1. Patient Safety and Quality 8 February 2013 Ralph T. Soule, Captain, US Navy, retired Division Director Aircraft Carrier Test, Evaluation, and Certification Naval Sea Systems Command ralph.soule@gmail.com www.ralphsoule.com High Reliability for Patient Safety DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited.

2. Presentation Name Patient Safety and Quality 8 February 2013 Submarine Maintenance and Medical Care Similar Attributes 2  Highly regulated  Safety is essential – severe consequences for failure  Operating environments are inherently hazardous  Complex, interdependent systems  People play a critical role in complex processes  Highly reliable, long- term operations are essential  Learning from experience is essential

3. Presentation Name Patient Safety and Quality 8 February 2013  Most of our “patients” don’t really want to see us  Our families have no idea what we’re talking about when we discuss work  We use a lot of hoses, gases, and electrical connections in our work  When something gets in our way, we just make an “incision” to move it  Workers wear strange clothing Submarine Maintenance and Medical Care Similar Attributes 3

4. Presentation Name Patient Safety and Quality 8 February 2013 Submarine Maintenance and Medical Care Differences 4  Ship’s cannot “elope” from shipyards  Shipyard maintenance involves teams of hundreds, up to thousands of people  Shipyard managers and engineers never say “this won’t hurt a bit”  The “patient” is awake the whole time and often gives us instructions to help us do the job “better”

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6. Presentation Name Patient Safety and Quality 8 February 2013 History - Loss of THRESHER High Reliability Lessons: Submarine Safety (SUBSAFE) and other maintenance processes Applications to Medical Care 6

7. Presentation Name Patient Safety and Quality 8 February 2013 Early Submarine Losses Submarines Lost 1915-1963 17 submarines lost to non-combat causes 1915:USS F-4 (SS-23) 1917: USS F-1 (SS-20) 1920: USS H-1 (SS-28) USS S-5 (SS-110) 1923:USS O-5 (SS-66) 1926:USS S-51 (SS-162) 1927:USS S-4 (SS-109) 1939:USS SQUALUS (SS-192) 1941:USS O-9 (SS-70) 1942:USS S-26 (SS-131) USS R-19 (SS-96) 1943:USS R-12 (SS-89) 1944:USS S-28 (SS-133) 1949:USS COCHINO (SS-345) 1958:USS STICKLEBACK (SS-415) 1963:USS THRESHER (SSN-593) 1968:USS SCORPION (SSN-589) 7 470 Lives Lost

8. Presentation Name Patient Safety and Quality 8 February 2013  Laid down, 28 May 1958, at Portsmouth Naval Shipyard, Kittery, ME.  Launched on 9 July 1960.  13 th nuclear powered attack submarine.  The first ship of its Class; leading edge of US submarine technology:  combining nuclear power with modern hull design  newly-designed equipment and components 8 USS THRESHER (SSN-593) USS THRESHER launching ceremonies at the Portsmouth Naval Shipyard, Kittery, Maine, 9 July 1960. She was fast, quiet, and deep diving

9. Presentation Name Patient Safety and Quality 8 February 2013 9 Submarine Buoyancy and Ballast Tanks

10. On April 10, 1963, while engaged in a deep test dive, approximately 200 miles off the northeastern coast of the United States, the U.S.S. THRESHER (SSN-593), was lost at sea with all persons aboard - 112 naval personnel and 17 civilians. THRESHER wreckage: About 200 miles off Cape Cod in 8,400 ft of water PNSY

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12. Presentation Name Patient Safety and Quality 8 February 2013 Navy Response to Loss of USS THRESHER  Immediately limited diving depth of all submarines  Court of Inquiry  THRESHER Design Appraisal Board  Focus:  Design  Construction  Operation  Testimony Before Congress 12

13. Presentation Name Patient Safety and Quality 8 February 2013 Investigation Conclusions 13 Loss of propulsion power Flooding in the engine room Unable to secure from flooding Spray on electrical switchboards Unable to blow ballast tanks

14. Presentation Name Patient Safety and Quality 8 February 2013 14 SUBSAFE PROGRAM LOSS of THRESHER Overhaul/Construction MAINTENANCE PROCESS CHANGES Inception of the SUBSAFE and Significant Culture Change

15. Presentation Name Patient Safety and Quality 8 February 2013 Key Lessons “The loss of the Thresher should not be viewed solely as the result of failure of a specific braze, weld, system, or component, but rather should be considered a consequence of the philosophy of design, construction, and inspection … it is important that we reevaluate our present practices where, in the desire to make advancements, we may have forsaken the fundamentals of good engineering. ” – ADM Rickover 15

16. Presentation Name Patient Safety and Quality 8 February 2013 Safety must be part of process design, not an afterthought Key systems were under-designed for knowable risks Failure to bound an unexpected problem An attitude that specifications were merely goals, did not need to be taken literally, and HQ permission not needed for failure to meet them Impact of accumulated conditions, not a single failure The Navy had not updated its way of doing business to meet the requirements of updated technology and high-performance ships that could operate in riskier environments Processes are only as good as their audit plan 16 Key Lessons

17. Presentation Name Patient Safety and Quality 8 February 2013 Navy High Reliability Practices Applied to Health Care  It is expensive and costly to wait for mistakes to learn  Use existing debriefing records to tune awareness  Safety is created in the moment, where work is done, by the people doing it  “High reliability is a continuous, ongoing, dynamic accomplishment."  The blindness of hindsight bias short circuits learning... 17

18. Presentation Name Patient Safety and Quality 8 February 2013 Getting it Wrong

19. Presentation Name Patient Safety and Quality 8 February 2013 Checklists Work Model: training, procedures, supervision Critiques/Fact Sheets Risk Management Audits/Surveillances Pre-operative safety briefings Post-event/procedure debriefs 19 Navy Maintenance Tools for Medical Care

20. Presentation Name Patient Safety and Quality 8 February 2013 Key: interactivity among participants Overview of procedure, team members, risks, constraints, anomalies, expected outcomes Each person Name Role What they need (from whom) What they provide (to whom) Reports to make (exact phraseology is important) Reports needed What was learned from last time Mostly likely problems and responses (what ifs?) 20 Pre-evolution briefs

21. Presentation Name Patient Safety and Quality 8 February 2013 Key: capturing each person’s perspective, follow up Was the desired outcome achieved? Things to do more often Things not to do next time Hazards caught (which ones remain open?) Assess work process tools (effectiveness/utility of pre- briefs, procedure, especially things not covered, but should be, training/qualifications -> management credibility rests with follow up) What were the surprises and how were they identified? Things to do differently next time 21 Post-action reviews (informal)

22. Presentation Name Patient Safety and Quality 8 February 2013 22 ACCIDENT TIME SAFETY LEVEL Minimum Optimum Understanding the Challenge - Actual - Perceived THE BATTLE WHERE YOU THINK YOU ARE WHERE YOU REALLY ARE

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24. Presentation Name Patient Safety and Quality 8 February 2013 “Those who cannot remember the past are condemned to repeat it.” - George Santayana 24 “A good pre-event briefing beats an accident investigation any day.” - ADM Kinnaird R. McKee

25. Presentation Name Patient Safety and Quality 8 February 2013 Questions 25

26. Presentation Name Patient Safety and Quality 8 February 2013  Bierly and Spender (1995). Culture and High Reliability Organizations: The Case of the Nuclear Submarine. Journal of Management: Vol. 21, no. 4, pp. 639-656. Holzmann, Mischari, Goldberg, and Ziv (2012). New tools for learning: a case of organizational problem analysis derived from debriefing records in a medical center. The Learning Organization: Volume 19, Issue 2, pp. 148-162. Better, Atul Gwande Loss of the USS Thresher, Hearings Before the Joint Committee on Atomic Energy (http://www.perfectpr.com/Thresher2.html) What Sank the Thresher? Dean J. Golembeski Managing the Unexpected, Weick and Sutcliffe 26 References

27. Presentation Name Patient Safety and Quality 8 February 2013 BACK-UP SLIDES 27

28. Presentation Name Patient Safety and Quality 8 February 2013 28 Culture- Key Element of Success

29. Presentation Name Patient Safety and Quality 8 February 2013 Culture- Key Element of Success Submarine Safety Approach  Technical  Cultural 29

30. Presentation Name Patient Safety and Quality 8 February 2013 Culture is a word for people’s “way of life”, meaning the way they do things. A Group of people has a separate culture when that group sets itself apart from others through its actions. 30 Culture- Key Element of Success SUBSAFE Culture

31. Presentation Name Patient Safety and Quality 8 February 2013  Work Discipline  Knowledge of and Compliance With Requirements  Material Control  Correct Material Installed Correctly  Documentation  Design Products (Specs, Drawings, Maintenance Standards, etc.)  Objective Quality Evidence (OQE)  Compliance Verification  Inspections, Surveillance, Technical Reviews, Audits  Continual Training 31 Culture- Key Element of Success The Fundamentals