Lessons from Healthcare Regulation in England – the case and consequences of Mid Staffordshire Hospital Andaz San Diego 30th January 2014 Peter Watkin Jones Partner, Eversheds LLP Solicitor to the Mid Staffordshire NHS Foundation Trust Public Inquiry

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Notes  on  Hospitals,  Nightingale  F,  3rd  ed  1863,  Longman  Green  Roberts  &  Green  

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Doing the sick no harm?

She had got a cloth, like a J-cloth, and she cleaned the ledges and she went into the wards, she walked all round the ward with the same cloth, wiping everybody’s table and saying hello, wiping another table and saying hello. Came out of there, went into the toilets and lo and behold, she cleaned the toilets with the same cloth, and went off into the next bay with the same cloth in her hand. You can’t believe what you saw, you really couldn’t believe what you saw.

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A visiting relative in 2006

Extract from Trust investigation report

Doing the sick no harm?

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Extract from Trust investigation report

Silence on the front line – Patients and Families •  Some of them were so stroppy that you felt that if you did

complain, that they could be spiteful to my Mum or they could ignore her a bit more.

•  There would have been a lot of little incidents that just

made you feel uncomfortable and made us feel that we didn’t want to approach the staff. I did feel intimidated a lot of the time just by certain ones.

•  I think he felt as though he didn’t want to be a nuisance.

Because of their attitude in the beginning when he first mentioned about the epidural, he felt as though it was a waste of time of saying that he was in pain.

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Silence on the front line - Nurses

There was not enough staff to deal with the type of patient that you needed to deal with, to provide everything that a patient would need. You were just skimming the surface and that is not how I was trained.

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A nurse

Silence on the front line - doctors

If you are in that environment for long enough, what happens is you either become immune to the sound of pain or you walk away. You cannot feel people’s pain, you cannot continue to want to do the best you possibly can when the system says no to you.

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A doctor who started in A&E in October 2007

Silence on the front line - doctors

•  “We have got to go on doing our job because we

have patients who need operations; we will have to mend and make do. Which is the Stafford way”.

•  Sir Bruce Keogh, Chief Medical Officer – “organisations trapped in mediocrity”.

•  Disengagement – “not my problem to solve”

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Reasons for professional silence •  Fiona Donaldson-Myles Study 2005 – Nurses felt reporting was

worthwhile if the institution had subsequently taken action to prevent recurrence.

•  Collegiality - feel of betrayal - role reversal; “you would also stick up for me” •  The employer not welcoming bad news and preferring it to be kept

quiet •  McGovern and Fisher 2010 – The 3 D’s

–  Denial; not an exact science –  Discounting; outside control –  Distancing; mistakes inevitable

•  Bystander apathy - diffusion of responsibility means it’s someone else’s business

•  Government: “A keen sense of personal responsibility is an important factor in a professional’s daily self-management and therefore to the continuing safety of patients”

•  “Safeguarding is everybody’s business”

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A Public Inquiry

The Terms of Reference for the Public Inquiry were:

To examine the operation of the commissioning, supervisory and regulatory organisations and other agencies, including the culture and systems of those organisations in relation to their monitoring role at Mid Staffordshire NHS Foundation Trust between January 2005 and March 2009 and to examine why problems at the Trust were not identified sooner; and appropriate action taken.

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A negative culture?

PRESSURE Targets

FT status Jobs

bullying

REACTION

Fear Low morale

Isolation Disengagement No openness

BEHAVIOUR Uncaring

Unwelcoming Tolerance

HABITUATION Denial

External assessments

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The hospital board

An absence of clinical governance - staff •  No systematic appraisal of staff •  No culture of self analysis •  Isolation and no peer review

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The hospital board

Complaints and information •  Risk register outdated •  Lack of knowledge of untoward incidents •  No effective learning from complaints •  Action plans – a reliance on assurance •  Patient and staff surveys not listened to •  Whistleblowing failures

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The hospital board - the executive

•  Lack of experience •  Great self confidence •  No effective clinical or professional voice on the

board •  Disengagement of nursing and clinical staff from

management

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The hospital board

•  Lack of openness •  Tolerance of poor practice – “The Stafford Way” •  An unwillingness to refuse to perform the

impossible or dangerous •  Finding excuses for mortality statistics – “Boards

use data simply for reassurance rather than the uncomfortable pursuit of improvement” (Keogh)

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The hospital board - Non executives

•  Not holding executive to account •  Wrongly categorising issues of risk to patients as

“operational concerns of no strategic significance” – a “false distinction”

•  Reliance on assurances which were not checked or challenged

•  Closed culture •  An acceptance that having systems was of itself

sufficient

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An isolated focus on finance – not patient safety

•  Focus on financial issues and targets •  No insight into import of decisions on patient

care •  Policies based on an assumption that strong

finances would equate to good quality care

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Those who could/should have picked up the signs of the need to protect the public •  GPs as local regulators •  National Leaders

– Department of Health and Strategic Health Authorities

– Commissioners (Primary Care Trusts) •  Quality regulators

– Healthcare Commission/Care Quality Commission

– Monitor – Health & Safety Executive

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Professional Regulators missing the signs •  General Medical Council – 17 references

•  Nursing and Midwifery Council – 3 references •  Professor Weir-Hughes – “The culture of

isolation overrode the professional responsibility to report”

•  Royal College of Surgeons – “dangerous”; “dysfunctional”

•  Universities/deaneries

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Recommendations of the Mid Staffordshire Inquiry

Categories 1-5 – all to achieve culture change 1.  Openness, candour and transparency 2.  Fundamental standards 3.  Compassionate, caring, committed nursing 4.  Accurate, useful and relevant information 5.  Strong patient centred healthcare leadership

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A watershed moment •  The Francis Reports – Putting the Patient first •  The Berwick Report – A learning culture

•  The Clwyd & Hart Report – The importance of learning from complaints

•  The Cavendish Report – Recognising the work of healthcare workers

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•  The Keogh report:

- Not confined to Stafford - No one operates in geographical, professional

or academic isolation

•  Government response to Francis: “While the remit of the Francis Inquiry was explicitly limited to the NHS, the Inquiry’s recommendations resonate across the health and care system as a whole”

•  Culture is about people, not institutions

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The Government response – some major headlines •  281 recommendations adopted in whole or in part •  Organisational recommendations re merger of functions

not adopted •  The Government response to the Health Committee’s 3rd

report – “After Francis: making a difference”

“Traditionally, the response of the Government and of the central organisations of the NHS to failure in care has been to acknowledge the individual failing and then emphasise the very large number of positive experiences and excellent outcomes that people experience every day in the NHS”

•  Assure first, ask questions later

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Category 1 Openness, transparency & candour – no blame culture •  Openness: enabling concerns and complaints to

be raised freely and fearlessly, and questions to be answered fully and truthfully

•  Transparency: making accurate and useful

information about performance and outcomes available to staff, patients, public and regulators

•  Candour: informing patients where they have or

may have been avoidably harmed by healthcare service whether or not asked

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Openness and transparency

•  Welcome complaints and concerns •  Swift and effective action and remedies •  Gagging clauses to be banned •  Independent investigation of serious cases of

failure •  Engaging with complainants and staff •  Information, bad and good, to be shared with

commissioners, regulators, and public

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Openness and transparency

•  Criminal offence of reckless or wilful false statements by Boards re compliance with fundamental standards

•  Criminal offence to give regulators misleading

information deliberately

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Candour

•  Statutory obligation –  Individual professionals under a duty to inform

the organisation – healthcare provider organisation under a duty

to inform patient, whether or not asked

•  Statutory sanction – Wilful obstruction of these duties should be a

criminal offence – Deliberate deception of patients in performing

duty should be a criminal offence

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Category 1 Openness, transparency and candour – Government response – 3 fold duty •  Statutory duty of candour on the service

provider to report mistakes that caused death or serious injury; possibly moderate harm (Dalton and Williams Consultation) from 2014 on every provider registered with CQC

•  Individual can then be prosecuted if offence committed with their consent, connivance or through neglect

•  Separate Criminal Offence for providers to supply false or misleading information in complying with a legal obligation

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Openness, transparency and candour – Government response

•  Contractual duty of candour – NHS Constitution (2013)

•  Separate Criminal Offence where organisations

or individuals are guilty of wilful or reckless neglect or mistreatment or patients

•  Trust should reimburse NHSLA compensation in

whole/part if not been open

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Professional duty of candour - Government response •  Common responsibility across the professions to be candid

when mistakes occur

•  Will be a professional duty to report near misses that could have led to death/serious injury/actual harm

•  Promptness in reporting is professional mitigation

•  Duty appears to be to report to patients; default position is to inform providers too

•  New guidance required by professional regulators

•  Is no duty of candour to tell patients of every error or near miss

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Professional regulation - timings

•  Cradle to grave within 12 months except in a small minority of cases

•  Improved liaison with healthcare regulator and a proactive/ generic approach

•  Parallel proceedings wherever possible; is there a real, not notional, risk of serious prejudice and injustice?

•  Law Commission review – overhaul possible

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Category 2 Fundamental standards

• What the public see as absolutely essential

• What the professions accept can be

achieved

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Fundamental standards; Examples

•  Prescribed medication given •  Food and water to sustain life and well being

supplied and any needed help given •  Patients and equipment kept clean •  Assistance where required provided to go to the

lavatory •  Consent for treatment obtained

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Fundamental standards Sanctions

•  Isolated incidents: no tolerance: investigate reasons and correct

•  Persistent failure – stop/close the service •  Death or serious harm caused by breach -

criminal liability for individuals and organisations unless not reasonably practicable to comply

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Category 2 Fundamental standards – Government response

•  CQC (regulator) to create fundamental standards •  Generalist inspection has run its course •  Inspection to involve experts and the public •  A failure regime allowing CQC to close a service or

ward without notice; prosecutions possible •  Staffing levels and fitness of directors will form part

of inspection selection criteria •  NICE to report by summer 2014 •  Boards to publish actual and planned staffing for each

shift monthly and review every 6 months •  Details of skill mix

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Category 3 COMPASSIONATE CARING COMMITTED NURSING •  Aptitude assessment on entry •  Hands on experience a prescribed requirement •  Named nurse [and doctor] responsible for each

patient •  Code of conduct and common training standards for

healthcare workers •  Registration requirement for healthcare workers plus

power to disqualify/share info re concerns •  Reward good practice; recognise special status of

providing care for the elderly •  Keogh – avoid over reliance on unregistered support

staff and temporary staff •  Publish staffing levels at least every 6 months

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Category 3 Compassionate Nursing – Government response •  Care Certificate (2 levels) rather than regulation –

Camilla Cavendish •  Pilots of 1 year pre degree experience

•  Develop appraisal and development programmes

•  Develop older person’s nurse post graduate training qualification

•  Staffing ratios to be identified and published

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Category 4 ACCURATE USEFUL RELEVANT INFORMATION

•  Individual and collective responsibility to devise performance measures

•  Patient, public, commissioners and regulators should have access to effective comparative performance information for all clinical activity

•  Improve core information systems

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LOOK ‘EM UP!

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Category 4 Accurate useful and relevant information – Government response

•  CQC and NHS England with others to make patient safety data accessible

•  Health & Social Care Information Centre to be the focal point •  Information on staffing, pressure sores, falls and other key

indicators •  Quarterly publication of never events •  Name of consultant and nurse responsible for care above bed •  Clinical outcomes by consultant being published in 10

specialities •  Data on friends and family test to be published (mental health

setting - December 2014) •  Quarterly reports on complaints data and lessons learned •  Spring 2015 – every patient can see their records online, and

book appointment

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Category 5 Patient Centred Leadership

•  Cultural “buy in” •  Common code of ethics, standards and conduct

for all senior managers and NHS leaders •  Liable for disqualification unless fit and proper

person •  Leadership staff college – accreditation scheme •  Mentoring

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Category 5 Patient Centred Leadership – Government response •  Providers to refer staff to Disclosure and Barring

Service if has harmed, or poses a risk of harm •  Fit and proper person test to also act as barring

scheme for board level by CQC (regulator)

•  Applies to public, private and voluntary sectors

•  Appraisals; performance management; provider ratings linked to performance

•  Fast track leadership programme; a drive to attract clinicians

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Conclusion •  Secretary of State: “We need to face up to the hard

truths”

•  “The public must be told the reality of NHS performance….without political or system interference”

•  Statement of common purpose

“We will listen” •  Secretary of State for Health: “We need to hear the

patient, seeing everything from their perspective, not the system’s interests”

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