To err is human: What about us physicians?

To err is human.
What about us physicians?
Dr. F H D Shehan Silva
MBBS (SJP) MD (Col) MRCP (Lon) Dip MedPract (LSTM)
MRCP (Geriatrics) MRCP (Diabetes and Endocrinology) IFME (Cantab) AFHEA (UK)
Ceylon College of Physicians. College Lecture: 2nd April, 2019

Outline
• Medical errors – epidemiology
• Medical errors – situation in Sri Lanka
• Practice and principles in patient safety and error evaluation
• Steps to improve patient safety in terms of medical errors

• PBS NOVA S34E03 - The Deadliest Plane Crash
• https://www.youtube.com/watch?v=JbY3T9TX_hA&t=99s

Tenerife Disaster – March 27th, 1977
Environment
Political crisis/ bomb
Heavy fog – Obstructed runway
Heavy and abnormal air traffic
Equipment
Faulty radio channels
Lightning system failure
Management
Hierarchical authority – God
phenomenon
Flight delay
Personnel
Wrong ground exit
Misunderstood order
Overconfident senior
pilot
Protocol not followed
Protocol altered
Method
Outcome
582 deaths
2 Boeing 747s
destroyed

What does aviation have to do with
medicine?
• Can we compare aviation and medicine in errors?
• High risk medicine deals with poor patient risks, inherent risks and
poor performance
• Human error can add to failures
• Major compensating decisions can circumvent adverse effects

• Source – National Safety Council, USA (1996)

To Err is human: Building a Safer
Health System (IOM, 1999)
• Resulted in increased awareness of US Medical errors.
Multiple studies by various organisations – Extrapolated to general
population
• Approx 44,000 – 98,000 deaths due to preventable medical errors
• More Americans killed in hospitals every 6/12 than the entire mortality in
Viet Nam war
• Death rate = 3 jumbo jet crashes every 2 days
The Institute of Medicine (IOM) study. To Err is Human; Building a Safer Healthcare System. Washington: National Academy Press, 1999.

• Europe – 8-12% patients admitting to a hospital has adverse effects
• UK – 1 in 8 had prescription or monitoring errors
• Brazil 45.5% - Errors in ICU
• OECD Health Policy Studies. Improving value in health care measuring quality, 2010
Tony Avery T, Barber N, Ghaleb M, Dean Franklin B,
• Armstrong S, Crowe S, Dhillon S, Freyer A, Howard R, Pezzolesi C, Serumaga B. Investigating the prevalence and causes of prescribing errors
in general practice in UK: PRACtICe Study. A report for the General Medical Council, 2012
• Filho FMA, Pinho DLM, Bezerra ALQ, Amaral RT, Silva ME. Prevalence of medication-related incidents in an intensive care unit. Acta Paulista
de Enfermagem 2015; 28(4): 331-336.

Medical Errors in Sri Lanka

What about the situation in Sri Lanka?
• Large body of anecdotal narratives from patients, their relatives and
also doctors
• No statistics available ‘Medical Errors in Sri Lanka’
• No category in ‘Indoor morbidity and Mortality Reports’ on patient
safety or medical errors in the Annual Health Bulletin
• Prof Susirith Mendis. Medical error and negligence. The Island. April 12, 2016, 6:59 pm

• A study on a secondary care hospital
Prescribing errors – 32.5%, Administration errors – 3%,
Medication errors (28.4%)
Thirumagal M, Ahamedbari MAR, Samaranayake NR, Wanigatunge CA. Pattern of medication errors among inpatients in a
resource-limited hospital setting. Postgraduate Medical Journal. 2017 Nov;93(1105):686-690.
• A study on factors affecting safety culture – tertiary setting
Overall patient safety 81.3%
Frequency of reporting 36.3%
Non punitive response to errors 39.4%
Workload and staff 15.7%
Communication openness and feed back 62.1%
Prevailing patient safety culture seems to be in a reactive stage but, with
strong ―blame Culture
M Amarapathy, S Sridharan, R Perera, Y Handa. Factors Affecting Patient Safety Culture In A Tertiary Care Hospital In Sri Lanka.
INTERNATIONAL JOURNAL OF SCIENTIFIC & TECHNOLOGY RESEARCH 2013, 2(3), 173-180

Our responsibility
• Primum non nocere: First do no harm - Hippocrates
• Make the care of your patient your first concern – GMC UK
• Service to humanity and not personal gain is the ideal… Everyone
entering the profession incurs an obligation to uphold its dignity and
honour, to exalt its’ standing and to extend the bounds of its’
usefulness.
(Medical ethics and etiquette – Dr E.M. Wijerama – 1948)

Safety & Quality
• Closely related but not completely overlapped
• Safety is the first part of quality – health care must guarantee its’
delivery
• More net clinical benefit will occur by improving quality
• Safety is freedom from injuries. Prevention of errors and adverse
events… a Utopia?

Harm, Hazard & Risk
• Harm – physical or psychological damage to an individual

• Error
• Failure of a planned action to be completed as intended or the use of a wrong
plan to achieve an aim
• Omission and Commission
ERRORS
Mistakes
Errors in Planning
Skill Based Errors
Errors in Execution
Knowledge Based
Incomplete
Rule Based
Redundant and
Inconsiderate
Action Based
(SLIPS)
Memory Based
(LAPSES)
Violations
Negligence
Rasmussen J. Skills, rules and knowledge: signals
signs and symbols, and other distinctions in human
performance models. IEEE Trans Sys, Man, Cyber
1983;13(3): 257-66

• Near Miss
An unplanned event that did not result in injury, illness, or damage
– but had the potential to do so
• Adverse Event (AE)
An injury caused by medical management rather than the underlying
condition of the patient
• Preventable Adverse Event
An adverse event attributable to an error
Negligence

• Never events
Serious, largely preventable patient safety incidents that should not
occur if the available preventative measures have been implemented
by healthcare providers
e.g. Amputation on a wrong leg
• Negligence
Failure to meet standard practice of an average qualified physician
practicing in the specialty in question
Bolam’s test

Clinical Administration Clinical Process or Procedure Documentation
Iatrogenic or Hospital
based Infection
Blood & Blood Products
Medication
Oxygen, Gas & VapourNutrition
Infrastructure and
Logistics
Equipment
Patient Accidents
Resources/
Organisational
Behaviour of HCW
Adverse
Events

Heinrich’s Law
Unnoticed Errors
Near Misses
Errors considered
insignificant
Errors that can
cause harm
Serious
Errors
Unreported
Reported
1
30
300

Theory of Errors
• Shame, Blame and Punish – past
• Modern theory – Errors are due to
Human Error At Risk Behaviour Reckless Behaviour
Intentional behaviour causing
errors
Most when drifting away from
rules & taking short cuts
Conscious disregard of patient
safety
Difficult to eliminate
Not blameworthy

Failures
Active Failures
• Unsafe acts that can be directly linked at the level of operator
• Occur at the time of incident and effects felt immediately
Latent Failures
• Not under direct control of operator
Fatigue
Stress & emotions
Interruptions
Complexity – poor design and organisation
Transition - handover

Swiss Cheese Effect (James Reason)
• Most accidents occur due to a series of small failures lining up
Slices – defences, barriers, safeguards
Holes – weaknesses, breeches. Constantly opening, closing and shifting
Alignment causes – ‘trajectory of accident opportunity’
• e.g. Fall in ward
Frail elderly patient on 3 drugs causing postural hypotension trying to go to the toilet when support staff workers were few
in a busy ward with a wet floor
Ceylon College of Physicians. College Lecture: 2nd April, 2019Reason J. Human error: models and management. BMJ
2000;320(7237):768-70

Systemic migration to boundaries. Amalberti et al (2006). Violations and migrations in healthcare: a framework for understanding and
management Ceylon College of Physicians. College Lecture: 2nd April, 2019

An experience in Sri Lanka
Case 1
• Mr A, 56 year old male
• Presented with cough and high fever – 3 days
some scattered crepitations on R/s
• ? Clinical Diagnosis of a LRTI and commenced treatment
• Chest X Ray ordered

• PMH/PSH –
a) Varicose vein surgical intervention with endovascular laser therapy by a
Surgical team at CNTH 3 years back
b) Investigated for Headache with MRI Brain in private sector 1 year back
• Management
Cardiovascular/ Respiratory stability was maintained
Escalated treatment to empirical treatment of Infective Endocarditis
Informed patient of the incidental detection without any prejudice
– Duty of Candour
Transferred to cardiothoracic unit NHSL
No evidence of Infective Endocarditis
Underwent open cardiac surgery for removal of wire

Post event
• Patient was discharged from NHSL. Not transferred back
• An official from the Ministry of Health contacted me & my trainer
regarding this event
Record of statement
• No further feedback from the Inquiries Unit of MoH
• No evidence of record found at Inquiries Unit

Consequence
• ?Process terminated due to poor association and causation - Unlikely
• ?Withdrawal of complaint by patient - Mediation
• ?Manipulation by the involved parties – Foul play

Reporting
• Leads to learning and improvement of safety
Generation of alerts –
Dissemination of ‘lessons learnt’
Analysis can reveal unrecognised trends and hazards
• Successful reporting and learning system should have/be
Non punitive
Lead to constructive response
Disseminate information and recommendations

Factors that impede error reporting
Fear of punishment
Punitive Culture
Embarrassment
Shame of being reported
Concern of error rates
Inappropriate use of
information
Errors are mistakes
Non intentional
We are humans
We all make mistakes
Learn and prevent
Identify areas to improve
Perception Reality
Samaranayake NR. Avoiding medication errors in the hospital: the wary forward. The Sri Lanka Prescriber. 2014 22(2). 6-9

Root Cause Analysis
• Primary aim – Leaning from mistakes to reduce likelihood of
repetition and not to apportion blame
• However – if recklessness, maliciousness or incapability are detected
– necessary steps could be taken

1) Gathering an mapping information
2) Identify care and service delivery problems – Omissions and
Commissions
3) Analyse problems – use tools
4) Generate recommendations and solutions
5) Implement solutions
6) Reporting & Dissemination

5
4
3
2
1
1 2 3 4 5
5
4
3
2
1
10
8
6
4
2
15
12
9
6
3
20
16
12
8
4
25
20
15
10
5
Risk Assessment
National Patient Safety Authority (NPSA), UK

Experience from UK
Case 2
• Mr Y, PMH - HTN and Mild mitral valve disease
• ED by ambulance at 21.13 hours on 18/06/17
• C/o Sudden-onset interscapular pain, dizziness, and transient lower
limb sensory impairment – 3 hours
• All symptoms resolved at the time of assessment by the on-call core
medical trainees (Doctor 1, followed by Doctor 2)

• Evidence of multiple organ dysfunction
hypotension, elevated lactate, raised urea and creatinine
• IV fluid resuscitation. Antihypertensives withheld
• CXR demonstrated an abnormal appearance of the mediastinum
ECG - AF with a ventricular rate of 110/min
• Point of care Troponin I, dDimer – normal

• Worsening (but asymptomatic) hypotension
transferred to ED resuscitation bay by nurses
• Repeat assessment by Doctor 2 - further IV fluid boluses - blood pressure picked up
• Transferred to an inpatient medical bed for on-going intravenous fluids/observation and
continuous cardiac monitoring
• Blood pressure remained borderline low overnight
• Consultant-led post-take ward round at 0910 hours the following morning
– Considering a Aortic Dissection
• CT scan at 10.50 hours revealed a type A Aortic dissection extending to the aortic root,
with features of contained rupture and a moderate haemopericardium
• The patient was urgently transferred to the Royal Papworth Hospital for surgical
intervention

Effect on Patient
• Emergency surgical repair
• Following extubation on D3 noted to have mild dysphasia
Acute perioperative stroke?
• NCCT brain & MRI Brain - longstanding right posterior cerebellar infarct
not accounted for the neurological findings.
• The dysphasia resolved spontaneously
But complicated by dysphagia and recurrent aspiration pneumonia
• Reviewed by the neurology and ENT teams
• No definitive cause could be identified for the dysphagia
• Discharged home on 02/08/18 (D45) with a safe swallow

Patient Factors
• Low Self reported pain score
• Self reporting of a twisting
movement – mechanical
• Resolved Lower limb sensory sx
Staff Factors
• Both doctors junior in service
• Unremarkable examination – low urgency for
• AF considered Chronic as patient reported of
Mitral Valve Disease
• Ramipril attributed to the renal dysfunction
• Rapid AF considered due to hypotension
• Hypotension responsive to fluid considered a
non critical process
Communication Factors
• Initial nursing documentation should
have alerted about dissection
• Nursing staff noted discrepancy of
Arm BP – missed by medical staff
• Nursing staff escalated patient to
Resus bed in ED
Task Factors
• No overall guideline for
junior doctors in diagnosis
and management of acute
chest pain in adults
Organisational strategic
• Failure to learn from
previous events
Education & Training
• Junior doctors unlikely to
have come across a similar
patient
Working Environment
• Patient assessed by
Doctor 1, before being
handed over to Doctor 2
for review (which
occurred after Doctor 1
had finished their shift).
• Patient subsequently
handed over to care of
Night medical registrar
Equipment & Resources
Nil

• Conclusion & Recommendation
Root cause – lack of comprehensive guideline to assist junior doctors in the diagnosis and
management of adult patients with chest pain
Development and published a guideline
Learning from this SI added in the Trust Patient Safety Improvement Plan (2018- 2020) -
Strengthening from learning from RCA investigations work stream which aims to agree a
dissemination framework for learning from Sis
Opportunity for reflection and counselling of doctors involved in a non punitive manner
Apology to the patient – informally, and formally by a letter

Clinical Governance
• Accountability
• Continuous improvement of quality
• Safeguarding high standards

Milestones of Quality in Sri Lanka
• Up to 2009 main focus – Implementation of 5S concept
• 2010 – MoH guidelines
Establishment of a Quality Management Unit (QMU) & Work
Improvement teams in hospitals
• 2012 – National Quality Assurance Programme
• 2015 –Master Trainers Health Quality and Safety

Current trend in Sri Lanka
• New reporting system - Adverse Events and Readmissions (2016)
(similar to reporting of notifiable diseases)
The guideline acknowledges
• Covering up of incidents, lack of knowledge of staff
• Blame and shame leads to under-reporting
• Deprive opportunity to learn from mistakes

• Part A
Filled by any HCW in any language
Filled in immediately after occurrence of the event when the subject and
environment is safe
Report immediately to senior most official and the director/superintendent
• Part B
Filled by the head of the unit
• Investigate the root cause and contributory factors documented after
discussion with involved individuals
• Dispatch to the QMU. 1 copy kept in the ward

• Further root cause analysis by Director, relevant consultant and other
stakeholders
• No breech of confidentiality or criticism
• Every attempt not to find fault with individual unless there is gross
negligence
• Preventative and corrective actions. Develop mechanisms to avoid
such events. Implement, monitor and audit
• Records maintained at QMU – report sent to D/HQS quarterly –
Annual report

Building a safe healthcare system
• Principles
• Policies
• Procedures
• Practice

Principles
• Safety is everybody’s business… in all levels
• Senior members to accepts setbacks and anticipates
errors
- Avoid ‘God Phenomenon’
• Safety issues considered regularly at the highest level of
priority
• Past events are reviewed and changes implemented

God Complex
• Unshakable belief of consistently inflated feelings of personal ability
privilege or infallibility
• Refusal to admit possibility of error or failure, even in irrefutable
evidence, intractable problems or difficult or impossible tasks
• ම ෝමෙන් මුලා මෙලා, ාමෙන් උදම් මෙලා…
ා ෙරි උගතා, ා ෙරි ජගතා සිතො මිනිො ම ෝඩමෙකී (Victor Ratnayake)

Tunnel Vision
• Irritation with anyone or anything interrupting
• Rigidity and unwillingness to accept suggestions
• Refusal of offers of assistance
• Reluctance to take breaks
• Confusion with the rest of the environment – grasping only a part

Principles
• Safety is everybody’s business
• Senior members to accepts setbacks and anticipates
errors
- Avoid ‘God Phenomenon’
• Safety issues considered regularly at the highest level of
priority
• Past events are reviewed and changes implemented

Principles
• Concentrate on rectifying the system vs. blaming the
individual
• Understand that effective risk management depends on the
collection, analysis, and dissemination of data
• Proactive approach in improving safety—
seeks out error traps
eliminates error producing factors
brainstorms new scenarios of failure

Policies
• Safety related information channeled to higher levels
• Risk management is not an oubliette – a trap door dungeon
• Safety meetings – multidisciplinary contribution
• Don’t shoot the messenger
• Top managers create a
reporting culture
just culture
open culture

• Reporting includes qualified indemnity, confidentiality,
separation of data collection from disciplinary procedures
• Disciplinary systems agree the difference between
acceptable and unacceptable behaviour and involve peers

Procedures
• Training in recognition and recovery of errors
• Feedback on error patterns
• Job Protocols
• Procedures must be intelligible, workable, available
• Supervisors need to train their charges in the mental as well
as the technical skills necessary for safe and effective
performance

Practices
• Rapid, useful, and intelligible feedback on lessons learnt
and actions needed
• Conclusions welcomed and acted on
• And when mishaps occur
• Acknowledge responsibility
• Mitigate
• Inform & Apologize

Look after yourself before looking after your
patients

Duty of Candour

Culture – a paradigm shift
• Reporting Culture
Staff have confidence in the local incident reporting system and use it to notify health care
managers of incidents that are occurring, including near misses
• Just Culture
Staff, patients and carers are treated fairly, with empathy and consideration when they have been
involved in a patient safety incident or have raised a safety issue
• Informed Culture
Staff feel comfortable discussing patient safety incidents and raising safety issues with both
colleagues and senior managers
• Learning Culture
The organization is committed to learn safety lessons
Communicates them to colleagues- Remembers them over time

Just Culture & No Blame Culture
• All HCW have a duty to protect just culture.
Clinicians acknowledge safety threats and striving to improve
safety
Administrators need to design to minimum risk
• No blame culture accepts that large amounts of unsafe acts as
‘honest errors’.
But there are flaws
1) Failure to confront wilful, repetitive dangerous behaviour
2) Failure to distinguish culpable from non-culpable mistakes

• There is none righteous, no, not one… for all have sinned and fallen
short of the glory of God
(Romans 3)
• සබ්මෙ පුථුජ්ජො උන් ත්තකා (?)
All worldlings are mad

Conclusion
• Human errors are inevitable
• Medical errors needs to be viewed as breakdown of defences
• Encouragement and facilitation of reporting
• Paradigm shift to no blame culture, just culture and
• Welcome learning process in errors
• Design systems to minimise errors
• Clinicians need to be more proactive in clinical governance

SAFETY
• Sense the error
• Act to prevent it
• Follow guidelines
• Enquire into event
• Take remedial action
• Your responsibility

Thank you
• “Lord, grant me the courage to realize my daily mistakes
so that tomorrow
I shall be able to see and understand in a better light,
what I could not comprehend in the dim light
of yesterday”
(Maimonides)

To err is human: What about us physicians?

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