Safe by Design

1. Safe by Design John Reiling, MBA, MHA President/CEO St. Joseph’s Community Hospital & SynergyHealth Inc. West Bend, WI

3. Background - IOM Report • The risk of dying as a result of medical error far surpasses the risk of dying in an airline accident. • Death on Domestic Flights - 1 in 8,000,000 flights

4. Background - IOM Reportcont’d Death in Hospitals from Medical Errors 1 in 343 Admits to 1 in 764 Admits Adverse Events in Hospitals 1 in 27 Admits to 1 in 34 Admits

5. The Patient Safety Learning Lab • The participants: • AMA -IHI • MGMA -UW-Milwaukee • AHA -University of MN • WHA -Center for Patient Safety at VA • JCAHO -AphA • NPSF -ISMP • VHA -ASQ • PSI

6. The Patient Safety Learning Lab Top 10 Recommendations for Facility Design • FMEA at each design stage • Standardization of Location • Involve patients/families in design process • Establish a checklist for current/future design • Critical information close to the patient • Noise reduction • Adaptive systems for function in the future • Articulate a set of principles for measurement • Equipment planning Day 1 • Begin mock-ups on Day 1

7. Visibility of patients to staff Standardization Automate where possible Scalability, Adaptive, Flexible Immediate accessibility of information, close to the point of service Noise reduction Patients involved with care FMEA at each stage of design Design for the vulnerable patient Human factors review Minimize fatigue Design Around Precarious Events Facility Safety Design Principles

8. Learning From Precarious Events • Operative/Post-Op Complications/Infections • Events Relating to Medication Errors • Deaths of Patients in Restraints • Inpatient Suicides • Transfusion Related Events • Correct Tube-Correct Connector-Correct Hole • Patient Falls • Deaths Related to Surgery at Wrong Site • MRI Hazards

9. Creating a Culture of Safety • Shared Values and Beliefs about Safety within the Organization • Always Anticipating Precarious Events • Informed Employees and Medical Staff • Culture of Reporting • Learning Culture • “Just” Culture • Blame-Free Environment Recognizing Human Infallibility • Physician Team Work • Culture of Continuous Improvement • Empowering Families to Participate in Care of Patients • Informed & Activated Patient

10. Human Factors The study of the interrelationships between humans, the tools they use, and the environment in which they live and work. Source: Incorporating Human Factors into the Design of Medical Devices, JAMA 1998

11. Lucian Leape • Pathophysiology of Error • Cognitive Mechanism • Well known – oft repeated processes • Problem solving

12. Donald Norman • Psychology of Everyday Things • Visible • Simplify • Affordances & Natural Mapping • Forcing Functions • Recovery Functions • Standardize • Top Two are Standardization and Simplification

13. Defenses Harm DANGER Hazards Latent condition pathways Causes Individual/Team Actions Investigations Task/Environmental Conditions Organizational Factors Where Do “the Holes” Come From?

14. Fallible Defenses(Or “The Swiss Cheese Model” of Safety) Some holes due to active failures Hazards Other holes due to latent conditions Harm

15. Latent Conditions Errors in the design, organization, training or maintenance that lead to operator errors and whose effects typically lie dormant in the system for lengthy periods of time. Source: To Err is Human, Institute of Medicine

16. Design Recommendations • Latent Conditions: • Noise reduction • Scalability, adaptability, flexibility • Visibility of patients to staff • Patients involved with their care • Standardization • Automate where possible • Minimize fatigue • Immediate accessibility of information, close to the point of service

17. Active Failures An error that occurs at the level of the frontline operator and whose effects are felt almost immediately. Source: To Err is Human, Institute of Medicine

18. Design Recommendations, con’t • Active Failures • Operative/Post-Op Complications • Events Relating to Medication Errors • Deaths of Patients in Restraints • Inpatient Suicides • Transfusion Related Events • Correct Tube-Correct Connector-Correct Hole • Patient Falls • Deaths Related to Surgery at Wrong Site • MRI Hazards

19. Process Recommendations • FMEA at each stage of design • Patients/Families involved in design process • Equipment planning day 1 • Mock-ups day 1 • Design for the vulnerable patient • Articulate a set of principles for measurement • Establish a checklist for current/future design

20. Pre-FMEA Concept/Adjacencies dFMEA vs pFMEA

21. FMEA Checklist Tool • Process: ___________________________________________ • Team Leader: _______________________________________ • Core Team:_________________________________________ • Other Action Results: • Process Issues or Changes • Design Features within Department

22. FMEA Process for Testing Adjacencies • ICU Patient Transport to Surgery, Radiology • ER Patient Transport of Critical Patients to Radiology, ICU • Behavioral Health Patient under Police Custody • Transportation of Patient from Emergency to Mental Health Registration Blood Tissues for Examination Supplies Waste (Infectious/Clean) Laundry Lab Draws Environmental Concerns (Can/Glass/Paper/Plastic) Pharmacy Food

23. Following FMEA for adjacencies the following changes were made: • Mental Health next to ER • ICU next to Radiology • 1st Floor Surgery, Radiology, Mental Health, ICU, & other services • Med/Surg – 2nd and 3rd floor • OB (New Life Center) on 2nd w/own C Section Room

24. Our Patient Safe Room

25. Process Redesign • Six Sigma, Lean Manufacturing, Human Factors, Safety Design Principles • Pharmacy • Logistics • Scheduling • ER Thru-put