1. Getting Started

2. 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

3. 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

4. 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’

5. 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
and

6. 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

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

8. 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)

9. 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!

10. 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

11. 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)

12. 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.

13. 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

14. 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.)

15. 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

16. 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.

17. 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

19. Examples of Concise Investigation Reports

20. An option for concise investigations...
Consider Multi-incident Investigations - With narrow themes

21. 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

22. 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

23. 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?

24. 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