Supercharging Histology Workflow
Kelsi Currier, MPHWorkflow Consulting SolutionsVentana Medical SystemsSeptember 2009
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Today’s Learning Objectives
• Be able to pinpoint patient safety RISKS in your AP lab
• Understand how your AP lab can unlock major GAINS with Lean methodologies
• Explore value of automation and workflow changes in the AP lab – a CASE STUDY
• Discover new solutions to move from planning to execution to create the AP lab of the FUTURE
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Ventana Medical Systems, Inc.
• Over 1,200 employees across North America
• Fully integrated commercial operations, manufacturing, research and development in Tucson, AZ
• 95 patents issued and pending
• 6,000+ systems installed in 2,000+ labs across 33 countries worldwide
• 24% annual growth
• Acquired by F. Hoffmann-La Roche in early 2008
• A division within Roche called Roche Tissue Diagnostics
Born from a relentless search to find a better and faster way to diagnose the patient
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Ventana Leads in Tissue-Based Diagnostics
• Superior workflow solutions in both automation and information systems
• A proven track record of innovation, execution and patient centricity
• Strong research and development investment
• World class capabilities in core technologies
• Unparalleled partnerships for next generation companion diagnostics
• Passion for improving standard of cancer patient care
“We will not rest until every cancer patient receives
the access to information, therapy options and
individualized care we know is possible.”
- Dr. Thomas Grogan
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ES
Gen
II
Nex
ESIH
C
Nex
ESSp
ecia
l Sta
ins
DIS
CO
VER
Y
Ben
chm
ark
Ben
chm
ark
XT /L
TD
ISC
OVE
RY
XT
Sym
phon
y
Ben
chm
ark
Ultr
a
HPVCervical Cancer
iVIEW™
C-KIT GIST
EGFR Colon
HER-2 Protein Breast
Rabbit Monoclonal
Breast Markers
ultraVIEW
HER2 SISHGene
(Europe)
Qdot600/605
Wor
kflo
w C
onsu
lting
Vant
age
Continuous Innovation for the AP Lab
VIA
S
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Workflow Consulting Servicesa safe, effective, efficient lab
Patient Centric Solutions
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Vantage & Advanced Workflow -Powering the Total Solution
The only complete lean workflow solution that maximizes lab productivity and patient safety
•Turnkey lab improvement solution, including lean six sigma consulting
•Streamlines laboratory workflow
•Provides positive identification, with one label for the entire lab
•Enables advanced, active tracking and reporting
•Integrates Ventana products, multiplying customer value
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Risks of Status Quo
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• Overcalling
• Missing diagnosis
• What do you see in your lab?
High Potential for Human Error
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High Potential for Human Error
• Misidentification of slides/cases
• Tissue floaters
• Redundant data entry
• Handwritten logs/manual information collection
• Labeling/re-labeling
• Batch processing
• Non-standard work practices
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Media Focus on Lab Safety
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Journals Focus on Lab Safety
2-week study in histology:
• Nearly 30% of cases had manual rework: 159 hours; 1.3 FTEs
• 89% of defects were made in the analytic phase
• 2% misidentification rate; 67% of those in slide labeling
– All could have been avoided with an integrated identification system
Source: Am J Clin Pathol 2007; 128 p423
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Declining reimbursement
Staffing shortages
Increasing regulatory requirements
Mounting competition from consolidation
Consumer demand for rapid turn on results
Higher test volumes; more diverse test mixes
Market Forces
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Getting It Right…
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Lean Methodologies Unlock Major Gains
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Lean Moves Labs to the Next Level
• Improves patient safety– Reduce errors
• Improves efficiency and reduces costs– More capacity– Better staff productivity– Reduce wasteful activities– Save time and steps– Happier staff
• Improves experience for your cancer patients– Faster turnaround times– More reliable results
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Case Study - A Midwest Reference Lab
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Case Study - Change Readiness Assessment
Workflow Consulting Solutions is a catalyst for change.Assessment tool measure dimensions for change management.
How widely acknowledged are the risks of the status quo?(Quality, Patient Safety, Productivity)
1 10High Recognition Low Recognition
How widely acknowledged are the risks of the status quo?(Quality, Patient Safety, Productivity)
1 10High Recognition Low Recognition
What is the level of severity if the change fails?(Strategic Alignment, Lost Opportunity, Loss of Credibility)
1 10Not a Big Deal Very Severe
What is the level of severity if the change fails?(Strategic Alignment, Lost Opportunity, Loss of Credibility)
1 10Very Severe
How big is this change for the organization culturally and in general?(Day to day work activities, Decision making, Logistically)?
1 10Minor Changes Major Changes
(Day to day work activities, Decision making, Logistically)?
1 10Major Changes
How much are the benefits of this change recognized by those involved in the change?(Cost Reduction, Employee Satisfaction)
1 10High Recognition Low Recognition
How much are the benefits of this change recognized by those(Cost Reduction, Employee Satisfaction)
1 10High Recognition Low Recognition
X
X
X
X
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• 80+ hours on-site with team – Involve leadership and establish accountability
– Observation and determine current state baseline
– Identify opportunities via Voice of Customer
• High level of engagement to ensure team embraces change
• Leverage expertise across Ventana
Case Study - A Two Way Partnership
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Steps to a Safe, Efficient, Effective Lab
1. Observe and record
2. Reduce or eliminate non-value added activity by mapping the flow of work through the lab
3. Map current workflow process and design future state
4. Engage team in change management to implement improvements
5. Prioritize opportunities for continuous process flow improvements
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Case Study - Current State Process Flow
Facts:
• 1000+ slides/cases per
day
• 17 FTEs
• 3 shifts
Facts:
• 1000+ slides/cases per
day
• 17 FTEs
• 3 shifts
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T a k e O u t T is s u e /s
5 s
R e m o v e T is s u e
S a m p le f r o m
C o n ta in e r
1 5 s
D e li v e r t o T is s u e
P ro c e s s o rs
1 0 s
C r e a t e B C la b e l fo r R e q
a n d s p e c im e n
3 0 s
P r o c e s s T iss u e 1 1
h o u rs
3 9 6 0 0 s
P la c e T is s u e
in C a s s e t te /s
1 0 sP la c e
C a s s e t te in F o r m a l in
in P ro c e s s o r
B a s k e t
1 0 sA d d D y e to M a r k
M a r g in s a n d /o r
O r ie n ta t io n N o te s a s R e q u ir e d
6 0 s
G a th e r E m b e d d in g
M o ld
5 s
P la c e T is s u e in B a s e o f
M o ld
5 s
F il l M o ld w i th
P a ra f f in
5 sP la c e
b lo c k o n C o o l in g
T r a y
5 s
S c r a p e o f f p a ra f f in
f r o m ca s s e t te s
6 0 0 s
F a c e B lo c k s
6 0 0 s
P u t o n ic e
5 s
L o a d B lo c k
1 0 s
In it ia te C u t t in g
4 5 sP la c e
T is s u e in W a te r B a th
5 s
F lo a t & S e le c t
T is su e fo r M o u n t
5 s
D ip S l id e a n d
M o u n t T is s u e o n
S l id e
5 s
P la c e S l id e s o n
S id e to D r y
5 s
P a s t c a s s e t t e s a n d s p e c i m e n
t h ro u g h w in d o w
1 0 s
M o v e s p e c im e n s
to g r o s s in g
s ta t io n
2 0 s
A re th e r e e n o u g h o r to o m a n y
C a s s e t te s ?
P r in t A d d i t io n a l o r D e le te E x tra C a s s e t te s
6 0 s N o
Y e sS e c t io n T is s u e
a s R e q u ir
e d
6 0 0 s
P a s s b lo c k to c u t t e r a s t h e y
n e e d th e m
3 0 0 s
L o a d S l id e to fu l ly a u to m a te d d e s c r e te H & E
s t a in e r t ra y
5 s
S ta in S l id e s
2 7 0 0 s W a i t fo rH is to te c h to r e m o v e
s l id e s
1 8 0 s
M o v e to d is t r ib u tio n
d e s k
6 s
P la c e C a s s e t te B a s k e ts in
T is s u e P r o c e s s o r
1 5 s
P ic k - u p s e t o f b lo c k s f r o m r e f r ig e ra to r
3 0 s
P o u r o f f F o r m a lin
1 0 s
D ra in p a ra f f in
1 8 0 sR e m o ve
C a s s e t te s f r o m
p r o c e s so r
6 0 s
D e liv e r B a s k e t s t o E m b e d d in g
S t a tio n s
1 0 s
W a it U n t i l E m b e d d e d
6 0 0 s
C a s s e tte s s i t o n
c o o lin g t ra y 5 2 a t
a t im e
9 0 0 s
T ra n s p o r t b lo c k s to o rg a n iz in g
a re a / t a b le
1 5 s
P u l l c o n tr o ls
3 0 0 s
C u t S l id e s
1 1 2 0 s
P la c e in o v e n
2 4 0 0 s
P la c e in X y le n e
3 0 0 s
R u n d o w n to w a te r
1 8 0 s
L a y o u t a n d m a k e la b e ls
6 0 0 s
M o v e to in te rn a l
P a t h o lo g is t o r c o u r i e r a r e a
1 2 0 s
C h e c k S p e c im e n s
a n d p a p e r w o r k
1 8 0 s
S p e c im e n w a i t fo r
G r o s s in g
3 0 0 s
M o v e r a c k o f tis s u e to e m b e d d in g
s ta t io n
3 0 s
G a th e r u n s ta in e d
s lid e s b a s e d o n
lo g
6 0 0 s
P u l l co n tr o ls
3 0 0 s
C u t s lid e s
1 1 2 0 s
P la c e in o v e n
6 0 s
P u l l a n t ib o d ie s
3 0 0 s
S ta in s l id e s
1 0 8 0 0 sT ra n s p o r t
t o D is t r ib u t io n
d e s k
6 0 s
S p e c im e n w a it fo r
P ro c e s s in g
6 0 0 s
M o v e ic e t r a y s to b e n c h
f r e e z e r
3 0 s
P la c e b lo c k s o n ic e tra y s
3 0 s
S o rt b lo c k s th a t g o o u t f i rs t
1 5 0 s
M a k e s lid e la b e ls
9 0 0 s
C h e c k r e a g e n t
le v e ls
6 0 s
R e m o v e s lid e s f r o m
s ta in e r
3 0 0 s
C o ve r s lip
4 5 s
P u l l s ta in s o lu t io n s
3 0 0 s
C h e c k r e a g e n t
le ve ls
1 5 s
P u t s l id e s o n
m a c h in e
3 0 s
S ta in s l id e s
3 6 0 0 s
R e m o v e S l id e s
1 5 s
lo o k a t c o n tro l
s l id e
1 2 0 0 s
R e v ie w t is su e h is to r y s h e e t
3 0 s
S lid e s it t in g d r y in g
6 0 s
S p e c im e n a c c e s s io n e d
0 s
N o
P a c k in b u c k e t to b e p ic k e d u p b y
H is to
2 0 sY e s
S o r t s p e c im e n b y c l in ic a l , c y to , a n d
A P
6 0 s
P ic k o u t A P
s p e c im e n s
3 0 sM a tc h
s p e c im e n s to p a p e r
w o rk
2 0 s
T a k e s p e c im e n s
o u t o f b u c k e t
1 0 s
R e m o v e s p e c im e n a n d r e q f r o m b a g
1 0 s
M a tc h s p e c im e n s to
re q
2 0 s
W a it fo r s p e c im e n s
to b e p ic k e d u p
1 2 0 s
S p e c im e n s p ic k e d u p b y
H is to
1 8 0 s
C r e a t e c a s s e t te s
6 0 sP la c e
c a s s e t te s o n to p o f c o n t a in e r
1 0 s
c a s s e t te s o n ly
N o
M o v e B C 's c a s s e tte s to T P
fo r lo a d in g
3 0 s
Y e s
R e v ie w r e q a g a in s t s p e c im e n c o n ta in e r
4 5 s
S c a n r e q in to
c o m p u t e r fo r b il l in g
4 5 s
S ta r t T P a t d i f fe re n t
t im e s
6 0 s
5 :2 3 p m
7 :1 5 p m
m u l tip le t im e p e r d a y
m o r n in g r u n a t 3 :a m
P r o c e s s T is s u e
7 5 m in u te s
4 5 0 0 s
S c a n b lo c k in t o B C
T ra c k in g s ys te m
5 s
P la c e la b e l o n s l id e
1 0 s
R u n n e r p ic k s u p 1 0 s lid e s a t a t im e
a n d t r a n s p o r t to D is c r e te H & E
s ta in e r
1 0 s
M a k e s c o p y o f r e q fo r d ic tio n
3 0 s
S l id e c u t
Y e s
G a t h e r b lo c k s
6 0 0 s
N o
B a k e s l id e s fo r 2
h o u r s
7 2 0 0 s
V e n ta n a B e n c h M a rk X T S ta in e r
C r e a te L is t in D a k o
c o m p u te r
1 5 s
D a k o A u t o S ta in e r
0 s
N o
Y e s
P e r fo rm D e p a r in f in iz e a n d A n t ig e n
re tr ie v a l
2 4 0 0 s
P r in t r e a g e n t
l is t
1 0 sM a p th e
r e a g e n t in th e D a k o c o m p u te r
3 0 0 s
G a th e r re a g e n ts
3 0 0 s
P u t r e a g e n t
o n s ta in e r
3 0 0 s
P u t p a t ie n t
s lid e s a n d c o n tro ls o n
s ta in e r
2 4 0 s
P u l l c o n tr o ls
3 0 0 s
C le a r s l id e o u t o f C o P a th l is t
6 0 0 s
S l id e c u t
N o
G a t h e r b lo c k s
6 0 0 s
G a t h e r u n s ta in e d
s lid e s b a s e d o n lo g
6 0 0 s
C u t s lid e s
1 1 2 0 s
P la c e in o v e n
6 0 0 s
B a k e s l id e s fo r 3 0 m in .
1 2 0 0 s
Y e s
T r a n s p o r t t o
D is t r ib u tio n d e s k
6 0 s
C o v e r s l ip
4 5 s
C le a r s l id e o u t o f C o P a th lis t
3 0 0 s
P e r fo r m d a ily m a in tA u to m a te d
H & E S ta in e r
3 0 0 s
P u t s lid e in to b o a rd
1 0 sS o r t G ro s s in g
D ic ta t io n R e p o r ts to
fa c i li ty G r o u p
6 0 0 s
R e t ie ve R e q f ro m G r o s s in g
6 0 s
P la c e s lid e in s l id e b o a r d
1 0 s
M a tc h a n d S ta p le
D ic a tio n R e p o r t to
R e q s
1 8 0 0 s
M a rk C y to c a s e s in A c ce s s io n
L o g w i th ye llo w m a rk e r b a s e d o f f H S a n d S B C lo g
3 0 0 s
L o o k a t s l id e fo r
g o o d s ta in
4 5 s
P la c e a ll p a p e r w o r k
w i th b o a rd e d c a s e s
3 0 0 s
A d d r e a g e n t p a c k s a s
n e c e s s a ry
6 0 s
V e r i fy c a s e s a n d b lo c k lis t
in C o P a th
6 0 0 s
B e g in b o a rd in g
s lid e s
6 0 s
C r e a te B C la b e l fo r R e q
a n d s p e c im e n
3 0 s
S c a n s p e c im e n a n d c a s s e tt e s in to
T r a c k in g s y s te m
4 5 s
S c a n c a s s e t te s in t o T r a c k in g
s ys te m
5 s
P r in t B C 'd s l id e la b e ls
f ro m m ir o to m y
p r in te r
5 s
P la c e s id e in s ta in in g
t r a y
2 0 s
S t a r t
S t a r t
Initial opportunity:
• 26% of TAT - reduce non-value adds• 20.57 hrs - reduce manual logging• $174,613 potential savings
Initial opportunity:
• 26% of TAT - reduce non-value adds• 20.57 hrs - reduce manual logging• $174,613 potential savings
Case Study - Future State Process Flows
25
Customer
Accessioning
Total C/T = 53.6 minutesValue Add: 6.2 minutes
1
Case Assembly
Total C/T = 253 minutesValue Add: 0.8 seconds
2
Cerner Co Path
Hospital grossed
cassettes
Information
Information
HospitalDoctor Client Specimens
372 seconds
53.6 minutes 60 minutes
210 seconds
184 minutes 90 minutes
44112 seconds
740 minutes 5 minutes
120 seconds
159 minutes 60 minutes
48 seconds
52.6 minutes 3 minutes
200 seconds
426 minutes 35 minutes
0.8 seconds
253 minutes Lead Time = 2120 minutes
VA / T = 45063 secondsRM = 0 secondsWIP = 2120 minutesFG = 0 secondsWork Balancing
Grossing
Total C/T = 184 minutesValue Add: 3.5 minutes
460 minutes
Tissue Processing
Total C/T = 740 minutesValue Add: 735 minutes
390 minutes
Embedding
Total C/T = 159 minutesValue Add: 2 minutes
45 minutes
Microtome
Total C/T = 52.6 minutesValue Add: 0.8 minutes
460 minutes
H&E Staining
Total C/T = 66.9 minutesValue Add: 60 minutes
13 minutes 35 minutes
Mysis LIS
PRL Hospital CoPath
IHC
Total C/T = 426 minutesValue Add: 200 seconds
1
Specials
Total C/T = 133 minutesValue Add: 30.4 minutes
1
1 minutes
1 minutes
5 minutes
5 minutes
Bottleneck areas>270 Min of Wait Time!
Use Lean and Six Sigma tools to systematically uncover non-valueadded activity/ways to maximize lab productivity and safety
Case Study - Identify Value System
26
Assumption: 17 people25 movements per person per day
Step Dist.
Receiving / Acc 225 ftGrossing / TP 25 ftEmbedding 120 ftMicrotomy 75 ftH&E Staining 120 ftDistribution 150 ftIHC and Consults 160 ft
Total905 ft
Grossing
Gross Staging
Area Cytology
Receiving Area
Slide Distribution
Desk
H & E Staining and Cover slipping
Special Stains
Embedding
Embedding
Microtomy
Microtom
y
Microtom
y
Microtom
y
Histology Supervisor
Office
ImmunoStaining
Totals:~ 58,125 ft / day ~ 11.1 miles / day ~ 3,176.6 miles / year
Case Study - Streamline Movements Current State Floor Plan
27
Case Study - Future State Histology Lab
Cut miles/yr in half!
28
Case Study - Reduce Manual Log Creation
Work Station Hours Associated CostAccessioning 3.97 $34,062Grossing 2.77 $23,737Embedding 1.30 $11,154Microtomy 0.87 $7,464H&E Staining 2.98 $23,981Immuno Staining 2.30 $19,447Special Staining 1.00 $8,580Case Assemble 5.38 $46,188
Total 20.57 $174,613
29
Process Steps Current State Future State minutes
Accessioning 53.6 11.5Grossing 183.7 31.8Tissue Processing 739.8 739.8Embedding 158.6 57.7Microtome 52.6 15.4H&E Staining 66.9 46.3IHC Staining 426.0 410.8Special Staining 133.1 117.9Case Assemble 252.7 188.9Total Time 2067 1620
Cycle Time saved 447 minutes7.4 hours $63, 492
Case Study - Reduce Cycle Time
30
Case Study - Reduce Overtime
Improvement Gains
• Current State Cycle Time in Accessioning: 29 minutes
• Future State Cycle Time in Accessioning: 11.5 minutes
• May Eliminate Over Time: 65.5 hours /pay period or $51,090/yr
31
Case Study - Improve Patient Safety
Akro-Mils Bins with Intersecting Dividers
Patient Safety Risk!
Patient Safety Risk!
Bar Coding
32
Case Study - Improve Patient Safety
Optimize workspace to reduce crowding
Patient Safety Risk!
Patient Safety Risk!
Automation
33
• Total Personnel Interviewed: 11• Key Themes Reported
in order of popularity with staff1) Workflow assessment (across total flow
and individual work cells) for alignment of Lean processes
2) Tracking/bar coding need (internal and external)
3) Leadership involvement and communication increase
4) Redundant/excessive paperwork5) Space increase needed
“Staff need more efficient workspace,
better communication from management,
more physical space in which to work, and less turnover in key
roles.”
Case Study - Voice of the Customer (VOC)
34
Case Study - Impact Summary
No. Process Improvement Process Step Priority Lean Improvement Concept
1 Elimination of Handwritten slides Microtome High Waste Reduction
2 Bar Code Tracking, Data / Quality Management Histology
High Waste Reduction
3 Eliminate / reduce log creation and management of paper work Histology
High Waste Reduction
4Redesign of laboratory
Histology High Visual Workplace, Workcell design
5 Improved Automation of H&E Stainer - H&E High Wait Time Reduction
6 Install Metric Board - Key Performance Indicators General High Visual Workplace
7 Additional Tissue Processors Tissue Process
Medium Wait Time Reduction
8Review/Update Standard Work
Grossing, Microtomy, Distribution
Medium Standard Work
9Courier Routing Optimization
Receiving and Distribution
Medium Wait Time , Batch size Reduction
10Initiate 5S Concept Histology
Low Visual Workplace
11 Runner to transport resources in the lab Histology Low Wait Time Reduction
35
Reduce TAT26%
LoggingSavings
$174,613
OvertimeSavings$51,090
Bar CodingSavings$63,492
Annual Savings$289,195
Case Study - Reference Lab Opportunity
• Improved safety
• Higher employee
satisfaction
• Better patient
experience
• More competitive
lab
36
Using Lean to Create the Lab of the Future
37
Lean Transforms AP Lab Performance
QuickerresponseQuicker
response
Greater flexibilityGreater flexibility
Better qualityBetter quality
Increasedvalue
Increasedvalue
38
Lean Keeps Focus on Execution
• Lean Six Sigma is established as a continuous, cohesive way of working (not a project)
• Leadership is on board and governance is in place; both are aligned to systematically review and improve business process
• Lab staff participate in establishing accountability and chain of command at the onset of Lean Six Sigma
• Teams are focused on business process, not just tools for improvement
• Emphasis is on culture change to sustain improvement
39
Greatest Challenge is Execution!
Process improvement leads to cost reduction…
Execution leads to quantum leaps in competitive advantage and long-term financial benefits
40
Better equipment
More Sophisticated Testing
Improved Patient Safety
More Reliable Information
Automated Work Processes
Greater Efficiency, Effectiveness
Financial Stability
Competitive Advantage
Future Lab – Safe, Effective, Efficient
41
The First Step…Map Out Your Plan
Kelsi CurrierDirector, Workflow ConsultingMobile: (520) [email protected]
Ventana Medical Systems, Inc.a member of the Roche group1910 E. Innovation Park DriveTucson, Arizona 85755www.ventanamed.com
Contact Information