Reducing Manual Steps, Improving Turnaround Times,

and Creating a Lean Laboratory Environment:

ISD Testing on the Dimension ® Integrated Chemistry Systems 32 Lab Products Review
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Turnaround Times, and Creating a
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ISD Testing on the Dimension® Integrated
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Contact Information
By: Tim Baker,
The Dark Intelligence Group, Inc.
Customer Service Managing Partner, Nexus Global Solutions
800-560-6363
21806 Briarcliff Drive Editor: Karen Appold
Spicewood, Texas 78669

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While all attempts have been made to verify information provided in this publication,
neither the author nor the publisher assumes any responsibility for error, omissions or
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the product and opinion of Nexus Global Solutions, a third party. Nexus Global Solutions was
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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
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Notes

Disclosure
Neither The Dark Report, Dark Intelligence Group, Dark Daily nor Robert Michel produced or
provided any content or opinions for this special report. None of the aforementioned entities or
persons endorses any of the products contained in this special report. This special report is solely
the product and opinion of Nexus Global Solutions, a third party. Nexus Global Solutions was
commissioned by Siemens Healthcare Diagnostics to produce this report.

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 30 ISD Testing on the Dimension ® Integrated Chemistry Systems 3

Notes Table of Contents

Disclosure 2
Introduction 4
Chapter 1. Study Area 6
Chapter 2. Background 7
Chapter 3. Study Methodology 9
Chapter 4. Results 12
Conclusion 16
References 19
Appendices
A-1 About Tim Baker 22
A-2 About Nexus Global Solutions 23
A-3 About Karen Appold 24
A-4 About DARK Daily 25
A-5 About The Dark Intelligence Group, Inc., and THE DARK REPORT 26
A-6 About the Executive War College on Laboratory and Pathology Management 27
Terms of Use 32

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 4 ISD Testing on the Dimension ® Integrated Chemistry Systems 29

Introduction
The challenges facing the clinical laboratory environment in the
past 10 years are well documented, and include significant medical
technologist vacancy rates, increased competition, and a significant
number of opportunities to inadvertently make testing errors.1,2 With
A cornerstone of such macroeconomic challenges, the industry has used a variety of
“Lean Thinking” methods to identify ways to increase productivity, decrease costs, and
in general, become more efficient at generating test results.
involves the
elimination of As a part of this focus on efficiency, laboratory administrators
waste, including have enthusiastically adopted Lean quality management methods
the identification that are designed to increase productivity and efficiency while
reducing operator stress and workload. These methods have been
and removal
adopted, in part, because of their “common sense” approach and
of inefficient ease of implementation. In the past decade, success stories and
processes implementation advice abound on how to adopt Lean in the laboratory
or tasks. environment.3

A cornerstone of “Lean Thinking” involves the elimination of waste,

including the identification and removal of inefficient processes
or tasks. In the laboratory, if manual processing steps can be
eliminated without sacrificing quality, then there will be less manual
manipulation of tubes, fewer opportunities for errors, and a better
overall turnaround time for reporting results.

In addition to the removal of waste, Lean also provides a benefit

in terms of workload leveling. As anyone who has worked in a
laboratory knows, problems meeting turnaround time goals and
maintaining efficient specimen processing occur whenever a surge
of work arrives into the laboratory. Workload leveling is simply the
practice of handling work in small, consistent batches which will

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 28 ISD Testing on the Dimension ® Integrated Chemistry Systems 5

In September 2005, a laboratory management meeting called encourage standardization and therefore reduce variation and errors.
Executive Edge was conducted in Toronto, Ontario, Canada, by The The most successful Lean projects address the issue of workload
Dark Intelligence Group and QSE Consulting. It provided pathologists
leveling and standardization along with waste removal.4
and lab directors in Canada with a customized meeting devoted to the
strategic and operational issues of laboratory management in Canada.
In vitro diagnostic (IVD) equipment manufacturers are
complementing these Lean efforts by providing analyzers and testing
solutions to help eliminate wasteful process steps, standardize the
The most
laboratory workload, and focus on improved turnaround times.5
successful Instruments with improved ergonomics, reagents with visual and
Lean projects color coded designators, and technology that encourages “continuous
address the issue operational flow” are all features that have become mainstream in
of workload IVD product development circles.

leveling and
standardization
along with waste
removal.

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 6 ISD Testing on the Dimension ® Integrated Chemistry Systems 27

Chapter 1: A-6
About the Executive War College
Study Area on Laboratory and Pathology Management
Every spring since 1996, the lab industry’s best and brightest
gather at the Executive War College on Laboratory and Pathology
Immunosuppressant drug (ISD) testing is an area of laboratory
Management to learn, to share and to network. Many consider it to
Immuno- testing where Lean principles have not been broadly addressed. be the premier source of innovation and excellence in laboratory and
As such, a study was conducted to evaluate if the possibility exists pathology management.
suppressant
to create a Lean environment for ISD monitoring in the routine
drug (ISD) Each year, a carefully selected line-up of laboratory leaders and inno-
laboratory setting. This document describes the findings of our vators tell the story of how their laboratories are solving problems,
testing is study, highlighting the advantages of a family of instruments that are tackling the toughest challenges in lab medicine and seizing oppor-
an area of making efficiency strides in the area of ISD testing: the Dimension® tunities to improve clinical care and boost financial performance.
The Executive War College is the place to get practical advice and
Integrated Chemistry Systems from Siemens Healthcare Diagnostics
laboratory solutions for the toughest lab management challenges. A unique case
(Tarrytown, NY). study format brings participants face-to-face with their most success-
testing where ful peers. They tell, first hand, how their laboratory solved intractable
Lean principles problems and successfully used new technology.
have not Many lab management secrets are shared, along with specific
been broadly “what-not-to-do’s” gained from hard-won experience! It’s not pie-in-
the-sky theory, but useful knowledge that can be put to use in any lab.
addressed. The Executive War College offers superlative networking, with lab
administrators and pathologists attending from countries as far away
as the United Kingdom, Germany, Brazil and Australia. It makes the
Executive War College a melting pot for all the best ideas, new lab
technologies and management strategies now reshaping the laboratory
industry. It’s also become a recruiting ground used by headhunters
and major lab organizations.

In the United Kingdom, The Dark Intelligence Group and the

Association of Clinical Biochemists (ACB) have co-produced a
meeting every February since 2003. Known at Frontiers in
Laboratory Medicine (FiLM), it attracts laboratory leaders and inno-
vators in the United Kingdom. Also featuring a case study format,
this meeting pioneered the international laboratory side-by-side case
study, where a North American laboratory and a United Kingdom
laboratory prepare a comparison of best practices and an operational
assessment of their two organizations.

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Reducing Manual Steps, Improving Turnaround Times,
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ISD Testing on the Dimension ® Integrated Chemistry Systems 26
A-5
About The Dark Intelligence Group, Inc. and THE DARK REPORT
The Dark Intelligence Group, Inc., is a unique intelligence service,
dedicated to providing high-level business, management and market
trend analysis to laboratory CEOs, COOs, CFOs, pathologists and
senior-level lab industry executives. Membership is highly-prized by
the lab industry’s leaders and early adopters. It allows them to share
“Membership innovations and new knowledge in a confidential, non-competitive
manner. This gives them first access to new knowledge, along with
is highly-
the expertise they can tap to keep their laboratory or pathology
organization at the razor’s edge of top performance.
prized by the
lab industry’s It offers qualified lab executives, pathologists and industry vendors
a rich store of knowledge, expertise and resources that are unavailable
leaders and
elsewhere. Since its founding in 1996, The Dark Intelligence Group
early adopters. and THE DARK REPORT have played in instrumental roles in support-
ing the success of some of the nation’s best-performing, most profit-
It allows able laboratory organizations.
them to share
The Dark Intelligence Group (TDIG) is headquartered in Austin,
innovations and Texas. This location makes it very accessible for any laboratory
new knowledge organization seeking input, insight and support in developing their
business operations, creating effective business strategies and crafting
in a confidential,
effective sales and marketing programs that consistently generate new
volumes of specimens and increasing new profits. The Dark Intelli-
non-competitive
gence Group, Inc. owns and operates two Web sites in the
manner. TDIG Website network:
http://www.DarkReport.com
http://www.DarkDaily.com
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Reducing Manual Steps, Improving Turnaround Times,
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Chapter 2:
Background
ISDs are prescribed for organ transplant patients in order to prevent
Clinicians rely graft rejection. They form the mainstay of treatment following organ
heavily on rapid
transplantation, ensuring long-term graft survival and improving
overall transplantation success rates. ISD therapy is administered
and accurate
mainly in two phases after transplantation. The induction phase
results of ISD is a phase of intense immunosuppression immediately following
transplantation. Patients are generally given high doses of ISDs that
testing to help
are titrated down over a period of approximately two to four months
them maintain
until maintenance levels are achieved. The maintenance phase of
this balance and ISD therapy occurs after the acclimatization of the transplanted
appropriately organ in the recipient. Dosages and target blood concentrations
manage the of ISDs are reduced to levels that prevent organ rejection while
minimizing side effects.6
care of their
transplant
Organ rejection can occur at any time post transplantation and
patients. hence, the lifelong administration of ISDs is usually required.
The commonly prescribed ISDs include cyclosporine, tacrolimus,
sirolimus, and mycophenolic acid. Because of their narrow therapeutic
ranges and the potential for toxic side effects, regular ISD monitoring
is required in order to maintain the balance between the prevention of
graft rejection and the minimization of adverse side effects. Clinicians
rely heavily on rapid and accurate results of ISD testing to help them
maintain this balance and appropriately manage the care of their
transplant patients.
Today, most chemistry tests are performed in the main routine
chemistry laboratory, with many tests consolidated onto a single
platform. Alternatively, ISD testing may deviate from this practice.
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Reducing Manual Steps, Improving Turnaround Times,
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ISD Testing on the Dimension ® Integrated Chemistry Systems 8 ISD Testing on the Dimension ® Integrated Chemistry Systems
These tests are often performed on dedicated analyzers outside of
routine laboratory testing areas. Additionally, the complex sample
handling that is required with many ISD protocols means that these
tests typically require processing procedures that differ from other
routine chemistry tests. As such, ISD testing is often performed in
batch mode by specific laboratory personnel trained in the specialized
sample processing required. These factors contribute to extended
With the
Dimension
turnaround times for reporting results that could impact transplant
patient management, as well as add additional costs in terms of
systems, laboratory space required for specialized analyzers, dedicated
elimination laboratory personnel, and more complex technology.
of manual
With the Dimension systems, elimination of manual processing steps
processing
and the standardization of testing have created an opportunity to
steps and the
merge ISD testing into the routine workload of the laboratory. This
standardization is helping laboratories employ Lean principles in their ISD testing,
of testing have while expanding the opportunity for more laboratories to offer
ISD monitoring as part of their routine services. More importantly,
created an
the elimination of manual processing steps may result in fewer
opportunity error opportunities, better use of operator time, and better overall
to merge ISD turnaround times for ISD results, leading to improved transplant
testing into patient management.
the routine
workload of the
laboratory.
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Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment:
25
A-4
About DARK Daily
DARK Daily is a concise e-news/management briefing on timely
topics in clinical laboratory and anatomic pathology group manage-
ment. It is a solution to the dilemma facing anyone in the laboratory
profession. New developments, new technology, and changing
“Dark Daily is healthcare trends make it imperative to stay informed to be success-
ful. At the same time, the Internet, cell phones, blackberries, laptop
a concise e-news/ computers and wireless devices are overwhelming any one individu-
al’s ability to absorb this crushing Tsunami of data.
management
DARK Daily is a quick-to-read, easy-to-understand alert on some
briefing on
key development in laboratory medicine and laboratory manage-
timely topics in ment. It has no counterpart in the lab world. Why? Because it is
produced and written by the experts at THE DARK R EPORT and The
clinical
Dark Intelligence Group, who know your world, understand your
laboratory and needs and provide you with concise, processed intelligence on only
those topics that are most important to you!
anatomic
pathology group You will find DARK Daily to also be an exceptionally valuable
resource in laboratory and pathology management. Some of the lab
management. It industry’s keenest minds and most effective experts will be offering
is a solution to their knowledge, their insights and their recommendations on win-
ning strategies and management methods. Many of these experts are
the dilemma unknown to most lab directors. As has proven true with THE DARK
facing anyone in REPORT for more than a decade, DARK Daily will be your invalu-
able— and unmatched—resource, giving you access to the knowl-
the laboratory edge and experience of these accomplished lab industry
profession. professionals.
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Reducing Manual Steps, Improving Turnaround Times,
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A-3
About Karen Appold
Karen Appold is the owner of Write Now Services, which offers
professional writing and editing services. She has extensive
experience working in the clinical laboratory industry. In addition
to The Dark Intelligence Group, Inc., clientele includes COLA,
American Medical Technologists, American Association for Clinical
Chemistry, American Society of Clinical Pathology, Clinical
Laboratory Standards Institute and ADVANCE Newsmagazines.
Ms. Appold has worked on editorial projects with Siemens Healthcare
Diagnostics, McKesson Corp., Xifin Inc., Integrated Laboratory
Automation Solutions, Aurora Interactive and more.
Ms. Appold is also published in many other health-care/medical
publications. She has a B.A. in English (writing) from Pennsylvania
State University and resides in Limerick, PA.
Contact: KarenAppold@comcast.net or 610-948-1961.
Visit www.WriteNowServies.com.
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Chapter 3:
Study Methodology
This study was commissioned by Siemens Healthcare Diagnostics
The primary and performed by Nexus Global Solutions (Nexus), a third-party
consulting firm that specializes in market and product research
goal was
for diagnostic companies.7 For this study, Nexus targeted two
to better
hospital laboratory sites in the United States utilizing the Abbott
understand and ARCHITECT i2000SR™ system. The primary goal was to better
document the understand and document the current state of ISD testing on this
platform in comparison to ISD testing performed on the Dimension®
current state of
RxL Integrated Chemistry System. Before visiting the sites, the
ISD testing on consultants reviewed the instructions for use (IFUs) for the assays of
this platform interest and compared them to the IFUs for Siemens’ assays. From
in comparison this review it was apparent that the hospital site protocols using the
to ISD testing ARCHITECT system for ISD testing would require a high degree
of manual sample handling through “pretreatment and extraction”
performed on
protocols, whereas the testing performed on the Dimension system
the Dimension® would require only a simple pipetting step before loading the tube(s)
RxL Integrated onto the instrument.
Chemistry
Site Details
System.
On-site studies were conducted at the following two facilities:
• A large university hospital laboratory located in the Southwest
United States. This laboratory processed high volumes of ISD
samples daily, including up to 200 tacrolimus samples per day.
ISD testing was performed outside of the routine chemistry
laboratory in the toxicology department. At the time of the
assessment, tacrolimus, cyclosporine, and sirolimus samples were
all tested on separate analyzers. This site offered tacrolimus and
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cyclosporine testing seven days per week from 6 a.m. to 11 p.m. A-2
Sirolimus testing was offered six days per week from 7 a.m. to 4
About Nexus Global Solutions
p.m. The consultants primarily watched the tacrolimus testing at
this site, noting the following details: Nexus Global Solutions is an independent, full-service consulting
– Only tacrolimus tests were performed on the tube firm dedicated to advancing excellence in health care diagnostics.
(no “tube sharing”). Nexus provides solutions globally to both laboratory organizations
and diagnostic companies through a combination of Lean, Six Sigma,
– Tests were batched in groups of up to 24 samples.
…the site and management science techniques.
– Batch testing was performed frequently throughout the day.
performed a – The turnaround time expectation for ISD samples arriving to
protocol for the laboratory by 7:30 a.m. is three hours.
pretreatment • A large community hospital laboratory located in the Midwestern
and extraction, United States. This site performed low- to mid-volume ISD
testing, averaging up to 30 total tacrolimus, sirolimus, and
defined by the
cyclosporine samples per day. ISD testing was performed by
manufacturer’s dedicated personnel in the routine chemistry department. The
IFUs, which site offered ISD testing Monday through Friday, with testing
required the performed once per day.
– There was no tube sharing.
operator to
– Tests were batched by assay.
manually – Batches were tested once per day at 12 p.m.
prepare the – The turnaround time expectation for ISD samples was
specimen before 24 hours. Samples received by 12 p.m. were expected to
loading it onto be resulted by 2 p.m.
– Samples arriving after 12 p.m. were held for testing
the analyzer.
the following day (or following Monday if they arrived
on Friday).

Both sites were using the Abbott ARCHITECT i2000SR system

for ISD testing. In each case, the site performed a protocol for
pretreatment and extraction, defined by the manufacturer’s IFUs,
which required the operator to manually prepare the specimen before
loading it onto the analyzer. This was a process that required up to 13
protocol steps and took upwards of 20 minutes to execute.8

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Reducing Manual Steps, Improving Turnaround Times,
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A-1
About Tim Baker
Mr. Baker has more than 38 years of management and engineering
experience. For the past 12 years, Mr. Baker led numerous
performance improvement engagements within the health care
diagnostic industry. His laboratory expertise spans the clinical,
anatomical pathology, blood donor, and molecular lab environments.
He also has extensive experience working directly with global in vitro
diagnostic organizations, providing both strategic and
tactical counsel.
Mr. Baker has a B.S. in chemical engineering from Oklahoma State
University and a MBA from Southern Methodist University. He is a
green belt in Six Sigma and a Lean certified trainer.
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As a part of this As a part of this study protocol, the consultants recorded the unique
process steps and measured the time required for testing on the
study protocol,
ARCHITECT system from the start of manual pretreatment and
the consultants extraction to result reporting. In addition, the ARCHITECT i2000SR
recorded the “loading pattern” was recorded. The work list and loading pattern
unique process for the ISD testing performed at the community hospital laboratory
steps and was recreated on the Dimension RxL Integrated Chemistry system
in order to better understand the differences in total ISD sample
measured the
processing between the two systems. This protocol was selected
time required for two reasons: 1) because it provided the opportunity to assess
for testing on the the total processing time for each of the three ISD tests of interest
ARCHITECT (cyclosporine, tacrolimus, and sirolimus), each of which had a unique
protocol for pretreatment and extraction on the ARCHITECT i2000SR
system.
system, and 2) because it represented the batch testing and average
turnaround times that are typical for many laboratories performing
ISD testing (see Conclusion).
For this study there were two primary areas of interest that were explored, and a
hypothesis for each one generated:
• Process Steps–Without manual pretreatment and extraction, the Dimension system would
not require as much manual tube manipulation. This could potentially save operator time and
result in fewer error opportunities.
• Turnaround Time–Without as many manual process steps, the tubes could be loaded onto the
Dimension system in a continuous, standardized manner resulting in better turnaround times.
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Chapter 4:

Results
ARCHITECT System Process Steps

After observing the Abbott ARCHITECT i2000SR system at the

…the amount of
participating U.S. sites it was found that the amount of time to conduct
time to conduct extraction and pretreatment for the various ISD assays could range from
extraction and approximately 12 to 21 minutes per batch, depending on the size of the
pretreatment for
the various ISD
assays could
batch and the tests being performed (Chart 1). The sirolimus protocol
incorporated a heating step, thus making it the longest pretreatment and
extraction procedure of all of the ISD tests performed.
Appendices
range from Chart 1: ARCHITECT i2000SR ISD Pretreatment and Extraction Time

approximately Sirolimus Cyclosporine Tacrolimus

12 to 21 minutes
per batch. 21:32

12:16

12:09

0:00 5:00 10:00 15:00 20:00

Time (mm:ss)

The pretreatment and extraction protocol at both sites required a

dedicated medical technologist who spent time manually processing
the workload before being able to move on to other functions. Of
note, neither site followed the manufacturer’s instructions for the
pretreatment and extraction procedure exactly as prescribed in the

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11. Assuming five minutes to load the tubes after accession and
labeling.
12. PM & Partner Consulting GmbH, Frankfurt, Germany;
www.pm-p.de; On behalf of Siemens Healthcare Diagnostics;
Apr. 2009.
The overall IFUs. When questioned about this, each site indicated that the time
involved in performing these steps exactly as prescribed would be
turnaround
prohibitive to completing the work in a timely manner.
time (from tube
arrival in the ARCHITECT i2000SR Turnaround Time
laboratory until
the reporting The overall turnaround time (from tube arrival in the laboratory
until the reporting of test results) varied. The Southwestern site had
of test results)
turnaround times that averaged approximately one hour since they
varied. performed ISD batch runs continuously throughout the day. At the
Midwestern site, work that arrived after 12 p.m. was effectively held
until the following day whenever batch testing commenced at (or
around) 12 p.m. Thus, in the case of the first patient, the turnaround
time for results was more than 24 hours (Table 1).

Table 1: ARCHITECT i2000SR ISD Testing Time

Turnaround Time
Tubes Arrive Accession & Extraction & ARCHITECT From Tube From Start
Test to Lab Label Pretreatment Load Test Complete Arrival of Testing
1 C 12:30* 12:45* 11:48 12:02 12:33† 24 hrs 3 mins 45 mins
2 T 17:30* 18:55* 12:05 12:20 12:50 19 hrs 20 mins 45 mins
3 T 19:00* 19:30* 12:05 12:20 12:51 17 hrs 51 mins 46 mins
4 T 8:00 STAT 8:15 12:05 12:20 12:51 4 hrs 51 mins 46 mins
†
5 C 9:20 9:50 11:48 12:02 12:34 3 hrs 14 mins 46 mins
6 T 10:05 10:16 12:05 12:20 12:52 2 hrs 47 mins 47 mins
7 T 10:10 10:15 12:05 12:20 12:54 2 hrs 44 mins 49 mins
8 T 10:14 10:30 12:05 12:20 12:59** 2 hrs 45 mins 54 mins
9 C 10:14 10:30 11:48 12:02 12:34 2 hrs 20 mins 46 mins
10 S 10:30 11:00 11:14 11:37 12:07 1 hrs 37 mins 53 mins
11 T 12:02 12:12 12:15 12:24 13:00 0 hrs 58 mins 45 mins
*previous day
†
critical result
**operator error / reorder required

Test Type: (C)yclosporine; (T)acrolimus; (S)irolimus Test Complete: The time at which the result was available for transfer to
the LIS.
Tubes Arrive to Lab: The time that the patient tube was delivered to the
laboratory 9 (*activity occurred the previous day). Turnaround Time from Tube Arrival: The total turnaround time of the test
from the time it was received in the laboratory until result was available for
Accession & Label: The start time for patient accessioning into the laboratory
transfer to LIS.
information system (LIS) (*previous day).
Turnaround Time from Start of Testing: The total turnaround time of the test
Extraction & Pretreatment: The time that the manual extraction and
from the start of sample processing (including pretreatment and extraction)
pretreatment procedures began.
until result was available for transfer to LIS.
ARCHITECT Load Time: The time the tube was loaded onto the ARCHITECT
i2000 system for testing.

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Dimension RxL System Process Steps

References
The Dimension RxL system was observed at a Siemens R&D facility.
1. American Society for Clinical Pathology documents, Wage
According to the IFU and as put into practice, the operator performed
and Vacancy Report: Laboratory Workforce Shortage Reaches
no manual pretreatment or extraction, and the only steps required for
Crisis, http://www.ascp.org/MAINMENU/ ABOUTASCP/
processing ISD tests were pipetting an aliquot of the sample into a
NEWSROOM/NEWSRELEASES/ASCP-WAGE-AND-
sample cup and the loading and unloading of the sample racks onto
The Dimension VACANCY-REPORT.ASPX (Mar. 3, 2009).
the Dimension system.10 The Dimension system therefore had fewer
system therefore steps, and accordingly, was a faster solution as detailed in Chart 2.
2. David Novis, MD, Reducing Errors in the Clinical Laboratory:
had fewer steps,
Chart 2: Dimension and ARCHITECT Systems—Average Processing
A Lean Production System Approach, LABMEDICINE, http://
and accordingly, Time Per Sample www.davidnovis.com/docs/0908_Novis_Feature.pdf (Sep. 2008).
was a faster
solution. 3. Performing a search on Google using the keywords “Lean
Dimension
Laboratory” returned 12.4 million hits. (May, 2011).

4. Tom Reynolds, Thinking Lean, http://www.labmanager.com/

articles.asp?ID=335 (Aug. 2009).
ARCHITECT

5. Continuous access and other instrument features are helping labs

0:00 0:07 0:14 0:21 0:28 0:36 0:43 0:50 to create a single, or optimal, piece flow process.
Specimen Prep Time Instrument Time

6. Halloran PF. N Engl J Med. 2004;351:2715-29.

7. www.thenexuscorp.com for more information.

8. Note that this step was performed individually for each type of test.

9. Defined as courier drop off time; *designates that the activity

occurred the previous day.

10. Like the ARCHITECT, controls were also performed on the system.

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 18 ISD Testing on the Dimension ® Integrated Chemistry Systems 15

thus the practices for performing tacrolimus testing are representative Dimension RxL System Turnaround Time
of the practices for performing all ISDs. The results of the survey
showed that more than half of all laboratories surveyed (56%) The ARCHITECT i2000SR Testing protocol (Table 1) was recreated on
performed tacrolimus testing in batch. The results also showed that the Dimension RxL system to understand the impact of the assay not
in the first four weeks following transplantation, during the critical requiring manual pretreatment and extraction. Without these manual
induction phase of immunosuppressant therapy, 43% of laboratories steps, samples could be quickly loaded onto the instrument and tested
took up to eight hours to report tacrolimus results. Another 15% took like all other chemistry and immunoassay tests on the Dimension
…the data
up to 24 hours to report results. When these results were broken down system’s test menu.11 This would eliminate the need for batch testing.
suggests that by instrument/vendor used for tacrolimus testing, 87% of Abbott The test results would be available as indicated in Table 2.
the Dimension customers performed tacrolimus testing in batch, with 63% taking
systems offer a up to eight hours and 20% taking up to 24 hours to report tacrolimus Table 2: Dimension RxL System ISD Testing Time
Turnaround Time
Lean approach results in the first four weeks following transplantation. Alternatively, Accession & Extraction & Dimension From Tube From Start of
Test Lab Arrival Label Pretreatment Load ¥ Test Complete Arrival Testing
81% of Dimension customers performed tacrolimus testing in random 1 C 12:30 * 12:45 * NA 12:50* 13:06* 36 mins 16 mins
to ISD testing
access, with 80% of them reporting results in one hour or less. 2 T 17:30 * 18:55 * NA 19:00* 19:16* 1 hrs 46 mins 16 mins
in the routine 3 T 19:00 * 19:30 * NA 19:35* 19:51* 51 mins 16 mins
4 T 8:00 STAT 8:15 NA 8:20 8:36 36 mins 16 mins
laboratory. In conclusion, the observations made at the two hospital sites and the 5 C 9:20 9:50 NA 9:55 10:11 51 mins 16 mins
6 T 10:05 10:16 NA 10:21 10:37 32 mins 16 mins
Siemens R&D facility provided evidence to prove that the hypotheses 7 T 10:10 10:15 NA 10:20 10:36 26 mins 16 mins
posed at the beginning of the evaluation are true. Additionally, the 8 T 10:14 10:30 NA 10:35 10:52 47 mins 16 mins
9 C 10:14 10:30 NA 10:35 10:53 47 mins 16 mins
data suggests that the Dimension systems offer a Lean approach to
10 S 10:30 11:00 NA 11:05 11:21 51 mins 16 mins
ISD testing in the routine laboratory. With a Lean approach to ISD 11 T 12:02 12:12 NA 12:17 12:33 31 mins 16 mins
*Previous day
testing, the opportunity for more laboratories to offer ISD monitoring ¥
Assume load 5 minutes after accessioning

as part of their routine services is greater. More importantly,

the elimination of manual processing steps may result in fewer
error opportunities, better use of operator time, and better overall
turnaround times for ISD results, leading to improved transplant
patient management.

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Reducing Manual Steps, Improving Turnaround Times, Reducing Manual Steps, Improving Turnaround Times,
and Creating a Lean Laboratory Environment: and Creating a Lean Laboratory Environment:
ISD Testing on the Dimension ® Integrated Chemistry Systems 16 ISD Testing on the Dimension ® Integrated Chemistry Systems 17

Conclusion significantly faster than the nearly eight hour average turnaround
time on the ARCHITECT system. Furthermore, the practice of
holding specimens to be tested on the following day is eliminated,
Without the need for manual pretreatment and extraction, the samples
dramatically improving the time at which test results are released.
performed on the Dimension RxL system can be loaded onto the
This ultimately allows for improved patient care.
analyzer after a simple pipetting step. This requires less than one
minute of time compared to the ARCHITECT i2000SR average time
Table 3: ISD Turnaround Time Comparison
…the individual of 15 minutes needed for sample processing before sample loading. Turnaround Time Turnaround Time
From Tube Arrival From Start of Testing
turnaround Additionally, the manual pretreatment and extraction protocols Test Lab Arrival Dimension ARCHITECT Dimension ARCHITECT
necessary for the ARCHITECT ISD assays require up to 13 protocol 1 C 12:30* 36 mins 24 hrs 3 mins 16 mins 45 mins
times are much 2 T 17:30* 1 hrs 46 mins 19 hrs 20 mins 16 mins 45 mins
steps and more than 20 distinct manual tasks that must be performed 3 T 19:00* 51 mins 17 hrs 51 mins 16 mins 46 mins
improved with by a technologist. Since these steps are manual, they present a higher 4 T 8:00 STAT 36 mins 4 hrs 51 mins 16 mins 46 mins

the Dimension probability for testing errors. 5 C 9:20 51 mins 3 hrs 14 mins 16 mins 46 mins
6 T 10:05 32 mins 2 hrs 47 mins 16 mins 47 mins
RxL system 7 T 10:10 26 mins 2 hrs 44 mins 16 mins 49 mins
8 T 10:14 47 mins 2 hrs 45 mins 16 mins 54 mins
At both sites studied during this analysis, the ISD testing was
over the 9 C 10:14 47 mins 2 hrs 20 mins 16 mins 46 mins
performed in batch in a different manner than the routine workload. 10 S 10:30 51 mins 1 hrs 37 mins 16 mins 53 mins
ARCHITECT This was due to the complex nature of the manual pretreatment and 11 T 12:02 31 mins 58 mins 16 mins 45 mins
Average
i2000SR extraction steps. Alternatively, the lack of manual pretreatment and * previous day
47 mins 7 hrs 30 mins 16 mins 47 mins

platform. extraction for the assays performed on the Dimension RxL system
meant that the samples could be loaded quickly onto the analyzer,
thus the need for batch testing is eliminated. This encourages
the Lean practice of workload leveling and results in improved
Dimension Turnaround Time from Tube Arrival: The time
from whenever the patient sample arrived in the laboratory
until the test result is available for release to the LIS.
ARCHITECT Turnaround Time from Tube Arrival: The time
from whenever the patient sample arrived in the laboratory
until the test result is available for release to the LIS.
Dimension Turnaround Time from Start of Testing: The
time from whenever the patient sample was loaded onto
the Dimension system until the test result is available for
release to the LIS.
ARCHITECT Turnaround Time from Start of Testing: The
time from whenever the pretreatment and extraction
protocol was initiated until the test result is available for
release to the LIS.

turnaround times for the individual tests.

As stated previously, the ISD workload from the community

Comparing the turnaround times from the two scenarios (Table 3) it
hospital was used as a basis for comparing the workflow between
is apparent that the individual turnaround times are much improved
the ARCHITECT and Dimension systems. One of the reasons the
with the Dimension RxL system over the ARCHITECT i2000SR
community hospital protocol was chosen was because the practice of
platform. The turnaround time for the Dimension system averaged
batch testing and the average turnaround time for results appears to
16 minutes from the start of sample processing to reporting results
be common for many laboratories performing ISD testing.
versus the 47 minutes required on the ARCHITECT system, which
included pretreatment, extraction, and analytical testing time.
A 2009 market research survey on tacrolimus testing activity was
From tube arrival in the laboratory to reporting of test results, the
performed in the United States, Germany, and Italy.12 Tacrolimus
Dimension system required approximately 45 minutes. This was
testing represents the largest percentage of ISD testing performed,

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