litigation and inquest forum, nottingham - june 2016
TRANSCRIPT
Litigation and inquest forumJune 2016, Nottingham
CQC and RCA/internal investigationsAndy Hopkin and Carl May-Smith
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
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
CQC’s RESPONSE TO REPORTED SERIOUS INCIDENTS• Other notification requirements
– STrategic Executive Information System (STEIS)– Public Health England (infection outbreaks)– RIDDOR– Duty of candour
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
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
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
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
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
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
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
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
Approach of Other Regulators• Police
– Consent– Powers under PACE– Search and seizure– Warrant on Magistrates Court– Warrant in Crown Court – “excluded material”
Approach of Other Regulators• HSE / GMC / Others
– Section 20 HSWA - legal privilege– Powers under Regulations– Production Orders
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
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
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
Other Practicalities• Remit• Author• Draft• Advice• Legal privilege
Apologies, explanations and press statements – how to navigate the minefieldRichard Briggs, Partner
Introduction• Setting the scene
• What is YOUR practice?
• Case Studies- discussion about what makes a letter of apology good?
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”
NHS guidance ‘Saying Sorry’
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
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
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.
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
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
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?
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?
Case Studies
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
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?
Questions
Learning from failure:Getting the message right
Lucy Reid, CMIIA, LL.M
www.anakrisis.com
The problem with investigations….40% healthcare investigations not adequate enough to find
out what happenedFailure to identify when an investigation is necessary Inconsistent application of the principles of investigation Investigation being undertaken on notes review onlyNot involving family/patient in the processDirectorates working in isolationFailure to identify and implement learning.
www.anakrisis.com
Failure to learnMid Staffordshire NHS TrustKent and Medway NHS TrustMorecambe Bay Hospital NHS TrustBetsi Cadwaladr University Health BoardSouthern Healthcare
www.anakrisis.com
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
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
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Learning through failure
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Open and objective Investigation to identify causes
Clear, concise report detailing findings and recommendations
Practical, sustainable action plan to address causes identified
The message in the reportIt is what will make change happenIt is what your investigation will be
ultimately judged onIt needs to be clearIt needs to be persuasive
www.anakrisis.com
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
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
The message in the reportBackgroundProcess followedWhat evidence was reviewedFacts and findingsRecommendations to address the causal factorsConclusions along with a clear explanation on how
they have been reached
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The message in the reportAvoiding 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 opinionUsing peer review to avoid word blindness
www.anakrisis.com
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.”
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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.”
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The message in the reportWhat 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
The message in the reportWhat 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”
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Implementing the lessonsBe practicalThe simpler the betterRecommendations need to be clearly linked to
the causal factors identifiedOwning the changeCommunicating the change
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