Feature
Laboratory Toolbox
for Process
Improvement
Six Sigma at North Shore –
Long Island Jewish Health System
Nancy Bliss Riebling, Laurel Tria
(North Shore–Long Island Jewish Health System,
Great Neck, NY)
DOI: 10.1309/H2U5QGDEGQ6MG1KT
labmedicine.com January 2008 Volume 39 Number 1 LABMEDICINE 7
Feature
uring the 1990s, the health care industry • It includes a robust control phase to sustain results.
D
began searching for better process-improve- In January 2002, the North Shore–Long Island Jewish (LIJ)
ment models. Quality programs like Total Health System launched its Center for Learning and Innovation
Quality Management (TQM) had failed to (CLI) in conjunction with General Electric and the Harvard
sufficiently address systemic inefficiencies or School of Public Health. The corporate university features sev-
deliver sustainable results. Without a tool to eral divisions, one of which is Operational Performance Solu-
expose and deal with actual root causes, one tions. This group of employees is trained in the use of Six Sigma
of the primary targets for slashing the budget became labor. and Lean to improve efficiencies and enhance quality. The
Simply trimming the workforce, however, was not the answer North Shore–LIJ Health System was the third health system
and did not produce the desired long-term effect. The clinical nationwide to implement a Six Sigma initiative. North
laboratory, which historically had been a revenue-generating Shore–LIJ Health System, headquartered in Great Neck, NY, is
department, now was becoming a cost center. The volume of the third largest nonsectarian health system in the country, com-
tests, complexity, and cost were skyrocketing. Laboratory prising 15 hospitals. The Center for Learning and Innovation
management found reliability could not be achieved through has trained 7 Master Black Belts, 25 Black Belts, and 158 Green
the control of accuracy in the analytical phase of the testing Belts. In conjunction with Six Sigma training, employees ac-
process alone, because studies showed 70% to 80% of labora- quire valuable change-management skills by taking classes in
tory errors occurred before that, in the preanalytical phase.1 change acceleration process (CAP) and fast-track decision mak-
At the same time, Six Sigma was gaining momentum in ing (FTD). As one of the original Master Blacks Belts and the
business communities worldwide. current Director of Operational Performance Solutions, my for-
mer department, the laboratory, became a pioneer in using Six
Sigma, Lean, and FTD for process improvement because of my
Six Sigma background as a medical technologist. Laboratory senior leader-
Six Sigma had its beginnings in the 1980s at Motorola as a ship’s support and willingness to think outside the box was
tool to manage production variation using rigorous statistical crucial for our success.
analysis. It taught organizations the need to master customer Created in 1998, the North Shore–LIJ laboratory model
focus, to process definitions, and to engage in measurement sys- consists of a strategically-located core laboratory using total labo-
tem analysis, root-cause analysis, and consistent process monitor- ratory automation, a rapid-response laboratory in each of the
ing. During the mid-90s, Jack Welch, CEO at General Electric, system’s 15 hospitals, a standardized laboratory information sys-
created a vision for his organization based on the Six Sigma tem (LIS), standardized laboratory instrumentation, and consoli-
methodology. It became the way they did business. It was the dated testing at the core laboratory. Work for the core laboratory
common language across diverse divisions. Six Sigma offers dis- comes from the health system’s hospitals, long-term facilities,
tinct advantages over traditional initiatives in the following ways: clinical trials, physician offices, and reference testing. The labora-
• Six Sigma focuses on customer requirements, the “Voice tory performs over 4 million tests per year, of which approxi-
of the Customer”; mately 65% are routine testing for the North Shore–LIJ
• It targets defects and process variation instead of averages; network, as well as all the network’s microbiology, special tests,
• It uses a highly-structured, data-driven framework for molecular diagnostics, and reference testing.
problem solving; and As part of the laboratory’s ongoing performance-improve-
ment process, accessioning errors have
been measured historically for years.
This was the first issue the laboratory
High Level Process Map:
High Level Process Map: tackled using the Six Sigma methodol-
ogy. Accessioning errors were a chronic
problem for which consultants had pre-
viously been engaged without arriving
at a successful resolution.
Requisition for blood work • Physician supplies demographic information
received at the core lab At the core laboratory, a multidis-
• Physician’s office draw specimens
ciplinary team of technical, compliance,
marketing, quality, and accessioning
Accessionerenters • Verify specimen with requisition management staff was assembled to
demographics & test • Register patient in LIS tackle the problem using the Define,
in Laboratory Information • Order test
System Measure, Analyze, Improve, and Con-
• Label specimen trol (DMAIC) approach.
Specimen • Specimens placed on CLAS or
Delivered delivered to department Define
During the Define phase, the team
developed a high-level process map
• Result (Figure 1) beginning with the initial
Results
• Chart step of the physician filling out the
• Bill requisition and drawing the specimen
to the last step when the final chart
copy is printed. Through careful data
Figure 1_High-level process map. collection and analysis, the team found
8 LABMEDICINE Volume 39 Number 1 January 2008 labmedicine.com
Feature
5% of the specimens accessioned at the core laboratory were
inaccurate or incomplete, which was in line with previously-
collected historical data. These inaccuracies caused delays in
reimbursement and decreased customer satisfaction. The Six
Sigma team used change acceleration process tools, such as the
threat/opportunity matrix, during the Define phase to obtain
buy-in from the laboratory staff for the necessity of pursing this
project. This tool demonstrated that, if successful, the labora-
tory would be able to increase productivity and customer satis-
faction while decreasing the number of incomplete or
inaccurate requisitions. If unsuccessful in the long term, the
core laboratory’s reputation would be diminished, leading to
a loss of revenue.
Measure
In the Measure phase, the first order of business was to
create operational definitions to define a defect. The team de-
fined a defect as a laboratory requisition with missing or inac-
curate demographic, test, or ICD-9 information. The team
performed a measurement system analysis by giving the requi-
sition checking staff a test of 25 requisitions—some good,
some bad. Each requisition was rated as good or bad on
whether or not all 7 fields were entered in the LIS correctly.
The gauge demonstrated repeatability, reproducibility, and
accuracy in more than 90%. A review of 5,607 requisitions
collected over a 1-week period revealed a defect rate of 283.
To calculate defects per million opportunities (DPMO), the percentage of the staff (5 out of 24) was making most of the
discrete data formula of D/ (U) (O) = 283/ (5,607) (7) × errors, which follows the 80/20 rule (Figure 2).
1,000,000 = DPMO = 7,210 was used, where D= Defect,
U=Unit, and O=Opportunity. The calculated DPMO of 7,210
is equivalent to a Sigma score of 3.9. The team also measured Improve
the number of requisitions processed per hour as 17 with an In the Improve phase, the team drilled down using the
SD of 7. The team used the CAP tool of a stakeholder analysis Five Why tool.2 They found the skilled nursing facilities used
to aid in determining a strategy to move those individuals who addressographs for patient demographic information.
were moderately against the project to a more supportive posi- Addressographs have multiple identifiers, making inter-
tion. It also helped identify those individuals who were likely pretation difficult for the accessioning staff. In addition, ad-
to touch the process and thus could be a resource to the team. dressographs tend to be illegible when run through an
addressograph machine. Peel-off labels located on the bottom
of the core laboratory’s patient chart could be placed on the
Analyze laboratory requisition, thus eliminating the need for the ad-
In the Analyze phase, the team benchmarked the core dressograph. The team also created desktop reference guides
laboratory’s performance against other reference laboratories to be positioned at each accessioning station to alleviate acces-
throughout the country. The core laboratory’s accessioning error sioning errors. This helped make all the information new hires
rate of 3.9 Sigma was comparable to industry standards; how- were supplied with at orientation and training readily avail-
ever, the productivity of the accessioning staff had a large able. Ongoing competency assessment was achieved by using
amount of variation and was below industry standard. The blind proficiency specimens throughout accessioning. The
team used tools, such as the cause and effect (fishbone) team modeled the assessment on the proficiency testing pro-
diagram, to capture all the possible reasons (X’s) for accession- gram performed in the technical areas of the laboratory that
ing errors (Y’s). They then began to create graphs (pictures) to are required for licensing.
separate the vital X’s from the trivial many. Graphical analysis
using Pareto charts (Figure 2) indicated 50% of the accession-
ing errors were due to incorrect entry of the Social Security Control
number for skilled nursing facility patients. This discovery was In the Control phase, the Six Sigma team implemented a
an enlightening observation or “ah-ha.” Before the analysis, the plan that incorporates individual- and moving-range control
team members had been convinced the culprit would be the charts for monitoring accessioner productivity. The DPMO
handwriting of physicians on the requisitions. This “X” proved and corresponding Sigma score for accessioning errors is mon-
to be statistically significant using the chi-square test for discrete itored. At the end of the control phase, the process went from
data. The null hypothesis that all types of demographic errors a 3.9 Sigma score to 4.5 Sigma. Productivity increased from
are the same was rejected because the P value of 0.002 was less 17 to 26 requisitions per hour with the standard deviation
than 0.05, and thus the team could conclude a statistical differ- decreasing by 50% (Figure 3). The accessioning department
ence in the number of defects that existed among the different was able to handle a 43% increase in outreach specimen vol-
demographic fields. The team also determined that a small ume without adding additional staff.
labmedicine.com January 2008 Volume 39 Number 1 LABMEDICINE 9
Feature
Figure 2_Graphical analysis using Pareto charts.
Fast-Track Decision Making develop and implement appropriate solutions. Specimen
Change acceleration process is a philosophy and tool movement within the laboratory was a “heartburn” issue
set designed to help overcome cultural barriers to change for staff. The issue presented to the frontline supervisors
by creating a shared need, shaping a vision, and mobilizing and employees of the accessioning and technical depart-
commitment. Fast-track decision making (FTD), which ments was how to facilitate the movement of specimens
is North Shore–LIJ’s version of GE’s “Work-Out” from the nontechnical to technical area of the laboratory.
process, is a rapid problem-solving approach with team The session led participants to propose the following 3
involvement and in-meeting decisions. It is a catalyst for recommendations:
change, focusing on the process to drive improvement 1. A runner position: someone to move specimens
and empowering the people closest to the process to around the accessioning department;
Figure 3_Productivity.
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Feature
Figure 4_Identifying waste with notes.
2. A color-coded book listing all laboratory tests and is reassigned to work full time on the issue. 3 The first step is
which department performed the analysis; and to create a value-stream map of the current process. Value-
3. Color-coded signs throughout the laboratory matching stream mapping entails diagramming the detailed activities
the color coding in the book so accessioning staff members of the process, showing the flow of materials and information
know where to deliver specific specimens in the laboratory. through the process, and incorporating baseline data for lead
The employees designed the signs and books. The times, queues, and cycle times.4 Each step is evaluated for its
response from employees was so favorable that the idea was value contribution to the end product and effect on quality. If
translated to other key areas within the laboratory, such as the step is a non-value-added step, it is considered waste and a
marketing and information services. good candidate for elimination.
There are 7 types of waste: transportation, inventory,
motion, waiting, overproduction, overprocessing, and defects
Lean (TIMWOOD). Business non-value-added steps are those
In 2005, the Operational Performance Solutions group which may not be eliminated due to licensure or accredita-
added the Lean methodology to their toolbox of improvement tion.3 The team consisting of content experts identified all the
methodologies. The principles of Lean thinking have been types of waste in the process using colored Post-It notes (Fig-
attributed to the Toyota Production System, which is to do ure 4). They prioritized the issues using N/3 voting, a tool to
the “right thing” in the “right way” to minimize waste. The prioritize the most important items from list and build con-
goal of Lean is to reduce the non-value activities within a sensus on the team. This is accomplished by dividing the total
process. Key tools for a Lean initiative are the following: number of items “N” by 3. Each team member then receives
• Value stream mapping that many votes to use all on one issue or on multiple issues.
• 5S The issues with the most votes are addressed first. Three key
• Kaizen issues were identified: problem requisitions and error process-
• Process balancing ing, client education, and issues management. The team used
The laboratory’s first Lean project was to improve billing tools such as brainstorming and the control-impact matrix to
efficiency. The core laboratory spent about 12.1% of each develop solutions. The team uncovered that errors needed to
dollar collected on billing-related expenses. The days sales be corrected in 3 different laboratory information systems
outstanding (DSO) was 127 days. The laboratory collected (accessioning, technical, and billing) and that three different
approximately 20% of gross charges on non-client bills. The departments were making the same corrections (overprocess-
laboratory scheduled a 3-day Kaizen event. The Kaizen ap- ing). The team used the tool of process balancing to develop
proach incorporates intense progress through the DMAIC their improvement strategy. Key design principles are to stabi-
process. The Define and Measure preparatory work is done by lize cycle times, balance tasks and labor across process steps,
the Black Belt prior to the event. During a Kaizen event, staff and to optimize the number of process steps. By giving the
labmedicine.com January 2008 Volume 39 Number 1 LABMEDICINE 11
Feature
Figure 5_Issue-management log.
Value Analysis Teams
billing clerk access to the 3 information systems, demographic
information could be corrected in all systems at once. This One of the challenges an organization faces when imple-
decreased the days-to-price from greater than 14 to less than 5 menting Six Sigma and Lean is translating the knowledge
and reduced the variation in accessioning cycle times. learned from a completed project to other areas. A laboratory
To enhance client education, a user-friendly requisition turnaround time project done at one hospital whose improve-
was developed with accompanying laminated guides and ments we would try to roll out at another hospital would
highlighted required information. Thank-you letters were meet resistance. The old adage “we’re different” would surface.
sent to physician offices that were 100% compliant. An Another project would be done with a similar outcome. As
issue-management log was designed for easy access on any part of the system initiative of standardization and best prac-
computer so issues could be logged and tracked (Figure 5). tice, Value Analysis Teams were established for key areas and
To create and maintain an organized, clean, and high- disciplines. The laboratory team consists of laboratory managers
performance workplace, the team used the 5S principles. 5S from all system facilities. The team reports monthly to senior
is a systematic way to improve the workplace, and the 5 S’s leadership on key indicators of patient experience, quality, and
stand for: Sort (remove all unnecessary items from the work financial performance. The laboratory’s quality initiative is “to
environment), Simplify (label and arrange key items in the decrease the turnaround time of routine laboratory tests from
area), Shine (clean the area), Standardize (develop a consis- draw to result to less than 60 minutes.” The laboratory cre-
tent way of performing the tasks), and Sustain (develop ated a multidisciplinary team with employees from the phle-
checklists and audits to maintain the improvement). botomy, accessioning, and technical departments at 4 different
The team reported out after the initial Kaizen and then hospitals. The team participated in a 3-day Lean Kaizen at one
at 30 and 60 days afterwards. Using tools such as the RACI hospital, and the improvements were rolled out as a pilot for all
chart, the team was able to keep track of their progress hospitals. Solutions included moving equipment into a horse-
(Figure 6). A RACI chart enables the team to keep track of shoe shape design to decrease non-value-added walking (Fig-
who is Responsible (to actively participate in an activity), ure 7), using a runner to get specimens down to the laboratory
Accountable (the key person for the deliverable), Consulta- in small timely batches, the purchase of additional small cen-
tion (a person with an expertise or decision making ability), trifuges, and the movement of printers and phones closer to
and Inform (people affected by the project). The improve- key technical areas. The team followed the Kaizen, 30- and
ments have been sustained. Current metrics show the billing 60-day report-out format. The team reconvened at another
department at a DSO of 91, with approximately 10.9% of facility for a one-day FTD. They reviewed the current process
each dollar collected spent on billing-related expenses. and then, using the strategies already implemented at the
12 LABMEDICINE Volume 39 Number 1 January 2008 labmedicine.com
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Figure 6_Responsible, Accountable, Consultation, and Inform (RACI) chart.
Figure 7_Redesigning workflow.
labmedicine.com January 2008 Volume 39 Number 1 LABMEDICINE 13
Feature
previous site, put the improvements in place, building on Table 1_Turnaround Times (TAT) Less Than 60 Minutes
what they learned while incorporating the existing culture of
the facility into their improvement strategy. The resulting
success (Table 1) created cross-functional teams across job
functions and facilities.
Lessons Learned
Implementing the tools of Six Sigma and Lean are a jour-
ney not for the fainthearted, as Chief Learning Officer Kathy
Gallo, RN, PhD, MBA, likes to say. In order to be successful,
the organization needs to commit the resources to educate the
staff in the methodologies.
Many organizations underestimate the people or the ac-
ceptance portion of the equation Q × A = E. The “Q” is the
quality or technical aspect of change, the “A” is the accept-
ance portion (the people who will or will not make it hap-
pen), and the “E” is the effectiveness of the change or project. 1. Pierangelo B. Errors in laboratory medicine. Clin Chem. 2002;48:691–698.
You can develop a robust solution using the tools (Q=7), but 2. For definition of the Five Why tool, go to www.asq.org/sixsigma/
if there is no buy-in from staff (A=1), the effectiveness is min- terms/index.html.
imal (E=7). If you achieve buy-in (A=7) by educating the staff, 3. Michael, G. The Lean Six Sigma Pocket Tool Book. New York, NY: McGraw
your effectiveness exponentially increases (E=49). Lessons we Hill; 2005: 2.
have learned are that education does not mean everyone on 4. Trusko B, Pexton C. Improving Healthcare Quality & Cost with Six Sigma.
Upper Saddle River, NJ: FT Press; 2007:378.
the team needs to be a statistics expert. Front-line staff can
learn to use control charts and develop operational definitions
and value stream maps while leaving the hypothesis testing to
the Black Belts. Senior leadership support is vital. Account-
ability at all levels is the key to success. Incorporating the
tools into the Value Analysis Teams has taken the organization
from a project perspective to common language approach. Six
Sigma and Lean are how we do business. LM
14 LABMEDICINE Volume 39 Number 1 January 2008 labmedicine.com