Prospective Review Ready, Set, GO

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Prospective Review Ready, Set, GO!

• June 2006

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5Ws and ROOT CAUSE

• Apparent Five Root
• Cause WHYs Cause

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Proactive/Prospective QI

• REACTIVE quality
• Focus on bad apples after the fact
• Downstream correcting system failures
• Goal- be appropriate
• Episodic effort
• Meet minimum standards

• PROACTIVE quality
• Focus on improvements in future ahead
• Upstream identify improvement potential
• Goal - to be better
• Continuous effort
• Exceed expectations produce excellent results

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Cause-Effect Diagram

• Team members contribute and learn

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Root Cause
Didnt complete project on time
Resources unavailable when needed
Took too long to hire Project Manager
Lack of specifics given to Human Resources Dept
Root Cause
No formal process for submitting job opening
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An interesting comparison

• Aviation
• Needs more than stick rudder skills to ensure
  safe reliable flights
• Crew Resource Management (CRM)
• started in mid-70s for aviators that lacked
  the right stuff to manage aircrews effectively
• NASA research linked accidents to failures of
  command, communication crew coordination

• Medicine
• Physicians, nurses, pharmacists technnologists
  educated and trained in separate silos
• Mastering intricacies of team behaviour is
  different from mastering textbook knowledge
• A predominant focus on knowledge acquisition does
  not prepare one for rapid paced clinical
  environments, distractions, hand-offs
  uncertainty

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Further Drill Down

• Aviation
• Preoccupation with minor mechanical problems
• Failure to set priorities
• Failure to delegate tasks/responsibilities
• Inadequate leadership
• Inadequate monitoring
• Failure to use available data
• Failure to communicate
• Ruffel Smith, 1979
• Lauber, 1993

• Operating Room
• Failure to brief own team/other team of plans for
  operation
• Failure to speak up inform team of workload or
  patient problems
• Failure to establish clear leadership
• Conflicts over course of action
• Failure to debrief actions provide training to
  peri-operative staff
• Helmreich Merritt, 1998

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Prospective Review /Analysis

• CCHSA Patient Safety goal to create a culture of
  safety
• Beginning 2006, CCHSA expects one patient safety
  related prospective analysis process per year
• Effective implementation of improvements
  changes is mandated

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What will CCHSA expect?

• Select a high risk process or activity
• Proactively analyze the process or activity
• Identify ways to improve the process make the
  activity safer
• The intent is to prevent adverse events

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What would be high risk?

• Medication use
• Operative procedures
• Patient/Client identification
• Blood administration
• Care to high risk populations
• Admission/Discharge/Transfer
• Adverse events during service delivery

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Prospective Analysis

• Linked with risk management
• Integrated risk management focus
• Identification of new opportunities for
  improvement of risk practices
• Prevention of risk
• Minimizing losses (traditional RM focus)
• The aim is for better understanding,
  communication, management of risk and improved
  decision making

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Prospective Review
TOOLS TECHNIQUES

• Failure Modes Effects Analysis
• Errors of Omission (James Reason)
• Simulation
• Fault Tree Analysis
• Hazard Analysis
• Worst Case Analysis
• Hazard Analysis Critical Control Points

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What is FMEA?

• FMEA is an acronym for Failure Modes and Effects
  Analysis
• FMEA focuses on when and how a system will fail
  not IF it will fail
• Methodology of FMEA
• Identify the potential failure of a system and
  its effects
• Assess the failures to determine actions that
  would eliminate the chance of occurrence
• Document the potential failures

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FMEA basic concepts

• Root Failure Impact on
• Cause Mode Client(s)

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FMEA review

• Steps in the process (map/flowchart)
• Failure modes what could go wrong?
• Failure causes why would failure happen?
• Failure effects what would be the
• consequences
  of each failure?

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FMEA

• Assign a Risk Priority Number (RPN) for each
  step, each failure mode the entire process
• RPN is a number 1-10 to define the level of
  likelihood of occurrence, likelihood of detection
  and for severity
• RPN is calculated by multiplying the numbers
  together. Failure modes with the highest RPN is
  the likely focus for improvement.

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FMEA Flow Chart
Assign a label to each process or system component
List the function of each component
List potential failure modes
Describe effects of the failures
Determine failure severity
Determine probability of failure
Determine detection rate of failure
Assign RPN
Take action to reduce the highest risk
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FMEA risk concepts

• OCCURRENCE probability that failure will occur
• SEVERITY of failure consequence for clients
• DETECTION risk that cause of failure will pass
  through undetected

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FAILURE MODE and EFFECT ANALYSIS

• What it is
• Failure mode and effect analysis is a tool that
  examines potential product or process failures,
  evaluates risk priorities, and helps determine
  remedial actions to avoid identified problems.
  The spreadsheet format allows easy review of the
  analysis.
• When to use it
• Failure mode and effect analysis is primarily a
  quality planning tool. It is useful in developing
  features and goals for both products and
  processes, in identifying critical
  product/process factors and designing
  countermeasures to potential problems, in
  establishing controls to prevent process errors,
  and in prioritizing process subunits to ensure
  reliability.

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FAILURE MODE and EFFECT ANALYSIS -2

• How to use it
• Create a nine-column spreadsheet. Label the
  columns as indicated in the example below Mode
  of Failure, Cause of Failure, Effect of Failure,
  Frequency of Occurrence, Degree of Severity,
  Chance of Detection, Risk Priority, Action, and
  Validation.
• Use brainstorming to identify all possible modes
  of failure. List each mode on a separate line in
  column 1.
• Identify all possible causes of failure for each
  mode. Use brainstorming to create a list of these
  causes and add them in column 2.

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FAILURE MODE and EFFECT ANALYSIS -3

• Determine the likely effect of each failure. In
  column 3, identify the potential impact of
  failures on the customer, the product, or the
  process.
• Create a table of assigned values. For columns 4,
  5, and 6, develop a consensus table of relative
  values for assumed frequency of occurrence, the
  severity of the failure for the customer, and the
  likelihood of detecting the problem.
• Record appropriate values in columns 4, 5, and 6.
  Using the table of assigned values, develop a
  consensus score for frequency of occurrence, the
  severity of the failure, and the chance of
  detection for each cause of failure.

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FAILURE MODE and EFFECT ANALYSIS -4

• Calculate the risk factor for each cause of
  failure. For each cause of failure, multiply the
  numbers in columns 4, 5, and 6. Record the
  product in column 7.
• Identify a remedy for critical failure modes.
  Concentrate on the small number of failure causes
  that can dramatically impact the product/process,
  and design actions that will significantly reduce
  the level of failure.
• Validate each action/remedy. Design a method of
  verifying that the remedy is in place and is used.

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Limitation of FMEA

• Deals with one failure mode at a time
• Adverse events are usually multiple failures and
  pre-existing hazards

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Errors Omissions Assessment (James
Reason)

• James Reason (NHS) developed a Errors and
  Omissions model
• Think of it as simplified FMEA
• Leaving out necessary steps/tasks is the most
  common human error type

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Errors Omissions Assessment (James
Reason)

• Tasks most likely to allow omissions are termed
  affordances. Reason outline 8 affordances
• High information (reliance on short term memory)
• Isolation
• Recursive (repeated procedural steps)
• Following (steps that follow main task)
• Hidden ( item to be acted on is not obvious)
• Interrupt (steps after unexpected interrupt)
• Departure (from standard procedure)
• Poor signals (weak, noisy or ambiguous)

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Errors Omissions ASSESSMENT (J. Reason)
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REMINDERS the five Cs

• Once the task analysis if completed, the
  affordances are specified
• REMINDERS
• Conspicuous catch the providers attention at the
  critical time
• Contiguous- positioned close in time space to
  the service location
• Context- information about where when to
  remember
• Content Provide information regarding what has
  to be done
• Count Allow the provider to count off the
  number of discrete tasks that need to be done

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Simulation

• Used in clinical education of health
  professionals
• Amplify real life experiences with guided
  experiences that evoke or replicate aspects in an
  interactive manner
• Useful especially in error prone, high risk or
  unusual situations
• Used to develop professionals skills without
  harming the patient
• Developing team skills
• Teach interaction skills using standardized
  approaches
• Can be applied to testing of emergency
  preparedness plans, strike and job action plans,
  Pandemic flu plans

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Benefits of Simulation

• Safety
• Improved efficiency in high cost clinical
  settings
• Scheduling availability
• Optimal conditions for learning
  learner-centered
• Crawl -walk -run
• Objective and immediate feedback
• Integration of multiple skills
• Useful as assessment tool

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SIMULATION the KEYSTONE

• By reducing errors during technically challenging
  procedures (surgery, interventions, etc)
• Errors are reduced by improved
• training with a focus on error identification
• Simulation technologies have a proven record in
  improving safety through decreased uncertainty

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Simulation

• Simulatons are only a tool, and must be
  integrated into a comprehensive approach
• Only through stringent validation of simulatons
  and their curricula will it be possible to have
  acceptance by the training and regulation bodies
• It is not Build it and they will come
• but validate it and they will come.

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Fault Tree Analysis

• What it is
• Fault tree analysis is a graphical representation
  of the major faults or critical failures
  associated with a product, the causes for the
  faults, and potential countermeasures. The tool
  helps identify areas of concern for new product
  design or for improvement of existing products.
  It also helps identify corrective actions to
  correct or mitigate problems.
• When to use it
• Fault tree analysis is useful both in designing
  new products/services or in dealing with
  identified problems in existing
  products/services. In the quality planning
  process, the analysis can be used to optimize
  process features and goals and to design for
  critical factors and human error. As part of
  process improvement, it can be used to help
  identify root causes of trouble and to design
  remedies and countermeasures.

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Fault trees are built using gates and events
(blocks).

• OR gate

• AND gate

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Fault Tree Analysis - 2

• How to use it
• Select a component for analysis. Draw a box at
  the top of the diagram and list the component
  inside.
• Identify critical failures or faults related to
  the component. Using Failure Mode and Effect
  Analysis is a good way to identify faults during
  quality planning. For quality improvement, faults
  may be identified through Brainstorming or as the
  output of Cause and Effect Analysis.
• Identify causes for each fault. List all
  applicable causes for faults in ovals below the
  fault. Connect the ovals to the appropriate fault
  box.

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Fault Tree Analysis - 3

• Work toward a root cause. Continue identifying
  causes for each fault until you reach a root or
  controllable cause.
• Identify countermeasures for each root cause. Use
  Brainstorming or a modified version of Force
  Field Analysis to develop actions to counteract
  the root cause of each critical failure. Create
  boxes for each countermeasure, draw the boxes
  below the appropriate root cause, and link the
  countermeasure and cause.

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Hazard Analysis

• Identify health safety hazards (OHS)
• Evaluating hazards associated with specific jobs,
  tasks, machine tools
• Prioritizing hazards in terms of risk posed
• Describing methods to control hazards implement
  corrective actions
• Explaining practical hazard controls
• Documenting detailed, safe work job practices,
  incorporating hazard analysis into each

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Worst Case Analysis

• Used in design of circuits, devices equipment
  (BIOMEDICAL)
• Worst case is simulated by taking all variables
  to -2 sigma or -3 sigma worst case values
• Tend to be overly pessimistic
• Useful as a fast check

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Hazard Analysis Critical Control
Points

• Developed as a food safety program
• Principle 1 - Conduct a Hazard Analysis
• Principle 2 - Determine Critical Control Points
• (CCPs)
• Principle 3 - Establish Critical Limits
• Principle 4 - Establish Monitoring Procedures
• Principle 5 - Establish Corrective Actions
• Principle 6 - Establish Verification Procedures
• Principle 7 - Establish Record Keeping and
• Documentation
  Procedures

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Hazard Analysis Critical Control
Points

• HACCP Principle 1 - Conduct a Hazard Analysis
• develop a list of hazards which are of such
  significance that they are reasonably likely to
  cause injury or illness if not effectively
  controlled. This process involves two stages 1)
  hazard identification and 2) hazard evaluation.
  During the first stage, a list is developed of
  the potential biological, chemical or physical
  hazards that may be introduced, increased, or
  controlled at each step in the production
  process.
• HACCP Principle 2 - Determine Critical Control
  Points (CCPs)
• CCP is a step which control can be applied and is
  essential to prevent or eliminate a food safety
  hazard or reduce it to an acceptable level.
  Examples of CCP's may include thermal processing,
  chilling, testing ingredients for chemical
  residues, product formulation control, and
  testing product for metal contamination.

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Hazard Analysis Critical Control
Points-2

• HACCP Principle 3 - Establish Critical Limits
• A critical limit is a maximum and/or minimum
  value to which a biological, chemical or physical
  parameter must be controlled at a CCP to prevent,
  eliminate or reduce to an acceptable level of
  occurrence of a food safety hazard. A critical
  limit is used to distinguish between safe and
  unsafe operating conditions at a CCP. Critical
  limits should not be confused with operational
  limits which are established for reasons other
  than food safety. Critical limits must be
  scientifically based. The critical limits and
  criteria for food safety may be derived from
  sources such as regulatory standards and
  guidelines, literature surveys, experimental
  results, and experts.

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Hazard Analysis Critical Control
Points-3

• HACCP Principle 4 - Establish Monitoring
  Procedures
• Monitoring is a planned sequence of observations
  or measurements to assess whether a CCP is under
  control and to produce an accurate record for
  future use in verification. Monitoring serves
  three main purposes.
• First, monitoring is essential to food safety
  management in that it facilitates tracking of the
  operation. If monitoring indicates that there is
  a trend towards loss of control, then action can
  be taken to bring the process back into control
  before a deviation from a critical limit occurs.
• Second, monitoring is used to determine when
  there is a loss of control and a deviation occurs
  at a CCP. When a deviation occurs, an appropriate
  corrective action must be taken.
• Third, it provides written documentation for use
  in verification. Ideally, monitoring should be
  continuous, which is possible with many types of
  physical and chemical methods (ie, temperature or
  pH levels). Most monitoring procedures need to be
  rapid because they relate to on-line "real time"
  processes and there will be no time for lengthy
  analytical testing. Personnel who are responsible
  for the monitoring process are often associated
  with production.

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Hazard Analysis Critical Control
Points-4

• HACCP Principle 5 - Establish Corrective Actions
• Where there is a deviation from established
  critical limits, corrective actions are
  necessary. An important purpose of corrective
  actions is to prevent foods which may be
  hazardous from reaching customers. Therefore,
  corrective actions should include the following
  elements 1) determine and correct the cause of
  non-compliance b) determine the disposition of
  non-compliant product and c) record the
  corrective actions that have been taken. Specific
  corrective actions should be developed in advance
  for each CCP and included in the HACCP plan. As a
  minimum, the HACCP plan should specify what is
  done when a deviation occurs, who is responsible
  for implementing the corrective actions, and that
  a record will be developed and maintained of the
  actions taken.

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Hazard Analysis Critical Control
Points-5

• HACCP Principle 6 - Establish Verification
  Procedures
• Verification is defined as those activities,
  other than monitoring, that determine the
  validity of the HACCP plan and that the system is
  operating according to the plan. One aspect of
  verification is evaluating whether the facility's
  HACCP system is functioning according to the
  HACCP plan. Rather than relying on end product
  testing, firms should rely on frequent reviews of
  their HACCP plan, verification that the plan is
  being correctly followed, and review of CCP
  monitoring and corrective action records. Another
  important aspect of verification is the initial
  validation of the HACCP plan to determine that
  the plan is scientifically and technically sound,
  that all hazards have been identified and that if
  the HACCP plan is properly implemented these
  hazards will be effectively controlled.
• Information needed for validation of the HACCP
  plan often include
• 1) expert advise and scientific studies and
  
• 2) in-plant observations, measurements, and
  evaluations.

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Hazard Analysis Critical Control
Points-6

• HACCP Principle 7 - Establish Record Keeping and
  Documentation Procedures
• Generally, the records maintained for the HACCP
  systems should include the following
• 1. A summary of the hazard analysis, including
  the rationale for determining hazards control
  measures.
• 2. The HACCP Plan
• Listing of the HACCP team and assigned
  responsibilities
• Description of the food, its
  distribution, intended use and consumer
• Verified flow diagram
• HACCP Plan Summary Table that includes
  information for
• Steps in the process that are CCP's
• The hazards of concern
• Critical limits
• Monitoring
• Corrective actions
• Verification procedures and schedule
• Record keeping procedures
• 3. Support documentation such as validation
  records.
• 4. Records that are generated during the
  operation of the plan.

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CRITICAL CONTROL POINTS

• ACKOFF a system of related elements forming a
  complex whole with a common aim
• BATALDEN MOHR health care is a system made up
  of inter-related processes
• JAMES each healthcare process consists of a
  small number of sub processes
• CCPs are embedded in each process

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Prospective Review
TOOLS TECHNIQUES

• Failure Modes Effects Analysis
• Errors of Omission (James Reason)
• Simulation- Emergency Preparedness, Strike
  Contingency Plan, Pandemic Outbreak Plan
• Fault Tree Analysis
• Hazard Analysis OHS
• Worst Case Analysis - Biomedical
• Hazard Analysis Critical Control Points Food
  Services
• Black- less complex
  Red- most complex

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Proactive Approaches-- Prospective Review

• Errors must be accepted as evidence of systems
  flaws, not character flaws
• 
  -Dr. Lucien Leape