Lab Quality Confab Process Improvement Institute. New Orleans, LA. John Waugh 11/3/2015

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Implementing a Single Quality Management System Across Multiple Hospitals of the Henry Ford Health System: Combining ISO 15189 with Lean to Deliver More Value Lab Quality Confab Process Improvement Institute New Orleans, LA John Waugh 11/3/2015

Henry Ford Lab Service Locations HENRY FORD HEALTH SYSTEM Pathology & Laboratory Medicine Service Line of Integrated Labs Hub & Spoke Delivery Model 11 million tests/yr 700 staff supporting -5 Acute care hospitals -9 ERs -30 Clinics Core Lab-Academic Hospital & ER Community Hospital & ER Medical Center & ER Medical Center Henry Ford Production System

Integration ONE leadership group Shared Information Systems Integrated Product Line HR Core Laboratory / Rapid Response Standardized Test Methods Shared Capital Process Purchase & acquisitions ONE Quality Management Plan Safety, education & competency Henry Ford Production System

At Henry Ford Health System we are Value Creators who happen to have a Laboratory. Data => Information => Value

Henry Ford Production System World Class Laboratories Culture of Relentless Improvement Staff Taught and Empowered to use Lean

Chemistry Color Coded Bins

The Henry Ford Health System, Henry Ford Production System, 2013 Blood Bank 5 S schedule

The Henry Ford Health System, Henry Ford Production System, 2013 Chemistry

Henry Ford Laboratories Lean Progression Lean Specialist Mandatory 8 hr Lean Education 2 Day Lean Training WBM hospital MAC hospital WAR hospital WYN hospital 2004 2005 2006 2007 2008 2009 2010 2011 2012 Henry Ford Hospital Hospital core and specialty laboratories Surgical Core Labs Lab support 26 Med Cntrs Immuno Cytology Micro biology Blood Bank Henry Ford Production System

Lean Tool Box 5 S Workspace, Visual Controls Capture Defects, Quick Fixes, PDCA, A3s Standard Work Value Stream Mapping Single Piece, Unidirectional Flow Kanbans Eliminating Waste

Create ORGANIZATION CHART for Continuous Improvement How is change authorized and made? Find Your Role Group Leader Group Leader Group Leader Team Leader Team Leader Shared members Team Leader Team Leader Workcell 1 Workcell 2 Workcell 3 Workcell 4 Workcell 5 Silo 1 Silo 2 Silo 3 Team Leader Work Product Customer-Supplier Interaction Henry Ford Production System

Building the Culture Improvement on Meeting Agendas Grand Rounds Jeffrey Liker, PhD Share the Gain, Recognition Part of Performance Management Plans

Two Lean Champions 14

New Target ISO 15189 Accelerators and Brakes Champions, Baldrige Award, Merger ISO Gap Analysis You re Ready... See You in 6 Months

Do I really have to do this? Why, Why, Why, Why, Why

Lean/ISO Quality Systems New Tools to Get to the Next Level. Electronic document control Daily Management system KPI Tracking Internal audit system (peer inspections) Deviation management system feeds kaizen and burn down plan

Controlling Posted Documents 19

Document Control 20

Out of Service 21

If you always do what you always did, you always get what you always got 22

Q T I P S Quality Timeliness Inventory Productivity Safety

The Elimination of Yellow

Target Setting Is 90% a good TARGET? 26

Critical Value Call Target 27

TAT 30 min / 35 min 28

TAT on Thurs/Fri?? 29

ISO 15189 Accreditation 2013 Development System Document Management Coaching System Audit System A policy, procedure, document control Standard Work, Connections, Pathways C Team Leader System Share the Gain Learnings Deviation Management Team Leader Facilitation Identify Defects Non Conformances Ongoing PDCA Continuous Improvement Customer-Supplier Communication at level of work PDCA-A3 Resolution P Daily Resolution Daily Countermeasure D Daily Management Improvement Management

Management Review Deviation Management

$1,000,000,000,000

Mis-ID in DC

$1,000,000,000,000 Never waste a Crisis

Top Concern: Reimbursement What do our Customers Want? Quality Safety Engaged Physicians Healthy Patients

The Politics Protecting Access to Medicare Act 2014 Clin Lab Fee Schedule Re-pricing 2017 10% 2020 15% 2018 10% 2021 15% 2019 10% 2022 15% 75% total

From Data to Information Evidence Based Medicine, HEDIS, MU Decision Driver: Admit, Discharge, Transfer, Take to Surgery, Imaging, Prescribe, Change dose 70-80 % of Decisions Based on Lab Data.at about 3.5% of the of US HC Spend

What if we shut down ALL Laboratories?

THE WAUGH STREET JOURNAL BREAKING NEWS.. LIGHTS OUT!! All USA Labs to Close by Year End Washington: In an unprecedented move today all USA laboratories agreed to close to drive down a jailbreak in US healthcare spending. The change spells an end to all clinical and anatomic pathology testing as we ve known it. This will further simplify claims management. Lab Week will be celebrated only one more time and then the party will truly be over. Experts predict that medical records will become much easier to read without the abundance of data and text. If the grand experiment fails, it is unlikely all Laboratories could re-open within a week or two. SENATORS ASK IF 3.5% CUT IN HEALTH SPEND WILL BE ENOUGH? USA HEALTHCARE SPEND TO DROP 3.5% Per YEAR Washington: In an unprecedented move today all USA laboratories agreed to close to drive down a jailbreak in US healthcare spending. The change spells an end to all clinical and anatomic pathology testing as we ve known it. This will further simplify claims management. Lab Week will be celebrated only one more time and then the party will truly be over, but will it be enough? Waugh: You turn off Laboratories and you turn off Healthcare

Value of the Laboratory How can we take what we uniquely know and create so much VALUE that our organizations could not possibly function without us? Our customers become our greatest advocates.

Pre-analytic Analytic VALUE

Value of the Laboratory The good news.pathology & Lab Uniquely positioned to drive value game changers. Molecular diagnostics: STDs, Resp, IHC stains NGS: Oncology, Pharma Costs, Patient Outcomes MALDI-TOF: LOS, Pharma, Isolation Rooms bed mgt. Antimicrobial Resistance, Blood Stream Infections Blood Product Utilization, Whole slide imaging (Tumor Boards) Medical Laboratory Formularies, Eval of Boutique Tests Automation, Informatics, Lean Methods, Defect Capture

50% Faster ED and In Patient Lab TAT since 2008 90% of ED Stats from 60 min => 30-35 min 95% of Troponin from 70 min => 35 min 90% of Inpatient STATS 90 min => 45 min

58% Faster Microorganism Identification since 2014 Optimize MALDI-TOF Workflow Bacterial IDs 2.2 day => 1 day Yeast IDs 4 days => 1.4 days 33% decrease LOS for Sepsis patients 24/7 Blood Culture monitor w/ Gram Stain

80% Faster Out Pt Lab Test Result Times since 2008 OP TAT from 50% same day Midnight to 90% 98% of testing reported by next 6am (excludes cultures and sendouts)

55% Lab Outreach Growth in 24 Months $2,045,542 Net Revenue Growth

97% Pathology O.R. Order Accuracy Post Epic Error Reduction in First 6 Months (2014)

73% Decreased CLIA Regulatory Defects Four Acute Care Hospitals evaluated Three Inspection Cycles Mock Peer Inspection Teams

64% Reduced Phlebotomy Complaints Wait times Hours of Operation (access) Call Backs / Re-Collects

Lessons Learned Did Well: Locals developed huddle boards Great lessons inside and outside of HC Not so Well: Quick fixes may not be the right fixes Data Capture Tool for Deviation Mgt