1. March 19, 2015 Health IT Implementation, Usability and Safety Workgroup David Bates, chair Larry Wolf, co-chair

2. Workgroup Members David W. Bates, Brigham and Women’s Hospital (Chair) Larry Wolf, Kindred Healthcare (Co-Chair) Joan Ash, Oregon Health & Science University Janey Barnes, User-View Inc. John Berneike, St. Mark's Family Medicine Bernadette Capili, New York University Michelle Dougherty, American Health Information Management Association Paul Egerman, Software Entrepreneur Terry Fairbanks, Emergency Physician Tejal Gandhi, National Patient Safety Foundation George Hernandez, ICLOPS Robert Jarrin, Qualcomm Incorporated Mike Lardieri, North Shore-LIJ Health System Bennett Lauber, The Usability People LLC Alisa Ray, Certification Commission for Healthcare Information Technology Steven Stack, American Medical Association Mickey McGlynn, Cerner Ex Officio Members Svetlana Lowry, National Institute of Standards and Technology Megan Sawchuck, Centers for Disease Control and Prevention Jeanie Scott, Department of Veterans Affairs Jon White, Agency for Healthcare Research and Quality-Health and Human Services ONC Staff Ellen Makar, (Lead WG Staff) 2

3. HIT Implementation, Usability and Safety Draft Workplan MeetingsTask March 19, 2015 9:00-11:00am ET A View of Health IT Quality Systems March 26, 2015 11:30am-1:30pm ET Comment on Certification NPRM (anticipated date for planning purposes) April 3, 2015 2:30-4:30pm ET Comment on Certification NPRM (anticipated date for planning purposes) April 21, 2015 12:00-2:00pm ET Comment on Certification NPRM (anticipated date for planning purposes) May 1, 2015 2:30-4:30pm ET Finalize NPRM Comments (anticipated date for planning purposes) May 11, 2015 11:30am-1:30pm ET RTI report out on the Safety Center Road Map May 12, 2015 – HITPC Meeting Certification NPRM Comments to the HITPC (anticipated date for planning purposes)

4. Agenda Objective: A View of Health IT Quality Systems 9:00 a.m.Call to Order/Roll Call Michelle Consolazio, Office of the National Coordinator 9:05 a.m.Framing Remarks David Bates, chair Larry Wolf, co-chair 9:15 a.m.McKesson and CMMI Institute Overview of Health IT Quality Systems Michael Marchlik, McKesson Kirk Botula, CMMI Institute 9:50 a.m. Group Discussion 10:45 a.m. Public Comment 11:00 a.m. Adjourn 4

5. 2014 Edition Certification Criteria: Quality Management System §170.314(g)(4) Quality management system. For each capability that an EHR technology includes and for which that capability's certification is sought, the use of a Quality Management System (QMS) in the development, testing, implementation and maintenance of that capability must be identified. – (i) If a single QMS was used for applicable capabilities, it would only need to be identified once. – (ii) If different QMS were applied to specific capabilities, each QMS applied would need to be identified. This would include the application of a QMS to some capabilities and none to others. – (iii) If no QMS was applied to all applicable capabilities such a response is acceptable to satisfy this certification criterion. Test procedure: http://www.healthit.gov/sites/default/files/170.314g4qms_2014_t p_approvedv1.2.pdf http://www.healthit.gov/sites/default/files/170.314g4qms_2014_t p_approvedv1.2.pdf 5

6. Health IT Quality Systems 3/19/2015 McKesson Corporation Confidential and Proprietary 6 Mike Marchlik, McKesson Kirk Botula, CMMI Institute

7. Overview of McKesson Business McKesson Quality Systems CMMI Framework Agenda 3/19/2015 McKesson Corporation Confidential and Proprietary 7

8. Solutions and Leadership Across Healthcare 1 based on 50K US pharmacies Payer & Financial Solutions Payment Automation & Value-Based Reimbursement Clinical Decision Support Health Plan Payment Management Financial Connectivity & Provider Applications Connected Care & Analytics Connectivity & Value-Based Care Pharmacy Network Health Information Exchange Population, Risk & Financial Analytics Physician Services Physician Practices & Evolving Risk Models Risk Management Revenue Cycle Outsourcing Practice Management Services Health System Software Health System Efficiency & Clinical Quality EHR Diagnostic Imaging Revenue Cycle Software 2 HIMSS Analytics 2014 #1#1 Medical Necessity / Utilization Mgmt Workforce Analytics 2 Pharmacy Network 1 Physician Services Physician Revenue Cycle Outsourcing In U.S. PACS #1#1 #1#1 #1#1 #2#2 #1#1 NO. 2 Provider Revenue Cycle Capacity and 3/19/2015 McKesson Corporation Confidential and Proprietary 8

9. Medical Device Software 21 CFR 820 ISO 13485 ISO 14971 Clinical Software MTS Quality System (ISO 9001) IEEE Stds. Administrative Software URAC IEEE Stds 3/19/2015 McKesson Corporation Confidential and Proprietary 9 McKesson Quality Systems CMMI – Development CMMI – Services SCP Standards MTS GA Process

10. 3/19/2015 McKesson Corporation Confidential and Proprietary 10 The MTS Quality Management System

11. Quality Management System IEEE 1042 Guide to Software Configuration Management IEEE 730 Standard for Software Quality Assurance Plans IEEE 1028 Standard for Software Reviews IEEE 1061 Standard for a Software Quality Metrics Methodology IEEE 1074 Standard for Developing Software Life Cycle Processes IEEE 1220 Standard for the Application and Management of the Systems Engineering Process IEEE 1490 A Guide to the Project Management Body of Knowledge IEEE 1498 Interim Standard for Information Technology-Software Life Cycle Processes-Software Development: Acquirer-Supplier Agreement IEEE 1540 Standard for Software Life Cycle Processes-Risk Management Management Responsibility IEEE 730 Standard for Software Quality Assurance Plans IEEE 830 Recommended Practice for Software Requirements Specifications IEEE 1028 Standard for Software Reviews IEEE 1058 Standard for Software Project Management Plans IEEE 1061 Standard for a Software Quality Metrics Methodology IEEE 1220 Standard for the Application and Management of the Systems Engineering Process IEEE 1490 A Guide to the Project Management Body of Knowledge IEEE 15939 Software Measurement Process Product Realization IEEE 1042 Guide to Software Configuration Management IEEE 730 Standard for Software Quality Assurance Plans IEEE 828 Standard for Software Configuration Management Plans IEEE 829 Standard for Software Test Documentation IEEE 830 Recommended Practice for Software Requirements Specifications IEEE 1008 Standard for Software Unit Testing IEEE 1012 Standard for Software Verification and Validation IEEE 1016 Recommended Practice for Software Design Descriptions IEEE 1028 Standard for Software Reviews IEEE 1058 Standard for Software Project Management Plans IEEE 1061 Standard for a Software Quality Metrics Methodology IEEE 1062 Recommended Practice for Software Acquisition IEEE 1063 Standard for Software User Documentation IEEE 1074 Standard for Developing Software Life Cycle Processes IEEE 1175 Standard Reference Model for Computing System Tool Interconnections IEEE 1175.1 Guide for CA Software Engineering Tool Interconnections- Classification and Description IEEE 1219 Standard for Software Maintenance IEEE 1220 Standard for the Application and Management of the Systems Engineering Process IEEE 1233 Guide for Developing System Requirements Specifications IEEE 1320.1 Standard for Functional Modeling Language-Syntax and Semantics for IDEFO IEEE 1320.2 Standard for Conceptual Modeling Language Syntax and Semantics for IDEFIX 97 (IDEF object) IEEE 1362 Guide for Information Technology-System Definition-Concept of Operations (ConOps) Document IEEE 1420.1 Standard for Information Technology-Software Reuse IEEE 1465 lnformation Technology-Software Packages-Quality Requirements and Testing IEEE 1471 Recommended Practice for Architectural Description of Software Intensive Systems IEEE 1498 Interim Standard for Information Technology-Software Life Cycle Processes-Software Development: Acquirer-Supplier Agreement IEEE 1517 Standard for Information Technology-Software Life Cycle Processes-Reuse Processes IEEE 1540 Standard for Software Life Cycle Processes-Risk Management IEEE 15939 Software Measurement Process Measurement, Analysis and Improvement IEEE 730 Standard for Software Quality Assurance Plans IEEE 982.1-1988 Standard Dictionary of Measures to Produce Reliable Software IEEE 1028 Standard for Software Reviews IEEE 1044 Standard Classification for Software Anomalies IEEE 1045 Standard for Software Productivity Metrics IEEE 1061 Standard for a Software Quality Metrics Methodology IEEE 1465 lnformation Technology-Software Packages-Quality Requirements and Testing IEEE 1490 A Guide to the Project Management Body of Knowledge IEEE 1540 Standard for Software Life Cycle Processes-Risk Management IEEE 15939 Software Measurement Process 3/19/2015 McKesson Corporation Confidential and Proprietary 11 There are over 30 domain specific IEEE Standards that map to ISO 9001

12. CMMI FDA Part 820 CMMI and Medical Device Regulations Overlap CMMI Provides direct support for ~67% of the FDA regulations (21 CFR part 820) 80% support / overlap with IEC 62304…60% for ISO 14971 12 CMMI Level 2ML3ML 4 & 5 ISO 14971 IEC 62304 34%62% 67% 3/19/2015 McKesson Corporation Confidential and Proprietary 12

13. McKesson Corporation Confidential and Proprietary 13 McKesson Enterprise Quality Improvement Corporate Quality Programs CMMIFDA SCP MTS MDS 3/19/2015

14. Reduction in defects >40% On-time completion increased by 60% 50% reduction in production support FTEs needed (priority defects reduced to 0%) 100% critical milestones met since CMMI adoption (5yrs prior) KLAS ranking rose from 6 to 1, remains in top 3 since CMMI achievement McKesson Corporation Confidential and Proprietary 14 CMMI at McKesson: Sample Program Results 3/19/2015

15.  An existing, proven, objective, industry standard representation of mature and capable processes, recognized as a quality indicator world-wide  Used to asses capability of processes for systems development and services deployment (e.g. implementation practices)  Incorporates a formal methodology for benchmarking process quality against businesses world-wide, and publishes quality achievement in freely-accessible website  Flexible for use on any business and/or process method (e.g. equally applicable for electronic medical records products as it is for decision support systems)  Describes an evolutionary improvement path from ad hoc, immature processes to disciplined, mature processes McKesson Corporation Confidential and Proprietary 15 CMMI Value Proposition 3/19/2015

16. March 2015 Kirk Botula, CEO

17. McKinsey & Company defines capability as: 17 What Are Capabilities? “anything an organization does well that drives meaningful business results.” Source: “Building Organizational Capability”, McKinsey Global Survey Results, March 2010;

18. CMMI Institute leverages over 30 years of ongoing work at Carnegie Mellon University by: Members of industry Members of government The Software Engineering Institute, a research facility funded by the U.S. federal governmen t This work established the Capability Maturity Model Integration (CMMI) ®, a capability improvement framework that guides organizations in high-performance operations. What is CMMI Institute? 18

19. CMMI Institute is a center for the research and advancement of the state of the practice of capability improvement for industry. It is the result of more than 20 years of ongoing work at Carnegie Mellon University by members of industry, government, and the Software Engineering Institute, a federally funded research and development center. CMMI offers a performance-improvement framework for helping organizations implement best practices across eight key capability areas: Project and Work Management People Management Service Delivery and Management Process Management Supporting Infrastructure Product Engineering and Development Supplier Management Data Management What does CMMI Institute offer? 19

20. -Defects -Cost -Time -Risk -Quality -Time to Market -Customer Satisfaction -Performance CMMI The Value of Mature Capabilities 20

21. Improved Quality Well-defined processes limit opportunities for error. Smart supplier management ensures quality results. Strategic people management empowers team members to develop skills that will help the organization succeed. 21 Tufts Associated Health Plans decreased software defects by 25%.

22. Decreased Costs and Enhanced Productivity Streamlined processes allow teams to integrate and collaborate more efficiently. Standardized project management practices reduce redundancy and waste. Identifying skill gaps helps beak down workflow bottlenecks. 22 General Dynamics reduced maintenance staff costs by 64% while doubling the size of the organization.

23. Higher Customer Satisfaction Service delivery strategies strengthen weak customer touch points. Effective product development instills customer confidence. Project management practices help teams meet and manage customer expectations. 23 Siemens increased their customer satisfaction index an average of 42% in three technical areas.

24. Improved On-Time Delivery Field-tested project management standards keep work on schedule. Clear development processes reduce scope creep and deadline extensions. Careful vendor management mitigates supplier delays. 24 JPMorgan Chase reduced average slippage of project delivery dates by 70-80%.

25. 25 The Global Impact of CMMI Over 10,000 organizations 101 countries 12 national governments 10 languages 500 partners 1,600+ appraisals in 2014

26. 26

27. CMMI Healthcare

28. Learn more about CMMI’s eight key capability areas at cmmiinstitute.com/capability-areas. cmmiinstitute.com/capability-areas Sign up to take a free online capability assessment at www.AssessYourCapability.com. www.AssessYourCapability.com Empower your employees to earn CMMI certifications that boost business results at cmmiinstitute.com/certifications. cmmiinstitute.com/certifications Help your people develop skills that will drive the organization’s success. Find courses at http://cmmiinstitute.com/training/http://cmmiinstitute.com/training/ Explore CMMI’s organizational frameworks –CMMI For Development (CMMI-DEV model)(CMMI-DEV model) –CMMI For Acquisition (CMMI-ACQ model)(CMMI-ACQ model) –CMMI For Services (CMMI-SVC model)(CMMI-SVC model) –People Capability Maturity Model (People CMM)(People CMM) –Data Management Maturity Model (DMM)(DMM) Learn More 28

29. Thank You

30. Group Discussion 30

31. Next Meeting: Thursday, March 26, 2015 11:30 AM-1:30 PM Eastern Time 31