SYSTEMATIC REVIEW

BMJ Qual Saf: first published as 10.1136/bmjqs-2012-001797 on 6 August 2013. Downloaded from http://qualitysafety.bmj.com/ on January 22, 2022 by guest. Protected by copyright.
Surgical checklists: a systematic
review of impacts and
implementation
Jonathan R Treadwell, Scott Lucas, Amy Y Tsou

▸ Additional material is ABSTRACT THE PROBLEM

published online only. To view
Background Surgical complications represent a Although surgery represents a mainstay of
please visit the journal online
(http://dx.doi.org/10.1136/ significant cause of morbidity and mortality with medical treatment, in industrialised coun-
bmjqs-2012-001797) the rate of major complications after inpatient tries, the rate of perioperative death dir-
surgery estimated at 3–17% in industrialised ectly due to inpatient surgery has been
ECRI Institute, Plymouth
Meeting, Pennsylvania, USA countries. The purpose of this review was to estimated at 0.4–0.8%, and the rate of
summarise experience with surgical checklist use major complications has been estimated at
Correspondence to and efficacy for improving patient safety. 3–17%.1 2 These complications include
Dr Jonathan R Treadwell,
ECRI Institute, 5200 Butler
Methods A search of four databases (MEDLINE, wrong patient/procedure/site surgery,
Pike, Plymouth Meeting, CINAHL, EMBASE and the Cochrane Database of anaesthesia equipment problems, lack of
PA 19462-1298, USA; Controlled Trials) was conducted from 1 January availability of necessary equipment,
[email protected] 2000 to 26 October 2012. Articles describing unanticipated blood loss, non-sterile
Received 31 December 2012 actual use of the WHO checklist, the Surgical equipment, and surgical items (eg,
Accepted 12 July 2013 Patient Safety System (SURPASS) checklist, a sponges) left inside patients. The com-
Published Online First wrong-site surgery checklist or an anaesthesia plexity of most surgical procedures
6 August 2013
equipment checklist were eligible for inclusion requires a well coordinated team to
(this manuscript summarises all but the prevent these events.
anaesthesia equipment checklists, which are
described in the Agency for Healthcare Research STRATEGIES FOR PATIENT SAFETY
and Quality publication). Surgical checklists can potentially prevent
Results We included a total of 33 studies. We errors and complications which may
report a variety of outcomes including avoidance occur during surgery or perioperatively.
of adverse events, facilitators and barriers to A variety of interventions have shown
implementation. Checklists have been adopted in promise for improving patient safety. For
a wide variety of settings and represent a instance, Neily et al3 found that surgical
promising strategy for improving the culture of team training which incorporated surgical
patient safety and perioperative care in a wide checklists along with communication
variety of settings. Surgical checklists were strategies was associated with a significant
associated with increased detection of potential reduction in surgical mortality. Arriaga
safety hazards, decreased surgical complications et al4 found that checklists dramatically
and improved communication among operating improved adherence to critical processes
staff. Strategies for successful checklist of care in simulated scenarios of surgical
implementation included enlisting institutional crises. Studies have suggested that check-
leaders as local champions, incorporating staff lists may reduce errors for many reasons,
feedback for checklist adaptation and avoiding including ensuring that all critical tasks
redundancies with existing systems for collecting are carried out, encouraging a non-
Open Access information. hierarchical team-based approach, enhan-
Scan to access more
free content Conclusions Surgical checklists represent a cing communication, catching near
relatively simple and promising strategy for misses early, anticipating potential com-
addressing surgical patient safety worldwide. plications, and having technologies to
Further studies are needed to evaluate to what manage anticipated and unanticipated
To cite: Treadwell JR, degree checklists improve clinical outcomes and complications. The WHO Surgical Safety
Lucas S, Tsou AY. BMJ Qual whether improvements may be more Checklist is a prominent example of a
Saf 2014;23:299–318. pronounced in particular settings. surgical checklist intended to ensure safe

Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797 299

 Systematic review

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surgery and minimise complications. Launched in checklist, the SURPASS checklist, a wrong-site surgery
June 2008, it has been translated into at least six lan- checklist or anaesthesia equipment checklists. We rec-
guages.5 The 2009 WHO checklist (http://www.who. ognise other surgical checklists exist; however, many
int/patientsafety/safesurgery/en/) contains 22 items in of these have only been implemented at a single insti-
three phases: tution. We also included articles describing use of
▸ Before induction of anaesthesia, covering areas such as anaesthesia checklists to detect equipment failure in
patient identification, anaesthesia equipment check and a simulated scenarios. This manuscript summarises all
pulse oximetry check. but the anaesthesia equipment checklists, which are
▸ Before skin incision, covering areas such as team intro- described in an Agency for Healthcare Research and
ductions, review of critical steps and antibiotic Quality (AHRQ) publication.11 An overview of the
prophylaxis. three types of checklists discussed in this paper is
▸ Before patient leaves operating room (OR), covering given in table 1. We included a total of 33 studies of
areas such as checking counts of instruments, specimen these checklists and tabulated the reported outcomes,
labelling and concerns for recovery. facilitators and barriers to checklist implementation.
In this paper we discuss the evidence for three
patient safety efforts associated with surgical check-
lists. The WHO Surgical Safety Checklist and the BENEFITS AND HARMS
Joint Commission Universal Protocol (UP) for Benefits
Preventing Wrong Site, Wrong Procedure, Wrong WHO checklist
Person Surgery6 have each been widely implemented The 2008 WHO Surgical Safety Checklist was tested
to improve care when surgical procedures are per- at eight sites around the world.5 These settings varied
formed. We also discuss the Surgical Patient Safety greatly in the number of beds (range 371–1800), the
System (SURPASS) checklist,7–10 which represents a number of ORs (range 3–39), and the income level of
more comprehensive approach, capturing clinical care the country (four low, four high). Surgical safety pol-
from admission to surgery to discharge. icies prior to implementation of the WHO Checklist
also differed regarding the use of routine intraopera-
tive monitoring with pulse oximetry (six of eight
REVIEW STRATEGY sites), oral confirmation of patients’ identity and surgi-
We conducted a systematic literature search of cal site in the OR (only two of eight sites), and
MEDLINE, CINAHL, EMBASE and the Cochrane routine administration of prophylactic antibiotics in
Database of Controlled Trials using a search strategy the OR (five of eight sites). None of the eight sites
developed by a medical librarian. The search strategy had a ‘standard plan for intravenous access for cases
(available upon request) included studies published of high blood loss’, or formal team briefings preopera-
from 1 January 2000 to 26 October 2012, and used a tively or postoperatively.
combination of medical subject headings and key- Baseline data were obtained at each site for
words related to checklists (‘anaesthesia checklist’, 3 months prior to checklist introduction, involving a
briefing, checklist, checkout, communication, docu- total of 3733 surgical procedures. In the subsequent
mentation, instrument, ‘safety checklist’, tool, ‘surgical 3–6-month period after checklist introduction, involv-
checklist’, protocol, ‘WHO checklist’). ing 3955 procedures, data showed decreases in patient
Given the limited scope of this review, we focused mortality (from 1.5% to 0.8%) and inpatient compli-
on any articles describing actual use of the WHO cations (from 11% to 7%). No single site was driving

Table 1 Overview of the three checklists

Checklist Clinical scope Staff involvement Categories and numbers of items
WHO Surgical Surgical care Surgeon(s), anaesthetist(s), Total of 22 items, in three categories:
Safety Checklist nurse(s) ▸ Before induction of anaesthesia
(7 items)
▸ Before skin incision (10 items)
▸ Before patient leaves operating
room (5 items)
SURPASS All surgical care between patient admission and Ward doctor(s), surgeon(s), Total of 90 items, in 11 categories
discharge anaesthetist(s), nurse(s) or
operating assistant(s)
Checklists based on Surgical care, but also (if applicable) when the Varies by site Varies by site
the Universal procedure is scheduled, when the patient enters the
Protocol healthcare facility, and anytime care is transferred
between caregivers
SURPASS, Surgical Patient Safety System.

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 Systematic review

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the findings, as evidenced by the persistence of find- whether blood products are available), team introduc-
ings after the removal of any single site in a sensitivity tions, and anticipation of critical events).
analysis. The authors found that the performance De Vries et al7 tested the 90-item SURPASS check-
rates for six specific safety indicators (eg, using a list. In six test hospitals, the 3-month period after the
pulse oximeter) also increased after checklist introduc- checklist was initiated (compared with the 3 months
tion, suggesting that the safety indicators may have before) saw numerous improvements: decreases in the
been responsible for the lower rates. percentage of patients with complications, in-hospital
In discussing the results, the authors acknowledged mortality, patient temporary disability and reopera-
that the underlying explanations were ‘most likely tions. No such improvements were found among the
multifactorial’ and included the following: five control hospitals. Interestingly, the degree of
▸ The checklist itself. improvement was associated with greater compliance
▸ A Hawthorne effect (ie, rates may have decreased with the checklist, providing greater confidence that
because OR personnel knew they were being measured). the checklist itself was responsible for improvements.
The authors argued against this possibility based on two A subsequent retrospective review of 294 medical
aspects of their data: this knowledge was in place before claims10 estimated that 40% of deaths and 29% of
and after checklist introduction, and the subset of proce- liability incidents might have been prevented if the
dures for which study personnel were present in the OR SURPASS checklist had been used. Further review of
had the same reductions in complications as procedures 6313 checklists performed found that 41% detected
when study personnel were absent from the OR. at least one oversight, with the most common occur-
▸ The simple existence of a formal pause or preoperative ring postoperatively (lack of postoperative instructions
briefing (which could be done without a ‘checklist’). concerning ventilation by the anaesthesiologist and
Such a pause is a necessary component of the checklist. missing medication prescriptions at discharge).19
▸ Increased uptake of safety technologies (eg, administer-
ing antibiotics in the OR rather than in preoperative Wrong-site surgery checklists
wards). This change could be considered a byproduct of In January 2004, the Joint Commission launched the
checklist introduction (ie, hospitals made more antibio- first version of the UP for Preventing Wrong Site,
tics directly available in the OR because of the presence Wrong Procedure, Wrong Person Surgery.6 20
of an antibiotics-related item on the checklist). Preoperative verifications of person, procedure and
▸ A broad change in safety culture and teamwork at that site are supposed to occur in the OR and (if applic-
site, an explanation supported by the finding that greater able) when the procedure is scheduled, when the
increases in safety attitudes at the pilot sites were asso- patient enters the healthcare facility, and anytime care
ciated with greater reductions in complications.12 is transferred between caregivers. Site marking should
Subsequent publications about the WHO Surgical involve only the operative site and should be visible
Safety Checklist have found improvements in urgent before the patient is draped. The ‘time out’ is to occur
surgery13 and safety attitudes.12 14 Haynes et al12 before incision and involve the entire OR team. The
reported that 80% of respondents considered the UP is not a checklist21 but could be implemented
checklist easy to use, 20% believed it took too long using one or more checklists. Steps 1 and 3 specific-
and 93% of respondents would want the checklist ally mention the potential use of a checklist.
used if they were undergoing surgery. Likewise, Wrong-site surgery is rare; estimates for various pro-
Helmio and colleagues15 found that 76% of OR staff cedures range from 1 in 13 000 procedures for
agreed the checklist improved safety, 68% agreed it wrong-site anaesthesia block to 1 in 4200 for wrong-
improved error prevention and 93% would want the side ureteral stents.22 A general systematic review esti-
checklist used if they were having surgery. Team mated that the overall rate was 1–5 per 10 000 proce-
members reported high satisfaction and positivity dures.23 Given the rarity, demonstrating a statistical
about the checklist, and estimated that it only took reduction would require an unfeasibly large study. A
about 2 min to complete.16 systematic review searched for literature and con-
cluded there was ‘no literature to substantiate the
SURPASS checklist effectiveness of the current Joint Commission
The WHO checklist focuses primarily on events Universal Protocol in decreasing the rate of wrong
occurring within the OR. However, an estimated 53– site, wrong level surgery.’23 Therefore, the preventive
70% of surgical errors occur outside the OR.8 17 18 benefits of a checklist to prevent wrong-site surgery
The SURPASS checklist7–10 attempts to address these are generally assumed based on clinical expertise.
errors by encompassing all care between patient
admission and discharge. Within the OR itself, the HARMS
SURPASS checklist is less specific than the WHO Direct harms of surgical checklists have not been
checklist (eg, the SURPASS checklist does not specific- reported. In 2011, Sewell et al24 reported that after
ally mention any of the following: pulse oximetry, dif- WHO implementation, the rate of lower respiratory
ficult airway, risk of blood loss (although it asks tract infections actually increased from 2.1% to 2.5%.

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Systematic review

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Whether this increase was caused by the checklist is incorporating real-time feedback into checklist
unclear; however the authors attributed rate reduc- protocols.
tions to the checklist, so they could also have attribu- Barriers to implementation generally fell into four
ted rate increases to the checklist. Despite the absence categories: confusion regarding how to properly use
of reported direct harms, some checklist users have the checklist, pragmatic challenges to efficient work-
expressed concern regarding potential harms. For flow, access to resources, and individual beliefs and
instance, some worry that checklist use decreases OR attitudes. First, OR staff were sometimes confused
efficiency or creates unnecessary patient anxiety. In about how to properly execute the checklist.15 27 31
2011, Kearns et al25 reported that 3 months after For instance, Levy et al31 found significant confusion
WHO checklist implementation, 30% believed it was about the timing of checklist items and who was
an inconvenience in emergency cases; however, this responsible for prompting checklist questions among
percentage was lower than it had been prior to imple- OR staff. While inadequate education may play a part,
mentation of the checklist when staff were asked Fourcade et al27 found that nurses were unfamiliar
hypothetically whether they believed it would be an with the checklist because of high staffing turnover.
inconvenience in emergency cases (53% said it would Vogts et al32 suggested that performance of ‘sign out’
be). OR efficiency might also be compromised if may be low since this section is not linked to a specific
checklists duplicated already existing safety procedures event in patient management, unlike the ‘sign in’ and
or if nurses responsible for performing the checklist ‘time out’ domains and thus lacks clarity.
were unfamiliar with its execution due to high staffing Second, checklist implementation occasionally
turnover. 26 27 In one study,27 staff expressed concerns created pragmatic problems for OR workflow.
that prompting patients for their name several times Particular challenges include extra time,27 32 especially
immediately before induction of anaesthesia might during emergency procedures,33 and duplication of
create unnecessary anxiety. safety checks already routinely performed.26 27 In the
study by Kearns et al25 30% felt that in emergency
IMPLEMENTATION CONSIDERATIONS AND COSTS cases, the checklist was inconvenient. Third, develop-
WHO checklist ing countries often lacked regular access to resources.
We included 23 reports of WHO checklist implemen- Yuan et al14 reported that inconsistent access to anti-
tation. Twenty-one studies reported WHO checklist biotics and batteries hampered checklist use in two
implementation at other sites and two reported Liberian hospitals. Likewise, Kasatpibal et al34
experience at institutions involved in the original reported that surgical sites were not routinely marked
study (table 2). because marking materials were unavailable in a Thai
Results from the 23 implementation reports appear hospital. Finally, individual attitudes of staff towards
in table 3. In keeping with WHO recommendations, the checklist played a major role in the outcome of
checklists were tailored and implemented differently implementation. Barriers included general surgeon
for a wide variety of contexts. At present, it remains resistance to changing habits, awkwardness of self-
unclear whether OR posters, paper tick boxes or elec- introductions and steep interpersonal hierarchy. Some
tronic medical records perform better. Feedback from nurses reported concerns about incurring legal
surgical teams was generally positive, but support responsibility if a complication occurred after they
tended to be greater from nurses and anaesthetists signed the checklist form.
than from surgeons. For example, Vats et al26 found
that anaesthetists and nurses were ‘largely supportive’
but some surgeons were ‘not very enthusiastic’.
Reasons cited for success included good training Health outcomes
and staff understanding, a local champion, support In terms of improved health outcomes (rightmost
from upper management, being able to modify the columns of table 3), 10 of the 21 implementation
checklist, distribution of responsibility, the feeling of studies reported relevant data. Among the 10 report-
ownership by team members, a stepwise implementa- ing studies, however, reductions were generally
tion process which incorporated real-time feedback, impressive. For example, Askarian et al35 found that
and enhanced communication and teamwork. surgical complications decreased from 22.9% to 10%.
Regarding communication, for example, Sewell et al24 Yuan et al14 reported that two Liberian hospitals
found that 77% of users thought the checklist found checklist introduction was significantly asso-
improved team communication; this percentage was ciated with fewer surgical site infections (adjusted OR
70% in the study by Kearns et al.25 The implementa- (AOR) 0.28; 95% CI 0.15 to 0.54) and surgical com-
tion study by Conley et al28 emphasised that the local plications (AOR 0.45; 95% CI 0.26 to 0.78).
champion should ‘persuasively explain why and adap- Similarly, the study at Royal Bolton36 found that
tively show how to use the checklist’. Styer et al29 and nine potential safety incidents were averted during a
Bohmer et al30 attributed success to recruiting senior 1-month period of checklist use. Other reported
leaders of their institutions to be local champions and improvements appear in table 3.

302 Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

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Table 2 Implementation studies of the WHO Surgical Safety checklist

Description of Patient Safety
Author [year] Practice (PSP) Study design Theory or logic model Description of organisation Safety context
Sewell et al 2008 WHO surgical checklist, Before and after study, ‘The underlying philosophy of the A UK hospital, orthopaedic operations. Pre-training period February–May 2009
[2011]24 unmodified comparing pre-training checklist is that a true team approach 28% of operations were urgent, and (480 operations). During this period: correct
period to post-training with good communication between 77% involved general anaesthesia checklist use was 8%, and 47% thought it
operating room team members is safer improved team communication; pre-training
and more efficient than a hierarchical staff perceptions: 55% thought it caused
system that relies on individuals’ an unnecessary time delay, 28% thought it
improved patient safety, 47% thought it
improved team communication and
teamwork, 64% would want the checklist
used if they were having an operation
Helmio et al 2008 WHO surgical checklist. No Before and after study ‘The idea of the checklist is to be an Finland, otorhinolaryngology head and One-month pre-implementation period in
[2011]55 specialty-related changes, but some add-on security tool for the defined safety neck surgery ORs. 747 operations in the May 2009 (304 operations): 17% were
‘minor changes.’ Checklist included in standard’ 2-month study periods combined. All urgent operations; 24% were on children;
publication; modifications did not subgroups of otorhinolaryngology head 16% were local anaesthesia. Before
exclude any items and neck surgery were included implementation: knowledge of OR-teams’
names and roles ranged from 61% to
92%. Discussing risks was 24%. Postop
instructions recorded 7–84%. Successful
communication 79–93%
Conley et al 2008 WHO surgical checklist, Case series None explicitly stated Five Washington State hospitals. Two Nothing reported about pre-existing safety
[2011]28 unmodified hospitals had <10 ORs, one had 10–20 culture. The Vice President for Patient
and two had >20. Two urban, two Safety at the Washington State Hospital
suburban and one rural Association provided ‘significant assistance’.
Checklist introduction December 2008 to
January 2009. Interviews conducted
September–December 2009. One of the
five hospitals had a recent wrong-site
incision that motivated surgical staff and
‘opened people’s eyes to the need for
ongoing patient safety efforts’
Bell and Pontin 2008 WHO checklist adapted different Case series ‘Without a doubt, the checklist works Large two-hospital trust in the UK with Nothing about pre-existing safety culture.
[2010]56, Bell57 for different surgical specialties. Checklist best when all staff members are engaged’ 10 000 staff and 850 000 patients To prepare for the checklist, they set up a
not included in publication annually Patient Safety Working Group
Sparkes and 2008 WHO checklist locally adapted. Case series Discussed various ways a checklist could Teaching hospital in the UK with 29 NR
Rylah [2010]58 Checklist included in publication; enhance safety, including teamwork and ORs in five locations performing

Systematic review
modifications did not exclude any items effective communication specialised complex surgery
Royal Bolton 2008 WHO checklist, unmodified. Local Case series Improve patient safety by enhancing Trust in the UK with eight ORs Prior to the checklist, the trust already had
[2010]36 adaptation of it was considered but teamwork and communication a core group of patient safety experts
ultimately not done assembled; this group met to discuss how
to introduce the checklist. They examined
the previous year’s 41 safety incidents and
all were ‘found to be avoidable had the
checklist been in use’
303

Continued

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 Table 2 Continued
304

Systematic review
Description of Patient Safety
Author [year] Practice (PSP) Study design Theory or logic model Description of organisation Safety context
Vats et al 2008 WHO surgical checklist adapted for Case series ‘the checklist ensures that critical tasks UK academic hospital Nothing reported about pre-existing safety
[2010]26 England and Wales. Checklist included in are carried out and that the team is culture. Piloted March–September 2008 at
publication; modifications did not adequately prepared for the operation’ a London hospital in 58% of operations
exclude any items (424/729) among the two ORs selected
(one for trauma/orthopaedics OR, the other
for GI/GYN)
Kearns et al WHO surgical checklist, version NR. Before and after study ‘Checklists may be used to improve UK study in obstetrics ORs. Tertiary Before introducing the checklist, they
[2011]25 Some obstetric-specific checks had been patient safety by ensuring that all referral obstetric centre with ∼6400 measured staff attitudes, preserving
added, but the list of revisions was not elements of a practice are instituted for deliveries per year respondent anonymity: 30% ‘felt familiar’
reported. Checklist not included in each new clinical event’ with others in the OR, 81% felt
publication communication could improve, 85% felt
that in elective cases the checklist would be
useful, 53% felt that in emergency cases
the checklist would be inconvenient
Norton and 2008 WHO checklist modified for Case series Checklist can help to reduce breakdowns Children’s hospital in the USA At this hospital they had been building a
Rangel [2010]59 paediatric operations and also to meet in communication, ineffective teamwork performing numerous types of paediatric quality infrastructure for 5 years prior, and
the 2009 Joint Commission Universal and lack of compliance with process surgery had already implemented the Universal
Protocol. Checklist included in measures Protocol
publication. Removed the following three
items from the WHO checklist: pulse
oximetry, difficult airway, anticipated
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

blood loss
Styer et al 2008 WHO checklist modified and Qualitative description Implementing checklist using a PDSA Teaching hospital in the USA with 44 ‘This initiative … was introduced to see
[2011]29 implemented as hospital policy. Selected cycle stepwise approach leads to ORs how the checklist might fit within our
modifications listed. Checklist not smoother transition and sustained hospital culture’
included in publication outcomes
Bittle [2011]60 2008 WHO checklist adapted for Qualitative description Checklists ‘ensure there is adherence to Large city hospital in New Zealand Quality service improvement team
individual hospital. Checklist not proven standards or care’
included in publication
Yuan [2012]14 2008 WHO checklist modified for local Before and after study Checklists are an inexpensive and feasible Two hospitals (each with 2 ORs) in Liberia is rebuilding health system
practice. Checklist included in publication way to potentially improve quality of Monrovia, Liberia. Hospital 1 (150-bed infrastructure after 14 years of conflict.
surgical care in ‘resource-limited settings’ primary community hospital), hospital 2 Checklist implementation was a
(200-bed, government referral hospital) collaboration with the Ministry of Health
and Social Welfare in Liberia to characterise
its impact in low resource context
Kasatpibal et al 2008 WHO checklist modified and Case series Checklists may reduce preventable University hospital in northern Thailand Average rate of surgical site infection in
[2012]34 translated. Hair removal added to adverse surgical events, but may be (1400 beds, 21 877 operations Thailand is 1.7%
checklist. Other modifications not difficult or inappropriate to implement in annually)
described. Checklist not included in a developing country
publication
Bohmer et al 2008 WHO checklist modified. Checklist Before and after Checklists may improve staff’s perception Institute for research in Operative NR
[2012]30 included in publication of patient safety and job satisfaction Medicine of the University of Witten/
Herdecke
Continued

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Table 2 Continued
Description of Patient Safety
Author [year] Practice (PSP) Study design Theory or logic model Description of organisation Safety context
Fourcade et al 2008 WHO checklist modified. Checklist Case series Checklists may improve surgical 18 cancer centres in France The French National Authority for Health
[2012]27 included in publication 1. Random sample of outcomes, but face barriers to efficient introduced a modified checklist as
80 surgeries from each implementation mandatory. Implemented by French
centre performed over National Federation of Cancer Centres
18-day interval. along with research team from
2. Interviews and Coordination for Measuring Performance
surveys of participating and Assuring Quality of Hospitals, Institut
staff Gustave Roussy
Perez-Guisado 2008 WHO checklist. Checklist included Descriptive Checklist ‘involves new philosophy of Reina Sofia Hospital (1684 surgeries) NR
et al [2012]62 in publication cross-sectional study of organisation that is easier to achieve in
plastics, reconstructive health workers with lower hierarchy’ (ie,
surgical procedures nurses, surgeon residents)
van Klei et al 2008 WHO checklist modified. Checklist Before and after Checklists enhance teamwork and University Medical centre Utrecht (The Checklist implemented in accordance with
[2012]33 available in online supplementary improve handovers decreased avoidable Netherlands) mandatory policy by the Dutch Health Care
material errors and complications Inspectorate
Takala et al 2008 WHO checklist, modified. Checklist Before and after ‘Checklist would improve awareness of Four university teaching hospitals in Pilot study to investigate usefulness of the
[2011]63 available in appendix safety-related issues and the fluency of Finland checklist in a variety of surgical specialties
operations as well as communication to inform development of a national
during surgery’ checklist
Truran et al 2008 WHO checklist, modified. Checklist Before and after The checklist may improve compliance Hospitals in the UK NR
[2011]64 not included with venous thromboembolism
prophylaxis guidelines
Vogts et al 2008 WHO checklist, modified. Checklist Case series Checklists ‘promote communication and Auckland City Hospital, New Zealand Checklist implemented 2 years prior
[2011]32 included in appendix teamwork within the OR’
Askarian et al 2008 WHO checklist. No modifications Before and after Checklist may improve patient safety by Referral educational hospital in Shiraz, The Iranian Ministry of Health, Treatment
[2011]35 noted, checklist not included in reducing surgical complications southern Iran (374 beds, 6 ORs) and Medical Education approved
publication nationwide use of checklist in 2009
Levy et al 2008 WHO checklist modified. Modified Case series Low fidelity of checklist execution may be Academic tertiary care children’s hospital Checklist compliance reported at 100%,
[2012]31 checklist not included in publication a barrier to improving health outcomes (Texas, USA) but fidelity of checklist use is unclear

Systematic review
Helmio et al WHO checklist (unclear if modified). Case series ‘This checklist has reduced complications Otorhinolaryngology department in four Checklist implemented in these hospitals
[2012]15 Checklist not included in publication and deaths significantly’ Finnish hospitals during WHO pilot project in 2009
GI, gastrointestinal; GYN, gynaecology; NR, not reported; OR, operating room; PDSA, plan–do–study–act.
305

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Table 3 Findings of implementation studies of the WHO Surgical Safety Checklist

Systematic review
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
Sewell et al Checklist forms placed in ORs, Training phase first (unreported ‘The initial implementation of the 77% thought it improved team Early complications 8.5% before
[2011]24 compulsory training video detailing duration). Post-training period June– checklist was met with resistance by communication, 68% thought it checklist training and 7.6% after.
correct and incorrect uses of the October 2009 (485 operations). some operating room team members improved patient safety, 80% would Mortality 1.9% before checklist
checklist, emphasis placed on all Correct checklist use 97%: 2 min. as there was a belief that many of want the checklist used if they were training and 1.6% after. Lower
team members being responsible. 20% thought it caused an the points were already in practice’ having an operation respiratory tract infections 2.1%
Active discouragement of a simple unnecessary time delay before checklist training and 2.5%
tickbox approach. Checklist training after. Surgical site infection 4.4%
was not associated with reductions before checklist training and 3.5%
in any complications or mortality after. Unplanned return to OR 1.0%
before checklist training and 1.0%
after
Helmio et al Training involved a presentation from One-month implementation period in ‘Use of the checklist improved ‘… overall, the operating room NR
[2011]55 an outside expert and three 45 min September 2009 (443 operations) verification of patient identity, but this personnel were supportive’.
lectures. Specific guidelines were in was still inadequate.’ ‘Our study Anaesthesiologists’ knowledge about
the OR, and short instructions on confirms that the surgical checklist fits patients had improved compared with
the back of the checklist well into otolaryngology.’ ‘We the pre-implementation period.
recommend the use of this checklist Preoperative check of anaesthesia
in all operations’ equipment increased from 71% to
84%. After implementation, staff were
more likely to accurately report patient
identity, procedure and operative side.
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

After implementation, there was

improvement in: knowledge of
OR-teams’ names and roles ranged
from 81% to 94%. Discussing risks was
38%. Postop instructions recorded
86%. Successful communication 87–
96%
Conley et al NR Duration of rollout: <2 months at The key is whether the local Interviews conducted, but no NR
[2011]28 three hospitals, >6 months at two champion can ‘persuasively explain quantitative summary of opinions
hospitals why and adaptively show how to use provided. Three hospitals were
the checklist.’ Implementation was discussed in detail
incomplete at three hospitals: One
cancelled attempts to implement the
checklist due to ‘fear of
insurmountable resistance and poor
interdisciplinary communication’.
Another cancelled attempts because
they were unable to move beyond
pilot testing. The third had less
effective implementation because of a
laissez-faire leadership style; no
training; staff understood neither why
Continued

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Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

Table 3 Continued
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
nor how the checklist could be
implemented
Bell and Pontin Training provided to prevent Piloted the checklist at one of the two ‘To implement the checklist ‘Communication and staff morale have NR
[2010]56, Bell57 ‘teething problems.’ Instead of hospitals first effectively, it was essential to engage definitely improved since the checklist
requiring paperwork, they used in all staff to ensure the theatre team was implemented’
each OR an A3 board (a drawing worked together.’ ‘Working with
board about 14×20 inches) that was individuals to identify any gaps or
colour-coded to aid completion. issues with implementation.’ Currently
Publicity campaign in both hospitals it is ‘being used as standard
throughout theatres’
Sparkes and “Extensive educational support and 3-month pilot, during which changes Even though people agreed with the Before checklist introduction: ‘Although NR
Rylah [2010]58 training” to the checklist were made. After the checklist in theory, it was difficult to all found the checklist to be useful,
pilot, and training, the checklist was change attitudes and behaviours, many senior clinicians felt that such
introduced to all 29 ORs in November particularly the senior team. The communication already took place
2009 checklist was required to be signed by informally, and that more paperwork
team members and ‘This had led to would not add to safety.’ Audit of 250
the fear that legal colleagues will cases in February 2010 found that team
apportion blame to those who have briefings occurred in 77% and time
signed the checklist when outs in 86%
complications occur’
Royal Bolton Drop-in educational sessions which May and June 2009 were spent ‘The importance of communicating ‘The feedback we received from staff 1-month pilot identified nine
[2010]36 involve 120 participants getting the word out about plans to with and involving people beyond this was very positive. Most people were potential incidents that were avoided
start using the checklist. Piloted first core group was recognised straight keen to introduce the checklist as as a result of the checklist
for 1 month in two of the Trust’s away.’ ‘Essentially it is all about quickly as possible’
hospitals in 62 operations. September changing the culture, which can be a
2009 was the trust-wide launch of the long process, but it’s well worth it’
checklist. ‘Every Trust is different but
implementing the checklist across the
Trust rather than a prolonged pilot
period.’ Within the first week 33% of
operations employed the checklist. By
1 month it was at 72%. Currently all
eight ORs use it
Vats et al Limited time given to training Checklist accelerated with use. Large Need a local champion as well as Anaesthetists and nurses were ‘largely ‘At our hospital, we found no
[2010]26 variability in how the checklist was local organisational leadership. supportive’. Some surgeons were ‘not significant change in overall
used: sometimes incompletely, hurried, Importance of being able to modify very enthusiastic’. Awkward morbidity or mortality, which were

Systematic review
dismissive replies, and without some to fit local needs, for example, there self-introductions, takes time to achieve already very low, after the
key participants. Compliance was was no need to check pulse oximetry comfort, steep interpersonal hierarchy, introduction of the checklist.
initially good, then fell when the because it is already always used ID the patient BEFORE draping, not However, there was a noticeable
research team was absent, and so the after. Complaints about duplication; improvement in safety processes,
team had to re-enter ORs to perhaps a revised checklist could have such as timely use of prophylactic
encourage greater use. Compliance less duplication antibiotics, which rose from 57% to
Continued
307

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 Table 3 Continued
308

Systematic review
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
ranged from 42% to 80% in the 77% of operations after the checklist
6-month period was introduced’
Kearns et al Training, humorous posters provided, Compliance with the preoperative part Authors cited four contributors to Staff attitudes 3 months after checklist NR
[2011]25 and ‘all staff empowered to remind of the checklist was 61% after success: allocation of responsibilities, introduction: 50% now ‘felt familiar’
the team to perform the checklist if 3 months and 80% after 1 year. local champion, sense of ownership with others in the OR; 70% felt
it was forgotten.’ Compliance with the postoperative by team members, and ongoing staff communication had improved; 80% felt
part of the checklist was 68% after consultation that in elective cases the checklist was
3 months and 85% after 1 year useful; 30% felt that in emergency
cases the checklist was inconvenient.
Fifty-eight patients were asked whether
they noticed the operating team
performing a series of checks before the
operation, and 75% said they did, and
another 19% remembered it after being
prompted. Of the combined 94%, they
all disagreed with the idea that the
checks would make them worried, and
93% said they were reassuring
Norton and 3×5 foot posters in each OR. Launch December 2008 pilot test in six ‘Use of the Paediatric Surgical Safety December 2008 pilot test of 30 Checklist caught one near miss
Rangel [2010]59 involved formal letter to staff, paediatric surgical services (general, Checklist encourages multidisciplinary procedures had 80–90% compliance, during sign in (site not marked),
electronic training application, neuro, orthopaedic, otolaryngology, teamwork and has brought increased with ‘overwhelmingly positive’ feedback. several near misses during time out,
multiple in-service training sessions, plastic surgery, and urology). February communication to our ORs and in ‘Team members have expressed (antibiotics not given, problems with
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

and mention in hospital newsletter 2009 pilot test on the revised other areas’ satisfaction with the flow and content consent forms, site marking not
procedures, and more minor edits were of the checklist’ visible after draping, missing
made. ‘Go-live’ date 1 April 2009 in equipment), and sign out (one team
all of the hospital’s ORs. Surgical realised a patient needed straight
chiefs were local champions, and one catheterisation, and reviewing
nurse champion was paired with each procedure name helped nurse
surgeon champion. They divided the documentation, one specimen was
responsibility for leading the Time Out incorrectly labelled)
phase among all team members, and
identified key speaking points.
Compliance at ORs improved over time
during this period from July 2009 to
February 2010
Styer et al Slide presentations, educational October 2008, 2-week trial. Day 1: Early endorsement by executive NR Allergies: RN added recent new
[2011]29 posters in ORs, one on one sessions, checklist used by 2 surgeons; leadership. Each discipline equally allergy to record
frequent email updates anaesthesia/nursing teams recruited to involved in leading effort. PDSA cycle Antibiotics: not given (3), wrong
participate and provide same day method for gradual implementation. antibiotic for procedure (2), surgeon
feedback. Day 2: feedback Real-time feedback. Each discipline changed mind about giving antibiotic
incorporated, used in 4 ORs, with 8 should lead a section of checklist. after confirming procedure, antibiotic
surgeons Provide data (process and outcome left in another room
December 2008: chiefs of nursing, measures). Checklist adopted as DVT: scheduled procedure typically
surgery, anaesthesiology and surgical hospital policy would not have required compression
services asked to endorse use as boots, but patient found to have
Continued

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 Table 3 Continued
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

Study phases and checklist Opinions, knowledge and

Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
hospital policy history of DVT
February 2008: checklist team Safety precautions: heparin drip had
established (leaders from surgery, not been discontinued
anaesthesia, nursing), project Plan for management of patient:
manager, administrative fellow chest radiograph after procedure for
March 2009: staggered 14-week unsuccessful central line placement
rollout to 44 ORs. Each surgical had been forgotten
service allotted 4 dedicated weeks of
attention (week 1: communication,
week 2: education, week 3: go live,
week 4: follow-up). During ‘go live’
period, checklist team observer
assigned to each surgery to educate,
provide real-time feedback, answer
questions
Bittle [2011]60 Quality division ‘coaches’ educated May 2010: ‘coaches’ from quality NR Initially ‘staff were anxious and Incorrect surgery site pointed out by
OR teams about checklist, and division assigned to OR to introduce somewhat apprehensive, but it is now patient
benefits checklist, first to plastics, then other an established step in an operation and Reported incidents fell from 12 to 11
specialties. Team meetings with coach, is carried out with confidence’ compared with reporting period of
OR manager, specialty clinical nurse previous year
manager, head of surgical department
and senior registrars preceded
implementation. Feedback regarding
checklist procedure obtained at 1 and
3 weeks
Yuan et al Certified registered nurse Two months prior and after. All Reasons for success: checklist ‘… the checklist’s focus on continuous Checklist associated with overall
[2012]14 anaesthetists (CRNAs) were patients followed prospectively for implementation catalysed efforts to improvement helped to foster a shift in improved adherence to ≥4 (out of 6)
identified as local leaders of surgical outcomes and complications until procure equipment (ie, pulse mind-set among staff who were “just safety processes, decreased surgical
teams. CRNAs along with surgeons, discharge or 30 days, whichever came oximeter) necessary for safety used to making it to the end of the site infections (AOR 0.28, 95% CI
OR staff participated in 2-week first processes day” to building a stronger culture of 0.15 to 0.54), surgical complications
training of lectures, written materials Reasons for failure include: lack of safety’ (AOR 0.45, 95% CI 0.26 to 0.78)
and direct guidance consistent access to crucial resources Stratified analysis revealed improved
Large printed poster placed in ORs (such as antibiotics, batteries); adherence limited to hospital 1 (AOR
checklist ‘did little to change the 4.06, 95% CI 2.2 to 7.6), decreased
entrenched hierarchy and relationship surgical site infections, surgical
dynamics of OR staff’; lack of complications limited to hospital 2
sustained checklist training beyond No improvement in surgical

Systematic review
2 weeks outcomes
Kasatpibal et al Circulating OR nurse participated in From March 2009 to August 2009, Compliance with marking of surgical Surgical teams often did not introduce NR
[2012]34 two meetings and 1-day data 42.6% of operations selected for site low because: marking materials themselves during time out for cultural
collection training session inclusion unavailable, procedure was emergent, reasons. ‘In Thai culture, people usually
91% of patients confirmed identity, and ‘Thai culture’ in which ‘Thais do introduce themselves only when they
site, procedure and gave consent. Only not make marks on other people, first meet someone and are shy about
19% of surgical sites marked. especially on the head’ publicising their roles’
Anaesthesia equipment and Also, ‘some surgeons assumed that Compliance with checklist high for
309

Continued

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 Table 3 Continued
310

Systematic review
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
medication checked in 90% of cases. wrong-site surgery would not occur life-threatening issues (drug allergies,
Pulse oximeter applied in 95% of because they had not experienced it difficult airways, profuse blood loss) and
cases. Allergies, difficulty airway, themselves’ confirmation of patient’s name, incision
aspiration risk and risk of >500 mL Compliance with hair removal and procedure. Notably, standards for
blood loss assessed in 100% of cases procedures was hampered by lack of these measures are already current
familiarity with proper procedure, lack hospital policy
of equipment and requests from Compliance was low for surgical site
surgeons marking and appropriate hair removal
Bohmer et al NR Survey administered before checklist All participating specialties were OR staff felt that communication culture NR
[2012]30 implementation, then 12 weeks after involved in formulation of the in OR was improved, and checklist
implementation questionnaire facilitated information about
The checklist was modified for ‘local intraoperative complications. The
conditions’ based on feedback from authors observed there was more
staff discussion of critical events between
Checklist introduced by department surgeons/anaesthesiologists
heads, demonstrating leadership
Baseline findings and improvement
after introduction of the checklist
were presented to staff
Fourcade et al NR 11–29 January 2010. Random sample Barriers to success: Checklist performed in 90.2% of NR
[2012]27 Training sessions, written materials of 80 records from medical record per 1. Many elements of checklist already surgeries. However, checklist was
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

and videos available from the French centre were analysed exist so checklist creates duplication completed in only 61% of cases
National Authority for Health, but Excluded topical anaesthesia, IR, GI 2. Poor communication between
use by participating centres was not endoscopy and CVC placement surgeon/anaesthetist
reported Subsequent interviews with staff and 3. Completing checklist took too
surgeons via semi-structured interviews much time, staff did perceive benefit
and email surveys 4. Some items confusing because
they did not fit in with customary OR
practices (or seemed inappropriately
timed)
5. High staff turnover, new staff
unfamiliar with checklist.
6. If OR staff not actively engaged
during checklist, nurses felt concerned
about ‘legal implications of signing
the checklist as they might be held
accountable for errors’
7. Some felt questions were
repetitive, might frighten patients
about to undergo anaesthesia
8. In 5 centres, box for checklist
could be checked if safety check not
performed for time constraints. Some
staff worried this would make
Continued

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Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

Table 3 Continued
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
checklists fail to improve patient
safety
Perez-Guisado NR January–December 2010 Local 10-question checklist already in Nurses achieved 99% implementation, NR
et al [2012]62 Responsibility for sections of checklist place, containing 8 items from WHO but surgeons and anaesthetists only
was divided between nurses, checklist completed checklists 79% and 72% of
anaesthetists and surgeons time, respectively
van Klei et al Information provided in regular 1 January 2007–30 September 2010 Checklist completion may be Checklist fully completed in 39% of all After implementation, 30-day
[2012]33 meetings to OR staff. Posters placed Checklist implemented 1 April 2009 necessary for improved health patients. Median number of items in-house mortality decreased from
in all ORs and electronic systems Monthly compliance reports provided outcomes documented was 16 3.13% to 2.85%. Checklist
to team managers. OR circulating Checklist may be less likely to be associated with decreased odds of
nurses designated in charge of completed in patients undergoing 30-day mortality (AOR 0.85, 95% CI
checklist completion emergency surgery who are at higher 0.73 to 0.98)
risk of mortality. This raises Incomplete checklist did not have a
methodological questions of how to significant effect on mortality
adjust for patient severity
Takala et al ‘Brief instructions on the use of the Study initiated in 2009 NR Nurses, anaesthetists and surgeons Implementation led to discovery of
[2011]63 checklist were on the checklist Nurses, anaesthetists and surgeons reported increased confirmation of systematic error in timing of
backside. Written guidelines on how surveyed regarding OR practices patient identity and awareness of prophylactic antibiotics administration
to use the checklist were also Then, the checklist was implemented names/roles of team members
available. Instructions were given in over 2–4 weeks Surgeons reported improvements in
order to avoid variation in the use of Finally, survey of OR practices repeated discussions of critical events with
the checklist in different hospitals 4–6 weeks after checklist anaesthesiologist (34.7–46.2%,
and operating theatres’ implementation p<0.001) and gave prescriptions and
instructions to post-anaesthesia care
unit more often
Truran et al NR Checklist introduced April 2009 NR Non-compliance with guidelines for NR
[2011]64 Study evaluated compliance with NICE venous thromboembolism prophylaxis
venous thromboembolism prophylaxis decreased after checklist from 6.9% to
guidelines for 3-week period prior to 2.1%
checklist implementation, and
6 months afterwards
Vogts et al NR November–December 2010 Authors suggest compliance with Compliance with ‘sign in’ and ‘time out’ NR
[2011]32 Medical student observed 100 ‘sign out’ section is low because the sections of checklist was high. However,
procedures, documented compliance timing is ‘not linked to a specific ‘sign out’ was only observed in 2/100
event in patient management’ and cases
nurses tasked with performing this

Systematic review
section have many competing
responsibilities at the end of
procedure
Askarian et al Checklist presented to OR head Included all elective general surgeries NR Obtaining information for time out and Surgical complications (before
[2011]35 Educational packages containing 3 months prior to checklist, followed sign out sections of checklist improved discharge) decreased from 22.9% to
checklist and guidelines were by 3 months after implementation after checklist implemented 10% after checklist implementation
distributed to surgeons, assistants, (144 patients) Surgical site infections decreased
311

Continued

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312

Systematic review
Table 3 Continued
Study phases and checklist Opinions, knowledge and
Author/year Training fidelity Reasons for success or failure behaviour Health outcomes
anaesthetists and nurses
Checklist presented to OR teams
Levy et al All OR team members except Direct observation of randomly Inadequate education during Although electronic medical record NR
[2012]31 physicians viewed a computer-based selected non-emergent surgeries over implementation led to confusion reported 100% compliance, only 4/172
training presentation one time 7-week period regarding practical execution of cases completed more than 7 out of 13
Large poster of checklist placed in checklist. (Unclear if physicians checkpoints
every OR received any training) Small post-study survey of OR staff
Checklist poster in OR lacked practical revealed confusion about proper timing
instructions for how checklist should of ‘time-out’ and team member
be executed, including which team responsible for ensuring checklist
members questions are directed execution
towards
Checklist was not adapted for
paediatric patients and may have
been less relevant
Helmio et al OR staff heard three informative Checklist implemented in September Nurses reported ‘some senior Checklist completion rates were: sign in NR
[2012]15 lectures before participating in WHO 2010. All surgeries (7148) between otolaryngologists had negative 62.3%, time out 61.1%, sign out
pilot study September 2010 and August 2011 attitudes towards the checklist’ 53.6%
‘Active leadership, regular audits and
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

Specific guidelines on use of included 76% of OR team agreed checklist

checklist were available in the OR Survey administered October 2011 feedback are important for successful improved OR safety, 68% agreed it
Brief instructions appeared on the implementation and maintenance of a improved error prevention, 93% would
back of the checklist checklist’ want checklist used during their own
surgery
Disregard for checklist use was revealed
in the open responses: ‘answers are
dismissive’, ‘it is noisy and staff is not
concentrating on the checks’ … One
senior otolaryngologist wrote, ‘Time out
has never been performed in my
operations’. In addition, there was
confusion about who should lead each
check section and when to do checks: ‘I
have never received the information on
how to use the checklist’
Positive comments included ‘the
checklist is beneficial’, ‘it should always
be used’ and ‘nowadays no operation
should be varied out without the
checklist’
AOR, adjusted odds ratio; NICE, National Institute for Health and Clinical Excellence; NR, not reported; OR, operating room; PDSA, plan–do–study–act.

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 Systematic review

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EDUCATION AND COMPLIANCE correct-site surgery checklist into an existing surgical
Regarding checklist training, 10 sites mentioned edu- checklist. Comparing 2008 with 2006, correct com-
cational sessions, seven used posters in the OR, two pletion was improved for four of the eight checklist
mentioned a hospital-wide publicity campaign, two items.
mentioned that training was provided (however no The North Carolina study37 implemented a check-
details were given), and eight either failed to mention list to prevent wrong-site surgery that was tailored to
training or stated that only limited training was pro- the hospital’s preferences and procedures. Staff com-
vided. Six studies mentioned a pilot testing period; mented favourably that they no longer had to remem-
these pilot tests lasted 1–3 months and often resulted ber everything on a cumbersome form.
in minor modifications to the checklist. No implementation advice was found on the Joint
Nine studies reported the degree of compliance Commission website or in other published documents.
with the checklist; one simply reported 97% compli- In August 2010, the Joint Commission conducted an
ance, and two others reported improvement over time online survey of over 2100 people.40 The website
(from approximately 60% to 80% in one study, and reports high agreement that organisations can fully
from 85% to 95% in another study). Notably, while implement the UP, its three steps are appropriate, and
compliance with checklist use was high, the checklists that ‘there is benefit’ in using it in the OR, ambulatory
were often left incomplete. Fourcade et al27 reported surgery and hospital units performing invasive proce-
checklist use in 90.2% of surgeries, but completion in dures (but the rates of agreement of benefit were
only 61%. Similarly, Levy et al31 found that although lower for ambulatory clinics and physician offices).
checklist compliance was 100% in the electronic The need to modify policies and procedures varied
medical record, only 4 of 172 checklists completed greatly across respondents, and no differences were
more than 7 out of 13 required checklist items. found between different types of respondents (eg,
Kasatpibal et al34 reported that staff had high compli- type of hospital, bed size).
ance with checklist items which had already been
standard hospital policy, but low compliance for COSTS
checklist items not routinely practiced. Costs of implementing a checklist mostly involve
checklist development and/or modification, formal
SURPASS checklist staff notification, training and additional OR time. In
Our searches identified no attempts to use the 2010, Semel et al41 performed a hypothetical decision
SURPASS checklist outside the Netherlands. The analysis of checklist introduction. The cost was esti-
website (http://www.surpass-checklist.nl/home.jsf? mated using the ‘opportunity cost of the work that
lang=en) describes a web version of the checklist would have otherwise been performed by the three
(called SURPASS Digital), which allows one to modify department checklist champions and the implementa-
the checklist, although the designers of SURPASS tion coordinator’, which was an estimated $12 635 in
strongly discourage it (http://www.surpass-checklist.nl/ 2008 dollars; per-use cost was only $11. But the cost
content.jsf?pageId=FAQ&lang=en). of a major surgical complication was estimated at
$13 372. In the base case, checklist introduction saved
Wrong-site surgery checklists money.
We identified four sites describing checklists based on Regarding time, Sewell et al24 reported that 20% of
the Joint Commission’s UP (table 4). The Swiss staff thought the WHO checklist caused an unneces-
study37 focused on verifying patient identity and sur- sary time delay. However, in 2011, Taylor et al16
gical site. Compared with the first 3 months of imple- reported that the WHO checklist took only about
mentation, the next 3 months saw better compliance 2 min on average.
in checking patient identity and proportion of surgical
site checks performed. Barriers to implementation ADOPTION AND DIFFUSION
included surgeons saying they already knew the On 15 May 2013, the WHO’s Surgical Safety Web
patients or the surgical site was obvious, and the Map (http://maps.cga.harvard.edu:8080/Hospital/)
failure to include the input of all surgical services in indicated that as of 26 March 2012, 4132 hospitals
developing the protocol. had expressed interest in using the checklist and 1790
The Swedish study38 involved two hospitals, each of of these hospitals have used the checklist in at least
which had a recent wrong-site surgery incident, and a one operating theatre.
root-cause analysis suggested that a time-out proced- Many professional organisations have recommended
ure might help. A time-out checklist was implemen- adoption of the WHO checklist. These include the
ted, and 1 year later, a questionnaire showed that Institute for Healthcare Improvement (http://www.ihi.
93% of team members believed the checklist contribu- org), the National Patient Safety Agency in the UK
ted to patient safety. (http://www.nrls.npsa.nhs.uk),42 43 the Canadian Patient
The English study39 was conducted at a children’s Safety Institute,44 45 the Washington State Surgical Care
hospital in which staff had incorporated an eight-item and Outcome Assessment Program46 (http://www.scoap.

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314

Table 4 Studies of wrong-site-surgery checklists implementing the Universal Protocol

Systematic review
Description of
Author/year Description of PSP Study design Theory or logic model organisation Safety context Implementation details
Garnerin Verification protocol for Case series ‘… the prevention of wrong patients Swiss anaesthesiology Prior to introduction of the checklist, all Verification protocol developed by an
et al checking patient and wrong site surgery, not to mention service located within a patients were required to wear ID interdisciplinary team. It required patients
[2008]37 identity and the site of accountability, demanded an 1200-bed university bracelets, and the operative site had to be to state their identity, comparing the
surgery intervention aimed at improving the hospital signed by the surgeon. Anaesthesiologists statement to the ID bracelet, OR schedule,
way both patient identity and site of were made aware that they were being and medical record. Similar types of checks
surgery checks were performed, while monitored for correct site of surgery. Nine consecutive
acquiring the ability to identify and months of data were obtained (October
correct deficiencies’ 2003–June 2004), and later 3 subsequent
months (October 2004, March 2005 and
October 2005)
Compared with the first 3 months of
implementation, the next 3 months saw
better compliance in checking patient
identify (63% up to 81%), complete
compliance with identity checks (10% up
to 38%), proportion of surgical site checks
performed (77% up to 93%), and
complete compliance with surgical site
checks (32% up to 52%). Compliance was
stable in subsequent periods
Authors attributed the improvements to
Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

increased use of wristbands upon

admission into the and the use of three
different sources for verification
Barriers included surgeons saying they
already knew that patients or the surgical
site was obvious, and the failure to develop
the protocol with the input of all surgical
services
Nilsson et al Preoperative ‘time-out’ Questionnaire None explicitly stated Two Swedish hospitals, In the autumn of 2007, there were two Implementation began in December 2007.
[2010]38 checklist after bed sizes not reported incidents of wrong-side surgery at these The checklist was a shared responsibility of
implementation hospitals, and a root-causes analysis the OR team. One year later, a
suggested that a time-out procedure might questionnaire was sent to all 704 surgeons,
help. The checklist was pre-approved by anaesthesiologists, operation nurses,
the heads of the operating and anaesthetic nurses, and nurse assistants,
anaesthesia departments soliciting their opinions about the new
time-out checklist. Of the 331 responders,
93% felt that the checklist contributed to
increased patient safety (either ‘without a
doubt’ or ‘probably’). When asked about
eight specific components of the time-out
checklists, the percentage of respondents
who felt the component was ‘very
important’ varied widely, from a low of
Continued

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Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

Table 4 Continued
Description of
Author/year Description of PSP Study design Theory or logic model organisation Safety context Implementation details
14% for the introduction of team members
to highs of over 80% for patient identity,
correct procedure, and correct side.
Regarding the sign-out, 91% felt that the
item involving the count of surgical
instruments and sponges was very
important
Owers et al Correct site surgery Case series None explicitly stated English children’s A surgical checklist already existed at this Five people were required to sign the
[2010]39 checklist incorporated hospital, bed size not facility; they added a correct site surgery documentation: marking surgeon, operating
into an existing surgical reported component surgeon, ward nurse, scrub nurse and
checklist anaesthetist. Two audit cycles: once in
2006 (sooner after implementation) and
once in 2008 (2 years later). Comparing
2008 with 2006, correct completion of the
eight items was not at all improved for four
items (ward nurse signed, operating
surgeon signed, scrub nurse signed, and
operating department practitioner signed)
but was improved for the other four (mark
site documented, no mark required
documented, entries legible, and marking
surgeon signed).‘The lack of
documentation, of course, may not reflect
that the new guidance and processes are
not being followed, but rather that the
documentation is regarded as a low priority
part of the process’
Anonymous Checklist to implement Case series Stated that the checklist provides cues Hospital in North Before this checklist, they were using a Original checklist in 2005, minor revisions
200765 the Universal Protocol, for staff when preparing for a Carolina, bed size not ‘cumbersome form’ to document their for 2006. Demonstrated the checklist
tailored to this procedure reported compliance with the Universal Protocol during educational staff meetings, and new
hospital’s preferences staff were given a primer. Staff gave
and procedures positive comments that they no longer had

Systematic review
to remember everything. The completed
checklist is kept as part of the medical
record
OR, operating room.
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org), the South Carolina Hospital Association,44 the changes such as improved communication and shifts in
Spanish Ministry of Health and Spanish Association of OR culture. Second, reporting bias may have played a
Surgeons,47 and the countries of France,44 Ireland,48 role. Eleven out of 21 implementation studies did not
Jordan48 and the Netherlands.33 Furthermore, several report health outcomes, potentially due to an absence
organisations in Australia and New Zealand have devel- of clear improvements after checklist implementation.
oped modified versions of the WHO checklist: the Third, the reported results do not mean that all surgi-
Royal Australasian College of Surgeons, the Australian cal checklists are beneficial; other surgical checklists
and New Zealand College of Anaesthetists, the Royal containing different items may or may not be
Australian and New Zealand College of Obstetricians beneficial.
and Gynecologists, the Australian College of Operating Many surgical staff have reported favourable atti-
Room Nurses, and the Australian Commission for tudes towards checklist implementation. However,
Safety and Quality in Health Care.49 numerous implementation issues remain, including
Sivathasan and colleagues50 conducted telephone how to modify a given checklist to a specific hospital
interviews with 238 hospitals in the UK. Almost all setting or specific surgical staff. Our report found that
(99%) of the hospitals had heard of the checklist, and barriers to effective implementation include confusion
its use was already compulsory in 65% of them. In hos- regarding practical aspects of checklist use, dealing
pitals where it was not required, 81% used it voluntar- with challenges to efficient workflow, obtaining
ily and 75% planned to make it mandatory in the regular access to resources and the beliefs and atti-
future. Notably, some ORs reported partial use of the tudes of participating staff, particularly surgeons. One
checklist, that is, intentionally skipping items or skip- recurrent theme in the literature on surgical checklists
ping the entire checklist because of time constraints. is the explicit encouragement of a team-based
In June 2009, the journal OR Manager received approach. The AHRQ continues to investigate factors
online data from 136 subscribers regarding use of the supportive of effective checklist implementation with
WHO checklist.51 Nearly half (48.5%) reported imple- the 2010–2013 project entitled, ‘Factors associated
menting the checklist and 64% said the checklist had with effective implementation of a surgical safety
improved safety in the OR. However, 11% of respon- checklist’.53 This project will elucidate how teamwork
dents stated that the checklist was not well accepted by may contribute to the impact of the checklist.
surgeons and another 63% said surgeons did accept it The WHO checklist’s wide adoption and dissemin-
but ‘with reservations.’ Nurses were found to have a ation suggests it may serve as a model for policy-
somewhat greater degree of acceptance. makers seeking to develop safety strategies in the
A 2009 UK survey of 12 oral and maxillofacial con- future. This checklist was explicitly designed to be
sultants found that all were aware of the WHO check- modified for widely varying contexts and executed in
list, but only 5 of 12 were actually using it.52 Ten of a short time frame to maintain feasibility. The WHO
12 expressed the belief that it would improve patient website instructs hospitals: ‘Do not hesitate to custom-
safety, but 4 of 12 said it would not improve team ise the checklist for your setting as necessary, but do
communication. not remove safety steps just because you are unable to
Regarding the UP, accredited hospitals are required accomplish them’ and emphasises that ‘It should take
to comply. Therefore the ‘diffusion’ of the UP is large, no more than a minute to complete each section of
by mandate. However, as stated earlier, the UP is not the checklist’ (ie, 3 min in total).54 The pilot study
a checklist. We found no published information on reported that, at various sites, introduction of the
how many hospitals actually use a checklist in their checklist took only 1 week to 1 month.5 Checklist
efforts to comply. implementation is relatively inexpensive, with some
hospitals simply printing posters to be hung on OR
DISCUSSION walls. These practical characteristics of the WHO
Several prominent authorities in the field of patient checklist may have significantly promoted its uptake
safety have promoted checklists in an attempt to and use. Notably, the WHO approach markedly
prevent mistakes related to surgery. Our report demon- differs from that stated by creators of the SURPASS
strates that checklists have been widely adopted, not checklist, who strongly discouraged its adaption.
only in Western countries, but in diverse contexts Although SURPASS is more comprehensive, it has not
throughout the world. Notably, we found evidence been widely implemented, potentially due to the
that checklists are associated with improved health out- resource intensive effort required to track patients
comes, including decreased surgical complications and throughout a surgical hospitalisation.
surgical site infections. Association, however, does not In conclusion, the WHO checklist, the SURPASS
imply causation. Thus, we note three important checklist and checklists implementing the Joint
caveats. First, checklists are often implemented as part Commission UP represent promising initiatives with
of a multifaceted strategy to improve care, which may suggestive evidence for improving patient safety. Future
render it difficult to determine whether improvements research may clarify the unique nature of their contribu-
should be attributed to checklists alone or to other tion and provide insights for effective implementation.

316 Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797

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BMJ Qual Saf: first published as 10.1136/bmjqs-2012-001797 on 6 August 2013. Downloaded from http://qualitysafety.bmj.com/ on January 22, 2022 by guest. Protected by copyright.
3 Neily J, Mills PD, Young-Xu Y, et al. Association between
Key summary points implementation of a medical team training program and
surgical mortality. JAMA 2010;304:1693–700.
4 Arriaga AF, Bader AM, Wong JM, et al. Simulation-based trial
▸ Surgical checklists such as the WHO Surgical Safety of surgical-crisis checklists. N Engl J Med 2013;368:246–53.
Checklist and Surgical Patient Safety System 5 Haynes AB, Weiser TG, Berry WR, et al. A surgical safety
(SURPASS) checklist offer a promising intervention for checklist to reduce morbidity and mortality in a global
decreasing patient morbidity and mortality due to population. N Engl J Med 2009;360:491–9. http://content.
surgical operations. nejm.org/cgi/content/full/NEJMsa0810119
▸ The WHO Surgical Safety Checklist has been success- 6 Facts about the Universal Protocol. Oakbrook Terrace, IL: The
fully adapted for implementation in a wide variety of Joint Commission, 2004. http://www.jointcommission.org/
settings, including all surgical specialties, academic assets/1/18/Universal%20Protocol%201%204%20111.PDF
and community hospitals, and industrialised and (accessed 9 Jan 2008).
7 de Vries EN, Prins HA, Crolla RM, et al. Effect of a
developing countries.
comprehensive surgical safety system on patient outcomes.
▸ Surgical safety checklists were associated with
N Engl J Med 2010;363:1928–37.
increased detection of potential safety hazards, 8 de Vries EN, Hollmann MW, Smorenburg SM, et al. Development
decreased surgical complications and improved com- and validation of the SURgical PAtient Safety System (SURPASS)
munication among operating room staff. Other factors checklist. Qual Saf Health Care 2009;18:121–6.
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improvements, may also explain these improvements. PAtient Safety System (SURPASS) checklist optimizes timing of
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include enlisting support from institutional leaders, 10 de Vries EN, Eikens-Jansen MP, Hamersma AM, et al.
training staff on using the checklist, adapting the Prevention of surgical malpractice claims by use of a surgical
checklist to incorporate staff feedback and avoiding the safety checklist. Ann Surg 2011;253:624–8.
11 Shekelle PG, Wachter RM, Pronovost PJ, et al. Making health
duplication of information already routinely collected.
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Acknowledgements The authors wish to thank Allison Gross, California-RAND Evidence-based Practice Center under
MS, MLS for performing literature searches, and Karen contract no. 290–2007-10062-I). Rockville, MD: Agency for
Schoelles, MD, SM and Paul Shekelle, MD, MPH, PhD for Healthcare Research and Quality (AHRQ), 2013 (Comparative
project oversight. Effectiveness Review No 211). http://www.ahrq.gov/research/
Contributors JRT contributed to planning the review, reviewing findings/evidence-based-reports/ptsafetyuptp.html
abstracts, extracting data, writing text and editing text. SL 12 Haynes AB, Weiser TG, Berry WR, et al. Changes in safety
contributed to planning the review, reviewing abstracts, attitude and relationship to decreased postoperative morbidity
extracting data, writing text and editing text. AT contributed to
extracting data, writing text and editing text. and mortality following implementation of a checklist-based
surgical safety intervention. BMJ Qual Saf 2011;20:102–7.
Disclaimer All statements expressed in this work are those of
the authors and should not in any way be construed as official 13 Weiser TG, Haynes AB, Dziekan G, et al. Effect of a 19-item
opinions or positions of the ECRI Institute, AHRQ, or the US surgical safety checklist during urgent operations in a global
Department of Health and Human Services. patient population. Ann Surg 2010;251:976–80.
Funding This work was supported by funding from the Agency 14 Yuan CT, Walsh D, Tomarken JL, et al. Incorporating the
for Healthcare Research and Quality (AHRQ), US Department World Health Organization Surgical Safety Checklist into
of Health and Human Services (Contract No practice at two hospitals in Liberia. Jt Comm J Qual Patient Saf
HHSA-290-2007-10062I). AHRQ reviewed contract
deliverables to ensure adherence to contract requirements and 2012;38:254–60.
quality, and a copyright release was obtained from AHRQ prior 15 Helmio P, Takala A, Aaltonen LM, et al. First year with WHO
to submission of this manuscript. Surgical Safety Checklist in 7148 otorhinolaryngological
Competing interests The authors declare no competing operations: use and user attitudes. Clin Otolaryngol
financial interests exist. 2012;37:305–8.
Provenance and peer review Not commissioned; externally 16 Taylor B, Slater A, Reznick R. The surgical safety checklist
peer reviewed. effects are sustained, and team culture is strengthened. Surgeon
Open access This is an Open Access article distributed in 2010;8:1–4.
accordance with the Creative Commons Attribution Non 17 Greenberg CC, Regenbogen SE, Studdert DM, et al. Patterns
Commercial (CC BY-NC 3.0) license, which permits others to of communication breakdowns resulting in injury to surgical
distribute, remix, adapt, build upon this work non-commercially, patients. J Am Coll Surg 2007;204:533–40.
and license their derivative works on different terms, provided the
original work is properly cited and the use is non-commercial. 18 Griffen FD, Stephens LS, Alexander JB, et al. The American
See: http://creativecommons.org/licenses/by-nc/3.0/ College of Surgeons’ closed claims study: new insights for
improving care. J Am Coll Surg 2007;204:561–9.
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318 Treadwell JR, et al. BMJ Qual Saf 2014;23:299–318. doi:10.1136/bmjqs-2012-001797