1. Foundation.cap.org v. # The Barcode-Driven Lab: Success in a Large System Rodney Schmidt, MD, PhD University of Washington, Seattle April 17, 2011 Place sub-brand here

2. Topics Why create the barcode-driven lab? –Why in a large, complex lab? –Overview of functionality Not the detailed “how”; workflow –Achieved benefits Error reduction FTE savings Important factors in success –UCLA, Sierra Pathology, NWP, NYU, OHSU What’s down the road?

3. Disclosure Bar-coding software developed at UW (OmniTrax and OmniImage) has been licensed by UW to Pathway Pathology Consultants for PowerPath end-users. Dr. Schmidt and his team have a revenue- sharing agreement with UW. Dr. Schmidt has a consulting agreement with Thermo-Fisher for educational talks.

4. Why barcode? Expensive –$23k/gross station –$10k/cutting station –Software Workspaces change –Wiring, networking Time investment –Software fast –Workspaces slow –Financing slow Processes change –Material handling –QA Jobs change –Workflow –Change management Pathologists affected! Who needs the hassle?!

5. Large Systems – Special Factors Multiple locations Trainees – Residents and Fellows Personnel turnover Outside materials (e.g. consults) Ancillary testing Higher fraction of complex cases Issues: Training, complexity, communication Need: Robust systems to help people do things right

6. Bringing Bar-coding to AP Track slides (2005) –Eliminate the “lost slide” problem –Ease conference prep Specimen labels (2006) –Tissue discards and tracking –Drive gross photography Block creation and labeling (2008) –Automated JIT production of barcoded blocks –Gross room QA process and tracking Slide creation and labeling (2008) –Automated JIT creation of barcoded slides –Facilitate workflow and QA Eliminate all manual labeling (and errors) Facilitate workflow – JIT information display

7. Material identification (2005) Handwritten specimen labels Manual, off- line cassette labeling Hand-written slide labels

8. Primary labeling errors (2004) ?

9. Targets – Gross Room Foolproof labeling –No human labeling/data entry Reduced dependence on support staff –Off-hours availability –Redirection of support personnel Reduced waste of cassettes Grossing step at least as fast as current (Record timestamps) The unsupervised Resident!

10. Targets - Accession Receive specimen and enter data into the LIS Generate a bar coded label for the specimen and laboratory request form. Minimum extra keystrokes (one)

11. Accession specimens Label specimens Transport for processing Reconcile with LIS Move to staging area Rack filled cassettes Request more cassettes Fill cassettes Lay out cassettes Move to gross bench Group with specimens Label cassettes Store excess with specs Classic Grossing Workflow * * * * * * * * QA steps Possible errors Handling steps

12. Just-in-Time Printing Accession specimens Bar-code specimens Transport for processing Rack filled cassettes Fill cassettes Lay out cassettes * * * * Scan/print cassettes Courtesy General Data Fewer handling steps Fewer (1) error opportunities Fewer QA processes Rescan cassettes

13. Benefits Efficiency –No manual pre-printing and sorting of cassettes –Quick just-in-time additional cassettes –Default cassettes from PowerPath specimen panels –Blocks automatically ordered in PowerPath Quality –No manual labeling (no errors) –Scanning specimen barcode assures correct specimen –Enter cutting instructions, # pieces –Records which blocks are sent for processing

14. Q&E Benefits “Classic”“Just-in-Time” Handling steps115 Error opportunities91 Manual QA steps74 Primary labeling errors988/yr (est.); (1.2%) 2 in 3 mo (initial); 0 in next 7 mo; (0.003%) Cassette wastage~25/d (~7%)~0 Grossing efficiency--At least as fast Support staff--0.75+ FTE saved

15. Histology – Embedding Target –View critical information about block and specimen –Efficient workflow Block scan: –Embedding instructions –Number of pieces of tissue –Specimen info –(Record timestamps)

16. Histology – Cutting Targets –Present critical information (block, specimen) –Eliminate manual slide labeling –Block/slide verification –Multiple workflows –No clutter –Efficient Touch-screens; no keyboards Block scan: –JIT slide printing/labeling –Info display Slide scan: –Block/slide match

17. Cutting - Benefits Elimination of hand labeling Much faster than manual labeling for blocks with many slides Fewer block/slide mismatches Overall throughput increased ~10%

18. Slide Life Cycle Histology work order completes with scanning Ship Resident review Deliver Faculty signout File Pull for conference Sendouts HistologyPathology Offices

19. Slides – Benefits Less staff time looking for slides Faster to find last location than make a phone call Fewer arguments over whether slides were delivered Fewer recuts? Improved job satisfaction –** Saved me 30 min the first day! ** Overall savings > 2.0 FTE!

20. Slides Benefits FTE Savings FTE Savings Histology +0.5 FTE Reduced time hunting for mis-delivered slides +0.5 FTE Auto completion of outstanding orders when slide is scanned Office staff +.5-1 FTE Reduced time for conference preparation +.25 FTE Increased efficiency regarding send outs

21. Barcodes Enable… Imaging –Gross photos –Photomicrographs –Documents –EM/IF HPV workflow –Reflex testing –Digene/Luminex Specimen management –Discards –Locations Winscribe automation

22. Specimen Discard Workflow –Device scans specimen barcode –Handheld device queries AP-LIS If case signout occurred <2wks prior If case signout occurred >2wks prior If note on Req Data tab, caution light and note display

23. Barcoding Benefits Direct personnel (FTE) –2.0Slide delivery and tracking –0.75 Cassette printing –0.1Specimen discards –0.1Document scanning –TBDFluorescence image import ~$150,000/yr assuming $50,000/FTE

24. Indirect personnel (FTE) –0.5 Scanned consult document availability 1 –TBDScanned Req forms –TBDSlide location info (e.g. Pathologists) Reduced loss of materials –Slide/Block tracking –Specimen discards Barcoding Benefits 1 Schmidt, RA, et al. Am J Clin Pathol 126:678-83, 2006

25. Error Reduction –Elimination of all manual labeling steps! –Reduced labeling errors Specimens Blocks –~988/yr to near 0 –“How did you manage to do that?!” Slides Gross photos Scanned documents Photomicrographs Barcoding Benefits

26. Reasons for Success Optimized workflow –Lean analysis –Close ties to users –Multiple workflows; exception trapping LIS interoperability –Initially with PowerPath; now general Just-in-time production of materials Selection of appropriate equipment

27. Where Next? Specimen transport –Within multiple sites in a large lab –Upstream all the way from the patient Result transport –All the way back to the patient Likely to need multiple systems  Need an industry barcode standard

28. Where Next? Tissue banking (becoming routine) –Unique identifiers (encrypted for research) –Repository management –Maintain provenance –Pre-analytic variables Tissue micro-arrays –Each sample linked back to patient

29. Where Next? Patient- and time-based disease data structures DiagnosisRecurrencePersistent (Time) Patient Links between serial samples of same disease Relation to clinical treatment Correlated blood samples All types of data IHC Cytogenetic Molecular Treatment 1Treatment 2 What does sample tracking mean for molecular testing?

30. Why barcode? Expensive… true, but reasonable ROI Workspaces change… it might be time Process changes… new processes are better Jobs change… but more valuable activity Pathologists affected… in good ways Time investment… pays off! Better lab efficiency Error/liability reduction Inventory control Resident autonomy Gateway to more functions

31. Conclusion Barcoding is becoming an expectation –Patient safety / error reduction It’s to your financial advantage For success, you must be sophisticated enough to know the difference between just putting a barcode on something and having a barcode-driven lab.

32. Acknowledgements Phil Nguyen Kevin Fleming Rosy Changchien Chris Magnusson Victor Tobias General Data Thermo-Fisher Accu-Place Dr. Erin Grimm Dan Luff Steve Rath Pam Selz Kim Simmons All the Techs and Office Folks!

34. Achieved Benefits Marked reduction in labeling errors Improved inventory control (i.e. knowledge of where things are) Direct savings of ~ 3 FTE Indirect savings of >> 0.5 FTE Improved image collection and management (paperwork, gross, micro, EMs, IF, etc) Increased job satisfaction