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HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital Harvard Medical School Information Received, I Understand
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Page 1: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Anatomic Pathology Information – The Challenge of Tracking and

Routing at MGH

Thomas M. Gudewicz, MDMassachusetts General Hospital

Harvard Medical School

Information Received, I Understand

Page 2: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Summary• 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

Page 3: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Outline

1. Mission, Vision and Driving Forces2. From 1896 to 2010 - The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing –

Today6. Building the Foundation

Page 4: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision and Driving Forces2. From 1896 to 2010 – The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing – Today6. Building the Foundation

Page 5: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

The Mission and Vision of the MGH Pathology ServiceThe Mission and Vision of the MGH Pathology Service

Page 6: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

To deliver the highest quality pathology services

and to move the field of pathology forward

Page 7: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Healthcare - The Driving Forces

Revenue

Customers

RevenueIncrease productivity Cut costsReduce waste

CustomersExternal

• Patients • Health care

providers• Other diagnostic

specialists• Researchers

CustomersExternal

• Patients • Health care

providers• Other diagnostic

specialists• Researchers

Internal• Technical staff• Administrative

staff• Residents and

fellows• Pathologists

RegulatoryRegulatory

GovernmentalInsurance

Page 8: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

MGH Pathology Products and Services

• 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.)

Page 9: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

MGH Pathology Products and Services

• Pathology and clinical laboratory 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.)

Information

Page 10: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision, and Driving Forces2. From 1896 to 2010, the Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing – Today6. Building the Foundation

Page 11: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

1896

2010

Page 12: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

ResearchLaboratories

Histo- compatibility Laboratory

Immunology Laboratory

Research Finance & Admin

Roles and Functions of the MGH Pathology Service

Clinical Services

InformaticsEducational Programs

Core Clinical Laboratories

Surgical Pathology

Service

Quality and Safety

Cytology Service

Microbiology Laboratory

Divisions:

Services:

Point of Care Testing

Diabetes Laboratory

HealthCare Center

Laboratories

Execute Mission Support Function

AutopsyService

Blood Transfusion

Services

Page 13: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

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

Page 14: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision, and Driving Forces2. From 1896 to 2010 – The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing – Today6. Building the Foundation

Page 15: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Sunquest CoPath / MGH Collaboration

• 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.

Aug 2009 – 10-yr. joint development agreement with Sunquest Information Systems on the next generation AP/CP based LIS.

Page 16: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Collaboration Project Requirements

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)

Page 17: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision, and Driving Forces

2. From 1896 to 2010 – The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing –

Today6. Building the Foundation

Page 18: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Tracking and Routing

Routing - system to determine where an asset is directed during the life cycle given the status of the system.

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.

Page 19: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Assets - DefinedHard Assets: Any

identified physical item assigned to a case• Tissue, blocks, slides.• Paper requisitions,

documents and reports

• x-ray film.

Soft Assets: Non-physical (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

Page 20: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Assets - Defined

Whether machine readable or not, assets must be

assigned a fixed, unique, traceable ID

S10-02341A2 L-3Doe, John

MBH Pathology

https://Archive132/Shared%20Documents/Proc34A

Page 21: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Tracking – Where is the Asset?

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

Page 22: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Routing – Where Do Assets Go?

Route: User defined criteria outlining the SPOTs that an asset must enter & exit for processing

3 Types:1. Standard Process 2. Contextual Process3. Business

Intelligence (BI) Process

Page 23: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Routing – Where Do Assets Go?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- & down- stream conditions (optimized Work in Progress (WIP), i.e., dashboard driven).

Page 24: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision, and Driving Forces

2. From 1896 to 2010 – The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing –

Today6. Building the Foundation

Page 25: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

MGH Tracking and Routing - Today

• Barcode technology.• Limited SPOTs (7).• Begins at

accessioning.• Ends in histology

prior to delivery of slides to pathologist.

• After that – all bets are off.

No existing software or automated rules.

Automated Tracking Automatic Routing

Page 26: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

MGH Barcoded Asset Tracking System

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.)

Page 27: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

MGH Barcoded Asset Tracking System

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

Page 28: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOLBarcode Use - Surgical

Pathology

Gross Lab Histology Lab

At patient point of collection a specimen barcode is (often) generated from the ADT systemPoint of

Collection

Create SpecimenBarcode

ADT System

Manual

Accession Desk1. Requisition2. Transcription 3. Container4. Cassettes

Gross Bench

Create Transcription

Case

Gross Lab

Enter Block Log

Gross Lab

Print New Cassettes

Gross Lab

Delete Extra Cassettes

Gross Lab

Discard or Save Specimen

ADTBarcode

Transcription Barcode

Requisition Barcode

AMP / PPth

MS Access

Soft Script Server

AMP/PPth Barcode

Extra Cassette

Container

Visual Basic / PPth

Share Ware /PPth(BW)

Histology Lab

Block Log Reconciliation

Cutting Station

Create Slide Labels

Check-out BenchSlide/Block

Scan Slide only

AMP / PPth

MS Access

AMP / PPth

Slide

Cassette

Manual

Page 29: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOLBarcode Use - Cytology and

AutopsyCytopathology

Autopsy Pathology

Cutting Station

Create Slide Labels

Check-out BenchSlide/Block

Scan Slide only

AMP / PPth

AMP / PPth

Slide

CassetteManual

Autopsy Accession

Label CassettesAMP /PPth

Non-Gyn Acc’sion

Create1. Requisition &2. Slide Labels

Gyn AccessionCreate

1. Requisition &2. FocalPoint labels

Open Cytotech FocalPoint

Review

Cytotech Signout

Focal Point

CustomScript

AMP / PPth

PPth

Manual Manual

ADT Barcode

Requisition Barcode

Page 30: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

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

Page 31: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

1. Mission, Vision, and Driving Forces2. From 1896 to 2010 – The Contrast3. The Challenge4. Tracking and Routing – Defined5. MGH Tracking and Routing – Today6. Building the Foundation

Page 32: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Building the Foundation

The overlay of automation technology on an existing

inefficient, sub-optimized manual tracking system will result in . . .

Implementing an Automated Tracking & Routing System

Processing

Storage

Garbage In

Garbage Out

Page 33: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Building the Foundation

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.

Success is based on:

Lean Six Sigma

Sounds like:

Page 34: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

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. Overproduction2. Waiting3. Transportation4. Processing5. Inventory6. Motion7. Defects

Building the Foundation

Page 35: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Previous MGH LEAN Experience

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.

Mar 2005 – Aug 2006 Histology Redesign

Project

Incorporated Lean concepts of workflow analysis, re-design, standardization, including the barcode system.

Page 36: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Foundation Building – 1st Step

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

Page 37: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Foundation Building – 1st Step

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

Page 38: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Foundation Building – 2nd Step

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

variability.

Page 39: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Foundation Building – 2nd StepMethods:• 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

Page 40: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Analysis Methodology

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®).

Page 41: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Workflow Chart – Back Bench

The Devil in the Details

Back Bench Process

Bac

k B

ench

DecalcificationLegal Case,

Save or Medical Device?

Cassette Deletion in PowerPath,

using Boston Workstation

Process Owner: Denise Bland-Piontek

Cytogenetics? Return to client

Dictation sent to SoftScript

Tumor Bank?

Needed for resident?

Special Instructions?

Cassettes printed at accession area

Send to Cytogenetics, Flow

Cytometry, Microbiology, Cytology Cell Block, Stones,

Molecular

MGH Consult?

Extra Tissue Stored

Specimen time stamped, with

stamper

<10 cassettes needed?

Requisitions batched, sent to

transcription

Photo req’d?Take a photo at

photo stationOR, Clinics, Consults, Cytology Specimens

Accessioner walks to Gross, tech cuts specimen sample

Paper log

Small Grossing

Bench

Reserve for Resident (may be significant delay)

Tissue Stored Indefinitely

Specimen received, logged(Accessioning)

Flow, Micro, Cytology, or

Stones?

Gross Only?

More or fewer cassettes needed?

After 8:30AM and Same Day

Rush?

Cassettes printed at cassette printing

station

Requisition Form

Save 6 weeks

Cassettes placed in racks, photo of

rack taken for tracking purposes

Enter case and number of

cassettes into logLegal, Medical or Save?

Bone?

Large or Small?

Client Want?

Extra cassettes placed in bucket for deletion from

case

Tissue older than 2 weeks?

Tissue discarded

Specimen sent to Histology

Work with PowerPath to

adjust number of cassettes

Add ribbon and note with

instructions to cassette

Send to Transcription for Accession

Y

N

Y

No

No

Y

Yes

No

No

No

No Yes

Small

Large

Yes

Yes

NoNo

More

Specimen grossed,

placed into appropriate cassette(s)

No

Yes

Yes

Save

Yes

LegalM.D.

No

Yes

No

Yes

NoYes

Yes

End

No

Specimen sample sent

to Tumor Bank

Specimen logged in

PPTH, labels printed

Upload to pat_dim2

Same Day Rush?

No

Specimen Hand Delivered to

Histology

Requisition hand delivered to Transciption

Yes

Delay

Access

Frozen Section?

N

Frozen Section Process

YFewer

Page 42: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

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.

Page 43: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

FMEA Cycle

Detect Failure Mode

Calculate Risk Priority Number

RPN = S x O x D

Recommend Actions

Identify Causes& Assign Occurrence #

(O)

Identify Prevention /

Detection Process & Assign

Detection #(D)

Identify Effects & Assign Severity #

(S)

The higher the RPN,

the more likely a

failure has a negative

effect on the system

Implement Actions & Check Results

Page 44: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

FMEA – Small Gross Bench• QA Assistant™ Web-based application• Download to PDF or MS Excel

• Document management• Generates reports

Page 45: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Examine bag and contentsScan bar code on

container / cassetteExamine tissue

Transfer cases from accession area to Small

Gross Room (SGR)

1

RUSH not brought to SGRRoutine case not brought to SGR

No or insufficient fixative / preservative in containerTissue missingTissue lostTissue too smallTissue damagedWrong tissue in containerTissue requires more cassettes than pre-labeled cassettesDescribed lesion not present on received tissueMultiple specimens submitted in single container

Reader not workingBar code unreadable

Accession errorRequisition or container missingMismatched requisition/containerLabels missing or illegible on containers or documentsCassettes missing or insufficientMismatch information on container and/or cassettes and/or requisitionSpecimen is a large gross room case Information mismatch on container and/or requisition Missing or illegible identifying information on container and/or requisitionSpecimen cannot be processedAdd-On material accessioned with new accession numberMissing or illegible clinical information on container and/or requisitionFixative or preservative leaked from containerContainer or documents contaminated with gross blood or bodily fluids

Failure Modes

Small Gross Room Process Step

FMEA – Failure Modes Summation

Page 46: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Initial Project Results

• 27 Functional Areas (FA) mapped for workflow

• Workflow confirmation by observation complete in 1 area and ongoing in 2nd but largest functional area

• 1 FMEA completed

Page 47: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Summary of 27 Functional Areas (FA)

StepsDecision

PointsHand Off's

Total 466 81 233

Ave/FA 17 3 9

Page 48: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Simple Sign-Out: 1 H&E slide

Functional Area StepsDecision

PointsHand Off’s

Accession & Gross 53 18 21

Histology 28 2 13

Embedding 29 6 8

Microtomy/Stain 11 1 4

Signout 15 2 3

Total 136 29 49

Ave 27 6 10

Page 49: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

AcknowledgmentsCarlos AlayaWilliam AminDenise Bland-PiontekMaya DaderlingJames HappelChris ObergDavid McClintockMichelle Schwab-Macdonald

Page 50: HARVARD MEDICAL SCHOOL Anatomic Pathology Information – The Challenge of Tracking and Routing at MGH Thomas M. Gudewicz, MD Massachusetts General Hospital.

HARVARDMEDICAL SCHOOL

Questions?


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