Sustaining The Gains in A Hospital Laboratory

First Place Poster at ThinkLab10
Lean Six Sigma: Sustaining the Gains in a Hospital

Laboratory
By Lorelei Bigelow, MLS (ASCP)

CE
, MLT (CSMLS), LSSBB
Carmen Wolkowski, ART (CSMLS), LSSBB

Leland Baskin, MD, MS
Mary Gorko, MLT (CSMLS), LSSBB

$EVWUDFW

Sustainability is the defining characteristic of long term significant process
improvement. The Foothills Medical Center (FMC) Chemistry laboratory
began utilizing Lean Six Sigma tools in 2005 to assist with meeting turn
around time (TAT) targets for STAT glucose testing. Performance fell below
acceptable limits in 2007. The goals of the project were to determine the
reasons that the target was not being met consistently and to implement
improvements that would be sustainable.

Calgary Laboratory Services utilized the internal expertise of the Operational
Performance Improvement (OPI) office to apply Lean Six Sigma
improvement methodologies at FMC. An OPI specialist worked with a team
composed of one bench technologist and two supervisory technologists from
FMC. Using a seven-week rapid improvement cycle, several improvement
opportunities were identified and implemented.

A formal sustainment plan was implemented that included standard work for
leaders, visual controls, control charts, and daily, weekly, monthly and
quarterly accountability processes. FMC Chemistry has met or exceeded TAT
targets for FMC Chemistry for STAT glucose specimens since the completion
of the event in March 2008.

Process excellence is a journey that may require travel down the same road
more than once. To realize the benefits of Lean Six Sigma, a structured
sustainment plan is essential. Each person in the value stream needs to
understand the reason the improvement is necessary and the importance in
maintaining the benefit.

Clinical Leadership & Management Review | Volume 24 | Issue 3 1
Introduction
Calgary Laboratory Services (CLS)
is located in Calgary, Alberta,
Canada and provides diagnostic
laboratory testing, information, and
related services to physicians and
other healthcare professionals. As
a wholly owned subsidiary of
Alberta Health Services, CLS
operates diagnostic medical
laboratories in four acute care
hospitals, a centralized testing
centre, laboratories in three urgent
care Health Centres, as well as
operating 18 Patient Service
Centres (PSC) throughout the
community. CLS serves over a
million people each year and
performs approximately 21 million
tests annually.
1

CLS stated vision is to become
"World Leaders in Laboratory
Medicine. In order to reach that
level, CLS has undertaken stepwise
process improvements, many of
which are overseen or led by the
Operational Process Improvement
(OPI) office. The office is operated
by medical technologists who have
all received specialized training in
operational improvement including
Lean and Six Sigma.

As the costs of medical care
increase at alarming rates,
laboratories and medical services
in general are seeking innovative
ways to control these costs and
retain employees without
sacrificing quality. Change
initiatives that lead to cost
reduction and employee retention
require extensive effort. `Lean and
`Six Sigma methodologies provide
tools to assist in the execution of
these initiatives. Lean and Six
Sigma are separate performance
improvement concepts with long
histories as single entities. The last
decade has seen a movement in
two directions:
First, application of the
two methodologies as an
integrated approach to
achieving process
excellence
2

Second, recognition of the
value of these
management tools in the
healthcare industry
3,4,5

Lean is a set of methods and tools
used for process improvement with
focus on eliminating "waste and
maximizing "flow.
6
Waste is any
activity that consumes time or
resources but does not add value
to the product, service, treatment,
or other deliverable as viewed from
the perspective of the patient or
customer. Therefore, each activity
in a process must create value
from the perspective of the
customer. The approach is
ìnclusive, in that Lean enables and
empowers employees doing the
work to identify and make
improvements.
4
The Lean concept
originated in the early days of
mass production in the first part of
the twentieth century going back
to Henry Ford.
7
Taiichi Ohno of
Toyota perfected these methods
with the creation of the Toyota
Production System.
8

Lean Six Sigma: Sustaining the Gains in a Hospital Laboratory Bigelow, Wolkowski, Baskin, Gorko
The philosophy of Six Sigma is to
apply clearly structured methods
and tools to achieve operational
excellence with defect-free
processes. The focus is on
eliminating or reducing variation.
9

The foundational methods and
tools employ applied statistics.
Motorola introduced the concept of
Six Sigma in the late 1980s, but it
was General Electric that brought
Six Sigma to the forefront of
common business knowledge and
practice in the 1990s.
2,9
A process
that operates at a Six Sigma level
has no more than 3.4 defects per
million opportunities, that is, the
process operates correctly 99.9997
percent of the time.

Applying Lean and Six Sigma
simultaneously provides a detailed
improvement structure with
complementary tools. The idea is
to blend the two root
methodologies into an approach
that optimizes quality, speed, and
cost of doing business.
2
The
desired outcome is stable, capable,
and predictable processes.

Background
CLS introduced the use of Lean
methodology for process excellence
in 2005. The overarching goals
included increased staff
satisfaction, meeting or exceeding
contractual turn around time
targets (TATs) and increasing
productivity.
10
The majority of
process improvement activity in
the first two years employed Lean
methods. Introduction of Six Sigma
concepts and tools began in 2007.
Over 100 events have been
completed to date including:
`Just Do It events - Root
cause of the problem is
known. The solution is
known, is simple and easy
to implement.
Kaizens - The word
"kaizen is derived from
the Japanese characters
"kai which means to take
apart and "zen which
means to make good.
6

These are longer projects
that require problem
analysis.
Seven-Week Rapid
Improvement Cycles
2
- A
systematic method to run
a Kaizen.
DMAIC projects -A Six
Sigma project plan with
five phases (Define,
Measure, Analyze,
Improve and Control)
9

Full day Ìn house training
seminars that include simulation
exercises are held monthly.
Completion of these activities is a
stepping stones toward the goal of
creating a Lean Six Sigma culture
at CLS.

Defining the Problem
Sustainability is the defining
characteristic of long term
significant process improvement. A
primary measure of performance is
the ability to meet or exceed TAT
targets. At CLS the TAT target for
STAT glucose testing is the
measure of time elapsed from
sample receipt in laboratory, to
electronic result reporting. The
target is 90 percent of glucose
analyses complete in 60 minutes.
Half of this time is reserved for
pre-analytical processing in the
Accession Department, so that only
30 minutes is available for
analytical testing.

The Clinical Biochemistry
Department (Chemistry) at
Foothills Medical Centre (FMC) site
consistently experienced
challenges in meeting the 30-
minute analytical portion of the
target. As of June 2005,
performance was well below the
expectation of clinical staff. (See
Figure 1, period from January 2005
to December 2005.) Lean Six
Sigma activities began in
December of 2005.

The FMC Chemistry laboratory
created a value stream map (VSM)
that depicted all activities, both
value and non-value added,
required to complete a service as
requested by the customer. This
map highlighted sources of waste
and provided direction for
improvement activities.
6,11
Ten
improvement opportunities were
identified from the mapping
session. A Kaizen event was
scheduled for each opportunity
between November 2005 and May
2006. The focus of each event was
the elimination of waste through
the use of Lean tools. Initial
success was substantial. However,
within one year performance was
slipping. No clear causes of
variability were apparent. Possible
factors included staffing changes,
interfacing with a new hospital
information system, and poor
communication of changes.

The 2007 project objective was to
determine the reasons that
improvements were not sustained,
and to implement improvements
that would be maintained long
term.

Where to Begin and How to
Proceed?
The FMC Chemistry Laboratory
applied Lean Six Sigma (LSS)
methodologies for the process
improvement project with direction
and support from the CLS OPI
office. An OPI LSS specialist
assembled a team composed of a
bench technologist, a senior
technologist, and a site leader from
FMC Chemistry Laboratory. A
seven-week Rapid Improvement
Event (that comprised five distinct
phases) was scheduled and
completed in December 2007.

The structure of the seven-week
event allows each phase to feed
the next through activities and
deliverables that are clearly
defined. The strength of this
methodology lies in the creation of
a defined objective that allows
measurement of success.
4

Phase 1 activities, completed in the
first week, were as follows:
Selected the process in need
of improvement
Created a charter document,
which outlined the historical
background, a problem
statement and the objective
of the event. The charter is
an essential binding
document that identifies
stakeholders, team
members, and the scope of
the event. The charter will
assign accountability, clarify
expected outcomes and set a
timeframe to ensure the
initiative is realistic.
12

Clarified scope using a SIPOC
(Supplier/Inputs/Process/Out
puts/Customers) diagram.
13

The event began by updating the
VSM created in 2005 to reflect the
current state (See Figure 2). One
key Lean principle is the never-
ending, ongoing pursuit of process
excellence.
6
Despite previous Lean
activities 15 "pain points in the
VSM were identified. Areas in the
VSM directly affecting the glucose
TAT were chosen for the process
improvement event. The scope of
the project was defined to ensure
manageability within the seven-
week cycle. (See Figure 3.)

Phase 2 activities occurred in week
two:
Clarified the problem and
objective by gathering data
to confirm current
performance
Determined a metric that
allowed the team to measure
and demonstrate success
Solicited feedback on the
problem from department
staff

Clarification of the problem and
objective included a re-evaluation
of previous improvement events.
It was evident that improved
processes were not sustained. (See
Figure 1, period from October 2006
to December 2007.) Instrument
limitations dictated that the
process utilized 26 of the 30
allowable minutes. Processes
implemented in the initial event
had deteriorated. Sources of waste
were inhibiting continuous flow of
specimens onto the analyzers
resulting in erosion of the four
minutes available for
troubleshooting.

Phase 3 activities completed by the
end of week three:
Organized collected data
Began the solution selection
process
Solution generation and
selection tools were utilized
with collaboration from all
staff and identified
stakeholders.

Processes were re-designed to
ensure continuous flow of samples
onto the analyzers with emphasis
on a structure that would ensure
sustainability.

Phase 4 allowed one week to
implement changes to the process:
Improvement solutions were
implemented
Staff were educated on
procedural changes
Metrics were gathered daily
to monitor success

Phase 5 ran for three weeks and
included:
Evaluation to ensure changes
were sustained
Creation of supporting
documentation
Development of a
sustainment plan

A formalized sustainment plan
defined standard work for leaders,
visual controls, control charts, and
daily/weekly/monthly/quarterly
responsibilities for all levels of
staff. During this phase the team
focused on obtaining complete
engagement and consensus from
all levels in the organization
regarding the leader standard
work. (See Table 1.)

Key Accomplishments
Immediate positive results were
evident. (See Table 2.) The key
accomplishments during the seven
weeks included the following:
Adopted best practices from
other CLS chemistry
departments that prevented
the analyzer from going into
standby mode between
sample deliveries. This
dramatically decreased the
frequency of the analyzers
13-minute initialization
process.
Re-evaluated bench coverage
and assignment of duties at
the Chemistry Sample
Handling and Analyzer
Operator benches. This
ensured:
Timely delivery of
samples to the
analyzers at all times
Extra resources during
peak workload times
Standardized receipt,
processing, and delivery of
samples to each of two
analyzers.
Standardized placement of
samples on the instrument to
easily identify which are
STATs. The practice
variability between
technologists was eliminated.
A STAT was now recognized
simply by its location on the
sample tray.
Created visual controls with
posted TAT control charts
specifically for each shift.
Initial response was
lukewarm. Staff had some
angst originating from the
comparative nature of
measurements between
shifts. Gradually, staff came
to accept the control process
and embraced the successes
that the charts highlighted.
Established standard work for
leaders. This was deemed
equally important as
standard work is for front line
staff. (See Table 1.)

What Was the Measure of Success?
Since the completion of the event
in March 2008, CLS FMC Chemistry
Laboratory has met or exceeded
TAT targets for STAT glucose
samples. (See Figure 3.)

Variance (%
2
) in the process was
reduced 74 percent from 12.65 for
the period from January 2005 -
December 2007 to 3.23 for the
period from February 2008 -
November 2009. (See Figure 4.)

Discussion
At the onset of Phase 1, the
general consensus among team
members was that control of the
60 minute TAT was not within their
power. The assumption was that
the fault lay in the FMC Accession
department and their inability to
deliver samples in a timely fashion.
Evaluation of the data indicated
this was not the case. (See Table
2.)

The FMC Accession department
was also involved in process
improvement activities. Kaizen
events occurred in the FMC
Accession department
simultaneously in 2005 with
significant initial success. Here too,
there was an eventual breakdown
of processes. In 2008 Lean Six
Sigma concepts including
continuous flow and visual signals
were used to develop and
implement an enhanced service
delivery model in FMC Accession. A
significant improvement was
achieved and has been sustained
for two years.
14

In contrast to the Chemistry event,
it is believed the key components
of success and `buy in for the
Accession event were intense
education and frequent celebration
of successes. Celebration is more
than an emotional release. Done
effectively, it involves a deep level
of analysis and enhanced
awareness.
15
Accession frontline
staff received formalized education
on both the new process and the
expected targets and their
meaning. In this case, leadership
members in the Accession
department were well trained in
Lean tools and believed in the
improvement.

Conversely, FMC Chemistrys
inability to sustain improvements
achieved in 2005 appeared to stem
from the lack of standard work for
leaders. Reliance on supporting
documents and training of front
line staff was not enough and the
eventual degradation of processes
occurred. A continuous
improvement culture had not
solidified within the area. This was
evident when the value stream
mapping was redone.

Chemistry team members all
agreed that the most difficult
portion of the improvement lay in
the development of the
accountability structure. Elements
such as peer-to-peer direction and
current management practices led
to difficult conversations and were
challenging for the team, team
lead, frontline staff, and all levels
of management. Although this was
challenging, the results have made
it well worth the effort.

By combining the lessons learned
from Chemistry and Accession, and
utilizing these lessons in CLS
improvement events, successful
sustainment is being achieved.

Conclusions
The journey to process excellence
may require travel down the same
road more than once. Realization
of benefits from Lean Six Sigma
improvement activities for the
long-term requires several
essential elements:
Development of Lean Six
Sigma leaders
Standard work at all levels of
an organization. This
includes the creation of a
structured plan for
accountability for all staff in
the department.
16

Implementation of a
comprehensive education
program to ensure every
person in the value stream
understands the reason for
the improvement and the
importance of maintaining
the benefit
Utilization of visual
management
Frequent celebration of
successes
CLS continues to utilize all of these
lessons learned along the path to
process excellence.

References

1. Calgary Laboratory Services
Corporate Website accessed
July 19, 2010.
www.calgarylabservices.com
2. Breakthrough Management
Group, and DeCarlo, N. The
Complete Idiots Guide to
Lean Six Sigma, New York:
Alpha Books Penguin Group,
2007.
3. deKoning H, Verver JPS, van
den Hevel J, Bisgaard RJM,
Does M. Lean Six Sigma in
Healthcare. J Healthc Qual.
2006; 174.
4. Zarbo RJ, Tuthill JM,
DAngelo R, Mahar B,
Neuman C, Ormsby A. The
Henry Ford Production
System, Reduction of
Surgical Pathology In-Process
Misidentification Defects by
Bar Code-Specified Work
Process Standardization. Am
J Clin Pathol. 2009; 131:468-
477.
5. Melanson SEF, Goonan EM,
Lobo M, Baum JM, Paredes
JD, Santos KS, Gustufson
ML, Tanasijevic MJ. Applying
Lean/Toyota Production
System Principles to Improve
Phlebotomy Patient
Satisfaction and Workflow.
Am J Clin Pathol. 2009;
132:914-919.
6. Womack J, Jones D. Lean
Thinking, 2
nd
Ed, New York:
Simon and Schuster, 2003.
7. Ford H with Crowther S.
Today and Tomorrow.
Garden City, New York:
Doubleday, Page & Company,
1926.
8. Liker JK. The Toyota Way,
New York: McGraw-Hill,
2004.
9. Gygi C, DeCarlo N, Williams
B. Six Sigma for Dummies.
Hoboken, NJ: Wiley
Publishing Inc, 2005.
10. Rudy E, Kuchinski D.
Lean Toward Success. CLS
Corporate Storytelling Lean
Sigma. 2007; 5
11. Tapping D, Shuker T.
Value Stream Management
for the Lean Office, New
York: Productivity Press,
2003.
12. $mbros
e C, Daley AT. How Do Your
Quality Initiatives Measure
Up? Clin Leadersh Manag
Rev. 2009; 23(2).
13. Waldo W, Jones T. A
Team Leaders Guide to Lean
Kaizen Events. Longmont,
CO: Breakthrough
Performance Press, 2006.
14. 6waine FB, Gray DC,
Baskin LB, Ibaraki C, Corpuz
C. Lean-Sigma as a Process
Improvement Tool in
Delivery of Laboratory
Services in an Acute Care
Setting. Am J Clin Pathol
2008; 130: 662- 663.
15. Jones G. How the Best
of the Best Get Better and
Better. Harv Bus Rev. 2008
Jun 86(6):123-7, 142.
16. Mann, D. Creating a
Lean Culture: Tools to
Sustain Lean Conversions,
New York: Productivity Press,
2005.

About the Authors
Lorelei Bigelow, MLS (ASCP)
CE
, MLT
(CSMLS), LSSBB, and Carmen
Wolkowski, ART (CSMLS), LSSBB,
are process excellence specialists
at Calgary Laboratory Services
where their projects focus on the
development, implementation,
training, and coaching of Lean Six
Sigma methodologies throughout
the organization.
Mary Gorko, MLT (CSMLS), LSSBB,
is a process excellence specialist
and is currently the quality
supervisor at Calgary Laboratory
Services.
Leland Baskin, MD, MS, FCAP,
FACB, is division head, Clinical
Pathology, Calgary Laboratory
Services, and clinical associate
professor, Department of Pathology
and Laboratory Medicine,
University of Calgary, Calgary, AB.
For questions on this manuscript,
please contact Lorelei Bigelow at
lorelei.bigelow@cls.ab.ca.
Figure 1. Plot of FMC Clinical Biochemistry Laboratory monthly mean
% glucose results verified within 60 minutes.

Figure 2. Current state value stream map.


Figure 3. The SIPOC map sets boundaries to the project and
identifies key suppliers, inputs, outputs, and customers.

Figure 4. Pre and post event variation.

Table 1. Communication plan for sustaining Lean advantages.

ROLE
Responsibilities Communication Plan
Technologist I
(Bench
Technologist)
x Follow procedures as outlined
in the SOPs
x Be cognizant of the process
and whether it could be
improved
x Utilize all levels in the
department (Tech I, II, III)
x Understand the metrics and
what they mean
x Shift reports - all
benches
x Read shift reports from
previous shift and day
x Provide suggestions and
solutions for
improvement
opportunities to senior
staff
x Verbal communication
between shifts
Technologist II
(Senior
Technologist)
x Walkthrough of department 4
times per day (at least)
interacting every time
Approx (0700, 0800, 1045,
1400)
x Feedback provided timely for
any questions or improvement
opportunities
x Monitor FTATs - investigation
daily to include highlighting
outliers, determining root
cause, recording in
spreadsheet, posting in
department, control charts
x Staff coaching and mentoring
of Lean processes will be
captured on a spreadsheet to
facilitate follow-up training.
x Multiple coaching sessions
and/or behavioural issues will
be forwarded to the supervisor
for additional facilitation
x Create LeanSmart similar to C-
Smart to be done quarterly
x Asking Lean and process
questions to staff
x Discussing with staff to
determine adequate
coverage for breaks
x Ensuring workload is
being managed
x Being visible in the
department to assist
with issues or concerns

Technologist III
(Site Leader)
x Walkthrough of department 4
times per day interacting half
the time
Approx (0800, 1200, 1400,
1600) - 1200 and1600 times
for interaction
x Back-up for FTATs when Tech
II is unavailable
As feedback from improvement
opportunities are identified,
evaluation and consultation with all
levels will occur in a timely manner,
to determine feasibility of
implementation (or not)
questions to staff
department to assist
with issues or concerns


Supervisor x Every day on site, at least
once a day walkthrough
and interaction with Tech
Is on day shift
x For evenings and nights, a
walkthrough with
conversation at least twice
a month
x Be available by
appointment for off-shift
Tech Is if Tech Is are
unable to remain after the
end of their shifts
x FTATs to be reviewed
monthly
x Behavioral issues to be
dealt with in a timely
manner.
x Follow-up facilitation for
multiple coaching and
tracking of success.
x First step is always
coaching/mentoring.
x Additional facilitation may
follow operational
guidelines set out in
collective agreement Coll
Agree Art #74.0 HR#5.12
questions to staff
department to hear
issues and concerns
x Communicate the
operational guidelines
and roles &
responsibilities of Senior
Staff to staff
x Lean to be a standing
item at monthly
meetings.
x When a staff member
asks a question directly
of a Supervisor, provide
the answer directly back
to the employee

Manager x Back-up of Supervisor
x On site assessment of Lean
processes to occur twice a
month on day shift (and
more if able). Every time
on site, an effort should be
made to enter the
department to create a
connection

questions to staff
department to hear
issues and concerns
x Communicate the
operational guidelines
and roles &
responsibilities of Senior
Staff to staff
Acute Care
Clinical
Biochemist and
Pathologist
x On-site assessment of Lean
processes once a month
questions to staff
Division Head x On site assessment of Lean
processes once a month
questions to staff
Executive x On site assessment of Lean
processes quarterly
questions to staff

Table 2. Implementation/evaluation metrics - four weeks.

Rapid Event Metrics
Implement/Evaluate
Pre
Event
Implement
Week End
Target
Evaluate
Week 1
Evaluate
Week 2
Evaluate
Week 3
Achieved
% Change
1.
Mean % Stat TAT <60 mins
Ìn Lab to `Verify
86% 93% 92% 94% 94% 94%
9%
Increase
2.
Mean % Stat TAT <30 mins
`Section Log In to `Verify
88% 93% 95% 95% 95% 97%
10%
Increase

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First Place Poster at ThinkLab10

Lean Six Sigma: Sustaining the Gains in a Hospital

By Lorelei Bigelow, MLS (ASCP)

Carmen Wolkowski, ART (CSMLS), LSSBB

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