1. VHA - OCCC VHA ISO 9001 Implementation Initiative and Synergy with Baldrige Criteria Washington, DC October 2010 Christopher LoGrasso MCPM, PMP, CMQOE, Regional Director for the National Office of Clinical Consultation and Compliance 1

2. VHA - OCCC 2 “You can’t have healthy patients without having healthy healthcare systems” –Robert L. Jesse, MD, PhD

3. VHA - OCCC ISO 9001 as the Foundation 3 Excellence Baldrige Criteria Efficiency Systems Redesign Effectiveness ISO 9001 QMS Regulatory Compliance

4. VHA - OCCC Baldrige Criteria and Known Performance Benefits The Baldrige Criteria provide an integrated, results- oriented framework for designing, implementing, and assessing the management of all operations –Leadership –Strategic planning –Customer Focus –Measurement, Analysis, and Knowledge Management –Workforce Focus –Process Management –Results 4

5. VHA - OCCC ISO 9001 Background The International Organization for Standardization (ISO) –ISO, founded in 1947, is a non-governmental, non-profit organization based in Geneva, Switzerland –ISO’s mission is to promote the development of standardization for related activities in the world ISO 9000 Family of Quality Management System (QMS) Standards –ISO 9000:2005 – Fundamentals and Vocabulary –ISO 9001:2008 – Requirements (subject for audit) –ISO 9004:2009 – Guidelines for Performance Improvements 5

6. VHA - OCCC Constructs of ISO 9001 Plan – Do – Check – Act Quality Management Principles –Customer Focus –Leadership –People Involvement –Process Approach –System Approach to Management –Continual Improvement –Factual Approach to Decision Making –Mutually Beneficial Supplier Relationship 6

7. VHA - OCCC ISO 9001 QMS Structure Clause 4 – Quality Management System (QMS) –Process Management, Documentation, and Records Clause 5 – Management Responsibility –Policy, Objectives, Planning, Responsibility and Authority, Documentation, Communications, and Management Review Clause 6 – Resource Management –Human Resources, Infrastructure, and Work Environment Clause 7 – Product Realization –Customer Requirements, Design, Purchasing, Production and Service Operations, and Calibrations Clause 8 – Measurement, Analysis and Improvement –Audit, Satisfaction, Inspection and Testing, Nonconformity, Corrective and Preventive Action, and Continuous Improvement 7

8. VHA - OCCC ISO 9001 and Healthcare Why is healthcare embracing ISO9001? –Healthcare organizations recognize the value of a system that combines all criteria for management including: Business Management Compliance Management Quality Management –Physicians’ Clinic of Iowa (PCI) and the U.S. Department of State Medical Services (MED) CURRENT NEW SYSTEM Copyright © 2010 ISO Consultants for Healthcare, LLC 8

9. VHA - OCCC Synergy Between ISO 9001 and Baldrige Implementation and use: –Series (sequentially) –Parallel (simultaneously) Quality system methodology –Structure –Purpose Performance improvement –Measures –Corrective/Preventive Action Customer focus 9

10. VHA - OCCC Synergy Between ISO 9001 and Baldrige (cont’d) 10 Baldrige Criteria 1.Leadership 2. Strategic Planning 3. Customer Focus 4. Information Analysis 5. Human Resources 6. Process Management 7. Business Results ISO 9001:2000 4Quality Management System 5.1Management Commitment 5.2Customer Focus 5.3Quality Policy 5.4Planning 5.5Resp., Authority & Communication 5.6Management Review 6.1Provision of Resources 6.2Human Resources 6.3Facilities 6.4Work Environment 7.1Planning of Product Realization 7.2Customer Related Processes 7.3Design and/or Development 7.4Purchasing 7.5Production and Service Operations 7.6Control of Measuring and Monitoring Devices 8.1General 8.2Measurement and Monitoring 8.2.1Customer Satisfaction 8.2.2Internal Audit 8.2.3Measurement and Monitoring of Processes 8.2.4Measurement and Monitoring of Product 8.3Nonconforming Product 8.4Analysis of Data 8.5Improvement 8.5.2Corrective Action 8.5.3Preventive Action Aligned Somewhat Aligned Not Aligned

11. VHA - OCCC Office of Clinical Consultation and Compliance Conceived from Secretary Shinseki T-21 initiative (SPD/ISO 9001 RME Action Plan) related to: –Vulnerabilities with reprocessing reusable medical equipment (RME) can expose patients to infectious diseases –Public nature of topic –Need to reduce the variation in the way we do business Aligned within the Office of the Principal Deputy Under Secretary for Health 11

12. VHA - OCCC OCCC Vision and Mission Vision: –Provide Veteran-centric care (Veteran is the customer) –Be forward thinking/proactive –Assist with the ability to provide reduced variation in the quality of care we provide Mission: –Implement the ISO 9001 Quality Management System across VHA –Begin by supporting RME initiatives –Provide on site consultation and education –Chair iQMS consortium for document control 12

13. VHA - OCCC OCCC Initiatives Stand up National Office and 7 Regional Offices Standardize knowledge tools and processes through Internationally recognized programs (ISCHMM) Support SPD with development of standardized SOPs and Competencies Provide education to stakeholders on our ISO 9001 QMS 13

14. VHA - OCCC OCCC Initiatives (cont’d) Integrate ISO 9001 standards within SPD/RME through educating, consulting, and supporting stakeholders Work synergistically with existing auditing teams to streamline and reduce audits, surveys, and inspections (SPD, SOARS, OIG, OMI, Pt. Safety…) Assist facilities in readiness for inspections and consistency with ISO 9001 Support rollout of oneSOURCE Chair iQMS Consortium 14

15. VHA - OCCC oneSOURCE Extensive database of clinical instrument documents Easy to access, view, and print Continuously updated as new clinical equipment come to market Documents will be added to oneSOURCE by request No more file drawers full of documents in a remote location No more personnel time spent accumulating and maintaining these files No more wasted time searching for lost or misplaced documents when needed 15

16. VHA - OCCC Integrated Quality Management System (iQMS) A system that will strategically unite and align quality and business processes, streamline the access and utilization of data repositories, and analytical systems The iQMS Consortium is an ad-hoc, integrated project team (IPT) committee of VHA inter-program subject matter expert representatives accountable for the procurement process for the software and initial design, implementation, and use of the system 16

17. VHA - OCCC References Burney, R., Levett, J., Dolan P., (2009, January). Iso- lating the problem. Quality Progress,42(1), 36-40. The Elsmar Cove Website. (2010). ISO 9001-QS-9000 (now TS 16949) Information Exchange: An Alignment Matrix. Retrieved October 19, 2010, from http://elsmar.com/level2/baldrige.html. http://elsmar.com/level2/baldrige.html Folkerts, T. J., (2007, May). The quality diet: Building a healthy business. Quality Progress, 40(5), 21-25. oneSOURCE Document Site. (2010). Retrieved October 21, 2010, from http://onesourcedocs.com/index.html.http://onesourcedocs.com/index.html 17

18. VHA - OCCC QUESTIONS We look forward to partnering with you to improve the care of our Nation’s Veterans! Chris LoGrasso christopher.lograsso@va.gov 202-603-4487 18