FIMDP 2013

DEPT OF COMMUNITY MEDICINE

SRM MEDICAL COLLEGE ,SRM UNIVERSITY

&

UNSW AUSTRALIA

9TH & 10TH JAN 2013

School of Public Health and Community Medicine

Seminar on Health Care Management

9th and 10th of January, 2013

Department of Community Medicine

SRM Medical College Hospital &

Research Centre

SRM University

Clinical governance and risk

management

Why do we need clinical governance?

Hospital medicine used to be simple, ineffective

and relatively safe.

Now it is complex, effective and potentially

dangerous.

Chantler C. The role and education of doctors in the delivery of healthcare. Hollister Lecture delivered at the Institute of Health Services \

Research, Northwestern University, Illinois, USA, October 1998. Lancet 1999;353:1178–81.

The incidence of errors:

Experiencing an adverse event in an intensive care unit 1 : 2

Being injured if you fall in hospital 1 : 2

An adverse event in ICU being serious enough to cause death or disability 1 : 10

Experiencing an adverse event or near miss in hospital 1 : 10

Experiencing a complication from a medication or drug 1 : 20

Developing a hospital acquired infection 1 : 30

Being harmed while in hospital 1 : 300

Dying from a medication error in hospital (as an inpatient) 1 : 854

Having a retained foreign body after surgery (intra-abdominal) 1 : 1,000

Being subjected to wrong site surgery 1 : 112,999

Dying as a result of anaesthesia 1 : 250,000

Contracting HIV as a result of a screened blood transfusion 1 : 2,600,000

Rates of medical errors

• United States: (lowest estimate) 44,000 - 98,000 preventable

deaths per year as a result of medical errors

• CDC estimated in 2000 that approximately 90,000 people die of

nosocomial infections alone, per year in the US

• United Kingdom: A total of 45% of patients experienced some

medical mismanagement and 17% suffered errors giving longer

hospital stay or more serious problems

• Australia: approximately18,000 preventable deaths, 50,000

permanently disabled patients per year

Patient safety timeline

Primum non

nocere

1847

Galen

Hipocraties(?)

4th Century

BC

Florence

Nightingale

It may seem a

strange principle to

enunciate as the

very first

requirement in a

hospital that it

should do the sick

no harm

1859

Dr Harvey

Cushing

(surgeon)

published detailed

descriptions of

harm caused to

his patients

secondary to his

own performance

1900s

The Institute

of Medicine

(IOM)

published To

Err is Human:

Building a

Safer Health

System in

November

1999

Leape LL,

Bates DW,

Cullen DJ, et

al. Systems

analysis of

adverse drug

events. ADE

Prevention

Study Group.

JAMA

1995;274:35-

43.

Ignaz

Semmelweis

Puerperal fever

mortality rates

for the First and

Second Clinic at

the Vienna

General Hospital

1841–1846

Ross McL

Wilson,

William B

Runciman,

Robert W

Gibberd

The Quality in

Australian

Health Care

Study, MJA ,

1995,: 163 6

Learning the

Lessons: The

Department of

Health's Response

to the Bristol Royal

Infirmary Inquiry

Report (Kennedy

report) (Department

of Health, 2001)

Patient safety

inquiries

1967 – 2013 and

counting …

Patient safety ten years on ...

• Institute of Medicine To err is human

• Bristol Royal Infirmary Inquiry

But

• Patient safety has been a concern since the origins of medicine

(Hippocratic oath/Florence Nightingale)

• Concerns raised in the 1800s (eg hand hygiene) continue to this day

and for very similar reasons –

• „we can cure childhood cancer, but we can‟t get clinicians to

wash their hands‟

What is clinical governance?

Clinical governance is a systematic approach to

maintaining and improving the quality of patient

care within health systems

Why did clinical governance

emerge?

The emergence of clinical governance …

Links between corporate and clinical

governance

• Scally and Donaldson: “a system through which NHS organisations

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.”2 (p. 62)

• Western Australian Government: “a systematic and integrated

approach to assurance and review of clinical responsibility and

accountability that improves quality and safety resulting in optimal

patient outcomes” (2001: 2)

Characteristics of events sparking

inquiries

• Widespread loss of life

• Threats to public health or safety

• Failure by the state in its duty to protect

• Failure in regulation

• Shocking events

Landmark Chambers, 2009

Study of eight inquiries: the need for CQI

• Eight inquiries, six countries:

– Bristol Royal Infirmary (UK)

– Campbelltown and Camden (Australia)

– Celjie Hospital (Slovenia)

– Glasgow‟s Victoria Infirmary (UK)

– King Edward Memorial Hospital (Australia)

– Royal Melbourne Hospital (Australia)

– Southland DHB Mental Health Services (New Zealand)

– Winnipeg Health Services Centre (Canada)

• Paediatric cardiac surgery, tertiary care, ED, pathology, gynaecology and obstetrics,

mental health services

Hindle, Braithwaite, Travaglia (2006)

Culture of high risk healthcare

• Quality healthcare is not evenly distributed;

• Health care can continue to operate far below standard for years, and sometimes

decades;

• Quality improvement processes are often deficient;

• Lack of supervision and monitoring;

• Lack of balance between professional autonomy and individual, team or professional

responsibility;

• Deficient teamwork, including lack of understanding and respect for other

professions;

• Denial or suppression of early warning signs;

• Dismissal of patient and clinician concerns;

• Failure of timely transmission of vital information to responsible individuals;

• Suppression and abuse of whistleblowers;

• Routine circumventing of existing procedures and protocols.

Hindle, Braithwaite, Travaglia (2006)

• The Ely Hospital, Wales (1967) - long stay patients, elderly

• Banstead Hospital, Cowley Road Hospital, Friern Hospital, St. James's Hospital, StorthesHall Hospital, St. Lawrence's Hospital, Springfield Hospital, UK (1968) – elderly

• Normansfield Hospital, Middlesex, UK (1978) people with learning disabilities

• Inquiries into the circumstances of the death of various children and others and the first Ashworth Inquiry Ashworth, UK (1985-96) –children

• Stanley Road Hospital, Wakefield, UK (1986) –elderly patients

• Cervical screening services, Cartwright Inquiry, NZ (1987 – 1988) – women

• Chelmsford Royal Commission, NSW (1990) –psychiatric patients

• Ashworth Special Hospital Inquiry, UK (1999) -criminal psychiatric patients

• Rodney Ledward, UK (1999) – women

• Grantham and Kesteven Hospital, Allitt -Clothier Report (1992, 1994) - children

• Winnipeg Health Services Centre, Canada (1995 – 1998) – children

• Cervical screening services at Kent and Canterbury Hospitals Trust - Wells Report, UK (1997) – women

• Royal Liverpool Children’s Inquiry (Alder Hey –Ashton report), UK (2000) – children

• King Edward Memorial Hospital, WA (2000 –2001) – women

• Bristol Royal Infirmary, Kennedy Report, UK (2001) – children

• The Victoria Climbié Inquiry, UK (2001) – child

• RMH, Victoria (2002) - the elderly

• Southland DHB, NZ (2001-2002)- psychiatric patient

• Three Inquiries: The Kerr/Haslam, Ayling, Neale, Inquiries (2003-2004) – psychiatric patients, women

• Camden and Campbelltown Hospitals, NSW(2002-2003)– locational disadvantage, lower SES, people from NESB

• Shipman, UK (2005) - elderly women, isolated individuals

• Healthcare Commission, Clostridium difficile(Stoke Mandeville, Maidstone and TumbridgeWells), UK (2006)

• Bundaberg, Patel Inquiries, Queensland (2006) –locational disadvantage, lower SES, Aboriginal and Torres Strait Islander patients

• E.coli Inquiry, South Wales (2006) – child

• Garling Inquiry Reeves, NSW (2008) – women;

• Garling Inquiry (acute healthcare), NSW (2008)

• Stafford General Hospital, UK (2010) – ED, elderly, confused, dying patients

Patient safety inquiries

Francis Inquiry into Stafford Hospital (2010)

• target-driven priorities which generated fear

• disengagement between clinicians and management

• low staff morale

• isolation

• lack of openness

• acceptance of poor standards of conduct

• reliance on external assessments

• denial

• bullying

• lack of information about patients‟ care or condition

• lack of involvement in decisions

• failure of communication between staff

• lack of engagement with families and friends

Inquiry recommendations range up to several

hundred. Most suggest variations on three

strategies:

• Organisational, service or team restructuring;

• Policy and guideline development;

• Staff training.

18

What does clinical

governance involve?

The key elements of clinical governance

• Recognisably (ie publicly available) high

standards of care

• Transparent responsibility and

accountability for those standards

• A constant dynamic of improvement (CQI)

Braithwaite and Travaglia (2008)

Links made between

corporate and clinical

governance

Strategies to ensure the effective

exchange of knowledge and

expertise

Sponsoring of a patient centred

approach to service delivery

Structures to improve quality and safety and

manage risk

Focus on quality assurance and

continuous improvement

Other aspects of CG

• Education and training

• Clinical audit

• Clinical effectiveness

• Research and development

• Openness

• Risk management

• Information Management

Link between corporate and

clinical governance

Clinical and corporate governance

Clinical governance

Corporate governance

Integrated Governance:

Structures, systems and processes that assure the quality,

accountability and effective management organisations‟ operation

and delivery of service;

Ethics

Aspects of

healthcare

services

related to the

delivery of

patient care

All other

aspects of the

„business‟ and

management

side of service

delivery

What is the link between clinical and corporate

governance?

Errors and adverse events are:

Either the result of incompetent clinicians

Or they are the result of incompetent managers

Or option 3:

They are the result of a failure to implement evidence based practice

AND evidence based management

I believe patient safety must be a fundamental component

of a modern health service.

It is closely connected with issues such as clinical

governance and evidence-based practice.

The culture of the NHS must change from a closed blame-

centred culture, to an open learning one.

We must not only ask the question „who made the

mistake‟? But what features of the health

organisation created the conditions where mistakes are

more likely‟?

CMO Sir Liam Donaldson

The importance of knowledge

exchange

Arena

Facade

Blind spot

The unknown

What we

don’t know

What

they

know

What they

don’t know

What we

know

What we know most about

• Types of errors [for certain groups]

• Rates of errors

• Systems/technical causes of errors

• Experience of clinicians {?}

• Errors of commission

• Types of patients who experience errors

• Differential rates of errors

• Errors of omission

• Sustained quality improvements

To distinguish:

• Data: are collections of facts, figures, statistics:

the building blocks (can be usable or not)

• Information: are data with a meaning by way of

a relational context (organised or processed

data – the who, what, when and where)

• Knowledge: is the appropriately applied data

and information (relevant, actionable) – the how

• Wisdom: evaluated understanding (discern,

judge)

Requirements of wisdom

• Emotional regulation – coping

• Knowing what‟s important

• Moral reasoning

• Compassion

• Humility (epistemic, cultural and other)

• Altruism

• Patience

• Dealing with uncertainty

(Hall, S.S. (2010) Wisdom: from philosophy to neuroscience. QUP: St Lucia.

Modified from: http://www.nwlink.com/~donclark/knowledge/context.html#join

The five tasks of health managers*

1. Generating new knowledge

2. Accessing/discovering existing knowledge

3. Capturing, representing and embedding knowledge

4. Facilitating knowledge development and application

5. Transferring knowledge across individuals, teams,

units, services and systems

Adapted from Helen Bevan’s work on from knowledge management

Patient/person centred

approach to care

Patient centred care

Health care that establishes a partnership

among practitioners, patients, and their families

(when appropriate) to ensure that decisions

respect patients’ wants, needs, and preferences

and that patients have the education and

support they need to make decisions and

participate in their own care

Institute of Medicine (2001) Crossing the Quality Chasm

Patient centred care focuses on:

• Whole-person care

• Coordination and communication

• Patient support and empowerment

• Ready access

Bechtel C.If You Build it, Will They Come? Designing Truly Patient-Centered Health Care. Health

Affairs.

Background – definition

• Risk has been defined as a central cultural construct of recent

times

• Risk can be understood as the possibility (or chance) of harm of

loss to an individual or group, the magnitude of that loss or harm

and the probability of its occurrence.

• Risk appears throughout the patient safety literature. There are the

risks associated with most medical treatments, often categorised

as „side-effects‟, complications or adverse events.

• In this context risk involves “... accepting that some degree of harm

may be unavoidable in many clinical situations is clearly

appropriate where the risks are weighed against the expected

benefits.”

• In comparison, vulnerability in healthcare has been

called the elephant in the room of healthcare (Hurst:

2008)

• Unlike the concept of risk, which has undergone

sustained examination over a decade, vulnerability has

proven difficult to define and is under-researched.

• While risk of harm is well understood, less is known

about patients‟ (either as individuals or in groups)

vulnerability to harm.

What is vulnerability?

• Vulnerability has been defined as susceptibility to any kind of

harm, whether physical, moral or spiritual, at the hands of an

agent or agency, a factor which … needs to be recognised

and negotiated in health care transactions. (Hurst: 2008)

• A functional definition of vulnerability is an individual or

groups' susceptibility to risk of harm.

• Vulnerability can be identified as occurring as a result of one

or more social, structural, situational or [we will argue]

systems causes

• Theoretically, the risk of injury and death as a result of

unexpected, unconsidered, incompetent, or incomplete

actions is equal for all patients.

• Yet there are indicators from patient safety studies to

suggest that certain individuals and groups may be

particularly vulnerable to errors, when social factors

(such as ethnicity, disability, gender and socio-economic

status) are considered.

FORMS OF VULNERABILITY TYPES

Bio-genetic vulnerability Demographic profiles and factors including age, individual health status, genetic

predisposition

Psycho-social vulnerability Location, social and psychological factors, including presence of carers and/or family

and friends, sexuality, disability, symbolic capital

Epidemiological vulnerability Groups and populations, both genetic and environmental illnesses and conditions

Socio-economic vulnerability Social, economic, cultural/religious, social and economic capital

Spatio-temporal vulnerability Time, space, physical transitions, environmental

Inter-personal vulnerability Relationship between patient and practitioner, "difficult/problem clients", "non-

compliant" clients

Cultural vulnerability Language, literacy, cultural and linguistic capital

Practice vulnerability Knowledge, skills, attitudes, stance of clinicians

Team vulnerability Communication, collaboration, peer relationships and pressures

Structural vulnerability Systemic, organisational, resources, media and public opinion

Organisational vulnerability Organisational, team, professional and locational culture and relationships

Roux-Dufort

What is it within all our systems that

makes us at risk for lower quality care

and poor outcomes?

Who is vulnerable within healthcare?

Participants‟ responses were allocated to four categories of high risk

groups:

1. Clinicians;

2. Individuals with bio-medical conditions;

3. Patients with liminal status; and

4. Socially vulnerable groups

Braithwaite, Travaglia, Nugus (2006)

Vulnerable patients

• The elderly and frail

• Indigenous communities and individuals

• People from culturally and linguistically diverse backgrounds and

refugees

• People with disabilities, especially cognitive impairments, mental

illnesses and sensory disabilities

• Children and youth

• Patients with literacy and communication problems

• People from lower SES

• Geographically isolated individuals

• Socially isolated individuals

• The homeless

• The frail and malnourished

• Patients with co-morbidities and chronic illness

• Patients with high acuity

Phase 2: vulnerable patients

• Patients with liminal status:

• Rapidly deteriorating patients;

• Patients in transit;

• Patients discharged early;

• Patients in emergency departments and Intensive Care

Units;

• Prisoners; and

• Certain locations and times

Braithwaite, Travaglia, Nugus (2006)

Structural responses and CQI

responses to patient safety

Structures to improve the quality and safety and management of risk

Modern patient safety

movement

Recognition of errors as a

major cause of death and disability Introduction

of error reporting systems

Protection of staff who

report errors

Performance standards (at

different levels)

Creation of safety

systems (including

clinical governance)

Comprehensive approach

to QI and safety

Focus on finding error

causes

Use of team training and simulation

Building leadership

and knowledge

Conclusion

Arena:

transformationBlind spot:

engagement

Façade:

compunction

Unknown:

humility

Humanity

THANK YOU