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Unlocking a Quality Management System’s Potential – Key Components and Self- Monitoring Tools

Unlocking a Quality Management System’s Potential – Key Components and Self- Monitoring Tools. Agenda. Introduction to the Research shield at Mayo Clinic Circumstances that led us to a Quality Management System (QMS) Key components of a QMS Self-monitoring t ools

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Unlocking a Quality Management System’s Potential – Key Components and Self- Monitoring Tools

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  1. Unlocking a Quality Management System’s Potential – Key Components and Self- Monitoring Tools

  2. Agenda • Introduction to the Research shield at Mayo Clinic • Circumstances that led us to a Quality Management System (QMS) • Key components of a QMS • Self-monitoring tools • Control limits and defined escalation

  3. Objectives • Explain key components of an effective QMS • Illustrate helpful tools that can be used to self-monitor • Discuss importance of control limits and defined escalation processes

  4. Mayo Clinic Research Shield • Physicians actively engaged in research ~ 640 • Individuals certifying research effort > 4000 • Research space > 900,000 sq. ft. • Grants and contracts > 4700 • In the top 25 NIH grant funding by institutions • Active Institutional Review Board-approved human research studies > 8,900 • Research and review articles in peer-reviewed journals > 5,700

  5. Research Funding Sources 11% 61%

  6. Research Finance at Mayo Clinic • Research Finance is an enterprise wide division with staff working in Arizona, Florida, and Rochester. The team is devoted to ensuring compliant financial processesfor post award activity for all funding types. • Organizationally in the Finance Department • Research Finance has employees working across 7 functional teams • Award Management • Award Compliance • Award Revenue • Cores • Program Services • Reporting • Quality

  7. Mayo Clinic Research Finance Historical Staffing • Staffing numbers • Pre Department of Justice (DOJ) investigation – 2003 – 25 FTE • Post implementation of controls and launch of QMS – 2008 – 100 FTE • QMS additions and enhancement, Self-monitoring in place, Working Differently initiative – 2013 – 88 FTE

  8. DOJ Investigation and Settlement • Whistleblower (qui tam) suit filed – Agents visit • Mayo settled for $6.5M • DOJ press release and investigation closed • Reviewed NIH funds spent • from 1992-2003 May 2005 November 2003 - May 2005 November2003 June 2005

  9. Transition • In June 2005, NIH sent a letter of inquiry asking for compliance related information and assurances related to 4 areas: • Cost Transfers • Financial Management Systems • Written Policies and Procedures • Roles, Responsibilities, and Training

  10. Mayo Clinic Response (2005-2008) Building the Framework • Conducted comprehensive gap analysis • Identified opportunities for improved compliance controls • Self-disclosed to NIH self-identified compliance issues • Met with NIH officials in Bethesda, multiple times to provide comprehensive updates

  11. Mayo Clinic Response (2005-2008) Building the Framework • Executed 26 projects • Automation • Policies & Procedures • Roles & Responsibilities • Tools • Implemented new Enterprise Resource Planning (ERP) system, including Grants Management module

  12. Strengthening the Framework(2008-2013) • In 2008, adopted a Quality Management System, modeled after International Organization of Standardization (ISO) framework • Cornerstones remain; • Added continuous improvement, competencies, and customer satisfaction elements • Enhanced training, measurement and analysis and our documentation system

  13. Start Management Commitment Culture Continuous Improvement Customer Service & Satisfaction QMS Administration Quality Management System - Key Components Measurement & Analysis Documentation System Competence, Awareness & Training

  14. Research Finance Mission Statement • Mayo Clinic Research Finance believes in quality management. Research Finance aspires to use quality as the vehicle behind all it does in an effort to meet and exceed our customers’ expectations. The Research Finance Quality Management System emphasizes a proactive approach to meeting our customers’ needs and to ensure continuous improvement. Management Commitment

  15. Establishing a Quality Culture • Work environment • Readiness • Employee engagement and empowerment • Expectations • Accountability • Promote teamwork • Promote continuous improvement Culture

  16. Self-Monitoring Tools

  17. QMS Annual Plan • Critical part of aQuality Management System • Identifies long term goals and current year objectives • Commits required resources in writing • Provides staff with direction for coming year QMS Administration Management Commitment Culture

  18. Annual Plan Content

  19. Annual Plan Content

  20. Documentation System • Policies, Procedures and Work Instructions • Policy– organization’s official position setting an expectation of behavior • Procedure– high level of roles and responsibilities explaining how it happens • Work Instruction –documents how to perform the work • Record Retention Documentation System

  21. Content Management System • Stores policies, procedures and work instructions • Automated emails or monthly reports • Identifies person/area responsible for documents • Check in/out, version control, and historical content available

  22. Competence, Awareness & Training • Employee performance appraisals • Learning management system • Training • Education based format (utilize Bloom’s Taxonomy) • Competency assessment Competence, Awareness & Training

  23. Bloom’s Taxonomy http://nashvilleisd.groupsite.com/uploads/files/x/000/04b/a15/performance_verbs_for_learning_objectives.png

  24. Standard Training Format • Title • Objectives utilizing Bloom’s Taxonomy • Define Cost Sharing • Introduce and discuss each objective • Test your knowledge questions • “____________or matching means that portion of project or program costs not borne by the Federal Government.” • Summary restating objectives • Cost sharing is the portion of project costs not borne by the Federal Government.

  25. Bloom’s Taxonomy

  26. Standard Training Format • Title • Objectives utilizing Bloom’s Taxonomy • Define Cost Sharing • Introduce and discuss each objective • Test your knowledge questions • “____________or matching means that portion of project or program costs not borne by the Federal Government.” • Summary restating objectives • Cost sharing is the portion of project costs not borne by the Federal Government.

  27. Competency Plan • Conduct needs assessment • Identify competencies addressed by job • Write goals and objectives • Determine teaching methods • Determine assessment methods • Determine program improvement methods

  28. Measurement and Analysis • Balanced Scorecard • Outcomes • Financial • Processes • People Strategic Plan Measurement & Analysis

  29. Measurement and Analysis • Compliance - Internal Control Evaluation (C-ICE) • Scoping • Flows & Controls • Testing • C-ICE Metrics

  30. Customer Service & Satisfaction What is customer service? Customer service is exceeding the needs of both internal and external customers. Tools: • Event Management • Voice of the Customer (VOC) Customer Service & Satisfaction

  31. Continuous Improvement Quality Assurance Continuous Improvement

  32. Quality Assurance Controls 90 % of all QA findings are process issues

  33. Continuous Improvement Quality Assurance

  34. Quality Assurance Control Chart

  35. Quality Assurance Tools

  36. Project Management vs. DMAIC

  37. Project Management (PMBOK)

  38. Linking DMAIC and Change * Many change management tools can (and should) be used in more than one phase.

  39. Control Limits and Defined Escalation Processes

  40. Self-Monitoring QMS • Identify controls • Visual • Easily understood • Defined escalation • Communicated • Administered

  41. Documentation Controls • Policies, procedures and work instructions warehoused in content management system • Expectations and due dates communicated

  42. Balanced Scorecard

  43. Documentation Controls

  44. QMS Metrics • Timely Federal Financial Report (FFR) submission • Past due employee performance appraisals • Completion of assigned compliance training • Successfully passing the Competency Assessment • Completion of C-ICE flows, controls and testing • Timely filing of documents for Record Retention

  45. Quality Assurance Control Chart

  46. Quality Assurance Controls 90 % of all QA findings are process issues

  47. Management Commitment Culture Continuous Improvement Customer Service & Satisfaction QMS Administration Does it really work? Measurement & Analysis Documentation System Competence, Awareness & Training

  48. Mission Mission Vision Vision Goals / Objectives Goals / Objectives QMS – Before and After QMS Implementation Before QMS After QMS

  49. Indicators of Success • Staff Costs: • FTE reduced nearly 15% over the past two years as a result of process improvement • Process Improvements: • 35 process improvement projects were completed in the last 9 months of 2013 • Accomplishments

  50. Mayo Clinic A-133 Audit Trend(Research Specific)

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