Editorial Commentary

As the world of health care becomes more and more complex and technology appears to rule the day, it seems imperative to take a breath and get
back to basics. Ethics infiltrates every aspect of professional practice and conflicting agendas seek to draw us away from the primary goal of all
health care practice; patient safety. Countless times each day, we make decisions, great and small, that affect our patients. Seamlessly, we incorporate
our education, experience, and hopefully a solid ethical foundation, in an effort to avoid life- and career-altering errors. One hospital has incorporated
a structure to integrate a collaborate approach to keeping patients safe.

When one hears the phrase "time-out," it takes us back to our childhood when these words were used as a discipline technique by many parents or a
sporting event where there is a pause in the action. Today, as professionals in the health care environment, the phrase "time-out" is used to prevent
patient harm and near misses. Wrong-site surgery can have devastating consequences for the patient and a negative impact on the entire surgical team
(Kwan, 2006).

This is a true story that occurred in an operating room (OR) while visiting a hospital outside of New York City, before "time-out" was implemented.
It all started when the nurse came into the OR to relieve the scrub person for lunch. When the relief person arrived, the OR was already set up and the
patient was positioned and had been intubated for surgery. The patient was scheduled for a right-sided procedure and the team had started to prepare
the patient for surgery. While the scrub nurse was rechecking the setup, she had a strong intuition about verifying the surgical site. She checked the
surgical schedule, which confirmed a right-sided procedure, but while looking at the patient, she realized that the patient was draped and positioned
revealing his left side. The schedule and surgical consent were then quickly rechecked by the circulating nurse, and both confirmed that right-sided
surgery was to be performed. The nurse felt her heart pounding faster and harder and yelled, "STOP!"

She said, "The schedule says, "RIGHT" as does the informed consent, but the patient is positioned with the left side up." Everything stopped. The
next step was to review the radiographs that were on the view box; that is when it was discovered that someone had hung the radiograph upside
down. This was a last-minute near miss that could have resulted in a sentinel event, with adverse consequences for all involved.

A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury
specifically includes loss of limb or function. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a
significant chance of a serious adverse outcome. (The Joint Commission, 2013, p. SE-1)

The consequences of such an error would impact the patient and his family, the surgeon, the staff, and the hospital itself. Clearly, the surgeon, the
staff, and the hospital would have had professional liability exposure for malpractice.

The Institute of Medicine published "To Err Is Human: Building a Safer Health System" (Kohn, 2000), revealing that many clinicians were unaware
of the numerous surgical-associated injuries, deaths, and near misses that occurred because there was no formal process for recognizing, reporting,
and tracking these events (Mulloy & Hughes, 2008). Wrong-side/site surgery is of great concern and includes surgeries or procedures performed on
the wrong laterality or site of the body. A "wrong-patient" or "wrong-surgery/procedure" is another concern, as it encompasses a procedure or
surgery being performed on a wrong patient (Carayon, Schultz, & Haundt, 2004). No error is acceptable.

Reporting sentinel events to The Joint Commission is voluntary and may represent only a small percentage of actual events. Currently, 26 states are
considered adverse event-reporting states. New York and New Jersey are states that voluntarily report to The Joint Commission, but even if you are
in a state that does not voluntarily report such events, there is still no excuse for these errors. Resources have confirmed that the reported numbers are
low, indicating wide variations in the number of wrong-site surgeries: one of 27,686 cases or one of every 112,994 surgeries (D'Ambrosia &
Kilpratrick, 2002).

In response to the occurrence of these preventable errors, on January 1, 2003, The Joint Commission issued two National Patient Safety Goals
(NPSGs), targeting wrong-site surgery:

NPSG 1 Goal: To improve the accuracy of patient identification by using two patient identifiers and a "time-out" procedure before invasive
procedures.

NPSG 4 Goal: To eliminate wrong-site, wrong-patient, and wrong-procedure surgery using a preoperative verification process to confirm documents
and to implement a process to mark the surgical site and involve the patient/family. (The Joint Commission, 2013)

One cause of wrong-site/side surgeries/procedures is a lack of a formal system verifying the correct site/side of surgery or a breakdown in the system
that verifies the correct site/side of surgery (Saufl, 2004). The goal to dramatically reduce or completely eliminate the incidence of wrong-site/side,
wrong-patient, and wrong-surgery can be accomplished by using a standardized perioperative process for the verification of the correct patient,
correct site/side, and correct procedure, as well as the physician marking the site with his or her initials. Patient participation in this process is
essential. This standardized process should to be used in ambulatory centers, procedural areas, bedside, and office-based settings or wherever the
potential for a wrong-site/side exists (Saufl, 2004).

The OR is a fast-paced and production-driven environment coupled with time constraints that foster the incidence of adverse events, which may
result in patient harm or death. Wrong-site/side, wrong-procedure, and wrong-person surgery can and must be prevented. The Universal Protocol for
prevention of wrong-site/side, wrong-person, and wrong-surgery is based on research that drives safe practice in high-risk areas. The value of
teamwork and communication has been studied for years in several high-risk industries, such as aviation. The cockpit and OR are similar, as they are
both high-risk learning environments; to some degree these two environments are interchangeable. Numerous findings suggest that current
weaknesses in the OR may be the result of a lack of standardization and team integration. The solution may be a standardized checklist for use in the
OR. The Universal Protocol provides structure in how critical communication takes place and ensures that no breakdown in communication occurs,
not unlike air traffic control. The advent of the "time-out" has applications throughout the health care environment and has proven to be a very
important tool in the organ transplant center. Organ verification is incorporated into our 10-element "time-out" protocol.

Where does the case manager fit in? The value of utilizing case managers in the perioperative process can go a long way to eliminate these
preventable errors. It is imperative that the perioperative nurse formulate partnerships with inpatient units/departments around unit care transition to
decrease fragmentation of care and increase patient and staff satisfaction. While the OR focusses on highly technical, production-driven end results,
case management integrates many factors including patient and provider satisfaction, cost factors, and providing a means of managing the
individual's health concerns (Yamamoto & Lucey, 2005). Case management intrinsically come from a global approach to patient care and affords
nurses the opportunity to demonstrate their roles in multidisciplinary health care teams. By using the case management approach, "nurse case
managers can optimize client self-care, decrease fragmentation of care, provide quality care across a continuum, enhance a patient's quality of life,
decrease length of hospitalization and promote the cost-effective use of scarce resources" (Yamamoto & Lucey, 2005, pp. 171-172). The nurse case
managers' and the perioperative nurses' roles are similar in their approach to patient and family education. While the perioperative nurse reinforces
the expectations of the operative course, case managers draw upon the support of the family to assist in the patient's short- and long-term recovery.

The role of the case manager in the perioperative process incorporates patient and family teaching while providing guidance for the multidisciplinary
staff. The goals of the nurse case manager in the surgical aspect of education are to "maximize outcomes, minimize cost, and support independence in
health and wellness" (Yamamoto & Lucey, 2005). This can be quite a challenge for the case manager, as some patients arrive just hours before
surgery or, as in most cases, the case manager opens "the case" only after the patient leaves the OR. However, as the health care system continues to
change, the role of the case manager will continue to evolve with the focus on preoperative interventions, in order to promote the patient's optimal
health care continuum and safety. This is an area that requires additional planning and team building to maximize the benefit to patients.

Evidence-based practice and research are integral to improved patient care and outcomes. Despite studies that show evidence-based practice is better
for patients and is associated with increased nurse engagement, nurses report that research findings are implemented in their hospital less than 50% of
the time. The hospital must be committed to building a culture of inquiry and meaningful self-assessment by facilitating evidence-based practices and
research in the clinical setting. An underlying problem in improving surgical safety is its complexity. Even the most straightforward procedures
involve dozens of critical steps; each with an opportunity for error, failure, and the potential for injury to the patient. From identifying the correct
patient, sending the correct patient to the OR suite, and identifying the operative site correctly and the surgeon selecting the correct procedure to
providing appropriate sterilization of equipment, following the multiple steps involved in safe administration of anesthesia, and orchestrating the
operation, OR, and their preoperative admission and floor personnel have had little guidance or structure for fostering effective teamwork and
thereby minimizing the numerous risks to surgical patients. The aim of the "Safe Surgery Saves Lives Program" is to remedy these problems (World
Health Organization [WHO], 2009). The goal is to improve the safety of surgical care around the world by defining a core set of safety standards that
can be applied in all countries and settings. The established framework for safe intraoperative care in hospitals involves a routine sequence of events.

These practices can be:

Highly recommended: A practice that should be in place for every operation.

Recommended: A practice that is encouraged for every operation.

Suggested: A practice that should be considered for any operation. (WHO, 2009)

The WHO Guidelines for Safe Surgery are central to this effort. Highly recommended practices are what each OR should implement.

The highly recommended practices are as follows:

 Before induction of anesthesia, a team member should inform the team that the patient is correctly identified, usually verbally with the
patient and with an identity bracelet, and should have a second identifier, such as date of birth.
 Confirm that informed consent was given by the physician for the correct surgery and that documentation confirms the correct site and
procedure with the patient.
 The site should be marked by the surgeon and be clearly visible.
 The OR team should collectively verify the correct patient site and procedure during a "time-out" or pause before skin incision. Again here,
patient participation before anesthesia can eliminate errors.

Utilization of a checklist reinforces established safety practices and ensures that beneficial preoperative, intraoperative, and post-operative steps are
undertaken in an orderly, timely, and efficient way. The checklist approach has several advantages. Checklists help memory recall, especially for
mundane matters that are easily overlooked in patients with critical, time-sensitive, dramatic, and distracting conditions. Checklists clarify the
minimum expected steps in a complex process. By helping a team work together, checklists establish a high standard of baseline performance. They
are particularly applicable to the OR setting where checklists have been used successfully around the world (WHO, 2009).

New York Presbyterian Hospital's Policy U100. "Universal Protocol for correct patient, procedure, site/side verification" outlines the "time-out"
processes as an active process involving all team members. Led by the attending physician, surgeon, or provider performing the procedure, the "time-
out" process begins after surgical draping and immediately prior to the incision/procedure. All staff members in the room cease all activity and
maintain a zone of silence during the time-out. The time-out elements include the following:

1. Patient verification using two identifiers.

2. Verification of correct procedure.
3. Verification of correct site(s)/side(s)/level(s): Required marking must be visible.
4. Correct position.
5. Verification that implants and equipment are available.
6. Relevant images (i.e.. radiographs, scans) are displayed and properly labeled.
7. Allergies, if any.
8. Antibiotics: Name, time, and dose administrated and/or to be administered.
9. Safety precautions based on fire, hazards, patient history, or medication use.
10. Verbal agreement that all time-out elements have been met.

Implementing and adhering to this protocol will eliminate wrong-site/side, wrong-patient, and wrong-surgery errors. All health care personnel must
be knowledgeable of the Universal Protocol and consistently adhere to the three key elements-patient identification, site marking, and "time-out"-to
eliminate or greatly reduce the number of procedural or surgical errors that occur in the United States.

Conclusion

The OR and procedural areas are complex environments that create many challenges to optimal clinical outcomes. Nevertheless, when all operative
team members are competent in their individual roles, yet work collaboratively exhibiting expertise as a team by utilizing the Universal Protocol,
patient safety is achieved with consistent, positive outcomes. All health care professionals have a responsibility and obligation to comply with the
Universal Protocol and are empowered to speak up in order to promote patient safety (Watson, 2006). In that "time-out" moment of silence, patient
safety is protected and confirmed.