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Risk Management and Safety in Health Care Organizations
Fadi El-Jardali, MPH, PhDNovember 1, 2016
Day 1
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Objectives � Increase knowledge about concepts of safety and risk
management in health care organizations� Understand the concepts of errors and human factors ,
incident reporting system and steps of risk management� to increase the knowledge to effectively implement risk
management and safety approaches and tools � to prepare participants to develop risk management and
safety plan for your organizations. � provide participants with hands on experience and practical
knowledge on risk management and safety in primary health care
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Learning outcomes � Understand the concepts of safety and risk management in
health care organizations� Understand the concepts of errors and human factors ,
incident reporting system and steps of risk management� Understand the system approach related Risk Management
and Safety in health organizations � Develop the knowledge regarding different type of risks in
the health care organizations� Understand and apply the risk management steps including
identifying, analyzing, evaluating, treating, monitoring and communicating risk
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Learning Outcomes (Cont’d)� Conduct risk assessment using the Severity Assessment Code (SAC) score � Apply skills to implement common tools for identifying and addressing
the root causes of critical incidences in organizations� Failure mode and effects analysis (FMEA) & RCA
� Apply incident reporting and investigation by using the incident reporting system / guidelines / form used in Kuwait
� Develop skills to fill incident report� Develop corrective action plan based on risk quantification results � Apply skills on ‘HOW’ to effectively develop, implement a risk
management and safety plan
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When you usually get to the end of the day, you always find two things…
1. You didn’t accomplish everything you imagined you would.
2. Your day wasn’t anything like how you’d imagined.
This distinction between Work as Imagined (WAI) and Work As
Done (WAD) is … everywhere
Thanks to Drs. Jeffrey Braithwaite and David Marx
What they do seems perfectly logical, obvious and feasible.
In health care, those doing WAI have designed, mandated or encouraged a bewildering range of tools, techniques and methods, to reduce harm to patients.
E.g., root cause analysis, hand hygiene campaigns, failure modes effects analysis ...
And there’s lots of others
…
But the rate of harm has flatlined at 10%
Meanwhile work is getting done, often despite all the policies, rules and mandates
WAD—workarounds
WAD—fragmentationDoctors in Emergency Departments in a study:�Were interrupted 6.6 times per hour.�Were interrupted in 11% of all tasks.�Multitasked for 12.8% of the time.
Doctors in Emergency Departments in a study:§ Spent on average 1:26 minutes on any one
task.§ When interrupted, spent more time on
tasks.§ And … failed to return to approximately
18.5% of interrupted tasks.
So work-as-imagined often have some sort of linear, mechanistic view of the system.
Instead, health care is a complex adaptive system delivered by people on the front line who flex and adjust to the
circumstances.
The amazing thing about health care isn’t that it produces adverse events in 10% of all cases, but that it produces safe care in 90% of cases.
Few people have ever looked at why things go right so often
What none of them know is that there are 600+ policies in operation right now, meant to “guide” their work.
Then when we observe their behaviours and see them taking patients’ histories, or giving out medications, or doing procedures, or taking x-rays of patients, or tending to their needs, or caring for them …
We can notice instead a lot of fraught, time-pressed, relentlessly busy work going on virtually across the entire shift.
Sometimes it never, ever unfolds like a policy or procedure says it should.
So, health care doesn’t look like this.
It looks like this.
And therefore the only real solution is to try and reconcile work-as-imagined and work-as-done.
A health system where the work-as-imagined policies, regulations, standards etc are much closer to an understanding of how work is actually done.
SUBWAY SAFETY – NEW YORK CITY
THE PROBLEM, AND THE SOLUTION
WHAT ABOUT BETTER SYSTEM DESIGN?
YET, IT’S NOT ONLY ABOUT SYSTEM DESIGN
Architecture examples
FOCUSING ON THE RIGHT THINGSØMonitor it allØBut actively
manage:§ System Design§ Safety Culture
SAFETY � How do we prevent
backing over a child?
Solutions
� TECHNOLOGICAL SYSTEMS
� •Backup camera� •Backup sensor with
automatic breaking� •Backup horn
� PROCEDURAL SYSTEMS� •Walk around back of car
before getting in� •Use a spotter
Yet, the most simple of steps, the walk around, most drivers do not do
Is that our “culture?”
� Quality is about achieving optimal outcomes and
also about avoiding risks minimizing harms
What Patient Safety Is and Is Not� It is not what most of us were thinking about 10 years ago
� It is not what ‘we have always done’
� It is the most significant change in the healthcare system in over a century
� It is changing the face of modern healthcare
Patient Safety: Challenges and Concerns� Difficulty recognizing errors
� Lack of information systems to identify errors
� Relationship of trust with providers
� Shortages of clinical professionals
� Concern about liability
� Limited capacity on how to use quality improvement tools
� Culture of patient safety is lacking
What is patient safety?
� Patient safety is the prevention of harm or injury to patients
� Patient safety is that which allows you to pursue quality
� I.e., without basic safety you can’t have quality.
� Patient safety is the identification and control of things that could cause harm to patients (i.e.
hazards)
Patient Safety Terms� Adverse Event
� Medical Error
� Sentinel Event
� Near Miss
� Retrospective Analysis
� Prospective Analysis
Ø Identifying risks and processes before they happenØ Bad outcome from careØ Major & enduring loss of functionØ An examination of past eventsØ Deficient process of careØCould have resulted in loss, injury or illness, but did not
Myth: Everyone else has a patient safety problem – except us.
An Organization’s Goal Should Be� To prevent or minimize risk of harm to patients, staff,
visitors, and volunteers, thereby reducing or eliminating any potential losses including financial ones
� Risk Management is about harm reduction which could be achieved by risk identification, risk assessment, risk control and evaluation
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Risk Management in Healthcare Institutions
� Risk management in the healthcare industry is increasingly becoming an important area of concern for health care organization, administrators, medical practitioners, insurers, consumer organizations and other key stakeholders.
� “ Medical institutions and medical professionals must take pro active actions to ensure the minimization and elimination of medical errors”
� Risk management in health care emerged as a result of the malpractice crisis of the 1970s.
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Risk Management in Healthcare Institutions
� Objectives of include:� The delivery of safe and quality healthcare to patients� Ensuring safety among patients, staff and visitors� Identifying and controlling hazards and injuries� Protection of assets and other resources
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Risk Management in Healthcare Institutions
� Stakeholders in Risk Management include:� Patients- right to safe and effective medical treatment� Government- ensure safety, clinical performance and quality to
protect public health� Manufacturers of medical equipment and drugs- required to
ensure good manufacturing practice and apply established standards for safety and risk
� Healthcare Facility-Proper selection of equipment / facilities; minimize the occurrence of injury or death to patient, employee or property damage.
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Risk Management is a Proactive Strategy
Its components include:�Risk identification�Risk assessment�Risk control�Evaluation of risk management activities
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Evaluation of Risk Management Activities� Organizations should regularly ask itself: How effective
is our risk management system?� Organization’s risk management practices need to be
evaluated. This includes:� Reviewing the frequency and severity of losses� Analyzing incident and occurrence trends� Reviewing policies and procedures that might prevent
or minimize risk� Assessing new or increased risk� Assessing the effectiveness of risk management
education and communication strategies
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“We cannot change the human condition, but we can change the conditions under which humans work.” (Reason 2000)
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Identify patient safety issues in your organization
Exercise
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From a Traditional View to a System Approach
� Person approach to patient safety (practitioner as potential culprit to be blamed)
� System approach to patient safety
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Some Reasons Why Errors Occur
� Complexity of health care processes
� Complexity of health care work environments
� Lack of consistent administration practices
� Deferred maintenance
� Clumsy technology
� Limited knowledge
� Poor application of knowledge
� Fatigue
� Sub-optimal teamwork
� Attention distraction
� Inadequate training
� Reliance on memory
� Poor handwriting
System Factors Human Factors
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Multi-Causal Theory “Swiss Cheese” diagram (Reason, 1991)
AdverseEvent
DEFENSES
Lack of Procedures
Punitive policies
Mixed Messages
Production Pressures
Zero fault tolerance
Sporadic Training
Attention Distractions
Clumsy Technology
Deferred MaintenanceTriggers
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w Untested Equipment
w Changing Patient Population
wTailored to fit
wIS Support
w Loss of Situational Awareness
w Method of Report
wLayout of Unit
wNoise Level
Failures in theSystem
OrganizationalFactors
Procedures
Communication Patterns
Environment
The “Swiss Cheese”Model of Accident Causation
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Two Ends of Health Care Systems
SharpEnd
BluntEnd
PATIENT
• Practitioners• Tools of the Trade
• Physical Infrastructure
• Financing, policies
• Health Plans, Payers...
•Regulations ...
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Quality & Safety Framework
Safe System
DEFENCES Self-assessmentSurvey
ReportContinuousAssessment
THE GAPS
Standards
External Review
Priority Areas for Action
Sustaining ImprovementAdapted from J. Reason
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No Quality & Safety Framework
UnsafeSystem
DEFENCESStandardsAssessment
IdentificationContinuous Improvement
THE GAPS
Goals?
Measurement?
Risk Management?
Sustaining Improvements?
Adapted from J. Reason
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Life at the Sharp End
1st Defense(distracted nurse)
2nd Defense(pharmacy)
3rd Defense(another distracted nurse)
Latent failure(understaffing)
TRIGGER(wrong drug prescribed)
Latent failure(no Rx tracking)
Latent failure(understaffing)
EVENT
PATIENT SAFETY
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Life at the Sharp End
1st Defense(distracted nurse)
2nd Defense(pharmacy)
3rd Defense(vigilant nurse)
Latent failure(understaffing)
Adverse Event Averted
TRIGGER(wrong drug prescribed)
Latent failure(no Rx tracking)
Latent failure(understaffing)
Sources: Reason J Human error: Models and Management, BMJ, 18 March 2000. Cook R. University of Chicago, 1991-99.
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Life at the Sharp End
1st Defense Template
Adverse Event Averted
TRIGGER(wrong drug prescribed)
Standardized approaches can reduce variability
and improve system efficiency
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What is the difference between focusing on the person and focusing on the system?
� Person approach
� Focus on individuals
� Blaming individuals for
forgetfulness, inattention, or
carelessness, poor production
� Methods: poster campaigns, writing another procedure, disciplinary
measures, threat of litigation,
retraining, blaming and shaming
� Target: Individuals
� System approach
�Focus on the conditions under which
individuals work
�Building defenses to avert errors/poor productivity or mitigate
their effects
�Methods: creating better systems
�Targets: System (team, tasks,
workplace, organization)
System Approach to Human Error� Humans are fallible and errors are to be expected, even in the
best organisations.
� Focus: conditions under which individuals work
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Errors are inevitable
………….but most are preventable
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Not Who caused the accidentbut What caused the accident?
“Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single
individuals.”
Lucien L. Leape, M.D.
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“We cannot change the human condition, but we
can change the conditions under which humans
work.” (Reason 2000)
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Questions Surveyors Might Ask
� Is there a reporting policy and process for actual and potential
adverse events?
� Are improvements made following incident investigation and
follow-up
Risk Management
�Focus on the system rather than the individual incident
� Is anticipatory not reactive in emphasis� Incident investigation and reporting supports
risk management by monitoring it
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concepts---
� Hazard versus Risk� Safety culture & the elements of a safe and healthy work
environment� Classification (categorization) of hazards in a PHC� The individual versus the work environment (Who is our
concern?)
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I. Hazard vs. Risk- 1� Hazard is any activity, situation or, substance that can cause
harm. It is a potential source of risk.
� Risk is the probability (odds) of a hazard causing harm.
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What is Risk?
The chance of something happening that will have an impact on the objectives. It is measured in terms of consequences and likelihood
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What is Risk? � Risk is the possibility of exposure to such factors as financial
loss, physical damage, injury or delay as a consequence of action or a lack of it.
� The level of risk exposure is the combination of the likelihood of risk occurring and consequences if it does occur.
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What is Risk? � Risks and their consequences might include, but are not limited to:
� Breach of legal or contractual responsibility� Breach of security� A threat to physical safety� An adverse event during the care process� Deficiencies in financial controls and reporting� Failure of a project to reach its objectives� Failure of equipment or computer system� Fraud� Patient or family dissatisfaction� Unfavorable publicity
� In any healthcare organization risks can arise from internal and external sources
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Hazard vs. Risk- 2
Risk = Hazard x f (Exposure)
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Describing risk – the ‘3 C’s’Risk is inherently negative, implying the possibility of
adverse consequences. 1. Describe the potential consequences if the risk
were to materialise2. Describe the causal factors that could make the risk
materialise3. Ensure that the context of the risk is clear, e.g. is the
risk ‘target’ well defined (e.g. staff, patient, department, PHC, etc.) and is the ‘nature’ of the risk clear (e.g. financial, safety, physical loss, perception, etc.)
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Which of the following are adequate descriptions of risk?
� Risk to patients due to errors and unsafe clinical practice caused by reduced skill base and competence of junior and middle grade medical staff
� Needlestick injury� OSH� Reduced staff retention and increased sickness absence due to
reduction in morale caused by increased workload, pressure and stress to achieve targets
� Inadequate patient transfer� Budget overrun and financial deficit due to cost of introducing new
technologies/medicines as required by NICE guidance� Medication error
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Why Risk Management?
The culture, process and structures that are directed towards the effective management of potential opportunities and adverse effects
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Accreditation Requirements�Organizations must have a documented
risk management plan
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Healthcare Risk Categories
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A. Patient Care-related Risks1. Inappropriate or incorrectly performed medical treatment
/ diagnosis 2. Confidentiality and appropriate release of information3. Protection from abuse, neglect and assault4. Securing appropriate informed patient consent for
treatment5. Nondiscriminatory treatment
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A. Patient Care-related Risks6. Protection of patient valuables from loss or damage7. Appropriate assessment and transfer of patients8. Patient participation in research studies 9. Access to care
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B. Employee-related Risks1. Occupational illness and injury
� Infections� Exposure to toxic chemicals� Electrical hazards� Sprains and back injuries� Burnout
2. Allegations of discrimination in recruitment, hiring, and promotion based on age, race, sex, national origin, disability; wrongful termination
3. Impaired physicians and other providers who pose a threat to patient or employee safety
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C. Risks related to visitors
1. Infections2. Injuries caused by slips, falls, and other
mishaps
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D. Property-related Risks1. Buildings and valuable equipment: risk of losses due to fires,
floods, etc2. Paper and/or electronic records (patient, business and
financial): risk of damage, destruction3. Property and liability losses
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Reducing harm by identifying and controlling hazards
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What is a hazard?� In safety, a HAZARD is anything that can put somebody or
something at risk of damage or injury or harm.
� In medicine, hazards are called risk factors.
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Why focus on hazards and harm?� In medicine, if we want to reduce the incidence rate of a disease
we
� Look for risk factors
� Figure out how they contribute to the disease
� Figure out how to reduce or eliminate the risk factor.
� In safety, if we want to reduce adverse events, we
� Look for hazards
� Figure out they contribute to the adverse events
� Figure out how to reduce or eliminate the hazard.
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How do you identify safety hazards?
� Proactive techniques, such as Healthcare Failure Mode and Effect Analysis (preventive medicine)
� Focused upon complex, face-paced areas of the hospital
� Accomplished prior to implementing new software or new devices
� Reactive techniques, such as Root Cause Analysis (RCA) (acute care medicine)
� Based on reports of close calls
� Based on reports of injuries
Contributory Factors1. Individual factors2. Team and social factors3. Communication factors4. Task factors5. Education and training factors6. Equipment and resources factors7. Working conditions8. Organizational and strategic factors9. Patient factors
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IV. Types (classes) of hazards
� Biological (infectious)� Chemical� Physical � Ergonomic� Psycho-social
� Safety
Health hazards
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Examples of hazards in a hospital
Biological Hepatitis (B, C); Tuberculosis; HIV; Rubella
Chemical Anti-neoplastics; Ethylene oxide; Anesthetic gases; Mercury; Asbestos; Formaldehyde
Physical Noise; Ionizing radiation; LaserErgonomic Work stations; Lifting & manual
handlingPsycho-social
Stress; Shift work; Violence
Safety Personal (Falls)/ Institutional (fire, explosions) 88
Risk perception
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Risk perception
90
Risk perception
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Daily Telegraph 20 August 200296
Clinicians � Delay or missed diagnosis/treatment resulting in increased
mortality & morbidity� Risk of harming patients associated with invasive procedures� Long waiting lists resulting in increased morbidity &
complaints� Medication error� Harm to staff due to violent patients
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Radiology/Pathology� Risk associated with missing specimen or X ray films� Patient Identification
� Medication, Xray & Path reports� Miss labeling of specimen
� Risk associated with Equipment Maintenance & Validation
� Risk associated with Manual handling� Risk associated with chemical waste handling� Risk associated with understaffing
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IT Concerns
� Non-human events: these events typically happen on an unpredictable basis without direct human influence
� local infrastructure failure: Emergency room is disconnected from the network backbone but some emergency help must be provided to patients.
� major industrial accidents: A large number of injuries must be treated while a power failure caused by that accident hinders provision of health care
� natural disasters: They may cause injury to the local community as well as to the local infrastructure. A power failure may hinder the operation of the medical equipment, but many injuries flood the emergency room at the same time.
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How to control hazards…
�RISK MANAGEMENT
�For example, in the case of occupational health and safety (OHS):�Hazard mapping�Job safety (hazard) analysis
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Example of Effective RISK MANAGEMENT (OHS related)� Leadership and support, with a broader role for OHS
committee (specialists) � Developing knowledge, ability and motivation � Solid, local understanding of OHS principles. � Proactive, systematic and comprehensive identification of
hazards, assessment and control of risks. � Solutions to control risks
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Steps in risk management
Step 1 Identify hazards and hazardous jobs
Step 2 Assign priority for each hazard and hazardous job
Step 3 Assess the risk to find out exactly what makes it hazardous
Work through the hazards and hazardous jobs in order of priority
Step 4 Control the risk(s) or fix the problem(s)
Step 5 Evaluate periodically to verify how successfully OHS risks are being managed
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PHC hazards by group at risk
HAZARD Staff Patient GuestBiological
Chemical
Physical
Ergonomic
Psycho-socialSafety
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Who is the staff?� Office workers � Clerks on floors� Physicians� Physicians-in-training� Medical students� Nurses/ Midwives� Nursing students� Orderlies/nursing assistants� Nursing supervisors� Pharmacists� Nutritionists� Social workers
� Lab technologists� Radiology technicians� Protection officers� Housekeeping� Drivers� Staff in laundry� Staff in kitchen� Staff in restaurants� Mortician� Technicians (electricity,
painting, plumbing, mechanic)
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PHC hazards by department
HAZARD Laboratory Radiology Etc..
Biological
Chemical
Physical
Ergonomic
Psycho-socialSafety
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Hazard mapping toolName of staff/ officer: Work area Date
Area Diagram Key Hazards Control measure
1.
2.
3.
4.
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1. Think about yourself and your colleagues – list 3 issues or concerns you have at work.
2. Now think about patients – list 3 issues or concerns you might have in relation to the safety or quality of care provided to patients in your department, PHC, etc.
3. Finally, think about your organisation– list 3 issues or concerns………..
Excercise
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Wrap up Day 1
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