Our June litigation and inquest forum for NHS staff covers: • apologies, explanations and press statements - how to navigate the minefield, by Richard Briggs and Jonathan Fuggle. This session looks at the differing practices of trusts and care providers both when the NHSLA is involved and when it is not. Practice tips and recommendations on how to handle specific scenarios will be explored • what makes a good investigation and writing it right, by Lucy Reid, AnaKrisis. Lucy Reid is a professional advisor to the CQC and has provided support and advice to numerous healthcare boards on corporate and clinical governance, risk management, reporting structures and assurance framework. Lucy discusses internal investigations and process, report writing and patient safety/learning from incidents • CQC and RCA/internal investigations, by Andrew Hopkin and Carl May-Smith. Andrew and Carl take a look at the CQC’s response to reported SIs, their approach to assessing the quality of SI investigation reports and Trust’s learning from mistakes, key lines of enquiry during inspections and practicalities associated with inadequate investigations and implications stemming from same. https://www.brownejacobson.com/health/services/inquests-and-investigations

1. Litigation and inquest forum
June 2016, Nottingham

2. CQC and RCA/internal
investigations
Andy Hopkin and Carl May-Smith

3. CQC’s RESPONSE TO REPORTED
SERIOUS INCIDENTS
• Required notifications direct to CQC
– Statement of purpose changes
– Registration changes
– Deaths and unauthorised absences (detained under
MHA)
– Admission of child or young person to adult
psychiatric
– DOLS applications and outcomes

4. CQC’s RESPONSE TO REPORTED
SERIOUS INCIDENTS
• Required notifications to NRLS (NHS bodies)
– Certain deaths of service users
– Allegations of abuse
– Events that stop or may stop service running safely
and properly
– Serious injuries to service users
• Notification failures are criminal offences

5. CQC’s RESPONSE TO REPORTED
SERIOUS INCIDENTS
• Other notification requirements
– STrategic Executive Information System (STEIS)
– Public Health England (infection outbreaks)
– RIDDOR
– Duty of candour

6. CQC’s RESPONSE TO REPORTED
SERIOUS INCIDENTS
• Risk based inspections
– CQC propose greater emphasis on inspection of
perceived higher-risk providers
– Also propose more targeted and unannounced
inspections
– Influenced by overall SI reporting data
– Influenced by individual incident reports
– Greatly influenced by ‘whistle-blowing’ including
reports of failure to investigate or learn form SI

7. CQC’s RESPONSE TO REPORTED
SERIOUS INCIDENTS
• Investigation of individual patient safety incidents
– From notifications, complaints or ‘whistle-blowing’
– Criminal investigation separate from registration
inspection
– Consider charges under Fundamental Standards

8. CQC ASSESSMENT OF SI
INVESTIGATIONS
• Inspections
– Provider Information Requests in advance
– Assessment of notifications, staff surveys and other
external data in advance
– Review during inspection
 Policies
 Documentation
 Management
 Staff

9. CQC ASSESSMENT OF SI
INVESTIGATIONS
• Adequacy of SI investigation, etc.
– see NHS Improvement ‘Serious Incident Framework’
and related guidance
– CQC want to see:
 consistent recording and reporting
 analysis including of trends
 identified learning
 dissemination of learning
 measurement of improvement

10. CQC ASSESSMENT OF SI
INVESTIGATIONS
• Key lines of enquiry: Safe
– track record on safety
 performance over time vs other services
 staff understanding of reporting
 safety goals set and monitored
– lessons learned and improvements made
 robust reviews involving all relevant persons
 lessons learned and action taken
 lessons shared throughout Trust / Provider

11. CQC ASSESSMENT OF SI
INVESTIGATIONS
• CQC review of NHS Trusts’ investigations and
learning from deaths
– request from SoS following Southern Health concerns
– throughout 2016 and published late 2016
– all acute, community and mental health trusts to be
contacted
– look at family involvement and use of learning

12. CQC Enforcement Update
• Increased registration action
– urgent conditions, particularly additional reporting
requirements
– s29A Warning Notices
– warning of potential Trust Special Administrator or
cancellation for NHS Trusts
– cancellation and suspension of GP surgeries and
adult social care providers (referring to SI failures)
– expectation of further criminal action

13. Approach of Other Regulators
• What is their interest?
– Suspect or assisting
– Route map
– Identify witnesses
– Identify key documents
– Evidence of steps taken since
– Accounts / admissions of suspects or witnesses

14. Approach of Other Regulators
• Police
– Consent
– Powers under PACE
– Search and seizure
– Warrant on Magistrates Court
– Warrant in Crown Court – “excluded material”

15. Approach of Other Regulators
• HSE / GMC / Others
– Section 20 HSWA - legal privilege
– Powers under Regulations
– Production Orders

16. Practical Issues re Investigations
and Prosecutions
• The Trust / Corporate Body – as D or assisting
– Resistance of Police to preparation – options
– May set out case against the Trust
– May be used to cross examine Trust witnesses
– Check position re action plan before public hearing
– DPA and issue of confidentiality
– Disclosure of SI to witnesses
– May want drafts – defence or prosecution

17. Practical Issues re Investigations
and Prosecutions
• Staff
– Author may be witness
– Do witnesses understand that not confidential
– Give evidence against colleagues
– Contents becomes public
– May be used to cross examine them

18. Practical Issues re Investigations
and Prosecutions
• Patient
– Shouldn’t be identified - DPA / Confidentiality
– Nature of treatment may be disclosed
– Possibility they asked to be a witness

19. Other Practicalities
• Remit
• Author
• Draft
• Advice
• Legal privilege

20. Apologies, explanations and
press statements – how to
navigate the minefield
Richard Briggs, Partner

21. Introduction
• Setting the scene
• What is YOUR practice?
• Case Studies- discussion about what
makes a letter of apology good?

22. Saying Sorry
“Saying sorry when things go wrong is vital for the
patient, their family and carers, as well as to support
learning and improve safety…. Patients, their families
and carers should receive a meaningful apology – one that
is a sincere expression of sorrow or regret for the harm
that has occurred”
NHS LA Guidance, “Saying Sorry”

23. Duty of Candour
“To err is human, to cover up is unforgiveable, to fail to
learn is inexcusable”
Sir Liam Donaldson, Making Amends 2003
• Statutory duty contained in Regulation 20 of the Health
and Social Care Act 2008 (Regulated Activities)
Regulations 2014
• NHS bodies in England from 27.11.14
• Other care providers regulated with the CQC from
1.4.15

24. Key Elements
• General duty to act in an open and transparent way
• Statutory duty applies to organisations
• As soon as is reasonably practicable after a notifiable
patient safety incident occurs, the organisation must
tell the patient (or their representative) about it in
person.
• Statutory duty to provide reasonable support to the
patient.
• Organisation must provide the patient with a written
note of the discussion

25. Notifiable Patient Safety Incident
• Incidents where a patient suffered (or could suffer)
unintended harm that results in death, severe
harm, moderate harm or prolonged psychological
harm.
• Severe and moderate harm definitions are derived
from the NPSA's Seven Steps to Patient Safety.
• Prolonged psychological harm means that it must
be experienced continuously for 28 days or more.

26. Saying Sorry – how, who and when
• Verbal apology to be followed up by written
apology
• Communication - Information must be given by
an ‘…appropriately nominated person’ as
determined by local policy
• Timing – as soon as staff aware something has
gone wrong

27. Saying Sorry – what to say
• Saying sorry is not an admission of liability but the right
thing to do
• Step by step open explanation of what happened
• Clear, unambiguous information, avoiding medical
jargon
• Ongoing support for patients and families – be open
about what is not known as well as what is
• Confidentiality issues
• Continuity of Care

28. Apologies, litigation and the
press
• Fear of making admissions is not a good reason not
to apologise and explain
• Improves patient experience and satisfaction with
organisation
• Potentially reduces litigation
• Claimant’s solicitors’ tactics – targets to get a
certain number of cases in press each year
• Anonymity Orders - more likely to increase press
interest?

29. What is YOUR practice?
• Who normally drafts letters of apology/press
releases?
• Who should and is best placed to draft the apology
letter?
• Involving the NHS LA and obtaining authority?

30. Case Studies

31. Practical Tips
• Introduction, to clear the throat
• Explain why you are writing
• Identify what went wrong but avoid gory detail
• If possible, explain why the error occurred
• Say sorry. Give an unreserved apology, do not be mealy mouthed
• Acknowledge the impact on the patient and family

32. Practical Tips
• Introduce warmth / empathy without saying that you know what
they are thinking
• If possible, set out what is being done to prevent the same error
happening again – what lessons have been learnt?
• Is money ever enough?
• Sign-off with care. Is there something to be positive about?

33. Questions

34. Learning from failure:
Getting the message right
Lucy Reid, CMIIA, LL.M
www.anakrisis.com

35. The problem with investigations….
 40% healthcare investigations not adequate enough to find out what
happened
 Failure to identify when an investigation is necessary
 Inconsistent application of the principles of investigation
 Investigation being undertaken on notes review only
 Not involving family/patient in the process
 Directorates working in isolation
 Failure to identify and implement learning.
www.anakrisis.com

36. Failure to learn
 Mid Staffordshire NHS Trust
 Kent and Medway NHS Trust
 Morecambe Bay Hospital NHS Trust
 Betsi Cadwaladr University Health Board
 Southern Healthcare
www.anakrisis.com

37. Learning through failure
www.anakrisis.com
36.4m flights – 210 fatalities
Error rate of 1:2,4m
400,000 p.a. deaths from preventable harm
2x 747 crashes per day

38. Learning through failure
“Aviation is predicated on the assumption that people
screw up. You (healthcare professionals) on the other
hand are extensively educated to get it right and so you
don’t have the culture where you share readily the
notion of error”
James Reason, 2003
www.anakrisis.com

39. Learning through failure
www.anakrisis.com
Open and objective
Investigation to identify
causes
Clear, concise report
detailing findings and
recommendations
Practical, sustainable
action plan to address
causes identified

40. The message in the report
 It is what will make change happen
 It is what your investigation will be ultimately
judged on
 It needs to be clear
 It needs to be persuasive
www.anakrisis.com

41. The message in the report
“There was a very poor quality of written investigations at all
stages. At least 30% of the reports were of a poor standard;
some would cause further distress to families if they were
shared due to the carelessness with which they have been
written; some had been returned by commissioners for
review and there is little evidence that there was any
effective effort to improve the quality of the reporting until
very recently.”
www.anakrisis.com

42. The message in the report
“When an investigation did occur, the report identifies the
overall poor quality of these investigations and of the
subsequent reports. There issues mitigate against the
learning that is possible….”
www.anakrisis.com

43. The message in the report
 Background
 Process followed
 What evidence was reviewed
 Facts and findings
 Recommendations to address the causal factors
 Conclusions along with a clear explanation on how they have
been reached
www.anakrisis.com

44. The message in the report
 Avoiding hindsight bias
 misinterpreting the findings as a result of the ‘benefit of
hindsight’
 hindsight is not the same as foresight.
 Avoiding outcome bias
 judging the quality of the decision on the basis of the
outcome.
 Distinguish between fact and opinion
 Using peer review to avoid word blindness
www.anakrisis.com

45. The message in the report
“This review of maternity services was commissioned by the
Chief Executive of the trust board following five unconnected
serious untoward incidents….It was not the purpose of the
review to reinvestigate these incidents.”
“The review team recognised that recent adverse clinical
events, whilst unconnected…had had a profound negative
impact on staff morale....The apparent ‘cluster’ of these
episodes appeared to the review team to have been
coincidental rather than evidence of serious dysfunction.”
www.anakrisis.com

46. The message in the report
“There were at least 10,306 deaths of service users in the
period and most were expected. …722 were categorised as
unexpected. Of these 272 (37.5%) deaths were investigated
as a CIR of which 195 were reported as SIRIs. This analysis
is based on the Trust’s categorisation of unexpected
deaths. It was outside the scope of the review to verify
whether all unexpected deaths were reported as such.”
www.anakrisis.com

47. The message in the report
What the report stated:
“The patient was wearing her own slippers when she fell on the way
back from the toilet”
What it did not state:
Were the patient’s slippers assessed on admission or during her stay?
Was this considered during a risk assessment?
If not, why not?
Would this have made a difference?
www.anakrisis.com

48. The message in the report
What the investigation found:
 The bed rail assessment was not fully completed and did not reach a
conclusion on whether the use of bedrails was indicated
 Nursing staff recalled that bed rails were not in use prior to the fall and
this is supported in the records
What the report stated:
“A bed rail assessment was completed at 19:00 on 24/10/2014 on
Ward Z and 04:00 on 01/11/2014”
www.anakrisis.com

49. Implementing the lessons
 Be practical
 The simpler the better
 Recommendations need to be clearly linked to the
causal factors identified
 Owning the change
 Communicating the change
www.anakrisis.com

50. Questions?
Lucy Reid, CMIIA, LL.M
Lucy.reid@anakrisis.com
www.anakrisis.com