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Clinical Risk Management Health is a Risky Business. Elizabeth J Haxby Lead Clinician in Clinical Risk Royal Brompton and Harefield NHS Trust. Department of Health. The New NHS: Modern , dependable (1997) A first class service:Quality in the new NHS (1998)

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Clinical risk management health is a risky business

Clinical Risk ManagementHealth is a Risky Business

Elizabeth J Haxby

Lead Clinician in Clinical Risk

Royal Brompton and Harefield NHS Trust

Department of health
Department of Health

  • The New NHS: Modern , dependable (1997)

  • A first class service:Quality in the new NHS (1998)

  • The NHS Plan: A plan for investment , a plan for reform (2000)

The new nhs modern dependable
The new NHS- modern, dependable

  • 10 year modernisation strategy

  • Focus on the quality of care

  • Clinical Governance

Clinical governance doh 1997
Clinical Governance DOH 1997

‘…this central plank of government policy will transform the health service putting ‘quality’ at its ‘heart’. Its adoption will ‘assure and improve clinical standards’ throughout the service providing that ‘good practice is disseminated and systems in place to ensure constructive improvements in clinical care’

Prof liam donaldson cmo 98 99
Prof Liam Donaldson CMO 98/99

‘ This is probably the most important development in the NHS for 30 years and will have profound implications for every hospital and primary care service as well as individual doctors and other healthcare professionals’

‘The introduction of clinical governance, aimed as it is at improving the quality of clinical care at all levels of healthcare provision is by far the most ambitious quality improvement initiative that will ever have been implemented in the NHS.

Clinical governance
Clinical Governance

‘ A framework through which NHS Trusts are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’

Scally G, Donaldson LJ Clinical governance and the drive for quality

improvement in the NHS in England BMJ 1998:61-64

New nhs a first class service quality in the nhs 1998
New NHS – a First Class service – Quality in the NHS (1998)

  • Clear National Quality Standards

    • NSFs, NICE

  • Dependable local delivery

    • Risk management, ACE reporting

  • Strong monitoring mechanisms

    • CHI

    • NPSA

  • Strategy
    Strategy (1998)

    • Arrangements for setting clear national quality standards through NSFs and NICE

    • Mechanisms for ensuring local delivery of high quality clinical services through clinical governance reinforced by a new statutory duty of quality and supported by programmes of life-long learning and local delivery of professional self regulation

    • Effective systems for monitoring delivery of quality standards in the form of a new statutory CHI and an NHS performance assessment framework together with national surveys of patient and user experience.

    Clinical governance3
    Clinical Governance (1998)

    • NHS culture change

    • Openness and participation

    • Education and research valued

    • Learning from failure

    • ‘Just blame’

    • Good practice and new approaches shared

    Clinical governance as assessed by chi
    Clinical Governance (1998)-as assessed by CHI

    • Patient involvement

    • Risk Management

    • Clinical Audit

    • Staffing and management

    • Education and training

    • Clinical Effectiveness

    • Use of information

    Quality (1998)

    • Setting clear standards

    • Accountability for service quality

    • Measures to ensure quality assured practice by NHS staff

    • Effective systems of ACE reporting . Analysis, learning and risk management to enhance patient safety

    • Robust inspection system

    • Spread good practice

    • Active participation and information for patients

    Standards for risk management
    Standards for Risk Management (1998)

    • NHS plan

    • RPST


    • Controls assurance

    • HSE

    • National Inquiries (Bristol)

    • (Human Rights Act 1998)

    Risk pooling scheme for trusts rpst
    Risk Pooling Scheme for Trusts (RPST) (1998)

    • Development and promotion of good risk management systems

    • Framework to focus risk management systems

      • improve patient care

      • organisational safety

  • Compliance ensures

    • fewer claims

    • reduced scheme contributions

  • CNST (1998)

    Requires as a condition of discounted premiums, the development of clinical incident reporting systems for compliance with its risk management standards.

    Controls assurance
    Controls assurance (1998)

    ‘…..Controls assurance project requires that boards of health authorities, NHS Trusts and Primary Care Trusts satisfy themselves that systems are in place to ensure that risks are assessed and properly managed…,

    May 2001

    Controls assurance1
    Controls assurance (1998)

    ‘…..Controls assurance project requires that boards of health authorities, NHS Trusts and Primary Care Trusts satisfy themselves that systems are in place to ensure that risks are assessed and properly managed…,

    May 2001

    Bristol inquiry
    Bristol Inquiry (1998)

    • CPD

    • Appraisal

    • Revalidation

      ‘ should be compulsory for all healthcare professionals’

    Fundamentals of risk management
    Fundamentals of Risk Management (1998)

    • Improve quality and safety

    • Identify improvements in processes and outcomes

    • Minimise the cost of failure

    Definition of risk
    Definition of Risk (1998)

    ‘ a risk is the likelihood of potential harm from a hazard being realised. The extent of that risk will depend on the likelihood of that harm occurring, the potential severity of that harm and the population which might be affected by the hazard’

    ‘..risk is the chance, high or low, that somebody will be harmed by a hazard’

    Health and Safety Executive

    Risk management
    Risk Management (1998)

    A systematic process for the identification,analysis

    and control of actual and potential risks and their

    resource implications.

    This will include risks to people, structure,

    reputation and any other issues which could impact

    upon or compromise the ability of the Trust to carry

    out is normal activities

    Clinical risk management aims
    Clinical Risk Management (1998)Aims

    • Improve quality of care by reducing number of occasions when harm occurs

      • Identification of causes (‘root cause analyses’)

      • Local or trust-wide action to improve quality

      • Need to encourage ‘blame free’ culture

    • Reduce costs of clinical negligence claims

      • Early identification of potential claims

      • Active claims management

    Patients (1998)

    ‘…..with that complexity comes an inevitable risk that at times things will go wrong……..the stakes are higher than in almost any other sphere of human activity’

    ‘….the challenge is to ensure that the modern NHS is as safe as possible for patients.’

    Secretary of State for Health

    Clinical adverse events
    Clinical Adverse Events (1998)

    • Harvard Medical Practice study (1984) 3.7%

    • Australian Healthcare Study (1994) 16.6%

    • English pilot study (2001) 10.8%

    Harvard medical practice study
    Harvard Medical Practice Study (1998)

    Incidence of adverse events and negligence in hospitalised patients

    Brennan TA, Leape L et al

    NEJM 1991;324:370-6

    HMPS (1998)

    • To develop more current and reliable estimates of the incidence of ACEs and negligence in hospitalised patients

    • ACE – injuries caused by medical management that prolonged hospitalisation, produced a disability at time of discharge or both

    • 51 acute hospitals in NYS in 1984

    • 30,121 randomly selected records

    HMPS (1998)

    • Two-stage screening process

      • Initial screen by trained nurses / medical records analysts

      • If positive reviewed by two doctors independently

      • Causation score

      • Disability score

      • Negligence factor

      • Specialists available for consultation

      • Reliability and validity tested

    HMPS (1998)

    • ACEs occurred in 3.7% of hospitalisations

    • 27.6% of ACEs due to negligence

    • 70.5% of ACEs resulted in disability <6/12

    • 2.6% ACEs resulted in permanent disabling injuries

    • 13.6% of ACEs resulted in death

    • 50.3% of deaths from ACEs due to negligence

    • 69% human error

    • ACE rate increased with age

    QAHS (1998)

    Quality in Australian Health Care Study

    Wilson RM, Runciman et al

    Med J Aust 1995;163:458-471

    QAHS (1998)

    • Goal to estimate patient injury and its direct consequences caused by healthcare in Australian hospitals

    • Quality improvement, measure of preventability to replace negligence in HMPS

    • 28 hospitals in NSW & SA in 1992

    • 14,129 randomly selected records

    QAHS (1998)

    • ACE – an unintended injury or complication which results in disability, death or prolongation of hospital stay and is caused by healthcare management rather than the patient’s disease

    • Two stage screening process

      • Presence on ACE (18 explicit criteria)

      • Disability

      • Causation

      • Preventability

      • Association with complexity, urgency and expected benefits

      • Type of error

    Qahs ace criteria

    Unplanned admission before index admission (1998)

    Unplanned readmission

    Hospital incurred injury

    Adverse drug reaction

    Unplanned transfer to ITU

    Unplanned transfer to other unit

    Unplanned return to theatre

    Unplanned organ injury/removal

    Other complications MI/CVA/PE

    Development of neurological deficit

    Unexpected death

    Inappropriate discharge

    Cardiac / Resp arrest / low APGAR

    Delivery / abortion injury

    Hospital acquired sepsis

    Documented dissatisfaction with care

    Litigation correspondence

    Any other undesirable outcome

    QAHS ACE criteria

    QAHS (1998)

    • 16.6% of admissions associated with an ACE

    • 77.1% disability resolved within 12 months

    • 13.7% resulted in permanent disability

    • 4.9% resulted in death

    • 51% of ACEs were considered preventable

    • ACEs accounted for 7.1 additional days in hospital

    • ‘decision –making’ ACEs associated with increased preventability, permanent disability and death

    QAHS (1998)

    • A high proportion of ACEs resulting in permanent disability or death occurred among;

      • Complex cases

      • Urgent cases

      • Cases in which management was considered life saving

      • Cases in which management was expected to provide major improvement in quality of life

      • Nearly half of all deaths occurred in association with life-saving interventions

      • 46.8% of all ACEs occurred in the OR

      • 10.8% of ACEs were drug related

    Qahs preventability
    QAHS Preventability (1998)

    • Failure to take precautions to prevent accidental injury

    • Failure in technical performance

    • Failure to employ indicated tests

    • Avoidable delays in treatment

    • Failure to act on results of tests or findings

    • Failure to take adequate history / examination

    • Practice outside area of expertise

    • Errors of omission 52% of ACEs

    • Errors of commission 27%

    • ACEs accounted for 8% of bed days at a cost of $4.7Bn

    QAHS (1998)

    • Areas to which efforts should be redirected to prevent recurrence of ACEs

      • Quality assurance / peer review

      • Education

      • System Change

      • Communication

    Human error is a prominent cause of adverse clinical events.

    The implication in terms of preventable adverse outcomes for

    patients are substantial.

    British study
    British Study (1998)

    Adverse Events in British Hospitals:preliminary retrospective review

    Vincent C, Neale G,Woloshynowych M

    BMJ 2001;322:517-19

    British study1
    British Study (1998)

    • Goal – to examine the feasibility of detecting ACEs through record review in British hospitals and make preliminary estimates of the incidence and cost of ACEs

    • 500 randomly drawn records from 2 acute trusts in north London

    • HMPS screening procedure and criteria

    British study2
    British Study (1998)

    • 10.8% of patients experienced an ACE

    • A third of these lead to moderate or greater impairment

    • In 8% ACE contributed to death

    • 48% of ACEs judged preventable

    • Preventable ACEs cost the NHS £1 bn per year in terms of additional bed days.

    Why are they different
    Why are they different? (1998)

    • Worse health care in Australia?

    • Availability of information?

    • Different definitions of ACEs

    • Different inclusion criteria

    • Discrepancies between 1st and 2nd stage reviews

    • Timing

    • Multicentre studies with pooling of data

    • No post-mortem data

    Retrospective review
    Retrospective Review (1998)

    • Quality of documentation and availability of notes

    • ACE definition

    • Recording of events

    • Context of event

    • Timing of review

    • Subjective

    • New treatments

    • Balance of risks

    • Assessment of Causation and Preventability is complex

    • Life expectancy / Limited care

    • No near miss data

    What is known
    What is known (1998)

    • 400 people die or are seriously injured in ACEs involving medical devices

    • Almost 1000 people experience serious adverse reactions to drugs

    • Approximately 1150 people who have recent contact with MHS commit suicide

    What is known1
    What is known (1998)

    • 28,000 written complaints are received which related to clinical care

    • 400 million is paid in compensation for clinical negligence claims (potential liability 2.4 billion)

    • Hospital acquired infection costs an estimated 1 billion

    Is this a new phenomenon
    Is this a new phenomenon? (1998)

    • Training Focus on error free practice

    • Striving for perfection

    • Mistakes unacceptable

    • Considered failure of character

    • Role models reinforce notion

    Organisation with a memory owam
    Organisation with a Memory OWAM (1998)

    To advise the Government on the steps that can be taken to ensure that the National Health Service learns from its experiences, so that the risk of avoidable harm to patients is minimised.

    Expert working group chaired by the Chief Medical Officer June 2000

    OWAM (1998)

    • When things go wrong it often has devastating consequences

    • Incidents display strong similarities to previous events

    • NHS reporting and data capture is incomplete

    Owam recommendations
    OWAM Recommendations (1998)

    • Introduce a mandatory reporting scheme for ACEs

    • Introduce a confidential reporting scheme for staff

    • Encourage a reporting and questioning culture in the NHS

    • Introduce a single system for analysis and dissemination of information

    • Make better use of existing sources of information

    • Improve the quality of investigations and inquiries

    • Undertake basic research into ACEs

    • Make full use of information systems

    • Ensure lessons are implemented quickly

    Why do things go wrong in healthcare

    Active failures (1998)





    Latent conditions

    Organisational characteristics which create an environment for active failures to occur or which lead to accidents themselves (System failures)

    Why do things go wrong in healthcare?

    Error types
    Error types (1998)

    • Slips and lapses

      • Memory/ attention failures

  • Mistakes

    • Inadvertently selects wrong action plan

    • Selects correct plan but implements it incorrectly

  • Violations

    • Factors dictated by environment

    • Attempting to solve unusual problems

    • Breaks rule to achieve goal

  • Human factors
    Human factors (1998)

    • Carelessness

    • Lack of attention

    • Inexperience

    • Complacency

    • Disregard for safety rules

    • Haste

    • Distraction

    • Misconduct

    • Alcohol/drugs

    Institutional factors
    Institutional factors (1998)

    • Inadequate work standards

    • Inadequate leadership

    • Lack of supervision

    • Inadequate training

    • Misuse of equipment

    • Checking failures

    • Maintenance failures

    Error producing conditions

    Unfamiliarity (1998)

    Time shortage

    Information overload

    Misperception of risk

    Poor feedback


    Hostile environment

    Lack of sleep

    Inadequate checking

    Monotony / boredom

    Poor instructions

    Error producing conditions

    Violation producing conditions

    Lack of safety culture (1998)

    Conflict between staff and management

    Poor morale

    Poor supervision

    Group norms condoning violations

    Macho culture

    Low self esteem

    Ambiguous / meaningless rules

    Violation producing conditions

    Root causes of medical errors

    Orientation (1998)


    Patient assessment



    Lack of information

    Staff competency


    Staffing levels



    Root causes of medical errors

    NHS Executive Data

    So……………….. (1998)

    ‘We must re-examine all that we do and re-design our many and complex systems to make them less vulnerable to human error’

    Leape et al BMJ 2000;320:725-6

    …..and……… (1998)

    ‘Accidents hardly ever happen without warning. The combination or sequence of failures and mistakes that causes an accident may indeed be unique, but the individual failures and mistakes rarely are….’

    Mike O’Leary (BA, UK), Sheryl Chappell (NASA, USA)

    Clinical risk management

    Pro-active (1998)





    Clinical Risk Management

    Risk assessment

    Hazard (1998) –something with potential to cause harm

    Risk –likelihood that the hazard is realised

    Extent of risk –No. of people affected

    Control measures –how to reduce risk

    Identify hazards

    Evaluate the risks

    Plans to reduce risks

    Risk-benefit analysis

    Judge acceptability / tolerability of risk

    Risk Assessment

    Hazards (1998)

    • Physical – heat, noise

    • Electrical – equipment

    • Radiation

    • Substances – water,acid, biological agents

    • Ergonomic – physical stress

    • Clinical – patient safety

    • Fires and explosions - cylinders

    Clinical risks
    Clinical Risks (1998)

    • High risk areas – obstetrics

    • Service provision – training / supervision /staffing

    • Complaints & litigation

    • Record keeping

    • Consent process

    • Audit / clinical effectiveness

    • Adverse events

    • Procedures and guidelines

    Controls (1998)

    • Policies and procedures

    • Compliance with professional guidelines

    • Compliance with national guidelines

    • Training / supervision

    NICE (1998)

    Criteria for risk tolerability
    Criteria for Risk Tolerability (1998)


    Broadly acceptable

    As low as reasonably practicable



    Adverse clinical event reporting
    Adverse Clinical Event Reporting (1998)






    Ace reporting
    ACE Reporting (1998)

    • Standardised reporting system

    • Co-ordination

    • Ease of reporting

    • Data on near misses

    • Mandatory reporting

    • Confidentiality

    • Feedback / debriefing

    • Implementation

    • Thanks not blame

    Prospective ace reporting
    Prospective ACE reporting (1998)

    • Contemporaneous

    • Systematic approach

    • Specific information can be requested

    • Reporter’s views on causation and preventability

    • Early root cause analysis

    • May focus on major events / miss minor events

    • Near miss information

    • Dependent on appropriate triggers / definitions

    • Constructive approach with open culture

    • Mandatory / voluntary reporting

    Adverse incidents
    Adverse incidents (1998)

    • ‘an event or circumstance that could have or did lead to unintended or unexpected harm, loss or damage’

      • ‘actual’ or ‘near miss’

      • NO need to establish fault/blame/error

      • Includes both ‘clinical’ and ‘non-clinical’ incidents

    • ‘near miss’ : an incident that did not lead to harm, but may have

    Clinical trigger events examples
    Clinical trigger events – (1998)examples

    • Cardiac surgery

      • Death awaiting surgery

      • Diagnostic problems

      • Intra-operative problems

      • Post-operative problems – e.g. neurological

      • Medication errors

      • Equipment problems

      • Any event thought likely to result in a claim

  • The full list is on the back cover of the report book

  • Grading of adverse incident reports
    Grading of adverse incident reports (1998)

    • Initial assessment by head of department or service

      • Actual or potential impact on individual

      • Risk assessment

        • Likelihood of recurrence

        • Most likely consequence

    • investigation of reported incidents

      • By local management if incident graded ‘green’ or ‘yellow’

      • By Risk Management office if incident graded ‘amber’ or ‘red’

    Grading of adverse incident reports 1 actual or potential impact on individual
    Grading of adverse incident reports (1998)1. Actual or potential impact on individual

    • Red

    • Amber

    • Yellow

    • Green

    Grading of actual or potential impact of adverse incident 1
    Grading of actual or potential impact of adverse incident - 1

    • Major (‘red’)

      • Removal of incorrect organ or limb

      • Suicide of patient

      • Serious hospital acquired infection e.g. legionella

      • Wrong blood group transfusion

      • Retained instruments/ swabs after surgery (unintentional)

      • Significant radiation overdose

      • Non-clinical: staff death or multiple injuries

  • All ‘major’ adverse events must be reported immediately to the site risk management office (Trust policy for investigation of major serious untoward incidents)

  • Grading of actual or potential impact of adverse incident 2
    Grading of actual or potential impact of adverse incident - 2

    • Moderate (‘amber’)

      • ‘semi-permanent’ harm (up to one year)

      • Neurological sequelae following surgery/intervention

      • Mislabelled blood specimens/request forms

        • Failure to check patient identification

      • Non-clinical – illness requiring more than 3 days absence from work

    Grading of actual or potential impact of adverse incident 3
    Grading of actual or potential impact of adverse incident - 3

    • Minor (‘yellow’)

      • ‘non-permanent’ harm (up to one month)

      • Medication dose administration omission x1

      • Non-clinical: short-term minor injury/illness

  • None (‘green’)

    • No obvious harm or injury

    • Minimal impact

  • Grading of adverse incident reports 2 risk assessment
    Grading of adverse incident reports 32. Risk assessment

    • Very low – Green

    • Low – Yellow

    • Moderate – Amber

    • High - Red

    Risk assessment grading matrix national patient safety agency doing less harm 2001
    Risk assessment grading matrix 3National Patient Safety Agency ‘Doing less harm’ 2001

    Risk assessment1
    Risk assessment 3

    • Includes the response to adverse incidents

    • Proactive risk assessment on a trust-wide basis

      • Need to include clinical activity

  • Forms the basis of entry into the trust risk register

    • Prioritisation in risk register by grade and numbered position in matrix

  • Review at directorate/trust level

  • Adverse incident root cause analysis
    Adverse incident root cause analysis 3

    • Finding the root cause

      • Outline sequence of events

      • Why did incident occur – causation

      • How did incident occur

        • Slip/trip/lapse (‘active’)

        • Latent cause (‘system’)

      • Isolated equipment failure rare cause of adverse incident

  • Recommendations/action plan

    • Directorate or Trust-wide level

  • Reporting bodies investigators
    Reporting Bodies (Investigators) 3

    • NPSA

    • MDA

    • MCA

    • HSE / RIDDOR

    • SHOT

    • IIU

    • CHI