Implementing a SAFE Infrastructure

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Implementing aSAFE Infrastructure By Dana M.
Langness, RN, BSN, MA Senior Director
Perioperative Services Regions Hospital, St. Paul
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Safe Site Protocol

• 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.

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Safe Site Protocol

• 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.

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Safe Site Protocol

• Safest in Americas (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.

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Safe Site Protocol

• 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 physicians
  initials.
• Surgeon performing the procedure marks the site.

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Safe Site Protocol

• 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.

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Safe Site Protocol

• 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 patients 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.

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Safe Site Protocol

• Aims
• Outcomes Eliminate wrong body part, wrong
  patient, wrong procedures.
• Processes Improve adherence to the safe site
  protocol components.

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Safe Site Protocol

• 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).

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Safe Site Protocol

• 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.

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Definitions

• Time-Out Verification Full verification
  performed just prior to the start of the
  procedure where the entire team actively and
  verbally confirms
• Patients 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

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Algorithm/Footnotes

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

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SAFE SITE Road Map

• 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.

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SAFE SITE Road Map

• SAFE Infrastructure needed to support the SITE
  Bundle.
• SITE SITE Bundle (protocol steps)

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Implementing a SAFE Infrastructure

• S SAFE SITE Teams
• A Access to information
• F Facility Expectations
• E Educate Staff Patients

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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.

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S - SAFE SITE Teams

• ACTION Provide Support and Expectations for
  SAFE SITE Champions (continued).
• The facility has a process in place to partner
  the physician and operational champions.
• Senior Leadership has defined roles, set
  expectations, and provides support for the
  champion(s).

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S - SAFE SITE Teams

• ACTION Adopt an interdisciplinary Team Approach
  to SAFE SITE with a designated coordinator for
  the operating room and to oversee implementation.
  

• 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.

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A - Access to information

• ACTION Verify the completion of each step of the
  SITE Bundle in Real-Time.

• 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).

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A - Access to information

• ACTION Audit the effective completion of the
  SITE Bundle.

• 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.

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A - Access to information

• ACTION Measure the outcomes of the SAFE SITE
  efforts.

• Have a process in place for reporting near-miss
  wrong site, wrong patient, and wrong procedure
  events.

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A - Access to information
ACTION Measure the culture in the OR and other
invasive procedure areas.

• 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.

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A - Access to information
ACTION Evaluate the SAFE SITE efforts for
learning opportunities.

• 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 facilitys medical staff

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F - Facility Expectations
ACTION Set expectations for implementation of
the SITE Bundle for any invasive procedure.

• Senior Leadership has set clear expectations for
  effective completion of the SITE Bundle
• Prior to any surgical procedure
• Prior to any invasive procedure

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F - Facility Expectations
ACTION Participate in a statewide effort to
institute a hard stop when the SITE Bundle is
not completed or until inconsistencies are
reconciled.

• 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)

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F - Facility Expectations
ACTION Hold team members accountable when the
SITE Bundle is not completed regardless of
whether or not an adverse event occurs.

• 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.

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F - Facility Expectations
ACTION Expect staff to speak up when they
become aware of a patient safety issue.

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

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E - Educate Staff and Patients
ACTION Provide SAFE SITE education for all
clinical staff involved in invasive procedures.

• 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.

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E - Educate Staff and Patients
ACTION Educate patients and families on their
role in SAFE SITE.

• Patient/family safe site procedure education
  tools are disseminated as appropriate.

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Questions?