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Innovation in Immunohistochemistry (IHC) Staining: Single Piece Flow IHC Slide Processing
Authors: Erika Klohe, BS, MBA, Claudiu V. Cotta, MD, PhD, Amy Posch, Renata Klinkosz, Elizabeth Rowe, Ellen Magcamit-Labay, Fredericka Jones, Michelle Wayman, Derick Mangalindan, Stephanie Sanchez, Kathleen Sergott, Sherri Lomayesva, Clinton Yip, Jeff Pearson, Mark Torowus, James Walker, Heather Free
Editor: Mark Terry
DARK Daily Laboratory and Pathology News @ darkdaily.com
www.darkdaily.com ©2011 Dark Intelligence Group, Inc.
Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 2
Table of Contents
Executive Summary� 3
Preface:Immunohistochemistry(IHC)andIHCWorkflow 6
Introduction 9
Chapter 1:SinglePieceFlowIHCPlatforms 11
Chapter 2:CCFIHCWorkCell 12
Chapter 3:CaseStudy 14
Chapter 4:Results:TimefromPathologistOrderedIHCStaintoInstrumentVerification 17
Chapter 5:Results:TimefromLISOrdertoRunCompletion 19
Chapter 6:Results:ImprovedProductivityintheIHCWorkCell 21
Conclusions 22
References 23
AppendicesA-1AbouttheAuthors 25A-2AboutVentaMedicalSystems,Inc./Roche 26A-3AboutDARKDaily 27A-4AboutTheDarkIntelligenceGroup,Inc.,andTHEDARKREPORT 28A-5AbouttheExecutiveWarCollegeonLaboratoryandPathologyManagement 29A-6 About MarkTerry 31Terms of Use 36
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 3
©2011 Dark Intelligence Group, Inc.
Executive Summary�Not all laboratory tests and procedures are easy to automate. In
particular, complex laboratory workflows that utilize microscopy or
imaging can be difficult to fully automate. In recent years a number
of approaches have been devised to automate part of the laboratory
workflow for staining processes, imaging procedures, or to link
various automated subunits of the workflows. Immunohistochemistry
(IHC) is a good example of the difficulties of creating a fully
automated workflow. It is estimated that 70% of the workflow in a
histology laboratory is manual. Key areas of automation are typically
staining and imaging. Most automation in the staining area depends
upon robotic pipetting systems, sometimes linked with ancillary
delivery systems for wash buffers and other bulk fluids.
Automated staining typically relies on batch staining, i.e., staining
large numbers of slides simultaneously. With an emphasis on
efficiency, especially using Six Sigma and Lean philosophies,
laboratories are attempting to find more effective and flexible ways to
handle automated staining in the immunohistochemistry laboratory
that do not rely on batch staining, but utilize single piece flow
processing system.
The Cleveland Clinic Foundation (CCF) in partnership with Ventana
Medical Systems, Inc., modified their batch IHC work cell by
implementing the BenchMark ULTRA single piece flow staining
platform. They replaced the BenchMark instruments with four
VENTANA BenchMark ULTRA staining platforms, which created
a mix of batch (BenchMark XT instrument) and single piece flow
(BenchMark ULTRA staining platform) capabilities. This redefined
how they manage their slide handling techniques, optimizing slide
prioritization across single piece flow or batch systems when needed.
It is estimated
that 70% of
the workflow
in a histology
laboratory is
manual.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 4
©2011 Dark Intelligence Group, Inc.
It also removed delays associated with slide sorting and wait-times
related to the longest staining protocols. This resulted in STAT slides
being integrated more easily into routine workflow, and bulk reagents
and instrument output being maintained continuously throughout the
workday.
The Ventana workflow team conducted a detailed time analysis to
define the best method for implementing workflow improvements at
CCF. To reach the optimum CCF instrumentation mix and antibody
test menu, Ventana implemented and analyzed three different and
separate workflow states: “Batch Only,” “Batch and Single Piece Flow
without Workflow Consultation,” and “Batch, Single Piece Flow, with
Workflow Consultation.”
The Ventana workflow team measured the time intervals between three
data parameters in the IHC process: IHC order data from the LIS, slide
start data from the instrument, and slide completion reports derived
from staining platforms. Despite eliminating two instruments, slide
capacity remained unchanged. Reagent positions decreased, but there
was no impact on the number of slides processed.
In addition, the Ventana workflow team identified high-demand tests
so CCF could pre-load the most common reagents in their test menu
across the BenchMark ULTRA platforms. The new process allowed
CCF to more finely tune lower demand tests into three categories
of batch-runs: short IHC run time, long IHC run time, and in situ
hybridization (ISH). This workflow improvement shifted 77% of the
laboratory’s testing from batch processing to single piece flow staining
platforms (the four BenchMark ULTRAs) and moved CCF further than
expected toward Lean workflow.
The Ventana
workflow team
conducted a
detailed time
analysis to define
the best method
for implementing
workflow
improvements
at CCF.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 5
©2011 Dark Intelligence Group, Inc.
The study then analyzed results for a number of different parameters,
including:
• The time from LIS Ordered to Instrument Verification.
• The time from LIS Ordered to Run Completed.
• An evaluation of Improved Productivity in the IHC Work Cell.
CCF and Ventana concluded that optimizing the mix of IHC staining
platforms, along with incorporating Lean workflow processes,
resulted in significant improvement in test turnaround time, cut-
off times, and increased slide throughput per full-time employee.
In addition, workflow consultation and the incorporation of Lean
workflow philosophies improved efficiency in conjunction with those
found with the implementation of the BenchMark ULTRA single
piece staining platform.
Optimizing
the mix of
IHC staining
platforms,
along with
incorporating
Lean workflow
processes,
resulted in
significant
improvement in
test turnaround
time...
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 6
©2011 Dark Intelligence Group, Inc.
PrefaceImmunohistochemistry (IHC) and IHC Workflow
Laboratory tests and procedures that involve microscopy or imaging
tend to have very complex workflows that do not lend themselves
well to full automation. As Rene J. Buesa says in her 2009 article in
the Annals of Diagnostic Pathology, “After a few years of operation,
all histolabs develop workflow problems.” In recent years a number
of approaches have been devised to automate part of the laboratory
workflow for staining processes, imaging procedures, or to link
various automated subunits of the workflows.
Immunohistochemistry (IHC) is a good example of the difficulties
of creating a fully automated workflow. At its most basic, IHC
involves using biological reagents such as antibodies or probes to
identify specific proteins or genes on tissue specimens, which are
then visualized using several different types of imaging – such as
fluorescence or bright microscopy, for example. The complexity
that contributes to the challenges of full automation in IHC include
expansive diagnostic test menus, types and preparation of tissue, and
the staining preferences of individual pathologist.
IHC workflow begins with a surgical biopsy of a tumor. The
specimen is accessioned and examined, processed in paraffin blocks,
then prepared as tissue sections onto glass slides. Standard, routine
staining is typically H&E (hematoxylin and eosin), more slides are
prepared, collated and delivered, then provided to a histotechnologist
and/or pathologist to analyze. IHC is then ordered, the more
complicated IHC procedures are performed on the slides, which are
then collated and delivered to a histotechnologist and/or pathologist
to analyze. In many cases multiple images are digitized, which allows
the images to be analyzed side-by-side by the pathologist. A report is
created and the paraffin blocks and prepared slides are archived.
“After a
few years of
operation,
all histolabs
develop
workflow
problems.”
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 7
©2011 Dark Intelligence Group, Inc.
It is estimated that 70% of the workflow in a histology laboratory is
manual. Key areas of automation are typically staining and imaging
(which usually occurs between the Collate & Deliver and Read Slides
area). Generally, automated staining in IHC relies upon robotic
pipetting systems. In addition, some automated systems link wash
buffers and other fluids via ancillary delivery systems.
As a result, IHC instrument performance times depend upon
incubation times of individual reagents and on the amount of time it
takes for a robotic arm or arms to move from one slide station to the
next, or from reagent wells to slides. Therefore, throughput rate for
automated IHC instruments are calculated based on the total time
necessary for the instrument to perform a full staining run and on the
number of slides stained.
For the most part, IHC automation for staining procedures has used
“batch runs,” i.e., staining large collections of slides simultaneously.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 8
©2011 Dark Intelligence Group, Inc.
This works reasonably well and provides good consistency and
quality of stain. However, modern laboratories have a continual push
for more efficiencies, often utilizing Six Sigma or Lean philosophies.
Lean essentially attempts higher levels of efficiency by optimizing
workflow. Batch processing of anything, however, does not fit in well
to the Lean philosophy.
In addition, an automated batch system does not adapt well to a STAT
sample that needs to be processed immediately. Some facilities and
companies have been working on developing more of a “single piece
flow processing” system, eliminating “batch processing” leading
to better run times and instrument capacity; it also provides more
flexibility in the workflow and better fits into Lean processes.
Modern
laboratories
have a continual
push for more
efficiencies...
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 9
©2011 Dark Intelligence Group, Inc.
IntroductionInnovation in immunohistochemistry (IHC) staining has evolved
significantly over the last two decades. The process of staining
has shifted from labor-intensive, manual techniques toward
semi-automated instruments with off-line processes such as
deparaffinization and antigen retrieval, and now to a new generation
of baking-through-staining automated instrumentation systems that
enable standardization, improved staining consistency, and expedited
turnaround times. While automation has positively influenced IHC
slide-staining quality and processes, the batch-run method has been
a constraint in achieving Lean workflow efficiencies and improved
productivity for the anatomic pathology laboratory.
In the article “Adapting lean to histology laboratories,” author Rene J.
Buesa discusses the evolution of IHC processes and the inherent “anti-
lean characteristics” of “large batch practice” that has permeated the
histolab culture in current times1.
This case study of the Cleveland Clinic Foundation (CCF) IHC
work cell analyzes the impact of implementing single piece flow
processing approach and comparing single piece flow output to batch
processing of IHC slides. Also, this paper examines how third-party
workflow consulting enhances the results associated with instrument
implementation by also incorporating Lean workflow concepts, such
as single piece flow.
The purpose of this study was to assess how Lean workflow concepts
can be incorporated with continuous flow instrumentation to improve
lab productivity and process. To analyze changes in workflow
efficiency, this study compares data from the following slide processing
milestones: LIS Ordered Time – the time that the test was ordered in the
The purpose of
this study was
to assess how
Lean workflow
concepts can be
incorporated
with single
piece flow
instrumentation
to improve lab
productivity and
process.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 10
©2011 Dark Intelligence Group, Inc.
LIS system; Instrument Verification Time – the time that the specimen
was placed on the instrument, as recognized by barcode reading; and
Run Complete Time – the time that the slide completed processing on
the instrument. These parameters were utilized to measure increases
in laboratory productivity and improvements to the flow of specimens
throughout the staining process.
These
parameters
were utilized
to measure
increases in
laboratory
productivity...
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 11
©2011 Dark Intelligence Group, Inc.
Chapter 1
Single Piece Flow IHC PlatformsIn October 2009, in collaboration with Ventana Medical Systems,
Inc., the Cleveland Clinic Foundation (CCF) modified their batch
IHC work cell by implementing the BenchMark ULTRA single
piece flow staining platform. Prior to this date, CCF used all batch
IHC automation, specifically a mix of VENTANA BenchMark and
BenchMark XT instruments.
The VENTANA BenchMark ULTRA staining platform is capable
of running 30 individual slides in a continuous and random access
format via independent slide processing drawers. Individual slide
processing eliminates the need to batch slides, maximizing run-time
efficiency and instrument capacity. It removes delays associated with
slide sorting and waiting for the longest staining protocol to finish
before gaining access to slides. The BenchMark ULTRA instrument
allows histotechnicians to load slides continuously as they are cut,
and unload completed slides as they finish staining. Accordingly,
STAT cases are easily absorbed into routine workflow and instrument
operators can replenish bulk reagents and manage instrument output
continuously throughout the workday while slides are processing.
It removes delays
associated with
slide sorting and
waiting for the
longest staining
protocol to finish
before gaining
access to slides.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 12
©2011 Dark Intelligence Group, Inc.
Chapter 2
CCF IHC Work CellCCF processes approximately 75,000 IHC slides per year, and staffs
the IHC lab five days per week from 6:30 a.m. to 3:00 a.m. Two
histotechnicians (HT) perform the tasks in the IHC work cell and
manage the various work streams in the lab. These work streams
include cutting IHC slides, IHC instrument operation (sample
labeling, loading/unloading slides and reagents, slide dehydration, and
cover slipping stained slides), preparing reagent and primary antibody
dilutions, performing manual stains, managing the Laboratory
Information System (LIS) interface, retrieving and filing blocks,
cutting control slides, and preparing slides for molecular testing. The
shifts overlap in the following manner:
• 6:30 a.m. – 4:00 p.m. 1 HT cutting slides,
1 HT operating IHC instruments
• 4:00 p.m. – 6:30 p.m. 1 HT cutting slides and
operating IHC instruments
• 6:30 p.m. – 8:30 p.m. 1 HT cutting slides,
1 HT operating IHC instruments
• 8:30 p.m. – 3:00 a.m. 1 HT cutting slides and
operating IHC instruments
Two
histotechnicians
perform the
tasks in the
IHC work
cell and
manage the
various
work streams
in the lab.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 13
©2011 Dark Intelligence Group, Inc.
IHC instrumentation used in the lab prior to October of 2009 was a
mix of BenchMark and BenchMark XT instruments. Table 1 shows
the number of slide and reagent positions the lab used to manage the
IHC caseload.
Table 1. Instrument Mix in the Lab (Prior to October 2009).
Instrument Type # of units Slide Positions Reagent Positions
BenchMark instrument 6 120 150
BenchMark XT instrument 4 120 140
Totals 10 240 290
Table 2 details the IHC cut-off time, batch run time, and slide
delivery time with 100% batch processing and instrumentation. Batch
processing represented the current state at the time of data collection.
Table 2. IHC Batch Order Cutoff and Run Times (Prior to October 2009).
IHC Order Cutoff Time
Average Batch Staining Start Time
Average Batch Run Completion Time
Slides Delivered to Pathologist
10:00 a.m. 11:00 a.m. 3:30 p.m. 4 p.m.
1:00 p.m. 2:00 p.m. 6:30 p.m. 8 p.m.
After 1:00 p.m. Overnight shift run Overnight 10:30 am (next day)
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 14
©2011 Dark Intelligence Group, Inc.
Chapter 3
Case Study�This case study analyzed the implementation of single piece flow
slide processing in the IHC work cell and measured gains in
workflow efficiency for slide processing and slide output. This study
also evaluated the benefits of incorporating workflow consulting to
balance CCF’s antibody test menu and instrumentation mix.
Workflow and Instrument Mix in the IHC Work Cell
Three separate workflow states were analyzed to measure the
productivity and efficiency in the IHC work cell. Table 3 shows the
IHC work cell time period, workflow state, and instrument mix.
Table 3. Cleveland Clinic IHC Work Cell States.
IHC Work Cell Time Period Workflow State Platform / Instrument Mix
A Until October 2009 Batch only 6 BenchMark instruments, 4 BenchMark XT instruments.
B October 2009 to January 2010
Batch and Single piece flow w/o Workflow Consultation
4 BenchMark XT instruments and 4 BenchMark ULTRA staining platforms in January 2010 soon after installation
C January 2010 to April 2010
Batch, Single piece flow, with Workflow Consultation
4 BenchMark XT instruments and 4 BenchMark ULTRA staining platform Lean workflow consultation measures implemented
Analysis of Workflow on Slide Processing
A workflow analysis was completed, measuring the time intervals
between three data parameters in the IHC process: IHC order
data from the LIS, slide start data from the instrument, and slide
completion reports derived from staining platforms. The following
This study
also evaluated
the benefits of
incorporating
workflow
consulting to
balance CCF’s
antibody test
menu and
instrumentation
mix.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 15
©2011 Dark Intelligence Group, Inc.
time intervals were compared across the three workflow states, as
detailed in Table 3 above:
• LIS Ordered to Instrument Verification (Pathologist Order to
Verified By Instrument)
• LIS Ordered to Run Completion (Pathologist Order to Slide Stain
Complete)
In October of 2009, the start of this study, the BenchMark instruments
were replaced with four VENTANA BenchMark ULTRA staining
platforms, thereby creating a mix of batch (BenchMark XT
instrument) and single piece flow (BenchMark ULTRA staining
platform) capabilities (see Table 4).
The resulting slide capacity for managing the annual IHC caseload
remained unchanged despite the elimination of two instruments.
Reagent positions decreased by ten in the new instrument
configuration; however, the decrease in reagent positions had no
impact on the number of slides that could be processed.
Table 4. Instrument Mix in the Lab (Post October 2009).
Instrument Type # of Units Slide Positions Reagent Positions
BenchMark ULTRA staining platform 4 120 140
BenchMark XT instrument 4 120 140
Totals 8 240 280
Benefits of Workflow Consultation and Lean
Workflow consultation identified high-demand tests based on volume,
and utilized this information to pre-load the most common reagents
in CCF’s menu across the BenchMark ULTRA platforms. Lower-
demand tests were batched on BenchMark XT instruments in the
following categories: short IHC run time, long IHC run time, and
in situ hybridization (ISH). The workflow plan ultimately shifted
The resulting
slide capacity
for managing
the annual
IHC caseload
remained
unchanged
despite the
elimination of
two instruments.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 16
©2011 Dark Intelligence Group, Inc.
77% of the lab’s testing from the batch processing systems to the
four BenchMark ULTRA single piece flow staining platforms. The
BenchMark XT instruments were used to run the remaining 23%
of the slide volume. Given the depth and breadth of CCF’s primary
antibody library, allocating the antibodies based on usage was a
critical step in establishing a Lean workflow.
Given the depth
and breadth of
CCF’s primary
antibody library,
allocating the
antibodies based
on usage was a
critical step in
establishing a
Lean workflow.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 17
©2011 Dark Intelligence Group, Inc.
Chapter 4
Results: Time from Pathologist Ordered IHC Stain to Instrument VerificationThe time from “LIS Ordered to Instrument Verification” and “LIS
Ordered to Run Completed” were compared across each of the three
workflow states detailed in Table 3. The analysis measured workflow
efficiencies in the IHC work cell, improved productivity in slide
processing, flow of specimens, and test turnaround time.
Time from Pathologist Ordered IHC Stain to Instrument
Verification
Figure 1 shows the distribution of “LIS Ordered to Instrument
Verification” times, for those verified within 12 hours, for each of the
three IHC work cell conditions described in Table 3 above (A, B, C).
Condition C illustrates that with workflow consulting and single piece
flow instrumentation, the time interval between placing an order
and instrument verification decreased, resulting in more of the daily
workload being processed sooner.
All B atch IHC P latforms
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12
Hrs from IHC orde r to ve rified
% I
HC
Slid
e V
olum
e
50% Batch & 50% Continuous access IHC lnstruments before Workflow consulting
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12
Hrs from IHC order to verified
% IH
C Sl
ide
Volu
mes
50% Batch & 50% Continuous access IHC Instruments after Workflow Consulting
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12
Hrs from IHC order to verified
% IH
C Sl
ide
Volu
me
Figure 1.: Hours from LIS Order to Instrument Verified.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 18
©2011 Dark Intelligence Group, Inc.
More specifically, Condition C demonstrates a 50% increase in
cases verified within the first 3 hours of the first shift, and a 21%
increase in cases verified within the first 6 hours of the first shift.
The latter condition enabled IHC slide processing to begin earlier in
the lab shift, improving overall test turnaround time and freeing lab
personnel to attend to other value-added work streams.
In order to prove statistical significance, a Kruskal-Wallis test (non-
parametric analysis of variance) was used to evaluate the difference in
“Order Time to Instrument Verification” between the three conditions
(Table 5). This test exhibited a significant time savings, with the
median “Order Time to Verification” improved by 30 minutes to 1
hour, comparing condition C to conditions A and B. Respectively,
Wilcoxon rank-sum tests measuring each pair condition also indicated
a significant difference in “Order Time to Verification” under
condition C compared to conditions A and B.
Table 5. Median Time from LIS Order to Instrument Verified by Condition.
IHC Work Cell Time Period Median Range p-value
A Until October 2009 4.32 (4:19) 0.13-102.00 0.1736 (compared to B);<0.0001 (compared to C)
B October 2009 to January 2010
5.05 0.00-50.27 0.1736 (compared to A);<0.0001 (compared to C)
C January 2010 to April 2010
3.80 (3:48) 0.27-28.98 <0.0001 (compared to A);<0.0001 (compared to C)
(It) enabled IHC
slide processing
to begin earlier
in the lab shift,
improving
overall test
turnaround time
and freeing lab
personnel to
attend to other
value-added
work streams.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 19
©2011 Dark Intelligence Group, Inc.
Chapter 5
Results: Time from LIS Order to Run CompletionFigure 2 shows the distribution of workload, from “LIS Order to Run
Completion,” for each of the 3 conditions during a 15 hour period
of time. The time from “LIS Order to Run Completion” appears
similar between conditions A and B, with condition C showing a shift
towards earlier run completion for more of the workload.
As shown in Table 6, the percentage of slides completed within 3,
6, and 12 hours approximately doubled after performing workflow
optimization, with 73% of slides run within 12 hours.
Table 6. Volume of Slides Complete Over Time by IHC Work Cell Condition.
IHC Work Cell Time Period
Slides Run Within 3 hours
Slides Run Within 6 hours
Slides Run Within 12 hours
A Until October 2009
8% 22% 35%
B October 2009 to January 2010
2% 14% 41%
C January 2010 to April 2010
14%(75% improvement from A-C)
46%(109% improvement from A-C)
73%(109% improvement from A-C)
All Batch IHC Instruments
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12 12 to 15
Hrs from IHC order to complete
% IH
C Sl
ide
Volu
me
50% Batch & 50% Continuous access IHC Instruments before Workflow Consulting
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12 12 to 15
Hrs from IHC order to run complete
% IH
C Sl
ide
Volu
mes
50% Batch & 50% Continuous access IHC Instruments after Workflow Consulting
0
10
20
30
40
50
60
0 to 3 3 to 6 6 to 9 9 to 12 12 to 18
Hrs from IHC order to run complete
% IH
C Sl
ide
Volu
me
Figure 2.: Hours from LIS Order to Run Complete.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 20
©2011 Dark Intelligence Group, Inc.
In order to evaluate statistical significance, a Kruskal-Wallis test
was used to evaluate the overall difference in time from “LIS
Ordered to Slide Completed” between the three conditions. This test
indicated that there was a significant difference in time completed
between these three conditions, with the median time decreasing by
approximately 3 hours after workflow optimization. Wilcoxon rank-
sum tests comparing each pair of conditions indicated that there was a
significant difference in “LIS Order Time to Slide Completed” under
condition C, compared to conditions A and B (Table 7).
Table 7. Median Time from LIS Order to Run Complete by Condition.
IHC Work Cell Time Period Median Range p-value
A Until October 2009 9.88 0.93-103.00 0.6125 (compared to B);<0.0001 (compared to C)
B October 2009 to January 2010
9.45 1.33-50.63 0.6125 (compared to A);<0.0001 (compared to C)
C January 2010 to April 2010
6.62 1.18-34.30 <0.0001 (compared to A);<0.0001 (compared to C)
The median time
decreased by
approximately
3 hours after
workflow
optimization.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 21
©2011 Dark Intelligence Group, Inc.
Chapter 6
Results: Improved Productivity� in the IHC Work CellProcessing 77% of CCF’s total IHC volume in single piece flow
mode on the BenchMark ULTRA staining platform resulted in
increased slide throughput, which translated to an additional IHC
order cutoff time for slide processing at 4 p.m. Table 8 shows the
new IHC order cutoff times that were established due to this study.
Workflow consulting identified opportunities for pulling a portion
of the overnight IHC slide processing into the evening shift on the
BenchMark ULTRA platforms. This workload shift was the most
significant efficiency gain.
Pathologists could now have 33% more of their daily slide volume
at 12:00 midnight rather than waiting until 10:30 a.m. The lab also
recognized a substantial time-savings benefit with the implementation
of the BenchMark ULTRA platforms through a decrease in the
pre-run slide sorting, a non-value added activity associated with
slide batching. With the 50 highest volume tests residing on the
BenchMark ULTRA, sorting was reduced to only those slides run on
a BenchMark XT instrument, or 23% of the workload.
Table 8. IHC Batch Order Cutoff and Slide Run Times (BenchMark ULTRA single piece flow staining platform and optimized workflow).
IHC Order Cutoff Time
Average Slide Start Time
Average Slide Completion Time
Slides Delivered to Pathologist
10:00 a.m. 11:00 a.m. 1:15 p.m. 3-4 p.m.
1:00 p.m. 2:00 p.m. 5:15 p.m. 7-8 p.m.
4:00 p.m. 6:30 p.m. 9:45 p.m. 12:00 midnight
After 4:00 p.m. Overnight shift run Overnight 10 a.m. (next day)
Pathologists
could now have
33% more of
their daily slide
volume at 12:00
midnight rather
than waiting
until 10:30 a.m.
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Innovation in Immunohistochemistry ( IHC) Staining:Single Piece Flow IHC Slide Processing 22
©2011 Dark Intelligence Group, Inc.
ConclusionsOptimizing the mix of IHC staining platforms and incorporating
Lean workflow processes within the IHC work cell delivered
significant improvements to the test turnaround time, extension of
test ordering (cutoff times), and increased slide-throughput per full
time employee (FTE). Workflow consultation and the incorporation
of Lean workflow concepts to the lab processes can add to the overall
slide processing efficiency gains found with the implementation of the
BenchMark ULTRA single piece flow slide-staining platform.
The workflow plan, in conjunction with the addition of the
BenchMark ULTRA platforms, reduced batching and increased the
continuous flow of specimens. Workflow optimization decreased
IHC turnaround times, reduced the time required to manage and
batch load stainers, supported and smoothed fluctuations in specimen
flow, and enabled the lab to increase throughput by integrating
Lean concepts such as single piece flow with single piece flow
instrumentation. The mix of instrumentation and optimized resource
allocation, jointly, facilitated extended IHC order cutoff times to
4 p.m. (from 1:00 p.m.), effectively providing an additional 33% of
slides available for sign-out by 12:00 midnight.
The implementation of a single-piece flow, single-piece flow IHC
platform, and integration of Lean methodology to the IHC work cell
enabled Cleveland Clinic Foundation to increase slide throughput,
expand test menu availability on the instruments, extend order
cutoff times, improve slide turnaround time, reduce manual sorting
processes, and reallocate FTE time to value-added activities, resulting
in significant advancements for laboratory productivity and process.
The workflow
plan, in
conjunction with
the addition of
the Benchmark
ULTRA
platforms,
reduced
batching and
increased the
continuous flow
of specimens.
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References1. Beusa, Rene J., Adapting lean to histology laboratories. Annals
of Diagnostic Pathology. 13 (2009) 322-333.
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Appendices
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©2011 Dark Intelligence Group, Inc.
Erika Klohe, Senior Product Manager supporting IHC and ISH staining solutions, comes to Ventana Medical Systems, Inc. with over ten years of experience in product development, marketing and project management. Erika’s diverse background in cancer diagnostic applications furthers the Ventana mission to improve the lives of all patients afflicted with cancer. Helping to outfit anatomic pathology laboratories with best-in-class automated instrumentation and reagents, Erika contributes to the global effort to empower cancer intelligence.
Claudiu V. Cotta, MD, PhD, is the Medical Director of the Cleveland Clinic immunohistochemistry lab. Dr. Cotta received his medical degree from Universitatea de Medicina si Farmacie Targu-Mures in Romania, and his PhD from the University of Alabama at Birmingham. After a residency in anatomic and clinical pathology at the University of Alabama at Birmingham, Dr. Cotta completed fellowships in hematopathology at the University of Texas M.D. Anderson Cancer Center. Dr. Cotta’s professional interests are hematopathology, molecular pathology, and flow cytometry.
Amy Posch is the Lab Manager of the Cleveland Clinic immunohistochemistry lab. Amy is a Medical Technologist (MT). She has worked in the Cleveland Clinic laboratories for 32 years.
Renata Klinkosz has been a Medical Technologist, MT, for 25 years. Renata has worked in the Cleveland Clinic immunohistochemistry lab for 15 years.
Elizabeth Rowe has been a Histology Technologist for 40 years. Elizabeth has worked in the Cleveland Clinic laboratories for seven years.
Ma. Elena Magcamit-Labay has been a Medical Technologist, (AMT)MT and (ASCP)HTL for 15 years. Ellen has worked in the Cleveland Clinic laboratories for three years.
Fredericka Jones has been a Histology Technician for eight years. Fredericka joined the Cleveland Clinic team in September 2011.Michelle Wayman has been a Histology Technician (ASCP)HT for 20 years. Michelle has worked in the Cleveland Clinic laboratories for ten years.
Roderick Mangalindan has been a Medical Technologist, (AMT)MT and (ASCP)HTL for 28 years. Derick has worked in the Cleveland Clinic laboratories for six years.
Stephanie Sanchez is a Biostatistician at Ventana Medical Systems. She has an MPH in Biostatistics and has worked at Ventana for two years.
Kathleen Sergott is the Major Account Manager at Ventana Medical Systems, a subsidiary of Roche. Kathleen has a Bachelor of Science Degree. She has worked with the Cleveland Clinic Health System for the past 10 years and Ventana since 2007.
Sherri Lomayesva is a Senior Technical Writer at Ventana Medical Systems, Inc. Sherri is a certified histotechnician and has worked at Ventana for three years.
Clinton Yip is a Manager of Workflow Consulting for Ventana Medical Systems, a member of the Roche Group. Clinton is a certified Lean Six Sigma Master Black Belt and has worked for Ventana for the last three-and-a-half years.
Jeff Pearson is a cytotechnologist and has worked in cytology for 10 years. For the last three years, Jeff has been a Marketing Manager at Ventana Medical Systems, Inc.
Mark Torowus is a Marketing Manager at Ventana Medical Systems, Inc. He is a trained Cytotechnologist. Over the past 21 years, his experiences ranging from managing an Anatomic Pathology laboratory to commercial responsibilities in the field of anatomic pathology.
James Walker is a Workflow Consulting Senior Manager for Ventana-Roche Diagnostics. He is a Lean Six Sigma Master Black Belt and holds a degree in Mechanical Engineering and a Masters in Business Administration. He has worked for Ventana for three years.
Heather Free is a Biostatistician at Ventana Medical Systems. She has an MPH in Biostatistics and has worked at Ventana for three years.
A-1About The Authors
Erika Klohe
Claudiu V. Cotta, MD, PhD
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Ventana Medical Systems, Inc. (“VMSI”), a member of the Roche
Group, innovates and manufactures instruments and reagents that
automate tissue processing and slide staining for cancer diagnostics.
VENTANA solutions are used in clinical histology and drug
development research laboratories worldwide. The company’s
intuitive, integrated staining and workflow management platforms
that optimize laboratory efficiencies to reduce errors support
diagnosis and inform treatment decisions for anatomic pathology
professionals. Together with Roche, VMSI is driving personalized
medicine through accelerated drug discovery and the development
of “companion diagnostics” to identify the patients most likely to
respond favorably to specific therapies. Visit www.ventana.com to
learn more.
VENTANA, the VENTANA logo, are trademarks of Roche.
VMSI Media Relations
Jacqueline Bucher Director, Corporate Communications Phone:
520-877-7288 e-mail: [email protected]
A-2About Ventana Medical Systems, Inc.
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©2011 Dark Intelligence Group, Inc.
“�Dark Daily is
a concise e-news/
management
briefing on
timely topics in
clinical
laboratory and
anatomic
pathology group
management. It
is a solution to
the dilemma
facing anyone in
the laboratory
profession.
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 healthcare trends make it imperative to stay informed to be success-ful. At the same time, the Internet, cell phones, blackberries, laptop computers and wireless devices are overwhelming any one individu-al’s ability to absorb this crushing Tsunami of data.
DARK Daily is a quick-to-read, easy-to-understand alert on some key development in laboratory medicine and laboratory manage-ment. It has no counterpart in the lab world. Why? Because it is produced and written by the experts at The Dark reporT and The Dark Intelligence Group, who know your world, understand your needs and provide you with concise, processed intelligence on only those topics that are most important to you!
You will find DARK Daily to also be an exceptionally valuable resource in laboratory and pathology management. Some of the lab industry’s keenest minds and most effective experts will be offering their knowledge, their insights and their recommendations on win-ning strategies and management methods. Many of these experts are unknown to most lab directors. As has proven true with The Dark reporT for more than a decade, DARK Daily will be your invalu-able— and unmatched—resource, giving you access to the knowl-edge and experience of these accomplished lab industry professionals.
A-3About DARK Daily
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“�Membership
is highly-
prized by the
lab industry’s
leaders and
early adopters.
It allows
them to share
innovations and
new knowledge
in a confidential,
non-competitive
manner.
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 innovations and new knowledge in a confidential, non-competitive manner. This gives them first access to new knowledge, along with the expertise they can tap to keep their laboratory or pathology organization at the razor’s edge of top performance.
It offers qualified lab executives, pathologists and industry vendors a rich store of knowledge, expertise and resources that are unavailable elsewhere. Since its founding in 1996, The Dark Intelligence Group and The Dark reporT have played in instrumental roles in support-ing the success of some of the nation’s best-performing, most profit-able laboratory organizations.
The Dark Intelligence Group (TDIG) is headquartered in Austin, Texas. This location makes it very accessible for any laboratory organization seeking input, insight and support in developing their business operations, creating effective business strategies and crafting effective sales and marketing programs that consistently generate new volumes of specimens and increasing new profits. The Dark Intelli-gence Group, Inc. owns and operates two Web sites in the TDIG Website network:
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A-4About The Dark Intelligence Group, Inc. and The Dark reporT
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A-5About the Executive War College 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 Management to learn, to share and to network. Many consider it to be the premier source of innovation and excellence in laboratory and pathology management.
Each year, a carefully selected line-up of laboratory leaders and inno-vators tell the story of how their laboratories are solving problems, tackling the toughest challenges in lab medicine and seizing oppor-tunities to improve clinical care and boost financial performance. The Executive War College is the place to get practical advice and solutions for the toughest lab management challenges. A unique case study format brings participants face-to-face with their most success-ful peers. They tell, first hand, how their laboratory solved intractable problems and successfully used new technology.
Many lab management secrets are shared, along with specific “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. 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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In September 2005, a laboratory management meeting called Executive Edge was conducted in Toronto, Ontario, Canada, by The Dark Intelligence Group and QSE Consulting. It provided pathologists and lab directors in Canada with a customized meeting devoted to the strategic and operational issues of laboratory management in Canada.
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Mark Terry is a freelance writer and editor specializing in clinical
diagnostics, telemedicine and biotechnology. He worked for 18 years
in clinical genetics prior to turning to writing and has published over
600 magazine and trade journal articles, 13 books and more than a
dozen book-length market research reports and white papers related to
clinical diagnostics. He is a member of the Association of Health Care
Journalists and the Association of Genetic Technologists.
A-6About Mark Terry
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Notes
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©2011 Dark Intelligence Group, Inc.
© 2011 by the Dark Intelligence Group, Inc.
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