Implementing a SAFE Infrastructure By: Dana M. Langness, RN, BSN, MA Senior Director Perioperative Services Regions H

2. July 2003 – Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery™ approved by Joint Commission. Became effective July 1, 2004 for all accredited hospitals, ambulatory care and office-based surgery facilities. Applicable to all operative and other invasive procedures. Safe Site Protocol

3. Universal Protocol included: pre-operative verification process; marking of the operative site; taking a ‘time out’ immediately before starting the procedure; and adaptation of the requirements to non-operating room settings, including bedside procedures. Safe Site Protocol

4. Safest in America’s (SIA) protocol development work built on the Universal Protocol Used learnings from surgical events to strengthen best practices Worked with the Institute for Clinical Systems Improvement (ICSI) to develop the “Safe Site Protocol for All Invasive, High-Risk or Surgical Procedures” protocol. Safe Site Protocol

5. Protocol Evolved with Event Learnings Summary of changes Added a second verification step for procedures involving implants. Added section specific to spine and other procedures involving levels. Removed the option of using an X to mark the procedure site – recommended physician’s initials. Surgeon performing the procedure marks the site. Safe Site Protocol

6. Protocol Evolved with Event Learnings Summary of changes (continued) Added recommendations for procedures involving multiple sites. Sites labeled on consent form and procedure site with appropriate number. Recommended pause, verbal verification and confirmation before each procedure site change. Added section on verification process for anesthesia prior to administration of sedation or regional anesthesia. Safe Site Protocol

7. Scope Patients of all ages having any type of invasive, high-risk, or surgical procedure performed in the operating room, clinic, procedural area, or at the patient’s bedside Includes processes involving patient consent and verification and marking of the invasive procedure or surgical site including any procedure involving laterality, levels, multiple sites/digits, or implants. Safe Site Protocol

8. Aims Outcomes – Eliminate wrong body part, wrong patient, wrong procedures. Processes – Improve adherence to the safe site protocol components. Safe Site Protocol

9. Hard Stop – The procedure is halted and will not proceed until the appropriate steps have been performed and/or discrepancies have been resolved. Intra-procedure Pause – Pause during the procedure(s); surgeon verbally indicates: Level(s) Internal laterality after a midline or orifice entry Implant information Invasive Procedure – Any procedure exposing patient to more than minimal risk. Includes, but not limited to, surgical entry, puncture or insertion of an instrument or foreign material into tissues, cavities or organs (Table of Invasive, High-Risk or Surgical Procedures). Safe Site Protocol

10. Laterality – any anatomical structure that occurs on both sides of the body, both internally and externally. Patient is reference for laterality; not clinician Level – any anatomical structures that include multiples linearly (e.g. spinal vertebrae, ribs). Possibles – possible sites and/or procedures listed on patient consent and decision to perform is based on findings of initial procedure. These should the same process for site marking and verification recommended for multiple sites.

11. Time-Out Verification – Full verification performed just prior to the start of the procedure where the entire team actively and verbally confirms: Patient’s identity Procedure to be performed Correct patient position Correct procedure side/site Necessary imaging, equipment, implants, or special requirements. Special Considerations Anatomical variations Outside events Definitions

12. Protocol Algorithm – outlines the process. Corresponding Footnotes – provide detail about the process components.

15. The Safe Site protocol provides the “what”; the SAFE SITE Roadmap is designed to help with the “how.” Roadmap is built on the protocol; incorporates additional learnings from Adverse Health Event Reporting. SAFE SITE Road Map

16. SAFE = Infrastructure needed to support the “SITE Bundle.” SITE = “SITE Bundle” (protocol steps)

17. Implementing a SAFE Infrastructure S = SAFE SITE Teams A = Access to information F = Facility Expectations E = Educate Staff & Patients

18. S - SAFE SITE Teams ACTION: Provide Support and Expectations for SAFE SITE Champions.  Senior Leadership has identified a: Physician Champion(s) for SAFE SITE. Operational Champion(s) for SAFE SITE in the OR. Operational Champion(s) for SAFE SITE in Other Invasive Procedure Areas.

19. S - SAFE SITE Teams

20. S - SAFE SITE Teams Adopt a Team Approach to Safe Site Surgery with an Interdisciplinary Team in the Operating Room to oversee and support the SAFE SITE work. Have a Designated Coordinator to oversee SAFE SITE Implementation (e.g., schedule Team Meetings, plan Staff Education). Individual Roles in the SITE Bundle (Patient Care Steps) are clearly defined and documented for the OR.

21. A - Access to information Real-time documentation of the completion of the SITE Bundle steps for all Interdisciplinary Team members involved in the procedure (e.g., a pre-procedure checklist).

22. Audit the completion of the SITE Bundle through Chart Audits. Audit the effective completion of the SITE Bundle through Observational Audits. Develop Standard Criteria for Auditors. A - Access to information

23. Have a process in place for reporting near-miss wrong site, wrong patient, and wrong procedure events. A - Access to information

24. A - Access to information Have a process is in place to gather staff perceptions of the safety culture in the OR. Have a process is in place to gather staff perceptions of the safety culture in other invasive procedure areas.

25. A - Access to information Review and analyze data on a regular basis for learnings and improvement opportunities. On a regular basis share data: Within and across teams With senior leadership With the facility’s medical staff

26. F - Facility Expectations Senior Leadership has set clear expectations for effective completion of the SITE Bundle: Prior to any surgical procedure Prior to any invasive procedure

27. F - Facility Expectations Institute a Level I Hard Stop if the site has not been signed or the informed consent and verification process has not been completed and reconciled. Level I Hard Stop = the patient is not moved into the OR (or other invasive procedure area, if possible). Institute a Level II Hard Stop if an active, verbal time-out by the full team has not been conducted. Level II Hard Stop = staff do not complete any additional steps to begin the surgery)

28. F - Facility Expectations Have a process in place to determine at-risk or reckless behavior, and the consequences, when the SITE Bundle steps are not completed regardless of whether or not an adverse event occurs. Medical staff policies address safe site surgery and other invasive procedures and include expectations for following the SITE Bundle.

29. F - Facility Expectations Senior Leadership clearly communicates that all staff are expected to speak up, and will be supported in speaking up, when safety issues are noted.

30. E - Educate Staff and Patients Expectations and supporting education are incorporated into new employee orientation for all staff, including new surgeons and the provider, involved in invasive procedures. Ongoing SAFE SITE clinical staff education is provided at least annually.

31. E - Educate Staff and Patients Patient/family safe site procedure education tools are disseminated as appropriate.

32. Questions?