Adherence to the WHO surgical safety checklist at Tibebe Ghion Specialized Hospital, Ethiopia: a prospective observational study

Abstract

Background

The WHO Surgical Safety Checklist (SSC) is a globally recognized 19-item tool designed to improve team communication and reduce perioperative complications and mortality. Despite its proven efficacy in promoting safety by helping clinicians adhere to evidence-based best practice, its global compliance varies. Consequently, this study aims to assess the adherence to the WHO surgical safety checklist at Tibebe Ghione Specialized Hospital, Bahir Dar, Ethiopia.

Methodology

Following ethical approval, a hospital-based prospective observational study was conducted on 213 surgeries performed at Tibebe Ghion Specialized Hospital from November- December, 2025. All patients who underwent elective surgery under anesthesia at TGSH during the study period were included. The WHO Surgical Safety Checklist was transformed into a structured Yes/No observational instrument and implemented through direct observation and chart review using a Kobo Toolbox–based questionnaire. Compliance with the three checklist phases (Sign In, Time Out, and Sign Out) was analyzed using the IBM SPSS Statistics for Windows, Version 26.0.

Results

A total of 213 surgical procedures were assessed using the Surgical Safety Checklist. The overall performance level across all checklist standards was 92.2%. The highest compliance was during the Sign-In and Time-Out phases, ranging from 89.7% to 99.5%. The lowest adherence was during the Sign Out phase, with adherence for specimen labeling, equipment problem reporting, and recovery management discussion was 75.1%, 76.5%, and 77.0%, respectively.

Conclusion and recommendation

Overall compliance with the WHO Surgical Safety Checklist was high, particularly during the Sign-In and Time-Out phases. Critical safety practices, including patient verification, anesthesia checks, team communication, and timely antibiotic administration, were consistently performed. In contrast, adherence during the Sign Out phase was comparatively lower, especially for postoperative planning, specimen labeling, and equipment-related checks. These findings highlight the need for targeted interventions to improve Sign Out compliance and further strengthen overall surgical safety and quality of care.

Introduction

Complications arising during surgery and anesthesia remain a significant concern in clinical practice, with serious adverse events such as wrong-site surgery still being reported [1]. Consequently, the implementation of effective strategies to prevent or mitigate perioperative complications is essential [2]. Among these strategies, the use of surgical safety checklists has been widely promoted as an evidence-based intervention to reduce surgical morbidity and mortality, formally introduced by the World Health Organization (WHO) through its Safe Surgery Saves Lives campaign internationally in June 2008 [3, 4].

Central to this global initiative is the WHO Surgical Safety Checklist (SSC), a 19-item tool designed to enhance patient safety by supporting clinicians in consistently applying evidence-based best practices [5]. Introduced in 2008, the checklist was developed to address critical safety concerns in surgical care, with particular emphasis on improving team communication, standardizing perioperative processes, and enhancing overall consistency of care [6, 7].

The WHO SSC has since been adopted worldwide as a standard measure to promote patient safety during surgical procedures [8, 9]. Evidence suggests that its implementation is associated with reductions in surgical complications and mortality, alongside improvements in interdisciplinary communication and adherence to established safety protocols [9, 10]. Structurally, the checklist is divided into three distinct phases: sign-in, conducted before the induction of anesthesia; time-out, performed before skin incision; and sign-out, completed immediately after skin closure or before the patient leaves the operating theatre [11].

The effectiveness of the WHO SSC, however, is closely linked to the degree of compliance with its proper use [10, 12]. Studies indicate that compliance rates may vary considerably between institutions that implement the checklist as part of structured research protocols and those that adopt it independently as routine clinical practice [13]. Nonetheless, use of the SSC has been associated with a significant reduction in postoperative complications—reported to be as high as 30%—as well as decreased mortality rates, improved adherence to standard processes of care, enhanced teamwork in the operating room, and potential cost savings [14, 15].

However, the mere presence of a surgical safety checklist does not, in itself, ensure patient safety; its effectiveness is contingent upon active, meaningful engagement by the entire surgical team, including surgeons, anesthetists, and nursing staff [16]. Despite the well-documented benefits of checklist implementation, persistent challenges remain in achieving consistent and complete utilization in routine clinical practice [17]. Inadequate completion of the WHO Surgical Safety Checklist has been shown to increase the risk of perioperative complications in patients [18].

Perioperative morbidity and mortality continue to be driven by preventable factors such as failures in communication, insufficient clarity regarding surgical plans, medication errors, wrong-site surgery, and unrecognized equipment-related issues [19]. Addressing these underlying causes requires not only the availability of safety tools, such as checklists, but also a strong culture of safety, effective teamwork, and sustained commitment to adherence throughout the perioperative period [7].

While appropriate utilization of the Surgical Safety Checklist (SSC) has been shown to reduce perioperative complications and improve patient outcomes, evidence regarding compliance levels remains limited in many settings, including the study area [20, 21]. Furthermore, despite demonstrated benefits in reducing intraoperative errors and enhancing patient safety, adherence to the SSC has frequently been reported as suboptimal in routine clinical practice [22]. Therefore, this study aimed to assess adherence to the WHO Surgical Safety Checklist at Tibebe Ghion Specialized Hospital, Ethiopia.

Methods and materials

Study design, setting, and period

This single-center prospective observational study was conducted using a consecutive sampling technique at the operating room theater at Tibebe Ghione Specialized Hospital (TGSH) in Bahir Dar, Amhara National Regional State, northwestern Ethiopia, from November to December 2025.

Inclusion and exclusion criteria

All patients who underwent elective surgical procedures under anesthesia at TGSH during the study period were included. Minor surgical procedures and interventions performed under local anesthesia were excluded from the sample. The study follows the Enhancing the Quality and Transparency of Health Research (EQUATOR) guideline, Strengthening the Reports of Observational Studies in Epidemiology (STROBE) [23].

Operational definition

Compliance

The WHO surgical safety checklist practice is considered compliant when it is provided according to the protocol, whereas a practice that is not performed as per the protocol is considered non-compliant [21].

Sign in

The verification process is performed before induction of anesthesia, usually by the circulating nurse, to confirm patient identity, procedure, site, consent, allergies, airway risk, and equipment readiness [24, 25].

Time out

A mandatory team pause before skin incision, involving all surgical team members to confirm patient details, procedure, site, anticipated critical events, sterility, and imaging availability [24, 25].

Sign out

The final safety review conducted before the patient leaves the operating room, ensuring procedure confirmation, instrument counts, specimen labeling, equipment problem reporting, and postoperative care planning [5, 25].

WHO SSC

A 19-item standardized checklist introduced by WHO to improve surgical safety, divided into three phases: Sign In, Time Out, and Sign Out [5, 26].

Sample size determination

To determine the sample size, the single population proportion formula was used. The sample size for the study was calculated by considering 95% confidence interval, 5% margin of error, and 17% level of proportion obtained from a previous study on the overall completeness of the checklist [27] since the expected compliance rate for the WHO surgical safety checklist is advised to be 100% and finally, the sample size for the study was calculated as:

Where n = is the desired sample size; z = is the standard normal distribution, usually set as 1.96 (corresponds to 95% confidence level); p = population proportion 17%=0.17, and q, which is 1-0.17 = 0.83 and d = degree of accuracy desired (marginal error is 5% (0.05)); then the sample size is . Finally, a total of 213 patients were included in the analysis, while four patients were excluded due to incomplete data.

Data collection instrument and procedure

The WHO SSC was adapted into a “Yes/No” questionnaire using the Kobo Toolbox. Data were collected through continuous direct observation and review of complete surgical safety checklist charts, which were documented digitally using Kobo Collect as the study proforma. A team of trained anesthetists (n = 3) collected the data after receiving half-day training. Supervisors monitored data quality. Medical records of the WHO surgical safety checklist were reviewed and observed during the intraoperative period and recovery, and the checklist’s use and completeness were assessed. The checklist was used in all observed cases, and overall adherence levels were reported to reflect its comprehensive use. The expected compliance rate for the WHO surgical safety checklist is advised to be 100% [4]. (Table 1)

Table 1.

The World Health Organization (WHO) surgical safety checklist standards

No.	Standards	Target (100%)	Evidence	Data source	Exception
1	Has the patient confirmed his/her identity, site, procedure, and consent?	100%	WHO	Direct observation and chart review	None
2	Is the site marked?	100%	WHO	Direct observation	None
3	Is the anesthesia machine and medication check complete?	100%	WHO	Direct observation and chart review	None
4	Is the pulse oximeter on the patient and functioning?	100%	WHO	Direct observation and chart review	None
5	Known allergy?	100%	WHO	Direct observation and chart review	None
6	Difficult airway or aspiration risk?	100%	WHO	Direct observation and chart review	None
7	Risk of > 500 ml blood loss (7 ml/kg in children)?	100%	WHO	Direct observation and chart review	None
8	Confirm all team members have introduced themselves by name and role?	100%	WHO	Direct observation and chart review	None
9	Confirm the patient’s name, procedure, and where the incision will be made.	100%	WHO	Direct observation and chart review	None
10	Has antibiotics prophylaxis been given within the last 60 min?	100%	WHO	Direct observation and chart review	Not applicable if no prophylaxis is indicated
11	Anticipated critical event to the surgeon: what are the critical or non-routine steps? How long will the case take? What is the anticipated blood loss?	100%	WHO	Direct observation and chart review
12	To anesthetist: Are there any patient-specific concerns?	100%	WHO	Direct observation and chart review	None
13	To the nursing team: has sterility (including indicator results) been confirmed? Are there equipment issues or concerns?	100%	WHO	Direct observation and chart review
14	Is essential imaging displayed?	100%	WHO	Direct observation and chart review	Not applicable if no imaging is required
15	Nurse verbally confirms: the name of the procedure?	100%	WHO	Direct observation and chart review	None
16	Completion of instruments, sponge, and needle counts?	100%	WHO	Direct observation and chart review	Not applicable where counting is not feasible
17	Specimen labeling (read specimen labels aloud, including patient name)?	100%	WHO	Direct observation and chart review	Not applicable if no specimen is collected
18	Is there any equipment problem to be addressed?	100%	WHO	Direct observation and chart review	None
19	To the surgeon, anesthetist, and nurse: what are the key concerns for recovery and management of this patient?	100%	WHO	Direct observation and chart review	None

Data quality management

To ensure data quality, the data collection tool (WHO Surgical Safety Checklist) was pretested on 10 patients at this hospital who were not included in the main study. The pretest was conducted one week before the actual data collection to evaluate the tool’s clarity, language, and grammatical accuracy. A one-day training session was conducted for data collectors and supervisors to familiarize them with the study objectives and data collection procedures. Throughout the data collection period, supervisors closely monitored the data collectors. The principal investigator reviewed all completed questionnaires for completeness, accuracy, and clarity before data entry into the database.

Data processing and analysis

Data were initially collected using Kobo Toolbox and subsequently exported to Statistical Package for the Social Sciences (SPSS) version 27.0 for analysis. The data were checked for completeness, coded, entered, and cleaned before analysis. Descriptive statistical analyses were conducted, and the findings were summarized using frequencies and percentages. Results were presented in the form of text and tables. Due to the study design and the nature of the collected variables (primarily binary checklist observations without detailed explanatory variables), conducting meaningful inferential and multivariable analyses was limited.

Data collection performance

Table 2.

Table 2.

Data collection performance questionnaire for the WHO surgical safety checklist practice

No.	The Standards of the WHO surgical safety checklist	Yes	No
1	Is Patient identity confirmed?
2	Is the procedure, site, and consent confirmed?
3	Is the site marked (if applicable)?
4	Is the anesthesia machine & medication check complete?
5	Is the pulse oximeter applied & functioning?
6	Is there a known allergy?
7	Is there a difficult Airway?
8	Is there a risk of ≥ 500 ml blood loss (7 ml/kg child)?
9	Do Team members introduce themselves?
10	Does the Team confirm the patient, procedure, and site?
11	Does Surgeon reviews: critical steps, duration, blood loss?
12	Does the Anesthesia team review concerns?
13	Does the nursing team review sterility & equipment?
14	Is Essential Imaging available?
15	Is the procedure name confirmed?
16	Is Instrument, needle, and sponge counts complete?
17	Is Specimens correctly labeled?
18	Is Equipment problems identified?
19	Is the postoperative care plan discussed?

Result

A total of 213 patients who underwent surgery were assessed using the Surgical Safety Checklist. The overall performance level across all standards was 92.2%. Overall compliance across checklist items was high, particularly during the Sign-In and Time-Out phases. Confirmation of patient identity, procedure, surgical site, and consent was achieved in 97.2% of cases.

During the Time Out phase, prophylactic antibiotic administration within 60 min before incision showed near-universal compliance (99.1%). Similarly, the surgeon’s review of critical steps, anticipated duration, and blood loss, as well as the anesthesia team’s review of patient-specific concerns, was documented in 99.5% of cases.

In contrast, the Sign Out phase demonstrated lower levels of compliance. Verbal confirmation of the procedure by the nurse was documented in 78.9% of cases. Completion of instrument, needle, and sponge counts was reported in 85.4%, while specimen labeling was confirmed in 76.5%. (Table 3).

Table 3.

Results of adherence to the WHO surgical safety checklist

No	Audit Performa	Response rate
		Number of anesthesia documents audited	YES		NO
		Total	No.	%	No.	%
	Sign-In phase
1	Patient identity, procedure site, and consent confirmed	213	207	97.2%	6	2.8%
2	Site marked	213	191	89.7%	22	10.3%
3	Anesthesia machine & medication check complete	213	204	95.8%	9	4.2%
4	Pulse oximetry applied & functioning	213	203	95.3%	10	4.7%
5	known allergy	213	204	95.8%	9	4.2%
6	Difficult airway or aspiration risk confirmed	213	202	94.8%	11	5.2%
7	Risk of ≥ 500 ml blood loss (7 ml/kg in children)?	213	203	95.3%	10	4.7%
	Time-Out phase
8	Have all team members introduced themselves by name and role?	213	206	96.7%	7	3.3%
9	The team confirms the patient’s name, procedure, and site.	213	207	97.2%	6	2.8%
10	Antibiotic prophylaxis has been given within the last 60 min.	213	211	99.1%	2	0.9%
11	The Surgeon reviews: critical steps, duration, and blood loss	213	212	99.5%	1	0.5%
12	The anesthesia team reviews any patient-related concerns	213	212	99.5%	1	0.5%
13	Nursing team reviews sterility & equipment issues, as well as any concerns.	213	207	97.2%	6	2.8%
14	Essential imaging displayed.	213	176	82.6%	37	17.4%
15	Nurse verbally confirms the name of the procedure.	213	168	78.9%	45	21.1%
	Sign-Out phase
16	Instrument, needle, and sponge counts are complete.	213	182	85.4%	31	14.6%
17	Specimen labeling (read specimen labels aloud, including patient name).	213	163	76.5%	50	23.5%
18	Whether there any equipment problems to be addressed	213	164	77.0%	49	23.0%
19	To the surgeon, anesthetist, and nurse: what are the concerns for recovery and management of this patient	213	160	75.1%	53	24.9%

Discussion

This prospective observational study evaluated adherence to the WHO Surgical Safety Checklist (SSC) at Tibebe Ghion Specialized Hospital and demonstrated a high overall compliance rate of 92.2%. This finding indicates substantial integration of the SSC into routine perioperative practice and reflects a strong institutional commitment to patient safety. The observed compliance exceeds the pooled global compliance rate of 73% reported in a recent systematic review and meta-analysis of WHO SSC use [9], as well as the aggregate adherence of 60.8% documented in a nationwide survey across 172 health facilities in Ethiopia [21]. It also surpasses earlier Ethiopian reports, such as 39.7% utilization at the University of Gondar Hospital [28] and 65% initial compliance in an Ethiopian referral hospital shortly after implementation [29]. Additionally, the overall compliance observed in this study is substantially higher than reports from other African countries, including Ghana (30.4%) and Tanzania (55.6%) [30, 31]. Similarly, studies conducted in Kenya have reported suboptimal adherence [32].

Importantly, the observed compliance exceeds that reported in several low- and middle-income countries (LMIC) settings, where adherence often remains inconsistent [21, 33], suggesting meaningful progress in checklist implementation within this context. The WHO SSC has been shown to significantly reduce perioperative morbidity and mortality when properly implemented [7, 34, 35], further emphasizing the importance of maintaining high adherence levels.

The high compliance observed in this study may be attributed to multiple reinforcing factors, including structured perioperative workflows, increased awareness of patient safety initiatives, and the presence of trained professionals actively engaged in checklist implementation. In contrast to earlier studies from sub-Saharan Africa reporting substantially lower adherence rates [21, 33], the present findings suggest that targeted institutional efforts—such as training, supervision, and accountability mechanisms—can significantly improve checklist utilization even in resource-limited settings. This underscores the importance of system-level interventions in translating global safety recommendations into routine clinical practice [36, 37].

Phase-specific analysis revealed a consistent pattern, with adherence highest during the Sign-In and Time-Out phases and comparatively lower during the Sign-Out phase. This trend has been widely reported in the literature and highlights a persistent gap in the final stage of perioperative safety checks [38, 39]. The high compliance in the Sign-In phase likely reflects its integration into anesthesia-related safety routines, where verification processes such as patient identification, equipment checks, and risk assessment are already standardized components of care. Similarly, the near-optimal adherence observed during the Time-Out phase may be driven by its emphasis on team communication and shared accountability immediately before incision, a critical moment that naturally commands the attention of all team members [36, 40].

The comparatively lower adherence observed during the Sign-Out phase represents a critical gap in perioperative safety practice. This phase plays a vital role in ensuring accurate specimen labeling, confirming instrument counts, and facilitating effective communication regarding postoperative care. However, consistent with previous studies, adherence to this phase is often suboptimal [38, 39]. Several factors may explain this finding. First, workflow-related challenges and time pressure at the end of surgical procedures may lead to premature task shifting, as surgical teams prioritize patient transfer and preparation for subsequent cases [19, 41]. Second, team engagement tends to decline after completion of the main surgical procedure, reducing the perceived importance of final safety checks [42]. Third, unclear assignment of responsibility for initiating and completing the Sign-Out process may result in gaps in accountability among team members. Additionally, communication breakdowns during this transition phase can further compromise checklist completion [7, 19, 41].

To address these challenges, several evidence-based strategies have been recommended. These include clearly designating a responsible team member (often the circulating nurse) to lead the Sign-Out process, embedding checklist steps into standardized operating room workflows, and reinforcing a culture of shared accountability and communication among surgical team members [43, 44]. Regular audit and feedback mechanisms, combined with targeted training and reminders, have also been shown to improve compliance with checklist protocols [36, 45]. Strengthening adherence to the Sign-Out phase is essential to ensure continuity of care and maximize the patient safety benefits of the WHO Surgical Safety Checklist.

The variability observed within specific checklist items further highlights gaps in communication and resource utilization. For example, lower compliance in confirming essential imaging and verbal procedure confirmation suggests that certain elements of the checklist may be perceived as less critical or are inconsistently prioritized. This aligns with existing evidence indicating that incomplete checklist execution is often linked not to lack of knowledge, but to behavioral and organizational factors, including team dynamics, hierarchy, and perceived relevance of checklist components [5, 9, 14].

Importantly, while the overall compliance rate in this study is high, adherence alone does not necessarily equate to effective implementation. The true impact of the SSC depends on the quality and fidelity of its use, including active participation, meaningful communication, and a shared culture of safety among surgical team members [4, 5, 14]. Superficial or “tick-box” completion of the checklist may limit its effectiveness in preventing adverse events. Therefore, future efforts should focus not only on improving completion rates but also on enhancing the depth and quality of checklist engagement.

The relatively strong performance observed in this study provides an opportunity to shift the focus from basic implementation to optimization. Targeted interventions aimed at strengthening the Sign-Out phase—such as assigning clear responsibility, integrating checklist steps into workflow protocols, and reinforcing team accountability—may yield substantial improvements in overall surgical safety. Additionally, periodic audits combined with feedback mechanisms could help sustain high compliance and address persistent gaps.

This study contributes to the growing body of evidence demonstrating that high levels of SSC adherence are achievable in LMIC settings when supported by institutional commitment and structured implementation strategies [21, 33, 36]. However, the findings also highlight that achieving uniform compliance across all checklist phases remains a challenge, particularly in the postoperative transition period. Addressing these gaps is critical to maximizing the safety benefits of the SSC and ensuring comprehensive perioperative risk reduction.

Conclusion

Overall compliance with the WHO Surgical Safety Checklist is high, particularly during the Sign-In and Time Out phases. Key safety practices, including patient identity verification, anesthesia checks, team introductions, and prophylactic antibiotic administration, were consistently followed. However, compliance was notably lower during the Sign Out phase, particularly in postoperative recovery planning, specimen labeling, and equipment issue resolution. This finding underscores the need for targeted interventions, such as focused staff training, reinforcement of accountability, and integration of Sign Out practices into routine workflow, to ensure comprehensive adherence across all phases of the checklist. Strengthening compliance in the Sign Out phase has the potential to enhance overall surgical safety and quality of care.

Limitation

Despite its strengths, including prospective design and direct observation, this study has limitations that warrant consideration. The single-center design and relatively short study period may limit generalizability. The potential Hawthorne effect was considered, as staff may modify behavior when observed. This may have contributed to higher compliance rates and is acknowledged as a limitation [46]. The nature of the collected data—largely binary checklist observations without detailed explanatory variables—restricted the ability to perform meaningful inferential or multivariable analyses to identify factors associated with compliance or non-compliance. The study also did not specifically stratify the checklist application by surgeon seniority.

Furthermore, the absence of outcome data precludes assessment of the direct impact of SSC adherence on patient morbidity and mortality. Future multicenter studies incorporating both compliance and clinical outcomes, as well as qualitative assessments of provider perspectives, would provide a more comprehensive understanding of SSC effectiveness.

Abbreviations

IRB

Institutional Review Board

LMICs

Low- and Middle-Income Countries

SSC

Surgical Safety Checklist

TGSH

Tibebe Ghion Specialized Hospital

WHO

World Health Organization

Authors’ contributions

S.A. Debas took part in conceptualization, methodology, formal analysis, investigation, resources, data curation, writing - original manuscript draft, writing – review & editing, visualization, and supervision. M.M. Taye, Y.T. Desta, A. A. Demsse, M.D. Tesema, N.S. Tegegne, S.T. Zegey Took part in methodology, formal analysis, investigation, writing review & editing, and visualization: Manuscript writing, paper revision, editing, and methodology. All authors approved the final version of the manuscript.

Funding

The authors declare that this study was conducted without any financial support.

Data availability

The data generated during and analyzed during this study are available from the corresponding request upon a reasonable request.

Declarations

Ethics approval and consent to participate

Ethical approval for this study was obtained from the Institutional Review Board (IRB) of the School of Medicine, College of Medicine and Health Sciences, Bahir Dar University (reference number: CMHS/IRB 01–008; protocol number: 4010/2025; assigned number: 003). Additionally, formal permission to conduct the study was secured from the hospital administration and operating room directors. Informed consent was obtained from each study subject following a detailed explanation of the study’s objectives and potential benefits. No personal identifiers were collected, and all data were recorded anonymously and used solely for research purposes. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. It did not interfere with standard patient care or expose patients or healthcare providers to any additional risk or harm.

Consent for publication

Consent for publication not applicable.

Competing interests

The authors declare no competing interests.