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Fig. 3.1 Adverse event reporting systems. (From Hanlon C, Sheedy K, Knifn T, Rosenthal
J.Guide to State Adverse Event Reporting Systems. November 2014. Used with permission from
the National Academy for State Health Policy. https://nashp.org/wp- content/uploads/2015/02/2014_
Guide_to_State_Adverse_Event_Reporting_Systems.pdf)
G. Molina and A. Haynes
Although the classication of events as never events, serious reportable events,
and/or sentinel events is instructive when creating solutions to ameliorate or prevent these events, the degree to which they are preventable should be taken into
account. The concept of preventable medical errors establishes an additional layer
of granularity to how we report, investigate, and create solutions to medical errors.
In 2013, more than 400,000 deaths per year were attributed to preventable medical
errors occurring in hospitals [9]. Additionally, the NQF estimated that 90,000
deaths can be attributed to healthcare-associated infections, and that these infections cost the healthcare system more than $4.5 billion [10]. In response to these
staggering statistics and associated costs, in 2008 the Centers for Medicare and
Medicaid Services (CMS) implemented a nonpayment policy for costs associated
with preventable errors and medical mistakes [11]. Studies evaluating the effect of
the CMS nonpayment policy have shown mixed results. After implementation of
the CMS nonpayment policy, there were no signicant changes in the incidence
of catheter-associated urinary tract infections or catheter-associated bloodstream
infections [12]. However, there was a signicant reduction in the incidence of
hospital-acquired pressure ulcers after implementation of the CMS nonpayment
policy [13].
The concept of never events provided a powerful incentive to develop qualityimprovement initiatives and programs that targeted the reduction of medical errors
and consequently improved the safety of healthcare. These initiatives have taken the
form of timeouts, debriengs, skin marking, and checklists. Throughout this chapter
we will review these concepts and provide guidance from lessons learned on how to
more effectively implement these programs to make healthcare safer for all.
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Timeouts andDebriefings
Creating a work-environment culture that promotes safety requires intentional steps
that invite members of the team to share their insights and expertise. Many organizations have adopted the concepts of timeouts, briengs, and debriengs. These can
be used in the context of an organization or an operating room at the start and conclusion of the workday. Conversely, timeouts, briengs, and debriengs can be used
in reference to a surgical procedure. We will predominantly focus our discussion of
these concepts to the latter context, that of a patient undergoing a surgical procedure.
A timeout usually takes the form of reviewing pertinent information before the
start of a surgical procedure. A timeout is similar to a brieng, which can take the
form of a coming together to discuss potential issues that may occur before that start
of a shift or a surgical procedure. The Institute for Healthcare Improvement developed the concept of “safety briengs,” which were designed to “increase safety
awareness among front-line staff and to help develop a culture of safety” [14].
Thinking of a timeout as a “safety brieng” can be instructive, and appropriately
highlights to participants its value in keeping the patient safe. A debrieng can take
the form of discussing what procedure was performed, whether there were any
unexpected events, and whether there are any specic post-procedure aspects of
care that should be discussed with all team members. Timeouts and debriengs are
essential components of safe surgical care that promote exchange of critical information at important points in time during the care of surgical patients, sometimes
referred to as pause points. A timeout must occur before the surgical procedure
begins, and a debrieng typically occurs before the patient is transported to the next
location of care, such as the post-anesthesia care unit (PACU) or Intensive Care Unit
(ICU). Timeouts and debriengs allow for a routine pause point to discuss and
review important information that all team members should be aware of, either
before the start of or at the end of a surgical procedure, before moving onto the next
stage of care.
Furthermore, timeouts and debriengs can be components of a program to
improve the safety of surgical care at a facility. A comprehensive program to
improve the safety of surgical care at a hospital or facility is multifactorial and can
include multiple interventions. Timeouts and debriengs can serve as “entry” interventions since their contribution to the safety of patient care and to the improvement
of workow systems can be clearly outlined to prospective participants. The lessons
learned in implementing timeouts and debriengs can inform future efforts to
improve other aspects of patient care, including implementing more transparent
reporting systems for medical errors, team crisis simulation, and/or implementation
of surgical safety checklists.
Fundamental Elements
Fundamental elements of effective timeouts and debriengs include the following
characteristics: (1) they should be a psychologically safe environment for all participants; (2) they should be routine and expected at the beginning (e.g., timeouts) and
conclusion (e.g., debrieng) of every procedure and, in the case of debrieng,
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G. Molina and A. Haynes
before the patient is transported to the next level of care; (3) they should be led by
at least one of the participants; (4) all profession-specic teams should contribute;
(5) they need to take priority over all other activities; and (6) they should be adapted
and modied as needed according to the hospital, facility, specialty, etc. We will
further elaborate on each of these six fundamental elements of an effective timeout
and debrieng.
Safe Environment
Team psychological safety, a construct rst introduced by Edmondson, is dened as
“a shared belief held by members of a team that the team is safe for interpersonal
risk taking” [15]. Timeouts and debriengs, therefore, should be characterized as
being a safe space for all participants to take part in. These team activities should
not feel rushed or rehearsed. They should never take on the tone of being judgmental or of identifying who to blame for what may have gone wrong or for lack of
knowledge. When participating in a timeout or a debrieng, members of each profession in the operating room should contribute essential information that is pertinent to their respective roles. For example, in a debrieng, the surgeon should state
what procedure was performed, whether there were any unexpected aspects of the
procedure, and whether there are any aspects of the post-procedure care that are
non-routine or out of the ordinary. Additionally, the surgeon can use his/her judgment on whether to share other aspects of the post-procedure care that may not be
intuitive or that may not be known by all the team members present. The surgeon
should feel comfortable in voicing any additional information that he/she feels
would be important to share. The same principles apply to an effective timeout.
Additionally, these moments are opportunities to share ideas for possible process
improvements through discussions of what went well and what would make things
better next time.
Routine andExpected
Timeouts and debriengs should be routine and an expected aspect of what happens
before the start of the procedure and at the conclusion of every procedure or team
activity. Specic to debriengs, they should happen when all critical aspects of care
have been provided and before the patient is transported to the next level of care.
When all participants expect a debrieng at the end of a procedure, it serves as a
pause point for the exchange of information that team members can save until this
point of the case. By making this routine, participants can save questions about the
name of the procedure, where the patient is going, and other questions related to the
care of the patient that is perceived to be essential. This also allows for these activities to be incorporated into the workow and for the development of a culture of
communication that prioritizes explicit information sharing and focus on
patient safety.
Led by aMember oftheOperating Room Staff
One member of the operating room staff should be the designated person to initiate and lead the timeout and debrieng although it is not necessary that it be the
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same person who leads both activities. At many hospitals, the circulating nurse is
the designated person who customarily initiates and leads the timeout and debriefing. The circulating nurse will ask if this is an appropriate time to perform the
timeout before the patient is brought into the operating room, and then the debriefing at the conclusion of the procedure. These questions are targeted to all staff in
the operating room, ensuring that each member has an opportunity to speak. Many
times, it is clear that it is an appropriate time to perform the timeout or debrieng,
and other times it is not. Having the person who has been designated to initiate
these activities ask whether it is an appropriate time to perform them allows all
members the opportunity to conrm that they are able to solely focus on the task
at hand.
Invitation toSpeak andContribute
By designating the person who will initiate and lead the timeout and debrieng,
this person can be instructed to ask each of the respective teams to contribute to
the discussion. At many institutions, the circulating nurse asks the surgeon to state
the name of the procedure as the initiation for the debrieng. The circulating
nurse then conrms the specimens that were sent (or are being sent, depending on
institutional policies) to pathology. He or she then conrms whether the instrument, needle, and gauze/sponge count were correct. Finally, he or she will ask the
surgeon and anesthesiologist if there were any unforeseen aspects of the surgery
and anesthesia and whether there are any foreseen issues with recovery. Although
it is essential that one participant be the designee for initiating and leading the
debrieng, this should not prevent any member of the operating room staff from
speaking up or contributing information that he/she identies as being important
to share with the group. Of note, a qualitative analysis of implementation of
debrieng programs at four hospitals identied that oftentimes the surgeon was
looked upon as having the responsibility to create an environment that promoted
open communication [16]. Therefore, it is essential for the surgeon to ensure that
his or her behavior is contributing to an environment conducive to effective communication. Brindle and colleagues found that the surgeon could accomplish this
by actively asking all members to contribute to the debrieng, giving voice to all
team members.
Priority over all Other Activities
A timeout should occur before any aspect of the surgical procedure is performed
and is part of the Joint Commission Universal Protocol. Operating room team members should not be distracted with other tasks while performing the timeout.
Therefore, the timeout should be performed immediately before the surgical incision is made, at a point where plans can still be changed if information revealed so
dictates. Conversely, the debrieng should occur at the conclusion of the procedure
or team activity. There should be no remaining critical tasks. This is essential
because all participants should be solely focused on the debrieng. If there are other
critical tasks to be performed, then participants are not able to exclusively focus on
debrieng. This may lead to failure to properly share or receive information that all
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G. Molina and A. Haynes
team members should know, and it might also lead to misinformation if the patient’s
condition changes. It would be helpful if institutions clarify when debriengs should
occur in relation to extubation of the patient and closure of the skin incision.
Performing the debrieng before these two tasks may be appropriate, but all members should be prepared to debrief again if the patient cannot be extubated as was
originally expected, or if there are issues with wound closure that change the management of the patient postoperatively.
Adapted andModified
Like most quality and safety tools, the timeout and debrieng processes should be
modied and adapted to the level of the institution, facility, or specialty. At the level
of the institution or facility, there are critical components of the timeout and debriefing processes that pertain to all procedures and ought not to be signicantly modied. These critical components include (1) name of procedure, (2) non-routine
aspects of the procedure, and (3) non-routine aspects of the anesthetic care.
Furthermore, debriengs may include the following other critical components: (a)
conrmation that the instrument, needle, and sponge/gauze count were correct; (b)
identication of the specimens that were sent or are being sent to pathology; (c)
location to which the patient will be transported after he/she leaves the operating
room, and (d) aspects of the postoperative care plan that may be out of the ordinary
or specic for the procedure at hand. Furthermore, the debrieng can also include
aspects of care that are pertinent to the procedure that was just performed. This
could include activity restrictions for vascular or orthopedic procedures, pain control, or any aspect of care that is important at the facility level or for the specic
procedure.
Successful Implementation ofaTimeout or Debriefing Program
A timeout or debrieng program can be part of a larger quality-improvement initiative or program that is being implemented across a facility or hospital or a standalone program to test the success of implementing larger programs in the future.
Implementation of a debrieng program is enhanced by having many of the following [16]:
1. Early and strong leadership support
2. Active involvement and participation by senior clinical leadership through par-
ticipation in, or observation of, debriengs
3. Relevant strategies to sustain the practice of performing effective debrieng
after the initial implementation phase (e.g., aligning participation in debrieng
training with credentialing and/or granting/maintenance of operating room
privileges)
4. Engagement of on-the-ground clinician leaders
Many, if not all, of these factors are also important for successful implementation
of any type of quality and safety intervention, including implementation of a timeout program.
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Skin Marking
Skin marking has become a universally accepted aspect of the pre-procedure process
to ensure that the right procedure is being performed on the right patient, on the right
side, and on the right site. The Joint Commission has incorporated skin marking into
the Universal Protocol, which they have called their “Speak Up” initiative [17]. The
Universal Protocol, or “Speak Up” includes the following three components: (1) conducting a pre-procedure verication process, (2) marking the procedure site, and (3)
performing a timeout. The Joint Commission states that the Universal Protocol has
the aim of “preventing wrong site, wrong procedure, wrong person surgery.”
The Joint Commission through its Universal Protocol outlines several aspects of
skin marking which, in our opinion should always be observed. For starters, there
are few surgical procedures for which a skin marking should be omitted. For surgical procedures on sites and/or patients that cannot be easily or safely preoperatively
marked, an alternative form of conrming the right location preoperatively should
be employed. The Joint Commission lists potentially extraneous sites or situations
that may not be conducive to preoperative site marking and these include: (1) mucosal surfaces or perineum, (2) minimal access procedures treating a lateralized internal organ (percutaneous or through a natural orice), (3) teeth, and (4) premature
infants (since skin marking may lead to permanent marks/tattoos). For these procedures/patients, an alternative process should be created, adopted, and effectively
implemented at the facility level. The alternative should come as close to as possible
to marking the site of interest. In these circumstances, all members of the operating
room team should be present, especially all members of the surgical team who will
be performing the procedure. The goal is to correctly identify the site that will
undergo a surgical procedure. The other important aspects of the Universal Protocol
that are identied by the Joint Commission should also be kept in mind when formulating this alternative process for patients/procedures/surgical sites that cannot
be readily or safely marked preoperatively.
Patient Involvement
An important recommendation that the Universal Protocol includes is encouraging
the involvement of the patient when the planned site for the surgical procedure is
marked. Involving the patient serves multiple purposes, including making sure the
patient understands the surgical procedure that is being prepared for, and making
everyone aware of the patient’s expectations. Furthermore, this action empowers the
patient to take an active role in their surgical care, something he/she cannot do when
they are under general anesthesia. However, it also should be recognized that patient
identication alone is insufcient for site identication, as patients may have variable understanding of the location of lesion or targets for procedures. Ultimately, all
these measures, including surgical marking and the Joint Commission Universal
Protocol, center on keeping the patient safe during surgery. Involving the patient
ensures that the patient is invested and actively participating in ensuring their own
safety. This can serve as a powerful message to not only the patient, but also to all
healthcare providers involved in the surgical care of the patient.
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Other Important Aspects ofSkin Marking
Other important aspects of skin marking that should be addressed include the following: (1) making sure that the skin marking happens preoperatively, and (2) making sure
that how the site is marked follows a hospital/facility standard. Ideally, we recommend
that the site be marked in the pre-induction/preoperative area. This allows for the
patient to conrm that indeed the correct site is marked, and for collateral information
to be checked (e.g., photos, radiographs, other documentation) to conrm location for
the procedure. Furthermore, this also allows for all members of the operating room,
including the circulating nurse and anesthesiologist, to understand the site that will be
operated on and/or voice any concerns they may have. In particular, the circulating
nurse and/or the anesthesiologist may have had a different understanding of what the
surgery was going to entail, based on the patient chart compared to the site that was
marked by the surgeon and/or surgeon-assistant (e.g., resident, fellow, or physician
assistant). Secondly, there should be a hospital/facility-level standard on how the site
marking is performed. For example, the site marking may take the form of the initials
of the person doing the marking or take the form of an okay sign or something similar.
We argue that circling the site or drawing an arrow to the site plus placing your initials
is the best way to mark the site. We suggest such steps because they ensure that the site
itself is marked or easily pointed to and they also ensure that anyone who visualizes the
site marking can then identify who did the marking. This therefore requires that the
initials be clear and easily readable. Although skin marking may be implemented as a
stand-alone intervention, it works best when it is part of a larger quality and safety
initiative. In particular, incorporating skin marking with timeouts and debrieng can be
synergistic. The surgical safety checklist, which we will learn more about in the following section, incorporates many of the concepts we have already addressed, including
never events, timeouts, debriengs, and skin marking.
Checklists
Checklists are a relatively recent addition to the toolkit for quality and safety in
healthcare. Pronovost and colleagues produced an early example of a team-based
procedural checklist in healthcare with their work toward reducing catheterassociated bloodstream infections in intensive care units through the use of an
evidence- based intervention [18]. Building on the success of checklists for central
line placement, the World Health Organization (WHO) brought together an international group of experts who developed the WHO Surgical Safety Checklist. The
pilot study of this innovation was the rst international, multi-center study of a
surgical checklist that demonstrated signicant reductions in postoperative mortality and postoperative complications. Since that time, checklists have proliferated as
tools for team communication and perioperative safety and are used in a large proportion of operations all over the world [19]. Checklists have evolved to include all
aspects of a surgical patient’s experience; for example, the SURgical PAtient Safety
System (SURPASS) checklist is a comprehensive set of checklists that aims to
improve the entire surgical pathway before, during, and after the operation itself [20].
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Origins oftheWHO Surgical Safety Checklist
Checklists in healthcare have been inspired by the pilot preight checklist created
in response to the fatal crash on October 30, 1935, of the Boeing 299, referred to as
the “Flying Fortress” and later as the B-17 bomber [21, 22]. The United States
Army Air Corps, the precursor to the United States Air Force, held a competition for
a technologically advanced bomber aircraft. The major aircraft manufacturers of the
day—Boeing, Douglas, and Martin—entered the competition for the contract. On
October 30, 1935, a test ight competition was held in Dayton, Ohio; the Boeing
299, a four-engine airplane, was the favored aircraft. Unfortunately, at 300feet
above the ground the “Flying Fortress” stalled and crashed during its second ight
and two of Boeing’s senior test pilots died. Analysis of the crash found that the vemember crew had neglected to switch off the elevator locking mechanism, which
controls the movement of the airplane nose. Previous airplanes had historically had
this switch on the outside of the airplane. However, this technologically advanced
aircraft, the rst of its kind, had the elevator locking mechanism inside the airplane.
The pilots were not able to level off the airplane because they had failed to switch
off the elevator locking mechanism, and the airplane’s nose kept climbing. This led
to the plane stalling during takeoff and fatally crashing. The pilot preight checklist
was then created to avert mistakes when ying complex airplanes. The checklist did
not instruct the pilot on how to y a plane, instead it prompted the pilot to perform
essential tasks every time when ying a plane. This became important as the complexity of ying airplanes increased with more technologically advanced aircraft.
Crew resource management training, which focuses on improving teamwork and
communication among the aviation crew, was developed in tandem with the creation and implementation of the pilot preight checklist. The pilot preight checklist has been expanded to more extensive checklists that cover all aspects of safety
and quality when operating an airplane. Furthermore, crew resource management
training has become the standard when training aviation crews on how to work
together effectively (Fig.3.2).
Although there was no single event in surgical care that paralleled the fatal
Boeing 299 crash, the WHO Surgical Safety Checklist was the product of an effort
Fig. 3.2 The XB-17
(Model 299) crashed
during its test ight at
Wright Field on October
30, 1935. U.S.Air Force
photo. (Used with
permission from: https://
www.nationalmuseum.
af.mil/Visit/MuseumExhibits/Fact- Sheets/
Display/Article/610002/
model- 299- crash/)
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G. Molina and A. Haynes
to improve the safety and quality of surgical care throughout the world. A convening
was organized of experts from around the world in surgery, anesthesia, nursing, and
other aspects of perioperative care. This convening led to the creation of ten essential objectives that were considered fundamental to the delivery of safe and highquality surgical care (Table3.2).
The ten essential objectives are common to all surgical procedures, and they are
essential steps in the care of a surgical patient. They have the common underlying
quality that if they are not performed, the patient could be placed in serious risk of
harm. Importantly, none of them instruct healthcare providers on how to perform
their duties. Instead, they highlight important pieces of information that need to be
communicated among the operating room team members.
The rst objective is to ensure that the operation is being performed on the correct patient, side and site. The second and third objectives center on safe anesthesia
delivery. The fourth and fth objectives ensure readiness to respond to potential
emergencies during an operation, such as discussion of anticipated blood loss, and
acknowledgment of allergic reactions. The sixth objective addresses preventing or
controlling existing infections, and complications that may ensue. The seventh
objective covers the importance of correctly counting all surgical sponges and
instruments to ensure that surgical sponges and instruments are not left behind
inside the patient. The eighth objective highlights the importance of labeling all
specimens so that they reach their correct destination and so that they can be attributed to the correct patient. The nal two objectives address the importance of communication and exchanging critical patient information in a timely and effective
Table 3.2 Ten essential objectives for safe surgery
Objective 1 The team will operate on the correct patient at the correct site
Objective 2 The team will use methods known to prevent harm from anesthetic
administration, while protecting the patient from pain
Objective 3 The team will recognize and effectively prepare for life-threatening loss of
airway or respiratory function
Objective 4 The team will recognize and effectively prepare for risk of high blood loss
Objective 5 The team will avoid inducing an allergic or adverse drug reaction known to be a
signicant risk to the patient
Objective 6 The team will consistently use methods known to minimize risk of surgical site
infection
Objective 7
Objective 8 The team will secure and accurately identify all surgical specimens
Objective 9 The team will effectively communicate and exchange critical patient
Objective 10 Hospitals and public health systems will establish routine surveillance or
Used with permission from World Alliance for Patient Safety: The Second Global Patient Safety
Challenge, Safe Surgery Saves Lives. © 2008. Used with permission from World Health
Organization (WHO). https://www.who.int/patientsafety/safesurgery/knowledge_base/SSSL_
Brochure_nalJun08.pdf
The team will prevent inadvertent retention of sponges or instruments in
surgical wounds
information for the safe conduct of the operation
surgical capacity, volume, and results
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manner, along with measurement of surgical outcomes. These ten essential objectives were then transformed into a checklist with three pause points. These three
pause points are: (1) before induction of anesthesia, (2) before the skin incision is
made, and (3) before the patient leaves the operating room (Fig.3.3).
These three pause points were selected because they represented critical points
in the care of a patient in the operating room. These three pause points represent
moments of “no turning back.” For example, once anesthesia is induced, the patient
has undergone a critical aspect of care in the operating room that carries potential
risks and complications. The same concept applies to the other two pause points—
making the skin incision and the patient leaving the operating room for the next
phase of care (e.g., ICU or PACU). The checklist was structured around these three
pause points because certain actions should be performed every single time before
these points of “no turning back,” when intervention(s) to ameliorate lapses or problems is still possible. Similarly, certain critical pieces of information should be communicated to all healthcare members in the operating room before each of these
three pause points. For example, in the rst pause point, it is paramount to conrm
that the patient has provided consent for the planned procedure. Additionally, it is
important to identify and conrm the patient’s medication allergies, whether the
patient has a difcult airway, and what the expected risk of blood loss is. Similarly,
there are other essential tasks that should be performed at the other two pause points
before proceeding.
Fig. 3.3 World Health Organization, Surgical Safety Checklist in English. https://apps.who.int/
iris/bitstream/handle/10665/44186/9789241598590_eng_Checklist.pdf
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