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Clinical Chemistry / IMPROVING PREANALYTIC PROCESSES

Improving Preanalytic Processes Using the Principles


of Lean Production (Toyota Production System)
Thomas J. Persoon, MS,1,2 Sue Zaleski, MA,1 and Janice Frerichs1

Key Words: Preanalytic; Process improvement; Lean production; Turnaround time

DOI: 10.1309/865V7UMFPUKGCF8D

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Abstract Laboratories are under constant pressure to improve their
The basic technologies used in preanalytic services. The mantra of “faster, cheaper, better” is heard in the
processes for chemistry tests have been mature for a laboratory world as loudly as in other sectors of society.1 Clinical
long time, and improvements in preanalytic processes chemistry laboratories have responded to these demands by
have lagged behind improvements in analytic and acquiring analyzers with improved throughput to speed up the
postanalytic processes. We describe our successful analytic process. The postanalytic process of reviewing results
efforts to improve chemistry test turnaround time from a and distributing them to the appropriate providers has been
central laboratory by improving preanalytic processes, largely automated by adoption of laboratory information sys-
using existing resources and the principles of lean tems (LISs) that use autoverification rules to reduce the number
production. Our goal is to report 80% of chemistry tests of results manually reviewed by laboratory scientists. The use of
in less than 1 hour and to no longer recognize a autoverification makes results available on-screen to clinicians
distinction between expedited and routine testing. We much sooner. Less attention has been given to preanalytic
used principles of lean production (the Toyota processes. In this article, we describe our successful efforts to
Production System) to redesign preanalytic processes. improve chemistry test turnaround time from a central (core)
The redesigned preanalytic process has fewer steps and laboratory by improving preanalytic processes, using existing
uses 1-piece flow to move blood samples through the resources and the principles of lean production.
accessioning, centrifugation, and aliquoting processes. The basic technologies used in preanalytic processes for
Median preanalytic processing time was reduced from chemistry tests (centrifugation and aliquoting) have been
29 to 19 minutes, and the laboratory met the goal of mature for a long time. There is little financial or technologi-
reporting 80% of chemistry results in less than 1 hour cal incentive to replace preanalytic equipment (centrifuges
for 11 consecutive months. and pipetters) unless they fail and become uneconomical to
repair. Operating the centrifuges, preparing sample aliquots,
and distributing samples to analysis stations traditionally have
been manual processes. Within the last decade, systems have
been developed to automate these processes, but they require
significant capital expenditures and long payback periods.
Thus, improvements in preanalytic processes have lagged
behind improvements in analytic and postanalytic processes.
Our laboratory supports a 763-bed acute care hospital, an
emergency treatment and level I trauma center, and numerous
general and specialty clinics located in the same physical
structure. The clinical chemistry laboratory handles 1,000 to

16 Am J Clin Pathol 2006;125:16-25 © American Society for Clinical Pathology


16 DOI: 10.1309/865V7UMFPUKGCF8D
Clinical Chemistry / ORIGINAL ARTICLE

1,500 samples per day and performs between 7,000 and Lakes, NJ). Tests were accessioned into an LIS (Cerner Classic,
10,000 analyses per day. Our interest in improving the prean- Cerner, Kansas City, MO) that assigned a unique accession num-
alytic chemistry test process was prompted by complaints ber to each sample and printed barcode labels that were affixed
from our customers about slow turnaround times and com- to the parent sample tube and any child (aliquot) tubes.
plaints from laboratorians about workplace stress. The word For samples requiring serum or plasma for analysis, cen-
most commonly used by laboratorians to describe the environ- trifugation of the blood collection tubes was performed at
ment in the preanalytic process work area was chaos. 3,000 rpm for 6 minutes (approximately 1,600g) with a Jouan
Interviews with laboratorians and direct observation of the C-412 centrifuge (Jouan, Winchester, VA) equipped with
workplace confirmed that the processes in place were no swinging bucket heads.
longer meeting the needs of the laboratory or its customers.
The laboratory’s traditional approach to resolving cus- Analytic Process
tomer complaints about turnaround time was to establish an Chemistry tests were performed on a Modular analyzer

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expedited process for that customer’s samples. Examination of (Roche Diagnostics, Indianapolis, IN) consisting of 1 ISE1800
workload data revealed that approximately 47% of chemistry module and 3 P800 modules as the primary analyzer. The sec-
tests were being ordered with the expectation of expedited pro- ondary analyzer initially consisted of a Hitachi 737 (Roche
cessing—the meaning of the term stat. Some customer groups, Diagnostics). The 737 was replaced with a Modular consisting
particularly the emergency treatment center, were requesting of an ISE and 1 P module in April 2002. Immunochemical
that service be expedited even beyond the stat classification. assays were performed on an Elecsys 2010 (Roche
We believed that providing additional categories of expe- Diagnostics). No significant changes were made to the opera-
dited testing would result in additional chaos by adding even tion of the chemistry analyzers during the study period, other
more processes and pathways to an already complicated envi- than replacing the secondary analyzer.
ronment. Additional processes and process complexity also Analyzers were linked to the LIS via a computerized
contribute to cyclic propagation of error-generating behavior.2 interface (Dawning Technologies, Fairport, NY). The LIS
Conversations with key customer groups revealed that all cus- uses a rule-based system to verify results from the analyzers
tomer groups desired faster turnaround time for chemistry that meet defined criteria and transmit them to the hospital’s
tests. Therefore, we chose to take a different approach to computerized medical record system. Results failing to meet
redesigning the processes. We believed that we could improve the acceptability criteria are held until reviewed by a clinical
service for all customers by using the tools of lean production laboratory scientist.
to create preanalytic processes that eliminated wasteful activ-
ities and delays. Our goal was to be able to report 80% of all Baseline Cycle Time Study
chemistry tests (including therapeutic drug monitoring and To determine a baseline for benchmarking process
thyroid hormones) in less than an hour, and we would no improvement toward our goal, we conducted a chemistry test
longer recognize requests for expedited (stat) testing. cycle time study before implementing changes. Adhesive labels
The concepts of lean production were first developed by were prepared with a time code that masked the arrival time to
the Toyota Motor Corporation during the last half of the 20th minimize the occurrence of the Hawthorne effect. A sample
century and since have become known as the Toyota Production identification station was established approximately 50 ft from
System.3 The major goal of lean production is to reduce waste the laboratory sample drop-off window. As incoming chemistry
in 7 categories: overproduction, inventory, transportation, samples were brought to the sample identification station, we
inspection, correction, motion, and waiting. Waste is defined as affixed a label to each that identified the time the sample passed
the elements of production that do not add value to the product the station. The samples then were delivered and processed in
or service being produced. Lean production has been adopted in the usual manner. As the samples reached the input rack of the
many industries but has been applied to health care only recent- main chemistry analyzer, we recorded the assigned time code as
ly, and there are few reports in the peer-reviewed literature.4-8 well as the LIS-assigned accession numbers. The time the
accession number was assigned was obtained retrospectively
from the LIS. From these data, we calculated the time delay
Materials and Methods before accessioning (time from sample delivery to accession-
ing) and the preanalytic cycle time (time from accessioning to
Preanalytic Process
delivery at the chemistry analyzer input rack).
Blood samples were received in evacuated glass tubes of
various sizes, containing no additives, lithium heparin anticoag- Performance Index
ulant, polyester separation gel, or a combination of anticoagu- Because significant resources are required to conduct a
lant and separation gel (Vacutainer, Becton Dickinson, Franklin complete cycle time study, we sought to develop a simpler,

© American Society for Clinical Pathology Am J Clin Pathol 2006;125:16-25 17


17 DOI: 10.1309/865V7UMFPUKGCF8D 17
Persoon et al / IMPROVING PREANALYTIC PROCESSES

automated measure of chemistry test turnaround time that Process Map


could be obtained on a daily basis. We determined that our LIS We observed the existing accessioning and preanalytic
could provide us with a report listing the percentage of chem- processes, with close attention to the process steps that might
istry tests completed in an hour for hourly and daily intervals. be wasteful, unnecessary, or inappropriate. Laboratorians
Because our goal was to report 80% of tests in an hour or less, involved in the process also were asked to describe the
we subtracted 80% from each period’s percentage completion processes and environment in the preanalytic work area.
rate to arrive at a performance index (PI). A positive PI is the These observations and descriptions were used to create the
percentage of tests completed above the 80% goal, and a neg- preintervention map of the process ❚Figure 1❚. Like most clin-
ative PI is the percentage below the 80% goal. We monitored ical laboratories, our laboratory purportedly provided 2 levels
hourly and daily PIs. The monthly PI was obtained by averag- of service, expedited (stat) and routine. However, the only dis-
ing the weekday PIs for the month. tinction between the process for an expedited sample and a

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Call for
Information

No
Accessioner Labeler

Accumulate Information Accession Print labels


requisitions
Yes tests
complete
Triage

Match
Open Separate
requisition
package paper from
number with
sample
tube number

Place tubes Find tube


in rack in rack

Store
requisitions
in holding
basket

Allow large
Sort aliquot Load Run Empty Prepare
Label tubes batch to
tubes centrifuge centrifuge centrifuge aliquots
accumulate

Centrifuge operator Centrifuge operator Centrifuge operator

Figure Key
Sort tubes Deliver Process activity Decision

and to multiple
aliquots locations

Blood specimen Barcoded blood specimen

Lab requisition Barcoded empty aliquot tube

Barcode label
Barcoded full aliquot tube

❚Figure 1❚ Preintervention process map, preanalytic process.

18 Am J Clin Pathol 2006;125:16-25 © American Society for Clinical Pathology


18 DOI: 10.1309/865V7UMFPUKGCF8D
Clinical Chemistry / ORIGINAL ARTICLE

routine sample was that the expedited sample would be moved constitute a process are performed on each object under-
to the front of whatever queue it was in at the time. With more going the process before the work is begun on the next
than 40% of the samples being marked stat, this distinction object; there is no batching. For example, when a requi-
was essentially meaningless. sition arrives in the laboratory accompanied by multiple
sample containers, the laboratorian handling each requi-
Intervention sition accessions all tests and labels all containers asso-
By using the information obtained from our observations ciated with that requisition, including containers for
and interviews, we redesigned the preanalytic process using aliquots not yet prepared. Only after accessioning is
principles of lean production and the Toyota Production complete are the containers sorted based on the next
System.9 In our process redesign, we were constrained to use process or destination.
the same laboratory space and human resources for preanalytic In the 1-piece flow process, no distinction is made
functions, although duties could be reassigned. The redesigned between stat and routine requests; rather, samples are handled

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process was submitted to supervisors and laboratorians for on a “first in, first out” (or FIFO) basis.
comments, and their suggestions were incorporated. The
process map for the redesigned process is shown in ❚Figure 2❚. Toyota Production System
In addition to redesigning the flow of work, we also
One-Piece Flow redesigned how the work would be accomplished, using 4
The redesigned process incorporates the concept of rules of the Toyota Production System.3 The rules and an
1-piece flow. In a 1-piece flow system, all activities that example application are given in ❚Table 1❚.

Store
requisitions
in holding
basket

Accessioner Accessioner Accessioner

Allow small
Open Information Accession batch to
Yes Print labels Label tube
package complete? tests accumulate

No
Send to Resolve
exception
handler
problems
Process activity
Figure Key
Decision

Blood specimen Barcoded blood specimen

Lab requisition Barcoded empty aliquot tube

Barcode label
Barcoded full aliquot tube
Exception handler

Centrifuge operator

Load Deliver
centrifuge Run Empty Aliquot Prepare aliquots to
with small centrifuge centrifuge
Sort tubes
needed?
Yes aliquots single
batch location

No

Deliver tubes
without
aliquots

Sorter-
circulator

❚Figure 2❚ Process map for the redesigned preanalytic process.

© American Society for Clinical Pathology Am J Clin Pathol 2006;125:16-25 19


19 DOI: 10.1309/865V7UMFPUKGCF8D 19
Persoon et al / IMPROVING PREANALYTIC PROCESSES

Redesigned Process to ring at this workstation. The accessioning workstations


In the redesigned process, 5 new workstations were cre- were configured to include a computer, label printer, rack con-
ated, with specific descriptive titles. ❚Table 2❚ describes the taining clean aliquot tubes, and baskets for incoming samples
principal duties of each workstation. Laboratorians are and samples ready to be distributed to the next workstation.
assigned to workstations for 2-hour periods, alternating The centrifuge workstation included open bench space to load
between sitting–cognitive task workstations (accessioner, and unload centrifuge buckets, 2 centrifuges, biohazard waste
exception handler, customer service/phones) and containers, and above-counter bins for transfer pipettes and
standing–physical task workstations (centrifuge operator, other consumables. The design of the centrifugation process
sorter-circulator) as much as possible. This rotation ensures called for a 6-minute centrifugation cycle at 1,500g followed
that laboratorians are cross-trained on all tasks in the area, by a 3-minute deceleration. The procedure for centrifuge oper-
maintain proficiency in these tasks, and experience task vari- ation called for starting a centrifuge batch every 6 minutes;
ety. In cases of staff shortage, this organizational structure can thus, the centrifuge operator has 3 minutes from the time the

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be collapsed to require fewer laboratorians by combining deceleration is complete to empty the centrifuge and load the
some duties. next batch. Aliquot preparation was performed when the oper-
To accommodate the new workstations, we made minor ator was not loading or unloading.
modifications to the laboratory work space. A customer ser- Following a training period, the redesigned lean process
vice workstation was established separate from the accession- was introduced. We conducted additional observations to
ing stations, and the primary telephone lines were configured monitor performance. Supervisors conducted daily evaluation

❚Table 1❚
Toyota Production System Rules3

Rule
No. Rule Example

1 All work shall be highly specified as to Samples needing centrifugation are loaded into waiting centrifuge bucket inserts in a
content, sequence, timing, and outcome. specified pattern (tubes not requiring aliquots in the center, tubes requiring aliquots on
the perimeter). A centrifuge batch is started every 6 minutes, regardless of the number
of samples to be centrifuged or in the accessioning queue. When the centrifugation is
complete, the tubes not requiring aliquots are removed and placed in a transport rack.
The tubes requiring aliquots are removed from the buckets one at a time and the
aliquots dispensed into prelabeled tubes. When the bucket inserts are empty, they are
returned to the loading point.
2 Every customer-supplier connection must If a requisition is received without complete information, the accessioner does not
be direct, and there must be an accession, but completes an “exception ticket” citing the missing information, attaches
unambiguous yes-or-no way to send it to the requisition, and places it in a basket. The sorter-circulator picks up exceptions
requests and receive responses. and delivers them to the exception handler. The exception handler resolves the missing
information issue, signs off on the exception slip, and returns the sample to an
accessioner to restart the accessioning process.
3 The pathway for every product and service The sorter-circulator delivers accessioned samples directly from the accessioners to the
must be simple and direct. centrifuge workstation and delivers centrifuged samples directly to the chemistry
analyzer loading workstation.
4 Any improvement must be made in Laboratorians wanting to change a “best practice” submit their ideas to a supervisor or
accordance with the scientific method, process engineer. An experiment is designed to test the effects of the change and
under the guidance of a teacher, at the conducted with appropriate measurements. If desired effects are achieved, the new
lowest possible level in the organization. information is incorporated into a best practice.

❚Table 2❚
Principal Duties for Each Workstation

Position Principal Duties

Accessioner (1 to 3 workstations) Unpack incoming samples; check for completeness of information; accession tests into LIS; affix labels
to parent and aliquot containers
Sorter-circulator Unload pneumatic tube carriers; distribute incoming workload to accession workstations; deliver
accessioned samples to next workstation; deliver centrifuged samples to next workstation; restock
supplies at accession workstations as needed
Centrifuge operator Load and unload centrifuges (2); prepare aliquots as needed
Exception handler Resolve problems with incoming workload (eg, lack of information, inappropriate samples); measure and
aliquot 24-hour urine specimens; back up accessioners during busy periods
Customer service Answer incoming telephone calls; accession requests for “add-on” tests

LIS, laboratory information system.

20 Am J Clin Pathol 2006;125:16-25 © American Society for Clinical Pathology


20 DOI: 10.1309/865V7UMFPUKGCF8D
Clinical Chemistry / ORIGINAL ARTICLE

meetings with laboratorians to find additional process prob- Increased PI


lems and reinforce the use of the lean process. As laboratori- ❚Figure 5❚ and ❚Figure 6❚ show the daily PIs for November
ans became more familiar with the lean process, their com- 2001 (before implementation of the lean production system)
ments were used to develop best practices for operating each and November 2002 (6 months after implementation of the
workstation. These best practices were disseminated at the lean production system). The monthly PIs for the 18 months
daily evaluation meetings and incorporated into the procedure following the beginning of the project are shown in ❚Figure 7❚.
manual and training for new staff. Following complete implementation of the lean production
During the study period, we experienced the usual system in June 2002, the monthly PIs became positive and
amount of employee turnover but neither added nor reduced remained positive for 9 consecutive months. The monthly
the number of budgeted full-time equivalent positions index became negative in March, April, and May 2003. Review
assigned to the preanalytic process. of the daily PIs for these 3 months revealed that each of these
months had 3 “bad days” on which the daily PIs were less than

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–10. Further investigation revealed that performance on these 3
days was suboptimal owing to failures of analytic instrumenta-
Results
tion. When the data for the analytic instrumentation failure
days were removed, the monthly PI became positive for March
Decreased Cycle Time and April and less negative for May. The 12-month period of
The redesign of the preanalytic process in our laboratory sustained improvement supports our conclusion that the per-
significantly improved chemistry test turnaround time. The formance improvements are the result of the improved preana-
results of the baseline and postimprovement cycle time stud- lytic lean process and not a manifestation of the Hawthorne
ies are shown in ❚Figure 3❚ and ❚Figure 4❚. The redesigned pre- effect or the result of seasonal or periodic changes in workload.
analytic process resulted in a 30% improvement in the 50th, Workload increased by an average of 0.54% per month during
80th, and 90th percentiles of the cycle time distribution. the study period, or 6.5% per year.

35 100

90
30
80
50th percentile 29 min

25 90th percentile 43 min


70

Cumulative Percent
60
20 80th percentile 35 min
No. of Samples

50

15
40

Samples
10 30
Cumulative %

20
5
10

0 0
0:00
0:02
0:04
0:06
0:08
0:10
0:12
0:14
0:16
0:18
0:20
0:22
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0:38
0:40
0:42
0:44
0:46
0:48
0:50
0:52
0:54
0:56
0:58
1:00

Cycle Time (Minutes After Accessioning)

❚Figure 3❚ Preanalytic process cycle time (before lean production).

© American Society for Clinical Pathology Am J Clin Pathol 2006;125:16-25 21


21 DOI: 10.1309/865V7UMFPUKGCF8D 21
Persoon et al / IMPROVING PREANALYTIC PROCESSES

35 100

50th percentile 19 min


90
30
80

25 70

Cumulative Percent
60
No. of Samples

80th percentile 24 min


20

50

15

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40
90th percentile 29 min

10 30

Samples
Cumulative % 20
5
10

0 0
0:00
0:02
0:04
0:06
0:08
0:10
0:12
0:14
0:16
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0:44
0:46
0:48
0:50
0:52
0:54
0:56
0:58
1:00
Cycle Time (Minutes After Accessioning)

❚Figure 4❚ Preanalytic process cycle time (lean production system).

20

15

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Performance Index

–5

–10

–15

–20
13

14

15

16

19

20

21

26

27

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29

30
7

9
6

ov

ov

ov

ov

ov

ov

ov

ov

ov

ov

ov

ov

ov
v

ov
No
No

Date

❚Figure 5❚ Performance index, November 2001 (before lean production).

22 Am J Clin Pathol 2006;125:16-25 © American Society for Clinical Pathology


22 DOI: 10.1309/865V7UMFPUKGCF8D
Clinical Chemistry / ORIGINAL ARTICLE

20

15

10
Performance Index

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–5

–10

–15

–20
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1

7
v

v
No

No

No

No

No

No

No

No

No

No

No

No

No

No

No

No
Date

❚Figure 6❚ Performance index, November 2002 (lean production system).

4
Performance Index

–2

–4

–6

–8
02

02
2

3
02

02
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0
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ct
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b
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ay

ay
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ec
ar

pr

ar

pr
Ju
Fe

Fe
Ja

Ja
Ju

Au

Se

O
A

A
M

M
D

M
M
N

Month

❚Figure 7❚ Monthly performance index average.

© American Society for Clinical Pathology Am J Clin Pathol 2006;125:16-25 23


23 DOI: 10.1309/865V7UMFPUKGCF8D 23
Persoon et al / IMPROVING PREANALYTIC PROCESSES

❚Table 3❚ lists examples of the kinds of waste eliminated A key element in our success is the use of the Toyota
with the lean process. Reduction of mislabeled and missing Production System rules in the implementation of the
tube errors was an additional benefit of the lean process. redesigned process. All 4 rules impose a discipline on the
Under the old process, the batching and unbatching of tubes process that results in consistency of output and quality.
occasionally led to missing tubes, and laboratorians would Convincing laboratorians that they needed to maintain this
spend considerable time locating the missing tubes. With the discipline was a major part of the change effort involved in the
new lean process and 1-piece flow, there are few opportuni- implementation of the lean process.
ties for a tube to be lost or misplaced, and these errors no In addition to the process changes, the lean production
longer occur. process required a paradigm shift by laboratorians. Incoming
The redesign of the preanalytic process also revealed workload would no longer be classified as stat or routine,
some hidden wastes in the system. In 1 clinic, the phle- because 1-piece flow and the lean process eliminated any dis-
botomists had developed an unwritten and unapproved prac- tinction in the handling of these samples. It is interesting to

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tice of obtaining an extra tube of blood from most patients in note that the stat vs routine paradigm is still widely accepted
case the physician decided to order additional tests after the in the clinical laboratory industry. Mohammad et al10
patient had left the clinic. Investigation revealed that only described the use of simulation modeling to determine the
10.8% of these tubes actually were used, and in nearly half of impact of increasing numbers of routine samples on routine
those cases, the additional tests could be done on specimens and stat turnaround times for a chemistry analyzer. Their study
already in the laboratory. Changing the practice to obtain extra presumed that there is a constant demand for stat testing and
tubes only when specifically requested by the physician result- examined the effect of increasing routine workload on stat
ed in more than 1,000 fewer specimens being processed per turnaround time. In our experience, requests for rapid turn-
month, with a concomitant decrease in the number of collec- around time are increasing, requiring laboratories to improve
tion tubes used and amount of biohazardous waste discarded. their processes for these samples. Carried to its logical conclu-
sion, this trend will result in no “routine” testing. Developing
a process that improves turnaround time for all samples is a
better long-term strategy for delighting laboratory customers
Discussion
than categorizing requests as stat and routine and trying to
We demonstrated that redesigning the preanalytic improve service for only 1 category.
processes to incorporate the elements of lean production and Review of laboratory processes with the goal of improv-
the Toyota Production System can result in significant ing them inevitably reveals wasteful practices, as we discov-
improvement in chemistry test turnaround time without the ered when we looked at the use of extra tubes of blood
addition of automation or other resources. Laboratories that obtained in 1 clinic. The informal initiation of this practice by
desire to improve their preanalytic processes but are not able front-line workers was well-intentioned—they wanted to
to acquire preanalytic automation systems may benefit from reduce the number of patient call-backs and additional phle-
this approach. botomies on a population of very sick patients—but it had the

❚Table 3❚
Types of Waste Eliminated by Using the Lean Process

Original Process Revised Process Wastes Reduced

Before accessioning, specimens were separated from Tests are accessioned for each specimen/requisition set, Motion; waiting;
requisitions and sorted into racks by priority. Tests and the barcode label is printed and affixed to the inspection;
were accessioned in batches from the sorted specimens. There is no sorting or batching during the correction
requisitions. Barcode labels were printed for an accessioning process.
accession batch, and the tube, requisition, and
barcode label were rematched before the barcode
label was affixed to the tube. Tubes occasionally were
misplaced, requiring additional search time.
Processing of specimens was delayed when specimens Specimens arriving with incomplete or incorrect Motion; waiting;
were received accompanied by a requisition with information are routed to an exception handler, inspection;
incomplete or incorrect information. The accessioning reducing the delay for specimens that have complete correction
process would be halted while the accessioner called and correct information.
the originating location to obtain the missing information.
Specimens that had been processed were stored in racks A laboratorian is designated as the sorter-circulator Waiting;
or baskets and were transported to the analytic work- whose job includes delivering specimens from the motion
stations when someone had the time or when the specimen processing area to the analytic workstations
laboratorian operating the workstation came to get them. on a regular basis.

24 Am J Clin Pathol 2006;125:16-25 © American Society for Clinical Pathology


24 DOI: 10.1309/865V7UMFPUKGCF8D
Clinical Chemistry / ORIGINAL ARTICLE

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© American Society for Clinical Pathology Am J Clin Pathol 2006;125:16-25 25


25 DOI: 10.1309/865V7UMFPUKGCF8D 25

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