1. Tuthill et al, Henry Ford Health Systen Bar Code Specified Surgical Pathology Workflow Joy J Mammen MD; Richard Zarbo MD; Adrian Ormsby MD; J. Mark Tuthill MD Henry Ford Health System Detroit, Michigan

2. Tuthill et al, Henry Ford Health Systen Context Introduction Automation of histopathology laboratory process have been difficult due to the variability: –specimen types –the expression of disease in a given patient –laboratory procedures required to arrive at pathologic diagnosis. A key challenge has been to automate specimen labeling –Manual labeling is tedious, error prone, and inefficient.

3. Tuthill et al, Henry Ford Health Systen Context Focus Revolutionary changes in materials available for use in the histopathology laboratory have allowed us to address this problem, automating cassette and slide label generation This decreases intra-lab identification errors and improves efficiency by driving workflow using bar code technology.

4. Tuthill et al, Henry Ford Health Systen Biopsy/Label Transport Accession Tissue Gross Exam Processing Embedding Cutting/ Slide Label Staining/Cover Case Collation Delivery Microscopic Exam Stain/Recut Order Dictation Transciption Report Signout SP processes at risk of mis-identification error Patient & Sample Identification

5. Tuthill et al, Henry Ford Health Systen Technology Cassette Creation Misys CopathPlus™ MHv 2.4 (Misys Healthcare, Raleigh, NC) LIS Custom interface to laser cassette etchers that use Labelase ™ software, both from General Data (General Data, Cincinnati, OH). –2 Dimensional barcodes etched on the cassettes –Cassettes are read at the microtomy stations using Dell Optiplex 745 PC (Dell, Roundrock, TX) and Symbol ™ barcode scanners (Motorola Inc., Holtsville, NY)

6. Tuthill et al, Henry Ford Health Systen Technology Label Generation Stain-resistant slide labels (Stainershield ™, General Data) on Intermec C4 (Intermec Inc., Everett, WA) direct thermal printers A report was developed in CoPathPlus™ that retrieves stain orders for each block.

7. Tuthill et al, Henry Ford Health Systen Design Prior to automation Tissue cassettes were printed with human-readable identification details using the –Leica cassette printers (Leica Microsystems, Bannockburn, IL) –Required re-entering demographic and case data into dedicated software After processing, sections were cut and mounted onto slides manually labeled with the case accession number and part number Stains were performed based on electronic requests that were available at the histology department through the LIS After staining, labels were batch printed from the LIS and affixed onto the corresponding slides.

8. Tuthill et al, Henry Ford Health Systen Design Automation Two General Data laser cassette etchers interfaced to CoPathPlus were placed at the accessioning stations. –During accession, cassettes are etched with the case number, patient name, part type abbreviation, and a 2D barcode. Once the block arrives at the microtomy station equipped with a PC, barcode scanner and label printer, the 2D barcode is scanned printing all slide labels for that particular block’s stain orders from the LIS.

9. Tuthill et al, Henry Ford Health Systen Design Automation Labels are printed on “Stainershield” label stock, applied to the glass slide and tissue sections are cut and placed –Blocks are positively identified and slides definitively labeled prior to staining. –Manual labeling is eliminated (reduced) –Cross matching slides with labels is eliminated Slide labels include all relevant data as well as a bar code (code 128C).

10. CoPath terminal Barcode label printer -Lab tag -Specimen containers Lab tag scanner, bar code reader Cassette etcher- 2D barcode Accession Station U-shaped Cell CoPath terminal 2D Barcode reader -Individual cassettes Slide label printer -Chemical resistant slide labels -Print 1 cassette not batch Microtome Station U-shaped Cell

11. Tuthill et al, Henry Ford Health Systen

16. Barcode Specified Surgical Pathology Workflow CoPath Scantron Lab Tag Imager Cassette Etcher Create cassette barcode Create Lab Tag & Specimen Container Barcodes Tray Scan container barcode to open case in CoPath CoPath 2 1 - Scan slide barcode to open case in CoPath & - View scanned lab tag in ThumbsPlus 4 Pathologist Signout Accession Gross Tissue Cutting 3 2 Specimens Verify original Lab Tag & created barcode ID Verify created container barcode with CoPath and cassette ID Microtome Create chemical resistant slide labels by cassette barcode Scan cassette barcode 3 4 Histology Verify patient name, SP # on Lab tag, slide and in CoPath 1 Verify on cassette & slide SP# and pt. name with CoPath

17. Tuthill et al, Henry Ford Health Systen Biopsy/Label Transport Accession Tissue Gross Exam Processing Embedding Cutting/ Slide Label Staining/Cover Case Collation Delivery Microscopic Exam Stain/Recut Order Dictation Transciption Report Signout SP processes targeted by barcode to reduce human labor and mis-identification error Patient & Sample Identification

18. Tuthill et al, Henry Ford Health Systen Results Most specimens received in the lab are currently being processed using this system with slide labels printed on demand at the microtomy station. Paper labels are still utilized for slides that requiring microwave processing since the StainerShiel labels undergo degradation Time required for labeling prostate biopsies having 36 slides was reduced from 20 minutes to 30-45 seconds

19. Tuthill et al, Henry Ford Health Systen Results The CoPath interfaces saves time and eliminates data entry errors related to re-keying data –This saves about two minutes per case. Thus this technology has: –saved time and effort as well as –eliminating labeling errors

20. Tuthill et al, Henry Ford Health Systen Results Post Bar Coding All Surg Path Case Mis-identifications 62% reduction all misidentifications Barcode 1.67% 0.62% 18 45 4 Pre-analytic derived 85% reduction Block & slide mis-ID 2694 cases 2877 cases

21. Tuthill et al, Henry Ford Health Systen Conclusions Integration of the barcode technology into the histopathology labeling process has resulted in process improvement, by saving time and reducing errors.