Managing Parallel Processes

During Healthcare Disasters

Simon Lindsay

1st March 2018

Introduction: The Background

• Success is moving from failure to failure with no

loss of enthusiasm Winston Churchill

• Our evidence shows that, all too often, the

quality of local investigations into serious

incidents and avoidable harm is not good

enough or is not happening Dame Julie Mellor, PHSO

• true ignorance is not the absence of knowledge

but the refusal to acquire it Karl Popper, (via Jeremy Hunt MP)

CASE STUDY

EB was admitted to hospital aged 37 for routine surgery, having been referred there with a history of sinus problems over a couple of years. She had been using a nasal spray twice a day to help the symptoms, had had a previous hernia repair and an appendic ectomy at the age of 7. She had also had 2 c/s, but no other history of note. The scheduled surgery was for endoscopic sinus surgery and septoplasty.

The surgeon, Mr T, was experienced and had worked in both the private and NHS sector. His anaesthetic col league, Dr S, also a consultant, had similar experience. They were supported by an experienced team.

Surgery appeared routine. There was no reason to believe it would be otherwise. Whilst there was slight restriction in neck movement, there was nothing to suggest that EB would pose a particular problem with regard to airway management during anaesthesia. Dr S noted there appeared to be little restriction in head movement. Mouth opening was normal, as was the thyro - mental distance. Dr S felt that these find ings did not constitute a major difficult airway potential. The proposed anaesthetic technique was to avoid tracheal intubation and maintain the airway with a laryngeal mask. EB was checked in at 08:30.

Anaesthesia was induced at 08:35, but it was not pos sible to insert the flexible laryngeal mask airway due to increased tone in the jaw muscles. After additional Propofol, Dr S tried different sized masks but neither worked. EB was starting to turn blue and her oxygen saturations dropped to 75%. By 08:39 th ey were at 40%. Attempts were made to ventilate the lungs using a facemask and oral airway but to no avail.

Dr S tried tracheal intubation but could not see any of the laryngeal anatomy on insertion of the laryngoscope. Oxygen saturations had dropped to 4 0% with a heart rate of 69bpm.

Mr T entered theatre. Further attempts at laryngoscopy and intubation were made; the tracheostomy set was brought to the anaesthetic room by a senior nurse who alerted the consultants to this. Mr T attempted intubation. It w as now 08:51, heart rate 140, oxygen saturations 40%. At 08:55 a laryngeal mask was placed successfully and oxygen saturations improved to 90% with raised blood pressure and heart rate. From 09:03 attempts were made to insert a tracheal tube through the la ryngeal mask but were unsuccessful. At 09:10 the procedure was abandoned and an oral airway inserted to restore satisfactory breathing.

EB was sent to recovery, but showed no signs of regaining consciousness after 1 hour. Breathing, blood pressure and oxygen saturation readings were all erratic. At around 11am, she was transferred to ITU but her condition did not improve. After 13 days of coma treatment was withdrawn and EB passed away.

With acknowledgements to www. chfg.org

Bevan Brittan LLP

Legal frameworks and processes (1)

• Coroners and Justice Act 2009 – investigation

of a sudden or unnatural death

• Inquest process

• Duty of care

• Civil claim

• Criminal prosecution

− Gross negligence manslaughter

− Corporate manslaughter

Legal frameworks and processes (2)

• Duty of candour

• Explanation and support

• Professional obligations

• Fitness to practice, GMC/NMC

• Employment obligations

• Internal investigation

• Disciplinary proceedings

• Corporate regulatory framework

• CQC investigation

• Coroner’s duties under Regulation 28

“Preparing for your child’s inquest…

… Is possibly one of the saddest tasks ever.

Truth, justice and accountability fought for in a

process with unimaginable physical and

emotional impact.

Enormous financial cost.

And so far from guaranteed

Don’t ever tell me this is an inquisitorial

process”

No blame culture

“Our experience over the past two years can be summarised as

harrowing grief, devastation, disbelief and destruction with repeated,

unremitting and remorseless (hobnailed) booting by A NHS Trust and B

Council. Neither body has expressed a drop of positive action, candour

or transparency. Fake apologies and dirty actions. Remarkable really.

…..I hope we manage to retain some ‘sanity’ during the unfolding of this

long awaited and deeply dreaded process. We’ve nothing to gain in

many ways. [My son] is dead. That ain’t going to change. Answers?

Within the boxes of documentation/reviews stacking up it’s pretty clear

what happened and why. There’s no need for the inquest to be

adversarial. With eight legal teams and the rows of ducks lined up, I

can’t see it being anything else”.

Purpose of an inquest

To answer the following 4 questions:

• Who died

• When he/she died

• Where he/she died

• How he/she died

• Either by establishing the immediate cause,

or

• The broad circumstances

• Regulation 28 duty: learning from incidents

Corporate Manslaughter

• Corporate Manslaughter

• Gross breach of duty of care causing death

• Caused by failures in the way activities are

managed or organised by senior

management

• The prevailing health and safety culture of the

organisation will be relevant

• The jury may have regard to any health and

safety guidance issued relating to the breach

Gross Negligence Manslaughter

• Common Law Offence: R v Adomako (1995)

• Four stage test: - The defendant owed a duty of care towards the deceased; and

- The defendant breached that duty of care; and

- The breach caused or significantly contributed to the death; and

- The breach should be characterised as gross negligence and

therefore a crime.

• Prosecuted by CPS

Penalty: Up to life imprisonment

Individuals and HSAWA

• Section 37: An individual director or manager can be held criminal

responsible for health and safety offences.

• Requires: consent, connivance or neglect on the part of, any director,

manager… or other similar officer of the body corporate or a person who

was purporting to act in any such capacity.

- What is consent? Knowledge and awareness of the circumstances

and the risks which caused the health and safety failure

- What is connivance? Knowing and not doing anything about the risks

- What is neglect? Unreasonable breach of a duty of care

• Prosecuted by HSE/CQC

Penalty: Unlimited fine and/or imprisonment (6 months - 2 yrs);

Prosecution by CQC

• Provision of regulated activities without

registration

• Breach of conditions of registration

• Breach of relevant sections of Registration

Regs and Regulated Activities Regs

• Caution / Penalty Notice

• Prosecution of:

− Registered Persons

− Individuals (ie Directors, managers or the

secretary of a corporate body)

Criteria for prosecution

• Where people using a registered service are

harmed or placed at risk of harm

• Factors affecting decision to prosecute

• The gravity of the incident

• Disregard of requirements

• Repeated or multiple breaches, The service

is breaching fundamentals of care

• The potential for wider learning points (single

case prioritised to send broader message to

encourage improvement)

Internal investigations

Taking control

Quiz: true or false?

The purpose of an internal investigation is:

a) To keep your boss and his/her boss happy

b) To settle old scores

c) To get to the truth

d) To learn

e) To improve practice

f) To shut the patient/family up

g) To avoid litigation

Different investigation techniques

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Z*= ________________________________________________________________________________

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x [(2CSi + PEi)/ 6] x (2CSj + PEj)/6] x Cij + ∑vi2

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∫1 2 qj ∫1 2 +rj ∫1 2 qr+l+j

Root Cause Analysis

• Root Cause Analysis is an evidenced based,

structured investigation process which utilises tools

and techniques to identify the true causes of an

incident or problem, by understanding what, why and

how a system failed.

• Analysis of these system failures and true causes

enables targeted and, where possible, failsafe actions

to be developed and implemented which demonstrate

significantly reduced likelihood of recurrence

National Patient Safety Agency material

Working out what went wrong

• Care Delivery Problems (CDP)

• Care deviated beyond safe limits of practice

• The deviation had a direct or indirect effect

on the eventual outcome for the patient National Patient Safety Agency

− failure to observe

− Failure to check medication delivery

− Mistake in diagnosis/treatment

− Equipment failure

Working out what went wrong

• Service Delivery Problems

• Decisions, procedures and systems that are

part of the whole process of service delivery National Patient Safety Agency

− Lack of proper audit procedures

− Inadequate training

− Deficient policy requirements

Identifying the root cause

• Establish the fundamental contributory factor

• ‘The one which had the greatest impact on

the system failure’

• ‘One which, if resolved, will minimise the

likelihood of recurrence locally and

organisationally’

• Keep asking why: Drill down

• NB: Causation in law – ‘caused or contributed

to’; contributed to means more than minimally

or trivially contributed to the outcome

Compiling the report

• Remember, everything you say may/can/will be

taken down and used in evidence against

someone else.

• It will be read by:

• The patient/family

• Lawyers

• Courts (Coroner, civil, criminal)

• CQC, commissioners

• Staff

• Media

Skinning a cat

• “Reliance on a single method of investigation

such as root cause analysis is not enough to

get to the heart of a case”

• Human Factors Analysis and Classification

System (HFACS)

• Starts from premise that the ultimate cause

of any undesirable event is organisational

malfunction

http://hfacs.com/hfacs-framework.html

Evidence – witness statements

Writing a statement IN THE [INNER NORTH LONDON] CORONER'S COURT

INQUEST INTO THE DEATH OF [JOHN DOE]

Her Majesty's Senior Coroner: [Mary Hassell]

STATEMENT OF DR TERRY FYED

I, Dr Terry Fyed, Specialist Registrar in Surgery employed by Whittington Health NHS, Highgate

Hill, London, WILL SAY AS FOLLOWS:

Writing a statement

IN THE COURT OF PROTECTION CoP Ref: 21222017

IN THE MATTER OF THE MENTAL CAPACITY ACT 2005

IN THE MATTER OF AB

Between

WHITTINGTON HEALTH

Applicant

-and-

AB

(By her litigation friend the Official Solicitor)

Respondent

STATEMENT OF DR TERRY FYED

I, Dr Terry Fyed, Specialist Registrar in Surgery employed by Whittington Health NHS, Highgate Hill,

London, WILL SAY AS FOLLOWS:

Writing a statement

STATEMENT OF DR TERRY FYED

I, Dr Terry Fyed, Specialist Registrar in Surgery employed by Whittington Health NHS, Highgate Hill,

London, WILL SAY AS FOLLOWS:

Writing a statement

IN THE INNER NORTH LONDON CORONER'S COURT

INQUEST INTO THE DEATH OF JOHN DOE

HMSC MARY HASSELL

STATEMENT OF DR TERRY FYED

I, Dr Terry Fyed, Specialist Registrar in Surgery employed by Whittington Health NHS, Highgate

Hill, London, WILL SAY AS FOLLOWS:

1 I am a Specialist Registrar in Surgery employed by Whittington Health. I make this statement in

connection with the inquest into the death of John Doe who died at the Whittington Hospital on 10th

January 2017. I make this statement on the basis of my knowledge of the care provided to him.

2 I qualified in medicine from the University of Hampstead in 2007. My qualifications are MBBCh. I

have been a Member of the Royal College of Surgeons since 2015 and have been employed as a

Specialist Registrar at the Whittington since 2016. Before then I held surgical posts at the Royal Free

and St George's Hospitals.

3 I remember Mr Doe well. I was first asked to see him as the on-call Registrar on 6th January having

been admitted for an elective procedure on the 5th

Witness Statements: Format/ Presentation

• Typed

• Numbered paragraphs

• 1.5 line spacing

• Page numbers

• Wide margins

• Justified

• Check spelling and grammar

• Full sentences

• Consistent tense

• Sign and date at the bottom of

each page

• Full dates (day/month/year)

• Express figures numerically (e.g. 5

rather than five)

• Be precise – with dates, times,

attendees;

• Provide the professional

designation of people referred to

• Consistent references (particularly

to the patient e.g. either David or

Mr Jones)

• Refer to any documents exhibited

within the body of the witness

statement (e.g. please see Exhibit

AB 1)

Witness Statements: Style

• Formal and professional (avoid

colloquialisms/slang)

• Choose language carefully – think

about how it may be seen by

others reading the witness

statement

• Clear, accurate and concise

• Avoid jargon/technical terms (or if

used, clearly explain them)

• Layman's terms – the Judge and

the family are unlikely to have

medical knowledge;

• Explain the obvious – whilst it is

obvious to you, it is probably not

obvious to others outside of your

field of expertise (do not take

anything as a given);

• Provide context and relevant

background information

• Personal opinion should be limited

– where it is your view rather than

fact, say so

• Do not stray outside your field of

expertise –

• Write abbreviation in full first with

the abbreviation in brackets, which

can then be used throughout the

rest of the document

• Be factual - but take care if you

use your statement to criticise the

organisation and colleagues

Witness Statements: Content

• Explain your clinical reasoning for your views– this is the most

important part of any witness statement

• Avoid the "ostrich" approach - deal with any errors or omissions –

don’t just hope that they won’t get picked up:

• be careful about how you phrase these

• only comment on errors or gaps that were either yours or within

your responsibility

• be honest and open, but don’t sell your clinical practice short

• Include factual information from the notes (including, where

appropriate, quotations)

• Clarify roles and responsibilities of those involved

Explain acronyms

• FLK

• LOBNH

• PLM

• UDI

• DD

• TTFO

• DMTM

• MFB

You can explain (some) entries

• “I wish my junior doctors would stop killing my

patients”

• “No point resuscitating”

• “A bit of a mad one”

But others are not so easy

• “This patient is very aggressive. He called me a ****. In

fact, the patient is wrong, he is the ****.”

• “Patient needs:

• Paracetamol - prn

• Voltarol - 150mg

• A good woman - 1 bd”

Case Study

Patient X attended A&E complaining of back pain. She was a known

drug abuser, particularly of opiates and had undergone surgery a few

months before attending. Her initial observations were within the

normal range. The provisional assessment was of musculo-skeletal

pain, but she was kept in for 4 hours just in case. The consultant on

duty asked to review her obs after 4 hours.

The obs were reported to the Consultant as normal by a nurse, but they

related to another patient. The patient herself said she was unwell but

was given paracetamol and discharged.

She made her way across the hospital and sat down in the main

reception lobby on a plastic chair. A porter saw her and phoned A&E to

see if she should be brought over. He just said she was not talking to

him. A nurse in A&E said she should be sent home. The patient was

discharged in unusual circumstances but was then readmitted about an

hour later and found to have retrocaecal appendicitis. She died a day

later.

Thank you!

This presentation contain information of general interest about current legal issues and is not intended to

apply to specific circumstances. It should not, therefore, be regarded as constituting legal advice.