Intersection of LEAN and the LIS. Megan Schmidt. Product Manager, Sunquest Information Systems, Inc. Patrick O Sullivan

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Intersection of LEAN and the LIS Megan Schmidt Product Manager, Sunquest Information Systems, Inc. Patrick O Sullivan Laboratory Director, Florida Hospital Orlando Agenda Manufacturing Mindset LEAN Principles in the Lab Six Sigma Methodology Role of LIS in DMAIC LEAN Redesign at Florida Hospital Focus Areas and Tools Used Process and Software Utilized Results Improvement metrics Controls in place Advice for those just embarking on LEAN in the Lab

A Manufacturing Mindset in the Lab LEAN Principles Laboratory Medicine faces production pressure Increase in lab tests with age and aging population are leading to expected increase in number of tests performed per year (increasing demand) Coincides with a decrease in the number of technologists in the field average med tech age is +50 and retirements expected. Meanwhile, less techs coming on board (decreasing supply) Labs will be tasked with managing workflow shortages while growing business and maintaining TAT Efficient processes and automation are needed to meet the demand with less resources A Robust Workflow Excellence Solution is Key to Ensuring Reliable Collection and Management of Lab Data Lab Tests Per Person Per Year (1) Utilization of lab tests increases dramatically for 65+ year old people 80 million baby boomers today are rapidly advancing into this age cohort Number of Medical Technologist Programs (2) The U.S. is graduating 30% fewer lab practitioners than 10 years ago and 50% fewer than 20 years ago (3) Shortage of medical lab personnel demonstrates an urgent need for continued improvement in workflow automation National Healthcare Expenditure as % of GDP (4) Rising U.S. healthcare costs continue to put pressure on hospitals to: Maximize efficiency by increasing adoption of automation Improve the quality of care in order to hold down overall healthcare costs (1) Source: Opening keynote at the Executive War College, April 2010, by Robert Michel. (2) Source: National Accrediting Agency for Clinical Laboratory Sciences. (3) Source: American Society for Clinical Pathology. (4) Source: CMS.

An efficient laboratory workflow is critical Order Specimen Collection Accessioning and Planning Analysis Results and Reporting Clinical Workflow? Or manufacturing workflow that delivers a clinical product? High volume environment Quality must be maintained High degree of accuracy required Repeatable process desired Manufacturing Mentality LEAN Identify and reduce waste Eliminate non-value added activities Improve responsiveness to the customer, adding value Reengineering labs to optimize workflow SI SIGMA Methodology of Continuous Improvement Reduce Cost of Poor Quality Elimination of Defects Minimize Variation DMAIC: Define, measure, analyze, improve, control

When to do a workflow Assessment Considering Work force reductions Issues with TAT, ED Issues with lost, missing or delayed samples Implementing or removing an automated line New hospital adding on Collection Management systems Growing Outreach LEAN Principles Eliminate Non-value added activities Demand fluctuations Cross-train, plan shifts to peak demand Real time operational metrics Waste-aware workforce with visibility to metrics

Typical Sources of Waste Performance Management Identify Trends and Proactively Address Data driven decisions Increase organizational transparency Increase patient safety Accurate diagnostic KPI tracking Real-time alerts

Engage all levels of the organization Continuous Improvement in the Lab Six Sigma Methodology: DMAIC Define, measure, analyze, improve, control

Define Determine which HID to run sample No Sample sent to HID 2 Resulted If an Add-on Lab able to locate sample Yes Placed on Line Measure Average TAT per test (mins) Specimen Collects Number of specimen collects per day Time spent relabeling Number of labeling errors Number and cost of adverse events due to mislabeling Processing Time spent receiving Time spent routing specimens in the lab - per specimen (mins) Add-ons # of add-ons needed per day Time spent looking for existing specimen (mins) # of misplaced specimens per day Time spent looking for specimens (mins)

Analyze Determine which HID to run sample No Sample sent to HID 2 Resulted If an Add-on Lab able to locate sample Yes Placed on Line Non-value added Opportunity for error Wasted time Implement changes Integrated Collection Manager Print instrument-ready labels at bedside Receive immediate alert on hand-held for add-on orders Lab Automation Integrate Robotic Lines to automatically receive and process Specimen Routing Tracking LIS determines HID, lab and spot to route the sample Track the location of any specimen at any time anywhere in the lab or enterprise Advanced Accessioning Enable system to use a foreign barcode for outside samples

Improve - New Process If an add-on, Lab located sample with LIS tracking LIS routes sample to correct analyzer in correct HID Placed on Line, where it is received into LIS Result Efficiencies Handling an outside specimen reduced from 5 minutes to 1 minute. 50,000 outside samples a month = annual benefit over one million dollars. Quality LIS tracking functionality reduced misplaced specimens from 10 a day to 0, Eliminated 25 minutes per misplaced specimen previously required to find them Turn Around Time Route optimization resulted in 30% reduction in turnaround times for lab tests Added over 40% more capacity as a result, while actually reducing FTE Control Specimen Management Pre-planning instructions for specimen processing and routing Business Intelligence and Analytics

LEAN at Florida Hospital Improved Process and Turn Around Times Florida Hospital Orlando Part of a 7 hospital system in Central Florida FH Orlando >1,000 beds Core Lab Specialty Laboratories: Micro, Histology, Serology, Infectious Disease, Molecular Diagnostics

Lean Journey Why? Unacceptable TAT s Major Chemistry, Order to Collect 70 80 minutes Hematology, 50 60 minutes Separate laboratories for Processing, Hematology and Chemistry Label driven process in phlebotomy Lean Journey Areas of Focus IP Stat TAT Processing Chemistry Hematology Blood Collection

AM Lab Completion (Orlando) % Complete 120.0 100.0 80.0 60.0 40.0 20.0 0.0 4/18/2004 4/19/2004 4/20/2004 4/21/2004 4/22/2004 4/23/2004 4/24/2004 % Rslt to 0500 % Rslt to 0600 % Rslt to 0700 % Rslt to 0800 % Rslt to 0900 % Rslt to 1000 ED TAT Collect to Result Orlando 120 100 Minutes 80 60 40 April May 20 0 APTT BMETPN BNP CKMB HEMGPD PT TROPOI IP Stat TAT Order to Result Orlando 90 80 70 60 Minutes 50 40 30 20 10 April May 0 APTT BMETPN CKMB GLU HEMGP HH K PT TROPOI

Lean Journey Tools Process Flow Mapping (Order to Machine) Phlebotomy Processing Spaghetti diagrams Video Taping Product 5S and standard workstation Standard Work Florida Hospital Core Lab Future State

Tentative Core Lab Layout Heme Review Diff Verify Slide Tube CVIS Instr. Rack Hema Verify Sample To Mach. Bench Fridge Chem. Tube Coag. CVIS Centrif. Chem. COAG Mach. Rack Mach s Chem. COAG Verify Splits Manual Bench Urine Tube OER Pour & Split Analyzer Verify Trash Florida Hospital Orlando Lab Future State July 2004 Other Dept. s 2 nd Analyzer Verify Trash Lean Journey Tools LEAN Identify and reduce waste Eliminate non-value added activities Improve responsiveness to the customer, adding value Reengineering labs to optimize workflow SI SIGMA Methodology of Continuous Improvement Reduce Cost of Poor Quality Elimination of Defects Minimize Variation DMAIC: Define, measure, analyze, improve, control

Lean Journey Focus Phlebotomy Reduce waste in wait time process Keep phlebotomist on the floor and eliminate Transport delays (people and label processes) Solutions Electronic collection System Real time information to phlebotomist, eliminate walking to lab to get labels/orders Maximize tube system to deliver sample Utilize Single piece Work Flow Positive Patient ID Bedside Label Printing

Single piece workflow example Collect Process Test Collect Process Test Last work completed in 13 minutes 10 20 30 Time 10 20 30 Time Last work completed in 30 minutes First work completed in 3 minutes Results Stat TAT

Results Productivity Results - Errors

Lean Journey Focus Processing Reduce Waste, motion and tube wait time Accelerate tube processing and loading of analyzers. Not in scope : Instrumentation Autoverification already being utilized Solutions Move Processing to Central area Remove walls and create core lab to contain Processing, Chemistry and Hematology Staff to meet workload demand Staffing vs. Specimens Received Saturday, April 3, 2004 # of Specimens Recieved 400 350 300 250 200 150 100 50 0 1 2 3 4 5 6 7 8 9 101112131415161718192021222324 Time 16 14 12 10 8 6 4 2 0 Staffing VOLUME STAFFING # of Specimens Recieved 400 350 300 250 200 150 100 50 0 Staffing vs. Specimens Received Wecdnesday, April 14 1 2 3 4 5 6 7 8 9 101112 131415161718192021222324 Time 16 14 12 10 8 6 4 2 0 Staffing VOLUME STAFFING

Travel Distance Before After Improve Chem 154 22 86% Hem 105 21 80% Micro 235 30 87% Serology 179 80 55% Original Layout Chemistry Hematology Receiving Phlebotomy Serology Travel Distance Chem Heme Serology Micro New Layout Automated Cell for Chemistry Main Lab Cell for Hematology Receiving Chemistry Hematology Receiving Manual Chemistry Supervisors Instructor Tube Systems Serology Send-out/PKU Phlebotomy Bone Marrow Serology Manual Chemistry

Additional tools needed Collection Manager Keep phlebotomist on floors To receive or not? Real time feedback Daily reports AM TAT STAT IP TAT ED TAT Close but not quite there Additional Tools & Tasks Enhanced front end automation Tecan FE500 to Beckman power processor Container tracking and post analytical storage tracking Real time monitoring Utilizing automation to receive samples Collection managers already have collector and collection time Visual Clues

New Tools Enhanced Autoverification Normal Values Non critical values Criteria based Instrument flags Delta failures Automated Storage Real time location information New Tools, New Processes Automated Storage Real time location information Automated Retrieval and rerun capabilities

Continued Monitoring (DMAI C ) 2011 Scorecard Laboratory - Orlando 2010 Actual Key Performance Indicators Goal 2011 Jan 2011 Feb 2011 Mar 2011 Apr 2011 May 2011 June 2011 July 2011 Aug 2011 Sept 2011 Oct 2011 Nov 2011 Dec 2011 Avg. Year to Date TEAM 12.1% *Overall Separation 15.5% 11.7% 11.4% 13.9% 13.8% 12.5% 12.8% 12.8% 13.6% SERVICE 27.5 ED Stat TAT Receipt to Result (Avg Min) <30 27.7 28.9 28.9 28.7 28.2 27.2 25.5 24.9 90.3% AM Lab Completion by 0630 >90% 89.0% 86.9% 84.6% 88.1% 87.7% 87.3% 90.7% 90.4% 82.1% IP STAT TAT (order to result in 120 minutes) >80% 80.9% 79.0% 80.9% 82.3% 79.1% 80.2% 81.8% 80.2% CLINICAL 79% Brain Attack Lab TAT (order to result in 45 min) >80% 100% 83% 79% 80% 95% 90% 2.39% Campus Blood Culture Contamination Rate <2.75% 1.91% 1.80% 1.66% 1.73% 1.70% 1.82% 1.91% 1.95% MARKET FINANCE 100.6% First Look Productivity Index 100% 103.7% 102.8% 99.2% 99.1% 96.4% 97.1% 100.7% 100.3% If I had to do it again Do a piece at a time in rapid succession Maybe?? Is big bang a better way? Chose tools based on the desired new processes Continue to leverage automation and reduce hands on time and chances for error

Florida Hospital Orlando Laboratory Innovation for better patient care Pre and post analytical Automation with chemistry analysis First Integrated system in the US 4 th Generation Automated Blood Bank Testing First in US Robotic Specimen Delivery DNA Sequencing Detecting bone marrow transplant chimerism Electronic Positive Patient ID