Incident Investigations and the Identification of Root Causes; An Overview

1. Incident Investigations and the Identification of Root Causes; An Overview • Marvin Shepherd, PE, FACCE

2. Introduction • Incident investigations require skills in: • Systems safety engineering • Investigative techniques • Human factors/human error • Root cause analysis

3. Device-Related Incident Investigations • Why investigate incidents? • Identify causes of failure • Specifically, root causes • Introduce changes to improve systems • Prevent repeat adverse events • Improve quality of systems

4. When Do We Investigate Healthcare Systems? • When system fails to deliver clinical benefit • When system delivers physical insult • When system functioning suggests a potential for failure

5. Indicators of System Failure • Device fails to deliver its clinical benefit • No Problems Found (NPF) • Operator work-arounds • Near misses • Operator complaints • Misuse of medical tape • Others?

6. Systems Safety Analysis • Includes all components of a health care system • Evaluates each system’s component for failure • Leads to root cause(s) of component failures

7. For Systems Failure… • At least one component of system must fail • Failed system’s component is not necessarily the device component

8. Systems and Minisystems • Minisystem is the smallest system that will deliver a clinical benefit • A system is one or more minisystems, i.e., patient physicals

9. Fundamentals of System Safety

10. The Device-Related Minisystem

11. Device Component • Must meet manufacturer’s specifications for safety and performance

12. Facility Component • Must meet construction, safety and performance standards

13. Patient Component • Must actively provide self-support only when appropriate • Must be in the population supported by the health care facility, i.e. no idiosyncratic characteristics

14. Operator Component • Must be educated/trained to assure performance and safety of patient when patient is subject to a minisystem • Operational conditions or personal factors must not distract operator

15. Importance of Operator Component • Operator error contributes to about 69% of all adverse events (Leape,1994, JAMA 272:1851-1868 ) • Operator is system’s component most difficult to analyze & correct • In U.S., “Culture of blame” still attempts to chastise operators for errors even though systems designs predispose operators to make errors

16. Environment Component • Other clinical minisystems must not interfere with any other minisystem • Any non-clinical system—internal or external to facility--must not interfere with the minisystem

17. Subcomponents of the Minisystem Model

18. Investigative Resources

19. Root Causes and Subcomponents • Component failures are “direct causes” of failure • Direct cause is doorway to root causes (RC) • Subcomponents are one level of RC • Deeper levels achieved by asking “why” • “Why” continues until RC level reached that is reasonable to correct

20. Root Cause Analysis-Methods • System’s Safety Analysis • Joint Commission & RCA • Failure Mode & Effects Analysis • Others…

21. Quality Improvement; Correcting Root Causes…A Check-list

22. Quality Improvement • First, brainstorm methods of eliminating root causes • List corrections and prioritize them • Select most practical and/or least expensive • Note: Correction may be associated with a system’s component that did not fail.

23. The Complete Minisystem’s Safety Model

24. Summary • To effectively identify root causes, learn: • Systems safety engineering techniques • Investigative techniques and the gathering of evidence • Human factors design and human error • Devices must be investigated as part of a minisystem; it is the failure of systems that should be reported, not failure of devices • Practice investigating simple, systems failures so you will be ready when a serious failure occurs

25. References: • Shepherd, M. A systems approach to medical device safety, In: Clinical Engineering Handbook, Ed. J. Dyro Pub: Elsevier Academic Press, 2004 • Shepherd, M. et al. Identification of human errors during device-related accident investigations, IEEE-EMBS Mag, May/June 2004 • Building a better delivery system; a new engineering/health care partnership, National Academies Press, Washington, D.C., Int Std Book Number 0-309-09643-X, 2005

26. References (continued) • Dyro, J., Shepherd, M. Advancing patient safety by white tape analysis, JCE, July/Sept 2005 • Shepherd system for incident investigation and reporting, Manual, Ed. M. Baretich, Pub. Baretich Engineering, 2005 • Moray, N. Error reduction as a systems problem, in Human error in medicine, Ed. M. Bogner, Pub. Lawrence Erlbaum Asso, Hillsdale, New Jersey, 1994

27. Contact Information • Marvin Shepherd, Devteq Consulting, 612 Wintergreen Lane, Walnut Creek, CA 94598, USA • Office: (925)945-0137 • E-mail: marvins523@astound.net