How well do we do in Pathology?

“…. Incorrect patient identification was involved in 13% of surgical errors and 67% of transfusion errors.” How well do we do in Pathology?

Studying the workflow

Understanding Workflow Case Record Creation Complex / Small Tissue Sample Examination Tissue Processing and Embedding Tissue Cutting Slide Sorting Pathologist Slide Reviewing No Further Testing Required Cutting and Sorting Grossing H&E Staining Reruns or Additional Testing Required Accessioning Special Staining IHC Staining Screening & Interpretation Slide Sorting (to Patient Cases) Sorting Archiving ISH Staining Administration Blocks and Slides to Storage Quality Assurance Histology laboratories have a very standardized workflow which mainly varies in the degree of automation, layout and work schedules rather then process steps

Manual Processes DIAGNOSIS Manual Processes Dominate the Pathology Lab Surgery and Sampling Accessioning and Grossing Embedding Sectioning Patient ID on Slide Tissue Sample on Slide DeparaffinizationMicroscopyH&E StainingTarget Retrieval Pathologist’s Interpretation IHC Staining

Three Pillars Right Patient Right Treatment RightDiagnosis

Integration of processes through the entire pathology laboratory eliminates steps that might introduce errors. Operating Room Right Patient? Correct Registration? Right Fixation Right Label? Right Sample? Correct Registration? Will the right specimen follow the right patient record? Is Data Registration done correctly? Specimen in the right block? Number on Block? Correct Registration? Right specimen to slide? Right label? Right Data Reg.? Right Staining? Right Reagent? Right Protocol? Concentration? Right Buffer? Correct Reg.? Right Label? Correct Diagnosis? Virtual Feedback? Right Patient? Right Storage and Retrieval?

Specimen Receiving and Data Entry Slide Viewing Staining Grossing Embedding Sectioning Processing Surgery Doctor The Pathology Lab Present Focus Areas Pathologist Patient Dako Link Middleware Hospital LAN and LIS Embedding Sectioning Grossing Processing

Sources of errors in process 3 14 = 4.8 mio procedures (3 choices in 14 steps) PreparationphasePreparationphase IHC Staining InterpretationphaseInterpretationphase Biopsing Fixation Preparation Sectioning Drying Deparaffination Pre-treatment Antibody Detection Counterstain Control Cut-off value Tumor entity Reporting Where Our Partnership Helps The Most! variations

Sources of errors in process 3 14 = 4.8 mio procedures (3 choices in 14 steps) PreparationphasePreparationphase IHC Staining InterpretationphaseInterpretationphase Biopsing Fixation Preparation Sectioning Drying Deparaffination Pre-treatment Antibody Detection Counterstain Control Cut-off value Tumor entity Reporting

PATHOLOGISTS

The Human Eye - Strength The human eye is unsurpassed at pattern recognition

Image Analysis System

Ohio University study found: That a well-trained data entry operator makes a data entry error 1 in every 300 keystrokes. Scanning a code 128 linear barcode produces 1 error in 2.8 million (worst case) and 1 error in 37 million (best case). Scanning a Datamatrix 2D code produces 1 error in 10.5 million (worst case) and 1 error in million (best case). Barcoding verses Keyboard Entry 1 Ohio University Center for Automatic Identification. “Code 16 and Code 49 Data Integrity Test Executive Summary” “DataMatrix and PDF417 Data Integrity Test Executive Summary” Online Linear BarcodeDatamatrix 2D code

Staffing issues Reference :-

Transcription problems

SOS 50S 505 5O5 S OS 17OS 84 B4 89 B7 B9 BY

Transcription problems

Diagnosing the Problem Specimen labelingSlide storage track Hand written comments in wax Tracking of block locations Post-it note tracking Manual slide workflow logs Manual test requests Manual archive track Center Oncology

Oct, Volume 1, Issue 1 Daily Morning Star Pathologist Sued, Wrong Diagnosis Given, woman looses breast. Mix up in specimens How does it Matter? Lawsuit $1,750,000

Tracking of the full workflow Expansion to the H&E area Use of cassettes for the whole laboratory The Paradigm Shift

How Laboratory Workflow Can Be Streamlined

The Pathology Lab Workflow Today Specimen Receiving and Data Entry Slide Viewing Staining Embedding Sectioning Grossing Processing

A Competitor Story-BG Pathology

SoftwareMiddleware Link ReagentsInstruments Pathology Lab Autostainer Plus LinkEnVision™ FLEX and FLEX+PT Link LAN and LIS Hospital The Link Solution

Dako Link Server Dako Link Managers Local Area Network (LAN) Hospital LIS Server Patient Pathologist LIS Connectivity Single point accessioning True Positive ID Less time spent entering data Fewer errors

Remotely diagnose and update instruments LIS Server Order protocols for new cases Program and label slides Quickly access the status of any case Monitor case completion and instrument status LAN Connectivity

Introducing Autostainer Plus Link Builds on the Dako Autostainer platform to continue providing confidence in your results Unites our trusted IHC stainer with innovative Dako Link software and connectivity options for added security

Program slides or connect to your LIS to retrieve test requests automatically Managing Your Data

Manage your workload and maximize laboratory efficiency Managing Your Data

Monitor slide and instrument status from any location Managing Your Data

Locate any slide quickly and print reports in seconds Managing Your Data

…from one workstation. Control multiple stainers… Instrument Connectivity …from another office …from another building …from another country

Staffing issues THANK YOU DR. ST.ALEXOV Reference :-