Serious Safety Events: What does a Manager do?

1. Serious Safety Events:What does a Manager do? David Gourley, RRT, MHA, FAARC Executive Director of Regulatory Affairs Chilton Hospital Pompton Plains, New Jersey

2. Serious Safety Events • Overview of serious safety events • Incident reporting • Incident investigation • Root cause analysis • Culture of safety • Second victim

3. Overview of serious safety events • Serious reportable event (National Quality Forum) • Never event (Agency for Healthcare Quality and Research) • Sentinel event (The Joint Commission)

4. Serious reportable event Preventing adverse events in healthcare is central to the National Quality Forum’s (NQF) patient safety efforts. To ensure that all patients are protected from injury while receiving care, NQF has developed and endorsed a set of Serious Reportable Events (SREs). This set is a compilation of serious, largely preventable, and harmful clinical events, designed to help the healthcare field assess, measure, and report performance in providing safe care. National Quality Forum

5. Never Events • Established by National Quality Forum • Spearheaded by IOM report “To Err is Human” • Originally 27 serious reportable events, expanded to 29 • Considered “largely preventable” • Incorporated into 26 states and DC into patient safety programs • Established to facilitate uniform and comparable public reporting • Drive national improvements in patient safety

6. Never Events • 2 million events annually • 90,000 deaths annually • $5.7 billion in additional healthcare costs • $29 billion in associated costs (additional healthcare expenses, lost work, lost income, disability)

7. Never Events • Care management events • Environmental events • Product or device events • Surgery-related events • Patient protection events

8. Sentinel Events An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.  Serious injury specifically includes loss of limb or function.  The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.  Such events are called "sentinel" because they signal the need for immediate investigation and response. The Joint Commission

9. Respiratory serious safety events • Ventilator-related death • Intubation complication • Medical gas mix-up • Critical value not reported • Stage IV pressure ulcer from BiPAP mask • Tubing misconnection • Home care oxygen fire • Alarm safety issue

10. Incident Reporting • Majority of events are not reported through hospital incident reporting systems • Estimated 86% not reported • Staff misperception of patient harm • Staff reluctance to report • Nurses most often report events • OIG estimates 27% of in-patients experienced at least one adverse event or temporary harm

11. Incident Reporting

13. Investigation and analysis of clinical incidents • Cursory investigation identifies only immediate and obvious deviations in practice • Hospital-wide clinical risk management offers detached investigation of serious events • Investigations often focus on actions and omissions of individual clinicians and not background of events • Fundamental cause usually systemic features

14. Steps in Incident Investigation • Secure the area and preserve evidence • Notify Risk Management/Human Resources (injuries, loss of life, criminal acts) • External reporting (law enforcement, regulatory agencies) • Gather information about area before, during, and after incident • Visit and inspect incident site

15. Steps in Incident Investigation • Gather information about area before, during, and after incident (cont.) • Identify and interview key healthcare workers, patients, and witnesses • Photograph/sketch pertinent aspects of site • Collect physical evidence • Position of injured patient/worker • PPE • Position of equipment • Evidence of equipment tampering

16. Steps in Incident Investigation • Gather information about area before, during, and after incident (cont.) • Collect physical evidence (cont.) • Materials being used at scene • Condition of environment • Lighting • Noise level • Smoke, dust, fumes, vapor • Odor • Housekeeping, maintenance, sanitation conditions

17. Steps in Incident Investigation • Gather information about area before, during, and after incident (cont.) • Collect physical evidence (cont.) • Background information • Employee records (license, certification, orientation, competency, performance evaluations) • Equipment records (maintenance and service records, operators manuals) • Policies and procedures • Previous incident reports • Material safety data sheets (MSDS), if applicable

18. Steps in Incident Investigation • Analyze facts, determine root cause and contributing factors • Report findings and make recommendations for corrective actions • Develop plan to evaluate effectiveness of corrective actions • Alter corrective actions as determined by ongoing monitoring

19. Scope of Root Cause Analysis (RCA) • Behavioral assessment process • Physical assessment process • Patient identification process • Patient observation procedures • Care planning process • Continuum of care • Staffing levels • Orientation and training of staff • Competency assessment • Supervision of staff

20. Scope of Root Cause Analysis (RCA) • Communication with patient/family • Communication among staff members • Availability of information • Adequacy of technological support • Equipment maintenance/ management • Physical environment • Security systems and processes • Control of medications (storage/ access) • Labeling of medications

21. Framework of contributing factors • Patient factors • Condition (complexity/seriousness) • Language and communication • Personality and social factors • Task factors • Task design and clarity of structure • Availability and use of protocols • Availability and accuracy of test results • Decision-making aids

22. Framework of contributing factors • Individual staff factors • Knowledge and skills • Competence • Physical and mental health • Team factors • Verbal communication • Written communication • Supervision and seeking help • Team structure (congruence, consistency, leadership)

23. Framework of contributing factors • Work environmental factors • Staffing levels and skill mix • Workload and shift patterns • Design, availability, and maintenance of equipment • Administrative and managerial support • Environment • Time delays

24. Framework of contributing factors • Organizational and management factors • Financial resources and constraints • Organizational structure • Policies, procedures, standards, and goals • Safety culture and priorities • Institutional factors • Economic and regulatory context • Links with external organizations

25. Interviews with staff • Setting the scene • Private setting, away from incident scene • Supportive and understanding • Not judgmental or confrontational • One interviewer, another person documenting • Establish chronology • Establish role of staff member in incident • Establish chronology of events as staff saw them

26. Interviews with staff (cont.) • Identifying care delivery problems • Explain concept to staff member • Ask staff member to identify main care delivery problem as they see them (do not assign blame) • Identify acts and omissions made by staff • Identify breakdowns in clinical process (deviations from practice) • Identify contributing factors

27. Building a Culture of Safety • Recognize that people are human and will make mistakes • Systems are designed to catch mistakes before they become errors • The need to review “near misses” to further reduce opportunities for error

28. Building a Culture of Safety • Leadership driven – must guide every decision • Acknowledge that our systems are most likely to cause errors, not our people • No healthcare decision is removed from patient safety • Need to recognize and correct at-risk behavior

29. Building a Culture of Safety ERROR Preventing errors from being made in the first place Detecting and reversing error before it causes harm Repairing or minimizing the damage caused by errors that cannot be prevented or reversed ADVERSE EVENT

30. Building a Culture of Safety “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

31. Building a Culture of Safety • Human error -inadvertent action; inadvertently doing other that what should have been done; slip, lapse, mistake. • At-risk behavior –behavioral choice that increases risk where risk is not recognized or is mistakenly believed to be justified. • Reckless behavior -behavioral choice to consciously disregard a substantial and unjustifiable risk.

34. “Second Victim” • Caregivers and staff involved in medical errors that harm patients • Staff can sustain complex psychological harm • Healthcare practitioners repeatedly exposed to emotional turmoil • Equivalent to post-traumatic stress disorder • Staff feel sadness, fear, anger, shame, panic, horror, apprehension • Effective support needed for practitioners

35. “Second Victim” • Five rights of second victims: T R U S T • Treatment that is just • Respect • Understanding and compassion • Supportive care • Transparency and opportunity to contribute

36. Serious Safety Events:What Does a Manager Do?