Patient Safety in Women’s health:View from the National Observatory

Prof James Walker

Clinical Associate

National Patient Safety Agency

Background

The NPSA:• was established July 2001

• is a Special Health Authority

• has been created to co-ordinate efforts to identify and learn from patient safety incidents

Clinical Governance

Governance Developed: • An organisation with a memory, which looked at

learning from adverse incidents in the NHS; and • Building A Safer NHS for Patients, which set out the

government’s plans to address OWAM’s recommendations.

Why is patient safety important?

Medicine in the old days was simple, safe and ineffective.

Now it is complex, very effective but potentially dangerous

Sir Cyril Chantler,Chairman of the King's Fund Chairman of Board

GOSH

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Source: General Register Office and OPCS, Reproduced in Birth counts, Table A10.1.3. Graph by Alison Macfarlane

Dea

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Abortion and miscarriage

Prolonged labour, trauma and other causes

Toxaemia

Haemorrhage

Puerperal sepsis

Puerperal phlebitis, thrombosis and embolism

Maternal mortality by cause (E&W) 1935-78

Maternal Mortality in Iraq

Maternal Mortality in Iraq

• Massive Obstetric Haemorrhage 28%• Post Abortion 19%• Eclampsia 17%• Infection 15%• Post Anaesthetic and Other 14%• Obstructed Labour/Ruptured Uterus 7%

Obstetric Claims

• Obstetric claims account for over 70% of all NHS litigation expenses with an average cost of cerebral palsy cases of £1.5m.

• Current estimate that obstetric claims amount to £400m of total £600m projected NHS costs.

Source:

Learning from litigation: an analysis of claims for clinical negligence

Vincent, Davy, Esmail, Neale, Elstein, Cozens, Walshe

August 2004

A problem in maternity services?

• Findings from root cause analyses of 37 adverse events/near misses in obstetrics (Ashcroft, 2002)– in 92% cases there no guidelines or protocols to advice on

clinical practice or organisational issues– 49% members of staff were unfamiliar with labour ward

protocols and failed to follow them

• CEMD report ‘Why mothers die 1997-1999’ highlighted need for guidelines to be used– “women are still dying of potentially treatable conditions

where the use of simple diagnostic guidelines may help”

Fire risk

"First, Do No Harm"

• Most practitioners are caring individuals– Highly skilled– Highly trained

• But we still make mistakes• Usually in repetitive (normal) tasks

– Omission

• It is not usually the emergency

Problems for the Beaver

• Learn task but watching and doing– Trial and Error

• Learning ends with the accident– No audit trail of problems– No “system” memory

• No guideline development• Continued accidents• The system is inherently dangerous

Safety First

• Simplifying and encouraging reporting of safety incidents

• More rapid reporting and notification of serious incidents to the NPSA within 36 hours leading to more rapid learning

• Capturing risky situations • Using patient safety data to inform

learning and action locally – analysis, learning and feedback.

Safety First highlights key areas for improvement in current safety reporting systems in the NHS. These include:

Event Reporting

• Mainstay of risk management • Part of every-day practice• Within the airline industry

– routine error (near miss) reporting followed by root-cause analysis and risk management, has led to a 4 fold reduction in major airline incidents

Error Analysis

• The traditional way

– person approach

– individual involved is questioned

– the problem tackled at that level

• Tackling the individual

– does not remove the pre-existing risk of error

– the error trap

Person Approach

• "If a surgeon has made a deep incision in the body of a man with a lancet of bronze and saves the man's life, or has opened an abscess in the eye of a man and has saved his eye, he shall take 10 shekels of silver.

• If a surgeon has made a deep incision in the body of a man with his lancet of bronze and so destroys the man's eye, they shall cut off his hand”– Laws of Hammurabi, Babylon, BC 1792

Root-cause analysis of major airline events

• Failure to follow accepted procedures • Misinterpretation of instruments • Incorrect decisions • Ignoring advice from colleagues • Failure of team working • Equipment failure • Pilot error

Themes from systematic review of the data

• High proportion of incidents reported relate to Trust maternity ‘trigger list’ categories

• Following these the top five themes are: – Communication– Staffing levels– Medication– Equipment– Patient ID

Reason’s ‘Swiss cheese’ model

some holes dueto active failures

other holes due tolatent conditions

hazards

losses

defences. barriers and safeguardsJames Reason 1997

System Approach

• Wider in its remit

– more open

– based on concept of system failures

– Different outcome for the individual

– more likely to produce solutions

• reduce the chance of recurrence.

• requires trusting environment

– a ‘no blame’ approach

Systems Approach

• More comprehensive covering

– The person

– Team

– Procedure

– Environment

– Organisation

Systems Approach

• Not

– ‘who made a mistake’

• but

– ‘how and why have the defences failed’

“We can’t change the human condition, but we can change the conditions under which humans work”

James Reasons

Solution

Defences, barriers, and safeguards

• Technical– alarms, physical barriers, automatic shutdowns

• Human – doctors, midwives, administrators

• Documentation– guidelines, standard operating procedures

• Act to – prevent error– protect the patient

• Defences are mostly successful– but not infallible.

Safety

• Driving is safer– Design

• Speed limits• ABS

– Safety• Car design• Seat belts• Airbags

• We are not better drivers

Increasing the number of Barriers to prevent Patient Safety Incidents

Swiss Cheese

Cheddar Cheese

Guidelines

• Keep them simple• For routine things

• Use checklists

• Use audit of practice

Are they effective?

“The distribution of methodologically sound clinical guidance does not, however, ensure

implementation”

The Obstetrician & Gynaecologist, 2001, p93

Guidelines

• Too many• Too complicated

• End unto themselves• Job is done

• Not proven or validated

Yorkshire Guidelines

• Consensus guidelines– Obstetricians and Anaesthetists– All units in Yorkshire

• Commenced May 1997 • By 1999, all units using• Regional audit of cases

– Each hospital auditing own cases– Regional co-ordination– Collection of data

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No of cases Stay over 24hours

Ventilated

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ICU admissions in Yorkshire

Airline industry similar to medicine

• requires concentration – long periods of little activity– sudden emergencies – instant decision making

• team working which is interdependent

In Medicine

• Experts often not present at time of crisis

• (a latent failure)

– be aware of the possibility of failure

– be prepared to recognise and recover

• Assess possible risks

– risk assessment

• Rehearsing familiar scenarios

– Drills

• Common sense training

Drills and Skills

• Teach basic skills– For all

• Multidisciplinary– Team working

• Update

Airline industry

• Guidelines for the routine• Check lists

• Drills for emergencies• Experience for the unusual

• If they make a mistake - they die too

Designing out faults

• Copied from industry

• Assess the environment leading to the event

• Design solutions

– Training/supervision

– Design equipment/Hospital

– Encourage change in behavior

• (Guidelines)

a) periodically plot spillage area on an X-bar chart, look for special causes (audit)

b) double the size of the fixtures (prevent)

c) hire an attendant to monitor and reprimand “less hygienic” users (supervise)

d) Hand out guidelines on entry to toilet

what would you do?

Source: Wall Street Journal, used by John Grout,NPSA Seminar, 17 January 2003

JFK International terminal men’s restrooms

e) etch the image of a fly on the porcelain - (Focus)

Source:Wall Street Journal, used by John Grout,

NPSA Seminar, 17 January 2003

JFK International terminal men’s restrooms

Drug Administration

Fully assess risk

• Past history• Woman’s understanding of the risk• Flagging of the problem• Notifying

– (warning/planning)• Guidelines

What about Obesity?

• Increasing problem • Not allowed to talk about

it• We do not weigh people

any more• Ignore the problem• Wait for the disaster

Approach to Risk

You need to know: Min age is 12. Max weight is 16st. Min height is 4'11''. Unsuitable for pregnant women or anyone unable to climb up into the cockpit or fit in a standard car seat.

You need to know: Full manual driving licence required. As a guide max weight is 16st to 18st and you should be between 5'1'' and 6'4''.

Solution Development Processes

• Understanding the what, how and why• Identify potential solutions• Risk assess solutions• Pilot and learn • Implementation • Evaluation and impact assessment

Where are we now?

• Guidelines to inform– Routine

• Checklists to focus– Prompts– Memory aids– Care Bundles

• Drills for skills– Regular – For all

• Audit trail – Prove what you do

We need to share the learning from our mistakes to try and stop them happening

again …..