Getting Started

Getting started Organisations should have a formal written procedure for ‘commissioning’ RCA investigations: It typically includes... Definition and classification of incidents Which incidents need RCA (Triggers and proportionality) Membership of investigation team and support Guidance on Terms of Reference Timescale guides Framework for report Involvement of patient and family Involvement of staff Investigative interviews for learning Contact with media Legal advice/police/HSE Link with trust board

Aims for the Investigation of Serious incidents Proportionate, appropriate, fair and reasonable (Also now credible, thorough, timely and candid) Right people at the right level using the right skills at the right time Investigate once and investigate right Guidance from DH DH = Department of Health

Triggers For Investigation Which PSI requires an RCA? Frequently occurring PSI / Prevented PSI Bacteraemias Incidents that have previously been the subject of an Alert PSI causing death or severe harm (serious incidents) ‘Never Events’

Never Events 17 new additions from Feb. 2011 Wrong site surgery Wrong implant/prosthesis Retained foreign object post-operation Wrongly prepared high-risk injectable medication Maladministration of potassium-containing solutions Wrong route administration of chemotherapy Wrong route administration of oral/enteral treatment Intravenous administration of epidural medication Maladministration of Insulin Overdose of midazolam during conscious sedation Opioid overdose of an opioid-naïve patient Inappropriate administration of daily oral methotrexate Suicide using non-collapsible rails Escape of a transferred prisoner Falls from unrestricted windows Entrapment in bedrails Transfusion of ABO-incompatible blood components Transplantation of ABO or HLA-incompatible Organs Misplaced naso- or oro-gastric tubes Wrong gas administered Failure to monitor & respond to oxygen saturation Air embolism Misidentification of patients Severe scalding of patients Maternal death due to post partum haemorrhage after elective Caesarean  section www.dh.gov.uk and www.npsa.nhs.uk

The RCA Process Getting Started Gathering Information & Mapping the Incident Identifying Care & Service Delivery Problems Analysing Problems & Identifying CFs and RCs Generating Solutions & Recommendations Getting started - Set up the Multidisciplinary team; Assess risk; Agree size / scope of investigation Implementing Solutions Writing the Report

Getting Started Classify the Incident Establish the core investigation team 3. Scope the incident

Classifying incidents Use organisational procedure for PSI classification Classify according to: The degree of harm or damage caused at the time Its realistic future potential for harm if it occurred again (required locally and for RCA but not for incident reporting to NPSA)

unexpected incident(s) NPSA definitions Prevented, not impacted on patient NO HARM LOW MODERATE SEVERE DEATH PATIENT SAFETY INCIDENT Any unintended or unexpected incident(s) which could have or did lead to harm for one or more persons receiving NHS funded care Good Catch Not prevented, but resulted in no harm NB: Difference between No Harm Prevented (good catch) and not prevented (good luck) Good Luck!

Selecting the RCA investigation team For incidents with death or severe outcomes: Core multidisciplinary team of 2-3 people One of which should be fully trained in incident investigation Good organisational skills Appropriate use of experts

How the core team involve others Those involved in the incident (Patient, Carer, Relatives, Staff) Expert Advice (e.g. Experts in the field or process. Expert Patient) Core Team (2-3)

Suggested composition of investigation teams Core Team Investigation Lead Day-to-day Leader: Drives activities. Process expert. +/- Project Manager Support Investigator / Admin. Support Secretarial responsibility. +/- Project Manager Other Team Member Non executive Director. Lay representative. Patient representative. Normally invited in and out of the core team Process Owner(s) Know how ‘things really work around here’. Ideas for change. Test changes Experts / ‘Champions’ Understand the science. Help develop evidence-based protocols and changes. Help with process/ facilitation etc. Lead culture change.

Selecting the RCA investigation team Near miss or less serious event investigations (high frequency) Can be undertaken by one person e.g. ward manager Can be a useful learning process for clinical teams

Selecting the RCA investigation team For all incident investigations need to have appropriate: Competence Objectivity Cultural sensitivity *Authority and credibility* *Authority and credibility is key to success. (Ref: Warwick university research studies.)

Level and Scope of RCA What level of investigation is required? Level 1 - Concise investigation Level 2 - Comprehensive investigation Level 3 - Independent investigation Where would you plan to start and finish the RCA? - Need full Terms of Reference for Serious incident investigations

Scope and Terms of Reference Scope = Start and finish points and extent of investigation ToR = Purpose, Structure, Common understanding What - Objectives, Scope/boundaries, Level, Deliverables How - Method, Arrangements Guidance, Resources Who - Commissioner/Sponsor, Lead, Team, Other orgs, Patient/Family When - Schedule, Realistic timeframes *ToR = important. Refer to Report writing guide on NPSA website In the investigation into the stabbing of George Harrison (by Michael Abram) – the incident happened on 30/12/99 the chronology started from 12/3/90, they looked at clinical records, interviewed staff, and the way the services were provided eg drug services in Knowsley, including the clinical governance arrangements and workload of people in clinical leadership roles.

Levels of RCA Investigation Level 1 - Concise investigation Used for ‘No, Low or Moderate Harm’ incidents, claims, complaints or concerns Commonly involves completion of a summary or ‘one page’ structured template Conducted by one or more people local to the incident (ward / dept / GP surgery) Level 2 - Comprehensive investigation For actual or potential ‘Severe or Death’ PSI outcomes Conducted to a high level of detail Conducted by a multidisciplinary team, or involves expert opinion / independent advice Conducted by staff not involved in incident, locality or directorate in which it occurred Overseen by a director level chair or facilitator Level 3 - Independent investigation As per the above ‘Level 2 but… Must be Commissioned and Conducted by those independent to the organisation involved For incidents of high public interest or attracting media attention For Mental Health Homicides defined by Department of Health guidance in England www.npsa.nhs.uk/rca

www.npsa.nhs.uk/rca

Examples of Concise Investigation Reports www.npsa.nhs.uk/rca

An option for concise investigations... Consider Multi-incident Investigations - With narrow themes www.npsa.nhs.uk/rca

Exclusions to RCA Investigations conducted for learning purposes Escalate or hand over the investigation of: People thought to be involved in a criminal act Those involved in purposefully unsafe acts (where a care provider intended to cause harm by their actions) Acts related to substance abuse by provider/staff 4. Acts involving suspected patient abuse of any kind Canadian root cause analysis framework

Legal Duties The Secretary of State has a statutory duty under section 2 of the NHS Act 2006 to secure patient safety. NHS bodies have a responsibility to ensure the safety and well being of patients and staff and to investigate when things go wrong. This responsibility is placed upon every NHS chief executive and upon the board of their organisation and is a critical component of corporate and clinical governance. NHS organisations must conform to national and local policies and procedures in discharging this responsibility. MOU

Getting Started - GROUP WORK With reference to your case study… Classify the Incident What is the actual severity (actual degree of harm caused)? What is the realistic severity and likelihood of a recurrence? Is an investigation required? 2. Establish the core investigation team? Who should be on the core team? What expert advice is needed? 3. Scope the incident Where should you start and finish? What level of investigation is required?

Key Points - Getting started Good investigations begin with good planning Select the most appropriate level of Investigation (Independent, Comprehensive, Concise or Multi-incident) Set (and keep to) clear terms of reference and timescales Enlist appropriate authority to investigate and effect change