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The Barcode-Driven Lab: Success in a Large System Rodney Schmidt, MD, PhD

University of Washington, Seattle April 17, 2011 Foundation.cap.org v. #

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?

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.

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?!

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

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

Material identification (2005)

• Handwritten specimen labels • Manual, off line cassette labeling • Hand-written slide labels

Primary labeling errors (2004)

1000 900 800 700 600 500 400 300 200 100 0 Blocks ?

Slides

Recorded Actual

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!

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)

Accession specimens

Classic Grossing Workflow

Label specimens

Label

cassettes

Group

with specimens

Move

to staging area * * *

Move

to gross bench

Lay out

cassettes

Fill

cassettes

Request

more cassettes * *

Store

excess with specs

Rack

filled cassettes

Reconcile

with LIS *

Transport

for processing *

Handling steps

Possible errors * QA steps

Accession specimens Bar-code specimens

Just-in-Time Printing

Fewer handling steps Fewer (1) error opportunities Scan/print cassettes

Lay out

cassettes

Fill

cassettes

Rescan

* * cassettes Fewer QA processes

Rack

filled cassettes *

Transport

for processing *

Courtesy General Data

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

Handling steps Error opportunities Manual QA steps Primary labeling errors Cassette wastage Grossing efficiency Support staff

Q&E Benefits

9 7 “Classic” 11 988/yr (est.); (1.2%) ~25/d (~7%) - - 1 4 “Just-in-Time” 5 2 in 3 mo (initial); 0 in next 7 mo; (0.003%) ~0 At least as fast 0.75+ FTE saved

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)

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

Cutting - Benefits

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

Histology

Slide Life Cycle

Pathology Offices Sendouts Faculty signout Histology work order completes with scanning Pull for conference Ship File Resident review Deliver

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!

Slides Benefits FTE Savings

Histology

+0.5 FTE +0.5 FTE Reduced time hunting for mis-delivered slides 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

Barcodes Enable…

• Imaging – Gross photos – Photomicrographs – Documents – EM/IF • Specimen management – Discards – Locations • Winscribe automation • HPV workflow – Reflex testing – Digene/Luminex

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

Barcoding Benefits

• Direct personnel (FTE) – 2.0

Slide delivery and tracking – 0.75 Cassette printing – 0.1

Specimen discards – 0.1

Document scanning – TBD Fluorescence image import ~$150,000/yr assuming $50,000/FTE

Barcoding Benefits

• Indirect personnel (FTE) – 0.5 Scanned consult document availability 1 – TBD Scanned Req forms – TBD Slide location info (e.g. Pathologists) • Reduced loss of materials – Slide/Block tracking – Specimen discards

1 Schmidt, RA, et al. Am J Clin Pathol 126:678-83, 2006

Barcoding Benefits

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

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

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

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

Where Next?

Patient- and time-based disease data structures (Time)

Treatment 1 Treatment 2

Patient

Diagnosis Persistent Recurrence

•Links between serial samples of same disease •Relation to clinical treatment •Correlated blood samples All types of data •IHC •Cytogenetic •Molecular What does sample tracking mean for molecular testing?

Why barcode?

Expensive Workspaces change Process changes Jobs change Pathologists affected Time investment … true, but reasonable ROI … it might be time … new processes are better … but more valuable activity … in good ways … pays off!

Better lab efficiency Error/liability reduction Inventory control Resident autonomy Gateway to more functions

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.

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!

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