Transcript Slide 1
Patient Safety
The New Healthcare Discipline
Louisiana Association for Healthcare Quality Patient Safety Boot Camp October 17, 2014 Phyllis Ragland, RN, CPHQ, CPPS
Why we are here today!
•
Medical Error
– “…an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”
“Isn’t it nice when things just work?”
http://www.youtube.com/watch?v=_ve4M4UsJQo
The New Healthcare Discipline
• Introduction to the new healthcare discipline of
Patient Safety
– Origin and evolution; • To Err is Human • Patient Safety & Quality Improvement Act of 2005 – Final Patient Safety Ruling – Relationship and alignment of Patient Safety, Quality, Risk Management; and – the commitment critical to becoming a highly reliable organization. • Bedrock of Patient Safety;
“To Err is Human” The Catalyst for Patient Safety
Creating Safety Systems in Healthcare Organizations Errors in Healthcare: A Leading Cause of Death & Injury Why do Errors Happen?
Building Leadership and Knowledge for Patient Safety
IOM “To Err is Human”
Protecting Voluntary Reporting Systems from Legal Discovery
Comprehensive Approach to Improving Patient Safety
Error Reporting Systems Setting Performance Standards and Expectations for Patient Safety
Protecting Voluntary Reporting Systems From Legal Discovery
President George W. Bush signs the Patient Safety and Quality Improvement Act 2005 with a component to create Patient Safety Organizations (PSO) that would provide organizations a new level of federal protection from discovery through submission of Patient Safety Work Product and support these organizations with patient safety education and improvement activities.
Defined Error Reporting Systems
• • •
Patient Safety Evaluation System (PSES)
• Mechanism through which information can be
collected, maintained, analyzed and communicated
• Common Formats: Provide
standardized definitions and reporting specifications
for the collection of patient safety data
Patient Safety Work Product (PSWP)
• Any data, reports, records, memoranda, analyses (e.g. RCA), or written or oral statements
assembled to improve patient safety and intended for submission to a PSO for Federal Protection of privilege and confidentiality
Network of Patient Safety Databases (NPSD)
• Receives, analyzes, and reports on de-identified patient safety event information with the
goal of large-scale aggregation and analyses
to help reduce adverse events and improve healthcare quality
PSES & PSWP Throughput: The Inclusion Process
Mechanism for collecting, managing, & analyzing patient safety data Patient Safety Evaluation System (PSES) Patient Safety Work Product (PSWP) Patient Safety Organization (PSO) Information assembled to improve patient safety and intended for submission to PSO
CMS Survey & Certification & Patient Safety Initiatives
• “CMS should further influence hospitals to reduce adverse events through enforcement of the conditions of participation. This could include more closely examining patient safety issues through the survey and certification process…”
Thomas E. Hamilton, Director
Survey & Certification Group Center for Clinical Standards & Quality Centers for Medicare & Medicaid 5 th Annual Meeting of PSOs
CMS Survey & Certification & Patient Safety Initiatives
• “AHRQ Common Formats - Information for Hospitals and State Survey Agencies (SAs) - Comprehensive Patient Safety Reporting Using AHRQ Common Formats” •
Memo # 13-19-HOSPITALS Dated March 15, 2013
• The CoP for Quality Assessment and Performance • • Improvement (QAPI) requires hospitals to track adverse patient events • However, HHS reports that hospitals fail to identify most adverse events Use of Common Formats may help meet tracking requirements • Hospitals using Common Formats and adept at analysis will be better positioned to meet QAPI requirements Surveyors are encouraged to become familiar with Common Formats
CMS Survey & Certification & Patient Safety Initiatives
•
CMS Surveyors will be evaluating
• • •
Adverse Event Oversight Systems
Program Design + Scope Feedback Systems + Learning Adverse Events Reporting: Reported Tracked Investigated Analyzed Used
5 Characteristics of High-Reliability Organizations
1. Preoccupation with failure 2. Reluctance to simplify interpretations 3. Sensitivity to operations 4. Commitment to resilience 5. Deference to expertise
http://www.beckershospitalreview.com/hospital-management-administration/5-traits-of-high-reliability-organizations-how to-hardwire-each-in-your-organization.html
Building Leadership and Knowledge for Patient Safety
• • • •
Fostering a culture of safety and learning
as a priority for everyone that works in the hospital
Mitigating Risk and Injury Strategies
through identification and implementation of proactive patient safety strategies
Planning and providing services
that meet the patient needs
Making available resources
– human, financial, and physical – for providing safe and quality care, treatment and services
Leaders Framework for Patient Safety
• • • • • • • •
Defined scope
of the Patient Safety Program Occurrences that reach the patient inclusive of Sentinel Events Near Misses Unsafe Conditions
Procedures for immediate response
to system or process • • • • failures Caring for the affected individual Containing risk to others Preserving factual information for analysis Disclosure System for
blame-free internal reporting
of a system or process failure and proactive risk assessment
Support system for staff members
who have been involved in an adverse or sentinel event (Second Victim)
Communication/Reporting avenues for dissemination
of lessons learned from RCA/FMEA/Proactive Risk Assessments and event reporting activities
Bedrock Of Patient Safety
New Healthcare Discipline Science of Patient Safety Driving Change through Measurement Mitigating Risk & Injury Using Data & Deep-Dive Analysis Redesigning for Patient Safety
Comprehensive Approach To Improving Patient Safety
Governing Board Leadership Organizational Chart
(Job Functions, Line Authority & Policy/Procedure in Day-to Day Operations and Provision of Care)
PATIENT SAFETY
Committee Structure
(Planning, Designing, Implementing & Evaluating Initiatives)
Organizational Infrastructure
Mission/Vision/Values
Relationship of Patient Safety to Risk & Quality Management
Synergy of Patient Safety, Quality and Risk Management
Creating Safety Systems in Healthcare Organizations
• • • • •
Maintain a culture of safety
that supports a safe and just culture
Identify
organizational champions
Deploy and sustain
patient safety strategies
Determine key drivers
for patient safety programs
Ensure the adoption
of current and advancing safety technologies
Creating a Culture of Safety
• •
Administer valid survey to assess culture of safety.
• Benefits: • Raise staff awareness about patient safety • Diagnose/Assess current status of organizational culture • Target low-performing domains for improvement • Identify domains of best practice to spotlight • Examine trends in culture over time • Evaluate the cultural impact of patient safety initiatives • Compare internal and external status and progress
Capitalize on “near-miss” reporting to assess culture of safety
• Set goals and develop actions to increase “near miss” reporting
http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/index.html
2012 AHRQ Patient Safety Culture Survey 12 Composite-Level Results http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/index.html
Patient Safety Awareness Ideas
• • •
Establish a Planning Team
• Team member selection (Utilize/Designate • • • Patient Safety Champions) Timeframe for Kick Off Solicit Leadership Support Establish Patient Safety Awareness Theme
Patient Safety Champion Kick Off
• Training program
Patient Safety Fair
• Awareness Signage • Success stories (Staff Posters, presentations) • Display topic-specific Patient Safety data graphics/status (include Culture of Safety results)
Patient Safety Awareness Ideas
• • • • •
Facility Open House
• Invite Community
Reward/Recognition Incentives for Staff
• Unit Award • Gift Shop Gift Certificates • Pizza Parties • Candy/Popcorn
Lunch & Learn Patient Safety Activities
• “Learn to Report & Report to Learn”
Patient Safety Awareness Simulation Center
• “House of Horrors”
Publish/Present Staff Patient Safety Stories
Science of Patient Safety
•
Essential Components of Patient Safety for creating a culture of safety & Mitigating Risk and Injury
–
Concepts
• •
System thinking and complexity Human Factors
–
Attitudes
• •
Teamwork Accountability
–
Skills
• • •
Error Causation Leadership Change Management.
What is Patient Safety?
• • “A discipline in the healthcare profession that
applies safety science methods
toward the goal of achieving a trustworthy system of health care delivery”….as well as… “an attribute of health care systems; it
minimizes
the incidence and impact of adverse events and
maximizes
recovery from such events.”
http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
How is Patient Safety achieved?
Applying the Safety Sciences
Attitudes
Teamwork, Accountability, Professionalism, Transparency, Just Culture, Etc.
Concepts
Science of Error Causation, System Thinking, Complex Systems, Human Factors, Applied Informatics, etc..
Skills
Error Analysis, Leadership, Change Management, etc..
http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
Patient Safety Complexity
•
Who is accountable and responsible for Patient Safety?
https://www.youtube.com/watch?v=cEGkrOtzqWo
System Thinking & Complexity
• • •
System Thinking
– “A conceptual framework, a body of knowledge and tools that has been developed over the past fifty years, to make the full patterns clearer, and to help us see how to change them effectively.”
Complexity
– “A series of unpredictable dynamic systems. The more complex, the more unpredictable dynamic systems are probable.”
System Failures
– “Attempting to solve complex issues without a systems thinking approach may lead to unintended consequences, despite the best intentions.”
http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
http://www.seedsystems.net/clientuploads/Slide1.jpg
System Thinking & Complexity: Example of Patient Safety Initiative
Restraint Management Key Functions Leadership Clinical Practice Information Management Staff Education Quality Measurement & Improvement Activities
Leadership Key Responsibility & Accountability Functions
Human Resources Supply & Equipment Medical Center Philosophy
Clinical Staffing
Procurement
Mission/Vision & Values Data Collection & Analysis (Time)
Supply Levels
Culture Medical Center Coordination Information Mgt Support
Designated Oversight
Why does the discipline of Patient Safety exist?
“The high prevalence of avoidable adverse events…” http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
What is the nature of Patient Safety?
“A subject within healthcare quality…” http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
What is the essential focus?
“Applying safety sciences to healthcare systems and processes…” http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
What are the properties of Patient Safety?
“…designed for the nature of illness/ condition and is dependent on understanding and learning from errors and system failures…” http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
Where does Patient Safety occur?
“…Point of care: Medical Unit, Intensive Care, Operating Room, Radiology, Outpatient Unit, Admissions, etc.…” http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
How does Patient Safety emerge?
Culture of Safety Communication Patient Centered Teamwork Just Culture Leadership Evidence-based http://www.ahrq.gov/downloads/pub/advances2/vol1/Advances-Emanuel-Berwick_110.pdf
Comprehensive Unit Safety Program (CUSP) – Change Management Tool
•
Definition:
–
CUSP
organizes change teams to improve processes by addressing system-level factors that impact patient safety •
Benefits:
– Integrates with range of safety models and initiatives – – Empowers staff Leads to Shared Mental Model – Expedites change through improved communication and collaboration – – Can be applied at any level and utilized by any group Enables wide selection of safety tools and approaches
http://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/
Why Do Errors Happen?
What you don’t know
CAN
hurt you!
Swiss Cheese Model
Near Miss or Unsafe Condition Incident
Clinical Groupings of Errors
• • • •
Diagnostic
• Error or delay in diagnosis • Failure to employ indicated test • Failure to act on results of monitoring or testing
Treatment
• Error in the performance of an operation, procedure or test • Error in administering the treatment • • Error in the dose or method of using a drug Avoidable delay/failure to treatment or respond
Preventive
• Failure to provide prophylactic treatment • Inadequate monitoring or follow-up treatment
Other
• Failure to communicate • Equipment failure • Other system failures
NQF List of “Never Events” resulting in death/serious disability
•
Care Management Event
•
Medication Error
•
Environmental Event
•
Restraint Usage
•
Patient Protection Event
•
Elopement
•
Potential Criminal Event
•
Assault (Sexual or Physical)
•
Product or Device Event
•
Contaminated Drugs
•
Radiological Event
•
MRI
•
Surgical Events
•
Retained Foreign Object
Human Factors
Things to keep in mind!
• • •
We ALL make mistakes!
Generally, human error is the result of factors or circumstances beyond our control.
Any system or process that is dependent on human perfection is intrinsically flawed.
Human Factors
“An explosion that killed seven Marines during a training exercise at an Army depot in Nevada in March was caused by human error , a military investigation has found. The blast, which also injured eight other service members , happened when a Marine operating a mortar ‘did not follow correct procedures, resulting in the detonation of a high explosive round at the mortar position,’ according to a news release from 1st Lt. Oliver David, a spokesman at the Marine Corps Base Camp in Camp Lejeune, N.C”
Human Factors
•
Multiple factors that contribute to
• • • • • • • • • • •
Human Error
Failure to communicate Lack of effective training Lapse in memory Lack of attention Fatigue Equipment that is poorly designed Noisy or poorly designed environment Person factors Inadequate technology No resources/guidelines Complexity of task
Mistake-Proofing for Human Factors
•
Design strategies to prevent errors
•
Automation
•
As appropriate
•
Incorporate “forcing functions”
•
Standardization
•
Reduce need to relay on memory
•
Develop checklists
•
Modeled by policy/procedure/guidelines
•
Incorporate into medical record documentation, as
• •
appropriate Reduce the number of process steps
•
Handoffs
•
Patient Movements Ensure redundancy (double checks)
•
High risk processes
Let’s take a break!
Next Up: Driving Change through Measurement
Driving Change through Measurement
• • •
Types of measurement techniques used to examine results and determines effectiveness of patient safety efforts Discussions around use of internal and external regulatory requirements to conduct an organizational data inventory to identify areas for actions Skills needed to conduct error analysis, conduct deep dive data analysis of event data and identify targeted strategies to improve the safety of patients.
Assessing Data Quality & Validity
• Key data assessment questions: – – What data do we have? Is there an inventory list?
Who is collecting the data?
• • Duplicate data collection occurring?
Utilizing the same standardized tool?
– What is the source of the data?
– – – Where is it housed? What is its scope (starting point to end point)?
What is its quality (standardized collection tools)? • • Is there confusion in usage, meaning and expectations?
Is there an inter-rater reliability process?
– – Who has oversight/responsibility for the data?
What reports are generated?
• Inclusive of Action Plans/Responsible Party/Due Dates – Who receives the reports?
Data Inventory Definition
• • •
Definition
– A structured and comprehensive way of identifying the organizational data asset.
Purpose
– To assure collection, analysis, reporting of critical data required by both internal and external requirements/directives by appropriate groups for performance improvement activities and decision-making.
Benefits
– Identify inconsistencies, omissions, duplications, and errors in patient safety data collection, analysis and reporting. – Communicate a comprehensive overview of patient safety data collection, analysis and reporting for an organizational shared mental model.
Steps in Conducting a Data Inventory
• • • • • • •
Communicate
Action Teams activities to Leadership/Manager/Committees/
Select/Develop Tool
to conduct Data Inventory
Identify/Assemble Team Conduct
Data Inventory Identify areas for
process improvement
– – New Data Elements Retired Data Elements – Modified Data Elements Develop
action plan
–
Include process for approval, repository and oversight
Conduct
annual evaluation
of Data Inventory for updates – – New Data Elements Retired Data Elements – Modified Data Elements
Data Inventory Example
Data Element Data Source Fall Events Event Reporting System Frequency Per occurrence Responsible Party Falls Committee Reporting Path -Unit Staff Meetings -Dept. Meetings - PI/PS
-
Committee Board NDNQI HEN Impact Areas All clinical & admin areas Regulatory Guide -PSO -TJC -CMS -NDNQI -HEN
Mitigating Risk & Injury using Data & Deep-dive Analysis
2012 AHRQ Patient Safety Culture Survey 12 Composite-Level Results http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/index.html
“Learn to Report & Report to Learn!”
100 50 0 300 250 200 150
8 <18 years
Age of Patient
242 185 181 112 Adult (18-64 years) Mature Adult (65-74 years) Older Adult (75-84 years) Aged Adult (85+ years)
100 50 0 300 250 200 150
8 <18 years
Age of Patient
242 185 66% ≥ 65 years & older 181 112 Adult (18-64 years) Mature Adult (65-74 years) Older Adult (75-84 years) Aged Adult (85+ years)
700 600 500 400 300 200 100 0
# of Patients with Repeat Falls
657 Unique Patients = 728 Falls 581pt = 581 Falls 1 Fall 20% = Multiple Falls Events 63% multiple fall events occurred during same episode of care (Injury = 1 Major, 1 Moderate, 6 Minor, 139 None) 53pt = 106 Falls 2 Falls 11pt = 33 Falls 3 Falls 2pt = 8 Falls 4 Falls
700 600
# of Patients with Repeat Falls
79% = Aggregate Single Fall Events
500 400 300 200 100 0
581 520 1 Fall 52pt 44pt 2 Falls 21% = Aggregate Multiple Fall Events 11pt 10pt 3 Falls 2pt 4pt 4 Falls 1pt 0 5 Falls 1pt 0 6 Falls
11pm - 12am 10pm - 11pm 9pm - 10pm 8pm - 9pm 7pm - 8pm 6pm - 7pm 5pm - 6pm 4pm - 5pm 3pm - 4pm 2pm - 3pm 1pm - 2pm 12pm - 1pm 11am - 12pm 10am - 11am 9am - 10am 8am - 9am 7am - 8am 6am - 7am 5am - 6am 4am - 5am 3am - 4am 2am - 3am 1am - 2am 12am - 1am 0
Fall Events by Time of Day
25 14 20 23 28 37 34 31 42 34 39 35 36 31 36 31 19 23 25 31 26 31 23
10 20 30 40 50
53
60
Activity Prior to Fall Event
200 180 160 140 120 100 80 60 40 20 0
180 TOP 5 Activity Categories 145 116 88 70 45 30 22 14 8 4 6
200 150 100 50 0 500 450 400 350 300 250
Interventions Used to Prevent Falls
TOP 5 INTERVENTIONS 458 446 434 389 365 313 225 185 178 151 80 77 26 21 5 12
200 150 100 50 0 450 400 350 300 250
Fall Patients on Anticoagulants
420 35% On Anticoagulants 229
Yes No
Scorecards
http://www.klipfolio.com/resources/articles/what-are-dashboards-scorecards
Dashboards
http://www.klipfolio.com/resources/articles/what-are-dashboards-scorecards
Let’s have lunch!
Next Up: Methodologies in Minimizing Risk & Injury
Methodologies in Minimizing Risk and Injury
• • • • • •
Gap Analysis Process Flow Charting Cause & Effect Diagraming Affinity Diagraming Root Cause Analysis (RCA) Failure Mode Effect Analysis (FMEA)
Gap Analysis
• • •
Definition
– Gap analysis refers to a study where a healthcare organization compares the present policy, procedure, SOP's, infrastructure with defined laid down standards such as Evidence-based Practice Standards, accreditation standards, regulatory standards, etc.
Benefits
– Produces a written status of the current compliance of the organization to the most recent internal/external guidelines and standards of care. – The written status, defined by organizational response, includes the identification of necessary actions to be taken to become compliant with internal/external guidelines and standards of care.
Examples
– http://www.hret-hen.org/ – http://www.ismp.org/selfassessments/Hospital/2011/Default.asp
Institute of Safe Medication Practice Self-Assessment Tool
Steps to conduct a Gap Analysis
1. Assemble the Gap Analysis team,
inclusive of both clinical and administrative staff who are directly involved in the system/process being assessed.
2. Define each item
on the Gap Analysis tool to compare current organizational practice to recommended practice.
3. Identify and discuss inconsistencies
in practice and/or perceptions related to each of the process steps.
4. Collect information
on the extent to which the process step is actually being carried out or in place, i.e. review of data reports, direct observation, policies/procedures/protocols.
5. Record the final consensus
as to the extent the safety practice is in place.
6. Measure the overall compliance
with the system/process steps, by calculating percentage (%) compliance by dividing the number of those items identified as compliant by the total number of items.
7. Identify responsible party
for follow up or action.
The target goal should be 100% compliant.
Gap Analysis Example
Institute of Healthcare Improvement (IHI) Appropriate Care Patient Safety Assessment Tool
Process Flow Chart Symbols
• • • • • • • • Start/End Process Step Decision Connector Inspection Wait Transportation (Movement) Document
Flowchart Exercise:
Medication Administration – Sliding Scale Insulin
Start 1. Define the process 2. Define the process boundaries 3. Identify steps, activities, decisions 4. Assign flowchart symbols 5. Are steps in sequence?
6. Put steps in sequence 7. Review and title flowchart Step Step Step Decision
YES
Step Document Stop
NO
Step
Interpreting the Process Flowchart
• • • • Examine each process step • Bottlenecks?
• Weak Links?
• Poorly defined steps?
• Cost-added-only steps?
Examine each decision symbol • Can this step be eliminated?
Examine each rework loop • Can it be shortened or eliminated?
Examine each activity step • Does the step add value for the end-user?
http://www.wisc-online.com/objects/ViewObject.aspx?ID=MFQ102 James Bork/author
Assess your Knowledge of Process Flow Charting
• Brainstorming with people involved in the process is a good way to identify the steps, activities, and decisions in a process. (True or False) • A point in a process at which a yes/no question is being asked or a decision is required is illustrated with a box or rectangle. (True or False) • It is best to flowchart a process as it was designed to be done rather than as it is actually being carried out. (True or False) • When examining your flowchart, rework loops are a good place to find opportunities for improved efficiency. (True or False)
Affinity Diagram
Organizing Ideas Brainstorming
Cause & Effect Diagram (Fishbone)
Staffing Environment Equipment Supplies Patient Competency Training Rules Policies Procedures Protocols Documentation Communication Event
Anatomy of an Error
Swiss Cheese Model of System Failure
Error Causation: Medication Error
Ishikawa Diagram (Fishbone)
Benefits of RCA and FMEA
• • • • •
Improve the Efficiency and Effectiveness of Operations
• Investigating and addressing root causes
Enhance Organizational Performance
• Increasing involvement and engagement • Enhancing Culture of Safety
Improve Safety and Quality
• Narrowing and eliminating gaps
Improve Financial Performance
• Streamlining processes, eliminating waste • Reducing risk of liability
Enhance Team Approach
• Empowering staff • Enhancing Critical Thinking Skills
Shared Characteristics
• • • • •
Oversight and support
of leadership
Goal
to reduce the possibility of future events and harm
Identification
of conditions that lead to harm
Non-statistical methods
of analysis
Team activities
that require people, time, materials and support
Pitfalls of RCA and FMEA
• • • • • • • • • • Conducting RCA/FMEA just to fulfill a requirement Choosing a process that is too complex Inadequate team member representation Lack of leadership support Wasting time on long debates Too little time for process redesign and implementation Failing to assign responsibility Failing to develop measurement guidelines Failing to track progress and follow up Failing to establish timelines
Organization Approach to Successful RCA & FMEA Activities
•
Leadership Support
• Importance of the activities • • Provision of resources Response to findings •
Ongoing Commitment to Safety
• Identification of potential risk • Improvement of processes •
Sustain and strategic performance improvement
• Establish/Maintain Culture of Safety • Utilization of tools to direct improvement efforts •
Effective information management
• Obtaining, managing and utilizing information to improvement systems/processes •
Well-trained and qualified personnel
• RCA/FMEA teams are trained in use of techniques/tools and knowledgeable about topics
Root Cause Analysis – Let’s get started!
• “
Root Cause Analysis
is a process for identifying the basic or causal factor(s) underlying variation in performance, including the occurrence or possible occurrence of a sentinel event…”
• “
Root Cause
: a fundamental reason for •
the failure or inefficiency of a process.”
“
Sentinel Event
…..
Definitions
• Sentinel Event (SE) • “An unexpected occurrence involving death • • or serious physical or psychological injury or
the risk thereof .
•
“or the risk thereof”
includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome SE signals the need for immediate investigation and response SEs and Errors are not synonymous!
Not all SEs are due to error and not all errors result in a SE
Appropriate Use of RCA
•
When to conduct a RCA
• Retrospective investigation of processes/systems failures that resulted in an adverse or sentinel event • Retrospective investigation of a near miss event that had the potential to • result in an adverse or sentinel event Retrospective investigation of a pattern of incidents or near misses to understand variation in systematically collected data. (
Aggregate RCA
)
Conducting a Root Cause Analysis
• • • • • • • • • Designing and Implementing Early Response Strategies Chartering and Assembling the Team Team Orientation Defining the Problem and Contributing Process Factors Measure – Collect and Assess Data/Information on Proximate and Underlying Causes Designing and Implementing Action Plans for Immediate and Long Term Improvement Developing Measures of Effectiveness Evaluating/Modifying Implementation of Improvement Efforts Communicating Results
Early Response Strategies
• • • • • • • • Immediate Response to Sentinel Events Appropriate Care Communication Risk Containment Preservation of Evidence Documentation of Event Disclosure Interviewing Involved Staff
STABILIZE & Treat the Patient if required Call for Medical Support if Required NOTIFY Supervisor & Provider SECURE Scene + Notify Security, if needed Prepare to Document Facts of Event Continue to care for patient and await direction ARRIVE on site immediately ARRIVE on site as needed Assure patient has needed care CONFIRM patient status Validate scene is secure NOTIFY Incident Response Team Assess & provide initial support Assure staff has needed support Notify Service Director, Coroner if required Remain at scene Notify Senior Admin/ Designee CONTACT CEO/Board as appropriate ARRIVE on site within 2 hours COLLECT names/contact info of staff/witnesses COLLECT preliminary info, Forensic evidence, photos, etc..
COORDINATE Disclosure to patient/family ARRANGE or CONDUCT Interviews Management of Serious Clinical Events: Early Response Strategies CONFIRM Documentation
Communication
•
Confidential Communication Loop
• Patients and families affected • Appropriate staff, Risk/Quality/Patient • • • Safety staff identified by organizational Sentinel Event Policy Colleagues who could provide clarification, expertise and support Organization’s and provider’s liability experts Others who could provide emotional support or problem-solving assistance
Risk Containment
•
The act of containing the risk from reoccurring
• Examples of immediate risk containment actions: • Separate storage for look-a-like drugs • Separate storage insulin and TB syringes • Validating all medical gas connections • Validating all infusion pumps are correctly • calibrated Communicating information and validating knowledge of correct practice to “need to know” staff
Preservation of Evidence
•
Evidence is critical in understanding what happened
• Process is defined by organizational policy • Included as part of Event Reporting Orientation • & Training Examples of evidence preservation include: • Biological specimens • • • • • • Medications/syringes/vials Supplies and supply packaging Blood bags/Blood administration tubing Dressings Equipment/equipment supplies/electrical cording Photos, as indicated • Bagged and sequestered
Documenting Adverse Events in the Medical Record
• • The most involved and knowledgeable member(s) of the care team are assigned to record factual statements of the event and any follow-up interventions and patient outcomes.
Do NOT document any information that is unrelated to the care of the patient. Example: “Incident Report completed” or “Risk Management/Legal Office notified”
Disclosure
•
When to Disclose a Medical Error
• Has a perceptible effect on the patient that • • • was not discussed in advance as a known risk Necessitates a change in the patient’s care Potentially poses an important risk to the patient’s future health Involves providing a treatment or procedure without the patient’s consent
Interviewing Involved Staff
• •
Create a safe environment
• Be non-judgmental • Staff are already anxious and easily defensive, • • respect is critical Assume staff had reasons for their actions Avoid confrontation and challenging questions
Asking the right questions in the right way
• Examples of open questions • “Tell me what happened?” • • “What do you think led up to the event?” “Explain how these assessments/inventions are done on your unit?” • Clarify the information when needed • “Tell me more about the handoff process.” • “Help me understand what was happening when you were giving medications?
ASSESS potential liability MEET with COS, CMD, Risk/Quality/ Patient Safety/Service Director Establish direction and assign responsibility, as indicated Charter RCA Team RCA Close Out Meeting MEET with Sr. Ldship Support Physician needs Assess/Needed action (as indicated) for any physician performance issues Communicate updates with Sr. Ldshp as indicated Meet with Incident Response Team WITHIN 7 working days.
WITHIN 21 working days.
PRESENT to PS/QI/RM Cmte, 1 st available meeting date WITHIN 1 working day Update Sr. Ldshp 1 st RCA RCA Risk Reduction Strategies present to Sr. Ldsp for sign off WITHIN 5 working days of Sr. Ldsp Sign Off – Communicate to Staff Management of Serious Clinical Events: Post Event RCA Close Out Meeting WITHIN 6 months – Follow up to assess status of recommendations
Organize a Team
• • • • • • •
Select team members (Facilitator & Leader)
Trained in RCA • • • • • • Subject Matter Experts Physician Champion Analytic Skills Performance Improvement knowledge Patient Safety knowledge Event-type expert (Falls, Pharmacy, etc..) Change Management Expert Representative(s) from relevant service/discipline Any level of staff closest to issue and has process knowledge Those involved in event (case-by-case decision) Decision-making authority
Team Meeting Preparation
• • • • •
Team Member Information/Resources
Timeline sequencing the event & RCA forms • Medical Record, Staff Interviews, logs, check sheets, etc.. Policies, Procedures, Protocols, SoC/SoP •
Define the Problem
“A well-defined problem statement describes what is wrong and focuses on the outcome, not why the outcome occurred.” •
Brainstorming the problem
• Define preliminary work plan Understand the scope of the plan (Charter) • Key Steps
Team Responsibilities
• • • •
Identify Contributing Process Factors
• • Flowcharting “What are the steps in the process?” “What actually happened?” • • • • Brainstorming 5 Whys Identify processes Supplement the list of process steps Affinity Diagram (organizing ideas) • Fishbone Diagrams “Which steps and linkages were involved in or contributed to the event?”
Flow Charting the Process
Start the Process Action Action Action of Omission or Commission Action Decision Action Action Stop the Process
“5 Whys” Tool
Problem Statement: (One sentence description of event) Why?
Why?
Why?
Why?
Why?
ROOT CAUSE(S): If removed, would this have been prevented?
Team Responsibilities
• • • • • •
Identify Other Contributing Factors
Procedure-related Failures Training-related Failures Equipment-related Failures
Measure – Collect and Assess Data on Proximate
• •
and Underlying Causes
Goal-directed activities/results of performance Assess Data on Proximate and Underlying Causes •
Prune and Confirm the List of Root Causes
“Is it likely that similar conditions will recur if • the cause is corrected or eliminated?”
If answer to each is NO = Root Cause
Team Responsibilities
•
Explore and Identify Risk Reduction
• • • • • •
Strategies relevant to Root Causes
Past RCA Action Plans (Effectiveness) Literature Reviews • • • • Evidence-Based Practice Guidelines Discipline-Specific (AORN) Diagnosis-Specific (AMI, Pneumonia) Procedure-Specific (Medication Safety) Error Prevention Strategies (Falls, Alarm Fatigue, Hourly Rounding, CUSP, TeamSTEPPS, Time Outs, Read-Back, etc..) Staff Recommendations Patient/Family Recommendations Others as identified
Definition: Action Plan
• •
“
Action Plan
: the product of the root cause analysis that identifies the strategies that an organization intends to implement to reduce the risk of similar events occurring in the future.”
Action Plan
identifies responsibility
for: • Implementation • Oversight/Responsibility • Pilot testing, as appropriate, • Time lines • Strategies for measuring the effectiveness
National Center for Patient Safety
(Focused on system change, not reliant on individual memory/vigilance)
• • • • • •
New devices with usability testing before purchasing Engineering control or interlock (forcing functions) Simplify the process and remove unnecessary steps Standardize equipment on process or caremaps Tangible involvement and action by leadership in support of patient safety INTERMEDIATE ACTIONS
• • • • • • • •
Redundancy Increase in staffing/decrease in workload Software enhancements/modifications Eliminate/reduce distractions Checklist/cognitive aid Eliminate look and sound-alikes Readback Enhanced documentation/communication Weaker Actions (Reliant on memory/vigilance)
• • • • •
Double checks Warning labels New procedure/memorandum/policy Training Additional study/analysis
Team Responsibilities
•
Develop the Action Plan targeting Risk Points
• • • • • • • • • • • • • •
or Common Causes
Training/Education Competence (lapses/low volume-high risk task) Supervision Staffing (workflow & workload) Communication Distraction due to environmental issues Information availability Storage and access Labeling Nomenclature Dosage calculation Equipment Abbreviations Handwriting
Tips related to Mistake-Proofing for Human Factors
•
Design strategies to prevent errors
•
Automation
•
As appropriate
•
Incorporate “forcing functions”
•
Standardization
•
Reduce need to rely on memory
•
Develop checklists
•
Modeled by policy/procedure/guidelines
•
Incorporate into medical record documentation, as
• •
appropriate Reduce the number of process steps
•
Handoffs
•
Patient Movements Ensure redundancy (double checks)
•
High risk processes
Team Responsibilities – Close Out
• • •
Finalize the RCA Documentation
Complete the organizational RCA Forms to include: • Event description • • Timeline of the event Results of data measurement • • Flowcharts, Fishbone, and other graphics Final root causes • Action Plan with assigned responsibility/target • • • dates Results of any pilot testing Supporting documents/references used Add to RCA system tracking mechanism • •
Present RCA to Senior Leadership for Approval
Present findings Provide needed clarification/justification
RCA: Let’s Practice
Case Study:
82 year old female admitted to the Outpatient Surgical Unit to undergo a Total Knee Replacement . The surgical procedure was uneventful and she was transferred to PACU for her recovery period of 1 hour and was transferred to the Inpatient Orthopedic Unit.
3 hours after coming to the Orthopedic Unit, she was found to be in respiratory arrest, a code was called, she was resuscitated and transferred to the ICU for post-code management.
RCA: Let’s Practice
What information does the Team need to focus on?
RCA: Let’s Practice
Case Study:
34 year old male was admitted to the Mental Health Unit for Manic-Depressive Disorder. Day 3 of his inpatient stay, he failed to report to the medication administration area for his afternoon meds. No communication of his failure to receive medications was followed through. Within the hour, a transport assistance found a male, dressed in mental health inpatient attire, wandering around the receiving dock and called Security. Security responded to the area and called the 2 locked mental health units, with a response of “no patients are missing”. 45 minutes later 1 unit called Security back and responded that the patient belonged on their unit.
RCA: Let’s Practice
What information does the Team need to focus on?
Transitioning to Failure Mode Effects Analysis (FMEA)
• •
Everything we learned and discussed for RCA applies to the FMEA process BUT in the “Proactive” mode!!!
• Team mix and responsibilities • Tools and techniques
So what’s different?
Definition
• “Failure Mode and Effects Analysis
is a team-based, systematic proactive, and reason-based technique that is used to prevent process and product problem before they occur. It provides a look not only at what problems could occur but also at how severe the effects of the problems could be.
•
…assumes that no matter how knowledgeable or careful people are, errors will occur in some situation and may even be likely to occur.”
Definitions
• • • • “
Failure:
When a system or part of a system performs in a way that is not intended or desirable.”
“
Mode:
the manner in which something can fail.”
“
Effects:
The results or consequences of a failure mode.”
“
Analysis:
The detailed examination of the elements or structure of a process.”
Steps to Conduct Failure Mode Effects Analysis (FMEA)
1. Select a high-risk process
2. Assemble a team
3. Diagram the process 4. Brainstorm potential failure modes and determine effects 5. Prioritize failure modes
6. Identify root causes of failure modes 7. Redesign the process/sub-process 8. Analyze and test the new process 9. Implement and monitor the redesigned process
Appropriate Use of FMEA
•
Risk Areas to Consider
• High Risk provision of care • Restraint Management • Poorly performing processes/systems • Low volume – low risk but repetitive in errors • Frequent Near Misses • Low volume – High risk • New services or programs • Electronic Medical Record Implementation • Bar Code Medication Administration • New CV unit • New patient population • New buildings or expansions • Aligns with Strategic/Operational Plans
FMEA Selection Process
•
Sources for Identifying High Risk Processes to Analyze
• Organizational PI data • Patient/Family Feedback (Satisfaction Survey) • Staff Feedback (Safety Culture Survey) • Occurrence Reporting System • • Aggregate RCA Findings Professional Associations • Mandatory Reporting Topics • Liability Insurance Companies • Sentinel Event Alerts and Statistics (Joint Commission)
Flow Charting for the RCA Process
Start the Process Action Action Action of Omission or Commission Action Decision Action Action Stop the Process
Flow Charting for the FMEA Process
PROCESS COMPONENTS 1. Physician writes order 2. Physician returns chart to desk 3. UC Enters order into system 1a. Unable to read orders 1b. Previous orders not discontinued 1c. Duplication of orders 1d. Write order for wrong patient 2a. Chart not collected 2b. Chart not returned 3a. Order not entered 3b. Wrong lab test entered 3c. Enter order for wrong day 3d. Enter order for wrong patient 3e. Order not customized 3f. Different UC enter orders differently 3g. Multitasking and distractions FAILURE MODES
Considering Potential Effects of Failure Modes & Prioritizing
Possible Failure Modes of 3. Medication Administration
3a. Wrong Drug 3b. Wrong Dosage
Potential Effects
PROBABILITY
Low likelihood (1 in 5,000)
SCORE = 2
Moderate likelihood (1 in 200)
SCORE = 3
3c. Wrong Time 3d. Wrong route High likelihood (1 in 100)
SCORE = 4
Low likelihood (1 in 5,000)
SCORE = 2 Potential Effects
SEVERITY
Injury with permanent loss of function; death
SCORE = 5 Priority Score 2X5=10
No injury but increased length of stay to monitor effects
SCORE = 2
Injury with no permanent loss of function
SCORE = 3
Injury with permanent loss of function; death
SCORE = 2 2X3=6 4X3=12 2X2=4
Communication and Tracking Status of RCA & FMEA
•
Quality/Risk/Patient Safety staff
•
Communication
• Results to appropriate staff/groups/committees as defined • in policy & procedures
Tracking
• Establish an effective tracking system for RCA & FMEA follow up • Status updates at pre-determined timeframes
Let’s take a break!
Next Up: Redesigning for Patient Safety
Redesigning for Patient Safety
• Application of the science, measurement and methodologies to redesign patient safety processes and systems – Evidence-Based Practice guidelines, tools and resources – Critical elements and skills necessary for oversight and management of patient safety improvement activities for system-wide implementation
“Isn’t it nice when things just work?”
http://www.youtube.com/watch?v=_ve4M4UsJQo
Redesigning:
Where do we start?
Gears & More Gears!!!
EXERCISE
Who is accountable and responsible for Patient Safety?
Governing Board Leadership Organizational Chart
(Job Functions, Line Authority & Policy/Procedure in Day-to Day Operations and Provision of Care)
PATIENT SAFETY
Committee Structure
(Planning, Designing, Implementing & Evaluating Initiatives)
Organizational Infrastructure
Mission/Vision/Values
Operationalizing Patient Safety Initiatives GB Leadership Organizational Chart PATIENT SAFETY Organizational Infrastructure
Mission/Vision/Values
Committee Structure Culture of Safety Leadership Commitment AHRQ Safety Culture Survey Staff Education Awareness Reward & Recognition Transparency Incident, Near Miss & Unsafe Condition Reporting Disclosure RCAs & Lessons Learned Story Telling Risk Assessment FMEA NCPS Patient Safety Assessment ISMP Medication Safety Self Assessment Other Internal/External Regulatory Requirements Process Improvement Mistake Proofing High Reliability Just Culture Technology EBP Initiatives CUSP/ TeamSTEPPS Hourly Rounding Patient/Family Advisory Councils Falls, Pain, Restraints, etc.
Surgical Never Events Others as Indicated Measurement/ Reporting Data Inventory Gap Analysis vs. Requirements /Findings Add/Delete/ Modify/Assign/ Report Sustain
Principles of Safe Design
• • •
Standardize
– Eliminate steps if possible
Create independent checks Learn when things go wrong
– What happened – Why – What did you do to reduce risk – How do you know it worked
Strategies for Implementation
•
Assessment
– Establish/Identify the “Planning Team” – Gather appropriate information for team review/discussion • Policy/Procedures • • Current literature/research Current/Historical data results & analysis • • Survey results Evidence-based practice models – Identify the need • Gap Analysis – Prioritize the need • Compare the potential risks and benefits • Compare the current competing initiative/activity priorities – Identify potential impacting factors • Supportive • Barriers
“ADAPTS Implementation Science Model”
Strategies for Implementation
• •
Deliverables
– Gain executive support of initiative implementation – Identify Champion Facilitator/Team Leader or Committee Chair – Identify the “Implementation Team” or Committee Members – Identify the resources necessary to carry out implementation
Activate
– Communicate goal, objectives, expected outcomes and process parameters to “Implementation Team” • Provide Gap Analysis Results to “Implementation Team” – “Implementation Team” utilizes Patient Safety Science methodologies to determine implementation plan for presentation to the “Planning Team”
“ADAPTS Implementation Science Model”
Strategies for Implementation
• •
Pre-training
– Champion presents groundwork to leadership and relevant department managers • Needed changes/additions/deletions to processes & process guidelines (Clinical & Administrative) – Initiate organization-wide awareness campaign – Makes final modifications to implementation plan
Training
– Appropriate staff are educated via appropriate teaching techniques (i.e. briefing, in-services, hands on training, etc.) – Completed training is documented and maintained
“ADAPTS Implementation Science Model”
Strategies for Implementation
•
Sustainability
– • • • •
“ Implementation Team”
or “designated entity” takes charge of sustaining implementation • Serve as “Subject Matter Experts” resource for organization Oversight of process/process guidelines Define measurement process Define the reporting structure and process Responsible for annual or designated timeframe evaluation • Make recommendations and coordinate the implementations of modifications as needed
“ADAPTS Implementation Science Model”
Setting Performance Standards And Expectations For Patient Safety
Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices (AHRQ Evidence Report No. 211) 1. Preoperative checklists and anesthesia checklists 12. Use of Pharmacist to reduce ADEs (MATCH)
2. Tools for Reducing Central Line-Associated Bloodstream Infections
3. On the CUSP: Stop CAUTI 4. Bundles to prevent ventilator-associated pneumonia 5. Hand hygiene.
6. "Do Not Use" list for hazardous abbreviations 7. Multicomponent interventions to reduce pressure ulcers 13. Patient preferences for life-sustaining treatment 14. Use of informed consent to improve patients' understanding 15. TeamSTEPPS® 16. Medication Reconciliation (MATCH) 17. Practices to reduce radiation exposure 18. Use of surgical outcome measurements 8. Barrier precautions to prevent healthcare-associated infections 9. Use of real-time ultrasound for central line placement 19. Rapid response systems 20. Utilization of complementary methods for detecting adverse events/medical errors to monitor for patient safety problems 21. Computerized provider order entry 10. Interventions to improve prophylaxis for venous thromboembolisms 11. Preventing Falls in Hospitals 22. Use of simulation exercises in patient safety efforts
http://www.ahrq.gov/research/findings/evidence-based-reports/makinghcsafer.html
AHRQ Guides
• http://www.ahrq.gov/research/findings/evide nce-based-reports/makinghcsafer.html#guides
IHI Patient Safety Leadership WalkRounds™
•
Definition
– A tool to connect senior leaders with people working on the front line as a way both to educate senior leadership about safety issues and to signal to front-line workers the senior leaders’ commitment to creating a culture of safety.
•
Benefits
– Demonstrate commitment to safety.
– – Fuel culture for change pertaining to patient safety.
Provide opportunities for senior executives to learn about patient safety.
– – Identify opportunities for improving safety.
Establish lines of communication about patient safety among employees, executives, managers, and employees.
– Establish a plan for the rapid testing of safety-based improvements.
http://www.ihi.org/knowledge/Pages/Tools/PatientSafetyLeadershipWalkRounds.aspx
TeamSTEPPS® (Team Strategies and Tools to Enhance Performance and Patient Safety®)
•
Teaches healthcare professionals skills and competency to integrate teamwork principles into daily practice throughout the organization and include:
Skills: • Leadership • Mutual Support • Situation Monitoring • Communication Competencies: • • Performance Attitudes • Shared Mental Model http://teamstepps.ahrq.gov/
Hourly Rounding
• •
Definition:
– Purposeful Hourly Rounding is…an evidence-based practice to: • Meet patient needs • Improve safety outcomes • Increase patient comfort • Improve the nursing care delivery experience • Reduce # of call lights • Reduce distances walked
Benefits
– Designed to promote high quality patient care • Increases patient satisfaction by average of 12 raw points – Provides health care that is safe • Reduces falls up to 50% • Reduces pressure ulcers up to 16% – Increases efficiency for staff • Anticipates reasons why the call lights ring • Reduces call lights up to 38% • Saves nurses from 150 – 300 hours per month
http://www.mc.vanderbilt.edu/root/pdfs/nursing/hourly_rounding_supplement-studer_group.pdf
Partnership for Patients (HEN Project)
• •
Goals:
• Reduce Preventable Complications by 40% to make care • safer Reduce Readmissions by 20% to improve care transitions
Areas of Focus:
• Adverse Drug Events • • Catheter-Associated Urinary Tract Infections Injuries from Falls and Immobility • • Obstetrical Adverse Events Pressure Ulcers • Surgical Site Infections • • Venous Thromboembolism Ventilator-Associated Pneumonia • Readmissions • Elective Delivery
http://partnershipforpatients.cms.gov/about-the-partnership/patient-and-family-engagement/the-patient-and-family-engagement.html
Patient Safety Competencies
• Patient Safety Competencies address: • Communication • Team participation • Risk Recognition • Recognition & Reporting of Errors • Accountability & Responsibility • Understanding Culture of Safety • • • Concepts Attitudes Skills • Patient Centered Care
Patient Safety Certification
•
Certified Professional in Patient Safety (CPPS)
– Establishes core standards for the field of patient safety, benchmarks requirements necessary for healthcare professionals, and sets an expected proficiency level – Gives those working in patient safety a means to demonstrate their proficiency and skill in the discipline.
– Provides a way for employers to validate a potential candidate’s patient safety knowledge and skill base, critical competencies for today’s healthcare environment http://cbpps.org
ARE YOU READY?
Q&A