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Original article

Compliance and use of the World Health Organization checklist


in UK operating theatres
S. P. Pickering1 , E. R. Robertson2 , D. Griffin1 , M. Hadi1 , L. J. Morgan2 , K. C. Catchpole5 , S. New3 ,
G. Collins4 and P. McCulloch2
1
Warwick Orthopaedics, Warwick Medical School, University of Warwick, Coventry, and 2 Quality, Reliability, Safety and Teamwork Unit, Nuffield
Department of Surgical Sciences, 3 Saı̈d Business School and 4 Centre for Statistics in Medicine, University of Oxford, Oxford, UK, and 5 Department of
Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA
Correspondence to: Mr P. McCulloch, Quality, Reliability, Safety and Teamwork Unit, Nuffield Department of Surgical Sciences, University of Oxford,
Oxford OX3 9DU, UK (e-mail: peter.mcculloch@nds.ox.ac.uk)

Background: The World Health Organization (WHO) Surgical Safety Checklist is reported to reduce
surgical morbidity and mortality, and is mandatory in the UK National Health Service. Hospital audit data
show high compliance rates, but direct observation suggests that actual performance may be suboptimal.
Methods: For each observed operation, WHO time-out and sign-out attempts were recorded, and the
quality of the time-out was evaluated using three measures: all information points communicated, all
personnel present and active participation.
Results: Observation of WHO checklist performance was conducted for 294 operations, in five hospitals
and four surgical specialties. Time-out was attempted in 257 operations (87·4 per cent) and sign-out in 26
(8·8 per cent). Within time-out, all information was communicated in 141 (54·9 per cent), the whole team
was present in 199 (77·4 per cent) and active participation was observed in 187 (72·8 per cent) operations.
Surgical specialty did not affect time-out or sign-out attempt frequency (P = 0·453). Time-out attempt
frequency (range 42–100 per cent) as well as all information communicated (15–83 per cent), all team
present (35–90 per cent) and active participation (15–93 per cent) varied between hospitals (P < 0·001
for all).
Conclusion: Meaningful compliance with the WHO Surgical Safety Checklist is much lower than
indicated by administrative data. Sign-out compliance is generally poor, suggesting incompatibility with
normal theatre work practices. There is variation between hospitals, but consistency across studied
specialties, suggesting a need to address organizational culture issues.

Paper accepted 22 August 2013


Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9305

Introduction highly successful. Claims have been made for its capacity
to induce indirect changes, such as improved situational
The World Health Organization (WHO) launched the awareness, in line with the evidence that structured
Safe Surgery Saves Life campaign1 in January 2007, to briefings and checklists improve factors such as team
improve consistency in surgical care and adherence to communication and information sharing6 .
safety practices. In June 2008, the WHO Surgical Safety The WHO Surgical Safety Checklist has since been
Checklist was designed to help operating room staff taken up by national healthcare governance organizations
improve teamwork and ensure the consistent use of safety in the USA and UK to ensure target compliance. In
processes2 . The WHO checklist has become one of the the UK National Health Service (NHS), hospitals are
most significant and widely used innovations in surgical required to audit and report their adherence rates to meet
safety of the past 20 years1,3,4 . set targets, and compliance is encouraged by a financial
Large benefits have been reported following implemen- incentive. However, clinical audit studies of WHO
tation of the checklist, including reductions in adverse Surgical Safety Checklist compliance have questioned
events3 and cost savings5 . Based on these reports, the the quality of compliance with the time-out and sign-out
WHO Surgical Safety Checklist has been regarded as sections of the checklist7 .

 2013 British Journal of Surgery Society Ltd British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd
Use of the World Health Organization checklist in UK operating theatres 1665

Audits of WHO Surgical Safety Checklist compliance interventions were selected for inclusion in the study
to fulfil regulatory requirements intend to record whether based on retrospective review of activity, and operating
all sections of the checklist are performed. These audits lists were targeted with the highest proportion of the
commonly record only the fact that an attempt was made, predetermined case mix. On days when data collection
not whether the attempt was adequate to fulfil its intended was scheduled, whole operating lists were observed,
purposes. Reports of problems with implementation and meaning the operations were consecutive. The surgical
application8 of the WHO Surgical Safety Checklist in the procedures that were observed constituted approximately
operating room have suggested that achieving compliance 15–25 per cent of the operations for the teams within that
to a level where benefit can reasonably be expected is more time interval and were therefore a large, representative
complex than expected9 . sample of contemporary activity within that theatre. The
There is little or no objective evidence as to how case mix for each of the surgical specialties was as follows:
widespread such problems of compliance might be, elective orthopaedics – primary and revision hip and
although the effectiveness of the checklist as a safety tool knee arthroplasties and arthroscopic procedures; trauma
is likely to be affected by poor implementation. orthopaedics – manipulation of fractures and dislocations
Five years after global implementation, the purpose under anaesthesia, open reduction and either internal
of this study was to explore how the WHO Surgical fixations or hemiarthroplasty procedures; vascular and
Safety Checklist is being used in practice in the UK. The general – arterial bypass, endarterectomies and hernia
objectives of the study were to assess WHO Surgical Safety repair; plastic surgery – excision of benign and malignant
Checklist performance quality by observing the time- lesions with a range of closure techniques including free
out and sign-out sections during emergency and elective flaps, upper limb and nerve surgery.
surgical procedures. Data collection protocols for each surgical procedure
were developed10 to record observational data, and a
dedicated section was created to record observations for
Methods
the WHO Surgical Safety Checklist time-out and sign-out
The data for this study were collected as part of a process based on the work of Lingard and colleagues11 .
multicentre observational and quality improvement study, Observers were trained in the use of these pro formas.
the Safer Delivery of Surgical Services, at three NHS For reasons of limited space and patient comfort, the sign-
Trusts with a total of five hospitals: one district general in section, which is performed in the UK in the small
hospital, three teaching hospitals and one tertiary referral adjoining anaesthetic room, was not observed.
centre. A variety of surgical procedures were directly The clinical observers included two surgical trainees
observed in their entirety by a pair of observers, one with a (M.H. and E.R.R.), one nurse practitioner (J.M.) and
background in surgery and the other in human factors (HF) three HF specialists (L.J.M., S.P.P. and L.B.) with higher
science. Observations were made in elective orthopaedic, degrees in HF and/or psychology. Data collection was
trauma orthopaedic, plastic, vascular and general surgery. completed in pairs, one HF specialist and one clinical
Within each surgical specialty a range of common surgical observer. A 2-month training phase was completed before

Table 1 Proportion of operations with attempts at World Health Organization time-out and sign-out in 294 operations at five hospital
sites

Site A Site B Site C Site D Site E Total for specialty

Time-out attempted
Elective orthopaedics 92 of 101 (91·1) 11 of 26 (42) 53 of 54 (98) 27 of 30 (90) – 183 of 211 (86·7)
Trauma orthopaedics – – 16 of 16 (100) – – 16 of 16 (100)
Vascular surgery – 15 of 21 (71) – – 24 of 24 (100) 39 of 45 (87)
Plastic surgery 19 of 22 (86) – – – – 19 of 22 (86)
Total per site 111 of 123 (90·2) 26 of 47 (55) 69 of 70 (99) 27 of 30 (90) 24 of 24 (100) 257 of 294 (87·4)
Sign-out attempted
Elective orthopaedics 4 of 101 (4·0) 2 of 26 (8) 3 of 54 (6) 0 of 30 (0) – 9 of 211 (4·3)
Trauma orthopaedics – – 0 of 16 (0) – – 0 of 16 (0)
Vascular surgery – 0 of 21 (0) – – 17 of 24 (71) 17 of 45 (38)
Plastic surgery 0 of 22 (0) – – – – 0 of 22 (0)
Total per site 4 of 123 (3·3) 2 of 47 (4) 3 of 70 (4) 0 of 30 (0) 17 of 24 (71) 26 of 294 (8·8)

Values in parentheses are percentages.

 2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd
1666 S. P. Pickering, E. R. Robertson, D. Griffin, M. Hadi, L. J. Morgan, K. C. Catchpole et al.

All information communicated


n = 141 (54·9%)

Time-out performed All team present


n = 257 (87·4%) n = 199 (77·4%)

Time-out not performed Active participation


n = 37 (12·6%) n = 187 (72·8%)

No. of operations n = 294

All information communicated


n = 20 (77%)

Sign-out performed All team present


n = 26 (8·8%) n = 18 (69%)

Sign-out not performed Active participation


n = 268 (91·2%) n = 20 (77%)

Fig. 1 Quality of the time-out and sign-out process at all National Health Service sites

observations were commenced, in which the HF specialists measure for the S3 study. In this paper all preintervention
were introduced to the operating theatre and the surgical assessment data are presented.
operations, and the clinical observers received lecture- All theatre staff included in the study were consented
based training on the principles of HF. for participation under ethical clearance from the Oxford
Intraoperative observation began when the patient A Ethics Committee (REC:09/H0604/39).
entered the operating theatre and ended when they left
it. Observers recorded whether a time-out or sign-out was Statistical analysis
attempted and, if it was, the attempted process was critiqued
on three quality parameters: whether all information The study was exploratory and therefore largely descriptive
was communicated, whether all team members were statistically. Continuous data are summarized by the
present, and whether active participation was noted. These median, interquartile range (i.q.r.) and range. Binary
parameters each received a yes/no result individually. ‘All data are summarized as proportions. Comparison of
team present’ required all of the team members taking proportions was performed with the χ2 test; P < 0·050 was
part in the operation to be present at its commencement; considered statistically significant. All statistical analyses
‘all information communicated’ required all points on the were performed in R version 2·15·3 (http://www.r-
checklist to be addressed verbally; and ‘active participation’ project.org/).
required whole-team interaction and engagement with
checklist completion. Observers recorded these parameters Results
independently for the time-out and sign-out, including the
onset time and duration of the process. The person leading A total of 294 operations were observed across five NHS
the time-out and sign-out was also recorded, defined as sites, between January 2011 and September 2012 (elective
the team member who read aloud the checklist questions orthopaedics, 211 operations; trauma orthopaedics, 16;
to the rest of the team. Following the conclusion of each vascular surgery, 45; plastic surgery, 22). A greater number
operation, observers compared findings and resolved any of observations were completed in orthopaedics as this was
disagreement by discussion. the main surgical specialty under study.
Observation of the WHO time-out and sign-out was
performed within the context of a wider study of work,
Completion of World Health Organization
the Safer Delivery of Surgical Services (S3), which aims to
time-out and sign-out
quantify the effect of quality improvement interventions
on theatre processes and safety. The observation of the Of the 294 observed operations, time-out was attempted in
WHO time-out and sign-out was selected as an outcome 257 and sign-out in 26. There was no significant difference

 2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd
Use of the World Health Organization checklist in UK operating theatres 1667

100

75
Completion (%)

50

25

0
Site A orthopaedics Site A plastics Site B orthopaedics Site B vascular Site C orthopaedics Site C trauma Site D orthopaedics Site E vascular Total
n = 101 n = 22 n = 26 n = 21 n = 54 n = 16 n = 30 n = 24 n = 294

a Time-out

100
All information communicated
All team present
Active participation
75
WHO time-out/sign-out attempted
Completion (%)

50

25

0
Site A orthopaedics Site A plastics Site B orthopaedics Site B vascular Site C orthopaedics Site C trauma Site D orthopaedics Site E vascular Total
n = 101 n = 22 n = 26 n = 21 n = 54 n = 16 n = 30 n = 24 n = 294

b Sign-out

Fig. 2 Attempt frequency and quality of the World Health Organization (WHO) time-out and sign-out process

Table 2Time-out quality parameter results and associated Table 3 Quality of time-out by specialty of time-out lead
proportion with sign-out attempted
Anaesthesia Surgical Nursing
Time-out Sign-out (n = 40) (n = 59) (n = 149) P*
compliance compliance
All information communicated 19 (48) 34 (58) 84 (56·4) 0·554
(n = 294) (n = 26)
All team present 36 (90) 46 (78) 114 (76·5) 0·172
All parameters 99 (33·7) 19 of 99 (19) Active participation 33 (83) 38 (64) 112 (75·2) 0·111
Two of three parameters 88 (29·9) 6 of 88 (7)
Values in parentheses are percentages. *χ2 test.
One of three parameters 54 (18·4) 1 of 54 (2)
No parameter 16 (5·4) 0 of 16 (0)
WHO time-out not attempted 37 (12·6) 0 of 37 (0) the accompanying paper checklist was destroyed at the end
Values in parentheses are percentages. WHO, World Health of the operation.
Organization.

in the attempt rate of time-out and sign-out between Performance time for time-out and sign-out
surgical specialties (P = 0·453). However, a significant process
difference in the proportion attempting a time-out was The median time taken to perform a time-out was 60 (i.q.r.
observed between hospital sites (P < 0·001) (Table 1). 55–80, range 10–240) s, and that for a sign-out was 60
In one of the sites (site A), signatures to mark completion (i.q.r. 50–60, range 30–180) s.
of the checklist were done electronically; in all other
sites signatures were marked on the paper version of
Quality of the World Health Organization
the checklist. At sites where completion of the checklists
time-out and sign-out
was paper-based, these were archived after completion of
the operation in the patient’s notes. At the site where Assessment of the quality of the time-out and sign-out is
checklist use was confirmed with an electronic signature, represented in Fig. 1.

 2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd
1668 S. P. Pickering, E. R. Robertson, D. Griffin, M. Hadi, L. J. Morgan, K. C. Catchpole et al.

For time-out, the quality criterion complied with least was performed, and satisfactory performance on all three
commonly was ‘all information communicated’, with only measures occurred in only 38·5 per cent of observed
slightly more than half of theatre teams communicating operations (99 of 257). These findings are in stark contrast
the full checklist. Compliance with the other two criteria, to administrative audits reporting compliance rates of
‘all team present’ and ‘active communication’, was over 70 between 66 and 100 per cent9 . Interestingly, administrative
per cent. Combining these three parameters and assessing audits were completed at each of the sites while this study
them against the time-outs attempted can give an indication was ongoing, and all showed high levels of compliance
of the quality of the time-out process, which showed a (more than 95 per cent).
significant difference between hospital sites (P < 0·001). The data are of concern because the benefits claimed
The sites and specialties differed in their method of for the checklist3 are contingent on it being performed
completion (Fig. 2). For example, active communication reliably14 , and it is reasonable to assume that poorly
in time-out was particularly low for site D orthopaedics, performed time-out and unperformed sign-out procedures
indicating that the WHO checklist was often completed will detract significantly from the effectiveness of the
by one person who did not verbalize the content to the rest checklist in reducing patient harm. Indeed, poorly used
of the team. checklists may have detrimental effects on safety and
teamwork both in aviation12 and in the operating
Association between time-out and sign-out theatre. ‘Widespread deployment of checklists without an
completion appreciation of how or why they work is a potential threat
For the 26 operations where a sign-out was attempted, to patients’ safety and to high-quality care’8 .
a time-out had been performed previously. There were The performance deficits found in this study display
no occasions where a sign-out was performed without a characteristics more in keeping with violations, defined
pre-existing time-out. as ‘behaviours that involve deliberate deviations from the
Owing to the paucity of occasions where the WHO written rules’13 , than with other categories of process
sign-out was attempted, further quality analysis was not deviation. Checklists have been used to improve safety
performed in detail. Table 2 shows the details of WHO for decades in many high-risk industries, with apparent
time-out performance with one, two or all three quality success14 , but questions have arisen about their ease of
parameters. Of the time-outs attempted, a small propor- introduction into workflow patterns and their true impact
tion, 16 (5·4 per cent) of 294 operations, did not score for on safety15,16 . Potential barriers include cultural accep-
any of the quality parameters. When only one parameter tance, poor training and faulty implementation strategy8 .
was observed, it was most frequently that all team members Violations may result from disengagement with the
were present (34 of 257, 13·2 per cent). When two para- process, when checklists can become ‘tick-box’ exercises.
meters were observed present, ‘all information communi- The design of the checklist itself must also be addressed
cated’ was most likely to be missing (58 of 257, 22·6 per as a potential source of adherence problems. It seems
cent). clear from the low implementation rate of the sign-out
procedure across different locations and specialties that
Impact of leader on quality of the World Health this part of the checklist has some serious incompatibilities
Organization time-out with standard operating theatre practice and culture
in the UK. Sign-out is supposed to be performed at a
The quality of the WHO time-out process was not
time of particularly high workload for theatre nursing
affected significantly by the discipline of the operating
and anaesthetic staff. Observational impressions and
team member (anaesthetic, surgical or nursing) who led
discussions with theatre staff reinforce the argument
the time-out (Table 3).
from ergonomic principles that, as currently performed,
sign-out represents an additional source of stress and
Discussion
workload to be managed concurrently with competing
In this direct observation study, the time-out section of the demands. Checklists can be vital at times of high workload,
WHO Surgical Safety Checklist was usually attempted, but only if they are used as the framework for performing
but the sign-out section was not. A difference in adherence the activities required14 ; if not used in this way they may
was found between NHS sites, but not between surgical represent a risk, in the form of an additional demand on
specialties, and the identity of the time-out process already divided attention17 . Sign-out therefore needs to be
leader made no difference to compliance. Three simple redesigned so that it is better integrated with the realities
measures were used to assess how well the time-out of workload in busy operating theatres.

 2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd
Use of the World Health Organization checklist in UK operating theatres 1669

Checklists appear in many different forms and the time-out quality appears to be sensitive and easy to use.
philosophy of checklists is well established18 . The WHO Limitations include the risk of a Hawthorne effect (imply-
Surgical Safety Checklist is designed to be generic and ing that normal adherence might have been even worse),
adaptable, but the manner of implementing it in many UK the relatively limited spread of hospitals and specialties
Trusts discouraged or forbade modification19 , leaving staff involved, and a degree of subjectivity in deciding whether
in many hospitals frustrated and disengaged by obvious all staff were actively engaged. The hospitals involved
mismatches between the process they were mandated to represented a balanced mix of types (university, specialist
follow and their specific local needs. Another important and district general), but are a small sample of the whole
aspect of implementation strategy that may have had hospital sector; a different sample might therefore yield dif-
unintended consequences was mandatory reporting of ferent results. However, the core findings around time-out
compliance by hospitals, with a 100 per cent target. and sign-out quality overall seem robust. The data collec-
This may potentially have encouraged tick-box compliance tion approach resulted in interobserver reliability not being
without engagement by staff with the meaning and purpose evaluable, which would have added strength to the method.
of the activity20 . Political and public awareness of patient The WHO Surgical Safety Checklist is not being
safety issues is increasing pressure for compliance rates to used appropriately in typical NHS Trusts. The sign-out
be visible in the public domain, and these are now appearing procedure is used particularly poorly, suggesting a basic
on Trust websites21 – 24 . This development carries a risk that incompatibility with the work systems of NHS operating
WHO Surgical Safety Checklist compliance could become theatres. The patient safety benefits intended by the
more important as an advertising tool than as part of a WHO Surgical Safety Checklist are unlikely to be realized
strategy for risk reduction. unless real compliance is improved considerably.
The finding that interhospital differences were signifi-
cant, whereas interspecialty differences were not, suggests
Acknowledgements
that these differences were a result of organizational cul-
ture at the local (theatre suite or Trust) level. However, The authors thank the management, surgical, anaesthetic
these findings must be regarded as suggestive rather than and theatre staff at the Trusts and sites that took part in
conclusive, because the number of hospitals and specialties this study for their cooperation and forbearance: Oxford
compared was small. At one site, WHO checklist compli- University Hospitals Trust (Nuffield Orthopaedic Cen-
ance appeared particularly low. Real compliance did not tre), Coventry and Warwick University Hospitals Trust
seem to be affected by the person who led the time-out. (Hospital of St Cross, Rugby, and University Hospital,
This work extends and confirms similar findings from Coventry), and Kettering District General Hospital Trust.
smaller studies. One investigation9 found that items The authors also thank J. Matthews and L. Bleakley for
were confirmed more commonly during time-out (range assistance in the intraoperative data collection.
100–72 per cent) than during sign-out (range 86–19 per This paper presents independent research funded by
cent), but only 13 per cent of time-outs and 3 per cent the National Institute for Health Research (NIHR) under
of sign-outs were checked properly (all items validated). its Programme Grants for Applied Research programme
Sivathasan and co-workers25 asked 421 hospitals in the UK, (reference no. RP-PG-0108-10020). The views expressed
before the national roll-out, about use of the surgical safety are those of the author(s) and not necessarily those of the
checklist and found that it was compulsory in 65 per cent. NHS, NIHR or the Department of Health.
They argued that much greater education and awareness Disclosure: The authors declare no conflict of interest.
would be needed for the roll-out to be effective. Rydenfält
et al.26 reported in a study of 24 videoed operations that
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 2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 1664–1670
Published by John Wiley & Sons Ltd

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