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Information Received, I Understand
Thomas M. Gudewicz, MD
Massachusetts General Hospital
Harvard Medical School

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• The complexity of pathology information workflow can be optimized by the application of automated systems, including asset tracking and routing
• Automating a system requires detailed information on workflow to optimize analysis and design considerations
• The collection and analysis of such information is in itself a definable process that assists design
• Iteration is a key component of optimizing analysis and design

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2. From 1896 to 2010 – The Contrast
3. The Challenge
4. Tracking and Routing – Defined
5. MGH Tracking and Routing – Today
6. Building the Foundation

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The Mission and Vision of the MGH Pathology Service

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To deliver the highest quality pathology services and to move the field of pathology forward

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Increase productivity
Cut costs
Reduce waste
Governmental
Insurance
Internal
• Technical staff
• Administrative staff
• Residents and fellows
• Pathologists

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• Pathology and clinical laboratory results and reports (clinicians, patients)
• Education and training (technologists, residents, fellows)
• Research materials (tissue, blocks, slides, data)
• Therapeutic modalities (blood and blood products, therapeutic phlebotomy, plasmapheresis, etc.)

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• Pathology and clinical laboratory reports
(clinicians, patients)
•
fellows)
• Research materials (tissue, blocks, slides, data)
• Therapeutic modalities (blood and blood products, therapeutic phlebotomy, plasmapheresis, etc.)

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1. Mission, Vision, and Driving Forces
3. The Challenge
4. Tracking and Routing – Defined
5. MGH Tracking and Routing – Today
6. Building the Foundation

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Roles and Functions of the MGH Pathology Service
Divisions:
Execute Mission Support Function
Clinical
Services
Educational
Programs
Research Informatics
Quality and
Safety
Finance &
Admin
Services:
Core Clinical
Laboratories
Cytology
Service
Surgical
Pathology
Service
Autopsy
Service
Microbiology
Laboratory
Blood
Transfusion
Services
Point of Care
Testing
Immunology
Laboratory
Diabetes
Laboratory
Histocompatibility
Laboratory
HealthCare
Center
Laboratories
Research
Laboratories

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MGH Pathology: Service Workload
Services
• Clinical laboratories: >10 million tests
• Surgical pathology: ~80,000 specimens
• Cytopathology: ~61,000 specimens
• Autopsy: ~300
• Microbiology: ~400,000 specimens
• Blood transfusion service:
• Donor center
• ~70,000 total blood component transfusions
• ~35,000 RBC units transfused
• ~3000 outpatients treated
Employees
• ~700 staff
• ~ 85 faculty
• ~ 80 trainees
Budget
• MGH ~$100M
• MGPO ~$25M

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1. Mission, Vision, and Driving Forces
2. From 1896 to 2010 – The Contrast
4. Tracking and Routing – Defined
5. MGH Tracking and Routing – Today
6. Building the Foundation

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Aug 2009 – 10-yr. joint development agreement with
Sunquest Information Systems on the next generation
AP/CP based LIS.
• Software co-development: efficient, flexible work, specimen & information flow.
• Strengthen the informatics infrastructure: use advanced diagnostic & information management
(IM) technologies.
• Provide a revenue stream: commercial distribution of the software.

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1. Retire PowerPath & Implement Sunquest
CoPath 5.0 AP-LIS.
2. Analyze, re-design, & optimize workflow top to bottom.
3. Apply automation, advanced diagnostic & IM technologies, digital pathology, molecular tests, operational Business Intelligence
(dashboards)

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1. Mission, Vision, and Driving Forces
2. From 1896 to 2010 – The Contrast
3. The Challenge
5. MGH Tracking and Routing – Today
6. Building the Foundation

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Tracking - system to determine at what point an asset is located (and where it has been) in the case life cycle.
Systems may be manual or automated.
Routing - system to determine where an asset is directed during the life cycle given the status of the system.

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Hard Assets: Any identified physical item assigned to a case
• Tissue, blocks, slides.
• Paper requisitions, documents and reports
• x-ray film.
Soft Assets: Nonphysical (electronic, virtual) information
• EMR, PACS
Images
• CD’s (?)
Unidentified (Hidden) Assets: Any asset created or required for production not assigned a system ID
• “Just-in-case” unstained slides
• Electronic image not linked to system
• Tissue blocks for IPX controls

S10-02341
A2 L-3
Doe, John
MBH Pathology
Whether machine readable or not, assets must be assigned a fixed, unique, traceable ID
HARVARD
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SPOT – Specimen
Point of Tracking
A station or location at which an asset is recorded or logged
(time in, receipt by, condition, etc.,)
Ideally, define SPOTs at hand-off points
• human-human
• human-machine
• machine-machine

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Route: User defined criteria outlining the
SPOTs that an asset must enter & exit for processing
3 Types:
1. Standard Process
2. Contextual Process
3. Business Intelligence (BI)
Process

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Standard: Route pre-defined at receipt by limited criteria
(e.g., prostate core bx – Route routine process, 3L H&E slide/block).
Contextual: Standard route modified by pre-defined data that drive special considerations (e.g., priority, day of week or time, pathologist, consult case, associated assets, phone requests).
BI: Real-time redirected routes based on up- & downstream conditions (optimized Work in Progress (WIP), i.e., dashboard driven).

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1. Mission, Vision, and Driving Forces
2. From 1896 to 2010 – The Contrast
3. The Challenge
4. Tracking and Routing – Defined
6. Building the Foundation

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Automated Tracking
• Barcode technology.
• Limited SPOTs (7).
• Begins at accessioning.
• Ends in histology prior to delivery of slides to pathologist.
• After that – all bets are off.
Automatic Routing
No existing software or automated rules.

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System:
• MGH internally customized system.
• Implemented late 2004 and fine tuned through
2006.
• Linear barcodes.
• Scanners (Symbol,
Orbit) single line and omnidirectional; keyboard wedge.
Program Interfaces:
• PowerPath/AMP
(Advanced Materials
Processing)
• Transcription Service
Server (SoftScript)
• MS Access Program
• Custom programs
(Visual Basic, etc.)

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Barcodes printed:
• Requisitions
• Gross transcription service
• Specimen containers
• Cassettes
• Slides
• Ventana
• FocalPoint
System Functions:
• 1° use is task automation
• Limited tracking information (PowerPath
Specimen Tab)
• Manual PowerPath tracking function exists

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At patient point of collection a specimen barcode is (often)
Point of
Collection generated from the ADT system
ADT
System
Manual
Create Specimen
Barcode
Gross Lab Histology Lab
ADT
Barcode
Accession Desk
1. Requisition
2. Transcription
3. Container
4. Cassettes
Gross Bench
Transcription
Barcode
Create
Transcription
Case
Gross Lab
Requisition
Barcode
Enter Block Log
AMP/
PPth
Soft
Script
Server
MS
Access
Barcode
Gross Lab
Print New
Cassettes
Extra
Cassette
Gross Lab
Delete Extra
Cassettes
Container
Gross Lab
Discard or Save
Specimen
AMP /
PPth
Share
Ware /
PPth
(BW)
Visual
Basic /
PPth
Manual
Histology Lab
Block Log
Reconciliation
Cassette
Cutting Station
Create Slide
Labels
Slide
Check-out Bench
Slide/Block
Scan Slide only
MS
Access
AMP /
PPth
AMP /
PPth

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Cytopathology
ADT
Barcode
NonGyn Acc’sion
Create
1. Requisition &
2. Slide Labels
Manual
Gyn Accession
Create
1. Requisition &
2. FocalPoint
labels
AMP /
PPth
Custom
Script
Requisition
Barcode
Open Cytotech
FocalPoint
Review
Manual
Cytotech Signout
Focal
Point
PPth
Manual
Autopsy
Accession
Label Cassettes
Autopsy Pathology
AMP /
PPth
Cassette
Cutting Station
Create Slide
Labels
Slide
Check-out Bench
Slide/Block
Scan Slide only
AMP /
PPth
AMP /
PPth

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Existing System Strengths and Weaknesses
Strengths
• Marginal Cost
• Asset IDs generated and distributed electronically
• Limited tracking possible
(Who, What, When, Where)
• Automation of routine tasks
• Good reliability
• Reduced errors
Weaknesses
• Limited SPOTs
• Customized programs
• LIS/equipment interface
• Succession planning difficult (programers)
• Linear barcode
• Manual action
• Not readable through objects
• Limited data capacity, ruggedness
• Orientation dependent

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1. Mission, Vision, and Driving Forces
2. From 1896 to 2010 – The Contrast
3. The Challenge
4. Tracking and Routing – Defined
5. MGH Tracking and Routing – Today

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Implementing an Automated Tracking & Routing System
The overlay of automation technology on an existing inefficient, suboptimized manual tracking system will result in . . .
Garbage
In
Processing
Storage
Garbage
Out

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Success is based on:
1. Detailed documented knowledge of the workflow from specimen collection to final storage or disposal of assets.
2. Use of analytical tools to identify and remove causes of defects (errors) and minimize variability.
3. Employee ownership and strong management and leadership support.
Sounds like:
Lean Six Sigma

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LEAN principles:
• Just in time supply
• Right person – right job
• Work flow continuity; up-stream processes in direct proximity to down-stream processes
LEAN - The Seven
Wastes
1. Overproduction
2. Waiting
3. Transportation
4. Processing
5. Inventory
6. Motion
7. Defects

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Mar 2005 – Aug 2006
Histology Redesign
Project
Incorporated Lean concepts of workflow analysis, re-design, standardization, including the barcode system.
Results:
• Reduced average routine surgical TAT from 48 hr to 20 hr.
• Reduced average
Biopsy TAT from 24 hr to 16 hr.
• Reduced overtime from 3.5 FTE’s in 2005 to 0.97 FTE’s in 2006
• Improved morale.

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st
Document workflow from specimen collection to final storage or disposal of assets.

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st
Present system – strengths, weaknesses, preferences.
• PowerPath LIS Analysis
• Exit interviews with users at all steps of production.
• Workflow Analysis
• Map workflow of existing production system.
Future system – capabilities, requirements and desires.
• Sunquest CoPath 5.0 requirements and specifications
• Generate Gap analysis
• Workflow
• Idealized workflow design

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nd
Use analytical tools to identify and remove causes of defects (errors) and minimize variability.

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nd
Methods:
• Work flow charts
• Failure Modes and
Effects Analysis (FMEA)
• Time motion analysis
• Workflow simulation
• Fishbone (Ishikawa) diagrams
• Histograms
• Pareto charts
• Check sheets
• Run charts
• Spaghetti diagrams
• Value Stream Map
• Project management tools
Charter
Change management
Resource plans

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1. Map work flow analyses by functional areas identifying all decision points and hand-offs.
2. Identify how the system falters or fails (failure modes).
3. Confirm process by direct observations.
4. Incorporate time-motion analysis, Spaghetti diagrams, etc. as necessary.
5. Simulate alternative work flows with available data (iGrafx ® ).

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Back Bench Process
Process Owner: Denise Bland-Piontek
OR, Clinics, Consults,
Cytology Specimens
Reserve for
Resident (may be significant delay)
Delay Photo req’d?
Yes
Take a photo at photo station
Upload to pat_dim2
No
No
Specimen time stamped, with stamper
Requisition Form
Yes
Frozen
Section?
Y
Frozen
Section
Process
N
MGH Consult?
Y
Send to
Transcription for Accession
N
Tumor Bank?
Y
Accessioner walks to Gross, tech cuts specimen sample
No
Flow, Micro,
Cytology, or
Stones?
Specimen sample sent to Tumor
Bank
Yes
Small
Grossing
Bench
Cassettes printed at cassette printing station
No
Small
<10 cassettes needed?
No
Large
Large or
Small?
Cassettes printed at accession area
Yes
Yes
More or fewer cassettes needed?
Fewer
More
Work with
PowerPath to adjust number of cassettes
No
Extra cassettes placed in bucket for deletion from case
Cassette
Deletion in
PowerPath, using Boston
Workstation
Gross Only?
Specimen grossed, placed into appropriate cassette(s)
Extra Tissue
Stored
Tissue older than 2 weeks?
Yes
Legal Case,
Save or
Medical
Device?
Yes
Dictation sent to
SoftScript
Save 6 weeks M.D.
Legal, Medical or Save?
Legal
Tissue Stored
Indefinitely
No
No
Paper log
Specimen received, logged
(Accessioning)
Y
Specimen logged in
PPTH, labels printed
Send to
Cytogenetics, Flow
Cytometry,
Microbiology,
Cytology Cell
Block, Stones,
Molecular
Yes
No
After 8:30AM and Same Day
Rush?
Save
Client Want?
Yes
No
Special
Instructions?
No
Bone?
Yes
Decalcification
Yes
Add ribbon and note with instructions to cassette
Requisitions batched, sent to transcription
No
Specimen sent to
Histology
Requisition hand delivered to
Transciption
Cassettes placed in racks, photo of rack taken for tracking purposes
No
Specimen Hand
Delivered to
Histology
Same Day
Rush?
Yes
Enter case and number of cassettes into log
End
Access
Cytogenetics?
No
Return to client Tissue discarded

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Failure Mode and Effects Analysis (FMEA)
• Product development and operations management tool for analysis of failure modes (FM) in various phases of a product life cycle.
• FMs are errors or defects in a process, design, or item.
• Team approach used to identify failure modes
(potential or actual) based on experience and risk analyses.
• Drives designs by prioritizing highest risk failures for early attention.

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Implement Actions & Check Results
Recommend
Actions
Detect
Failure Mode
The higher the RPN, the
Calculate
Risk Priority Number
RPN = S x O x D more likely a failure has a negative effect on the system
Identify Effects &
Assign Severity #
(S)
Identify
Prevention /
Detection Process
& Assign
Detection #
(D)
Identify Causes
& Assign
Occurrence #
(O)

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• QA Assistant ™ Web-based application
•
Download to PDF or MS Excel
• Document management
•
Generates reports

Transfer cases from accession area to Small
Gross Room (SGR)
FMEA – Failure Modes Summation
Small Gross Room Process Step
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Examine bag and contents
Scan bar code on container / cassette
Examine tissue
1
RUSH not brought to SGR
Routine case not brought to
SGR
Accession error
Requisition or container missing
Mismatched requisition/container
Labels missing or illegible on
containers or documents
Cassettes missing or insufficient
Mismatch information on container
and/or cassettes and/or requisition
Specimen is a large gross room case
Information mismatch on container
and/or requisition
Missing or illegible identifying
information on container and/or
requisition
Specimen cannot be processed
Add-On material accessioned with new
accession number
Missing or illegible clinical information
on container and/or requisition
Fixative or preservative leaked from
container
Container or documents contaminated
with gross blood or bodily fluids
Reader not working
Bar code unreadable
Failure Modes
No or insufficient fixative /
preservative in container
Tissue missing
Tissue lost
Tissue too small
Tissue damaged
Wrong tissue in container
Tissue requires more cassettes
than pre-labeled cassettes
Described lesion not present on
received tissue
Multiple specimens submitted
in single container

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• 27 Functional Areas (FA) mapped for workflow
• Workflow confirmation by observation complete in 1 area and ongoing in 2 nd but largest functional area
• 1 FMEA completed

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Steps
Total 466
Ave/FA 17
Decision
Points
81
3
Hand
Off's
233
9

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Functional Area Steps
Accession & Gross 53
Histology 28
Embedding 29
Microtomy/Stain 11
Signout 15
Total 136
Ave 27
Decision
Points
18
2
6
1
2
29
6
Hand
Off’s
21
13
8
4
3
49
10

Carlos Alaya
William Amin
Denise Bland-Piontek
Maya Daderling
James Happel
Chris Oberg
David McClintock
Michelle Schwab-Macdonald
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