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February 20, 2015 Health IT Implementation, Usability and Safety Workgroup David Bates, chair Larry Wolf, co-chair.

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Presentation on theme: "February 20, 2015 Health IT Implementation, Usability and Safety Workgroup David Bates, chair Larry Wolf, co-chair."— Presentation transcript:

1 February 20, 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 February 6, 2015 1:00 PM-3:00 PM ET Quality Management Systems Overview AHRQ Special Emphasis Notice February 20, 2015 1:00 PM-3:00 PM ET Vendor Quality Management Systems Certification Criteria March 10, 2015 – HITPC Meeting Anticipated date to be charged by the HITPC with commenting on the Certification NPRM March 19, 2015 9:00-11:00am ET Certification NPRM overview and prepare to comment (anticipated date for planning purposes) 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 Finalize NPRM Comments (anticipated date for planning purposes) April 21, 2015 12:00-2:00pm ET Implementation discussion – Medication Reconciliation example (tentative) May 1, 2015 2:30-4:30pm ET TBD May 12, 2015 – HITPC Meeting Certification NPRM Comments to the HITPC (anticipated date for planning purposes) May 11, 2015 11:30am-1:30pm ET RTI report out on the Safety Center Road Map

4 Agenda Objective: Vendor Quality Management Systems Certification Criteria 1:00 p.m.Call to Order/Roll Call Michelle Consolazio, Office of the National Coordinator 1:05 p.m.Review of Agenda David Bates, chair Larry Wolf, co-chair 1:10 p.m.Cerner Quality Management System Overview Shelley Looby Cerner Corporation Sharon Muehlmeier, Cerner Corporation 1:40 p.m. Group Discussion 2:45 p.m. Public Comment 3:00 p.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 February 20, 2015 IUS Workgroup: Cerner Quality System

7 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 7 Cerner’s attestation response The Cerner Quality System (CQS) is a “home grown” quality management system designed to comply with: 21 CFR Part 820 Quality System Regulations, ISO 13485:2003/2012 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and ISO 9001:2008 Quality Management system requirements. Cerner has developed our quality system based on the commitment to achieving safety and effectiveness of products and services in the interest of the public health and in the interest of each client. CQS establishes how Cerner shall embody quality throughout the lifecycles of the solutions and services we provide.

8 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 8 Cerner’s attestation response (continued) Cerner’s quality system is a dynamic system and is intended to remain so through continuous feedback, monitoring by system audits, management review, and corrective and preventive action. The plan-do-check-act cycle is employed to ensure continuous improvement throughout our corporation.

9 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 9 Cerner’s attestation response (continued) The Cerner Quality System, CQS, applies to all the solutions and services Cerner offers to our clients. It prescribes the systemic control of the following activities to ensure that client needs and requirements are met with safe and effective solutions and services: Management review Document control and record retention Corrective and preventive actions Complaint handling Materials, suppliers, equipment and facility controls Design controls and change management Production and process controls Internal audit

10 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 10 Cerner’s attestation response (continued) Each group within Cerner must establish quality objectives that support CQS and our goals of safe and effective solutions and services. Continuous measurement and monitoring of the objectives allows for Cerner to identify negative trends and apply corrective actions, identify positive results and focus on sustainability and to proactively recognize new opportunities for quality assessment. Cerner takes very seriously its obligation to the public health. Cerner’s quality system is a total systems approach designed to ensure quality throughout Cerner.

11 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 11 The Cerner Quality System (CQS) historically….. 2001 CQS was implemented corporate wide Corrective Action Board created 2002 Cerner became one of the few software development companies to get ISO 9001 certification 2004 Quality Representative Community was formed 2005 ISO 13485:2003 certification added for select locations

12 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 12 CQS components There are seven components to Cerner’s Quality System. All of the components are required and work together to support development of Cerner solutions & services.

13 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 13 Risk management Risk is managed through the development, documentation and maintenance of the following Risk Analysis processes: IT Security & Privacy Risk Management Evaluations Hazard Analysis / Solution Risk documents Business Continuity & Disaster Recovery This ensures: Risk is identified and managed Vulnerabilities/weaknesses are understood Hazards/threats that could harm the business are mitigate/eliminate hazards/threats that could harm business The continued overall quality and protection of Cerner's business activity

14 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 14 Introduction to Cerner’s risk-based processes Cerner Quality System ISO 9001:2008 Low Risk Cerner Quality System ISO 9001:2008 FDA 21 CFR Part 820 Medium Risk Cerner Quality System ISO 9001:2008 FDA 21 CFR Part 820 ISO 13485:2003 EN ISO 13485:2012 ISO 14971:2007 EN ISO 14971:2012 IEC 62304: 2006 BS EN 62366:2008 High Risk

15 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 15 Risk based process workflow

16 BRNDEXP 2.1 0714 © 2014 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner 16 Quality Focused Development Cerner’s risk-based software development processes are based on a standard development lifecycle model that prescribes quality focused development activities: Prioritization uses a portfolio management approach for project planning Continuous risk management to assess, control, and evaluate solution risk User-centered design methodology incorporated to optimize end-user experience and productivity Verification and validation injected early and often to evaluate and maintain quality Quality assurance activities in place to monitor, assess, and drive process improvement

17 Group Discussion 17

18 Next Meeting: Thursday, March 9, 2015 9:00 AM-11:00 AM Eastern Time 18

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