A Systems Approach to Quality Improvement Lean, Six Sigma by nvw54192

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									 Systems Approach to

Healthcare Quality Improvement



     Muhanad Hirzallah, PhD
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          Speaker’s contact info
          Muhanad Hirzallah, PhD
Director of Business Applications- Mayo Clinic
Lean – Six Sigma Master Black Belt and
  Consultant
Faculty – Mayo Clinic College of Medicine

Phone 1-507-269-1237
Email: hirzallah.muhanad@mayo.edu
OR hirzalla@yahoo.com
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                 Agenda
• Types of Processes and Process Thinking.
• Value vs. Waste.
• Lean, Six Sigma, and Lean Six Sigma.
• Case Study
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           Types of Processes
Primary Process: serving an external customer
  Example: Diagnostic or treatment process for the
  patient.


Secondary Process: serving an internal
customer
  Support the primary processes
  Example: Laboratory tests, hiring staff, billing for
  services, equipment maintenance, appointment
  scheduling, etc.
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            Process Thinking

“Brilliant process management is our
strategy. We get brilliant results from
average people managing brilliant
processes… our competitors often get
average (or worse) results from brilliant
people managing broken processes.”
                     Mr. Cho, President,
                     Toyota Corporation
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                Definitions
Waste: Any activity in a process that
 consumes resources but does not serve to
 transform a customer request to a finished
 service.

Value: anything which the customer(s) of
 your process would knowingly and
 happily pay you for.
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              Value stream Map



            Supplier     Hospital       Customer

                TOTAL VALUE STREAM

A Value Stream is the set of all activities, both value
added and non-value added, required to bring a
service from start to finish
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                   Types of Waste

Waiting             Inventories       Overproduction




Transportation /    Motions           Re-prioritization
Material            (movement)
Movement

Over-processing     Defects           Mis-utilization of
                                      skills
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Breakdown of a typical process

                                  Incidental Work,
                                  also called NVA-
                                  E: a task that
                                  doesn't
                                  necessarily add
                                  value, but has to
                                  be done to
                                  support the
                                  existing system




 Value   Incidental   Waste
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               Breakdown of a typical process
Value
                   Incidental Work                                  Waste
 Add


                                       Current process lead time

Value
                 Incidental Work                                   Waste
 Add

 Traditional process improvement focuses on
 improving efficiency in the value-add activities:
        •Work longer, harder, faster
        •Add more people
        •Add more equipment
                                                                    Lean focuses on improving the value
                                                                    stream by systematically eliminating
Value                                                               waste:
                   Incidental Work                     Waste             •Increase capacity & speed of processes
 Add                                                                     •Work smarter / safer




                                                      Lead Time
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                          Six Sigma
Six Sigma is a rigorous and a systematic methodology that
utilizes data and statistical analysis to measure and improve a
company's operational performance, practices and systems

                              Sigma
    Statistically...          Level       DPMO
  Six Sigma refers to a       2        308,537
                                          Goal          ~93.3%
  process that produces       3         66,807          “Good”
  only 3.4 Defects Per        4          6,210
  Million Opportunities       5            233         99.99966%
                              6              3.4         “Good”
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      The Classical View of Quality                       The Six Sigma View of Quality
           “99% Good” (Z = 3.8σ)                             “99.99966% Good” (Z = 6σ)
        20,000 lost articles of mail per hour                Seven lost articles of mail per hour

       5,000 incorrect surgical operations                  1.7 incorrect surgical operations
       per week                                             per week

       2 short or long landings at most                     One short or long landing at most
       major airports daily                                 major airports every five years

       54,000 wrong drug prescriptions                     24 wrong drug prescriptions
       each year                                           each year



*Source: The International Journal of Newspaper Technology, Nov 2006
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Lean Sigma - DMAIC Methodology
  Define    What problem needs to be solved.


  Measure   Compliance with the target


  Analyze   Best practices and deficiencies


  Improve   Generate creative solutions


  Control   Monitor the improvement
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                                                                                                      Replication/
      Define            Measure Analyze                        Improve              Control       Wider implementation


                                                                                                   “If applicable”
                                          Quality improvement cycle
                                                                                                         On-going
Primary Activities:     Primary Activities:                         Primary Activities:           Primary Activities:
•Develop Charter        •Map the current state process              •Devise process changes       •Efforts transition to
•Obtain approval from   •Establish measurement system               •Test the changes             implementing/replicating
sponsoring group        •Gather data                                • Validate that the changes   approved processes
•Identify Team          •Baseline current performance               lead to anticipated           •Improvement efforts are
•Obtain commitment of   •Identify key drivers of defects/           outcomes & repeat as          limited at this point
time and resources        performance issues                        needed                        •Obtaining resources and
                        •Validate the “critical few” drivers        • Document new process        training
                         through analysis                           • Implement new process
                                                                    • Devise process controls
                                                                    • Hand off to operational
                                                                    owners
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Improvement team structure and roles
                 Typically 5-8 members
                                                                  •Cross
                             Project        Measurement
                                                                  functional
                             Manager          Coord.
                                                                  •Work in the
                       Others                        Process      process
                      as needed                    Improvement
                                        Process       Expert      •Represent
                                         Owner
                                                                  different
                       Infrastructure             Ops/Nursing
                                                  Administrator   roles /
                          partners
                                                                  positions
IT, Communications,                     Content
Education, Facilities,                  Experts
Finance, Legal, Regulatory
Process Issues                          D       M       A        I        C

          1. “Too many errors!” – high defect rate

                 Axis of Current Defect Rate
 Worse than                                                        Better
   50%                  10 to 20%               1 to .1 %        than . 1%




 Gross waste             Gross variation     Below-the-surface       Perfecting
 & instability         & below-the-surface       variation
                             waste

          Just do it            DMAIC framework applies
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       2. “It takes too long!” or too expensive
Use value stream mapping to set the context end to end and to
identify where the waste is
    Heavy use of lean tools to standardize and improve process
    flow
    Defects are either:
         Instances where end-to-end lead time went beyond
         customer requirement
         Specific instances of waste
    Issue also expressed as:
          The wait time is excessive
          We have a capacity issue
         Our margin needs to increase
          We can’t keep adding (staff/equipment/space)
                  DMAIC framework applies
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        A good DMAIC project?
Involves a currently-existing, fairly
standardized process that can be mapped in
detail
Has baseline data available or that can be
readily captured
Not producing results the customer wants
Not clear what should be done to the
process to improve.
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        A good DMAIC project?
Scope is such that the project should reach
the Improve phase in a “reasonable
timeframe”
A priority issue and resources are available
to assure success
Has strong support from the project
champion
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               Summary
DMAIC is a powerful method for quality
improvement.

No two projects will be the same

The exact set of tools used for any two
projects may not be the same

The time spent in each phase of DMAIC for
any two project may not be the same
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 Case Study: Protocol Development
Clinical trial protocol development
consists of the documentation, logistical
and scientific reviews, approvals, and
financial planning required for conveying
a study from concept to activation and
the beginning of patient accrual.

Customer’s input from informal and
formal surveys information:
Slow process.           Costly
Too many steps.         Difficult to track
         Define      D   M    A    I   C




Scope
  Multidisciplinary – Cancer,
  Cardiovascular, Transplant research
  Multisite – MC Florida, MC Arizona, and
  MC Rochester
  Primary measure – time from protocol
  concept to IRB submission.
          Define      D    M    A   I    C



Goals
 To reduce timeframe from 39 weeks to a
 maximum of:
   10 weeks for internally-authored protocols.
   4 weeks for externally-authored protocols.
 Reduce rework.
 Standardize, streamline, and eliminate
 redundancy in the protocol development
 process across 3 sites.
Define
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       Define       D   M    A   I     C
           Define



Benchmarking

Deliverables
 PI Manual
 Training Tools / SOPs
 Readiness Checklist for other units
          Measure     D    M    A    I   C




Value Stream Map
  Define tasks and measure time for each
  Count the number of items waiting
  Calculate total time, total process time,
  and the value added ratio
    Total time > 188 days
    Process time ≈ 14 days
    Value added ratio ≈ 7.4%
        Measure    D    M   A    I   C




Current State Kaizens
 Protocol template standardization
 FDF improvements
 Communication/Approvals plan
 Committee approvals process
Measure   D   M   A   I   C
Measure
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         Analyze    D    M   A    I    C




Root Cause Analysis
 Fishbone diagrams were used to
 discover the root causes of process
 defects.

Brainstorming
  Team members brainstormed ideas and
  circulated for review and approval.
  Higher rated ideas were given higher
  priority due to limited resources.
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         Improve




Future State Value Stream Map
  3 week process
  First In First Out system
  Total process time = 4 working days
  Total wait time – Non value added
  essential = 10 working days
  Value added ratio = 27.5%
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         Improve




Additional Future State Kaizens
  Clarify principal investigator roles
  Provide project management training
  for coordinators
  Improve fist time quality (checklist
  creation)
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                      3/4 Week FIFO Process
      Step 11
       Step                     Step 22
                                 Step                    Step 33
                                                          Step
      11Week
        Week                   1-2 Weeks
                                1-2 Weeks                11Week
                                                           Week
••Review protocol
   Review protocol
••Define study in NCCS
   Define study in NCCS
••Complete Correlative                               ••Conduct post peer
                                                        Conduct post peer
   Complete Correlative       ••PI/Sponsor
                                 PI/Sponsor            review meeting to
  Research Information
   Research Information         Reviews Consent         review meeting to
  form                           Reviews Consent       finalize protocol
                                                        finalize protocol
   form                       ••PIM Requested
                                 PIM Requested         (and possibly
••Draft Consent and send
   Draft Consent and send       through MIRIS           (and possibly
  to PI/Sponsor                  through MIRIS         forms)
                                                        forms)
   to PI/Sponsor              ••PRC/HRC
                                 PRC/HRC             ••Complete IRB
••Start IRBe application
   Start IRBe application       approval obtained       Complete IRB
••Obtain CPT codes from          approval obtained     application and
                                                        application and
   Obtain CPT codes from                               submit ––OR- NCI
  sponsor (if applicable)
   sponsor (if applicable)                              submit OR- NCI
••Start regulatory                                     submission
                                                        submission
   Start regulatory                                  ••Attend PIM
••Send out for Peer Review
   Send out for Peer Review                             Attend PIM
••Add on to PRC/HRC                                    (OSPA)
                                                        (OSPA)
   Add on to PRC/HRC
  agenda
   agenda
••LCA-drug only, no
   LCA-drug only, no
  funding
   funding
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            Improve




Logistics Review Meeting
  Replaces Peer Review
  Replaces multiple disconnected emails
  Transitions into fully electronic environment
  Allows for open discussion and debate
  Eliminates inconsistencies & contradictory
  language
  Positive customer feedback
          Improve      D   M    A    I      C




Standardized Templates
  Color coded for responsible party
  Reduction from 64 total templates to 22
  1-on-1 PI education
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        Control Phase
Consistent and improved process
Establish Control Charts

Control plan
 Monitor performance to ensure
 the process success.
 Reaction plan.
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             Lessons to share
DMAIC is very effective in improving
Healthcare processes including
administrative/ business processes.

Other institutions benchmark with Mayo
protocol development process.

Partnership with industry.
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             Lessons to share

Process owners commitment is critical to the
success of the initiative.

The right skills on the team.

Customer and External effect.
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         Unexpected Successes

$150,000 supplement grant from NCI

$750,000 internal grant to include the
patients enrollment.

A manuscript, accepted for publication by the
Journal of Clinical Oncology.
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Happy Customers
    Ultimate Goal:
    Accelerating the
    time to improve
    patient access to
    trials

    Meet customer
    demands
    Improve staff
    satisfaction
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