Note: Checklist should not be a tick box! Need to ensure training and teamwork underpin changes (NHS England 2014, Bolton- Maggs,2014) Check the prescription: is this the correct component? Check for special requirements: does the patient need irradiated components or specially selected units? (Bolton-Maggs,2014)

32 Training: what s s being done? Most medical schools only provide 1-2 hours education on blood transfusion even though 6% of hospital patients are transfused (Karp et al, 2011,Morton et al, 2010) Training should be multi-disciplinary those that work together should train together Standardised training programmes e.g e-learning Need to include training in patient safety including effect of human factors (Bolton-Maggs,2014) 32

33 E-learning: Proposed new developments Pathways for specific job roles : Phlebotomists: includes haemovigilance module, ABO blood group fact sheet and sampling video Porters: includes haemovigilance and collection modules and ABO fact sheet and importance of positive patient identification 33

34 Porters Pathway Pathway Description This Learning Pathway has been specifically designed for Porters, Health Care Support Workers (HCSW) and other staff who are solely involved in the collection of blood. The pathway consists of three points of learning which include two core units from Module 1 Safe Transfusion Practice and an ABO serology fact sheet. Learning Objectives On completion of this pathway the learner will be able to demonstrate understanding of: The most common errors in the transfusion process Basic ABO serology The correct procedures for collecting blood safely Target Audience Aimed at Porters, Health Care Support Workers and other staff solely involved in the collection of blood. Recommendation Pathway endorsed by the Scottish Clinical Transfusion Advisory Committee in January 2014 which standardises theory based learning in the blood collection procedure for a specific staff group. Completion of the porters pathway will be accepted as evidence of learning as part of the Trainers and Assessors Accreditation Programme for blood collection competency. w w w. l e a r n b l o o d t r a n s f u s i o n. o r g. u k For more information, please contact NSS.LBTQuery@nhs.net

35 Conclusion Avoidable transfusions and sampling errors are repeatedly reported as the most commonly occurring SAEs Strategies to consider: PBM & transfusion alternatives Use of strategies examining the link between work processes/environment/human factors Multi-disciplinary, standardised education & training More effective root cause analysis : needs to be done correctly & evidence needed of success in preventing harm to patients 35

36 Further reading & resources Themed issue of Transfusion Journal: October 2014 Volume 54 (1) AABB (several publications) NHS Blood and Transplant: 36

37 Further resources:joint Professional Advisory Committee (JPAC) Includes a Toolkit with information on transfusion practice:

38 Thank you : Questions? 38