Tan et al.

Patient Safety in Surgery (2021) 15:3

https://doi.org/10.1186/s13037-020-00276-0

RESEARCH Open Access

Attitudes and compliance with the WHO

surgical safety checklist: a survey among
surgeons and operating room staff in 138
hospitals in China
Jie Tan1* , James Reeves Mbori Ngwayi1, Zhaohan Ding2, Yufa Zhou3, Ming Li3, Yujie Chen4, Bingtao Hu5,
Jinping Liu6 and Daniel Edward Porter7

Abstract
Background: Ten years after the introduction of the Chinese Ministry of Health (MoH) version of Surgical Safety
Checklist (SSC) we wished to assess the ongoing influence of the World Health Organisation (WHO) SSC by
observing all three checklist components during elective surgical procedures in China, as well as survey operating
room staff and surgeons more widely about the WHO SSC.
Methods: A questionnaire was designed to gain authentic views on the WHO SSC. We also conducted a
prospective cross-sectional study at five level 3 hospitals. Local data collectors were trained to document specific
item performance. Adverse events which delayed the operation were recorded as well as the individuals leading or
participating in the three SSC components.
Results: A total of 846 operating room staff and surgeons from 138 hospitals representing every mainland province
responded to the survey. There was widespread acceptance of the checklist and its value in improving patient
safety.
860 operations were observed for SSC compliance. Overall compliance was 79.8%. Compliance in surgeon-
dependent items of the ‘time-out’ component reduced when it was nurse-led (p < 0.0001). WHO SSC interventions
which are omitted from the MoH SSC continued to be discussed over half the time. Overall adverse events rate was
2.7%. One site had near 100% compliance in association with a circulating inspection team which had power of
sanction.
Conclusion: The WHO SSC remains a powerful tool for surgical patient safety in China. Cultural changes in nursing
assertiveness and surgeon-led teamwork and checklist ownership are the key elements for improving compliance.
Standardised audits are required to monitor and ensure checklist compliance.
Keywords: WHO safety checklist, Compliance, China

* Correspondence: [email protected]
1
School of Clinical Medicine, Tsinghua University, Beijing 100084, China
Full list of author information is available at the end of the article

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Tan et al. Patient Safety in Surgery (2021) 15:3 Page 2 of 12

Introduction 2015 their completion rates of all components improved

The World Health Organization (WHO) launched the to over 80% [6]. However as of 2020 the 33 item MoH
Safe Surgery Saves Life campaign in January 2007 with SSC remains the officially designated checklist. Yet no
the aim of improving consistency in surgical care and Chinese publication or report can be referenced to de-
adherence to safety practices. In June 2008 the WHO scribe the process of creating the MoH SSC. In contrast,
Surgical Safety Checklist (SSC) was published to help the WHO Guidelines for Safe Surgery 2009 explicitly fol-
operating room staff improve teamwork and ensure the low WHO recommended steps in technical guideline de-
consistent use of safety processes [1]. Use of the WHO velopment, including detailed documentation of the
surgical safety checklist (SSC) is associated with a signifi- process of guideline development [4].
cant decrease in postoperative complication (30%) and Emerging evidence suggests that the use of the safety
mortality rates [2], improved compliance with standard checklist in practice is unreliable and that Operating
processes of care and better quality of teamwork in the Room teams display significant variation in how they use
operating room [1]. Other benefits which have been re- the tool [7]. Observational studies of surgical ‘time-outs’
ported following implementation of the checklist include and ‘sign-outs’ in a number of countries, including the
cost savings [3]. The WHO SSC has become one of the US, UK, Switzerland, and Australia have concluded that
most significant and widely used innovations in surgical required checks are often only partially completed or
safety of the past 20 years. completed in an abbreviated manner, team members are
In the WHO Guidelines for Safe Surgery 2009, it is frequently absent during the checks, or they often fail to
written ‘This checklist is not intended to be comprehen- actively participate [8–11]. There is little or no objective
sive. Additions and modifications to fit local practice are evidence as to how widespread such problems of com-
encouraged’ [4]. As a member of the World Alliance for pliance might be, although the effectiveness of the
Patient Safety, the Chinese Ministry of Health (MoH) checklist as a safety tool is thought to be affected by
has devoted long-term administrative efforts to imple- poor planning and haphazard introduction methods
ment the SSC albeit after significant modification, for [10].
example by increasing number of items from 22 to 33. Ten years after introduction and implementation of
Although most element of the WHO SSC remain part of the MoH SSC, the purpose of this study was to explore
the officially designated MoH SSC there are sufficient how elements of the WHO Surgical Safety Checklist are
differences to warrant comment. The three components being used in practice in China by observing all three
of the SSC, colloquially known as ‘Sign–In’, ‘Time-Out’ checklist components during elective surgical proce-
and ‘Sign-Out’ all remain as key checklist components in dures. In particular we wished to investigate which items
the MoH SSC. However, five items found in the WHO in the WHO SSC continue to be discussed as part of the
SSC are removed completely. Although some deleted safety culture in operating suites in China even if they
items are included as part of other formal checklists (for are absent from the MoH SSC. In this study, we also
example ‘difficult airway and aspiration risk’ is part of a sought to understand the attitudes and perceptions of
separate pre-operative anaesthetic check-list), these do the professionals using the Surgical Safety Checklist.
not mandate that problems should be discussed with
other team-members. Some single items in the WHO Methods
SSC which include multiple checks have been split (for We developed a questionnaire for operating room staff
example ‘has the patient confirmed his/her identity, site, and surgeons based on other research in this area [12,
the procedure and consent?’ becomes four separate items 13] and which would be delivered through a ubiquitous
in the MoH SSC). Finally, there are several additional in- social media platform. Number of questions was prede-
terventions found mainly in ‘sign-in’ and ‘sign-out’ com- termined to be less than 20 (estimated completion time
ponents. These differences are highlighted in Table 1. 7–8 min) since on-line survey abandon rates increase
Since March 2010 the MoH stipulated that implementa- significantly beyond this point [14]. Specifically, our sur-
tion of their SSC would be one of the core measure- vey consisted of four domains: 1. Questions 1–4 repre-
ments for assessing hospital performance. However, sented basic and demographic information about the
uptake of the MoH SSC among surgical teams remained responder’s role and hospital level. 2. For teamwork and
low in a survey led by Peking Union Medical College safety environment, the Safety Attitudes Questionnaire
Hospital (PUMCH) in 2012 which revealed that full (SAQ) is a validated instrument used to measure atti-
completion rates were only 84.7, 55.1 and 33.1% at each tudes and perceptions in various safety-related domains
of the three successive checklist stages [5]. PUMCH in healthcare [15]. A modification has been developed
attempted a further revision in 2015 with items reduced for use in the operating rooms in which six items relat-
to 22 [6]. Following a re-implementation programme ing to teamwork and safety climate are relevant to
carried out at four hospitals between June and December checklist intervention [13]. 3. For attitudes towards the
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 3 of 12

Table 1 Different versions of the Surgical Safety Checklist (SSC) (items adjacent to each other in the two checklists have
equivalence)
Sign-in Time-out Sign-out
WHO SSC MoH SSC WHO SSC MoH SSC WHO SSC MoH SSC
Has the patient confirmed Confirm the patient’s Confirm all team Confirm the patient’s
his/her identity, site, the name, gender, age members have name, gender, age
procedure and consent introduced themselves by
name and role
Confirm the procedure Confirm the patient’s Confirm the The name of the Confirm the name of
name, procedure and patient’s name, procedure the procedure
where the incision will be gender, age
made
Surgery consent Confirm the Confirm the usage of
procedure the drug and blood
transfusion
Anesthesia consent Confirm the Completion of Completion of
site and is the instrument, sponge and instrument, sponge
site marked? needle counts and needle counts
Is the site marked Confirm the site and is What are the critical or What are the Specimen labelling Specimen labelling
the site marked? non-routine steps critical or non-
routine steps
Is the anesthesia machine Confirm the type of How long will the case How long will Skin condition
and medication check anesthesia take the case take
complete
Is the pulse oximeter on Check the anesthesia What is the anticipated What is the Any IV tubes, gastric
the patient and machine, including blood loss anticipated tube, urinary
functioning putting on the pluse blood loss catheter, or any
oximeter other tubes
Known allergy Known allergy Are there any patient- Are there any Where will the
specific concerns patient-specific patient be
concerns transferred to
Difficult airway or Has sterility been Has sterility Whether there are any
aspiration risk confirmed been confirmed equipment problems to
be addressed
Risk of >500 ml blood loss Are there equipment Are there What are the key
issues or any concerns equipment concerns for recovery
issues or any and management of the
concerns patient
Skin condition Has antibiotic prophylaxis Drug
been give within the last administration
60 min pre and intro-
operation
Skin prepartion before Is essential imaging Is essential
surgery displayed imaging
displayed
IV line establishment
Skin test result of
antibiotics
Preparation of blood
products
Prothesis/implant/
imaging
WHO World Health Organsiation. MoH Chinese Ministry of Health

checklist, the same published survey instrument had de- patient anxiety due to repetitive checks of their identity
signed six additional items specifically related to the re- and potential problems during surgery and were previ-
sponder’s opinion of the checklist [13] and these were ously used in a European survey of patients’ attitudes
also included in our survey. 4. The survey included two [12]. All responses were recorded on a five-point Likert
questions about staff perception and observation of scale (1 = disagree strongly, 2 = disagree slightly, 3 =
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 4 of 12

neutral, 4 = agree slightly, 5 = agree strongly). At the end of problems with instruments, pre-operative medication
of the questionnaire, we included an open comments or central venous access [16]. All adverse events were
question to explore unstructured opinions. documented during the operative procedure.
The survey was sent to operating room staff and sur- We targeted a cohort of 1000 completed SSC observa-
geons over a 4-week period from 1 May 2020 to 29 May tions. Each site accumulated 200 observations from
2020. Responses were accepted up to end of July 2020. January to June 2020 except for site B where the obser-
An online network of Chinese national surgical confer- ver was unavoidably assigned to other duties during this
ence attendees (2019) as well as surgical, anaesthetic and period. Therefore total observations were for 860 SSCs.
nursing trainee networks (2016–2020) were engaged via
the social media platform WeChat®. Onward dissemin- Statistical analysis
ation of the survey among hospital operating room col- Data were analysed using IBM SPSS® Statistics 26.0. De-
leagues was encouraged. scriptive statistics (frequencies and percentages) were
We conducted a prospective observational study at five calculated to demonstrate the overall quality of checklist
Level 3 hospitals in four provinces (Beijing, Shandong, use, analysed by hospital (Sites A to E). Chi-square (+/−
Zhejiang and Henan). These hospitals were part of an Yates correction) was used to assess significant associa-
informal training network for medical personnel. Hos- tions between hospital for any of the categorical vari-
pital compliance-rates with the surgical safety checklist ables assessed. For all analyses, significance was set at
was unknown prior to the study. As in previously pub- p < 0.05.
lished methodology, each hospital identified one operat-
ing room to serve as the study room [1]. The focus of Results
this study was entirely on observations of operating A total of 846 individuals from 138 hospitals represent-
room staff behaviour and not on the patient. Hence in- ing all mainland Chinese provinces responded to the
stitutional ethical approval was not a requirement for survey (Table 2). 74.3% were working in a Level 3 hos-
this study. pital (most advanced level), 15.5% in a Level 2 hospital,
A local data co-ordinator was chosen at each site who 1.9% in a Level 1 hospital and 8.3% in private hospitals.
was also the observer (2 anaesthetists, 2 nurses and 1 We obtained responses from staff with a representative
surgeon). These underwent training to enable them to distribution of roles in the SSC process (332 surgeons
document specific item performance via a combination (39.2%), 299 anaesthetists (35.3%) and 215 operating
of observation and occasional verbal confirmation with room nurses (25.4%)).
the surgical team. The observer had no other clinical re- The mean safety attitude score was 4.06 (minimum
sponsibilities at the study site during the period of ob- score = 1, maximum score = 5). Negative questions were
servation and was not empowered to intervene if an reverse-scored. The four items asking a positive question
item was not performed. Only if all three sections of the scored well, with mean 85.6% affirming their environ-
WHO surgical safety checklist were observed could the ment as safe and collegiate, however the two negative
case be included in this study. Data collected included items ‘it is difficult for me to speak up’ and ‘personnel fre-
surgical specialty and staff compliance with specific quently disregard the rules’ scored less well with mean
WHO SSC items. 73.4% disagreeing with these statements (X2 = 42.50, p <
The presence, absence or lack of engagement of key 0.0001). 88.1% of all responders stated that they would
clinical staff during each stage was also documented feel safe being treated there as a patient.
during each of the three components, with additional Following its universal implementation from 2010 it
observations of operating room staff behaviour during was assumed that the MoH SSC was the official version
the ‘timeout’ component. An earlier study of SSC check- used in all hospitals. For the domain ‘attitudes towards
list compliance in China recorded overall staff attitudes the checklist’, only 12.7% of responders deemed that the
as ‘attentive’, ‘hasty’, ‘casual’ or ‘missing’ [6]. We wished checklist ‘took a long time to complete’. 78.8% agreed it
to record actual engagement of individual professionals was ‘easy to use’. A large majority agreed that the check-
with the aim of discovering if these could illuminate the list improved operating room safety and communication
cause of poor compliance with specific SSC items. Dur- (90.4 and 85.6% respectively) and 89.5% thought that the
ing the critical ‘time-out’ component the role of the pro- checklist helped prevent errors in the operating room.
fessional who led the process was recorded, as well as Only 3.4% disagreed with the statement that they would
whether each professional took an active part in the want the checklist used if they were having an operation.
process and whether they stopped what they were doing Questions about anxiety induced in patients revealed
during the process. that over 40% considered that a conscious patient might
Adverse events were defined as events that resulted in become anxious during repetitive confirmation of her/
an operative delay due to check-list related identification his identity, the procedure and operation site, or
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 5 of 12

Table 2 Survey questionnaire results from Chinese operating room staff and surgeons
Question Basic and Demographic information
number
1 What is the name of your hospital N = 138 hospitals
2 What level of hospital do you work at Level 3: Level 2: Level 1: Private: 8.3%
74.3% 15.5% 1.9%
3 Please state your profession Theatre Anesthetist: Surgeon:
Nurse: 35.3% 39.2%
25.4%
4 Gender Male: Female:
54.1% 45.9%
Teamwork and Safety environment Strongly Disagree Neither Agree Strongly Teamwork and
disagree agree or agree Safety
disagree environment
score
5 I would feel safe being treated here as a patient 4.0% 2.2% 5.7% 39.0% 49.1% 4.27
6 Briefing OR personnel before a surgical procedure is 3.3% 4.8% 6.7% 34.0% 51.1% 4.25
important for patient safety
7 I am encouraged by my colleagues to report any safety 1.8% 4.2% 10.3% 48.5% 35.3% 3.84
concerns I may have
8 In the opearitng room here, it is difficult to speak up if I 33.1% 42.4% 12.8% 7.2% 4.5% 3.92
perceive a problem with patient care
9 The physicians and nueses here work together as a well-co- 0.9% 5.1% 6.0% 50.0% 37.9% 4.19
ordinated team
10 Personnel frequently disregard rules or guidelines that are 36.2% 35.0% 13.6% 11.5% 4.0% 3.89
established for the OR
Attitudes towards the checklist Strongly Disagree Neither Agree Strongly
disagree agree or agree
disagree
11 The checklist was easy to use 2.7% 2.8% 15.7% 51.8% 27.0%
12 The checklist took a long time to complete 19.4% 49.4% 18.6% 9.1% 3.6%
13 The checklist improved operating room safety 0.8% 0.8% 7.9% 42.9% 47.5%
14 Communication was improved through use of the checklist 0.8% 2.0% 11.6% 52.0% 33.6%
15 The checklist helped prevent errors in the operating room 2.5% 2.0% 6.0% 46.7% 42.8%
16 If I were having an operation, I would want the checklist to 1.9% 1.5% 5.7% 42.1% 48.8%
be used
Staff perception and observation of patient anxiety Strongly Disagree Neither Agree Strongly
disagree agree or agree
disagree
17 Do you think that a conscious patient may become anxious if 10.0% 20.2% 28.8% 33.8% 7.1%
we repetitively confirm the patient’s identity, the procedure
and operation site and discuss the potential airway problems
and blood loss in their hearing
18 Have you ever experienced a patient becoming anxious Yes: No: 48.2%
because of the issue above 51.8%

discussion of potential airway hazards and blood loss in hospitals. Hospital characteristics and cases by surgical
their hearing. Over half claimed that they had experience specialty are reported in Table 3. Just over half of the
of a patient becoming anxious because of this. Further- cases were orthopaedic, with general surgery, gynaecol-
more, the most common open comment was that poten- ogy and thoracic surgery contributing 16, 12 and 11%
tial blood loss and airway risk should not be discussed in respectively.
the presence of a conscious patient. As shown in Table 4, compliance with the sign-in
At all sites completion of checklists was paper-based items varies from hospital to hospital, but the five items
and these were archived in the patient’s medical record of the WHO SSC which remain part of the MoH SSC
after completion of the operation. Complete information achieved over 95% compliance. The remaining two items
was obtained from 860 checklist processes in the five which are omitted from the MoH SSC were discussed
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 6 of 12

Table 3 Site characteristics, number and specialty of operations for observed checklists. Abbreviations: ENT-Ear, Nose and Throat
Item Sub-item Site A Site B Site C Site D Site E Total
No of beds 760 1600 1200 1850 1390 6800
No. of Operating Rooms 9 20 45 12 28 114
Hospital level General Level Public, level Public, level Public, level Public, level Public, level \
3 3 3 3 3
Star Level No No No 5 star No \
No. of surgical checklists observed by Elective Orthopaedics 159 18 51 196 10 434
specialty
Elective General surgery 21 7 25 \ 85 138
Elective Gynecology 9 6 16 \ 62 93
Elective Urology 11 \ 15 \ 3 29
Elective Thoracic \ 29 31 4 40 104
Surgery
Elective Cardiac Surgery \ \ 8 \ \ 8
Elective Neurology \ \ 6 \ \ 6
Surgery
Elective Vascular \ \ 3 \ \ 3
Surgery
Elective ENT Surgery \ \ 45 \ \ 45
Total 200 60 200 200 200 860

less than 90% of the time. These were ‘Difficult airway The WHO Guidelines for Safe Surgery 2009 states that
or aspiration risk’ (84%) and ‘Risk of>500ml blood loss’ certain information should be sought specifically from
(90%). the surgeon (critical stages, length of surgery, anticipated
Different professionals were responsible for leading blood loss) and from the nurse (sterility and equipment
the ‘sign-in’ component at different sites (Table 5). De- issues) [4]. Surgeon compliance with their responsible
pending on local policy checklist leaders were a combin- items averaged 52.3%, whereas nurse compliance aver-
ation of professionals although at three sites aged 91.7%. Surgeons were significantly worse than all
anaesthetists were not involved. other group and nurses significantly better (X2 = 735.5
Table 4 shows that the WHO SSC checklist item and 744.4 respectively, both p < 0.0001).
‘introducing team members by name and role’ which is Table 5 shows levels of engagement from doctors and
not part of the MoH SSC was rarely completed at any nurses at different sites during the ‘time-out’ component.
site (< 2%). The other nine items all remain part of the There was no clear association between doctors or
MoH SSC. These steps were completed well in some nurses who failed to engage or to stop their activity dur-
centres but not in others. Five items scored over 90% ing the timeout process and lack of compliance with
compliance (patient identification /incision site, confirm- items which are usually within their sphere of know-
ation of antibiotic prophylaxis, confirmation of sterility, ledge. On the other hand, the three hospitals in which
equipment issues, display of essential imaging). Three anaesthetists took the lead in completing the checklist
items achieved less than 60% compliance (identification showed a significant association with the three surgeon-
of critical / non-routine steps, length of surgery and an- related items being better performed, in contrast to
ticipated blood loss). From Table 4 all professional nurse-led processes in which these items were not done
groups engaged in the time-out process at each site, al- well (X2 = 315.6, 433.6 & 426.6 respectively, all p <
though overall compliance according to professional 0.0001).
groups ranged from 86 to 100%. Leadership role varied Table 4 shows that the three items which remained
(nurses at two sites, and anaesthetists at three sites). part of the MoH SSC achieved a high rate of compliance
Staff engagement in an actual ‘time-out’ (where staff stop (over 97%). However, the two items encompassing
what they are doing to listen and participate) varied equipment problems and patient recovery plans and
greatly; two sites achieved total compliance, whereas the concerns were discussed less frequently (66 and 28%
other three had very poor engagement from at least one respectively).
of doctors, nurses or anaesthetists. The ‘time-out’ com- Participation rates across disciplines were high
ponent was not seen to be done at all in 6% of cases at (Table 5), however anaesthetists were infrequently repre-
Site C (Table 4). sented at two of the five sites. Overall, checklists were
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 7 of 12

Table 4 Compliance with the WHO Surgical Safety Checklist items

Item Site A Site B Site C Site D Site E Total
Sign-in’ phase Has the patient confirmed his/her identity, site, the procedure and consent 100.0% 100.0% 98.0% 100.0% 100.0% 99.5%
Is the site marked 96.5% 80.0% 97.5% 100.0% 100.0% 97.2%
Is the anesthesia machine and medication check complete 100.0% 100.0% 81.5% 100.0% 100.0% 95.7%
Is the pulse oximeter on the patient and functioning 100.0% 95.0% 96.0% 100.0% 100.0% 98.7%
Known allergy 100.0% 100.0% 95.5% 100.0% 100.0% 99.0%
Difficult airway or aspiration risk 87.5% 0.0% 74.5% 100.0% 99.0% 84.0%
Risk of >500 ml blood loss 97.5% 63.3% 70.5% 100.0% 99.0% 89.9%
Overall ‘sign-in’ 94.8%
Time-out’ phase Confirm all team members have introduced themselves by name and role 2.0% 0.0% 0.0% 6.0% 0.0% 1.9%
Confirm the patient’s name, procedure and where the incision will be made 100.0% 100.0% 79.5% 100.0% 93.0% 93.6%
Has antibiotic prophylaxis been give within the last 60 min 100.0% 100.0% 92.0% 100.0% 100.0% 98.1%
What are the critical or non-routine steps 22.5% 25.0% 62.0% 100.0% 10.0% 47.0%
How long will the case take 25.0% 85.0% 79.0% 100.0% 11.0% 55.9%
What is the anticipated blood loss 23.5% 65.0% 80.5% 100.0% 8.0% 53.8%
Are there any patient-specific concerns 20.0% 60.0% 73.0% 100.0% 100.0% 72.3%
Has sterility been confirmed 100.0% 50.0% 77.5% 100.0% 100.0% 91.3%
Are there equipment issues or any concerns 98.5% 65.0% 77.5% 100.0% 100.0% 92.0%
Is essential imaging displayed 98.0% 85.0% 95.0% 100.0% 100.0% 97.3%
Overall ‘time-out’ 70.3%
Sign-out’ phase The name of the procedure 97.50% 100% 98% 100% 100% 98.9%
Completion of instrument, sponge and needle counts 100% 100% 96.50% 100% 100% 99.2%
Specimen labelling 99% 75% 97.50% 100% 100% 97.4%
Whether there are any equipment problems to be addressed 83.50% 0% 0% 100% 100% 65.9%
What are the key concerns for recovery and management of this patient 7% 10% 0% 100% 11% 28.1%
Overall ‘sign-out’ 77.9%
Average compliance (all items) 75.3% 66.3% 73.7% 95.7% 78.7% 79.8%
Average compliance (for items in both WHO SSC and MoH SSC) 81.2% 81.4% 86.9% 100.0% 83.6% 87.4%
Average compliance (for items only in WHO SSC) 55.5% 14.7% 29.0% 81.2% 61.8% 53.9%
Proportion of items reaching 100% compliance 8/22 7/22 0/22 21/22 15/22
WHO World Health Organisation, MoH Chinese Ministry of Health, SSC Surgical Safety Checklist

completed before the patient left the operation suite 97% Discussion
of the time (range 80–100%). Based on the attitudes survey, operating room staff and
Overall compliance rates of all 17 items which surgeons who had used the WHO SSC before hold a
remained part of the MoH SSC was87% (Table 4). The generally positive view of the checklist. Only 5.5% of
other five items removed from the MoH SSC were dis- them thought it difficult to use and more than 85% of
cussed in 54% of cases overall. One hospital (site D) the OR staff perceived it had value in ensuring patient
achieved 100% compliance in 21/22 of their checklist safety and improving communication. More than 90% of
items (the next best hospital achieved 100% in 15/22). responders claimed that they would want the checklist
At site D overall compliance was 96%, significantly bet- used for their own care. Even when clinicians express
ter than any of the other hospitals (site D compared with some scepticism about the WHO SSC, the fundamental
next best site X2 = 567.3, p < 0.0001). perception of its value in providing safe care suggests
The incidence of adverse peri-operative events varied that a well-designed implementation program can be
among hospitals (Table 6). At most sites overall fre- successful in achieving clinician acceptance and use of
quency was less than 3%. However, nearly 30% of cases the checklist [13]. Dixon-Woods, in a recent review of
from site D had missing instruments which led to an op- ethnographic studies of the operating room process con-
erative delay. cluded that major barriers to patient safety were present
 Tan et al. Patient Safety in Surgery
(2021) 15:3

Table 5 Percentage compliance with WHO Surgical Safety Checklist roles by profession
Site A Site B Site C Site D Site E
Doctor Nurse Anesthetist Doctor Nurse Anesthetist Doctor Nurse Anesthetist Doctor Nurse Anesthetist Doctor Nurse Anesthetist
Sign in Who participated in this part? \ 100% \ 100% 100% \ 98% 87% 92% 100% 100% \ 100% 100% 100%
Time- Who participated in this part? 97% 98% 93% 100% 100% 100% 90% 86% 93% 100% 100% 100% 100% 100% 100%
out
Who led this part? \ 100% \ \ \ 100% 1% 1% 92% 21% 11% 68% \ 100% \
Who stopped to do the ‘time- 15% 97% 26% 80% 100% 85% 2% 3% 74% 100% 100% 100% 100% 100% 100%
out’?
Sign out Who participated in this part? 86% 100% 7% 100% 100% \ 75% 98% 86% 100% 100% 100% 100% 100% 100%
Was the WHO checklist completed before 95% 80% 99% 100% 100%
the patient left the operating room?
Page 8 of 12
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 9 of 12

Table 6 Adverse event categories and incidence (number with percentage in parentheses)
Site A Site B Site C Site D Site E Overall
Number of surgical checklists observed 200 60 200 200 200 860
Missing instrumentation leading to intraoperative delay 5(2.5%) 1(1.7%) 2(1%) 48(29%) 11(5.5%) 67 (7.8%)
Missing medication before incision \ \ 16(8%) \ 14(7%) 30(3.4%)
Broken instruments 2(1%) \ \ 4(2%) 1(0.5%) 7(0.8%)
Contaminated instruments 4(2%) 1(1.7%) 3(1.5%) \ 2(1%) 10 (1.2%)
Others (difficulty in achieving central venous access) \ \ 2(1%) \ \ 2 (0.2%)
Total 11(1.1%) 2 (0.7%) 23 (2.3%) 52 (5.2%) 28 (2.8%) 116 (2.7%)

at both structural and cultural levels [17]. Observational precipitate real patient concerns and anxieties among
studies have shown an association between good team- Chinese patients remains the subject of further study.
work and decreased risk of postoperative complication The WHO SSC has been shown to have a beneficial
[18]. Implementation of a WHO Safe Surgery Saves impact on postoperative mortality and morbidity and on
Lives checklist-based quality improvement project was team effectiveness in the operating room in a number of
associated with a small but significant increase in mean studies. Institutions whose frontline workers and man-
teamwork and safety climate score among operating agers score higher on safety climate surveys have been
personnel [13]. Positive changes in perception of team- found to have lower rates of adverse patient safety indi-
work and safety climate by these clinicians correlated cators as defined by the Agency for Healthcare Research
with the degree of improvement in postoperative mor- and Quality [25]. Checklists are behavioural interven-
bidity and mortality [13]. tions; meaning they require a change in the behaviour of
Over half of responders said they had seen a patient the Operating Room team to be effective. The interven-
becoming anxious during use of the checklist, which has tions recommended in the WHO SSC are explicitly evi-
not been reported before. It is possible that one reason denced [4]. Modification of the checklist to suit local
for poor compliance of staff with these parts of the conditions is allowed in the WHO Guidelines for Safe
‘sign-in’ component is that they would not wish to upset Surgery 2009; since it should not ‘enforce behaviours
their conscious patient. There is support from a Euro- that the practitioners do not agree with or cannot follow’.
pean study that discussion of airway and haemorrhage There is a presumption that the additional items found
issues can cause more anxiety than repetitive questions in the MoH SSC are more suitable for the Chinese oper-
about identity and operative site [12]. It is unfortunate ating suite environment however despite the lack of ex-
that we cannot identify any published description or ra- plicit evidence. It is also suggested that each component
tionale for removing items from the MoH SSC, however of the SSC should ideally have between 5 and 9 items
potentially all five omitted items could induce anxiety if [4], however the MoH SSC ‘sign-in’ component consists
overheard by the patient by highlighting patient risk, an of 14 items and the ‘time-out’ consists of 11 items. Al-
absence of existing strong teamwork, equipment prob- though one research group published methodological
lems or ongoing patient concerns. In contrast, the ma- justification for a modified SSC in China [5] this version
jority of items added to the MoH SSC do not have these is not used nationally.
characteristics (Table 1). In China the doctor-patient re- We found that 5 out of 7 items during the ‘sign-in’
lationship is often considered tense and fragile [19]. For component achieved over 95% compliance which com-
example, surveys in 2013 found that approximately 70% pares favourably with that of other large studies in China
of patients did not trust physicians [20] and in 2018 that [5, 6]. The remaining two items which are not part of
over 60% of obstetricians had experienced a personal the MoH SSC were questions which the anaesthetist and
lawsuit, and a similar proportion agreed with the con- surgeon would have more direct knowledge than the
cept of practicing defensive medicine [21]. Multiple and nurse (difficult airway and anticipated blood loss).
well documented reports confirm a high and growing in- Table 4 shows that despite the presence of these clini-
cidence of violence against medical personnel [22], riots, cians at only 60.4% of ‘sign-in’ components, overall dis-
attacks, and protests in hospitals [23] and even cold- cussion rates for these items of the WHO SSC remained
blooded murder [24]. It is not surprising that in such an over 80%. The WHO Guidelines for Safe Surgery 2009
environment every encounter which could induce pa- highly recommends that that ‘before inducing anaesthe-
tient anxiety is scrutinised with the objective of mitigat- sia, the anaesthetist should consider the possibility of
ing its negative effects. Whether the checklist large-volume blood loss’ and explains that ‘the expected
interventions which are from the MoH SSC might blood loss will be reviewed again by the surgeon before
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 10 of 12

skin incision. This will provide a second safety check for anaesthetist at ‘sign-out’ at two sites may have had an
the anaesthetist and nursing staff’. We found that al- impact on this observation.
though the ‘risk of blood-loss’ intervention is removed All SSCs were signed-off as showing every item was
from the sign-in component of the MoH SSC it was still completed, however no item showed 100% compliance
discussed nearly 90% of the time. Perhaps this high fig- at all sites. This is similar to findings in some other
ure provides a reason for the relatively low compliance countries. One survey in the United States showed that
with the same item in the ‘time-out’ component which nearly 40% of respondents simply checked off boxes
was only discussed 54% of the time. Whether the phys- ahead of time [27]. The overall rate of compliance for all
ical environment for the pre-anaesthetic ‘sign-in’ compo- items of the WHO SSC and across all five sites was
nent is relevant to difficulties in discussing safety issues 79.8%, similar to the approximately 80% ‘completion
is unknown, however the design feature of a separate an- rate’ observed in 2015 across four sites recorded in a
aesthetic room adjacent to the operating room is not previous large Chinese study [6]. However, one hospital
common in Chinese hospitals. (site D) had a significantly better compliance-rate than
In the ‘time-out’ component, both the MoH SSC and all the others. At site D policing of operating room
the PUMCH SSC omit the item ‘introducing team mem- checklist behaviour was much more robust than any of
bers by name and role’, the latter giving reason that ‘it the other hospitals. Members of a supervisory theatre
was not necessary for most Chinese procedures as most group were devolved the authority to ‘spot-check’ com-
operating teams are relatively fixed’. Among all the pliance at any time. Lack of checklist engagement held
WHO SSC items this was least performed (less than 2% the risk of imposition of a monetary penalty (equivalent
of ‘time-outs’). When the item is removed from the ana- to about 15 US$) to be subtracted from base-salary and
lysis, other items of the ‘timeout’ achieve an average represented poor behaviour to be raised during annual
compliance rate of 78%, similar to the 80% compliance- staff appraisal. At site D the stimulus for formation of
rate achieved by PUMCH in 2015 [6]. the inspection group was a voluntary effort to improve
The use of anesthetists to lead the ‘time-out’ was part auditable safety programmes in the hospital, driven by a
of the final SSC protocol in the PUMHC study in 2015 desire to gain extra ranking points for the hospital in na-
[6], with the authors suggesting that anesthetists ‘exhibit tional hierarchy tables. Together with site E, site D had
stronger leadership’ than the circulating nurse. The pos- the highest inter-professional participation rates in all
sibility that team members other than the circulating sections of the SSC.
nurse may lead the time-out are allowed in the WHO The WHO Guidelines for Safe Surgery 2009 affirms
Guidelines for Safe Surgery 2009 report; ‘The Checklist that ‘checklists must be tested in their clinical setting to
coordinator can and should prevent the team from pro- affirm their value’. In China we found that all items
gressing to the next phase of the operation until each step within the WHO SSC were being discussed to varying
is satisfactorily addressed, but in doing so may alienate degrees in all five hospitals we surveyed. Those which
or irritate other team members. Therefore, hospitals must are omitted in the China SSC were discussed over half
carefully consider which staff member is most suitable for the time, suggesting a deeper recognition of the rele-
this role’. In our study the three items which are known vance of those interventions to patient safety.
mainly to the surgeon (critical steps, length of surgery Table 6 shows that the majority of the operative pro-
and anticipated blood loss) were poorly completed over- cedures were carried out without significant peri-
all (all compliance less than 60%). The strong statistical operative adverse issues. Although site D had obvious
association of poorer compliance with a nurse-led problems with instrument tray completeness during the
process rather than anaesthetist-led is stark, and may be period of observation, all cases included discussion about
due to lower status of nurses with less role flexibility in equipment problems during the ‘sign-out’ component.
China [26] and therefore an unwillingness to interrupt The value of the SSC may be clearly seen in the care
the surgeon. The PUMCH study explicitly attempted to taken to identify and redress instrument failures prior to
establish the circulating nurse to lead the SSC but this starting surgery at site D.
failed [6]. A higher profile for nurse confidence/assert- We used purposive and snowball sampling so as to as-
iveness training as an adjunct to patient safety might certain professionals from every Province in Mainland
shift this dynamic. China. However this valid sociological method to sample
Completion rates for items of the ‘sign-out’ compo- hard-to-reach groups is a non-random method and has
nent which remain part of the MoH SSC are superior inherent selection biases which are uncontrolled. The re-
(98%) to those reported in China before [6]. However, sults of our survey on attitude may therefore not repre-
‘equipment problems to be addressed’ were only dis- sent all views or even representative views of operating
cussed in 66% of cases and ‘concerns for recovery and room staff and surgeons although we have no reason to
patient management’ in 28%; the lack of an believe they do not. Furthermore, sampling of
Tan et al. Patient Safety in Surgery (2021) 15:3 Page 11 of 12

compliance followed established protocol elsewhere in Received: 8 November 2020 Accepted: 7 December 2020
which a single operating room in each centre was
chosen for observation. Selection bias in terms of case-
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