Lab Efficiency and Patient Safety
Rose Romeo PhD, DABCC, FACB
Redwood City, 94065
Learning Objectives
 Examine the science of Patient Safety
 Review approaches for Laboratory Efficiency, including Lean
and Six Sigma
 Share some thoughts on implementation and rollout
Origins of the Science of Patient Safety
 Originated with the Institute of Medicine’s Report in the
1990’s
 Overview provided via Wikipedia:
 http://en.wikipedia.org/wiki/Patient_safety
 Variety of Initiatives
 Review of sources/topics follows…..
CLN, January, 2013 Volume 39 (10):
Improving Safety via Laboratory Outputs
http://www.nih.gov/news/health/aug2012/nhgri-22.htm
What is Patient Safety?
http://www.ahrq.gov/downloads/pub/advances2/vol1/advances-emanuel-berwick_110.pdf
Bottom Line: Drive by Process (and not Finger Pointing
VA National Center for Patient Safety
http://www.patientsafety.gov/
Joint Commission-Patient Safety
http://www.jointcommission.org/topics/patient_safety.aspx
NPSG for Laboratory Services
JCAHO…Specifics on Laboratory Goals
National Patient Safety Foundation
http://www.npsf.org/
AHRQ Patient Safety NetSearch on laboratory-and filter by target
http://psnet.ahm.gov/search.aspx?searchStr=laboratory
Tool to Take Home:
Patient Safety Training Course…..
Retrieved from: http://www.jhsph.edu/offices-and-services/center-for-teaching-and-learning/training/patient_safety.html on January 29, 2013
Time to move to a discussion of
Efficiency…..
Efficiency~Improved Patient Safety
Integrating Efficient Laboratory
Processes with Patient Outcomes
GP26 A4?
ISO 15189?
Systems Approach
Other?
Lean-Six
Sigma?
Selection of
Methodology
Lean?
Six
Sigma?
Improved Patient
Outcomes
Systems Approach-Quality Systems
 Originated as Business Tool
 Processes/Policies specific for an institution the promote Quality
Outputs
 Can drive the entire process of ongoing improvement
 Now referenced in multiple regulated environments
 Pharma
 Guidance Document
 Device
 21CFR820
 CLIA
 CLSI GP26A4
 ISO 15189
 Other
How do the Laboratory Systems differ?
 Both have considerable Overlap in components
 Primarily differ in terminologies w/similar outputs
 ISO 15189 offers accreditation
 CLSI GP26 is a choice
Key Point for Your Needs:
Figure out what is of most value
What about the Methodologies?
 Do I really need to select a particular methodology?
 Short answer=It depends
 On your
 Needs
 Approach to System Implementation
 Executive Support
Clash of the Titans
 Six Sigma vs Lean
 Endless Debate
 Specialized versus Hybrid
Methodologies:
Multiple Flavors of Each Method
 Six Sigma-“reduction of errors”
 Classified by “Belt Color”
 White-Green-Black
 Lean- “reduction of waste”
 Multiple classifications
 3P-5S-Kaizen etc etc
 See Combo versions as well
 5S-3P-Lean-Six Sigma
History of Six Sigma
http://www.sixsigmaonline.org/six-sigma-training-certification-information/articles/the-history-and-development-ofsix-sigma.html
18th Century
Europe:
“normal curve
metric”
Walter
Shewhart & 3
sigma deviation
Motorola coins
term “Six
Sigma”
Six Sigma in Healthcare
http://www.sixsigmaonline.org/six-sigma-training-certification-information/articles/six-sigma-and-it-use-inhealthcare.html
 Article emphasizing fit for Six Sigma and Laboratory
Operations & Processes
 Definition (especially of the customer)
 Prioritization
 Itemization
 Completion
 Notes: Not all issues will be a fit for Six Sigma, but
 Six Sigma can be a very good fit for a Healthcare setting due
to “the repetition of processes”
History of Lean-Ford….Toyota
http://www.lean.org/WhatsLean/History.cfm; http://leanenvironment.com/lean-e/About-Lean.php
A Brief History of Lean Manufacturing
Eli Whitney Invents the Cotton Gin (1794) and interchangeable parts
Frederick Taylor published the Principles of Scientific Management (1911)
Henry Ford invents the moving assembly line, and dozens of innovations between 1908 and 1913
Training Within Industry (TWI) developed to increase production in WWII.
W Edwards Deming transfers info to Japanese companies in the reconstruction
Taiichi Ohno, Kiichiro Toyoda and Shigeo Shingo invent mfg methods, JIT and SMED
Womack and Jones Publish Lean Thinking in 1995
How to figure out what you need…
http://www.epa.gov/lean/environment/methods/index.htm
BUT…….
Systems &
methodologies
alone do not
guarantee
Quality
http://www.huffingtonpost.com/2013/01/30/toyota-recall_n_2579685.html
Owning “It”
 Communicating use of methodologies…
 Doesn’t always translate to practice
 When systems approach practices
 Errors are found before they impact customer (patient)
 Challenges
 Corporate promises
 Timelines
 Resources
SOOOO……
Resources:
Key Factor in Improved Efficiency Executive Support
 The opposite of micro management
 Illustrates understanding of Systems approach
 Supportive
 Who’s Driving?? One needs the right people
 Owner & Delegates
 Need Leaders & Managers
 Open to Flexibility and Change
Over-engineering can be an issue
 Plan up front (Hybrid approach??)
 Drive by measurable desired outcomes
 RACI Matrix
 http://en.wikipedia.org/wiki/Responsibility_assignment_mat
rix
 Who’s Responsible (aka who does the work)
 Who’s Accountable (aka “who’s neck is on the line”)
 Who get’s Consulted (but doesn’t necessarily get a vote)
 Who is Informed?
Methodologies-Six Sigma
 Quality Systems should encompass all programs/tools for
Efficiency & Patient Safety
 Six Sigma-See chapter 1-Henry
 Defect Reduction
 DMAIC (Lots of similarities w/CLSI Process Mgt QSE)
 Define
 Measure
 Analyze
 Improve
 Control
Lean Processes: 5S and 3P
5S
3P
 Workplace Organization
 Similar to Design Control
 Sorting
 Production
 Straightening
 Preparation
 Sweeping
 Process
 Standardizing
 Sustaining
http://en.wikipedia.org/wiki/5S_(methodology)
http://www.epa.gov/lean/environment/met
hods/threep.htm
Questions to Ask Before Adopting Methodology
(vs. defining your own custom methodologies)
 What is the desired output?
 Will consolidation increase the probability of success?
 What are my metrics (and how will they be measured?)
 What are the acceptance criteria?
 What will I do if I don’t make my timelines, or the data suggests
something else should have been measured?
Once all is in place, Where to Start?
 Process Flow Charts
 Need to have your processes mapped out to communicate to all
 Aids in defining specifications and where (and what) you want
to measure
 Ask: Where do I want to go?
 Work with applying basics of methodologies to see what fits
best
 Keep revisiting your existing processes and make your system
work
Potential of Improved Efficiency
 Improved
 Patient Safety
 Worker Safety
 Cost Savings
Questions for Consideration?
 When might 3P be used in favor of 5S?
 When might the reverse be true?
 How to incorporate Six Sigma into your recipe?
Self-Assessment Questions
1. The Six Sigma Methodology addresses
A.
Design processes
B.
Statistical assessment of error
C.
A&B
D.
All of the Above
2. The 3P Methodology does NOT address design
A.
True
B.
False
3. Which of the following is a true statement:
A.
Methodologies for improvement are part of a Quality System
B.
A Quality System is part of the Lean Methodology
C.
5S is a type of Lean Methodology
D.
A&C
4.
A.
B.
Individuals assigned to Lean-Six Sigma Teams should be open to change
True
False
Additional References
 Guidance for Industry: Q10 Pharmaceutical Industry; Retrieved from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInfor
mation/Guidances/ucm073517.pdf on January 30th, 2013
 The Quality System Regulation, Title 21 of the Code of Federal Regulations,
part 820, Retrieved from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?C
FRPart=820&showFR=1 on January 30, 2013
Any Questions??
THANK YOU!!