Reed 2016
Reed 2016
Original research
h i g h l i g h t s
This is an innovative concept rather like “mind the gap” on underground trains (London tube).
This study reveals that cultural aspects may underpin the process of SSC that need further study.
The delivery of the SSC and completeness of the SSC clearly improved with the audio delivery of the SSC.
a r t i c l e i n f o a b s t r a c t
Article history: Background: In February 2010, the UK National Patient Safety Agency set a mandate that the World
Received 16 April 2016 Health Organisation's Surgical Safety Checklist (SSC) should be completed for every surgical patient
Received in revised form within the NHS in a bid to improve surgical safety. However since its introduction, there have been issues
5 June 2016
with checklist compliance, staff engagement and surgical serious incidents continue.
Accepted 18 June 2016
Available online 22 June 2016
Aims: This study seeks to explore if an unavoidable pre-recorded audio delivery of the SSC improves
compliance and staff engagement with the checklist.
Methods: The performance of the time-out and sign-out sections of the SSC were observed in three
Keywords:
Safety culture
phases: standard practice, audio prompt and full audio delivery. Two researchers visited operating
Checklists theatres throughout a three-week period. The outcome measures were occurrence of time-out/sign-out,
Compliance completion of checklist, and presence, and engagement of staff during checklist administration. Staff
feedback on the process was also sought.
Results: Observation of time-out and sign-out was undertaken for 92 procedures. Time-out and sign-out
were performed for 100% of the procedures when using full audio delivery of the SSC, an improvement
on findings during the standard practice phase (time out- 97.4%, sign out- 86.8%). The compliance with
completion of checklist items also improved with audio delivery of the SSC. However, the presence of all
key staff and active participation of team members with the checklist was unaffected by the mode of
delivery. Team members' self-reported engagement did not significantly vary across the different
practices.
Conclusion: The intervention seems to improve rate of checklist completion, particularly signout. It also
brought more consistency on the questions read out during checklist administration. It doesn't neces-
sarily ensure all key staff are present neither does it significantly improve staff engagement in the
process.
© 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
1. Introduction
http://dx.doi.org/10.1016/j.ijsu.2016.06.035
1743-9191/© 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
100 S. Reed et al. / International Journal of Surgery 32 (2016) 99e108
events’ such as wrong site surgery and retained foreign objects in researchers played a single prompt over the speakers stating either
the patient [4]. The WHO SSC includes an initial Team Brief prior to “STOP: Time-out” or “STOP: Sign-out” after which the theatre team
the start of the operating list, where all team members discuss the would carry out time-out or sign-out using standard practice,
cases for the day, and three main stages: sign-in prior to anaes- reading the questions aloud themselves. During phase 3, the trial of
thesia, time-out prior to start of surgical procedure and sign-out full audio delivery of the SSC, the same prompts as in phase 2 were
after completion of procedure [5]. played, followed by all the checklist questions detailed in appendix
The initial trial of the WHO “Safe Surgery Saves Lives” program 1. Questions were manually played from the iPod™ touch by re-
showed a reduction in rate of death and post-operative complica- searchers, one at a time. They played the next question after a
tions [6], but despite widespread adoption, surgical ‘never events’ response from staff. Speakers were set to full volume so the audio
and other theatre e related serious incidents still occur, which could be heard clearly anywhere in the operating theatre including
could in part be due to problems with compliance to the SSC [3,7]. the scrub room. During the intervention phases [2 and 3], at Team
Several studies have identified issues in particular with sign-out Brief staff were asked not to initiate timeout and sign-out and
compliance [3,8,9]. instead the researchers would do this. The audio intervention for
Literature has also shown varying levels of staff engagement timeout was delivered prior to the start of the procedure and the
with the process and inconsistent delivery of checklist information exact timing varied based on team preference, but this was always
[3] and omission of items [8]. In a French study [10], staff in nine out before the start of the surgery. Theatres were selected at random
of eighteen centres, reported that the checklist took too long to with exclusion of Cardiology, Ophthalmology, Obstetrics and
complete as they already had a heavy workload and did not Emergency lists as they use a modified checklist. The following
perceive the added benefit. Five centres reported that items could specialities were observed: General, Maxillofacial, Ears Nose &
be ticked off even when they had not been checked, because of time Throat, Plastics, Trauma & Orthopaedics, Gynaecology, Vascular,
constraints. In these cases, the items were ticked only to comply Cardiothoracic and Urology. Wherever possible, observations took
with the management audit and therefore failed to improve patient place in the same theatre for the full day, so that cases were
safety. consecutive and the same staff were observed throughout the day.
These issues with the current format of the SSC suggest there is A data collection proforma was developed and completed for each
scope for improvement. It has also been suggested that future operation.
research should be focused on checklist design in order to improve
behaviours in the operating theatre [11]. 2.2. Measures
We explored if an alternative method to delivering the WHO SSC
was effective in addressing these problems. Researcher-led delivery To determine the effectiveness of the audio prompt and audio
of the SSC via pre-recorded audio was trialled. The hypothesis was delivery, one researcher recorded observational outcome measures
that this would bring consistency to practice and make the check- of compliance with time-out and sign-out for each procedure. This
list unavoidable, increasing overall compliance. is based on the approach used in previous research [3,12,13]. The
following variables were collected:
2. Methods
1. Was a time-out/sign-out performed? If staff made an attempt at
The study took place in the operating theatres of a large teaching performing a timeout or sign-out this was recorded a single yes/
hospital. This was a comparison study between standard SSC no result. If yes, then the following additional data was
practice and pre-recorded audio delivery of the SSC. The focus was collected:
on aspects of the performance of the time-out and sign-out sections 2. Was all information communicated? For procedures where a
of the WHO checklist. The study took place over a three week time-out/sign-out was attempted, the individual time-out and
period in October 2015 and was organised into three phases: sign-out questions that were asked and discussed were recor-
Phase 1: Observation of staff performing the time-out and sign- ded as a yes/no result for all questions for that case. A per-
out sections of the SSC under standard practice. centage for overall completeness of time-out and sign-out items
Phase 2: Trial of pre-recorded audio prompt played prior to was determined, and a mean value for each phase is calculated.
time-out and sign-out, after which staff proceeded with the usual 3. Were all team members present? In order for this condition to be
standard practice. The audio played three words: “STOP: Time Out” met, a minimum of the following staff must have been present in
and “STOP: Sign Out”. theatre at the time of SSC performance: Operating Surgeon,
Phase 3: Trial of full pre-recorded audio delivery of the time-out Anaesthetist, Anaesthetic Practitioner, Scrub Practitioner, Team
and sign-out sections of the SSC wherein all questions related to Leader (may be Scrub Practitioner), Circulating Person (i.e. n ¼ 6).
time out and sign out were delivered by the audio prompt. This was recorded as a simple yes/no result, if no was recorded,
Standard practice for time-out and sign-out involves the theatre then the team members absent were recorded. The number of
Team Leader reading the checklist aloud from a pre-printed card procedures with the minimum number of staff present was
and confirming responses from the appropriate team members. counted and converted into a percentage for each phase.
The researchers observed discretely from a distance equal to that of 4. Was there active participation [3] of team members with the
the team member furthest from the leader. If checklist items were process? Team active participation with the checklist is ranked
not audible from this position then they were recorded as not for every question on a red-amber-green ‘traffic light’ scoring
communicated. The checklist used is an adapted version of the system, defined follows:
WHO checklist specific for this Trust (appendix 1). This version
includes an additional question about throat pack compared with Red ¼ None of team members stopped other activities and
the standard WHO version. engaged with the process.
Amber ¼ One or more team member not stopped and engaged
2.1. Intervention and delivery with process.
Green ¼ All team members stopped and fully engaged with the
The audio interventions were delivered via an iPod™ touch process meaning that their sole focus/activity was the checklist.
connected to Bose™ Bluetooth speakers. During phase 2 the For each procedure, the number of individual questions that
S. Reed et al. / International Journal of Surgery 32 (2016) 99e108 101
were ranked as green for timeout and sign-out was converted into a performed in only 33/38 cases (86.8%) with standard practice, but
percentage. An overall mean percentage ‘green’ active participation 29/29 cases (100%) with audio delivery of the SSC.
for each phase was calculated. The observational outcome measures of compliance with the
Team member feedback was sought in all phases of the study in checklists that were performed across the three phases of the study
the form of open questions and self-reported engagement scores. are displayed in bar charts. Fig. 1 shows the results for time-out and
This was delivered via questionnaires (appendix 2). The self- Fig. 2 for sign-out.
reported engagement scores were compared across the phases.
3.2. Was all information communicated?
2.3. Analysis
For time-out, completeness of checklist item communication in
Fisher's exact test was used to determine whether there were phase 1 was on average 61% complete, this increased to 68% during
any differences between the three phases in respect of the number phase 2, when the audio prompt was played and 100% when the
of time-outs and sign-outs performed, and the presence of the audio delivery was used as the researchers automatically played all
minimum number of team members. Significance was set at the 5% the questions from the audio recording.
level. Sign-out completeness also increased from 85% with standard
practice to 100% when the audio delivery was performed. This
2.4. Ethics shows for both time-out and sign-out all information was
communicated when audio delivery was used.
The study was approved by the Hospital Research Development Only 61% of the time-out information in phase 1 and 68% in
and Innovation department and Biomedical & Scientific Research phase 2 was communicated when the team asked the SSC ques-
Ethics Committee (BSREC) at the University of Warwick. tions, the frequency of questions asked in these phases is displayed
in Fig. 3. This shows which questions in particular were not regu-
3. Results larly communicated. In the majority of cases the team introduction
(11%), throat pack (25%) and essential imaging (41%) questions are
92 procedures were observed over the three week period. The not addressed. Importantly, the confirmation of patient identity
frequency of time-out/sign-out performance during those cases for and procedure questions was addressed in every case.
each study phase is detailed in Table 1 and the breakdown of cases
and specialties is shown in Table 2. There was no significant dif- 3.3. Minimum team members present
ference between any of the phases (p > 0.05).
We used randomization to select the theatre lists observed. This This criteria is consistently met with high levels during time-out
pragmatic design was used to reflect a sample of normal practice across all phases of the study, but the lowest is 86% during the audio
across a range of specialties in a large teaching hospital, rather than delivery. This is not the case for sign-out, where this condition is
in specific specialties. To tease out differences between specialties met in only 67e83% of cases, showing that key team members were
would need a much larger study than this pilot. The focus of the more often absent from the sign-out process, than the time-out.
study was staff behaviour within a surgical department rather than The differences observed were not significant, however (p > 0.05).
within the individual specialties. Because procedures varied in
length and were randomly selected, the 3 groups were not identical 3.4. Active participation
in baseline characteristics.
The percentage of questions asked that were rated as green was
highest when time-out was performed via audio delivery (Fig. 1).
3.1. Rate of time-out/sign-out performance
Similarly the percentage of time-outs scoring 0% green for all
questions was 2 out of 29 (6.7%) for audio delivery. This is compared
During the standard practice phase one case did not have a
to standard practice where a higher proportion, 10 out of 37 (27.0%)
time-out carried out (Table 1).
of time-outs had 0% green. This could suggest the audio delivery
The rate of time-out performance increased to 100% with the
was better at getting the attention and participation of the team.
audio prompt and audio delivery of the checklist. Sign-out was
For sign-out however most checklist questions were scored as
amber and for all three phases the total green score is only 17%e27%
Table 1 (Fig. 2). The highest participation with sign-out was shown to be
Completion of time-out and sign-out sections of the SSC during the three phases. when the audio prompt was played in phase 2, but overall there
Phase Total number of Number of Number of was generally poor active participation of staff with sign-out.
cases observed time-outs sign-outs
performed (%) performed (%) 3.5. Team members' feedback
1: Standard practice 38 37 (97.4%) 33 (86.8%)
2: Audio prompt 25 25 (100%) 24 (96%) The patterns of self-reported engagement, were not signifi-
3: Audio delivery 29 29 (100%) 29 (100%) cantly different across the phases (Fig. 4).
Total 92 91 86
A good proportion of staff reported the audio checklist was a
Table 2
Distribution of surgical speciality lists in the three phases of the study.
Phase 1 5 5 1 10 1 10 1 5 38
Phase 2 3 0 0 5 0 6 1 10 25
Phase 3 3 16 0 2 0 0 5 3 29
Total 11 21 1 17 1 16 7 18 92
102 S. Reed et al. / International Journal of Surgery 32 (2016) 99e108
Fig. 2. Measures for sign-out performance for each phase of the study.
positive enhancement to standard protocol as it was loud and clear, Furthermore, audio delivery of the checklist enabled communica-
which prompts staff to stop their activities and engage. The auto- tion of 100% of all questions for both time-out and sign-out and an
mated nature also put at ease staff who were not confident enough improvement in overall team participation at time-out.
to ask everyone to stop for the checklist or read it out themselves, We found that there is an absence of some team members
particularly when working with an unfamiliar team. during some time-out and sign-out and there are varying levels of
However, some staff expressed concerns about the use of an active participation of staff with the SSC. This is in agreement with
audio prompt for procedures where the patient is awake. The loud previous studies [3,14,15].
nature of the prompt and audio checklist can be startling and Under standard practice, not all SSC items were always
perhaps even distressing for patients. addressed but this finding suggests that the pre-recorded audio
Some staff felt the audio prompt negated human communica- brings consistency to the delivery of the SSC firstly by completing a
tion and team work whilst the majority who gave negative feed- time-out and sign-out for every case and secondly by addressing all
back were mainly bothered by the fact that it took longer than items on the checklist in all cases.
standard protocol, forcing them to disengage and continue with All checklist items were addressed for all the time-outs and
their busy schedule whilst the audio was being played. Due to the sign-outs delivered by audio compared to standard practice. This
set nature of the recording, the lack of tailoring to fit the particular indicates the intervention allows for a more accurate and thorough
procedure was not appreciated by some staff. completion of the checklist. There is no conscious decision involved
Other feedback included concerns over financing of the audio with whether or not each question needs to be asked, but instead
checklist, should it be widely adopted and the possibility of IT all questions are automatically asked for every case.
malfunctions. The initial time-out team member's introduction question, was
rarely addressed during standard practice and audio prompt phases
4. Discussion (Fig. 3) as this was mostly done at the start of the list during the
Team Brief. As a result, this lowered the completeness score of
Our results demonstrate that with audio delivery intervention in checklist items for these phases. Nonetheless, there were occasions
phase 3, time-out and sign-out was performed in 100% of the cases. when additional team members had joined the operating theatre
S. Reed et al. / International Journal of Surgery 32 (2016) 99e108 103
Fig. 3. Frequency of questions asked at time-out in Phase 1 and Phase 2 of the study.
Fig. 4. Team members' self-reported engagement scores for each phase of the study.
after the Team Brief and were not introduced. Equally the throat toward the audio delivery of the SSC or a feeling of dis-
pack question was frequently omitted by staff as it was not relevant empowerment, leading them to leave the room during phase 3.
for most procedures. However there were instances when this This is consistent with some of the staff feedback we received
question was not asked yet the patient had a throat pack. This stating it negated human communication.
represents a potential risk to patient safety if the throat pack was There were generally more staff members present during the
retained and the team later forgot about it. The introduction and time-outs than the sign-outs for both the standard practice and the
throat pack questions account for only 2 out of 9 (22.2%) items. The interventions. This supports evidence of poor compliance with the
difference between standard practice and the audio delivery was sign-out process.
39% which equates to an average of 3.5 questions asked per pro- In all phases, the majority of sign-out items did not have active
cedure less than with the audio delivery, so even when excluding participation of all team members. Staff members were often busy
these questions there is still a notable improvement with audio with other tasks during the process of timeout/sign-out. Examples
delivery of the checklist. include the anaesthetist adjusting the anaesthetic machine and
There was a decline in the number of team members present surgeons scrubbing or writing the operation note after de-
during the audio delivery of time-out compared to standard de- scrubbing. This suggests staff feel pressure for time in the oper-
livery. It is possible this was due to feelings of opposition from staff ating theatre and may be distracted. For SSC performance to be
104 S. Reed et al. / International Journal of Surgery 32 (2016) 99e108
optimal, all staff should be focused on the process for obvious The purpose of sign-out is to ensure a thorough check at the end
reasons. Further staff education and investigation into the reasons of the procedure so that equipment is accounted for and procedure
behind this could help in this regard as it seems the alternative details are confirmed before the patient leaves the operating room.
method of delivery has not been successful in improving this aspect It is an extra opportunity for staff to raise any concerns before the
of SSC performance, especially for the sign-out process. patient goes to recovery. Our study achieved the completeness of
The dramatic reduction in active staff participation with the sign-out but not active participation from all staff members. It is
time-out when the prompt was played compared with standard worth considering what measures are required to archive active
practice might imply the audio prompt was disempowering. participation of members of staff at every element of the SSC.
Research has suggested that barriers to implementation of the Furthermore, are top e down imposed changes to staff practice
SSC include staff hierarchy, time constraints, inconsistent delivery conducive to long term achievement of the goal of the proposed
with omission of items, viewing the checklist as a tick box exercise, intervention or will presence and participation of patients and their
nobody assuming responsibility for sign-out checks leading to it representative lead to the desired goal? Introduction of the SSC did
being omitted [8]. achieve its goal of reducing operating room errors and a huge
Our method will address the inconsistent delivery and confu- culture change was needed to implement this intervention globally.
sion over when sign-out should be performed, ensuring it is not Ten years after the introduction of the SSC, our study proposes that
accidently omitted, as occurred during standard practice. It will also it is time to amend the delivery of the SSC to enhance compliance
address problems related to hierarchy of the person leading the with the SSC.
checklist, which was highlighted in our feedback from staff as being
an issue. However, other barriers such as time constraints and staff Ethical approval
perceiving the checklist as a tick box exercise may have been
increased, as highlighted in the staff feedback. The study was approved by the Hospital Research Development
and Innovation department and Biomedical & Scientific Research
4.1. Limitations Ethics Committee (BSREC) at the University of Warwick.
5. Anticipated critical events e surgery. 1. Has the procedure been recorded in the medical notes and
6. Is a throat pack been inserted? opera?
7. SSI bundle: Antibiotic prophylaxis, glycaemic control, hair 2. Have all instrument, sharp and swab counts been completed?
removal and warming. 3. Has the integrity of the instruments been confirmed?
8. Has VTE prophylaxis been prescribed? 4. Have all the specimens labelled?
9. Is essential imaging displayed? 5. Have any equipment problems been identified and addressed?
6. Has the throat pack been removed? (if applicable).
7. What are the key concerns for the recovery of this patient.
Sign-out
Please circle the number that closely reflects your assessment of how the WHO surgical safety
checklist went today
1. Do you feel that the checklist was done at an appropriate me? ……………….If not, why?
Agree Disagree
3. Do you feel that the team was engaged with the checklist?
Not engaged at all 1 2 3 4 5 Fully engaged
5. What do you perceive to be the problems with the surgical safety checklist?
7. Do you think the checklist could be delivered in a different format? If so, what?
106 S. Reed et al. / International Journal of Surgery 32 (2016) 99e108
Role…………………………………………………… Phase 2
Please circle the number under each item that closely reflects your assessment of the audio prompt
for the surgical safety checklist.
1. Do you feel that the checklist was done at an appropriate me? ……………….If not, why?
Agree Disagree
3. Do you feel that the team was engaged with the checklist?
Not engaged at all 1 2 3 4 5 Fully engaged
7. Do you feel the audio prompt would be well received by theatre staff?
Strongly disagree Disagree Agree Strongly agree
7. Do you have any other comments/sugges ons regarding the audio prompt?
S. Reed et al. / International Journal of Surgery 32 (2016) 99e108 107
Role…………………………………………………… Phase 3
Please circle the number under each item that closely reflects your assessment of the audio
checklist for the surgical safety checklist.
1. Do you feel that the checklist was done at an appropriate me? ……………….If not, why?
Agree Disagree
3. Do you feel that the team was engaged with the checklist?
Not engaged at all 1 2 3 4 5 Fully engaged
7. Do you feel the audio checklist would be well received by theatre staff?
Strongly disagree Disagree Agree Strongly agree
9. Do you have any other comments/sugges ons regarding the audio checklist?
World Health Organisation, 2008 [cited 2015 16th November]. Available from:
http://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_
Checklist_finalJun08.pdf?ua¼1Available http://www.who.int/patientsafety/
Appendix A. Supplementary data safesurgery/ss_checklist/en/. from.
[6] A.B. Haynes, T.G. Weiser, W.R. Berry, S.R. Lipsitz, A.H. Breizat, E.P. Dellinger, et
Supplementary data related to this article can be found at http:// al., A surgical safety checklist to reduce morbidity and mortality in a global
population, N. Engl. J. Med. 360 (5) (2009) 491e499.
dx.doi.org/10.1016/j.ijsu.2016.06.035. [7] C. Rydenf€alt, G. Johansson, P. Odenrick, K. Åkerman, P.A. Larsson, Compliance
with the WHO surgical safety checklist: deviations and possible improve-
References ments, Int. J. Qual. Health Care 25 (2) (2013) 182e187.
[8] A. Vats, C.A. Vincent, K. Nagpal, R.W. Davies, A. Darzi, K. Moorthy, Practical
challenges of introducing WHO surgical checklist: UK pilot experience, BMJ
[1] Agency NNPS, Surgical Safety Checklist Saves Lives: NHS National Patient 340 (2010) b5433.
Safety Agency, 2010 [cited 2015 14th November]. Available from: http:// [9] N. Vogts, J.A. Hannam, A.F. Merry, S.J. Mitchell, Compliance and quality in
www.npsa.nhs.uk/corporate/news/surgical-safety-checklist-saves-lives/. administration of a surgical safety checklist in a tertiary New Zealand hospital,
[2] Organisation WH, WHO Safe Surgery, 2015 [cited 2015 2nd November]. N. Z. Med. J. 124 (1342) (2011) 48e58.
Available from: http://www.who.int/patientsafety/safesurgery/en/. [10] A. Fourcade, J.L. Blache, C. Grenier, J.L. Bourgain, E. Minvielle, Barriers to staff
[3] S.P. Pickering, E.R. Robertson, D. Griffin, M. Hadi, L.J. Morgan, K.C. Catchpole, et adoption of a surgical safety checklist, BMJ Qual. Saf. 21 (3) (2012) 191e197.
al., Compliance and use of the World Health Organization checklist in U.K. [11] C. Rydenf€alt, Å. Ek, P.A. Larsson, Safety checklist compliance and a false sense
operating theatres, Br. J. Surg. 100 (12) (2013) 1664e1670. of safety: new directions for research, BMJ Qual. Saf. 23 (3) (2014) 183e186.
[4] Evidence N, Agency NPS. The WHO Surgical Safety Checklist: to reduce harm [12] L. Morgan, S.P. Pickering, M. Hadi, E. Robertson, S. New, D. Griffin, et al.,
by consistent use of best practice. A combined teamwork training and work standardisation intervention in
[5] Safety WAfP, WHO Surgical Safety Checklist and Implementation Manual:
108 S. Reed et al. / International Journal of Surgery 32 (2016) 99e108
operating theatres: controlled interrupted time series study, BMJ Qual. Saf. 24 Effectiveness of facilitated introduction of a standard operating procedure
(2) (2015) 111e119. into routine processes in the operating theatre: a controlled interrupted time
[13] L. Morgan, M. Hadi, S. Pickering, E. Robertson, D. Griffin, G. Collins, et al., The series, BMJ Qual. Saf. 24 (2) (2015) 120e127.
effect of teamwork training on team performance and clinical outcome in €, M. Micallef, E. Khabiri, A. Ourahmoune, et al., Is the
[15] S. Cullati, S. Le Du, A.C. Rae
elective orthopaedic surgery: a controlled interrupted time series study, BMJ surgical safety checklist successfully conducted? an observational study of
Open 5 (4) (2015) e006216. social interactions in the operating rooms of a tertiary hospital, BMJ Qual. Saf.
[14] L. Morgan, S. New, E. Robertson, G. Collins, O. Rivero-Arias, K. Catchpole, et al., 22 (8) (2013) 639e646.