1. Communication and Optimal Resolution (CANDOR) Toolkit Module 4: Event Reporting, Event Investigation and Analysis

2. Objectives Define the key elements of a timely and comprehensive event reporting system. Define the process of a timely and efficient event investigation. Identify the key components of an effective event analysis. 2 Module 4

3. CANDOR Event Reporting, Investigation, and Analysis Module 4 3

4. “The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes.” Dr. Lucian Leape Professor, Harvard School of Public Health Testimony before Congress on Health Care Quality Improvement 1 Event Reporting Culture

5. Key Elements of an Event Reporting System Supports a rapid response to harm events. Obtain staff and providers’ feedback post-event. Obtain patient and family feedback post-event. Allows for immediate, anonymous, and/or confidential reporting and input from frontline staff and providers. Provides potential protection of event analysis from discovery. Provides immediate and ongoing feedback to reporters. Protects patients from future harm events. Module 4 5

6. Sources for CANDOR Event Reports FDA Device/Drug Reports Regulatory Bodies Patient Safety Organizations Electronic Health Record Peer Review Event Reviews Event Reporting System Morbidity and Mortality Forums HSOPS Complaints HCAHPS Letters Claims Consumer Reporting PatientsProviders External Environment Internal Environment Module 4 6

7. CANDOR Event Checklist Module 4 7

8. Preparing Staff for a CANDOR Event Reporting System Ensure staff understands how to prepare, and has the ability to submit, an event report. Provide guidance on how to report an event. Conduct training for all staff. Provide a mechanism for followup and feedback on the event. Support managers. Seek feedback to identify ways to make the process “user friendly.” Module 4 8

9. Event Reporting Outcomes Caregiver support Patient and family engagement and support Continuous organizational learning Innovative solutions Improved culture of safety Module 4 9

10. Event Investigation and Analysis Module 4 10

11. Setting the Stage for Event Investigation Module 4 11 CANDOR Event No Harm Event Near Miss Unsafe Conditions Actual Harm to Patient Potential Harm to Patient

12. System And Individual Accountability 2 Module 4 12 Why did the event happen? How prevalent are the behaviors associated with the event? System accountability – Processes, policies – Prevention mechanisms Individual accountability – At-risk behaviors – Performance factors Additional Resource: AHRQ CUSP Toolkit - Apply CUSP

13. Traditional Event Investigation and Analysis Process Event 2-4 weeks later Root Cause Analysis Team meets Determine “root causes.” Assign a solution to each “cause.” Assign person responsible. 1. Send report to leadership and board. 2. Follow up 6 weeks later to ensure compliance. 3. Close case, satisfied. Module 4 13

14. CANDOR Process for Event Investigation and Analysis Module 4 14 Event Occurs Activate CANDOR Response Team. Perform a preliminary review. Inspect scene. In-depth Review Interviews, chart reviews, site visit. Develop timeline. Identify Core- review Team members. Confirmation and Consensus Meeting Share pertinent findings. Obtain confirmation and consensus on contributing factors. Solutions Meeting Develop targeted solutions. Evaluate and measure solutions. Finalize event review documents. Followup Occurs at: 30 days 60 days 90 days Occurs within 30-45 business days after the event Occurs within 72 hours after the event

15. System-Focused Event Investigation and Analysis Guide 3 Module 4 15

16. Followup Patient and family 4,5 Caregivers Patient and family advisory councils Medical liability carriers – Mello et al: Communication-and-resolution programs: the challenges and lessons learned from six early adopters 6 Mello et al: Communication-and-resolution programs: the challenges and lessons learned from six early adopters – Boothman and Hoyler: The University of Michigan's early disclosure and offer program 7 Boothman and Hoyler: The University of Michigan's early disclosure and offer program Module 4 16

17. Event Investigation and Analysis Outcomes Caregiver support Patient and family engagement and support Continuous organizational learning Innovative creation of solutions Impact on the safety culture Module 4 17

18. References 1.Leape LL. Testimony, United States Congress, House Committee on Veterans’ Affairs, October 12, 1997. 2.Apply CUSP module, CUSP Toolkit. Rockville, MD: Agency for Healthcare Research and Quality. http://www.ahrq.gov/professionals/education/curriculum- tools/cusptoolkit/modules/apply/index.html. Accessed August 8, 2015. http://www.ahrq.gov/professionals/education/curriculum- tools/cusptoolkit/modules/apply/index.html 3.Guide to Patient and Family Engagement in Hospital Quality and Safety. Rockville, MD. Agency for Healthcare Research and Quality. http://www.ahrq.gov/professionals/systems/hospital/engagingfamilies. Accessed July 21, 2015. http://www.ahrq.gov/professionals/systems/hospital/engagingfamilies 4.Carman KL,et al. A Roadmap for Patient and Family Engagement in Healthcare Practice and Research. Gordon and Betty Moore Foundation. Palo Alto, CA; September 2014. http://patientfamilyengagement.org/#sthash.HZNslZP1.WpGsc2si.dpuf. Accessed July 21, 2015. http://patientfamilyengagement.org/#sthash.HZNslZP1.WpGsc2si.dpuf 5.Parker SH, Krevat SA, Morales CL, Fairbanks RJ. System-Focused Event Investigation and Analysis Guide. Columbia, MD: MedStar Health. Washington DC: Georgetown University. 6.Mello MM, et al. Communication-and-resolution programs: the challenges and lessons learned from six early adopters. Health Affairs. 33.1 (2014): 20-29. http://content.healthaffairs.org/content/33/1/20.full.pdf+html. Accessed September 10, 2015 http://content.healthaffairs.org/content/33/1/20.full.pdf+html 7.Boothman, R and Hoyler MM. The University of Michigan's early disclosure and offer program. Bulletin of the American College of Surgeons. 98.3 (2013): 21-25. http://bulletin.facs.org/2013/03/michigans-early-disclosure/. Accessed August 21, 2015. http://bulletin.facs.org/2013/03/michigans-early-disclosure/ Module 4 18