Implementing Patient Safety Programmes – the story no one ever wants to tell! Expert Seminar - Paris 22 – 24 May 2006 Sue Osborn/Susan Williams Joint Chief Executive National Patient Safety Agency “ to improve safety of patients by promoting a culture of reporting and learning from patient safety incidents affecting patients receiving National Health Service funded care” Purpose of NPSA Help the NHS to: • learn from things that go wrong • develop and implement solutions to problems • improve patient safety in frontline services Focus on: • systems not individuals • learning not judgement • fairness not blame • openness not secrecy • all care settings not just acute National Health Service Northern Ireland Wales Scotland England National Health Service • State funded healthcare system • 3rd largest employer in the world behind Chinese Army and Indian Rail Industry • Biggest organisation in Europe UK context • • • • • • • Population 65 million 560 NHS Healthcare Organisations 2 million prescriptions every day 360 million patient contacts over a year 40-50 million clinical decisions per million population per year Budget £92.6 billion ($170.3 billion) 7% of Gross Domestic Product (US 13.6%) The National Patient Safety Agency • Collect and analyse information on adverse events from local NHS organisations, NHS staff and patients and carers: • Assimilate other safety-related information from a variety of existing reporting systems and other sources in this country and abroad; • Learn lessons and ensure that they are fed back into practice, service organisations and delivery; • Where risks are identified, produce solutions to prevent harm, specify national goals and establish mechanisms to track progress. National Reporting & Learning System • electronic system to enable NHS organisations, staff and patients to report patient safety incidents to a national database • links to local risk management systems Patient safety incident ‘any unintended or unexpected incident which could have or did lead to harm for one or more patient receiving NHS funded healthcare’ • Source: Seven steps to patient safety: a guide for NHS Staff (NPSA) NRLS Five levels of severity • No harm –Those prevented (near miss) –Those that were not prevented • Low harm • Moderate harm • Severe harm • Death NRLS dataset ‘What’, ‘When’, ‘Where’ … and a little ‘How’ & ‘Why’ but NOT Who notification and basic learning data hypothesis generating single high level dataset specialty extracts free text to help understanding data analysis tools flexibility over time to develop new data fields stable during national roll out Overview of analysis of NRLS data • • • • • Routine monitoring reports Thematic analysis Ad hoc analysis Benchmarking information for trusts Exploratory – Reviews of selected incidents – Data mining • The Patient Safety Observatory: analysis of other data sources Patient Safety Observatory • Building a memory: Preventing harm, reducing risks and improving patient safety Number of incidents and reporting trusts Table of incident reports by care setting Table of incident reports by degree of harm Total reported incident types Who reports: staff type (where known) No. % Ambulance staff 738 0.58 Dental staff-general and community 135 0.11 Diagnostic and therapeutic staff 5875 4.62 Manager 4629 3.64 Medical staff 9741 7.67 Nurse/midwife/health visitor 87079 68.53 Optician optometrist 12 0.01 Other 12044 9.48 Pharmacy staff 3050 2.4 Support staff (clinical and administration) 3759 2.96 Total 127062 100.00 Reported incident types • • • • • Acute/hospital sector Ambulance services Mental health Learning disabilities General Practice Reported incident types in acute/general hospitals Reported incident types in ambulance services Reported incident types in mental health services Reported incident types in learning disability services Reported incident types in general practice Turning information into learning Reported incident types in acute/general hospitals Acute incidents: medication process Medication Process Frequency % 24791 61.5 Prescribing 6454 16.0 Preparation of medicines 6315 15.7 518 1.3 1778 4.4 269 0.7 Administration/supply Other Monitoring Supply or use over the counter Description of medication incident Description Frequency % Wrong/unclear dose or strength 7459 18.5 Omitted medicine 6851 17.0 Wrong drug or medicine 4203 10.4 Wrong frequency 3813 9.5 Wrong quantity 2337 5.8 Wrong/transposed/omitted medicine label 1661 4.1 Bench marking information: feeding back to individual organisations NPSA Activity Analysis For Chief Executive, Foundation Trust NHS Feedback to individual organisations • Report available to individual organisation via secure internet site • Password protected-only NHS organisations can access NRLS extranet launch • New service available to all NHS organisations in England and Wales from 2 May 2006 • Each NHS organisation has their own individual report providing a comparison between their data and similar organisations over a 3 month period • Similar organisations are “clustered” in line with existing definitions • Reports to be made available quarterly NHS organisation clusters • • • • • • • • • Ambulance Mental Health Learning Disability Primary Care Organisations Large Acute Medium Acute Small Acute Acute Specialist Acute teaching Influencing Role An Example of Influencing Role – Connecting for Health • To deliver IT systems which improve clinical safety. • To provide suppliers with an easy to use and robust safety management system. • To provide Trusts with assurance and clear guidance on the actions they need to take to ensure systems are deployed in an effective and safe manner. Requirements All CfH products and every request to connect with spine must have: • End-to-end hazard assessment • Safety case • Safety closure report Must have clinical authority to deploy (issued by Clinical Safety Officer or Director of Knowledge Process and Safety) before products can be accepted into integration testing and deployment Clinical Safety Organisation NHS CfH Programme Board Risk Reduction Board Chair: NHS Trust Clinical Director NHS CfH Clinical Risk and Safety Team Chair: Sir Muir Gray NHS CfH Clinical Safety Officer Maureen Baker Technical Assurance Test Manager Project or Compliance Safety Officer Supplier Safety Officer Clinical Experts Clinical Risk Minimisation Programme of work to that allows identified safety solutions to be fed into CfH – includes • Right Patient Right Care • Safer prescribing • Safer handover As problems identified through NPSA’s Patient Safety Observatory, those with technology solutions can be fed into CfH through this work programme Embedding Safety Educational Module for Junior Doctors • Aimed at doctors in second foundation year. • Module linked to patient safety learning requirements in AoMRC’s Curriculum for Foundation Years • Educational material to be available online at www.saferhealthcare.org • Material will support clinical tutors in Trusts to deliver module Content of educational module • • • • Principles of human error Principles of risk assessment Safer systems Learning from when things go wrong (including incident reporting and RCA) • Being open • Doctors Net – 39,000 interactions with online materials on patient safety Solutions: preventing errors: a hierarchy Design out the potential for harm Make incorrect actions correct Make wrong actions more difficult Make it easier to discover errors Preventing errors: a hierarchy Design out the potential for harm Preventing Errors: a hierarchy Before After Solutions information design for patient safety Good Good Bad Bad Safe medication practice • Improving infusion device safety (Safer Practice Notice 02) • National standards for dispensed medicines • Oral liquid medicines and feeds (Design) • Developing a new connector for spinal therapy (Design) • Guidance on safe medication packaging (Design) • Reducing patient safety incidents associated with anticoagulants • Safer practice with high dose morphine and diamorphine Solutions / Safer Practices Forms of NPSA advice • A patient safety alert requires prompt action to address high risk safety problems • A safer practice notice strongly advises implementing particular recommendations or solutions • Patient safety information suggests issues or effective techniques that healthcare staff might consider to enhance safety Learning about falls and use of bed rails Acute incidents: patient accidents Patient Accident Incidents Frequency % 128354 91.5 Collision/contact with an object 6098 4.3 Contact with sharps (includes needle stick) 1519 1.1 Inappropriate patient handling/positioning 1093 0.8 Exposure to cold/heat (includes fire) 1176 0.8 722 0.5 1355 1.0 6 0 Slips, trips, falls Exposure to hazardous substance Other Not stated National Reporting & Learning System: falls • Analysed random samples of 500 falls in detail in acute settings Where do patients fall? (n=500) fall whilst mobilising 9% 1% 2% fall from bed 32% 10% fall circumstances unclear fall from chair fall from toilet or commode 18% 28% fall in bathroom or shower fall other Falls from bed (n=140) 3% 7% fall from bed with bedrails 36% 54% fall from bed definitely without bedrails fall from bed probably without bedrails fall from sitting position on side of bed Severity of injury in falls from bed 45 number of incidents 40 35 no harm 30 low 25 moderate 20 severe 15 death 10 5 0 fall from bed with bedrails fall from bed fall from bed fall from sitting definitely without probably without position on side bedrails bedrails of bed 100 with/100 without bed rails site of injuries in fall from bed number of incidents 25 20 15 no bedrail 10 bedrail 5 0 arm bottom chest head leg/hip spine location of injury other Incidents involving bedrails Incidents directly involving bedrails no harm low moderate numbers 20 15 10 5 0 caught by bedrail struck bedrail trapped limb other (bedrail fell off onto foot) Learning about the misplacement of nasogastric tubes Misplacement of NG tubes: the incident On Thursday 5th December 2002 an NG tube was inserted to allow the feeding of an 8 year old girl. The standard tests for placement were performed and feeding commenced Unbeknown to all, the tube had been inadvertently inserted through the trachea and bronchus into the left pleural space Despite repeated tests the misplacement was not recognised for 24 hours during which time she was fed through the tube The subsequent chest infection could not be treated adequately and on 22nd December 2002 the girl died at home Methods for checking position • • Observation for respiratory distress during insertion The ‘whoosh’ test – Insufflation of tube with air whilst auscultating over epigastrium • Testing of NG aspirate for acidity – Litmus paper – pH paper • • • X-ray Observing ‘bubbling’ when tube placed under water Experimental methods – Use of carbon dioxide detectors – Enzymatic analysis of NG aspirate What had gone wrong? • Understanding gained whilst writing report for Coroner • Information from: – Timeline • Constructed by risk management department • Based on physiotherapy records – Statements – Literature search – Tests carried out on unit • Two tests used: – The ‘whoosh test’ – Testing of aspirate with litmus paper Coroner’s recommendations • • • • Alert Trusts about risks associated with litmus paper ‘Whoosh’ test to be withdrawn from use A review of the next edition of the Marsden Manual Feed manufacturers to be required to show the pH level of their food • Tube manufacturers to include advice on appropriate tests for placement • Consideration of a scheme for reporting adverse events and lessons learnt nationally – National Reporting and Learning System NPSA involvement Coroners recommendations based on one case • Patient Safety Managers identified 10 more deaths • Literature review, No test perfect, pH and x-ray most reliable • Range of 0.3% - 20% misplacements reported in literature • Limited studies in UK, particularly in relation to neonates • NRLS not in operation at the time Potential for aggregate Root Cause Analysis Aggregate RCA • Powerful method of determining underlying causes across a number of incidents • Originally developed in high hazard industries • Advantage - actions taken to improve care are based on information from a number of events and so are more likely to address common problems. • Not been done before in UK Root causes • Use of unreliable bedside tests • Limited awareness of risks • Lack of decision tree • Lack of competency based training solution ‘fast tracked’ NG Alert and Carer Briefing Compliance • 99% of acute trusts compliant • 85% of primary care trusts Learning about MRI scanners MRI scanners and metal: the risks • Metal within the body, such as pacemakers, could be displaced with fatal results. • Metallic equipment attached to the patient can malfunction. • Metal attached to the patient, such as callipers could result in a dislocation or fracture • Loose metal objects become projectiles, with potential for fatal injury if a patient or staff member is in their pathway. Starting point • USA fatalities brought to NPSA attention prior to NRLS rollout • Professional bodies ‘guidance is in place in the UK’ • UK managers state a problem is ‘extremely rare’ NRLS data • 526 reports of PSIs in MRI units • 31 of these reports related to implants • Five pacemakers, one implantable defibrillator, one heart valve and three aneurysm clips went undetected. All of these are potential fatalities. NPSA observatory • NHSLA – pacemaker/MRI fatality • MHRA – 200 reports related to MRI • Literature – 14 deaths in other countries Visits by PSMs • Small projectiles almost everyday occurrence • Frontline staff depending on constant vigilance rather than safer systems • Significant variations in strength and number of barriers between units Proposals NPSA to work with clinical experts and frontline staff: • To develop patient centred written and visual information • To scope the formation of a comprehensive register of MRI compatible materials. • To scope and cost a pilot of additional physical barriers such as metal detectors. • To improve staff documentation and procedures (e.g. referral forms and checklists) to take account of human factors. • To support commissioning for patient safety in MRI Learning for safer patient identification Information from NRLS • Search on “patient incorrectly identified” = 1506 incidents Error types Percent of total Error types Number a) Mismatches between patients and the documentation on their samples, records, blood transfusion samples and products, and medication. 975 64.7 b) Missing wristbands or wristbands with incorrect data on them. 236 15.7 c) Mismatches between patients and their medical records. 155 10.3 d) Failures in the manual checking processes. 140 9.3 1506 100.0 Total Error type by location in acute/general and mental health Location Ward Laboratory Accident and Emergency Outpatients Radiology Operating theatre General areas Intensive Care Unit Day Care Services Recovery Room Anaesthetics Ambulatory Care/ Independent Treatment Centre Therapy Mental Health Unit (ward) Other Total Mismatches with the documentation 329 161 121 78 85 48 73 28 10 3 1 Wristband use 112 4 15 3 14 39 18 14 3 8 Mismatches with medical records 46 4 6 41 13 15 17 4 4 Manual checking process 53 7 5 19 19 12 4 6 4 1 1 14 952 2 232 1 2 153 2 132 Missing wristbands or wristbands with incorrect data Specialty No wristband in place Incorrect data on the wristband Totals Surgical Specialties 29 37 66 Medical specialties 28 22 50 Diagnostic services 25 10 35 Obstetrics and Gynaecology 25 9 34 Accident and Emergency 5 7 12 Dentistry-General and Community 1 Anaesthetics 1 1 1 Other 13 24 37 Total 126 110 236 NPSA patient ID programme Wristband Safer Practice Notice Nov 2005 Identified 236 reports to NPSA of errors concerned with missing or incorrect wristbands Action for NHS: •Ensure acute hospital inpatients wear wristbands that accurately identify them •Make effective arrangements for implementing and monitoring this action Solutions work programme: • Right Patient, Right Care • Correct site surgery (Patient Safety Alert 06) • Wrist band compliance (Safer Practice Notice 11) • Standardisation of wrist bands • Exploration of bedside checking • Programme of work to reduce the risk of patients receiving the wrong blood during transfusions Learning from deaths Crash call trolley incidents – Jan – Feb 2005 • • • • • • • • • Delay in response to crash call. No support given by ward staff to patient who had arrested until arrival of crash call doctor. Door locked/no equipment/ no resuscitation attempted despite no knowledge of patient status re resus. Attempt to call crash team to collapsed patient. Subsequently found that crash call phone in switchboard accidentally left off the hook. Patient coughing up some bright red blood following radiotherapy. Crash Team call. Apparatus missing from crash trolley/emergency lights not working/insufficient staff to cope with the situation. Patient suffered cardiac arrest. Crash trolley found not to have been replenished with essential drugs following previous use. Equipment on crash trolley was incomplete rendering it unusable and delaying the ability to remove vomit of patient to obtain a clear airway. Cardiac arrest call. Incomplete equipment on crash trolley meant unable to provide appropriate care. Patient collapsed whilst on commode in community. Dr called and declared patient dead. After doctor left patient found to be alive. Crash team called. 2 PSIs for same incident. Patient’s condition declined to cardiac arrest without appropriate monitoring or outreach team being called. Example of NRLS/PSO -tracheostomy • • • • • • • Clinical concern re transfer from ICU to general wards NRLS: 36 incidents, one death NHSLA: 45 litigation claims Feb 96 to April 05, of which 13 related to the management of tracheostomy tubes, including 7 deaths MHRA: 10 similar incidents since 1998 HES: increase in tracheostomies being performed in the last 5 years, and a higher proportion of patients who have had a tracheostomy being cared for outside of surgical and anaesthetic specialties NPSA Bulletin Scoping work with other organisations NRLS: other examples of analysis and issues identified • • • • • • • • • patient ID problems in lab tests – lab results or samples being mis-identified non-medical devices/IT equipment – errors or failure of computing and other non-medical equipment leading to incidents missed/delayed diagnosis – incidents relating to this, particular in emergency care infusion pumps – inappropriately attaching an infusion pump line to an intravenous line pre-filled syringes – supply problems of emergency pre-filled syringes oxygen cylinders – people smoking near use of oxygen, cylinders falling on people bleeps not working, leading to failure to respond to urgent calls Fire and burn risk from skin preparations and diathermy Swabs missing from surgery Summary of ambulance NRLS data 1/4/05 – 30/06/05 • Patient accident (33%) – Injury from vehicle steps – Instability of trolleys and chairs – Patient falling • Access/admission/transfer/discharge (29%) - OOH care - Transfer of Care • Consent/communication/confidentiality (11%) - Prioritisation of calls • Medical device/equipment (11%) – Defibrillator failure • Treatment procedure (5%) • Consent, communication, confidentiality (3%) Are we learning from these tragedies? Evaluation and Impact Patient Safety Alert Impact Potassium Chloride Patient Safety Alert 01(2002) • 100% reduction in deaths since 2002 • 97% uptake of actions Crash call Patient Safety Alert 02 (2004) • Survey in 2002 indicated 27 different numbers being used for crash calls across 173 trust • 100% compliance. All trusts using 2222 Methotrexate Patient Safety Alert 03 (2004) • 87% of GP practices have implemented safety alert Cleanyourhands Patient Safety Alert 04 (2004) • 99% of trusts in England and 100% of hospitals in Wales implementing cleanyourhands campaign Nasogastric Feeding Tubes Patient Safety Alert 06 (2005) • 99% of acute trusts in England have implemented this notice. Correct Site Surgery Patient Safety Alert 06 • 70% of acute trusts in England have completed the actions and 38% of acute trusts in Wales NHS Health Organisations - The Road to Resilience 8,000 NHS staff trained in Root Cause Analysis 7 Steps to Patient Safety General and Primary Care National Reporting and Learning System Cultural Tools Being Open MaPSaF Scenario Based Decision Making Foresight Training Chief Exec Checklist and Board Training Incident Decision Tree Feedback PSO Bulletin Extranet Patient & Public Reporting Vulnerable – High Reliability - Resilience Proactive Risk Assessment Toolkits The Challenges Faced The Future NHS Health Organisations - The Road to Resilience 8,000 NHS staff trained in Root Cause Analysis 7 Steps to Patient Safety General and Primary Care National Reporting and Learning System Cultural Tools Being Open MaPSaF Scenario Based Decision Making Foresight Training Chief Exec Checklist and Board Training Incident Decision Tree Feedback PSO Bulletin Extranet Patient & Public Reporting Vulnerable – High Reliability - Resilience Proactive Risk Assessment Toolkits “A structured systematic means for ensuring that both general and particular aspects of what the organisation does are effectively managed to meet the high standards of safety.” Reference: Waring A (1996) Safety Management Systems. London: Chapman and Hall Senior Management Commitment • Safety is a primary goal of the organisation. • Senior management has the ability to drive safety systems. • Identified person(s) to take responsibility. • Open communication about safety issues. • Appropriate resource allocation to address concerns. • Integration of safety with other management systems. A Proactive approach to Risk • Formal and informal meetings about safety. • Risk assessments considered a part of every day working practices. • Integration of known risks and potential risks incorporated into a register for all risks (a risk register). • Links between the risk assessment process and business performance. • A clear understand of how those risks can be managed through defences and controls. • Solutions to minimise risk. • Changes to procedures to work around the risk. • Communication about risks to staff and public alike. Reactive Processes • • • • Open and fair culture. Confidential reporting systems. Feedback on information and action taken. Incident analysis used to identify conditions which need correction – informing risk assessment processes (moving from reactive to proactive approach). Accountability and Follow Up • Risk registers translated into action plans. • Action plans describe specified accountability. • Risk register and action plans (and risks themselves) are monitored and reviewed through audit processes. • Formal assurance processes to show that reporting goals have been achieved. • Feedback. NPSA Guidance Safety Check List Senior Management Commitment Proactive Approach to Risk Reactive Processes Safety Management System Accountability and Follow up Delivering safer healthcare – A leadership checklist for NHS Chief Executives “…The ability of a system or organisation to react to and recover from disturbances at an early stage, with minimal effect on the dynamic stability.” Reference : Hollnagel E, Woods D and Leveson, N (Eds). Resilience Engineering. Ashgate Publishing, in press, due for publication January, 2006. How do Staff • • • Prevent something bad from happening? Prevent something bad from becoming worse? Recover from something bad once it has happened to minimise harm? Reference: Westrum R. Being resilient. In: Hollnagel E, Woods D and Leveson, N (Eds). Resilience Engineering. Ashgate Publishing, in press, due for publication January, 2006. Reference: Reason, 2005 Features of Local Safety Units It is proposed that each unit: • is integrated into the Chief Executives network in the Health Authority; • works closely with the Strategic Health Authority to ensure patient safety is core to the targets for Trusts and the performance management and improvement work; • is aligned with a University Department(s) conducting research into safety; • has expertise in human factors and design; • has resources to provide training in the fundamentals of patient safety; • delivers the ‘Patients for Patient Safety’ initiative locally; • takes the lead nationally for a particular area such as mental health, vascular surgery or general practice (as has been the model with Public Health Observatories); • develops solutions to local safety problems and disseminates these across all Units; • engages experts from safety conscious industries in the area to transfer expertise from these industries into healthcare; The following diagram sets out the different elements of a programme for a health community: Strategic Health Authority: agreement of role and remit, including how support can be accessed across an area (eg: local safety units) Work with the providers of under and post-graduate education and the KSF* Patient and public involvement Programmes that address issues across all levels within organisations Board and senior manager programmes – some specific to the organisation, some generic across organisations Organisational programmes – some specific to the organisation, some generic across organisations Clinical safety programmes designed to address specific safety issues in each organisation (eg: eliminating central line infections or preventing patient suicides) Clinical safety programmes designed to address issues across and between organisations (eg: discharge summaries or medicines reconciliation) Support from safety experts in other local industries *KSF – Knowledge and Skills Framework Patient Safety at National Level – Functions at a National Level • • • • • • Bearing in mind the criteria above, we believe that there are a number of functions that should continue to be discharged at a national level, at least in the medium term. managing the national reporting and learning system. The WHO guidelines for adverse event reporting and learning systems state that the system must be confidential and safe for the individuals who report and reporting must lead to a constructive response. It is important that these principles continue to be reinforced; developing robust mechanisms to provide regular reports back to both organisations and the public about the information collected, demonstrating learning from reports and facilitating the spread of knowledge and solutions developed at a local level; drawing together information on risks in the health care system to inform future direction, priorities and action through the Patient Safety Observatory; influencing health service policies at a national level to enable safety to be embedded across all policy areas for example CfH, HR, finance, regulation, development of educational curricula and performance management; coordinating work across a range of national organisations with key roles in safety – e.g. Royal Colleges, other ALBs. Patient Safety at National Level – Functions at a National Level – cont’d • • • • • • • influencing national initiatives such as purchasing and information technology; influencing at the EU level in areas such as the free movement of professionals, the regulation of drugs and healthcare devices; providing expert advice distilled from a wide range of safety conscious industries and university departments and translating this into the healthcare setting; influencing healthcare industries to improve safety including drugs and medical devices; developing tools and techniques to support staff across the NHS in delivering the fundamentals of patient safety, such as the ‘Seven Steps to Patient Safety’, the RCA toolkit and prospective risk assessment methods; developing methodologies for involving and engaging with patients and the public on patient safety; developing national solutions, for example the Potassium Chloride Alert, which required work at a national level with the pharmaceutical industry to ensure that diluted product was available across the NHS; Features of a National Function • organisational values aligned with the ‘open and fair’ culture associated with successful safety systems; • trusted that reports will be used for learning rather than for punitive purposes; • sufficient authority and independence to publish data and learning in a timely and regular fashion; • credibility with patients and the public; • linked with local safety units, with mechanisms for them to be formally represented within the national function; • governance arrangements that facilitate stronger ties with and buy-in from national and local stakeholders. Summary Now that the NRLS is in place and many of the building blocks of a safety system have been developed, if not yet fully embedded, we believe that we have a reached a point where it is appropriate to enhance the skills and resources for patient safety at an intermediate and local level. Alongside this there remain major national roles to both support and encourage local delivery and to provide national leadership and action where there is clear benefit in national delivery, policy and influence but…….. Implementing Patient Safety Programmes – the story no one ever wants to tell! Expert Seminar - Paris 22 – 24 May 2006 www.npsa.nhs.uk