Litigation and inquest forum, Birmingham - June 2016
Download as PPTX, PDF1 like141 views
The document addresses the CQC's responses to serious incidents within healthcare settings, emphasizing the importance of timely notifications and thorough investigations. It highlights the need for effective communication, particularly regarding apologies to patients and their families after incidents, and outlines statutory duties under the Health and Social Care Act. Additionally, it discusses the inadequacies in current investigation practices within healthcare, advocating for more structured approaches to learning from failures to enhance patient safety.
Litigation and inquest forum, Birmingham - June 2016
- 1. Litigation and inquest forum June 2016, Birmingham
- 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 Jonathan Fuggle, Partner LIFO, Nottingham 9 June 2016
- 21. Introduction • Setting the scene • Case Studies- discussion about what makes a letter of apology good? • What is YOUR practice?
- 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
Editor's Notes
- #25: open and honest culture must exist throughout an organisation. Reasonable support could be providing an interpreter to ensure discussions are understood, or giving emotional support to the patient following a notifiable patient safety incident Duty applies to an ORGANISATION though it is clear from CQC guidance that it is expected that an organisation's staff cooperate with it to ensure the obligation is met. 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.
- #26: moderate harm" means— harm that requires a moderate increase in treatment (unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care); And severe harm which is not permanent , "severe harm" means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user's illness or underlying condition. "prolonged psychological harm" means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
- #27: Guidance from NHS LA Saying Sorry, December 2013 Richard – the guidance states that there should be a local policy that sets out the process of communication with patients an raising awareness about this will provide staff with confidence to communicate effectively – local policy should say who is the most appropriate person to give both verbal and written apologies
- #28: Key point is that any information given is based on facts known at time and that healthcare professionals should explain that new information may emerge as an investigation is undertaken and that patients, families and carers will be kept up to date with progress of investigation Should not delay a meaningful apology for any reason including where there is a formal complaint of a claim. Policies and procedures should give full consideration of and respect the privacy and confidentiality of the patient their family and staff Patients entitled to expect that they will continue to receive all usual treatment and continue to be treated with dignity, respect and compassion
- #30: Discussion about what different Trust’s do – how involved they are in the drafting of letters If admissions of liability have already been made do they think they should have to seek NHSLA authority before providing an apology?
- #36: The Ombudsman recently published a report on the quality of investigations within healthcare based upon their experience of service user complaints and their own enquiries. Their findings echo the concerns reported by Coroners and patient representative groups. The quality of healthcare investigations meant that they were not identifying what actually happened and if we don’t know why the incident has occurred, we can’t prevent it from happening again Many organisations were reliant on a clinician to report an incident or the risk team to flag something up The principles of investigation have been inconsistently applied meaning that how an incident was investigated has been up to the individual investigator rather than taking an agreed approach Some investigations were undertaken based upon a review of the notes alone with investigators not speaking to the clinicians involved resulting in not only an incomplete picture of what happened but also incorrect assumptions being made Despite the fact the family/patient are often at the centre of the incident, many investigations did not involve them in the process – this proliferates the mistrust and anger that they may be feeling and fails to provide them with any reassurance Many incidents have a number of events leading up to the end result which contributes to the error occurring. Despite this investigations have been undertaken in isolation – focussing on one element of the patient’s care Unsurprisingly given these findings, there was also a failure to identify and implement learning
- #37: Include key messages from recent examples
- #38: The error rates between aviation and healthcare are significantly different The figure for healthcare errors is considered to be grossly underestimated – in America it is estimated that the number of deaths due to avoidable error is more than 500k pa So why the difference?
- #40: The key to learning from incidents..
- #41: Why the report is so important
- #42: Southern Healthcare Report
- #43: Southern Healthcare report
- #46: Fielding report What does this extract tell you? What message would you take away from it?
- #47: Southern Healthcare Report This is a much clearer example of being clear about what the investigation covered and the source of the information quoted. It’s
- #50: Need to be practical Make sure the recommendation/action reflects the findings Talk about learning through osmosis