ISO 9001:2015 CoxHealth Implementation. Leadership Development Institute December 15, 2016 Arlo Stallion

Transcription

1 ISO 9001:2015 CoxHealth Implementation Leadership Development Institute December 15, 2016 Arlo Stallion

2 Objectives Create better understanding of what ISO 9001 is and is not Brief overview of ISO 9001 & accreditation relationship Launch the CoxHealth ISO 9001 model Define leadership expectations Overview of CoxHealth ISO 9001 requirements in breakout sessions

3 Personal Story

4 ISO 9001 Transformation Don t be intimidated with the unknown Learn everything you can Participate Embrace the challenge Leaders and the organization will both reap the rewards

5 The secret of change is to focus all of your energy, not on fighting the old, but on building the new Socrates

6 Common ISO 9001 Misconceptions ISO 9001 is: A journey not a destination A business management system not a quality initiative, pillar, or a compliance model About continual improvement not perfection Separate from accreditation but required Applicable to all settings not just hospital A framework that provides leadership with the structure and tools to focus on what is important.

7 Accreditation & ISO 9001 Connection NIAHO Hospital Accreditation requires ISO 9001 conformance by the 4 th year. ISO 9001 conformance is a condition of accreditation DNV-GL is our accrediting body and our ISO 9001 Registrar two separate roles. Accreditation requirements are built into the key processes. Enables concurrent assessment of accreditation & ISO 9001 conformance. Accreditation assesses base requirements/industry standards. ISO 9001 assesses business practice performance to meet customer requirements. Highest level of assessment

8 Transformation Path from Accreditation to ISO 9001 Certification Implementation Conformance Certification System Development Planning Continual Improvement NIAHO Accreditation NIAHO Accreditation + ISO Pre-assessment NIAHO Accreditation + ISO Initial Visit Stage 1 NIAHO Reaccreditation + ISO Certification Stage 2 Y 1 Y 2 Y 3 Y 4 YR 1 YR 2 YR 3 YR 4

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10 Customer Requirements ISO 9001 Business Management System Input Resources & Facilities Management Responsibility Delivery of Patient Care Measure & Improvement Output Customer Satisfaction (Value)

11 The ISO 9001 Mantra A Continual Improvement Planning Policies Procedures P Improve it Say what you do C Measurement Analyze results Records & Audit Prove it Do what you say D Deliver care & services

12 Ever Feel Like This?

13 ISO 9001 Creates Alignment Standardization & Enables Integration Working Smarter Studer Baldrige/Magnet Performance Management Baldrige/Magnet Population Health ISO 9001 Business Management System MVV Objectives Integration/Growth

14 ISO 9001 Implementation Team Frank Romero, MD - VPMA Arlo Stallion, System Director Regulatory Affairs Vicki Good, System Director Quality & Patient Safety Tracy Mitchell, System Director Population Health Scott Rogers, System Director Performance Integration & Innovation Jim Brown, System Director Health Care Analytics Gina Ellerbee, System Director Clinical Education Shawn Snider, System Director Radiology Shelly Hillhouse, PI Manager Ad Hoc Leaders

15 PLAN DO CHECK ACT 4 Context 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance & evaluation 10 Improvement ISO 9001: Understanding Context 4.2 Interested Parties 4.3 Scope 4.4 QMS 5.1 Leadership & Commitment 5.2 Quality Policy 5.3 Organizational roles, responsibilities, & authorities 6.1 Actions to address risks & opportunities 6.2 Quality objectives & planning 6.3 Planning of change 7.1 Resources People Infrastructure Environment for operation of processes Monitoring & measuring resources Organizational Knowledge 7.2 Competence 8.1 Operational Planning & control 8.2 Requirements for products & services 8.3 Design & Development 8.4 Control of externally provided products & services 8.5 Production & service provision 9.1 Monitoring, measurement, analysis, & evaluation Customer Satisfaction Analysis & evaluation 9.2 Internal Audit 9.3 Management Review 10.1 General 10.2 Nonconformity & corrective action 10.3 Continual Improvement 7.3 Awareness 7.4 Communication 7.5 Documented Information 8.6 Release of products & services 8.7 Control of nonconforming products & services Act Check Plan Do

16 ISO 9001 Gap Analysis Painful essential first step ISO 9001 Clause 3/ /2016 4: Quality Management System 37.5% 84% Top Priorities 5: Management Responsibility 54.2% 69% 6: Resource Management 91.6% 91.6% 7: Product Realization (Healthcare delivery) 94.4% 94.4% 8: Measurement, Analysis, Improvement 68.8% 77.7% 2015 Transition clauses 70% 72.5% Total Conformance 71% 83%

17 National Networking ISO 9001 Certified Sentara Healthcare - Virginia Advocate Health Care - Chicago Lee Memorial Health System - Florida Florida Hospital Houston Methodist

18 CoxHealth Business Management System Quality Policy Mission/Vision/Values Quality is the ability to deliver, through a consistent and efficient system, healthcare that meets or exceeds the customer s rational value expectations. Commitment Statement CoxHealth aims to enhance customer value through the effective application of the Business Management System, including processes for continual improvement and the assurance of conformity to customer, statutory, & regulatory requirements.

19 Strategic Direction Our Patient Create one Patient Experience CoxHealth Key Strategies Coordinating Care & Reducing per Capita Cost Attract, Grow, & Retain Talent Blanket our Region with appropriate services In the right places Top Decile in Patient Experience CoxHealth Operational Objectives and Goals Top Decile in Employee Satisfaction Top Decile in Quality & Safety Outcomes Top Decile in Financial Metrics Top Decile in Employee Giving Mission, Vision, Values

20 Functional Integration Hospital Management Review Structure CoxHealth Parent Board System CMC Board Board Quality & Safety System Management Review Medical Executive Committee Communication Q & S issues Medical Center Management Review Administration Entity Medical Staff Issues Medical Staff Clinical Operations QMS Monitoring & Improvement Activities Support Operations

21 Safe Customer Requirements = Inputs S T Timely E Effective Output = Customer Value E Efficient Quality Service P Patient Centered E Equitable Cost

22 Key Management Processes Management Review Top Management System level & Entity Level Planning Strategic, Financial, & Business Planning Revenue Cycle Measurement Analysis Improvement Registration, billing, collections, accounting, billing & audit HCA, Quality, CQI, audits, Regulatory, Patient Safety, Innovation, PI

23 Core Operational Processes Cycle of care is continuous Patient Centered Designed for all healthcare delivery systems Emergency Inpatient Outpatient Post acute care Ambulatory

24 Key Support Processes Develop & Manage Care Force Manage Information Manage Supplies, materials, & products Environmental Health & Safety Manage Facilities Manage Equipment Employees, Volunteers, Students, Contracted, Medical Staff, Training and Development EMR, Information Technology, HIPAA, Communication, Customer Service, Health Information Management Materials Management, Blood Products, Medications, Food Services, Sterilization, Linen Employee Safety (OSHA), Emergency Management, Hazardous Materials, Radiation Safety, Security, Employee Health, Infection Prevention Engineering, Utilities, Construction, Maintenance, Environmental Services Medical Equipment, Imaging Equipment, Laboratory

25 Customer Requirements Safe, Timely, Effective, Efficient, Equitable, Patient Centered Business Management System Key Process Interaction Mission Improve the health of the communities we serve through quality health care, education, & research Vision: To be the best for those who need us Values: safety, compassion, respect, integrity Management Review Core Operational Processes Planning Revenue Cycle Key Management Processes Measurement Analysis & Improvement Inputs Outputs Customer Value Quality, Service, Cost Key Support Processes Develop/Mgt Careforce Manage Information Manage Supplies, Materials, Product Environmental Health & Safety Manage Facilities Manage Equipment

26 Process Approach Matrix Management

27 Plan & Manage Process Change Change is carried out in a planned manner Consider purpose and potential consequences Impacts to the business management system Availability of resources Allocation and reallocation of responsibilities Changing knowledge needs Control both planned and unintended change

28 Hours/days days/weeks months months years Planning & Controlling Change Significance of planning & control Long Range objectives Planning Medium determine resources Control Short Range interventions to control deviations from the plan to still meet requirements Examples: Triage system, scheduling

29 ISO 9001 Expected Results Customer focus enables meeting customer needs Create consistency and greater efficiencies Process standardization and integration Leader and employee engagement Sustainability in an uncertain environment Continual improvement to be the best for those who need us

30 ISO 9000: Leadership Statement Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization s objectives. Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes, and resources to achieve its objectives.

31 Leadership Expectations You are the key ingredient to success Active participation Develop an understanding of the need to move from a department or entity mindset to a system Embrace the process approach to management and continual improvement Communicate, communicate, communicate

32 Leadership Commitment Excellence does not happen by accident It requires a well thought-out, well communicated plan that is embraced by everyone. Join us on this journey to excellence

33 Questions