AJCP / Original Article
Providing Critical Laboratory Results on Time, Every Time
to Help Reduce Emergency Department Length of Stay
How Our Laboratory Achieved a Six Sigma Level of Performance
Kenneth E. Blick, PhD
From the Department of Pathology, University of Oklahoma Health Services Center, Oklahoma City.
Key Words: Lean; Six Sigma; Automation; Robotics; Test turnaround time; Length of stay
DOI: 10.1309/AJCPNUTIPQTRRG0D
ABSTRACT
Objectives: To develop a fully automated core laboratory,
handling samples on a “first in, first out” real-time basis
with Lean/Six Sigma management tools.
Methods: Our primary goal was to provide services to
critical care areas, eliminating turnaround time outlier
percentage (TAT-OP) as a factor in patient length of stay
(LOS). A secondary goal was to achieve a better laboratory
return on investment.
Results: In 2011, we reached our primary goal when we
calculated the TAT-OP distribution and found we had
achieved a Six Sigma level of performance, ensuring that our
laboratory service can be essentially eliminated as a factor
in emergency department patient LOS. We also measured
return on investment, showing a productivity improvement
of 35%, keeping pace with our increased testing volume.
Conclusions: As a result of our Lean process improvements
and Six Sigma initiatives, in part through (1) strategic
deployment of point-of-care testing and (2) core laboratory
total automation with robotics, middleware, and expert
system technology, physicians and nurses at the Oklahoma
University Medical Center can more effectively deliver
lifesaving health care using evidence-based protocols that
depend heavily on “on time, every time” laboratory services.
© American Society for Clinical Pathology
Blick_2012110583.indd 193
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Offering a rapid and predictable laboratory service is
essential for the practice of real-time evidence-based medi-
cine; rapid diagnosis and interventions are required for good
patient outcomes, especially in critical care patients.1 This is
particularly true in the high-volume emergency department
(ED), where physicians establish required turnaround time
targets for various critical care tests and expect clinical labo-
ratories to hit these targets on a consistent basis. While turn-
around time statistics such as mean and standard deviation are
clearly important benchmark parameters to monitor, we have
shown that turnaround time outliers play a more significant
role in delayed patient diagnosis and treatment. Indeed, turn-
around time outliers (ie, sample results not meeting clinician
expectations or laboratory goals relative to laboratory turn-
around time targets) are disruptive to the orderly triage and
flow of patients through evidence-based protocols, especially
protocols involving critical care.2,3 We found the laboratory
turnaround time outlier percentage (TAT-OP) to be a rate-
determining factor in the patient length of stay in the ED.
Out of frustration, ED physicians tend to respond to a
defective and unpredictable laboratory service that misses
promised turnaround time targets by (1) calling the labora-
tory, checking to see if there has been a failure of process,
or (2) ordering essentially all tests as stat priority, thinking
that the test will receive a faster turnaround time and delays
will be avoided. In our laboratory in 2002, stat test requests
had ballooned to nearly 50% due to turnaround time delays.
In addition, 2 of our technologists were assigned to handle
calls from concerned physicians and nurses regarding per-
ceived testing problems. When errors or problems did occur
in the laboratory in 2002, they were usually handled as part
of a batch process, causing additional delays, thus further
Am J Clin Pathol 2013;140:193-202 193
193 DOI: 10.1309/AJCPNUTIPQTRRG0D 193
7/3/13 3:43 PM
 Blick / Providing Critical Laboratory Results on Time, Every Time
affecting clinical decision making and care. And when these
problems occurred during the laboratory’s shift change, they
were handed over to other technologists for follow-up, fur-
ther complicating the process.
Industry has greatly improved efficiencies through
effective use of Lean/Six Sigma approaches: Lean initiatives
focus primarily on optimization of processes and workflows,
as well as the elimination of steps in a process that add no
value, while Six Sigma endeavors to eliminate defects in
services or products as perceived by the customer. To reduce
problems and provide better, more predictable service to the
ED and other critical care areas of the hospital, laboratories
must focus on eliminating any remaining legacy core labora-
tory batch-testing processes and replace them with real-time
testing tools. Several approaches to real-time testing are
available, including (1) whole-blood point-of-care (POC)
testing at the bedside, especially in critical care areas of the
hospital and in the ED, as described by Lewandrowski1 at
Massachusetts General Hospital, and (2) total laboratory
automation (TLA) solutions as practiced in our laboratory
at Oklahoma University Medical Center, Oklahoma City.
Although total automation of the core laboratory and POC
testing are costly to set up and maintain, we believe that
strategic application of both of these real-time testing
approaches is essential for overall success in improving
TAT-OP significantly for those tests required by the ED and
other critical care areas.
The Oklahoma University Medical Center consists of
2 freestanding hospitals: one is devoted to adult care, while
the other focuses on care for children. The ED is the only
level 1 trauma center in the state of Oklahoma, currently
handling more than 60,000 patient encounters per year; the
children’s hospital ED encounters nearly 10,000 patients
yearly. In 2012, our laboratory performed nearly 6 million
tests. Approximately 20% of this testing volume came from
an active outreach testing program.
As an essential part of our real-time approach for critical
care testing, we initiated a number of changes to the preana-
lytical aspects for essentially all laboratory testing, critical and
noncritical. First, we deployed electronic physician ordering
for laboratory testing along with real-time specimen collec-
tion using our nursing staff. As part of this process change,
we installed local barcode printers in all patient care areas
for specimen labels. Specimen requirements were printed
on the labels along with any other special instructions to the
nurses. Also, training programs were initiated for nurses for
phlebotomy, specimen handling, and POC testing. Pneumatic
tubes were installed in all patient care areas in the hospitals
and clinics. We also standardized the collection tubes for
chemistry to 100-mm lithium heparin plasma tubes, thus (1)
avoiding confusion for nurses in selecting the tube and (2)
eliminating the wait for specimens to clot once they arrive
194 Am J Clin Pathol 2013;140:193-202
194 DOI: 10.1309/AJCPNUTIPQTRRG0D
Blick_2012110583.indd 194
in the laboratory. Also, these collection tubes included a gel
barrier so that essentially all testing could be performed on the
same positively identified patient’s primary collection tube.
To focus on improving service to the ED and other criti-
cal care areas of the hospital, we developed a plan in 2003
to update our core laboratory to include a total laboratory
automation track system coupled with a middleware-based
information system with decision-making algorithms for
autoverification of results and real-time quality control. A
middleware approach was required because we had found
that our legacy laboratory information system was incapable
of performing these tasks. As mentioned, we also implement-
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ed Lean/Six Sigma management techniques with the goal of
achieving a Six Sigma level of quality performance.4 Lean/
Six Sigma are business management tools that were devel-
oped for production environments and first used at Toyota
and Motorola, respectively. More recently, they have been
adapted to improve processes and quality in the clinical labo-
ratory. While Lean management is focused on improvements
in efficiency through overall process redesign, Six Sigma
seeks to improve quality and performance by controlling
variability and minimizing defects or errors. Others5,6 have
shown that implementation of Lean/Six Sigma processes in
a laboratory environment can improve service by decreasing
turnaround time and reducing errors. We wanted to use Lean/
Six Sigma management tools to develop a fully automated
core laboratory that handles samples on a “first in, first out”
real-time basis with no queues, no batch processing, and no
special handling for priority/stat samples—all implemented
using an essentially “paperless” approach. As part of this
initiative, we also strategically deployed POC testing, espe-
cially in critical care areas in our pediatric hospital. Since
pediatric specimen collection tubes cannot be placed on our
current automation track system, we view decentralized real-
time bedside testing on a state-of-the-art handheld device as
real-time automation for children. Accordingly, as part of this
project, nurses were trained throughout the medical center to
perform critical care testing on POC devices when appropri-
ate. Our primary goal was to provide services to the critical
care areas such as the ED so that TAT-OP was eliminated as
a factor in the ED patient length of stay. A secondary goal
was to improve the efficiency of the laboratory and achieve
a better return on investment (ROI) while dealing effectively
with the diminishing availability of medical technologists in
the Oklahoma City area.
Materials and Methods
For laboratory turnaround time computation, we used
the time from when a sample was received in the laboratory
to the time when results were verified and reported out. We
then computed the mean turnaround time and TAT-OP on a
© American Society for Clinical Pathology
7/3/13 3:43 PM

monthly basis from July 2003, when we began our process
improvement project, through March 2012, 6 months after
achieving a goal of Six Sigma–level performance. Specifi-
cally, during this period, we monitored the turnaround time
for potassium, an important analyte in the basic and com-
prehensive metabolic panel for the ED, noting the raw count
of tests not meeting the promised turnaround time targets.
We also monitored turnaround time targets for hematology
for our ED services. A turnaround time target mean of 40
minutes was selected by our ED physicians as desirable
for potassium in chemistry, with 60 minutes considered an
acceptable outlier limit, while 30 minutes was set as the
target mean for hemoglobin in hematology. To achieve
these specific turnaround time targets, we initiated monthly
monitors and monitoring dashboards as part of an active
program employing modern management principles of Lean
and Six Sigma. To ensure success, we designed this quality
improvement program to include all essential steps of the
laboratory process, including preanalytical, analytical, and
postanalytical. Clearly, the focus of this article is chemis-
try improvements through deployment of TLA and POC
testing. However, to date, we have also achieved a 3.1 s
level in our hematology ED turnaround time outcomes data
using the aggressive 30-minute benchmark for hemoglobin
outliers described earlier. More than 93% of hemoglobin
results have met the turnaround time target mean set for
hematology. Note that hemoglobin is part of the complete
blood count (CBC), and thus the hemoglobin turnaround
time reflects the completed CBC panel turnaround time.
The approach we used in hematology was similar to our
chemistry automation; we employed automation tracks,
Remisol Advance middleware (Beckman Coulter, Brea, CA)
for autoverification, and a 24/7 dashboard screen to iden-
tify problems in real time. For the preanalytical phase, we
implemented electronic physician order management on our
MEDITECH hospital information system (Medical Informa-
tion Technology, Westwood, MA) along with local barcode
printing using MedPlus (Medical Information Technol-
ogy) and JMI Barcodes (JMI Barcodes, Raleigh, NC). We
deployed Pevco pneumatic tubes (Pevco, Baltimore, MD)
throughout the hospitals and clinics for specimen delivery to
the central specimen receiving and processing (CRP) area.
We also initiated a real-time specimen collection program
using nurses, thus eliminating the phlebotomy team. Using
Lean principles, our CRP area was revamped so that speci-
mens are handled only once.
For our decentralized critical care testing initiative, we
deployed POC handheld testing devices and managed this
expanded program from the core laboratory with 2 registered
medical technologists serving as POC coordinators. Inter-
faces for these remote POC devices were handled by local
network hubs with each device given a unique IP address.
© American Society for Clinical Pathology
Blick_2012110583.indd 195
AJCP / Original Article
A 7-bed chest pain unit previously had been established in
the ED to support bedside cardiac marker testing on a POC
testing device. Middleware was deployed to manage all
POC testing (RALS; Medical Automation Systems, Charlot-
tesville, VA), including autoverification and quality control
review by core laboratory technologists.
For the analytical and postanalytical testing processes in
the core laboratory, a total automation robotic track system
(Beckman Coulter) was installed in the chemistry section in
2003-2004. It included (1) a specimen scanning and track-
ing/software Preplink interface; (2) a rapid in-line robotic
centrifuge with a 4-minute spin cycle; (3) a conveyor puck
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system for a physical track-instrument interface connection
for our 3 chemistry analyzers, SYNCHRON LX20 (Beck-
man Coulter), and our Advia Centaur immunology systems
(Siemens, Tarrytown, NY); (4) specimen tube decappers and
recappers; and (5) an in-line robotic refrigerated specimen
“stockyard” for up to 3,000 tubes. The implementation plan
for the system included project management tools such as
Gantt charts and a full-time project engineer for our site; we
held biweekly progress meetings and required strict adher-
ence to assignments, testing, validation, and timelines. The
entire chemistry system was implemented over a 5-month
time frame and completed in April 2004, 1.5 months ahead
of the projected completion date.
Middleware software, Remisol Advance (Beckman
Coulter), was obtained. This middleware manages the fol-
lowing analytical and postanalytical functions: (1) track
automation; (2) instrument interfaces and monitoring; (3)
autoverification and release of laboratory results; (4) speci-
men retrieval; (5) quality control, including real-time qual-
ity control based on exponentially weighted patient moving
averages; (6) instrument interfacing and communication
with the MEDITECH laboratory and hospital information
systems; and (7) a 5-screen dashboard to monitor the entire
system in real time. The 5-screen dashboard deployed in
chemistry also includes a real-time monitor of pending ED
test requests. One core laboratory technologist operates the
dashboard workstation on a 24/7 basis.
Autoverification rules were used on the Remisol
Advance middleware with algorithms to check all patient
results for problems based on (1) normal range checks; (2)
critical range checks; (3) absurd result flags; (4) specimen
indices for hemolysis, lipemia, and icterus; (5) instrument
flags, including photometer range checks; (6) computational
checks, including anion gaps; (7) delta checks; (8) qual-
ity control range checks; and (9) patient running means
checks. When patients’ results fail autoverification for any
rule, the dashboard immediately alerts the technologist and,
depending on the rule involved, also lists corrective action
consistent with approved laboratory policy for handling the
problem identified.
Am J Clin Pathol 2013;140:193-202 195
195 DOI: 10.1309/AJCPNUTIPQTRRG0D 195
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 Blick / Providing Critical Laboratory Results on Time, Every Time
For our paperless compliance initiative, we imple-
mented Compliance360 software applications (Sai Global,
Alpharetta, GA). Using this application, we eliminated all
paper records, including laboratory procedures and policies,
documentation for inspections and checklists, method quali-
ty control data, and evaluation studies. We also implemented
Compliance360 applications for e-mail support for timely
and online review of documents by laboratory supervisors
and directors.
All Six Sigma calculations were performed on an Excel
worksheet (Microsoft Office 2003 and 2007; Microsoft,
Redmond, WA) programmed with macros and graphics fea-
tures designed specifically for this purpose (QI Macros SPC
Software for Excel developed by Jay Arthur; http://www.
spcforexcel.com/statistical-tools-and-features-included-spc-
for-excel). Calculations of s levels were based on a propri-
etary best-fit relationship between industry-accepted defects
and s levels. Prior to importing to this spreadsheet, raw data
were extracted from our MEDITECH laboratory informa-
tion system database and imported into an Access database
(Microsoft Office 2003 and 2007). Ad hoc real-time queries
were made in the Access database to specifically select sub-
sets of data for import into the Excel Six Sigma spreadsheet.
To estimate ROI for the laboratory, we calculated
the paid hours per test. For this calculation, the total paid
monthly hours for the technologists working in chemistry
was divided by the total number of reportable tests generated
over that month’s pay period.
Results
Our annual core laboratory test volume is approaching
6 million tests, with an annual growth rate of 6% to 8%
observed from 2003 through 2012. To cope with this volume
increase of more than 78% and to better serve the ED by
achieving a Six Sigma level of TAT-OP performance, we
had to streamline our laboratory processes. We have previ-
ously shown2,3 that while there is a correlation between ED
length of stay and turnaround time means, a much stronger
relationship was observed between ED length of stay and
TAT-OP. Therefore, we set our goal to achieve a Six Sigma
level of performance for the laboratory TAT-OP, count-
ing each missed turnaround time target as a process defect
as perceived by our ED physicians. Sigma levels used in
industry in defects per million (DPM) are as follows: 2s =
308,500 DPM, 3s = 66,800 DPM, 4s = 6,200 DPM, 5s =
230 DPM, and 6s = 3.4 DPM.
One problem we faced initially was the need to level
the inflow of specimens to the laboratory so that we could
maximize the efficiency of our CRP area and our laboratory
automation system and thus decrease both turnaround time
196 Am J Clin Pathol 2013;140:193-202
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Blick_2012110583.indd 196
means and TAT-OP. Typically, core laboratories receive
samples in batches from phlebotomy teams and therefore
process specimens in batches. This leads to bottlenecks and
increased lag times, especially for those samples requiring
additional processing/handling steps. In our laboratory,
approximately 60% of our daily workload of samples arrived
between 5:00 and 10:00 am. Through our Lean initiatives,
we were able to redesign and streamline our preanalytical
processes so that specimens flow into the laboratory in a
more uniform real-time fashion, thus allowing for more
efficient and timely processing and analysis on a “first in,
first out” basis. ❚Table 1❚ shows the distribution of specimen
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arrival into the laboratory throughout the 24-hour day, with
only 24% now arriving from 5:00 to 10:00 am. With our
new, more efficient preanalytical processes, the number of
specimens arriving in the CRP area is essentially flat, with
no major peaks and valleys as in the past. Indeed, our legacy
specimen collection approach was based on a laboratory
phlebotomy team making collection rounds, clearly a batch
approach. A transport team was also employed for deliver-
ing specimens to the central core laboratory, yet another
batch approach. By decentralizing specimen collection and
transport using nurses for collections along with our pneu-
matic tube system for specimen transport, we were able to
achieve a more consistent “single-piece” flow of specimens
❚Table 1❚
Leveling of Specimen Arrival Time Distribution at the
Oklahoma University Medical Center’s Laboratory Central
Specimen Receiving and Processing Area
No. of Routine No. of Stat No. of Total
Hour Specimens Specimens Specimens % of Daily Total
0 111 14 125 Hours 0-5, 19%
1 45 6 51
2 104 11 115
3 110 3 113
4 203 11 214
5 226 7 233 Hours 5-10, 24%
6 92 17 109
7 97 14 111
8 132 32 164
9 123 45 168
10 115 32 147 Hours 10-15, 28%
11 158 27 185
12 209 37 246
13 129 46 175
14 133 31 164
15 134 26 160 Hours 15-20, 21%
16 191 20 211
17 142 19 161
18 80 12 92
19 48 17 65
20 77 7 84 Hours 20-23, 8%
21 67 12 79
22 56 2 58
23 40 9 49
Total 2,822 457 3,279
© American Society for Clinical Pathology
7/3/13 3:43 PM

to our CRP areas. It is noteworthy that nurses were initially
resistant to perform phlebotomy services, and in the early
stages, we saw an increase in specimen labeling errors and
had specimen contamination issues. However, we effec-
tively addressed these problems and others by (1) requiring
laboratory orientation and training programs for all nurses
and (2) initiating a detailed monthly monitoring system with
feedback to nursing administration for specimen misidenti-
fication and contamination issues.
After our preanalytical smoothing of specimen arrival
into the CRP, as shown in Table 1, the peak specimen flow
rate was observed to be 246 specimens per hour. Accordingly,
we put in place CRP staffing resources, along with our track
automation system that could handle this volume of specimens
without queues forming in the CRP or on the automation track
system. Note that our plan had to include a continuous flow
of specimens on our TLA track system, which employed
an automated centrifugation unit at a rate-limiting step of
approximately 300 tubes per hour. We also redesigned our
CRP area with a focus on Lean/Six Sigma industry concepts
and the “5S+1” processes redesign approach: sort, straighten,
shine, standardize, sustain, and safety.
Note also that we have achieved a major reduction in
the number of stat requests, down from approximately 50%
prior to implementation of our Lean processes to less than
14% currently. However, since we are using a real-time
“first in, first out” approach, these current stat requests are
treated no differently than non-stat test orders, allowing for a
more efficient flow of samples throughout the laboratory and
reducing the demand on our technologist’s time. Also, prior
to our process redesign, more than 40% of our testing was
performed on aliquots of the primary sample, often called
“pour-off tubes.” Aside from the additional delays involved
in preparing aliquots manually, this process was fraught with
labeling errors in the CRP area. Our new process essentially
eliminates most aliquots by having all testing performed
from the same primary barcoded collection tube on the TLA
system. Each sample is delivered by the track software to
the appropriate testing instruments connected to the track in
sequential fashion.
Prior to implementing Lean processes and total automa-
tion in the core laboratory, an individual specimen might
have gone through as many as 18 steps before results were
reported. The process flow map using legacy systems and
prior to implementing Lean/Six Sigma processes is shown
in ❚Figure 1❚. Also shown in Figure 1 are process steps
that should be eliminated with Lean involving time delay
(process wait states), personnel safety issues (biohazard
exposure, repetitive motion injury, etc), and patient safety
issues (medical mistakes, relabeling, etc). After installation
of our total walk-away automation system and implementa-
tion of Lean/Six Sigma processes in CRP and the chemistry
© American Society for Clinical Pathology
Blick_2012110583.indd 197
AJCP / Original Article
laboratory, we were able to eliminate more than 48 steps
in our entire process and to manage sample analysis much
more efficiently. This new process flow map is shown in
❚Figure 2❚, with the fully automated steps shown in yellow.
Importantly, by deploying the “first in, first out” strategy, we
were able to eliminate special handling in the CRP area for
samples with stat/priority test requests. Moreover, testing on
more than 70% of our samples is now accomplished by our
physically handling the sample only once.
To facilitate monitoring of our complete laboratory pro-
cess with rapid review and reporting of results, we installed
a 5-screen monitoring dashboard in chemistry. It allows 1
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monitoring technologist to track specimens throughout the
entire process. This includes autoverification and results
tracking with real-time alerts for problem results and/or
samples; monitoring and management of all instruments;
handling of multiple patient-related problems, including
critical results notification to our attending physicians; and
ensuring that all ED samples are handled in a timely manner,
essential to our Six Sigma project.
From June 2008 through October 2009, we observed
a steady decrease in TAT-OP for our ED test results, as
shown in ❚Figure 3❚. In 2011, we reached our primary goal
when we calculated the mean turnaround time and TAT-OP
distribution for potassium, an analyte of significant impor-
tance to the ED and part of the basic and comprehensive
metabolic panels for ED patients ❚Figure 4❚, and found
that the core laboratory had achieved a Six Sigma level
of performance using our ED established outlier cutoff
of 60 minutes as a benchmark. Note that all panel results
had to be reported before the potassium turnaround time
was logged for our Six Sigma calculations. Our mean ±
SD turnaround time for potassium was 27.5 ± 7.2 minutes,
which is well within the benchmark of 60 minutes. With 0%
defects, we have achieved the Six Sigma level of less than
3.4 DPM, which demonstrates that our laboratory service
can be essentially eliminated as a factor in ED length of
stay, per specifications set by our ED physicians. Note that
a small number of specimens (<1%) rejected for hemolysis,
lipemia, and icterus, as well as samples requiring special
handling such as dilution, were not included in our Six
Sigma calculations.
As mentioned previously, we regard bedside POC
testing as automation of testing for children, especially in
critical care areas of our pediatric hospitals where specimen
volume requirements and test turnaround time are the main
concerns. Indeed, more than 30% of our neonates are classi-
fied as very low-birth-weight infants, with 10% classified as
micropremies. While core laboratory testing might require
as much as 300 mL of plasma, our POC testing requires less
than 100 mL of whole blood. Examples of real-time POC
test deployment include (1) neonatal intensive care unit
Am J Clin Pathol 2013;140:193-202 197
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 Blick / Providing Critical Laboratory Results on Time, Every Time

electrolyte and blood gas results available to care providers ❚Figure 5❚. This suggests it took us approximately 6 years to
with a sample collection to result mean turnaround time in 2.3 achieve the total productivity gains of our Lean/Six Sigma
minutes compared with a 30- to 60-minute within-laboratory initiatives. It is noteworthy that by consolidating to 1 vendor
turnaround time and (2) POC ED testing for cardiac troponin for automation tracks, middleware, instruments, reagents,
in less than 30 minutes from sample collection to result vs installation, training and support, reagents, and expendables
60 minutes or more for core laboratory troponin results, even from the multivendor approach we were using prior to our
with total automation. Note that these non-POC results are Lean/Six Sigma project, the overall budget for these new
based on our within-laboratory turnaround time studies. automation systems and reagents remains essentially the
We have also measured our ROI success, a secondary same as our inefficient multivendor legacy approach. In fact,
goal of our project. Since approximately 60% of our expens- this was a constraint imposed on all bidding vendors. We
es are related to personnel costs, we monitored technologist also required each vendor to provide a “cost per reportable
productivity as a ratio of “paid hours per test.” This parame- result” quote; thus, we did not purchase any of the required

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ter shows steady annual improvement, more rapid at first and hardware, software, and system support described. Accord-
then culminating with an overall decrease of approximately ingly, all tangible improvements in technologist productiv-
35% over the measurement period from 2004 through 2010 ity (ie, increased testing with the same or fewer staff in the

ER In-house Add-on Reference

specimens specimens tests testing
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7 6 5
be
benchch

❚Figure 1❚ Pre–Lean/Six Sigma initiative process flow map depicting steps in receiving and processing samples, with all steps
“hands-on.” Process steps eliminated after Lean/Six Sigma are crossed out. DAU, drugs of abuse; ER, emergency room; LIS,
laboratory information system; RxL, Dade RxL chemistry analyzer; TDM, therapeutic drug monitoring.

198 Am J Clin Pathol 2013;140:193-202 © American Society for Clinical Pathology

198 DOI: 10.1309/AJCPNUTIPQTRRG0D

Blick_2012110583.indd 198 7/3/13 3:43 PM

 AJCP / Original Article

core laboratory) represent a true ROI. Our laboratory budget increasing number of primary care patients, especially those
spreadsheets after implementation of Lean/Six Sigma were without insurance coverage. Delays in treatment are a major
greatly simplified; essentially, they show the projected num- health care concern, and hospitals must now focus on initia-
ber of annual patient tests and the cost per individual patient tives that improve the movement of patients through evi-
result, with the final proposed budget computed accordingly. dence-based medicine protocols in the ED and other critical
We also projected 6% to 8% annual growth when consider- care areas. Lean and Six Sigma are management tools that
ing our budget, a growth rate that we actually observed. can be used to redefine and streamline hospital procedures to
optimize performance and minimize errors. Effective Lean/
Six Sigma approaches to modern patient diagnosis and man-
Discussion agement involve the use of evidence-based medicine (EBM)
In the ED of many hospitals, multiple factors contrib- built on peer-reviewed protocols. Such EBM protocols have
ute to delays in diagnosis and treatment and to increases in placed increasing demands for real-time diagnostic labora-

Downloaded from https://academic.oup.com/ajcp/article-abstract/140/2/193/1760907 by guest on 05 June 2019

patients’ length of stay. Overcrowding is one such factor, tory services since we have found that laboratory data at our
and health care trends suggest that ED overcrowding will Oklahoma University Medical Center facility comprise up
be exacerbated with the aging of the US population and the to 80% of the objective information on the patient’s chart.3

AxSYM RXL
Day
Daa
ay Store
torre for
f
10
11 12 1
2 shift?
shiif
ift? No day
ay shift?
shif
s 11 12 1
9 3 10 2
8 4 9 3
7 6 5 8 4
7 6 5

Yes
Specimen Redraw or Specimen
OK? ultrafuge OK? 11 12 1
10 2
9 3
8
7 6 5
4
Sort
Sort to
instrument?
rum
um
m

10
9
11 12 1
2
3
Adjust
stt rack
ust ra
DAU T
TDM M 10
11 12 1
2
8
7 6 5
4
for tube
be size
tub
b s
o
or 9 3 11 12 1

Architect
ch
hite
hiit Immunolyte
8 4 10 2

D
DAU U
7 6 5 9 3
8 4
7 6 5

10
11 12 1
2 Decap
cap p and
a
TDM
9 3
8
7 6 5
4
pourr into
in t cup
nto

Pour
Pour off
of Load Fix Specimen
ec
cim
ci No Redraw No Specimen
urine
uriin
ne reagents, problem OK?
OK
K? OK?
calibrate Load
reagents, Fix
calibrate problem
L
Load d
nally
y
yze
analyzer
11 12 1

Decap
ecap p and
a 11 12 1
Decap and
10 2 11 12 1
9 3 10 2 10 2
8 4
nd b
and beg
begin 9 3
pourr into
in t cup
nto
nt
9 3

pour into cup

Manual No
7 6 5 8 4 8 4
7 6 5

run Load
L d
7 6 5

review of 10
9
11 12 1
2
3
analyzer
naly
ly
y
yze
Data results and
nd begin
b
beg
8 4

No
7 6 5

run Manual
Ma ua
Analysis review
e of
ie
ew 10
11 12 1
2
Load
Lo d Load
9 3
reagents,
gee
en Fix
F x reagents, Fix
Data results
res lts 8 4

calibrate
cali rate calibrate
7 6 5

problem
rob
blem
b problem
Analysis
Specimen
11 12 1
10 2

OK
K?
K
OK?? 9
8
7 6 5
4
3

Load
L d Load
Specimen 11 12 1 11 12 1
analyzer
naly
ly
y
yze 10
11 12 1
2 analyzer
Unload
Unl oad
10 2

OK?
OK
K?
K
10 2
11 12 1 9 3

and begin
10 2 9 3 9 3

and
nd begin
b
beg No
8 4 8 4 8 4

analyzer
nallyze
9 3

Yes No
7 6 5 7 6 5 7 6 5
8 4
7 6 5
run Manual
Ma ual 11 12 1
run Manual 11 12 1

review
ew of
ie review of
10 2
10 2

Unload
Unlo
oad
11 12 1 9 3
9 3
10 2 8 4

results
res lts Data results
8 4

Yes
7 6 5

analyzer
naly
lyze
9 3

Data
7 6 5
8 4
7 6 5

Release Analysis
ally
llys
ys Analysis
10
9
11 12 1
2
3
Transfer
ansfer to results
8
7 6 5
4
generic
eric racks
c ra
Release Specimen
10
11 12 1
2 Transfer
ansfer to results Specimen
9
8
7 6 5
4
3

generic
c racks
eric ra OK?
OK
K?
K OK?

Chemistry
10
11 12 1
2 Unload
Unlo
oad 10
11 12 1
2 Unload
Batch tests 9 3
analyzer
naly
lyze
9 3
analyzer
8
7 6 5
4
Yes 8
7 6 5
4
Yes
Hematology
Coagulation

Sort tubes Release

ele
e
eas Release
for storage results
esu
ult results

Transfer to
generic racks
Transfer to
cold storage

© American Society for Clinical Pathology Am J Clin Pathol 2013;140:193-202 199

199 DOI: 10.1309/AJCPNUTIPQTRRG0D 199

Blick_2012110583.indd 199 7/3/13 3:43 PM

 Blick / Providing Critical Laboratory Results on Time, Every Time

ER In-house Reference
specimens specimens testing
ER Order Inlet
specimen Samples
entered
pneumatic delivered
in LIS
tube

Verfify bar
Labels Patient code read
printed in registration
phlebotomy
area
Autoracked
Hematology outlet specimens
Order entry
Phlebotomy and label
monitors printing
order
activity Centrifuge

Label
Phlebotomy tubes
dispatched Decapper To hematology
for collection section

Load to
Specimen transport LX connection
collected, racks

Downloaded from https://academic.oup.com/ajcp/article-abstract/140/2/193/1760907 by guest on 05 June 2019

labeled, and Autoreview
Datalink or results
bagged
LX connection
Return
to lab
Autoracked OK?
Outlet specimens
Park
Order No No
No tube
Capper
Yes Manual
Label To immunoassay review
printed and special
assay sections
Label Refrigeration
attached? stockyard
Yes
Label
applied
10
9
11 12 1
2
3
Process
Tech and time 8
7 6 5
4
wait states Decapper
of draw entered
in LIS Biohazard
exposure
Yes Add-on
Patient request from
safety LIS
Specimens
received Automated
in LIS process Datalink No OK? Yes Release
request rerun

❚Figure 2❚ Post–Lean/Six Sigma design eliminating special handling for STAT samples and retaining only 2 manual steps; totally
automated steps are indicated in yellow. ER, emergency room; LIS, laboratory information system; LX, Lx20 Beckman Coulter
chemistry analyzer.

Although diagnostic laboratory test results play an

increasingly important role in the ED practice of EBM,
laboratory services are frequently too slow and turnaround
160
times for results are unpredictable. Untimely and unpredict-
140 able laboratory services can be another contributing factor in
120 treatment delays and ED length of stay. In the past, such poor
No. of Outliers

100 laboratory services employing outdated, legacy batch solutions

that cause delays in the ED and other critical care areas have
80
been essentially ignored. Today, however, corrective action to
60 eliminate laboratory delays is an essential component of any
40 effective ED and hospital-wide Lean management plan. Also,
20 patients, insurance carriers, and the government are becoming
more aware of core measures of local hospital performance,
0
including poor ED processes and parameters. Proposed “pay-
ne
Se Au uly

O mb t
N cto er
D em er
em er

Fe nua r
br ry
M ary

Ap h
M il
ay
ne
Se Au uly

O mb t
ct er
er
e s

e s
e

for-performance” policies will essentially require hospitals

c
pt gu

pt gu
ov b
ec b
Ja b

ob
ar
Ju

Ju
J

J
u

to maximize efficiency in critical care areas such as the ED.

Applications of Lean and Six Sigma processes in the ED
❚Figure 3❚ Improvement of monthly turnaround time outlier need to begin immediately at first patient contact and should
percentage for emergency department samples. be driven by specific time-based targets, especially where

200 Am J Clin Pathol 2013;140:193-202 © American Society for Clinical Pathology

200 DOI: 10.1309/AJCPNUTIPQTRRG0D

Blick_2012110583.indd 200 7/3/13 3:43 PM

 AJCP / Original Article

900 LSL 0 USL 60

800

700

600

500
Tube Count

Downloaded from https://academic.oup.com/ajcp/article-abstract/140/2/193/1760907 by guest on 05 June 2019

400

300

200

100

0
–1 0 1 2 4 5 6 7 8 1011121314161718192022232425262829303132343536373840414243444647484950525354555658596061
Minutes

❚Figure 4❚ Turnaround time distribution depicting laboratory performance at the Six Sigma level for turnaround time outlier
percentage for emergency department patients. Mean (SD) = 27.5 (7.2) minutes; median = 26 minutes; mode = 24 minutes;
n = 4,916; % defects = 0; s = 6.0. LSL, lower specification limit; USL, upper specification limit.
Paid Hours/PP Test Volume

0.20
timely life-saving interventions may be required. An indi- 0.18
vidual patient’s Lean protocol requirements are dictated by 0.16
0.14
(1) the time of presentation and (2) the pathophysiology of the 0.12
0.10
presenting condition. These should be the main rate-limiting 0.08
0.06
factors in ED length of stay and not factors such as labora- 0.04
tory performance. We have demonstrated that poor laboratory 0.02
0.00
performance is correctable through Lean/Six Sigma initiatives. 2004 2005 2006 2007 2008 2009 2010
Laboratory turnaround time outlier percentage is wide- Years After Automation
ly believed to be a rate-determining factor in ED length of
❚Figure 5❚ Realized annual improvement in laboratory
stay, and there is evidence to support this.2,3 This observa-
productivity at the Oklahoma University Medical Center core
tion suggests that physicians in the ED should adjust their
laboratories. PP, pay period.
expectations and time management to match worst-case
laboratory turnaround time outlier performance. However,
using Lean and total laboratory automation initiatives, if One problem in most core laboratories is the legacy
laboratory TAT-OP can be reduced to less than 3%, our batch approach to specimen handling and analysis, which
data show that the laboratory can become less of a signifi- adds to the complexity and confusion of laboratory pro-
cant factor in overall ED length of stay.3 Therefore, totally cesses. Specimens from non–critical care patients and
eliminating turnaround time outliers or defects for ED clinics are presumed to be a lower priority and are handled
patients is the desired Six Sigma goal. separately from those arriving from critical care areas such

© American Society for Clinical Pathology Am J Clin Pathol 2013;140:193-202 201

201 DOI: 10.1309/AJCPNUTIPQTRRG0D 201

Blick_2012110583.indd 201 7/3/13 3:43 PM

 Blick / Providing Critical Laboratory Results on Time, Every Time
as the ED. This allows blood specimens to queue up in
CRP, leaving them unprocessed for variable periods and
potentially contaminated as metabolic changes occur in the
cellular components of the specimen; specimen contamina-
tion can cause test results that no longer reflect the actual
physiologic state of the patient.7 Metabolic sensitive ana-
lytes such as electrolytes, glucose, blood gases, pH, phos-
phate, urea, and enzymes are frequently ordered for critical
care patients and are particularly influenced by delays such
as those inherent in legacy batch processes. Moreover, in
a rapidly changing patient in critical condition, such test
results delayed more than 30 to 60 minutes may not actu-
ally reflect the current biochemistry in the patient. There-
fore, optimized critical care requires real-time laboratory
results for EBM clinical decisions. Laboratory data must
be available on time, every time to have maximum clinical
value. In addition to causing delays, legacy batch analysis
requires “prioritizing” of specimens for testing and thus
ensures that separate stat testing processes can never be
eliminated by the laboratory.
To solve these problems, we initiated an approach where
each specimen is processed and tested in real time, on a “first
in, first out” basis. Although our workload has increased
78% from 2004 through 2011, our full automation and Lean
initiatives have allowed us to increase productivity to more
than compensate for the increased volume. Moreover, the
number of stat requests has dropped from more than 50% to
14% as a result of physician ordering patterns in response
to more consistent turnaround times and reduction in TAT-
OP. In October 2011, we achieved a Six Sigma level of
TAT-OP performance when we showed that our turnaround
time for potassium, an analyte of significant importance to
the ED and part of the basic and comprehensive metabolic
panels, was a mean of 27.5 minutes with nearly 0% defects
at a 60-minute TAT-OP outlier cutoff benchmark. Our chief
of the ED service stated that this Lean/Six Sigma effort has
essentially eliminated our laboratory as a factor in ED length
of stay for all patients presenting to the ED at the Oklahoma
University Medical Center.
202 Am J Clin Pathol 2013;140:193-202
202 DOI: 10.1309/AJCPNUTIPQTRRG0D
Blick_2012110583.indd 202
Conclusion
As a result of our Lean process initiatives and core
laboratory total automation system, we have increased our
productivity, keeping pace with a 6% to 8% annual increase
in testing volume, without adding technologists. At the same
time, we improved our turnaround time and TAT-OP to
achieve a Six Sigma level of performance. By implementing
these changes and continuing our quality monitors, we are
ensuring that our laboratory service to the ED is “on time,
every time” and, accordingly, is not a significant factor in
patient length of stay.
Address reprint requests to Dr Blick: Dept of Pathology,
Downloaded from https://academic.oup.com/ajcp/article-abstract/140/2/193/1760907 by guest on 05 June 2019
Oklahoma University Health Sciences Center, PO Box 26307,
Oklahoma City, OK 73190.
   Acknowledgments: I thank Sandra Piepho for her editorial
assistance and Archie Masterson for his technical assistance.
References
1. Lewandrowski K. How the clinical laboratory and the
emergency department can work together to move patients
through quickly. Clin Lab Mgmt Rev. 2004;18:155-159.
2. Holland LL, Smith LL, Blick KE. Reducing laboratory
turnaround time outliers reduces emergency department (ED)
length of stay (LOS) an 11 hospital study. Am J Clin Pathol.
2005;124:672-674.
3. Holland LL, Smith LL, Blick KE. Total laboratory
automation can help eliminate the laboratory as a factor
in emergency department length of stay. Am J Clin Pathol.
2006;125:1-6.
4. Garber C. Six Sigma: its role in the clinical laboratory. Clin
Lab News. April 2004:10-14.
5. Cankovic M, Varney RC, Whitley L, et al. The Henry
Ford Foundation System: Lean process redesign improves
service in the molecular diagnostic laboratory. J Mol Diagn.
2009;11:390-399.
6. Riebling N, Tria L. Six Sigma project reduces analytical
errors in an automated lab. MLO Med Lab Obs. 2005;37:20,
22-23.
7. Boyanton BL, Blick KE. Stability studies of twenty-
four analytes in human plasma and serum. Clin Chem.
2002;48:2242-2247.
© American Society for Clinical Pathology
7/3/13 3:43 PM