Setting up a hospitalwide patient safety programme

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Setting up a hospital-wide patient safety
programme

• Cor J. Kalkman, M.D. Ph.D.
• Ian P. Leistikow, M.D.
• Patient Safety Center
• University Medical Center Utrecht, the Netherlands

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Session content

• 13.30 Introduction
• 13.40 Getting started
• 13.50 Setting goals
• 14.00 Root Cause Analysis HFMEA
• 14.30 Involving the patient
• 14.40 Embedding PS in management cycles
• 14.50 Changing the culture
• 15.00 End of session

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Introduction
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University Medical Center Utrecht
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University Medical Center Utrecht

• Budget
• Employees
• Students
• Beds
• Admissions
• Outpatient visits
• Scientific publications

• 650.000.000
• 9.300
• 3.000
• 1,042
• 28,000
• 330,000
• 1.700

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Board of Trustees
Board of Directors
Support Staff
Patient Safety Center
Education and Training
12 Divisions
Research
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Patient Safety Center

• Research topics
• Measuring safety
• Measuring outcome
• Handovers/transfer of care
• Gaming simulation
• www.patientsafety.nl

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Patient Safety Center

• Education
• Patient safety education for medical students
• Patient safety training for residents
• Patient safety training for nurses
• RCA training
• HFMEA training
• Human Factor training
• www.patientsafety.nl

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Patient Safety Center

• Implementing Patient Safety
• assisting the Board in setting safety goals
• helping departments/wards to use material
• Embedding patient safety in the organization
• www.patientsafety.nl

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• Getting started

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Getting started

• Implementing a patient safety program
• A major change

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Getting started classic books
www.medicalerrors.ca/books.htm
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Getting started classic books
www.medicalerrors.ca/books.htm
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Getting started classic books
www.medicalerrors.ca/books.htm
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Getting started classic books
www.medicalerrors.ca/books.htm
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Getting started classic books
www.medicalerrors.ca/books.htm
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Getting started recommended books
www.medicalerrors.ca/books.htm
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Getting started recommended books
Complications Atul Gawande
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• Implementing a patient safety program
• A major change

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Getting started recommended books
What
How
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Safety in High Reliability Organizations

• Characteristics HROs
• Preoccupation with failure
• Reluctance to simplify interpretations
• Sensitivity to operations
• Commitment to resilience
• Deference to expertise
• Weick Sutcliffe. Managing the unexpected.
• 2001

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Creating major change

• The Eight Stage Process for Creating Major Change
• Establishing a sense of urgency
• Creating the guiding coalition
• Developing a vision and strategy
• Communicating the change vision
• Empowering broad-based action
• Generating short-term wins
• Consolidating gains and producing more change
• Anchoring new approaches in the culture

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• Setting goals

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Setting goals first some questions

• Please show hands if you agree
• My organization has an incident reporting system
  for employees

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Setting goals first some questions

• Please show hands if you agree
• My colleagues feel free to report incidents

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Setting goals first some questions

• Please show hands if you agree
• Safety costs money

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What best describes the prevailing attitude in
your organization?

• Solving existing problems
• OR
• Solving potential problems

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Setting goals Starting point
GENERATIVE (High Reliability Orgs)
HSE is how we do business
round here
PROACTIVE
Safety leadership and values drive
continuous improvement
Increasingly Informed
CALCULATIVE
We have systems in place to
manage all hazards
Increasing Trust and Accountability
REACTIVE
Safety is important, we do a lot
every time we have an accident
PATHOLOGICAL
Who cares as long as
we're not caught
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Setting goals

• Structure
• Incident reporting system
• quality indicators, benchmarking
• Patient safety board
• Methods
• Promoting just culture
• Root Cause Analysis
• (Health care) Failure Modes and Effects Analysis
• Crew Resource Management
• Safety Rounds
• Training Education

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• Risk Analysis

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Risk analysis

• Reactive
• Incident reports
• Root Cause Analysis
• Proactive
• black pistes
• Healthcare Failure Mode and Effect Analysis

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What is Root Cause Analysis?

• The root causes are the fundamental issues which
  have led to an incident occurring
• What?
• How?
• Why?
• Its not about who

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An event occurs
CIRC Central Incident Reporting Committee
Event reported to CIRC for initial screening
File event for trends tracking
Assign local RCA experts to investigate
no
yes
Does this event fit criteria for RCA?
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Root Cause Analysis - Steps
Collect relevant information
Sort and map information
Generate solutions recommendations
Identify problem and focus
Analyze information
Write report
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Collect relevant information - Question

• A nurse administers adrenaline instead of heparin
  through an IV line
• How would you collect appropriate information?

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Collect relevant information

• Patient chart,
• Interview
• Nurse
• Head of the ward
• Attending physician
• Visit the room
• See the vials

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Collect relevant information
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Collect relevant information
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Sort and map information

• Time line
• Time-person grid
• What do we miss?

10.00
10.01
10.10
10.15
10.16
10.16
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Identify problem and focus

• Dont try to save the world
• Focus on the event at hand

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Analyze information

• 5 whys
• Barrier analysis
• Fishbone
• Brainstorming
• Brain writing
• Identify root causes

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Analyze information - WHYs

• Why did nurse administer adrenalin?
• ? she flushes the IV line and expected the vial
  to contain heparin
• Why did she confuse adrenalin with heparin?
• ? there should only have been heparin in the
  drawer
• ? vials are identical
• ? she didnt do a double check
• Why was adrenalin in the drawer?
• ? etc

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Barrier analysis - Reasons model
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Barrier analysis - Reasons model
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Barrier analysis
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Generate solutions - Question

• Please place the following solutions in order of
  strength
• new policy on flushing lines
• remove all vials from patient room
• fire the nurse
• double-check
• replace one vial with pre-filled syringe
• redesign labels of vials
• hold a meeting an tell everybody this happened

strong
weak
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Generate solutions recommendations

• Physical - e.g. introduce pre-filled syringe
• Natural - e.g. remove vials, change labels
• Human action - e.g. double-check
• Administrative - e.g. new policy on flushing,
• hold a meeting

strong
weak
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Write the report

• structure
• be objective
• write for a layman

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Effect of safety program on incident reporting
Start patient safety program
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Proactive black pistes
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Healthcare Failure Mode and Effect Analysis

• A prospective assessment that identifies and
  improves steps in a process thereby reasonably
  ensuring a safe and clinically desirable outcome.
• A systematic approach to identify and prevent
  product and process problems before they occur.

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HFMEA vs RCA

• HFMEA
• Pro-active
• Process
• Occurrence
• 140 hours
• Multidisciplinary
• Blame-free

• RCA
• Retrospective
• Incident
• Recurrence
• 30 hours
• Multidisciplinary
• Blame-free

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What is a Failure Mode?

• Different ways that a process or sub-process can
  fail to provide the anticipated result.

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General Electric GE 90-115B Turbofan for Boeing
777-300ER
FMEA terminology MTBF (mean time between
failures)
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GE90-115 high bypass turbofan

• must demonstrate an in-flight shutdown rate of
  less than 0.02 per thousand flight hoursto gain
  Extended Twin Operations certification
• one shutdown per 50,000 hours of flight, orin
  normal commercial service, once every 10 yr

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Hazard Matrix
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HFMEA - examples

• Hip fracture from ER to theatre
• Blood transfusion
• Medication in ICU
• Fixation of restless patients
• Acute heart patients from ER to CCU
• Perioperative continuity of medication
• Special diets for patients with metabolic disorder

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The HFMEA process
Step 1 - Define the topic
Step 2 - Assemble the team
Step 3 - Graphically describe the process
Step 4 - Conduct the analysis
Step 5 - Identify actions and outcome measures
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Step 1

• Define the scope of the HFMEA along with a clear
  definition of the process to be studied.
• Patients with hip fracture
• Starting point Emergency Room admission
• End point incision in the operating theatre

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Step 2

• Assemble the team
• multidisciplinary team with subject matter
  expert(s) plus advisor

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Step 2 - Question

• Hip fracture from ER to theatre
• Who should be on the team?

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Step 3

• Develop and verify the flow diagram
• Consecutively number each process step
• If the process is complex identify the area of
  the process to focus on (manageable bite)

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2
3
4
5
6
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Step 3

• Identify all sub processes under each block of
  this flow diagram. Consecutively letter these
  sub-steps.
• Create a flow diagram composed of the sub
  processes.

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Step 3
1
2
3
4
5
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5A. Choose medication 5B. Calculate dose 5C.
Adjust machine 5D. Gently apply mask 5E. Distract
reassure patient
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Step 4

• List potential failure modes of each (sub)step
• Determine severity probability
• List all failure mode causes

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Step 4 A
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Step 4 B
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Severity rating
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HFMEA - step 4
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HFMEA - step 4 D
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The HFMEA process

• STEP 5 - Actions and outcome measures
• Decide to Eliminate, Control, or Accept the
  failure mode cause.
• Describe an action for each failure mode cause
  that will eliminate or control it.
• Identify outcome measures that will be used to
  analyze and test the re-designed process.

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The HFMEA process

• STEP 5 - Actions and outcome measures
• Identify a single, responsible individual by
  title to complete the recommended action.
• Indicate whether top management has concurred
  with the recommended actions.

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HFMEA - step 5
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• Involving the patient

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Involving the patient

• Why involve the patient?
• The patient brings unique perspective
• Subjective patient safety
• Major stakeholder
• Extra barrier
• BUT

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Involving the patient

• Patient involvement does not lessen
• the responsibility of care providers

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Involving the patient

• HOW?
• Advisory
• Focus groups
• HFMEA
• RCA
• Safety board

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1. Give all information about your state of
health Be prepared when you speak to your doctor.
Write questions down. Tell the doctor how you
feel and what you expect from him/her.
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2. Speak up if you dont understand
something Speak up if something is unclear or
confusing. Make sure you get enough information
about all medicine you receive
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3. Discuss the surgical procedure beforehand Let
the physicians mark the operative site. Ask what
precautions you can take (e.g. not eating), how
long the procedure will take and how you will
feel afterwards.
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4. Make a list of all medication you use Include
medication that has not been prescribed. Include
a list of medication that you are allergic for or
that have proven not to work on you.
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5. Ask questions when medication you are given is
different than you expected Make sure you only
take your own medication
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6. Comply with instructions and advice Ask what
you can and cant do. Speak up if you get
conflicting instructions. Make sure you know who
you can contact in case of questions or problems.
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If you think something has gone wrong, discuss
this with your physician or nurse. Ask What
happened? How could it happen? What are the
consequences for me now and in the future? Whats
being done about it? Have a family member or
friend with you when you discuss this.
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Involving the patient patient responses to the
advisory
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• Embedding PS inmanagement cycles

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Embedding patient safety

• Leadership
• Get the Board on board

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Safety dashboard

Amount of RCAs 1 Amount of admission days
875 Reports / admission day 0.17(148/875)
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Embedding patient safety (1)

• Stimulation of just culture
• Stimulation of reporting errors and near-misses
• Patient safety education
• Goal
• Creating an organization that naturally learns
  from mistakes

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Embedding patient safety (2)

• Management
• Balanced Score Card
• Recommendations HFMEA RCA
• Professionals
• Involvement with HFMEA RCA
• Education
• Communication

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• Changing the culture

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• Always face the facts

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speaking up addressing your supervisorsunsafe
behavior
Do you speak up to him/her when your supervisor
acts unsafely?
Yes
No
Medical specialist
Resident
(senoir) nurse
OR / anethesia nurse
Specialized nurse
specialist
Other
Unsafe behavior behavior that can lead to
unnecessary harm to the patient
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Changing the culture

• Communicate, communicate, communicate
• Introduction for new personnel
• Presentations on wards
• Safety magazine
• Measure progress

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Changing the culture

• Measuring progress employee questionnaire
• My department takes enough measures to improve
  patient safety
• I can talk about errors and unsafe situations
  without fear of negative consequences

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Take Home Messages

• Patient safety is a major change
• State a clear vision
• Set realistic goals
• Use structures methods
• Leadership is essential
• Safety is a marathon, not a sprint
• www.patientsafety.nl