James H. Abernathy, III, MD, MPH, FASE

1. RIPCHORD – Realizing Improved Patient Care through Human-Centered Operating Room DesignMapping and Graphically Analyzing Tasks as a Means to Understand and Inform Operating Room Design for Improved Safety Outcomes and Operational Efficiency James H. Abernathy, III, MD, MPH, FASE Assoc. Professor, Dept. of Anesthesia and Perioperative Medicine, The Medical University of South Carolina Scott Shappell, PhD Professor and Chair, Dept. of Human Factors and Systems, Embry-Riddle Aeronautical University David Allison FAIA, ACHA Alumni Distinguished Professor and Director of Architecture + Health, Clemson University Representing the RIPCHORD research team including Scott Reeves MD/MBA, Gary Palmer, Gregory Swinton and Joel Greenstein PhD

2. Presentation Overview • The Healthcare Problem • Safety & Outcomes • Efficiency • The Problem Context • The Architectural Problem • The Pilot Study • Graphic Methodology • Findings • Discussion

3. The Healthcare Problem • Improving Safety, Outcomes and Operational Efficiency in the OR. • Little understanding of the role the design of the OR in these issues • Lack of Human Factors research that links measures of safety to the physical design of the OR

4. The Problem Context IoM Report on Safety, 1999 • 44,000 to 98,000 people die each year from medical accidents • Cost of errors equals $17 billion to $29 billion • 20% = Surgical errors • 16% = Medication errors

5. Disruptions have been correlated with surgical errors (r = 0.67) 160 interruptions in flow per case In CT surgery 17.4 teamwork breakdowns per hour 87% of litigated surgical cases had a communication failure between providers 12.3 % of cardiac surgical cases suffer from a preventable error 7 % of surgical admissions have a human error 16 % of inpatients harmed by human error

6. “If medical errors were a disease, they would be the sixth leading cause of death in America—just behind accidents and ahead of Alzheimer's” Marty Makary, MD – Johns Hopkins General Surgeon WSJ – September 2012

7. Medical Errors kill enough people each week to fill 4 jumbo jets

8. Problem Context • Never Events in the OR

9. A Complex Milieu • Intense life and death event • Complex procedures • Lots of equipment • Many players • Surgeons • Nurses • Anesthesiologists • Perfusionists • Residents/Students • Transient Observers

10. Functional/Spatial Stages • Pre-Op: Room set up • Nurses set up and prepare sterile tables. Frequent trips to sterile core • Anesthesia personnel check machines, prepare medications and equipment • Perfusionists prime and prepare the cardiopulmonary bypass machine

11. Functional/Spatial Stages 2.Pre-Op: Patient arrival • Patient brought in by anesthesia team • Patient is greeted by OR team – Perfusionists, Nurses, Surgeons, Anesthesiologists • Induction of Anesthesia occurs which includes insertion of invasive monitors

12. Functional/Spatial Stages 3. Pre-Op: Patient Preparation • After induction of anesthesia • Anesthesia team: TEE performed • OR Team: Patient is positioned for the operation • Surgeons: Vein harvest site is identified

13. Functional/Spatial Stages 4.Pre-Op: Timeout • Structured conversation to ensure • right patient, • right operation • Ensure OR team is on same page

14. Functional/Spatial Stages 5.Pre-Op: Patient Prep • Patient is washed with chlorhexidine • Patient is wrapped and draped with sterile drapes • Anesthesia drape goes up

15. Functional/Spatial Stages 6. Operative Phase: Incision • OR nurse moves surgical instrument tables close to the patient • Surgeons make incision in patient chest • Anesthesiologist continue to monitor and treat patient vital signs • Perfusionists continue preparing bypass machine

16. Functional/Spatial Stages 7.Operative Phase: Chest Open • Patient’s chest is opened by surgery fellow • Left Internal mammary artery is harvested • Vein harvested from patient’s leg by attending surgeon

17. Functional/Spatial Stages 8.Operative: Bypass begun • Anesthesia confirms adequate anticoagulation and appropriate physiologic state for bypass • Perfusion moves equipment into place near patient and prepares lines • Surgery team inserts cannulas and as a group, patient is transitioned onto cardiopulmonary bypass

18. Functional/Spatial Stages 9.Operative Phase: Bypass Ends • Patient separated from cardiopulmonary bypass • Surgeons remove cannulas and bleeding stopped. • Scrub Nurse begins inventory of surgical materials/instruments • Heart-lung machine shut down and disconnected “teardown” begun by perfusionists

19. Functional/Spatial Stages 10.Operative: Chest Closed • Surgeons close chest • Scrub Nurse completes inventory of surgical materials and instruments • Anesthesia continues hemodynamic and hematologic management. • Perfusion moves heart-lung machine back or out of room • Perfusion boom returned to dormant position along wall

20. Functional/Spatial Stages 11.Post-Op: Transition • Surgical drapes and wraps removed • Instrument tables pushed back against wall • Anesthesia team prepares patient for transport to ICU

21. Functional/Spatial Stages 12.Post-Op: Patient Exit • Patient moved onto gurney from table • Patient transported back to recovery or ICU by remaining team members

22. Functional/Spatial Stages 13.Post-Op: Close out • Scrub and Circulating Nurses clean up remaining equipment and close out procedure

23. Functional/Spatial Stages 14.Post-Op: Room Turn-over • Environmental Service Staff clean up room • EVS staff sets up room for next procedure

24. Pilot Study Site: MUSC The Medical University of SC • Quaternary Care Academic Medical Center • Ashley River Tower [ART] opened 2008. • 10 OR Surgical Suite with clean core • 2 rooms dedicated to cardiac procedures • XX Cardiac procedures annually

25. RIPCHORD • Realizing improved patient care through human-centered operating room design (RIPCHORD) • Two industrial engineers with expertise in HF workflow disruptions observed 10 cardiac operations from entry into the OR until they left for ICU. • Each disruption was documented on an architectural layout of the OR suite and time stamped during phase of surgery (pre-operative, operative, post-operative).

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27. RIPCHORD • Our goal was to develop a standard taxonomy for observing flow disruptions • 1080 unique observations • Identified six main categories • Communication • Usability • Physical Layout • Environmental Hazards • General Interruptions • Equipment Failures

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33. Initial conclusions of RIPCHORD • Layout was the single largest contributor to flow disruptions in the cardiac OR. • Interruptions and usability continue to impact surgical flow, but communication failures occurred less than expected. • Environmental factors and equipment failures were infrequent • As expected, disruptions varied across phase of the operation with layout impacting pre-operative and operative phases • The perfusionist was differentially impacted by layout issues • Notably, nurses were most often impacted by interruptions

34. Historically Little Focus on Physical Environment/Layout Screened 1400 articles 55 studies involving error in cardiac surgery

35. The Architectural Problem • Most human factors research does not provide useful design related information on: • Physical movement between discrete tasks and work points • Configuration of the physical environment [equipment & room] • Physical barriers, obstacles and points of congestion

36. Traditional Human Factors Tools Link Analysis • Indicates functional linkages between activities and work points but not movement path[s] through space. • Does not indicate the real and potential physical constraints, and areas of congestion • Does not indicate points of potential risk or hazard.

37. Broad Architectural Questions • Does the physical configuration of the OR setting [both architectural space and movable equipment] impact clinical safety, outcomes and performance in the OR? • If so, can links between errors or more specifically task interruptions, critical clinical activities and the built environment be established, geographically anchored and visually documented?

38. Specific Architectural Questions • Where do critical activities and movements occur? • Where are the places of highest volume of movement and activity? • Where are the places of potential or actual hazards, constrained movement or high risk activity? • Are there co-relationships between task interruptions or errors, clinical movement and activities, and spatial elements?

39. OR Study Site • Room Area: • 662 NSF • Room Dimensions: • 29 x 24.6 Feet • Room Specs: • Surgical Boom • Anesthesia Boom • Perfusion Boom

40. Movement/Link Analysis Process

41. Movement Links: Pre-op Nursing – Anesthesia – Perfusion – Surgeons • Line density = frequency • Line width = physical movement path • There is a significant amount of movement and activity throughout the room by nursing, anesthesia and perfusion personnel in preparation for a procedure.

42. Movement Links: Operative • Instrument tables and perfusion equipment is moved close to the surgical table. • The circulating nurse, anesthesia and perfusion personnel continue to move about during the operative phase of the procedure.

43. Movement Links: Post-Op • Surgical instrument tables are moved back to wall • Perfusion equipment is moved back and broken down, tubing is unplugged and discarded • Patient is transferred to a gurney and taken to ICU or Recovery.

44. Interruptions: Pre-Op • Interruptions at the in-swinging entry door with the perfusion boom, perfusion equipment and personnel. • Anesthesia work area at the head of the table is congested, as there are three or more people working in the center of surrounding anesthesia equipment and supplies in tight quarters.

45. Interruptions: Operative • The perfusion area is a congested thoroughfare • Perfusion near entry door conflicts w traffic entering room • Access to patient side of equipment is behind surgeon • Anesthesia personnel continue to move about within their constrained workspace.

46. Interruptions: Post-Op • Conflicts continue at in perfusion area in general • Conflicts continue at the in-swinging entry door during transfer of patient and movement of gurney.

47. Recommendations • Expand anesthesia work space at head of table • Expand space for perfusion between table and wall and/or eliminate travel through area • Swing entry doors out and/or relocate closer to the footwall of the room.

48. IMPLICATIONS • Separately, layout and human factors play a critical role in surgical flow and patient safety. • However, when considered together the implications for healthcare architecture are magnified. • To fully understand the complexities of cardiac surgery and implications for surgical flow, a systematic approach to disruptions that include architecture, human factors, personnel, and traditional medicine are required.