THE USE OF SURGICAL SAFETY CHECKLISTS DURING TIME-OUTS IN RURAL AND
URBAN OPERATING ROOMS
A Dissertation
Presented to
The Faculty of the Graduate School
At the University of Missouri
In Partial Fulfillment
Of the Requirements for the Degree
Doctor of Philosophy
By
VANESSA LYONS, MSN, RN, CNOR
Dr. Lori Popejoy, Dissertation Supervisor
December 2015
The undersigned, appointed by the dean of the Graduate School,
have examined the Dissertation entitled
THE USE OF SURGICAL SAFETY CHECKLISTS DURING TIME-OUTS IN RURAL AND URBAN
OPERATING ROOMS
Presented by Vanessa Lyons, MSN, RN, CNOR
A candidate for the degree of
Doctor of Philosophy
And hereby certify that, in their opinion, it is worthy of acceptance.
Dr. Lori Popejoy
Dr. Bonnie Wakefield
Dr. Amy Vogelsmeier
Dr. Gregory Alexander
Dr. Mihail Popescu
DEDICATION
This work is dedicated to my family. To my best friend and husband, Evan, this
would not have been possible without your support. You have been there to encourage
me when I did not think I could finish. You were supportive when I was not home as
much as I wanted to be and picked up the slack I left behind. You worked just as hard as
I have on this project and your name should be on this work. To my children, Mariah,
Thomas, and Laya, you were my motivation to complete this project. The best way for
me to teach you the importance of education is to model it in life. Do not ever give up
your dreams because they are too hard. I do not know anyone who regretted their
education but I know plenty who regretted not continuing their education. I must also
mention my extended family: my mother, Janice Curtis; my in-laws, Tom and Deborah
Balash; and my siblings, Spencer Ervin and Ron and Susan Ervin. Every one of you
supported me when I needed it the most. Thank you for your love and encouragement.
ACKNOWLEDGEMENTS
I need to express my gratitude to many people for making this project possible.
First, I need to acknowledge my employer, Murray-Calloway County Hospital, and the
Perioperative Services Department. My directors, Norma Butler and Jill Asher, have
been the most supportive and accommodating employers for which anyone could hope.
Norma, you could not have imagined the Pandora’s Box you opened when you gifted me
my first membership to AORN. You lit a fire in me and fanned the flame for a passion for
perioperative nursing. Jill, you provided me everything I needed to finish this project.
You have been one of my biggest cheerleaders when I needed it the most. I could not
have done this without both of you. To my coworkers in surgery, you have been with
me through this entire journey. You are an amazing group of people and I am honored
to have the opportunity to work with you.
I also need to thank my Sunday School class, Tenderhearts, and my teacher,
Martha Parker. Everyone is this group has cried with me, prayed for me, and walked
with me during this entire process. Words cannot express my gratitude for everything
you have done to encourage and inspire me.
I would also like to thank the Sinclair School of Nursing for the support provided
during this experience. I could not have completed this project without the faculty, staff
and resources that were available to me during this program.
Finally, I must thank the members of my doctoral committee for their guidance,
leadership, support, and encouragement. Dr. Lori Popejoy, you have been an amazing
ii
mentor, advisor, and friend. You always knew when I needed a pat on the back or a kick
in the behind and never hesitated to give either one. Because of this, I will be eternally
grateful. Thank you for the opportunity to work with you, not only on this project, but
all of the other projects. I would also like to thank Drs. Greg Alexander, Amy
Vogelsmeier, and Bonnie Wakefield. You provided your time and expertise to help me
succeed and it has been an extraordinary experience. I am honored to have had the
opportunity to work with each of you. Dr. Mihail Popescu, thank you for serving on my
committee and the opportunity to work with you on the ontology project. It was a
challenging but enriching experience that provided immeasurable knowledge.
I am humbled by the support from so many amazing, talented, intelligent, and
caring individuals to help me reach my goals. Words can never express my appreciation
for everything you have done for me. Thank you for supporting me and sharing your
expertise with me during this process. I could have never done this without all of you.
iii
TABLE OF CONTENTS
Acknowledgements ................................................................................... ii
List of Illustrations................................................................................... vii
List of Tables .......................................................................................... viii
Abstract ................................................................................................... ix
Chapter One: Introduction ........................................................................ 1
Perioperative Patient Safety .................................................................................. 1
Time-outs and Checklists........................................................................................ 3
Compliance with Surgical Safety Checklists ............................................................. 4
Rural Population and Healthcare ............................................................................ 6
Time-outs and Rural Operating Rooms ................................................................... 7
Aims and Research Questions ................................................................................ 8
Chapter Two: A Meta-Analysis of Surgical Safety Checklists .................... 25
Abstract ............................................................................................................... 25
Introduction ........................................................................................................ 25
Method ............................................................................................................... 27
Sample Inclusion and Exclusion Criteria ................................................................ 28
Data Management Procedures ............................................................................. 29
Data Coding and Analysis ..................................................................................... 30
Results ................................................................................................................. 31
iv
Discussion ............................................................................................................ 33
Chapter Three: Methods ......................................................................... 52
Conceptual Model................................................................................................ 52
Study Design ........................................................................................................ 53
Study Setting and Population ............................................................................... 53
Procedure ............................................................................................................ 54
Measurement instrument .................................................................................... 54
Data Analysis ....................................................................................................... 56
Human Subjects Involvement and Characteristics ................................................. 56
Sources of Materials ............................................................................................ 57
Potential Risks ..................................................................................................... 57
Recruitment and Informed Consent ..................................................................... 57
Protections against Risks ...................................................................................... 58
Potential Benefits of the Proposed Research to Human Subjects and Others ........ 58
Importance of the Knowledge to be Gained ......................................................... 58
Summary ............................................................................................................. 59
Chapter Four: Results .............................................................................. 62
Abstract ............................................................................................................... 62
Introduction ........................................................................................................ 62
Background ......................................................................................................... 63
Methods .............................................................................................................. 65
Results ................................................................................................................. 67
v
Discussion ............................................................................................................ 72
Conclusion ........................................................................................................... 75
Chapter Five: Discussion.......................................................................... 88
Abstract ............................................................................................................... 88
Introduction ........................................................................................................ 89
Barriers to Successful Implementation ................................................................. 91
Keys to Successful Implementation ...................................................................... 93
Conclusion ........................................................................................................... 98
Chapter Six: Conclusion ......................................................................... 109
Vita ....................................................................................................... 156
vi
LIST OF ILLUSTRATIONS
Figure
Page
1. Surgical Safety Checklist Search Results ........................................................... 47
2. Donabedian's Structure, Process, Outcome Model in the Perioperative Setting 53
3. States Represented in Study ........................................................................... 68
vii
LIST OF TABLES
Table
Page
1. WHO Surgical Safety Checklist ......................................................................... 48
2. Surgical Safety Checklist Studies Included in Sample ....................................... 49
3. Results of Surgical Safety Checklist Meta-Analysis............................................ 51
4. Sample Demographics ..................................................................................... 85
5. Time-Out Process Results ................................................................................ 86
6. Checklist Content ............................................................................................ 87
7. Recommendations for Successful Surgical Safety Checklist Use .......................108
viii
ABSTRACT
The purpose of this study was to examine the time-out process and checklist use
immediately prior to incision in rural operating rooms. Operating rooms continue to be
one of the most common locations for adverse events such as wrong site surgery and
retained foreign items, despite interventions aimed at reducing the occurrence of these
adverse events. Surgical safety checklists were introduced by the World Health
Organization as a tool to improve perioperative patient safety. Operating room safety
impacts both urban and rural operating rooms, and little research has been completed
examining surgical safety practices in rural operating rooms. Research indicates that
urban and rural hospitals are influenced by different factors such as financial influences
and patient mix but how these factors affect patient care is unknown. This study used
Donabedian’s framework of structure, process, and outcome to examine the current
time-out process and checklist use in rural and urban operating rooms with a
comparison of current practice and the standards of care from The Joint Commission
and recommended practices from the Association of PeriOperative Registered Nurses
(AORN). Adherence to recommended practices were measured through a survey of
intraoperative nurses. Seventy-seven rural and forty-seven urban nurses completed the
survey. Time-outs were completed by almost all subjects (98.7% rural [n = 76], 100%
urban [n = 47]) but compliance was lower for verbal confirmation from team members
(66% rural [n = 50], 75% urban [n = 35]) and for the cessation of all other activities
(55.8% rural [n = 43], 57.4% urban [n = 27]). Rural (83%, n = 63) and urban (85%, n = 40)
ix
respondents report using a checklist during the time-out. Checklist items most often
included in the time-out include the patient’s name, consent, site marking, and
antibiotic administration. Checklist content were less likely to include team names,
anticipated case duration, and surgeon’s anticipated critical or non-routine steps. Urban
nurses were significantly more likely (58% [n = 22] vs. 25% [n = 15], p < .05) to verify
sterilization indicators. Barriers identified by urban subjects were checklist fatigue,
anesthesia and surgeon resistance. Barriers reported by rural subjects were a lack of
upper management support, lack of education, lack of monitoring, and practice
variances between surgeons and organizations. This research shows that while checklist
use has been adopted in many organizations, its use is lacking consistency across both
settings and there is a need to understand variation in practice in order to develop
effective strategies to improve utilization.
x
CHAPTER ONE: INTRODUCTION
Every month, 15,000 Medicare beneficiaries are estimated to die from
preventable medical errors (Office of the Inspector General, 2010). This extraordinarily
high rate of error persists despite an increased emphasis on patient safety (Landrigan et
al., 2010). In addition to the cost of lives, the financial cost of medical errors for
Medicare beneficiaries between 2007 and 2009 was $7.3 billion with surgical errors
alone costing $1.5 billion annually (Agency for Healthcare Research and Quality, 2008;
Reed & May, 2011). The full cost of medical errors for all patients would make this total
considerably higher.
Perioperative Patient Safety
Preventable adverse events cause nearly 210,000 deaths annually, making it the
third leading cause of death in the US (James, 2013). The surgical setting is one of the
most common locations for medical errors (Gawande, Zinner, Studdert, & Brennan,
2003; Rogers et al., 2006). In the United States, 45 million inpatient surgical procedures
are performed annually (Centers for Disease Control and Prevention (CDC), 2011). It is
projected that the average American will undergo over nine surgical procedures in their
lifetime, six of which will occur in the operating room (Lee, Regenbogen, & Gawande,
2008). One-half to two-thirds of all errors are attributed to surgical care with one in ten
surgical patients dying from a preventable postoperative complication (Gawande et al.,
2003; Leape et al., 1991; Reed & May, 2011; Rogers et al., 2006). While not all
postoperative deaths are preventable, patients who experience an adverse event are 12
1
times more likely to die postoperatively than those who did not experience an adverse
event (Fecho, Lunney, Boysen, Rock, & Norfleet, 2008; Reed & May, 2011). Nearly 20%
of surgical patients do not receive appropriate antibiotic prophylaxis (Agency for
Healthcare Research and Quality, 2011). Over 5% of all surgical patients experience a
catheter-related urinary tract infection (Agency for Healthcare Research and Quality,
2011). The rate of postoperative sepsis, directly related to the inappropriate use of
preoperative antibiotics, has not changed since 2008 (Agency for Healthcare Research
and Quality, 2015).
The surgical environment contributes to adverse events. First, the patient is
frequently under an anesthetic rendering them incapable of participating in their own
care during a surgical procedure, which increases the surgical team’s responsibility to
protect the patient from harm. Second, the surgical setting is prone to the development
of unsafe practices because it is a high stress environment focused on productivity
(Espin, Lingard, Baker, & Regehr, 2006). Finally, multiple and simultaneous demands on
team members time and attention reduce the focus on a single task, which further
contributes to likelihood of making errors (Espin et al., 2006). Additionally, these
unique features of surgical environments encourages team members to develop unsafe
“work arounds” in an attempt to manage multiple workload demands, administrative
tasks, and/or physician expectations. Finally, successful surgical procedures require a
coordinated effort between nurses, surgical technologists, anesthesia, surgeons, sterile
supply, radiology, pathology, and laboratory. With so many different team members
involved in patient care, communication failures are common (Lingard et al., 2004).
2
Time-outs and Checklists
Communication breakdown is identified as the most common contributor to
errors and adverse events (Lingard et al., 2004; Makary et al., 2006; Stahel et al., 2010).
Preoperative briefings are one way to improve communication among team members.
In 2004, The Joint Commission introduced the Universal Protocol to prevent wrong site
surgery (The Joint Commission, 2015). One requirement of this protocol is a
preoperative briefing known as the time-out; an intentional pause in surgery
immediately prior to the start of the procedure for all team members to verify the name
of the patient and the correct procedure. In 2009, WHO studied the use of a surgical
safety checklist to guide preoperative briefings, including the time-out and found that its
use reduced morbidity and mortality by one third (Haynes, A B. et al., 2009). As of 2012,
1,790 facilities worldwide have implemented the WHO’s Surgical Safety Checklist (World
Health Organization, 2012). The following year, AORN released the Comprehensive
Surgical Safety Checklist which combines the content of the WHO Surgical Safety
Checklist with the Joint Commission’s Universal Protocol in one checklist (AORN, 2013;
The Joint Commission, 2015).
Preoperative briefings, as found in the checklists have been shown to improve
compliance with safety measures such as preoperative antibiotic prophylaxis
administration (Askarian, Kouchak, & Palenik, 2011; de Vries, Dijkstra, Smorenburg,
Meijer, & Boermeester, 2010; Paull et al., 2010). Furthermore, briefings improve
teamwork (Böhmer et al., 2012; Haynes, A B et al., 2011; Helmiö et al., 2011; Kearns et
al., 2011; Lyons & Popejoy, 2013; Makary et al., 2007; Paige, John T., Aaron, Deborah L.,
3
Yang, Tong, Howell, D. Shannon, & Chauvin, Sheila W., 2009; Wolf, Way, & Stewart,
2010), employee satisfaction (Böhmer et al., 2012), and communication (Awad et al.,
2005; Helmiö et al., 2011; Kearns et al., 2011; Lingard et al., 2008; Lyons & Popejoy,
2013; Makary et al., 2007). Briefings also reduced postoperative complications (Askarian
et al., 2011; de Vries, Prins, Crolla, den Outer, van Andel, van Helden, Schlack, van
Putten, Gouma, Dijkgraaf, Smorenburg, & Boermeester, 2010; Haynes, A B. et al., 2009;
Lyons & Popejoy, 2013; Panesar et al., 2011; Young-Xu et al., 2011), mortality (de Vries,
Prins, Crolla, den Outer, van Andel, van Helden, Schlack, van Putten, Gouma, Dijkgraaf,
Smorenburg, & Boermeester, 2010; Haynes, A B. et al., 2009; Lyons & Popejoy, 2013),
wrong site surgery (Makary et al., 2007), nonroutine events (Einav et al., 2010), nearmisses (Panesar et al., 2011), and operating room delays (Wolf et al., 2010). Semel et al.
(2010) found that facilities performing 4,000 non-cardiac surgeries a year saved over
$100,000 annually by implementing the checklist. Surgical safety checklists are now a
quality measure for ambulatory surgery because they have been demonstrated to be
effective for preoperative briefings (Centers for Medicare & Medicaid Services, 2012).
Compliance with Surgical Safety Checklists
Despite research indicating the positive effects of the use of surgical safety
checklists, facilities have had difficulty implementing this tool. Some studies report that
the checklist was seen as inconvenient, and its use required adjusting ingrained
behavior patterns (Aveling, McCulloch, & Dixon-Woods, 2013; Gardezi et al., 2009;
Lingard et al., 2005). Barriers to use include anxiety with unfamiliar processes, hierarchy
of staff, logistics and timing, duplication, relevance of checklist, absence of
4
consequences when the checklist was not completed, misuse of the checklist, and a lack
of integration into existing hospital information systems (Aveling et al., 2013; Braaf,
Manias, & Riley, 2013; de Vries, Hollmann, Smorenburg, Gouma, & Boermeester, 2009;
Fourcade, Blache, Grenier, Bourgain, & Minvielle, 2012; Gagliardi, Straus, Shojania, &
Urbach, 2014; Haugen, Høyland, Thomassen, & Aase, 2015; Low, Walker, Heitmiller, &
Kurth, 2012; Lyons & Popejoy, n.d.; Mahajan, 2011a; Makary et al., 2006;
Papaconstantinou, Jo, Reznik, Smythe, & Wehbe-Janek, 2013; Russ et al., 2015; Vats et
al., 2010; Wæhle, Haugen, Søfteland, & Hjälmhult, 2012). Even when checklists were
implemented, the use was frequently inconsistent in timing and location (Gagliardi et
al., 2014; Lingard et al., 2005; Low et al., 2012). Studies on compliance with surgical
safety checklists show use rates ranging from 12% to 100% (Berrisford, Wilson, Davidge,
& Sanders, 2012; Borchard, Schwappach, Barbir, & Bezzola, 2012b; de Vries et al., 2012;
de Vries et al., 2009; France, Leming-Lee, Jackson, Feistritzer, & Higgins, 2008;
Kasatpibal et al., 2012; Kearns et al., 2011; Mainthia et al., 2012; Nugent et al., 2013;
Vogts, Hannam, Merry, & Mitchell, 2011). No research has found 100% compliance in
the overall completion of all of the components of a structured surgical safety checklist
despite some facilities reporting 100% compliance with documentation of compliance
(McDowell & McComb, 2014; Morgan et al., 2013a). This raises the concern that
compliance with surgical safety checklists may be even lower than reported in the
existing literature.
5
Rural Population and Healthcare
Most research about perioperative patient safety occurs in urban facilities
despite the fact that one in five Americans lives in rural areas (U.S. Census Bureau,
2013b). The rural population is more likely to be poor, older, and have multiple
comorbid medical conditions (Institute of Medicine, 2005). Despite the health needs of
this population, rural areas frequently experience a shortage of health care workers
with only 9% of physicians practicing in rural areas (van Dis, 2002). Almost 2,000
hospitals service this population, and about 75% of these hospitals have 50 or fewer
beds (American Hospital Association, 2013; van Dis, 2002). The increased number of
comorbid conditions greatly increases the complexity of care required by rural patients
(Vartak, Ward, & Vaughn, 2010) by increasing the risk of postoperative complications
and morbidity (Roche, Wenn, Sahota, & Moran, 2005).
Rural hospitals also face unique challenges to overcoming quality of care issues.
Rural hospitals have a larger percentage of nurses educated at the diploma or
associate’s degree level (Newhouse, 2005). Nurses with diploma or associate’s degree
levels of education are less likely to have received training and education about quality
improvement or to evaluate research studies at a basic level, both are skills needed to
implement evidence-based practice (Burns, Dudjak, & Greenhouse, 2009; Hutchinson &
Johnston, 2004; Olade, 2003,2004; Schoonover, 2009). In addition, educational
opportunities to develop these skills are less available for health care professionals in
rural locations (Jukkala, Henly, & Lindeke, 2008; Newhouse, 2005). Nurses in rural
hospitals are expert generalists and may provide care to a variety of patients from
6
pediatrics to geriatrics, and across the lifespan from birth to death (Bushy & Bushy,
2001).
Rural hospitals are challenged to remain financially viable. Finances play an
important role in rural hospital quality of care. With the current financial crisis in
healthcare, budget constraints of rural hospitals may limit the implementation of
technological advances that can improve quality and safety, such as electronic medical
records, barcode medication administration technologies, and automated dispensing
cabinets (Calico, Dillard, Moscovice, & Wakefield, 2003; Newhouse, 2005).
Finally, rural hospitals may have difficulty measuring quality of care. The low
patient volumes experienced by rural hospitals make the accurate measurement of
quality indicators such as prophylactic preoperative antibiotic administration difficult
(Lutfiyya, Sikka, Mehta, & Lipsky, 2009; Moscovice & Rosenblatt, 2000; Newhouse,
2005). The difficulties of quality indicator measurements are reflected by the exclusion
of some rural hospitals in quality indicator reporting (Leapfrog Group, 2007). Critical
access hospitals, which are generally located in rural areas, are not required to submit
quality reporting for Medicare’s pay-for-performance programs as well as penalties for
substandard care.
Time-outs and Rural Operating Rooms
There is a dearth of research regarding the time-out process in rural operating
rooms. One study examined the effects of the implementation of a checklist for the
time-out on teamwork in a rural operating room (Paige, John T. et al., 2009). This study
found that the use of a time-out protocol such as a checklist improved time-outs and
7
teamwork in the rural setting; however, there is little research on how rural facilities use
these tools (Paige, John T. et al., 2009). A second study that included the rural setting
also found that the use of a surgical safety checklist improved patient outcomes;
however, this study only included one rural hospital and aggregated the findings with
the results from seven urban facilities (Haynes, A B. et al., 2009). Almost all research on
time-outs occurred in large, teaching facilities. Many of the interventions designed to
improve the time-out process have been developed and tested in large, urban facilities
and may or may not be applicable to the rural setting. Compliance with time-out
recommendations may also be an issue as one study in an urban setting found that
verifications of surgical site markings, patient positioning, radiographic imaging, and
verification of the availability of the appropriate equipment and implants occurred in
less than 30% of surgical cases (France et al., 2008).
Aims and Research Questions
This descriptive survey study of rural and urban operating room team members
describes the use of surgical safety checklists during time-outs. Specifically, this study
identified the time-out process, the extent to which surgical safety checklists were used
immediately prior to incision, variations from standards of care and recommended
practices, and barriers to using a surgical safety checklist during the time-out. The
specific aims of this study were:
Specific Aim 1: To describe the current state of time-out preoperative briefings
in rural and urban operating rooms.
8
Research Question 1.1: How do rural and urban operating room staff members
currently conduct time-out preoperative briefings?
Research Question 1. 2: How do time-out preoperative briefings in rural
operating rooms differ from the time-out preoperative briefings in urban operating
rooms?
Specific Aim 2: To identify compliance in the time-out process and checklist use
from The Joint Commission’s Universal Protocol and AORN’s Comprehensive Surgical
Safety Checklist in rural and urban operating rooms.
Research Question 2.1: Does the time-out preoperative briefing process differ
from The Joint Commission’s Universal Protocol and AORN’s Comprehensive Surgical
Safety Checklist in rural and urban operating rooms?
Research Question 2.2: How does the compliance to The Joint Commission’s
Universal Protocol and AORN’s Comprehensive Surgical Safety Checklist in rural
operating rooms differ from the compliance in urban operating rooms?
Specific Aim 3: To identify factors that influence compliance in the time-out
preoperative briefing in rural and urban operating rooms.
Research Question 3.1: What prevents the completion of all recommended
time-out preoperative briefing and checklist components in rural and urban operating
rooms?
This study explores the time-out process and the use of surgical safety checklists
in rural and urban operating rooms. Chapter 2 is a meta-analysis of the effects of
surgical safety checklists was conducted and that identified the safety benefits of
9
surgical safety checklists. Chapter 3 discusses the methods used in this study. Chapter 4
presents the results of the study as a manuscript submitted for publication. Chapter 5 is
a manuscript discussing the barriers to implementation and recommendations for
practice. Chapter 6 concludes with a review of this study. This study provides a
knowledge base for the successful implementation and improved use of surgical safety
checklists.
10
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CHAPTER TWO: A META-ANALYSIS OF SURGICAL SAFETY
CHECKLISTS
Lyons, V. E., & Popejoy, L. L. (2014). Meta-analysis of surgical safety checklist effects on
teamwork, communication, morbidity, mortality, and safety. Western Journal of Nursing
Research, 36(2), 245-261. doi: 10.1177/0193945913505782
Abstract
The purpose of this study is to examine the effectiveness of surgical safety
checklists on teamwork, communication, morbidity, mortality, and compliance with
safety measures through meta-analysis. Four meta-analyses were conducted on 19
studies that met the inclusion criteria. The effect size of checklists on teamwork and
communication was 1.180 (p=0.003); morbidity and mortality 0.123 (p=0.003) and 0.088
(p=0.001) respectively; and compliance with safety measures was 0.268 (p<0.001). The
results indicate that surgical safety checklists improve teamwork and communication,
reduce morbidity and mortality, and improve compliance with safety measures. This
meta-analysis is limited in its generalizability based upon the limited number of studies
and the inclusion of only published research. Future research is needed to examine
possible moderating variables for the effects of surgical safety checklists.
Introduction
In the United States, 51.4 million ambulatory surgery visits and 48 million
inpatient surgeries are performed annually (Centers for Disease Control and Prevention
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(CDC), 2011; Cullen, Hall, & Golosinskiy, 2009). This results in the average person
undergoing 3.4 inpatient operations and 2.6 outpatient operations in their lifetime (Lee
et al., 2008). The operating room is one of the most common locations for medical
errors and adverse events with one half to two thirds of all errors being attributed to
surgical care. (Gawande et al., 2003; Leape et al., 1991; Rogers et al., 2006).With over
275,000 surgical procedures performed daily, an emphasis on perioperative safety is a
necessity. The most commonly cited cause of surgical error is breakdown in
communication (Lingard et al., 2004; Makary et al., 2006). One documented method to
improve communication and reduce errors and adverse events is the surgical safety
checklist, introduced by the World Health Organization (WHO) (Haynes, A B. et al.,
2009).
Checklists are designed to improve patient outcomes by providing a visual tool
for standardized communication (Haynes, A B. et al., 2009). The WHO conducted the
first study of surgical safety checklists and found that the use of the checklist reduced
morbidity and mortality by over 30% (Haynes, A B. et al., 2009). Since the release of this
landmark study, hospitals have adapted and implemented checklists to improve patient
outcomes. Moreover, the Centers for Medicare & Medicaid Services (CMS)
recommended the use of surgical safety checklists as a quality measure in 2016.
Despite the increased use of surgical safety checklists, research regarding the
effects of surgical safety checklists has been varied. Researchers have examined the
effects of surgical safety checklists on antibiotic prophylaxis administration (Askarian et
al., 2011; de Vries, Dijkstra, et al., 2010; Paull et al., 2010), perception of teamwork
26
(Böhmer et al., 2012; Haynes, A B et al., 2011; Helmiö et al., 2011; Kearns et al., 2011;
Makary et al., 2007; Paige, J. T., Aaron, D. L., Yang, T., Howell, D. S., & Chauvin, S. W.,
2009; Wolf et al., 2010), postoperative complications (Askarian et al., 2011; de Vries,
Prins, Crolla, den Outer, van Andel, van Helden, Schlack, van Putten, Gouma, Dijkgraaf,
Smorenburg, & Boermeester, 2010; Haynes, A B. et al., 2009; Young-Xu et al., 2011), inhospital mortality (de Vries, Prins, Crolla, den Outer, van Andel, van Helden, Schlack, van
Putten, Gouma, Dijkgraaf, Smorenburg, & Boermeester, 2010; Haynes, A B. et al., 2009),
employee satisfaction (Böhmer et al., 2012), wrong site surgery (Makary et al., 2007),
communication (Awad et al., 2005; Helmiö et al., 2011; Kearns et al., 2011; Makary et
al., 2007), and operating room delays (Wolf et al., 2010). Most studies identified
significant improvements in the surgical process and patient outcomes but the size of
the improvement varied greatly across the studies. No comprehensive review or metaanalysis has been conducted to provide a measurement of the effect of these checklists
on teamwork, communication, patient outcomes, and compliance with recommended
safety measures. To overcome this gap in the state of the science about surgical safety
checklists, the researchers conducted a meta-analysis that quantitatively synthesizes the
current literature. This paper reports the meta-analysis results on the effect of surgical
safety checklists on teamwork, communication, morbidity, mortality, and compliance
with operating room safety measures.
Method
Meta-analysis is a method to quantitatively combine research findings from
multiple studies that allow researchers to measure the effects of interventions on
27
outcomes from multiple studies thus increasing the power and precision of study
findings (Cooper, Hedges, & Valentine, 2009). The following research questions guided
this meta-analysis: (1) What is the effect of surgical safety checklists on teamwork and
communication? (2) What is the effect of surgical safety checklists on patient morbidity
and mortality? (3) What is the effect of surgical safety checklists on compliance with
recommended surgical safety measures?
Sample Inclusion and Exclusion Criteria
In meta-analysis, it is essential to employ diverse search strategies to avoid
introduction of bias from narrow searches (Cooper, Hedges, & Valentine, 2009). For this
meta-analysis, the researcher conducted a database search of CINAHL, Proquest, and
Medline databases using the search terms “checklist,” “operating room,” “surgery,”
“perioperative,” “surgical,” “teamwork.” and “communication tools.” This search
included an author search for the Checklist Manifesto author Atul Gawande (2010) and
Alex Haynes, the principal investigator of the WHO study (2009). The researcher also
conducted a search for studies that were previously cited in the research studies.
Finally, a Google Scholar search identified any additional research studies, conference,
and presentations that may have been missed using other search strategies.
Research studies were included if they were in English, conducted in inpatient or
ambulatory operating room settings, used a surgical safety checklist conducted
immediately prior to incision by the operating team, used communication and
teamwork measures that had documented reliability and validity, or reported
complications related to surgery as identified by the American College of Surgeons’
28
National Surgical Quality Improvement Program (Khuri et al., 1995). The complications
included from the aforementioned program are acute renal failure, bleeding requiring
the transfusion of 4 or more units of red cells within the first 72 hours after surgery,
cardiac arrest requiring cardiopulmonary resuscitation, coma of 24 hours’ duration or
more, deep-vein thrombosis, myocardial infarction, unplanned intubation, ventilator
use for 48 hours or more, pneumonia, pulmonary embolism, stroke, major disruption of
wound, infection of surgical site, sepsis, septic shock, the systemic inflammatory
response syndrome, unplanned return to the operating room, vascular graft failure, or
death. Mortality was defined as patient death in or out of the hospital from any cause
within 30 days after surgery (Grover et al., 1994). Recommended surgical safety
measures were defined as the 19 evidenced-based practices indicated on the WHO’s
Surgical Safety Checklist as outlined on Table 1 (World Health Organization, 2008).
Finally, studies were included that utilized a two group post intervention comparison or
a one group pre-posttest design and reported sufficient statistical results to be able to
calculate an effect size.
Data Management Procedures
As research studies were located, abstracts were examined for inclusion in the
meta-analysis. Eligibility for the meta-analysis was based upon the previously identified
inclusion and exclusion criteria. EndNote, a bibliographic management software
program, was used to organize publications. Full text documents were collected and
saved as PDF documents attached to the reference in EndNote. Using the abstract,
studies were categorized into one of three categories: not eligible, possibly eligible, and
29
eligible. All search strategies and results were saved and documented for record
keeping. Full text documents of abstracts categorized as possibly eligible were
retrieved, read, and judged as eligible or not eligible. A hard copy of each research
study was printed out and organized in a file cabinet drawer dedicated to the metaanalysis project. The final studies in the eligible category were coded in the codebook
for inclusion in the meta-analysis.
Data Coding and Analysis
Coded variables included: (a) characteristics of the study setting (teaching status,
number of operating rooms, number of licensed beds); (b) surgical checklist details
(components, training, time of use, type of surgery); and (c) outcomes (time until final
measurement, teamwork measures, communication measures, morbidity measures). In
addition, data needed to complete effect size estimations (sample size, means, standard
deviation, standard error, direction of effect) were also coded for each study. Each study
was coded by one researcher on two separate occasions. The coding was then
compared and no differences were found.
The standardized mean difference of post-intervention scores (d) was used to
estimate effect sizes (Cooper, 2010). Conceptually, a standardized mean difference is
the mean of the treatment group minus the mean of the control group, divided by the
pooled standard deviation. The effect size is a unitless measure which can be averaged
across primary studies using different measures of constructs. A random-effects model
was used for data analysis because of the heterogeneity across studies in order to
include both within study and between study variance (Cooper et al., 2009). The
30
random-effects model assumes that the true effect size varies across different studies
based upon different confounding variables (Cooper et al., 2009). Heterogeneity was
expected because of site, intervention, and measurement variables. Statistical
heterogeneity was calculated using the Q and I² statistics for between study variation
and observed variation due to real differences in effect size. Calculations were
completed using an Excel spreadsheet designed with the required formulas for
statistical analysis. A significance level of p<0.05 was used for this study.
Results
Figure 1 illustrates the flow diagram of the literature search. A total of 55 articles
were identified from the search. There were 36 articles excluded because data needed
for the meta-analysis were not included. These missing data included statistical results
needed for effect size calculations (28 studies), eligible outcome variables (5 studies), or
not using a checklist as the intervention (3 studies). The remaining 19 studies were fully
eligible for inclusion in the meta-analysis and are listed in Table 2. The research sample
varied based on the goals of the study. Some studies examined patients while others
examined surgical procedures. These samples differed because patients may undergo
multiple surgical procedures; thus procedures may include a single patient multiple
times. Finally, studies that examined teamwork and communication sampled
employees or staff members.
There were a number of differences in the studies. The sample included national
and international studies with three studies including multiple countries. The majority of
studies were from the United States (n = 9); the rest were Great Britain (n = 1),
31
Netherlands (n = 2); Liberia (n = 1), Iran (n = 1), Germany (n = 1), and Finland (n = 1).
Three studies conducted by the WHO had multiple countries in the sample (Canada,
India, Jordan, New Zealand, the Philippines, Tanzania, England, and the United States).
Ten studies used a single group, pre-posttest design (Awad et al., 2005; Böhmer et al.,
2012; Haynes, A B et al., 2011; Helmiö et al., 2011; Kearns et al., 2011; Makary et al.,
2007; Paige, J. T. et al., 2009; Paige et al., 2008; Paull et al., 2010; Wolf et al., 2010), five
studies used a two-group, pre-posttest design (Askarian et al., 2011; de Vries, Prins,
Crolla, den Outer, van Andel, van Helden, Schlack, van Putten, Gouma, Dijkgraaf,
Smorenburg, & Boermeester, 2010; Haynes, A B. et al., 2009; Weiser et al., 2010; Yuan
et al., 2012), three studies used a retrospective analysis design (de Vries, Dijkstra, et al.,
2010; Neily et al., 2010; Young-Xu et al., 2011), and one study used a randomized
control trial (Calland et al., 2011). Sample size varied from 20 to over 3,000 and the
units of analysis were hospitals, surgical team members, patients, and surgical
procedures. Some studies examined specific types of complications such as pneumonia,
while others focused on all postoperative complications. Samples were calculated as a
single unit regardless of the type of sampling unit used in the study with regard to
statistical analysis. Teamwork and communication was measured with the most variety
due to the availability of different tools to measure teamwork and communication.
Heterogeneity was interpreted by I² and classified as low (25%), moderate (50%), or high
(75%).
The results of the four meta-analyses on the outcome measures are displayed in
Table 3. A positive effect size indicates an improvement in outcomes. For the effect of
32
checklists on teamwork and communication, ten studies were included in the analysis.
The summary effect size of these studies was 1.180 (SE = 0.392, 95% CI = 0.411 - 1.999,
p = 0.003). Teamwork and communication also demonstrated high heterogeneity (Q =
638.500, p = 0.035, I² = 98.6%). Seven primary studies were included in the metaanalysis for morbidity. The summary effect size for morbidity was 0.123 (SE = 0.041,
95% CI = 0.043 – 0.204, p = 0.003). Morbidity analysis also showed a high level of
heterogeneity (Q = 13.474, p = 0.035, I² = 77.7%). Mortality analysis consisted of four
studies with a summary effect size of 0.088 (SE = 0.026, 95% CI = 0.038 - 0.139, p =
0.001) indicating reduced mortality. The results of the analysis of mortality identified a
moderate amount of heterogeneity (Q = 6.013, p = 0.035, I² = 50.1%). Finally, the
compliance meta-analysis for effect size included four studies. The summary effect size
was 0.268 (SE = 0.052, 95% CI = 0.166 - 0.370, p = 0.000) and the analysis found low
heterogeneity (Q = 3.193, p = 0.035, I² = 6%).
Discussion
This study sought to measure the effect of surgical safety checklists on teamwork
and communication, morbidity, mortality, and compliance with safety measures. The
positive effect found in this study indicated improvement in outcome variables following
the checklist intervention. The meta-analysis identified the use of a surgical safety
checklist reduced morbidity and mortality, improved teamwork, communication, and
compliance with safety measures in operating rooms. These results should be
interpreted with some caution because the heterogeneity found in the analyses
indicates large variability in the studies which could inflate the effect size.
33
The strongest effect of checklists was on teamwork and communication. As
previously noted, surgical error is commonly attributed to breakdown in communication
(Lingard et al., 2004; Makary et al., 2006) and surgical safety checklists were originally
designed to improve communication between surgical team members (Awad et al.,
2005; Carney, West, Neily, Mills, & Bagian, 2010; Haynes, A B. et al., 2009). These
results confirm that surgical safety checklists are effective in improving communication
and potentially reducing surgical error and adverse events since a significant number of
these are caused by a breakdown in communication (Gawande et al., 2003; Rogers et
al., 2006; The Joint Commission, 2013).
Surgical mortality is estimated to be 21 out of every 1,000 surgical procedures
(Fecho et al., 2008). In addition, with almost 100 million surgical procedures performed
annually in the US, roughly 1,000,000 patients will die within 30 days of surgery (Centers
for Disease Control and Prevention (CDC), 2011). While the effect size for morbidity and
mortality was small, given the number of surgical procedures performed each year even
a small improvement in these outcomes would save lives and reduce the burden of
complications.
This meta-analysis also found a significant improvement in compliance with
safety measures with the use of surgical safety checklists. As with communication this
result was expected because a checklist provides a visual reminder of recommended
safety measures, reducing the reliance on memory and improving compliance (AbdelRehim, Morritt, & Perks, 2011; Rydenfält et al., 2013). For example, a surgical safety
checklist provides a reminder to surgical team members to ask the patient about
34
surgical site, or administer a prophylactic antibiotic within 60 minutes of incision. These
reminders increase compliance with safety recommendation resulting in reduced
incidence of surgical site infections.
Teamwork, communication, morbidity, and mortality were significantly
heterogeneous. This finding was not surprising and occurred because of the varied units
of analysis of the studies e.g. when measuring morbidity, samples were surgical
procedures, patients, or hospitals. Mortality had a moderate variability but was limited
in sample type to hospitals or patients. This can explain why there is less variability for
mortality. Patients can experience multiple complications from one procedure or
patients may undergo multiple procedures. Mortality is a single event relating back to
only one patient and one procedure. Since the number and types of outcomes vary
more for morbidity than mortality, it is logical to see a larger variance on morbidity than
on mortality. In contrast, compliance with safety measures showed low heterogeneity.
The samples in all of the included studies were adults undergoing surgical procedures.
The consistency of the units of analysis can explain the low heterogeneity.
Future research on the effect of surgical safety checklists would be strengthened
by the conduction of a moderator analysis. The publications range in dates from 2005
through 2012 showing the relative newness of checklists as an intervention and more
research is needed in order to complete a reliable moderator analysis. Possible
moderators identified in this study include length of time between implementation and
evaluation, size of facility, type of surgical procedure, content of the checklist, and type
of facility. While possible moderators were identified during the conduction of this
35
meta-analysis, a moderator analysis was not conducted due to the small number of
available studies for inclusion. Conducting a moderator analysis would provide evidence
about which characteristics maximize the benefits of the use of a checklist. As more
primary studies accrue, adequate studies will be available to conduct moderator
analysis.
There are limitations to this meta-analysis. First, only published research was
included. There is a tendency in scholarly publications to publish research that results in
significant findings (De Oliveira, Chang, Kendall, Fitzgerald, & McCarthy, 2012; Dwan et
al., 2008). Studies that fail to find significant results are either not submitted or not
published. This tendency could result in non-significant findings being excluded due to a
possible publication bias. Next, there were 28 studies with statistically significant
findings that were not included due to a lack of reported data necessary to calculate an
effect size. The inclusion of these studies may have significantly increased the effect size
of surgical safety checklists. Another limitation was the lack of a second coder to
validate the coding of the studies. Finally, the studies used different sampling units: nine
studies used surgical team members, six studies used patients, three studies used
surgical procedures, and two studies used facilities. This difference could have an
impact on the effect as patients may undergo multiple surgical procedures or
experience multiple complications making a comparison of patients to procedures, or
complications difficult, however, the random-effects model compensates for these
differences in units of analysis. The studies were screened to ensure that multiple
results from the same study were not included in the analyses.
36
Limitations of the primary studies themselves could also affect the findings of
this meta-analysis. An increase in awareness of communication resulting from training
on the use of the checklist could have improved communication even without the use of
the checklist thus increasing the measured effect of the checklist for communication.
The measures used in primary studies frequently required the use of subjective opinions
of team members and may have presented a bias into the subjective findings as
participants may respond with socially acceptable answers or with responses that the
participants feel the researcher is expecting. Compliance with safety measures could
have been influenced by potential observer bias as practitioners may have changed
their practice when being monitored or observed increasing the measured effect of
surgical safety checklists. Finally, the studies included the use of surgical safety
checklists that were designed and personalized by each facility to meet their needs.
While the checklists included much of the same content (patient identity, procedure,
preoperative antibiotic administration, venous thrombosis prevention, etc.), there may
have been other characteristics in the checklist or how it was implemented that affected
the findings and reduced the generalizability.
This is the first study to our knowledge that quantitatively synthesized the effect
of surgical safety checklists on teamwork, communication, morbidity, mortality, and
compliance with safety measures. Findings from this meta-analysis indicated that the
use of surgical safety checklists resulted in significant positive effects on teamwork and
communication, morbidity, and mortality but not on compliance with safety measures.
Future research is needed to identify moderating variables that can positively influence
37
the effect of surgical safety checklists on patient outcomes. The use of the surgical
safety checklist as a safety measure is growing exponentially and more research about
how to maximize the benefits of this tool is needed.
38
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46
Figure 1: Surgical Safety Checklist Search Results (Moher, Liberati, Tetzlaff, & Altman, 2009)
47
Table 1: WHO Surgical Safety Checklist
Elements of the WHO Surgical Safety Checklist
Before induction of anesthesia:
 The patient verifies his or her identity, surgical site, and procedure and the consent is
completed
 The surgical site is marked, if applicable
 The pulse oximeter is on the patient and functioning
 Any allergies are communicated to all team members
 The patient’s airway and risk of aspiration is addressed and all applicable supplies and
assistance are available
 If there is a risk of at least 500 ml blood loss, IV access and fluids are available
Before skin incision:
 All team members are introduced by name and role
 The patient’s identity, surgical site, and procedure are confirmed
 Anticipated critical events are reviewed
o Surgeon reviews critical and unexpected steps, operative duration, and anticipated
blood loss
o Anesthesia provider reviews concerns
o Nursing staff reviews confirmation of sterility, equipment availability, and other
concerns
 Prophylactic antibiotics are administered no longer than 60 minutes before incision if indicated
 All essential imaging is available
Before the patient leaves the operating room:
 Nursing staff reviews the following:
o Name of procedure is recorded correctly
o All needle, sponge, and instrument counts are completed and correct, if applicable
o Any specimens are labeled correctly, including the patient’s name
o Any equipment issues are addressed
 The surgeon, nurse, and anesthesia provider reviews any key concerns for the recovery and
care of the patient
48
Table 2: Surgical Safety Checklist Studies Included in Sample
Author and Year
of Publication
Yuan et al., 2012
Sample Size
Sample Type
Outcome measures
Focus of Analysis
Control = 232
Patients
Compliance with 4 or
more safety measures
(airway assessment, use
of pulse oximetry, IV
placement, antibiotic
prophylaxis, completion
of surgical pause,
completion of sponge
count)
Death within 30 days of
surgery
Occurrence of any major
complication within 30
days of surgery
Incidence of major
postoperative
complications within 30
days of surgery
Compliance with 3 safety
measures (sign in, time
out, and sign out)
Surgical team members’
perceptions of teamwork
(Safety Attitudes
Questionnaire)
Major complications
within 30 days of surgery
Mortality within 30 days
of surgery
Complications occurring
during hospitalization
Postoperative mortality
during hospitalization
Compliance with
safety measures
Surgical team members’
perception of
interprofessional
cooperation based upon
an attitude survey
Surgical team members’
perceptions of improved
communication through
a questionnaire
Antibiotic prophylaxis
administered 30 minutes
or more before incision
Teamwork
Communication
Treatment =
249
Askarian,
Kouchak, &
Palenik, 2011
Control = 144
Haynes et al.,
2011
Control = 281
Weiser et al.,
2010
De Vries et al.,
2010
Böhmer et at.,
2012
Patients
Treatment =
150
Treatment =
257
Control = 842
Treatment =
908
Control =
3760
Treatment =
3820
Control = 71
Surgical team
members
Patients
Patients
Surgical team
members
Treatment =
71
Kearns et al.,
2011
De Vries,
Dijkstra,
Smorenburg,
Meijer, &
Boermeester,
2010
Control = 53
Treatment =
46
Control = 369
Surgical team
members
Surgical
procedures
Treatment =
403
49
Compliance with
safety measures
Teamwork
Communication
Morbidity
Mortality
Morbidity
Mortality
Teamwork
Communication
Compliance with
safety measures
Calland et al.
2009
Haynes et al.,
2009
Control = 23
Treatment =
24
Control =
3733
Surgical
procedures
Equipment and personnel
communication
determined through
observation
Occurrence of any major
complication, including
death, during the period
of postoperative
hospitalization up to 30
days
Surgical team member’s
perceptions of teamwork
climate though the Safety
Attitudes Questionnaire
Compliance with
prophylactic antibiotic
administration within 60
minutes of incision
Surgical team members’
perceptions of team
coordination through the
Safety Attitudes
Questionnaire
Observed and riskadjusted 30-day
morbidity rates
Teamwork
Communication
Patients
Facilities
Observed and riskadjusted 30 day mortality
rates
Mortality
Surgical team
members
Perceptions of
communication among
anesthesia, surgeon, and
nurse through a
communication survey
Surgical team members’
perceptions of successful
communication through
a questionnaire
Peer assessment of team
performance through the
Operating Room
Teamwork Assessment
Scale
Surgical team members’
perceptions of teamwork
through the Operating
Room Teamwork
Assessment Scale
Teamwork
Communication
Patients
Treatment =
3955
Wolf, Way, &
Steward, 2010
Paull et al., 2010
Makary et al.,
2007
Control = 72
Treatment =
44
Control = 74
Treatment =
74
Control = 306
Surgical team
members
Facilities
Surgical team
members
Treatment =
116
Young-Xu et al.,
2011
Control = 42
Neily et al., 2010
Treatment =
42
Control = 74
Awad et al., 2005
Treatment =
74
Control = 213
Patients
Treatment =
213
Helmiö et al.,
2011
Paige et al., 2008
Control = 304
Treatment =
443
Control = 20
Surgical team
members
Surgical team
members
Treatment =
20
Paige, Aaron,
Yang, Howell, &
Chauvin, 2009
Control = 36
Surgical team
members
Treatment =
36
50
Morbidity
Mortality
Teamwork
Communication
Compliance with
safety measures
Teamwork
Communication
Morbidity
Teamwork
Communication
Teamwork
Communication
Teamwork
Communication
Table 3: Results of Surgical Safety Checklist Meta-Analysis
Outcome
measure
Numbe
r of
include
d
studies
(k)
10
Mean
effect
size
(d)
p
value
Standa
rd
error
95% CI
lower
limit
95%
CI
upper
limit
Q
p value
of Q
I²
1.180
0.003
0.392
0.411
1.999
638.500
0.035
98.6
7
0.123
0.003
0.041
0.043
0.204
13.474
0.035
77.7
Mortality
4
0.088
0.001
0.026
0.038
0.139
6.013
0.035
50.1
Compliance
with safety
measures
4
0.268
<0.001
0.052
0.166
0.370
3.193
0.035
6
Teamwork
and
Communicati
on
Morbidity
51
CHAPTER THREE: METHODS
The purpose of the study was to identify the current time-out process and
checklist use by perioperative teams and to compare this process with The Joint
Commission’s Universal Protocol and AORN’s Comprehensive Surgical Safety Checklist in
rural and urban operating rooms. An assessment of the time-out process identified
variations from these standards and recommended practice. These variances were
examined through a survey of perioperative staff members regarding the conduction of
time-outs.
Conceptual Model
This study used Donabedian’s framework of structure, process, and outcome.
This framework is linear and consists of three dimensions: structure, process, and
outcomes (Figure 2). Each dimension is positively or negatively affected by the previous
dimension. Structure refers to the healthcare setting (Donabedian, 1988). Many factors
impact the dimension of structure, including physical resources (human and material)
and organizational factors (management design, social and safety cultures). The process
relates to the actual provision of care. In the perioperative setting, this refers to the
preparation, performance, and resolution of the surgical procedure. Finally, outcomes
occur as a result of the structure and process dimensions. Donabedian noted that in
healthcare, the goal is to improve positive outcomes and reduce negative outcomes
(Donabedian, 1988). There is very little research regarding rural perioperative patient
52
safety. This study identified characteristics of perioperative structure that contribute to
the time-out process.
Figure 2: Donabedian's Structure, Process, Outcome Model in the Perioperative Setting
Study Design
This study used a cross-sectional survey design. Cross-sectional surveys are
frequently used to assess patient safety climates in a variety of settings, including the
operating room (Bleakley, Boyden, Hobbs, Walsh, & Allard, 2006; Bognár et al., 2008;
Haynes, A B et al., 2011; Sexton et al., 2006; Wolf et al., 2010). A cross-sectional survey
was used to obtain a description of the current state of time-outs and to generate
future research questions.
Study Setting and Population
This study used a comprehensive cross-sectional survey design of perioperative
nurses in rural and urban operating rooms who are involved with direct patient care.
Rural determination was based upon the U.S. Office of Management and Budget
definition of metropolitan and micropolitan areas (U.S. Census Bureau, 2013b). Urban
53
areas are defined as a city with a population of more than 50,000 or a total
metropolitan statistical area population of at least 100,000. Any area that does not
meet this definition of urban will be classified as a rural location.
Procedure
The P.I. recruited participants through AORN member groups and word of
mouth. Contact was made through social media sites such as AORN's social networking
site, ORNurseLink, Facebook, and email. The P.I. shared a standardized message, about
the P.I.’s background, purpose of the study, and process for accessing the electronic
survey. Additionally, a link to the survey was included in the message. Participants were
also encouraged to give the survey link with other perioperative nurses.
Measurement instrument
A survey developed by the P.I. was used as the measurement tool for this study.
This survey was developed based upon the process outlined in The Joint Commission’s
Universal Protocol (The Joint Commission, 2015) and content from AORN’s
Comprehensive Surgical Safety Checklist (Brown-Brumfield & DeLeon, 2010).
Demographic data included accreditation status of facility, number of operating rooms,
years of experience at the current hospital, years of perioperative experience, job title,
hours of direct patient care, professional certification status, education level, and zip
code of facility. The survey asked about compliance with the required process as
directed by The Joint Commission and the content of the time-out as recommended by
AORN.
54
A pilot study of the survey was conducted using a think aloud protocol with 18
perioperative nurses with perioperative experiences ranging from 1 year to 25 years. In
this pilot study, each nurse was provided a copy of the survey and asked to verbally
answer each question to the researcher. If the subject had any difficulty understanding
the question or did not feel the responses adequately answered the question, the
subject was asked about what part of the question was unclear and for suggestions on
how to improve the question. Based upon the feedback from the subjects, the survey
was edited for clarity.
An electronic survey platform, Qualtrics, was used to administer the survey.
Qualtrics is an online survey tool which allows researchers to develop surveys, collect
responses, and analyze data (Qualtrics Inc., 2015). The survey asked nurses if each of the
surgical checklist components were addressed always, usually, sometimes, rarely or
never. In addition, the process of the time-out was evaluated according to the Joint
Commission’s Universal Protocol. Process questions included identification of
participating team members in the time-out process, the cessation of all other activities
during the completion of the time-out, and verbal confirmation from all team members.
For each item that is identified as completed “sometimes”, “rarely”, or “never”, staff
members were asked why they are not completed routinely. The primary investigator
tested the functionality of the electronic survey in both Windows and iOS operating
systems using Internet Explorer, Mozilla Firefox, Safari, and Google Chrome browsers.
55
Data Analysis
Data was downloaded from Qualtrics in a spreadsheet format for analysis. IBM
SPSS Statistics for Windows, Version 22 was used for statistical analysis (IBM Corp.,
2013b). Chi-square and Mann-Whitney U tests were conducted to adjust for nonnormally distributed data with a significance level of p <.05. Normality was determined
using Shapiro-Wilks test.
A content analysis was performed on the open-ended responses to identify any
reoccurring concepts in responses using Dedoose software (Dedoose, 2015). Dedoose is
an internet-based application for coding qualitative and mixed methods research. Openended responses were copied to separate word documents based upon location
classification and question. Each document was uploaded individually into Dedoose for
coding based upon question.
Human Subjects Involvement and Characteristics
This study is a cross-sectional survey of perioperative nurses to identify and
compare the time-out process in rural and urban operating rooms. Participants were not
excluded on the basis of age, gender, or race. No special classes of populations such as
fetuses, neonates, children, prisoners, incarcerated individuals, or other vulnerable
populations were included in this study because the participants had to be active
providers of healthcare.
56
Sources of Materials
Data collection occurred through surveys of perioperative nurses. No individually
identifiable information was collected except in the instance of subjects voluntarily
providing a name and contact information for possible follow-up interviews. Any
individually identifiable information was stored electronically through a secure online
storage system.
Potential Risks
Potential risks included possible personal and professional distress caused by an
increased examination of patient safety practices however this risk was minimal and did
not exceed that which the subjects would encounter in normal daily activities.
Recruitment and Informed Consent
Recruitment of participants occurred through social media communication,
email, and word of mouth. The study link was shared on AORN’s online community,
ORNurseLink, Facebook, and emailed to perioperative nurses. Individual participants
were encouraged to share the survey with other perioperative nurses and AORN
chapters were encouraged to share the survey with their membership. This study was
approved by the Health Sciences Institutional Review Board at the University of
Missouri. A waiver of documentation of consent was approved due to the minimal risk
associated with participation. All participants were provided with information regarding
the purpose of the study, the risks and benefits of the study, and the voluntary nature of
participation in the study. Additionally, the contact information for the P.I. and faculty
57
advisor also was provided. Participants were informed that completing the survey would
serve as their consent to participate.
Protections against Risks
Protection against personal and professional distress was provided through
reinforcement of the voluntary nature of the responses and participation can be
terminated at any time during the survey. Contact information for the P.I. and the I.R.B.
were provided to all participants.
Potential Benefits of the Proposed Research to Human Subjects and
Others
Potential benefits to research participants were minimal but may include a sense
of personal and professional satisfaction related to participation in patient safety
research. Benefits to perioperative healthcare workers include the development of a
broader knowledge regarding the time-out process. The resulting knowledge will assist
in the development of patient safety initiatives tailored to meet the needs perioperative
nurses in order to improve perioperative patient safety. The minimal risk of
participation for participants was outweighed by the potential benefits that the
obtained knowledge would provide for patient safety.
Importance of the Knowledge to be Gained
The financial and human costs of medical errors are significant. Through
examination of preoperative communication, patient safety can be improved in all care
settings. Unfortunately, despite rural hospitals constituting over 30% of all hospitals,
58
research into preoperative briefings such as the time-out has been limited to large,
urban facilities (American Hospital Association, 2013). To address the unique needs of
the rural hospital, more research into the process of time-outs of these facilities is
needed. The study will provide a starting point for patient safety initiatives tailored to fit
the differing needs of rural and urban operating rooms.
Summary
Strengths of this research include the objective nature of the Comprehensive
Surgical Safety Checklist. Concerns regarding methodology primarily include the
possibility of a participant bias in responses to the survey. Participant biases occur when
participants tend to respond in a way that is consistent with what the participant feels
the researcher is desiring. However, this bias should not affect the comparison between
groups.
The information obtained through this study will begin to provide a clearer
picture of the time-out process in rural and urban operating rooms. Baseline
information is needed to begin to develop interventions to improve communication and
improve postoperative outcomes.
59
References
American Hospital Association. (2013). Fastfacts on US hospitals.
http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
Retrieved from http://www.aha.org/aha/resource-center/Statistics-andStudies/fast-facts.html
Bleakley, A., Boyden, J., Hobbs, A., Walsh, L., & Allard, J. (2006). Improving teamwork
climate in operating theatres: The shift from multiprofessionalism to
interprofessionalism. Journal of interprofessional care, 20(5), 461-470.
Bognár, A., Barach, P., Johnson, J. K., Duncan, R. C., Birnbach, D., Woods, D., . . . Bacha,
E. A. (2008). Errors and the burden of errors: Attitudes, perceptions, and the
culture of safety in pediatric cardiac surgical teams. The Annals of Thoracic
Surgery, 85(4), 1374-1381.
Brown-Brumfield, D., & DeLeon, A. (2010). Adherence to a medication safety protocol:
Current practice for labeling medications and solutions on the sterile field.
AORN, 91(5), 610-617.
Dedoose. (2015). Dedoose, web application for managing, analyzing, and presenting
qualitative and mixed method research data (Version 5.3.22). Los Angeles, CA:
SocioCultural Research Consultants, LLC. Retrieved from www.dedoose.com
Donabedian, A. (1988). The quality of care: How can it be assessed? JAMA: The Journal
of the American Medical Association, 260(12), 1743-1748.
60
Haynes, A. B., Weiser, T. G., Berry, W. R., Lipsitz, S. R., Breizat, A.-H. S., Dellinger, E. P., . .
. for the Safe Surgery Saves Lives Study Group. (2011). Changes in safety attitude
and relationship to decreased postoperative morbidity and mortality following
implementation of a checklist-based surgical safety intervention. BMJ Quality &
Safety, 20(1), 102-107. doi:10.1136/bmjqs.2009.040022
IBM Corp. (2013b). IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM
Corp.
Qualtrics Inc. (2015). The world's leading enterprise survey platform. Retrieved from
www.qualtrics.com
Sexton, J. B., Makary, M. A., Tersigni, A. R., Pryor, D., Hendrich, A., Thomas, E. J., . . .
Pronovost, P. (2006). Teamwork in the operating room. Anesthesiology, 105(5),
877-884.
The Joint Commission. (2015). Universal Protocol. Retrieved from
http://www.jointcommission.org/standards_information/up.aspx.
U.S. Census Bureau. (2013b). 2010 census urban and rural classification and urban area
criteria. Retrieved from http://www.census.gov/geo/reference/ua/urban-rural2010.html
Wolf, F. A., Way, L. W., & Stewart, L. (2010). The efficacy of medical team training:
Improved team performance and decreased operating room delays. Annals of
Surgery, 252(3), 477-485.
61
CHAPTER FOUR: RESULTS
Lyons, V. E., & Popejoy, L. L. (n.d.). Time-out and checklists: A survey of rural and urban
operating room personnel. Manuscript submitted for publication.
Abstract
Surgical safety checklists were introduced to improve patient safety. Urban and
rural hospitals are influenced by differing factors but how these factors affect patient
care is unknown. This study examined time-out and checklist processes in rural and
urban operating rooms and shows that while checklist use has been adopted in many
organizations, use is inconsistent across both settings. An understanding of these
variations in needed in order to improve utilization.
Introduction
Despite an increased emphasis on patient safety, 400,000 deaths occur annually
in United States hospitals due to preventable harm (James, 2013). Adverse events occur
in one-third of hospital admissions with operating rooms being one of the most
frequently cited location for medical errors (Classen et al., 2011; James, 2013). In an
effort to curb preventable errors in the operating room, the Joint Commission
introduced time-outs in its Universal Protocol in 2004 (The Joint Commission, 2015).
Then in 2009, the World Health Organization expanded this process by introducing
surgical safety checklists (Haynes, A B. et al., 2009); however, compliance with this
intervention is reported to be as low as 12% (Borchard, Schwappach, Barbir, & Bezzola,
2012a; Haynes, A B. et al., 2009). Furthermore, the majority of research on time-outs
62
and surgical safety checklists has been conducted in urban settings resulting little being
known about the use of recommended safety processes in the rural setting. The
purpose of this study was to describe and compare the differences in time-out
processes and surgical safety checklist use between rural and urban operating rooms,
and to identify barriers to use of surgical safety checklists.
Background
Surgical safety checklist
Communication breakdown is identified as the most common contributor to
errors and adverse events (Stahel et al., 2010). Preoperative briefings are one way to
improve communication among team members, and expand upon the traditional timeout by including additional safety measures such as discussion of patient allergies and
antibiotic administration. In 2009, The World Health Organization (WHO) studied the
use of a surgical safety checklist to guide preoperative briefings and found its use
reduced morbidity and mortality by one-third (Haynes, A B. et al., 2009). In 2010, AORN
released the Comprehensive Surgical Safety Checklist which combined the content of
the WHO Surgical Safety Checklist with The Joint Commission’s Universal Protocol
(AORN, 2013; The Joint Commission, 2015). Preoperative briefings have been shown to
improve compliance with safety measures such as preoperative antibiotic prophylaxis
administration (Askarian et al., 2011; de Vries, Dijkstra, et al., 2010; Paull et al., 2010),
teamwork (Böhmer et al., 2012; Haynes, A B et al., 2011; Helmiö et al., 2011; Kearns et
al., 2011; Lyons & Popejoy, 2013; Wolf et al., 2010), employee satisfaction (Böhmer et
al., 2012), and communication (Helmiö et al., 2011; Kearns et al., 2011; Lyons &
63
Popejoy, 2013). Briefings also reduced postoperative complications (Askarian et al.,
2011; de Vries, Prins, Crolla, den Outer, van Andel, van Helden, Schlack, van Putten,
Gouma, Dijkgraaf, Smorenburg, & Boermeester, 2010; Lyons & Popejoy, 2013; Panesar
et al., 2011; Young-Xu et al., 2011), mortality (de Vries, Prins, Crolla, den Outer, van
Andel, van Helden, Schlack, van Putten, Gouma, Dijkgraaf, Smorenburg, & Boermeester,
2010; Lyons & Popejoy, 2013), wrong site surgery , non-routine events (Einav et al.,
2010), near-misses (Panesar et al., 2011), and operating room delays (Wolf et al., 2010).
Despite the benefits, facilities have had difficulty implementing surgical safety
checklists. Studies report the checklist was seen as inconvenient and its use required
adjusting ingrained behavior patterns (Braaf et al., 2013; Haugen et al., 2015;
Papaconstantinou et al., 2013). Barriers to use include unfamiliarity with the checklist
process, hierarchy between surgeons and nurses, logistics and timing, duplication,
perceived irrelevance of checklist, absence of consequences for not completing the
checklist, misuse of the checklist, and a lack of integration into existing hospital
information systems (Aveling et al., 2013; Borchard et al., 2012b; Fourcade et al., 2012;
Gagliardi et al., 2014; Low et al., 2012; Mahajan, 2011b; Morgan et al., 2013b; Russ et
al., 2015; Rydenfalt, Ek, & Larsson, 2014; Sendlhofer et al., 2015; Treadwell, Lucas, &
Tsou, 2014; Vats et al., 2010; Vogts et al., 2011). Studies on compliance with surgical
safety checklists show a wide range of use from 28% to 99% (Berrisford et al., 2012; de
Vries et al., 2012; Kasatpibal et al., 2012; Kearns et al., 2011; Mainthia et al., 2012;
Nugent et al., 2013; Vogts et al., 2011) justifying the concerns regarding compliance.
Rural and urban settings
64
Most research about perioperative patient safety occurs in urban facilities
despite the fact that one in five Americans lives in rural areas (U.S. Census Bureau,
2013b). The rural setting presents unique challenges to health care quality. The rural
population is more likely to be poor, older, have multiple comorbid medical conditions,
and have limited access to healthcare (DeNavas-Walt & Procto, 2015; Meit et al., 2014)
There is scant research regarding preoperative briefings in rural operating rooms and no
studies comparing rural and urban settings. Many of the interventions designed to
improve preoperative briefings have been developed and tested in large urban facilities,
and may or may not be applicable to the rural setting.
Methods
Study design and Sample
This was a descriptive, cross-sectional electronic survey study of operating room
personnel. Study participants were recruited through a convenience snowball sampling
approach through AORN’s online community, social media, email, and through word of
mouth. Participants were encouraged to recruit perioperative staff members to
complete the survey. Rural and urban determination was based upon the U.S. Office of
Management and Budget classification (U.S. Census Bureau, 2013a). Urban was defined
as any city with a population of more than 50,000 or a metropolitan area of more than
100,000. Any area that did not meet the classification for urban was considered rural.
Respondents were asked to provide the zip code for their workplace for classification
purposes only. Approval for this study was obtained through the University of Missouri
Institutional Review Board.
65
Instrument
Data were collected using an investigator-developed survey based upon The
Joint Commission’s Universal Protocol and AORN’s Comprehensive Surgical Safety
Checklist. Content validity was established using a focus group of 18 perioperative staff
members. The participants completed the survey and provided feedback about how to
improve question readability. The final survey included 6 individual demographic
questions, 3 organizational demographic questions, and 27 time-out and checklist
questions. There were 13 multiple choice, 18 6-point Likert scale questions, and 5 openended questions. Participants were first asked about the frequency and initiation of
time-outs and team member participation. Participants were next asked about the use
and format of surgical safety checklists during time-outs. Finally, participants were
asked to identify the frequency of verbalization (not included, never, rarely, sometimes,
usually, or almost always) of each component of AORN’s Comprehensive Surgical Safety
Checklist. The survey concluded with open-ended questions regarding additional
components of the time-out, barriers to the verbalization of each component, and any
additional comments regarding time-outs and surgical safety checklists. A copy of the
instrument is available through the primary investigator.
Data collection and analysis
Qualtrics, an electronic internet survey platform, was used for data collection
(Qualtrics Inc., 2015). After the survey was built in Qualtrics by the primary investigator,
functionality was tested by completing the survey through multiple platforms and
operating systems. The survey was tested in both Windows and iOS operating systems
66
and in a variety of browsers such as Internet Explorer, Mozilla Firefox, Safari, and Google
Chrome. After functionality had been confirmed, the primary investigator emailed the
survey link to perioperative nurses and posted on AORN’s online community,
ORNurseLink, and social media. Individual participants were encouraged to share the
survey with other perioperative nurses and AORN chapters were invited to share the
survey with their membership.
The data was downloaded from the survey platform in a spreadsheet format for
analysis. All statistical analyses were completed using IBM SPSS Statistics for Windows,
Version 22 (IBM Corp., 2013a). Statistical analysis included chi square and MannWhitney U test to adjust for non-normally distributed data with a significance level of p
<.05. Normality was determined using Shapiro-Wilks test.
For the open-ended responses, a content analysis was completed using Dedoose
software (Dedoose., 2015). Dedoose is a web-based application for coding of qualitative
and mixed-methods research. Responses were downloaded into a spreadsheet and
grouped according to location. Responses were then copied to separate word
processing documents according to the question answered and location. Each document
was then uploaded into Dedoose and thematically coded by question for similar
comments, concerns, or problems. The responses were coded by the primary
investigator for common themes.
Results
There were a total of 134 respondents, (77 rural, 47 urban). Of these, 10 surveys
were excluded because respondents did not provide a zip code for rural or urban
67
classification or respond beyond the demographic questions (n = 6 and 4, respectively).
Respondents represented 30 states (Figure 3). The majority of respondents had worked
in the perioperative setting greater than 10 years (76.6% rural [n=59], 78.3% urban
[n=36]) and had an undergraduate nursing degree (71.4% rural [n=55], 74.5% urban
[n=35]). Over half of the respondents had CNOR certification (55.8% rural [n=43], 73.9%
urban [n=34]). The difference in certification rates between the groups was approaching
significance (p =.055) with urban nurses being more likely to be certified than rural
nurses. Most respondents worked in not-for-profit organizations (77.9% rural [n=60],
87.2% urban [n=41]). Significantly more urban respondents worked in Joint Commissionaccredited organizations than rural respondents (85.7% rural [n=66], 97.9% urban
[n=46], p=.03) (Table 4).
Figure 3. States Represented in Study
68
Time-out process
Time-outs were reported to occur almost always by a majority of the
participants (98.7% rural [n=76], 100% urban [n=47]). Verbal confirmation of the timeout was reported almost always by 66% of rural respondents (n=50), compared to 75%
of urban respondents (n=35), but the result was not significant (p =.79). Just over half of
respondents from both groups (55.8% rural [n=43], 57.4% urban [n=27]) reported all
activity almost always stops during the time-out process. Nearly, 90% urban (n=42) and
99% of rural respondents (n=73) viewed the initiation of the time-out as the
responsibility of the circulator, and 52% of rural and 51% of urban respondents (n=40
and n=24, respectively) also viewed it as a surgeon’s responsibility. Almost all team
members participated in the time-out more than half of the time but the surgeon was
significantly more likely (p = .01) to have participated in the time-out in urban operating
rooms than in rural operating rooms, while other team members were significantly
more likely to have participated in rural operating rooms (p = .02) (Table 5).
Checklist use
Over 82% of rural (n=63) and 85% of urban (n=40) respondents used some form
of a surgical safety checklist during time-outs. Nearly equal numbers of both groups
used a hospital-designed checklist (45% rural [n=33], 50% urban [n=23]). One-third
(n=15) of urban respondents used a paper format, while 43% (n=31) of the rural
respondents reported using paper. The most common checklist items in both rural and
urban operating rooms were the patient’s name, the procedure name, consent, site
marking, and antibiotic administration. The least common checklist items for rural
69
operating rooms were team member names and anticipated case duration. For the
urban operating rooms, the least common items were surgeon’s anticipated critical or
non-routine steps and anticipated case duration. Urban operating rooms were
significantly more likely to include the verification of sterilization indicators than rural
operating rooms (p=.04). Respondents reported communicating items not included in
AORN’s Comprehensive Surgical Safety Checklist. The most frequent additions were
patient allergies, fire risk, beta-blocker administration, DVT prophylaxis, patient’s date
of birth, and pregnancy test results (Table 6).
Self-identified barriers
Open-ended responses were voluntary and were provided by only 17% of all
respondents. Common self-identified barriers included using checklists as needed,
checklist fatigue, the process for use, surgeon resistance, and perceived lack of benefits.
Rural participants were more likely to cite a lack of upper management support,
education, a need for monitoring compliance, and practice variances between surgeons
and organizations as barriers to the use of checklists. Urban respondents were more
likely to cite checklist fatigue, anesthesia and surgeon provider resistance as barriers to
checklist use.
Rural and urban respondents reported using checklists when needed but not as a
routine practice for all cases. For example, one rural respondent stated “If there are
equipment concerns or any problems anticipated someone would communicate that to
the team probably before the time-out”. One urban respondent stated “If it is a short
70
case the [doctor] will mention it so we can send for the next patient. The site is not
verified unless it is [bilateral]”.
Checklist fatigue was a concern among rural and urban respondents. One urban
respondent noted “It becomes routine, and it's questionable if staff are truly
participating or just going along with what someone else said”. Another urban
respondent states “We always do a time-out and sometimes I feel that it has started to
be ‘routine’ or done by rote. Sometimes I wonder if some people are paying attention”.
Finally, one rural respondent states “It seems like we keep adding checklists. The
surgical and anesthesia members start to block some of it out because it seems to be
redundant”.
The process was cited as a barrier to implementation by respondents in both
settings. Respondents reported verifying content included in the Comprehensive
Surgical Safety Checklist prior to the time-out. For example, an urban respondent stated
“Sterilization confirmation is a continuous expectation, just as maintaining sterile
technique, therefore we do not mention this in a time-out.” and a rural respondent
stated “Equipment concerns are usually done prior to time-out. Team members are
introduced before time-out”. The most frequently mentioned items completed at times
other than the time-out included team members names and sterilization indicators for
both urban and rural respondents.
Surgeons were also identified as a barrier in both settings. The surgeon is
focused on time and urban and rural respondents reported this pressure can impact the
time-out process. One rural respondent stated “Some surgeons do not want a lengthy
71
time-out, so if too many details are added, they complain”. An urban respondent shared
“The surgeon or anesthesia says it isn't necessary to tell the anticipated time of
procedure, they don't mention anticipated blood loss, and they are in a hurry to start so
the scrub tech doesn't say anything about sterilization indicators”. “He [the surgeon]
wants the [time-out] to be quick” was the response of another rural respondent.
Finally, the lack of value was mentioned by respondents. One respondent shared
“Also in the surgeries we perform, we lose very little blood other than total joints and
[cesarean sections] where the blood loss is predictable so not worth adding in a [timeout]”. Another comment was “We know how long most surgeries last so don't need to
ask”. Finally, another respondent stated “I don't think it's necessary to say team
members’ names or expected case duration”. These comments were more frequent in
the rural setting than the urban setting (14 rural, 7 urban). Respondents from urban
settings also had concerns about the benefits of the checklists. As one urban respondent
stated “I find that stating names and introduction of staff that have been working
together for years the source of jokes and ridicule”.
Discussion
Consistent with prior research, this study found the most common barrier to
implementation was the process of using the checklist (Braaf et al., 2013; Haugen et al.,
2015; Treadwell et al., 2014). Participants in rural and urban settings both commented
some of the information included in the Comprehensive Surgical Safety Checklist was
verified at times other than the time-out. This is supported by the survey results
indicating low compliance with these components.
72
Urban and rural respondents frequently commented they modify the content of
the checklist depending on the unique characteristics of the patient or the procedure.
The use of checklist content on an “as needed” basis requires operating room staff to
remember to include the content when needed, which defeats the primary purpose of
checklists which is to reduce the reliance on memory (Gawande, 2010).
Respondents in both settings disclosed some negative perceptions of checklists.
Comments indicated some respondents did not value the inclusion of some content in
the time-out, which is consistent with previous research (Braaf et al., 2013; Haugen et
al., 2015; Sendlhofer et al., 2015). Additionally, checklist fatigue was mentioned by some
respondents. There were some concerns the increasing frequency and number of
checklists could discourage meaningful participation by team members. Respondents
commented that the use of multiple checklists makes the process redundant and
resulted in staff members becoming complacent in the practice.
Staff and physician resistance, altering checklists to fit individual circumstances,
and missing data elements in the checklist are worthy of more study. The checklist has
been in use for six years and it is time to reconsider what is working and what is not.
Process reviews should be conducted to identify opportunities for modifying the
checklist for to fit into workflow and reduce redundancy without jeopardizing patient
safety. Additionally, checklist education should extend beyond the use to include the
reasons behind the content included in the checklist. The education must be
interdisciplinary to allow opportunities to address the concerns from all team members
73
and to promote teamwork. Separate education for individual disciplines discourages
interdisciplinary collaboration.
Limitations
This was a small study limited by sample size. The results of a larger scale study
on the process and content may show additional significant differences not present in
this small study. Additionally, this study did not take into consideration multiple
respondents from the same organization. Finally, the snowball sampling method, the
recruitment of participants through AORN, and the recruitment through social media
may have resulted in a sample that is not representative of all perioperative staff
members. The use of social networking and an electronic survey could also impact the
findings as the rural population may have limited internet availability (Stenberg et al.,
2009). Prior to the study, the PI conducted a poll of rural operating room nurses in one
state to determine whether an electronic or paper survey would be preferred by
respondents. The majority of nurses polled preferred paper surveys. The use of
ORNurseLink limited the sample to only members of AORN which may not reflect the
characteristics of the perioperative nursing population. Additionally, not all AORN
members are active on ORNurseLink. Facebook was also used to recruit through sharing
of the link and posting on AORN chapter pages. This was difficult because to post on
these groups, the person posting must be a member of the group. Facebook also limits
the number of times a post can be posted to prevent spamming which can limit
recruitment.
74
Conclusion
This study identified considerable variances from recommended practice when it
comes to the time-out process and the use of surgical safety checklists in both rural and
urban settings. While few differences between rural and urban settings were identified,
a larger scale study would provide a clearer picture of how checklists are used in each
setting. The documented benefits of checklists support the need to identify factors
affecting adherence in order to increase compliance and improve patient safety, and to
consider if changes to the checklist are needed.
75
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84
Table 4. Sample Demographics
Demographics
Years with current employer
<6 months
6 months-2 years
3 years-5 years
6 years-10 years
11 years or more
Years of operating room experience
<6 months
6 months-2 years
3 years-5 years
6 years-10 years
11 years or more
No degree
Undergraduate degree
Graduate degree
Certified
For-profit
Not-for-profit
Employed by Joint Commission Accredited
organization
85
Rural
Urban
6(7.8)
5(6.5)
11(14.3)
18(23.4)
37(48.1)
4(8.5)
6(12.8)
10(21.3)
8(17)
19(40.4)
1(1.3)
1(1.3)
4(5.2)
12(15.6)
59(76.6)
1(1.3)
55(71.4)
21(27.3)
0(0)
1(2.2)
2(4.3)
7(15.2)
36(78.3)
0(0)
35(74.5)
12(25.5)
43(55.8)
14(18.2)
60(77.9)
66(85.7)
34(73.9)
5(10.6)
41(87.2)
46(97.9)*
Table 5. Time-Out Process Results
Time-out process
Time-out performed prior to
any surgical procedure
Verbal confirmation during
the time-out
All activity stops during timeout
Responsible for time-out
initiation
Verbally participates in timeout
Checklist used
Which checklist is used
Checklist format
n(%) - Rural
Almost always
Usually
Almost always
Usually
Sometimes
Rarely
n(%) Urban
Number(percent)
76(98.7)
47(100)
1(1.3)
0(0)
50(65.8)
35(74.5)
19(25)
8(17)
5(6.6)
3(6.4)
2(2.6)
1(2.1)
Almost always
Usually
Sometimes
Rarely
Circulator
Surgical
technologist
Anesthesia
Surgeon
Other
Circulator
43(55.8)
26(33.8)
6(7.8)
2(2.6)
73(94.8)
7(9.1)
27(57.4)
16(34)
2(4.3)
2(2.6)
42(89.4)
4(8.5)
14(8.2)
40(51.9)
1(1.3)
77(100)
7(14.9)
24(51.1)
1(2.1)
47(100)
Surgical
technologist
Anesthesia
Surgeon*
Other*
Uses checklist
WHO
AORN
Hospital-designed
Do not know
Other
Do not use
Paper
Electronic
White board
Other
Do not use
57(74)
39(83)
68(88.3)
68(88.3)
18(23.4)
63(82.9)
10(13.7)
9(12.3)
33(45.2)
7(9.6)
1(1.4)
13(17.8)
31(42.5)
13(17.8)
10(13.7)
6(8.2)
13(17.8)
41(87.2)
47(100)
3(6.4)
40(85.1)
7(15.2)
5(10.9)
23(50)
3(6.5)
1(2.2)
7(15.2)
15(32.6)
11(23.9)
6(13)
7(15.2)
7(15.2)
86
Table 6. Checklist Content
Checklist
n(%)
Rural
Urban
Team member names 32(53.3) 18(46.1)
n(%)
Rural
14(23.4)
Urban
6(15.4)
Usually/Almost
Always
n(%)
Rural
Urban
14(23.3) 15(38.4)
Patient’s name
1(1.7)
1(2.6)
0(0)
0(0)
59(90.3) 38(97.4)
Procedure name
0(0)
1(2.6)
0(0)
0(0)
60(100) 38(97.4)
Incision site
12(20)
9(23.1)
6(10)
6(15.4)
42(70)
24(61.6)
Consent verified
9(15)
2(5.2)
3(5)
2(5.1)
48(80)
35(89.7)
Site marked and
visible
Relevant images
available
Equipment concerns
4(6.6)
1(2.7)
3(5)
2(5.4)
53(88.4) 34(91.9)
10(16.7) 2(5.2)
8(13.3)
5(12.8)
42(70)
15(25)
11(18.3)
7(18.5)
34(56.6) 29(76.3)
Surgeon’s anticipated 19(32.2) 9(23.7)
critical or nonroutine
steps
Anticipated case
29(48.3) 18(47.3)
duration
Anticipated blood loss 27(45) 10(26.3)
18(30.5)
15(39.5)
12(37.3) 14(36.8)
18(30)
9(23.7)
13(21.7) 11(29)
18(30)
14(36.7)
15(25)
Antibiotic prophylaxis 2(3.3)
2(3.4)
0(0)
56(93.4) 38(97.5)
16(26.7)
11(28.2)
34(56.7) 22(56.4)
13(21.7)
2(5.2)
15(25)
16(26.6)
8(20.5)
29(48.4) 23(58.9)
Anesthesia concerns
Not included/Never
2(5.3)
1(2.6)
10(16.7) 6(15.4)
Sterilization indicators 32(53.3) 14(36.9)
confirmed*
Scrub and circulating 15(25) 8(20.5)
nurse concerns
*=p<.05
Rarely/Sometimes
87
32(82)
14(36.9)
22(57.9)
CHAPTER FIVE: DISCUSSION
Lyons, V. E., Popejoy, L. L., & Vogelsmeier, A. (n.d.). Thinking outside the box: Improving
surgical safety checklist use. Manuscript submitted for publication.
Abstract
The operating room is one of the most common locations for preventable errors.
The communication failures are the most common cause of these errors. To improve
quality of care in the operating room, the World Health Organization introduced surgical
safety checklists to improve communication and reduce preventable errors. Surgical
safety checklists have been shown to improve morbidity, mortality, communication, and
teamwork, however, research shows that the positive effects of the surgical safety
checklist is dependent on the quality of use. Research shows that compliance with
checklist use is low across different operating room settings causing a concern that the
full benefits of the checklist are not being realized. Barriers to implementation include
staff resistance, timing, redundancy, and the social structure of the operating room.
Recommendations for implementation and continued quality management include
active leadership, extensive discussion and training, checklist design, and quality
improvement activities. This article discusses these barriers and recommendations to
improve compliance and perioperative quality of care.
88
Introduction
Patients undergo an estimated 234 million surgical procedures worldwide
(Weiser et al., 2008). Surgical adverse events, such as wrong site surgery, retained
foreign items, and surgical site infections, are the most frequently reported adverse
events in healthcare and over 60% of these events are potentially preventable (De Vries,
Ramrattan, Smorenburg, Gouma, & Boermeester, 2008; Mendes, Martins, Rozenfeld, &
Travassos, 2009). The most commonly reported contributing factor to these adverse
events is communication breakdown (Lingard et al., 2004). In the operating room,
communication failures can lead to inefficient use of resources, lower staff satisfaction,
and adverse events (Lingard et al., 2004). To improve patient safety, surgical safety
checklists were developed to address communication failures in the operating room but
the implementation has not been without resistance (Borchard et al., 2012b).
We conducted a survey study to better understand staff compliance with the
time-out process and surgical safety checklists (Lyons & Popejoy, n.d.). This study shows
that compliance with the recommended practices of these checklists is low across
different settings. Our findings indicate that, while checklists are used in many
organizations, the use is inconsistent and shows a lack of understanding of the purpose
of the checklist. In the six years since the introduction of a surgical safety checklist, its
use is broad but does not yet permeate deeply enough to change ingrained behaviors,
beliefs, and attitudes of staff and surgeons. Therefore the purpose of this article is to
describe barriers to successful implementation of surgical safety checklists and to
provide recommendations to improve compliance and quality of use.
89
To prevent adverse events in surgery, the World Health Organization followed
the lead of the aviation industry and developed a checklist to emphasize verification of
important safety measures in the operating room (Gawande, 2010). Pilot testing of the
surgical safety checklist, which included safety measures such as procedure name,
antibiotic administration, and anti-embolism measures, showed a 30% reduction in
morbidity and mortality in a wide variety of operating room settings (Haynes, Alex B. et
al., 2009). The checklist includes 19 items to be verified at 3 separate times: Prior to
entering the operating room, prior to incision, and at the end of the procedure. These
processes are designed to be a guide for team communication to reduce reliance on
memory (Gawande, 2010).
The positive effects of checklist use are well documented. Lyons and Popejoy
conducted a meta-analysis and found use of surgical checklists can reduce mortality and
morbidity (Bergs et al., 2014; de Vries, Prins, Crolla, den Outer, van Andel, van Helden,
Schlack, van Putten, Gouma, Dijkgraaf, Smorenburg, Boermeester, et al., 2010; Haynes,
Alex B. et al., 2009; Lyons & Popejoy, 2014; van Klei et al., 2012; Weiser et al., 2010).
Other research indicates that compliance with safety interventions included in the
checklist, such as antibiotic prophylaxis and thromboembolism prevention, increased
after checklists were introduced (Truran, Critchley, & Gilliam, 2011; W-Dahl, Robertsson,
Stefánsdóttir, Gustafson, & Lidgren, 2011). Checklists have also been reported to
improve teamwork and communication in the operating room (Lyons & Popejoy, 2014).
Finally, checklist use has the potential to improve safety attitudes and culture (Haynes,
90
Alex B. et al., 2011). In a study of 257 operating room clinicians, more than 90% say they
would want the checklist used if they were a patient (Haynes, Alex B. et al., 2011).
The effects of surgical safety checklists; however, are dependent on correct use
of the checklist (van Klei et al., 2012). Compliance with surgical safety checklists may not
be sufficient to consistently ensure these improved patient outcomes (Lyons & Popejoy,
n.d.). Borchard and colleagues conducted a systematic review and found checklist use
ranged from 12% to 100% (2012b). Mindless recitation of checklist requirements are
also a concern because suboptimal checklist use can result in no improvements in
patient outcomes and may actually contribute to patient harm (Bergs et al., 2014; Bosk,
Dixon-Woods, Goeschel, & Pronovost, 2009; Braaf et al., 2013; Cullati et al., 2013;
Fourcade et al., 2012; Gagliardi et al., 2014; Hannam et al., 2013; Haugen et al., 2015;
Levy et al., 2012; Morgan et al., 2015; Morgan et al., 2013b; Russ et al., 2015; Rydenfalt
et al., 2014; Saturno, Soria-Aledo, Da Silva Gama, Lorca-Parra, & Grau-Polan, 2014;
Sendlhofer et al., 2015; Sheena et al., 2012; Sparks, Wehbe-Janek, Johnson, Smythe, &
Papaconstantinou, 2013; van Klei et al., 2012; Vogts et al., 2011; Walker, Reshamwalla,
& Wilson, 2012). Staff members may begin to view the checklist as a check-box activity
and verification of measures become rote instead of intentionally directed; thereby,
allowing errors to occur (Lyons & Popejoy, n.d.). We have classified the barriers to
successful implementation into two groups: human factors and environmental
characteristics.
Barriers to Successful Implementation
Human factors
91
There are a number of barriers to implementation. The number one barrier to
surgical checklist use is staff resistance (Lyons & Popejoy, n.d.; Russ et al., 2015). Staff
resistance to change is multifactorial. There may be a lack of education about why the
checklist was developed which contributes to staff resistance in using the checklists
(Lyons & Popejoy, n.d.). The simplicity of the checklist can lead to the incorrect
assumption that its introduction does not require much training. As a result of a lack of
training, surgical team members are unaware of the reasons behind checklist use and
are not trained in how to use it, which results in unfamiliarity, inconsistent execution,
and variable quality of use (Aveling et al., 2013; Fourcade et al., 2012; Low et al., 2012;
Lyons & Popejoy, n.d.; Vats et al., 2010). Additionally, checklist implementation planning
may not allow for front line staff input, reducing the sense of ownership by the staff
(Gagliardi et al., 2014). Without staff buy-in, team members may use the checklist as a
checkbox task and not a communication guide (Papaconstantinou et al., 2013).
Environmental characteristics
The checklist process may become a barrier to use (Lyons & Popejoy, n.d.). The
timing of some of the checklist components is a potential problem. Some of the safety
checks, such as verification of sterilization indicators, are completed prior to the timeout because delaying this verification until the time out may be too late to prevent
patient harm (Lyons & Popejoy, n.d.; Russ et al., 2015). Additionally, there is redundancy
built into the checklists, such as with verifying allergies, which are checked by both
nurses and anesthesia. This redundancy, intended as a mechanism to identify potential
errors at multiple points before they occur (Institute of Medicine, 2004), can be
92
misunderstood by staff as extra-work. The operating room setting places a strong
emphasis on efficiency and anything that may be perceived as unnecessary, such as
redundant safety measures in the checklist, may result in shortcuts and workarounds
(Braaf et al., 2013; Haugen et al., 2015).
The checklist is greatly impacted by the social structure of the operating room
(Lyons & Popejoy, n.d.; Wæhle et al., 2012). The operating room has historically been a
hierarchical environment in which the surgeon is perceived to be the captain of the ship;
therefore, surgeon resistance to checklists results in staff members also dismissing the
process. The perceptions of teamwork and communication, key elements of checklist
use, vary across disciplines supporting the need for improvements in these areas before
successful implementation can be achieved (Makary et al., 2006).
Keys to Successful Implementation
Successful checklist use requires a focus beyond the checklist and demands that
the safety culture of the organization be examined (Haugen et al., 2015; Vats et al.,
2010). Implementation of processes such as surgical safety checklists is complex and
requires multidisciplinary participation at every level of the organization. Even with the
support of administration, the implementation of a surgical safety checklist cannot be
effective without attempting to change the culture in the operating room (Porter,
Narimasu, Mulroy, & Koehler, 2014). Some keys to successful implementation include
active leadership, checklist design, extensive discussion and training, and ongoing
feedback (Table 7) (Gagliardi et al., 2014; Haugen et al., 2015; Low et al., 2012; Russ et
al., 2015).
93
Active leadership
Team facilitators need to be in place not only for implementation but also for
continued support. Facilitators must be able to manage resistance in a proactive and
positive manner (Russ et al., 2015). Additionally, clinicians such as anesthesia providers
and surgeons should be recruited as facilitators to reduce this hierarchy in the operating
room. The checklist is designed to improve multidisciplinary communication which
should start in the planning phase. The use of facilitators should continue beyond the
implementation into ongoing quality management.
Extensive discussion and training
Interdisciplinary training and education about teamwork, not just checklist
implementation, is key to successful implementation (Haugen, Murugesh, Haaverstad,
Eide, & Softeland, 2013). Successful implementations must involve team trainings, not
just individual training (Haugen et al., 2015). The aviation industry utilizes human factors
and team building trainings in conjunction with safety trainings with the understanding
that the tools to improve safety cannot be adequately implemented without the
necessary skills to utilize them (Vats et al., 2010). It has been reported that team
members do not believe the checklist is a team responsibility and instead view it as the
responsibility of a nurse or surgeon. Checklist implementation offers opportunities to
encourage development of mutual respect and collaboration across disciplines that are
required for successful checklist use. Interdisciplinary training allows for team members
to practice communication and address concerns in an encouraging environment and
provide opportunities for role-playing difficult situations (Paige et al., 2007). Content of
94
the education should include the background of checklist development, evidence
supporting its use, and the benefits to patient safety and the local organization (Russ et
al., 2015). Educational sessions should also provide examples of its correct use and
simulate difficult situations to prepare staff members on how to manage resistance
(Russ et al., 2015). This allows staff members to discuss concerns and provide scenarios
based upon their experiences at the bedside and promotes real world simulations.
Checklist design
Checklists must be customized to the local organization. Customization to the
facility and/or procedure type allows for opportunity for employee feedback thus
promoting ownership of the process (Russ et al., 2015). It is imperative that end users
are involved from the beginning. Without this involvement, team members may not use
the checklist in a meaningful way (Gagliardi et al., 2014). Modifications of the checklist
should focus on the needs of the patients and consideration of the surgical team
usability including integration with current processes and practices (Russ et al., 2015). A
workflow analysis should guide the modifications by focusing on current safety
processes compared to the ideal safety processes. Removal of non-applicable
verifications and unnecessary repetitions should also be a priority. End-users should be
included in this process in order to identify hidden processes and workarounds and to
promote buy-in.
The physical design of the checklist can also promote or detract from
compliance. To be used effectively as a communication tool, the checklist should be
visible to all team members (Russ et al., 2015). Having a paper checklist is not conducive
95
to team participation and cannot be integrated into electronical records effectively.
Electronic checklists are one solution to displaying checklists. Changing from a paper
checklist to a displayed electronic checklist can improve compliance with the safety
measures by 30% (Mainthia et al., 2012). Electronic checklists can facilitate team
participation by encouraging dynamic interactions among team members (Norton,
2012). Staff members reported forgetting to use the checklist. The visibility of an
electronic checklist can guide and remind users, thus reducing reliance on rote memory
and improving compliance with individual safety measures (Borchard et al., 2012b;
Norton, 2012). It can improve workflow by assisting with documentation through
automated data capture; however, some research suggests that there may be increased
variation between observed compliance and documented compliance with electronic
checklists, possibly due to staff using the tool as a check box activity instead of a
communication tool (Norton, 2012; Saturno et al., 2014).
Quality improvement
It is absolutely necessary to obtain feedback about use. Staff members need to
know results of audits and its effect on patient outcomes (Gagliardi et al., 2014; Low et
al., 2012; Russ et al., 2015). There is research to suggest that staff members believe that
the checklist offers no benefits because they hold the mistaken belief that the events
the checklist is designed to prevent would never occur at their local organization
(Aveling et al., 2013). Champions and organizational leadership should conduct audits
and report on improvements at the local organization. Additionally, examples of how
the checklist prevents possible errors in the organization should be shared to
96
demonstrate the value in the checklist to the specific setting. Some organizations are
reluctant to share this information openly with staff but this information is needed to
demonstrate the need and value of checklists.
It is essential that compliance be measured by observation as opposed to record
audits. Significant discrepancies between documentation and observed behaviors
indicate that documentation of compliance may not provide an accurate picture of
behaviors (Gagliardi et al., 2014; Mahmood et al., 2015; Saturno et al., 2014). Strict
reliance on documentation audits may result in a false sense of security in the degree of
implementation penetration and accuracy, of checklist use due to an inflated
completion rate. Audits should include observation, preferably without the participants’
awareness in order to prevent a possible Hawthorne effect. A “secret shopper”
approach is one effective method to complete the observation. In this method, team
members are secretly auditing the process without the knowledge of the other team
members. Results are shared with the staff and the identity of the auditor is kept
confidential. A second option for observational audits is peer reviews by representatives
from each discipline.
Finally, a process needs to be in place to provide consequences for
noncompliance (Gagliardi et al., 2014; Russ et al., 2015). Initially, a review should be
conducted to identify any barriers to the checklist process. After barriers are addressed,
remediation should be provided if indicated. If compliance continues to be an issue, a
policy outlining consequences should guide any disciplinary process. Decisions regarding
consequences must be planned and clearly communicated prior to implementation.
97
Without clear consequences for noncompliance, successful implementation may never
be achieved.
Conclusion
Surgical safety checklists offer a great start for improving patient safety but the
checklist itself is not a magical tool. Successful checklist implementation must include
addressing teamwork and safety culture. Without addressing underlying issues of
hierarchy, staff resistance, and process concerns, checklist will never be fully integrated
into the operating room. The use of a checklist alone does not guarantee improved
patient outcomes but including it in comprehensive team trainings will lay the
foundation for successful implementation and long term maintenance.
98
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Table 7. Recommendations for Successful Surgical Safety Checklist Use
Active leadership
 Utilize team facilitators
 Manage resistance
 Interdisciplinary representation
 Ongoing leadership beyond implementation
Extensive discussion and training
 Thorough analysis of current workflow
 Develop use cases that simulate a variety of circumstances for checklist use
 Extensive training using:
 Interdisciplinary education
 Checklist training must be part of a wider teamwork training initiative
 Role play difficult situations
Checklist design
 Customized to local organization
 Feedback from end users
 Workflow compatibility
 Visible to all team members simultaneously
Quality improvement
 Ongoing feedback on quality and effectiveness at the local level
 Transparency regarding near misses caught by checklist use
 Compliance measured through observation, not chart audits
 Consequences for noncompliance
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CHAPTER SIX: CONCLUSION
It has been over 15 years since the release of To Err is Human: Building a Safer
Health Care System which brought patient safety to the center stage of health care
(Kohn, Corrigan, & Donaldson, 2000). Despite the call to arms from this pivotal study,
patient safety in the US healthcare system continues to be a problem. Operating rooms
are a unique environment within the healthcare system; the majority of operating room
errors result from a lack of communication and patient safety initiatives must focus on
improving intraoperative communication (Lingard et al., 2004). The operating room
setting consists of characteristics that make effective communication difficult. Multiple
team members are performing various tasks at the same time. There is great emphasis
on efficiency with speed being a priority. The patient, an essential partner in patient
safety, is frequently under anesthesia and is unable to advocate for themselves. The
perceived hierarchy of the social environment discourages other team members from
speaking up about patient safety concerns. With these influences, it is not surprising
that adverse events occur so frequently in the operating room.
The airline industry successfully implemented checklists to improve safety and
made flying one of the safest ways to travel (Gawande, 2010). In 2009, the World Health
Organization followed in the airline industry’s footsteps and tested the use of a
standardized checklist in the operating room (Haynes, Alex B. et al., 2009). The results
showed that this tool improved communication and resulted in a 30% improvement in
mortality and morbidity. Based upon these results, hospitals all over the world began
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implementing checklists (World Health Organization, 2012). AORN took the contents of
the WHO checklist and combined it with requirements of The Joint Commission’s
Universal Protocol to create the Comprehensive Surgical Safety Checklist (Association of
periOperative Registered Nurses (AORN), 2013). The purpose of the checklist was to
provide verification of essential patient safety measures while improving
communication by encouraging all team members to be active participants in the
process while reducing the reliance on memory (Gawande, 2010).
Research now shows that the effects of the checklist is dependent on the
successful implementation and use by surgical team members (van Klei et al., 2012).
Compliance with checklist measures appears to be lacking as staff members may use the
checklist as a check box activity instead of a communication tool (Levy et al., 2012;
Sparks et al., 2013). With the effect of compliance on patient outcomes, it is important
to understand how the checklist is used and the reasons behind low compliance.
This study sought to describe the time-out process and the use of surgical safety
checklists in rural and urban settings through a survey of perioperative staff-members
(Lyons & Popejoy, n.d.). While almost all respondents reported conducting time-outs,
just over half report performing the time-out according to the standards of The Joint
Commission. The most common issues in the time-out process were a lack of verbal
confirmation from all team members and a lack of cessation of all activities not directly
related to the time-out. Regarding compliance, the results are consistent with previous
research. The most common components verified during the time-out in both groups
were the patient’s name, procedure, site marking, and antibiotic prophylaxis. The
110
components included the least in the time out were team members’ names, anticipated
case duration, and anticipated blood loss. Compliance rates for each component ranged
from 22% to 100%. The patient’s name was the only component reported to be included
by 100% of rural respondents. No component was reported to be included by 100% of
urban respondents. Urban respondents were significantly more likely to verify
sterilization indicators and have verbal participation from the surgeon. Rural
respondents were significantly more likely to have other team members verbally
participate in the time-out beyond the surgeon, anesthesia provider, surgical
technologist, and circulator.
Respondents were also asked about barriers to the use of checklists in the
operating room (Lyons & Popejoy, n.d.). Common barriers identified by rural
respondents focused on the lack of leadership support, education, and compliance
monitoring. Additionally, rural respondents discussed the difficulty in consistently using
checklists when performance expectations vary across settings and surgeons. Urban
respondents identified resistance from anesthesia providers or surgeons and checklist
fatigue as common barriers. Clearly, the implementation and use of checklists needs to
be improved.
Based upon the findings of this study and previous research, several proposals
for improvement were presented. First, the use of checklists require active leadership.
This leadership committee must be multidisciplinary and be utilized beyond the initial
implementation for managing ongoing resistance and continuous quality improvement.
Next, the training on checklist use must be included in a larger teamwork and
111
communication training program. Simply providing education on the checklist alone is
not enough to change the underlying safety culture of the organization. The training
should also include simulations of various difficult scenarios to allow team members to
role-play. The checklist itself should be designed for usability by modifying the checklist
to meet the needs of the individual organization. Additionally, the checklist must be
visible to all team members simultaneously in order to promote a team approach to the
use of the checklist. Finally, compliance must be monitored through observation and
feedback specific to the local setting on outcomes should be provided to team
members. Based upon compliance reporting, a system of consequences must be in place
for low compliance.
Although the sample for this study is small, it is unique in that this study
measured compliance through self-reporting of behavior. The anonymous design of the
survey allowed respondents to answer the questions honestly without fear of
repercussions. Previous research has used chart review and observation to measure
compliance. Chart review has been shown to be exaggerated when compared to
observational results (Gagliardi et al., 2014; Low et al., 2012; Mahmood et al., 2015). On
the other hand, observational measures of compliance presents the risk of a possible
Hawthorne effect where participants may improve compliance due to the presence of
the observer.
This study is not without its limitations. First, this study had a small sample size.
Possible differences in practices in the two settings may not have been identified due to
this small sample. Additionally, the survey methodology allows for participant bias
112
where participants may respond with answers they view as desirable by the researcher.
Future research should consist of a larger scale survey to provide a more accurate
picture of possible differences between the settings. The findings from this study can be
used to develop safety initiatives and interventions tailored to meet the needs of the
different settings.
113
References
Association of periOperative Registered Nurses (AORN). (2013). Comprehensive
checklist. Retrieved from
http://www.aorn.org/Clinical_Practice/ToolKits/Correct_Site_Surgery_Tool_Kit/
Comprehensive_checklist.aspx.
Gagliardi, A. R., Straus, S. E., Shojania, K. G., & Urbach, D. R. (2014). Multiple interacting
factors influence adherence, and outcomes associated with surgical safety
checklists: A qualitative study. PLOS One, 9(9), e108585.
doi:10.1371/journal.pone.0108585
Gawande, A. (2010). The checklist manifesto: How to get things right. New York:
Metropolitan Books.
Haynes, A. B., Weiser, T. G., Berry, W. R., Lipsitz, S. R., Breizat, A.-H. S., Dellinger, E. P., . .
. Safe Surgery Saves Lives Study, G. (2009). A surgical safety checklist to reduce
morbidity and mortality in a global population. The New England Journal of
Medicine, 360(5), 491-499. doi:10.1056/NEJMsa0810119
Kohn, L. T., Corrigan, J., & Donaldson, M. S. (2000). To err is human: Building a safer
health system. Washington, D.C: National Academy Press.
Levy, S. M., Senter, C. E., Hawkins, R. B., Zhao, J. Y., Doody, K., Kao, L. S., . . . Tsao, K.
(2012). Implementing a surgical checklist: More than checking a box. Surgery,
152(3), 331-336. doi:10.1016/j.surg.2012.05.034
114
Lingard, L., Espin, S., Whyte, S., Regehr, G., Baker, G. R., Reznick, R., . . . Grober, E.
(2004). Communication failures in the operating room: An observational
classification of recurrent types and effects. Quality and Safety in Health Care,
13(5), 330-334. doi:10.1136/qshc.2003.008425
Low, D., Walker, I., Heitmiller, E. S., & Kurth, D. (2012). Implementing checklists in the
operating room. Pediatric Anesthesia, 22(10), 1025-1031.
doi:10.1111/pan.12018
Lyons, V. E., & Popejoy, L. L. (n.d.). Time-out and checklists: A survey of rural and urban
operating room personnel. Manuscript submitted for publication.
Mahmood, T., Haji, F., Damignani, R., Bagli, D., Dubrowski, A., Manzone, J., . . .
Mylopoulos, M. (2015). Compliance does not mean quality: An in-depth analysis
of the safe surgery checklist at a tertiary care health facility. American Journal of
Medical Quality, 30(2), 191-191. doi:10.1177/1062860614567830
Sparks, E. A., Wehbe-Janek, H., Johnson, R. L., Smythe, W. R., & Papaconstantinou, H. T.
(2013). Surgical safety checklist compliance: A job done poorly. Journal of the
American College of Surgeons, 217(5), 867-867.
doi:10.1016/j.jamcollsurg.2013.07.393
van Klei, W. A., Hoff, R. G., Van Aarnhem, E. E. H. L., Simmermacher, R. K. J., Regli, L. P.
E., Kappen, T. H., . . . Peelen, L. M. (2012). Effects of the introduction of the WHO
"surgical safety checklist" on in-hospital mortality: A cohort study. Annals of
Surgery, 255(1), 44-49. doi:10.1097/SLA.0b013e31823779ae
115
World Health Organization. (2012). Surgical safety web map. Retrieved from
http://maps.cga.harvard.edu:8080/Hospital/.
116
Appendix A. Meta-analysis codebook
Report Characteristics
Author name
Location of report (journal article, webpage, pdf document, etc.)
Year
Study setting
Teaching status
Teaching - 1
Non-teaching – 2
Not identified – 0
Location
Northeast - 1
Southeast - 2
Midwest - 3
Northwest - 4
Southeast - 5
Not identified - 0
Size
Bed size
Less than 100 – 1
100-199 – 2
200 – 299 – 3
300 or higher – 4
Not identified - 0
117
Number of operating rooms
Less than 5 – 1
5-9 – 2
10-14 – 3
15-19 – 4
20 or higher – 5
Not identified - 0
Independent variable
Components of checklist
Time Out - 1
Preoperative antibiotic administration - 2
DVT prevention - 3
Blood components available - 4
Concerns of other team members – 5
Not identified - 0
Any additional training beyond the checklist training
Communication training - 1
Teamwork training – 2
None identified - 0
Checklist initiated by whom
Nurse - 1
Surgeon - 2
Anesthesia – 3
Not identified – 0
118
Time of initiation of checklist in each procedure
Prior to arrival in the OR – 1
After arrival and before incision – 2
At the end of the procedure – 3
Not identified - 0
Type of surgical procedure
General - 1
Orthopedic - 2
Cardiac - 3
Pediatric – 4
Other - 5
Not identified - 0
Dependent variable
Length of time until final outcome measure
Less than 3 months – 1
3-5 months – 2
6-8 months – 3
9-11 months – 4
1 year or more – 5
Not identified - 0
Communication measures
Errors/Breakdowns in communication - 1
Perceptions of teamwork - 2
Staff satisfaction - 3
119
Perceptions of safety – 4
Not measured - 0
Postoperative outcome measures
Death - 1
Adverse events - 2
Errors - 3
Infection rates - 4
Cardiac events - 5
Length of hospitalization -6
Not measured - 0
Effect Size
Sample size
Means
Standard deviation
Standard error
Direction of effect
120
Appendix B. Institutional Review Board approval notification
121
Appendix C. Time-out and checklist survey
Rural Hospital Time-Out Checklist Survey
You are being asked to participate in a research study about the use of surgical safety
checklists during time-outs in rural hospitals. This study is part my dissertation study to
complete the requirements for my PhD at the University of Missouri, Sinclair School of
Nursing. The purpose of this research is to determine how rural operating rooms use
surgical safety checklists during time-outs. You are being asked to complete this short
survey about how surgical safety checklists are used at your organization. This survey
should take you approximately 5 minutes to complete. At the completion of the survey,
you will be asked if you are willing to answer any possible follow-up questions from the
researcher. If you are willing to answer future questions, please provide your contact
information. Your participation in this survey study is voluntary. Your answers will be
kept confidential and will not be shared with anyone outside of this study. For the
purpose of this survey, a time-out is a momentary pause taken by the surgical team
immediately before skin incision or the start of an incisionless procedure in order to
confirm that several essential safety checks are undertaken. The time out involves
everyone on the surgical team. A checklist is a standard visual list of tasks that must be
completed before the operation can proceed. For any questions or concerns please
contact,
Vanessa Lyons, MSN, RN, CNOR PhD Candidate University of Missouri
[email protected] (270)978-2536 Lori Popejoy, PhD, APRN, GCNS-BC
Associate Professor [email protected] (573)884-9538
122
Q1 What is your job title?
 Circulator (1)
 Surgical Technologist (2)
 RNFA (3)
 Anesthesia provider (4)
 Charge nurse/ Board runner (5)
 Operating Room Educator (6)
 Director/ Assistant Director (7)
 Other (please describe) (8) ____________________
Q2 How many years have you worked in the operating room at your current employer?
 less than 6 months (1)
 6 months - 2 years (2)
 3 years - 5 years (3)
 6 years - 10 years (4)
 11 years or more (5)
Q4 How many years have you worked in the operating room overall?
 less than 6 months (1)
 6 months - 2 years (2)
 3 years - 5 years (3)
 6 years - 10 years (4)
 11 years or more (5)
Q5 What is your highest level of education?
 High school or equivalent (1)
 Vocational or technical program (2)
 Associate's degree (3)
 Diploma nurse (4)
 Bachelor's degree (5)
 Master's degree (6)
 Doctorate (7)
Q6 Are you certified (CNOR, CRNFA, CST)?
 Yes (1)
 No (2)
Q7 About how many hours a week do you perform direct patient care?
 less than 10 (1)
 10 - 19 hours (2)
 20 - 29 hours (3)
 30 or more hours (4)
123
Q8 Is your hospital for-profit or not-for-profit?
 For-profit (1)
 Not-for-profit (2)
 Do not know (3)
Q9 Is your hospital Joint Commission accredited?
 Yes (1)
 No (2)
Q10 What is your zip code? This is for rural classification purposes only.
Q11 Do you complete a time-out prior to starting any surgical procedure?
 Almost always (76% - 100% of the time) (1)
 Usually (51% - 75% of the time) (2)
 Sometimes (26% - 50% of the time) (3)
 Rarely (1% - 25% of the time) (4)
 Never (5)
Answer If Do you complete a time-out prior to starting any surgical procedure? Never Is
Not Selected
Q12 During the time-out, do all team members verbally confirm agreement with the timeout?
 Almost always (76% - 100% of the time) (1)
 Usually (51% - 75% of the time) (2)
 Sometimes (26% - 50% of the time) (3)
 Rarely (1% - 25% of the time) (4)
 Never (5)
Answer If Do you complete a time-out prior to starting any surgical procedure? Never Is
Not Selected
Q13 During the time-out, do all team members stop any activity not directly related to the
time-out?
 Almost always (76% - 100% of the time) (1)
 Usually (51% - 75% of the time) (2)
 Sometimes (26% - 50% of the time) (3)
 Rarely (1% - 25% of the time) (4)
 Never (5)
124
Answer If Do you complete a time-out prior to starting any surgical procedure? Never Is
Not Selected
Q14 Who is responsible for starting the time-out (check all that apply)?
 Circulator (1)
 Surgical technologist (2)
 Anesthesia provider (3)
 Surgeon (4)
 Other (please specify) (5) ____________________
Answer If Do you complete a time-out prior to starting any surgical procedure? Never Is
Not Selected
Q15 Which team members verbally participate in the time-out (check all that apply)?
 Circulator (1)
 Surgical technologist (2)
 Anesthesia provider (3)
 Surgeon (4)
 Other (please specify) (5) ____________________
Answer If Do you complete a time-out prior to starting any surgical procedure? Never Is
Not Selected
Q16 For which surgical procedures is a time-out typically not conducted?
Q17 Do you use a checklist during the time-out?
 Yes (1)
 No (2)
 Do not complete a time-out (3)
Answer If Do you use a checklist during the time-out? Yes Is Selected
Q18 Which checklist do you use?
 World Health Organization (WHO) (1)
 AORN Comprehensive Surgical Safety Checklist (2)
 Hospital-designed checklist (3)
 Other (please specify) (4) ____________________
 Do not know (5)
Answer If Do you use a checklist during the time-out? Yes Is Selected
Q19 What is the format of your checklist?
 Paper (1)
 Electronic (2)
 White board/ Dry erase board (3)
 Other (please describe) (4) ____________________
125
Answer If Do you use a checklist during the time-out? Yes Is Selected
Q20 How often are the following items verbalized during the time-out process?
126
Not
included
in the
checklist
(1)
Never
(2)
Rarely
(1% 25% of
the time)
(3)
Sometimes
(26% 50% of the
time) (4)
Usually
(51% 75% of
the time)
(5)
Almost
always
(76% 100% of
the time)
(6)
Team
member
names (1)






Patient's
name (2)






Name of
the
procedure
(3)






Incision
site (4)






Consent
verified (5)






Site
marked
and visible
(6)






Relevant
images
properly
displayed
(7)






Equipment
concerns
(8)






Surgeon's
anticipated
critical or
non routine
steps (9)






Anticipated
case
duration
(10)






Anticipated
blood loss
(11)






127
Antibiotic
prophylaxis
within one
hour before
incision
(12)






Anesthesia
concerns
(13)






Sterilization
indicators
confirmed
(14)






Scrub and
circulating
nurse
concerns
(15)






Answer If Do you use a checklist during the time-out? Yes Is Selected
Q21 Please list any additional parts of the checklist used by you or your team that has
not been mentioned.
Answer If Do you use a checklist during the time-out? Yes Is Selected
Q22 We are interested in understanding challenges to the use of surgical safety
checklists. If you did not answer "almost always" to any of the items regarding the
specific content of the time-out process, what prevents you from verbalizing these items
more often?
128
Q23 Is there anything else you would like to tell us about the use of checklists during
time-outs at your hospital? Please include any questions, concerns, observations, or
experiences. If there is any information that we have not covered in this survey, please
feel free to mention it here.
Answer If Do you use a checklist during the time-out? Yes Is Selected
Q24 Would you be willing to share your checklist?
 Yes (1)
 No (2)
Q25 Are you willing to be contacted for further questions? If so, please complete the
following information:
Name (1)
Phone (2)
Email (3)
Q26 Preferred contact method:
 Phone (1)
 Email (2)
129
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VITA
Vanessa Ervin Lyons was born in 1977 to Robert and Janice Ervin. She has four
brothers and one sister and grew up in Paducah, Kentucky. She attended Reidland High
School where she was active in band, color guard, and choir and graduated with honors.
She attended Murray State University where she majored in math and psychology for
four years before changing her major to nursing and transferring to Madisonville
Community College. During her first semester of nursing, the terrorist attacks of 9/11
required the army to relocate her husband to Germany and she transferred to Paducah
Community College to finish her degree closer to family. She earned an Associate’s
Degree in Arts, an Associate’s Degree in Science, and an Associate’s Degree in Applied
Science in Nursing from Paducah Community College in 2003. In 2009, she completed
her Masters in Nursing with specialization in education from Walden University. Shortly
afterward, she was accepted as a PhD student at the University of Missouri where she
also completed a graduate certificate in informatics in 2013. She currently works as the
Staff Development and Technology Coordinator at Murray-Calloway County Hospital in
Murray, Kentucky. She also is an instructor for Grand Canyon University in Phoenix,
Arizona. She is very active in the Association of periOperative Registered Nurses, serving
on the National Committee on Education, Scholarship Committee, Continuing Education
Committee, and is currently the education chair for the Informatics Specialty Assembly.
She is married to Evan and has three children, Mariah, Thomas, and Laya. She is an
active volunteer with the high school band, speech, and archery teams.
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