1. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Leading Practices in Managing Multi-Patient Events Risk Management Conference 27 April 2015 Polly Stevens, VP, Healthcare Risk Management Annette Down, Senior Healthcare Risk Management Specialist

2. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Introduction to HIROC’s new guide to Critical incidents and multi-patient events Overview of approach to multi-patient events Case studies Topics 2

3. 3 Leadership Crisis management Crisis communications Patients and Families Disclosure Staff Second victim Just culture Key Concepts Systems thinking Complexity High reliability Medical malpractice Analysis Interviews Recommendations Implementation Reporting Confidentiality Multi-Patient Events

4. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Multi-patient Events Defined Individual, or a series of related events, that injure or increase the risk that many patients would be injured because of health care management (Dudzinski et al, 2010) Commonly involve – Infectious disease outbreaks – Sterilization failures – Diagnostic errors – Privacy breach

5. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM The number of impacted patients may be unknown Often unknown if actual harm occurred Probability of harm and severity vary; no two multi- patient events are alike Some notifications may be more urgent than others Decision on who and how to notify must be made carefully in a timely manner Resource intensive Documentation management Media coverage Common Challenges 5

6. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM “The organization itself needs to be the first to present the information to the public. Transparency needs to trump concerns about increasing legal liability.” (p.1126). Chafe et al. (2009) 6

7. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Proactive disclosure to all unless strong, ethically justifiable case against disclosure Disclosure obligations greatest when the events resulted from preventable errors or system failures Obligations to patient care, transparency and retributive justice far outweigh risks to the organization Dudzinski et al. (2010) 7

8. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Concern Raised – Consider potential immediate needs – Interdisciplinary team – Timely notification to HIROC Lookback – Timeframe – Determine threshold for harm – Database Patient Notification – Method – Notify – Track notification Communication Strategy Ideally What Should Happen 8

9. 9 HIROC has developed a checklist to assist subscribers with managing multi-patient events

10. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM Decision impacted by many factors – Number of potentially affected patients, urgency, whether testing/follow-up is required and relationship to care provider In-person notification – Ideal if low number of affected patients – May be accompanied by follow-up letter with details and next steps Method for Notification 10

11. 11 HIROC has developed scripts/letter templates for the following types of multi-patient events: Infectious disease outbreak Sterilization failure Diagnostic errors Privacy breach

12. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM If considering (or engaged in) look back, or, suspect a multi-patient event, notify HIROC early on Immediate access to HIROC/legal/clinical experts who can help to ensure an effective and ethical process High potential for class action lawsuit Reporting to HIROC 12

13. 13 Case Studies

14. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM A multi-site hospital declares an outbreak of C. difficile at one of its sites. At this time 25 patients have tested positive, 10 patients are in hospital receiving treatment and one patient has died. Two months later, an outbreak is declared at each of the other three sites. Four months after the initial outbreak the hospital realizes that 42 patients have passed away related to C. difficile infection. Five months after the initial outbreak the hospital notes that there are 102 reported cases of C. difficile across all three of its sites; of those cases 40 are attributed deaths where in 70% of the cases C. difficile was a factor. Case Study #1 14

15. 15 Voting Questions

16. PARTNERING TO CREATE THE SAFEST HEALTHCARE SYSTEM A community hospital became aware through an employee and subsequent privacy audit that another employee in Health Information Management inappropriately accessed 190 health records of patients, including children and patients with mental health issues, over three years. The employee accessed clinical data including lab tests and x-ray results. Case Study #2 16

17. 17 Voting Questions

18. 18 “As complex as serious clinical events are, many special circumstances can make them dramatically more complicated. At the top are adverse events where tens, hundreds, or thousands of patients may have been affected – major failures of the health care system, including cases around poor sterilization practices or contamination of endoscopic devices, hepatitis outbreaks, interpretations of diagnostic studies, pseudomonas outbreaks, overdoses of radiation, and cases where it can’t be determined how many patients were impacted.” Conway et al 2011, p.25

19. 19 Polly Stevens pstevens@hiroc.com 416-730-3075 riskmanagement@hiroc.com Annette Down adown@hiroc.com 416-730-2602