Risk Management and Safety in Health Care Organizations Fadi El-Jardali, MPH, PhD November 1, 2016 Day 1 1
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 2
Learning outcomes 3 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
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 4
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 fragmentation Doctors 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, timepressed, 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-asimagined and work-as-done.
A health system where the work-asimagined 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 THINGS Ø Monitor it all Ø But 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 happen Ø Bad outcome from care Ø Major & enduring loss of function Ø An examination of past events Ø Deficient process of care ØCould 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 41
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. 42
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 43
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. 44
Risk Management is a Proactive Strategy Its components include: Risk identification Risk assessment Risk control Evaluation of risk management activities 45
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 46
We cannot change the human condition, but we can change the conditions under which humans work. (Reason 2000) 47
Exercise Identify patient safety issues in your organization 48
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 49
Some Reasons Why Errors Occur System Factors Complexity of health care processes Complexity of health care work environments Lack of consistent administration practices Deferred maintenance Clumsy technology Human Factors Limited knowledge Poor application of knowledge Fatigue Sub-optimal teamwork Attention distraction Inadequate training Reliance on memory Poor handwriting 50
Multi-Causal Theory Swiss Cheese diagram (Reason, 1991) Triggers Lack of Procedures Punitive policies Production Pressures Mixed Messages Zero fault tolerance Sporadic Training Attention Distractions Deferred Maintenance Clumsy Technology DEFENSES Adverse Event 51
The Swiss Cheese Model of Accident Causation Organizational Factors w Untested Equipment w Changing Patient Population Procedures wtailored to fit wis Support Communication Patterns w Loss of Situational Awareness w Method of Report Failures in the System Environment wlayout of Unit wnoise Level 52
Two Ends of Health Care Systems PATIENT Sharp End Practitioners Tools of the Trade Physical Infrastructure Health Plans, Payers... 53 Blunt End Regulations... Financing, policies
Quality & Safety Framework Continuous Assessment DEFENCES Report Survey Selfassessment THE GAPS Standard s External Review 54 Safe System Sustaining Improvement Priority Areas for Action Adapted from J. Reason
No Quality & Safety Framework DEFENCES Assessment Standards Continuous Improvement Identification THE GAPS Goals? Measurement? 55 Unsafe System Risk Management? Sustaining Improvements? Adapted from J. Reason
Life at the Sharp End PATIENT SAFETY TRIGGER (wrong drug prescribed) 1 st Defense (distracted nurse) 2 nd Defense (pharmacy) 3 rd Defense (another distracted nurse) Latent failure (understaffing) Latent failure (no Rx tracking) Latent failure (understaffing) 56 EVENT
Life at the Sharp End TRIGGER (wrong drug prescribed) 57 1 st Defense (distracted nurse) 2 nd Defense (pharmacy) 3 rd Defense (vigilant nurse) Adverse Event Averted Latent failure (understaffing) 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.
Life at the Sharp End Standardized approaches can reduce variability and improve system efficiency TRIGGER (wrong drug prescribed) 1 st Defense Template Adverse Event Averted 58
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) 59
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 60
Errors are inevitable.but most are preventable 61
Not Who caused the accident but 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. 62
We cannot change the human condition, but we can change the conditions under which humans work. (Reason 2000) 63
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 64
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 65
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?) 66
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. 67
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 68
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. 69
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 70
Hazard vs. Risk- 2 Risk = Hazard x f (Exposure) 71
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 materialise 2. Describe the causal factors that could make the risk materialise 3. 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.) 72
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 73
Why Risk Management? The culture, process and structures that are directed towards the effective management of potential opportunities and adverse effects 74
Accreditation Requirements Organizations must have a documented risk management plan 75
76 Healthcare Risk Categories
A. Patient Care-related Risks 1. Inappropriate or incorrectly performed medical treatment / diagnosis 2. Confidentiality and appropriate release of information 3. Protection from abuse, neglect and assault 4. Securing appropriate informed patient consent for treatment 5. Nondiscriminatory treatment 77
A. Patient Care-related Risks 6. Protection of patient valuables from loss or damage 7. Appropriate assessment and transfer of patients 8. Patient participation in research studies 9. Access to care 78
B. Employee-related Risks 1. 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 79
C. Risks related to visitors 1. Infections 2. Injuries caused by slips, falls, and other mishaps 80
D. Property-related Risks 1. Buildings and valuable equipment: risk of losses due to fires, floods, etc 2. Paper and/or electronic records (patient, business and financial): risk of damage, destruction 3. Property and liability losses 81
Reducing harm by identifying and controlling hazards 82
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. 83
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. 84
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 85
Contributory Factors 1. Individual factors 2. Team and social factors 3. Communication factors 4. Task factors 5. Education and training factors 6. Equipment and resources factors 7. Working conditions 8. Organizational and strategic factors 9. Patient factors 86
IV. Types (classes) of hazards Biological (infectious) Chemical Physical Ergonomic Psycho-social Health hazards Safety 87
Examples of hazards in a hospital Biological Chemical Physical Ergonomic Psychosocial Safety Hepatitis (B, C); Tuberculosis; HIV; Rubella Anti-neoplastics; Ethylene oxide; Anesthetic gases; Mercury; Asbestos; Formaldehyde Noise; Ionizing radiation; Laser Work stations; Lifting & manual handling Stress; Shift work; Violence Personal (Falls)/ Institutional (fire, explosions) 88
89 Risk perception
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96 Daily Telegraph 20 August 2002
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 97
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 98
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. 99
How to control hazards RISK MANAGEMENT For example, in the case of occupational health and safety (OHS): Hazard mapping Job safety (hazard) analysis 100
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 101
Steps in risk management Step 1 Step 2 Step 3 Step 4 Step 5 Identify hazards and hazardous jobs Assign priority for each hazard and hazardous job Assess the risk to find out exactly what makes it hazardous Work through the hazards and hazardous jobs in order of priority Control the risk(s) or fix the problem(s) Evaluate periodically to verify how successfully OHS risks are being managed 102
PHC hazards by group at risk HAZARD Staff Patient Guest Biological Chemical Physical Ergonomic Psychosocial Safety 103
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) 104
PHC hazards by department HAZARD Laboratory Radiology Etc.. Biological Chemical Physical Ergonomic Psychosocial Safety 105
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Hazard mapping tool Name of staff/ officer: Work area Date Area Diagram Key Hazards Control measure 1. 2. 3. 4. 107
Excercise 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.. 110
111 Wrap up Day 1