Surgical Safety Checklist Use and Post-Caesarean Sepsis in the Lake Zone of Tanzania: Results from Safe Surgery 2020.

BACKGROUND: Maternal sepsis accounts for significant morbidity and mortality in lower income countries, and caesarean delivery, while often necessary, augments the risk of maternal sepsis. The aim of this study was to investigate the effect of Safe Surgery 2020 surgical safety checklist (SSC) implementation on post-caesarean sepsis in Tanzania. METHODS: We conducted a study in 20 facilities in Tanzania's Lake Zone as part of the Safe Surgery 2020 intervention. We prospectively collected data on SSC adherence and maternal sepsis outcomes from 1341 caesarian deliveries. The primary outcome measure was maternal sepsis rate. The primary predictor was SSC adherence. Multivariable logistic regression was used to estimate independent associations between SSC adherence and maternal sepsis. RESULTS: Higher SSC adherence was associated with lower rates of maternal sepsis (<25% adherence: 5.0%; >75% adherence: 0.7%). Wound class and facility type were significantly associated with development of maternal sepsis (Wound class: Clean-Contaminated 3.7%, Contaminated/Dirty 20%, P = 0.018) (Facility Type: Health Centre 5.9%, District Hospital 4.5%, Regional Referral Hospital 1.7%, P = 0.018). In multivariable analysis, after controlling for wound class and facility type, higher SSC adherence was associated with lower rates of maternal sepsis, with an adjusted odds ratio of 0.17 per percentage point increase in SSC adherence (95% CI: 0.04, 0.79; P = 0.024). CONCLUSIONS: Adherence to the SSC may reduce maternal morbidity during caesarean delivery, reinforcing the assumption that surgical quality interventions improve maternal outcomes. Future studies should continue to explore additional synergies between surgical and maternal quality improvement.

In-Hospital Postoperative Mortality Rates for Selected Procedures in Tanzania's Lake Zone.

BACKGROUND: Postoperative mortality rate is one of six surgical indicators identified by the Lancet Commission on Global Surgery for monitoring access to high-quality surgical care. The primary aim of this study was to measure the postoperative mortality rate in Tanzania's Lake Zone to provide a baseline for surgical strengthening efforts. The secondary aim was to measure the effect of Safe Surgery 2020, a multi-component intervention to improve surgical quality, on postoperative mortality after 10 months. METHODS: We prospectively collected data on postoperative mortality from 20 health centers, district hospitals, and regional hospitals in Tanzania's Lake Zone over two time periods: pre-intervention (February to April 2018) and post-intervention (March to May 2019). We analyzed postoperative mortality rates by procedure type. We used logistic regression to determine the impact of Safe Surgery 2020 on postoperative mortality. RESULTS: The overall average in-hospital non-obstetric postoperative mortality rate for all surgery procedures was 2.62%. The postoperative mortality rates for laparotomy were 3.92% and for cesarean delivery was 0.24%. Logistic regression demonstrated no difference in the postoperative mortality rate after the Safe Surgery 2020 intervention. CONCLUSIONS: Our results inform national surgical planning in Tanzania by providing a sub-national baseline estimate of postoperative mortality rates for multiple surgical procedures and serve as a basis from which to measure the impact of future surgical quality interventions. Our study showed no improvement in postoperative mortality after implementation of Safe Surgery 2020, possibly due to low power to detect change.

A multimodal mentorship intervention to improve surgical quality in Tanzania's Lake Zone: a convergent, mixed methods assessment.

BACKGROUND: Safe, high-quality surgical care in many African countries is a critical need. Challenges include availability of surgical providers, improving quality of care, and building workforce capacity. Despite growing evidence that mentoring is effective in African healthcare settings, less is known about its role in surgery. We examined a multimodal approach to mentorship as part of a safe surgery intervention (Safe Surgery 2020) to improve surgical quality. Our goal was to distill lessons for policy makers, intervention designers, and practitioners on key elements of a successful surgical mentorship program. METHODS: We used a convergent, mixed-methods design to examine the experiences of mentees, mentors, and facility leaders with mentorship at 10 health facilities in Tanzania's Lake Zone. A multidisciplinary team of mentors worked with surgical providers over 17 months using in-person mentorship, telementoring, and WhatsApp. We conducted surveys, in-depth interviews, and focus groups to capture data in four categories: (1) satisfaction with mentorship; (2) perceived impact; (3) elements of a successful mentoring program; and (4) challenges to implementing mentorship. We analyzed quantitative data using frequency analysis and qualitative data using the constant comparison method. Recurrent and unifying concepts were identified through merging the qualitative and quantitative data. RESULTS: Overall, 96% of mentees experienced the intervention as positive, 88% were satisfied, and 100% supported continuing the intervention in the future. Mentees, mentors, and facility leaders perceived improvements in surgical practice, the surgical ecosystem, and in reducing postsurgical infections. Several themes related to the intervention's success emerged: (1) the intervention's design, including its multimodality, side-by-side mentorship, and standardization of practices; (2) the mentee-mentor relationship, including a friendly, safe, non-hierarchical, team relationship, as well as mentors' understanding of the local context; and (3) mentorship characteristics, including non-judgmental feedback, experience, and accessibility. Challenges included resistance to change, shortage of providers, mentorship dose, and logistics. CONCLUSIONS: Our study suggests a multimodal mentorship approach is promising in building the capacity of surgical providers. By distilling the experiences of the mentees, mentors, and facility leaders, our lessons provide a foundation for future efforts to establish effective surgical mentorship programs that build provider capacity and ultimately improve surgical quality.

Outcomes of a multicomponent safe surgery intervention in Tanzania's Lake Zone: a prospective, longitudinal study.

BACKGROUND: Evidence-based strategies for improving surgical quality and patient outcomes in low-resource settings are a priority. OBJECTIVE: To evaluate the impact of a multicomponent safe surgery intervention (Safe Surgery 2020) on (1) adherence to safety practices, teamwork and communication, and documentation in patient files, and (2) incidence of maternal sepsis, postoperative sepsis, and surgical site infection. METHODS: We conducted a prospective, longitudinal study in 10 intervention and 10 control facilities in Tanzania's Lake Zone, across a 3-month pre-intervention period in 2018 and 3-month post-intervention period in 2019. SS2020 is a multicomponent intervention to support four surgical quality areas: (i) leadership and teamwork, (ii) evidence-based surgery, anesthesia and equipment sterilization practices, (iii) data completeness and (iv) infrastructure. Surgical team members received training and mentorship, and each facility received up to a $10 000 infrastructure grant. Inpatients undergoing major surgery and postpartum women were followed during their stay up to 30 days. We assessed adherence to 14 safety and teamwork and communication measures through direct observation in the operating room. We identified maternal sepsis (vaginal or cesarean delivery), postoperative sepsis and SSIs prospectively through daily surveillance and assessed medical record completeness retrospectively through chart review. We compared changes in surgical quality outcomes between intervention and control facilities using difference-in-differences analyses to determine areas of impact. RESULTS: Safety practices improved significantly by an additional 20.5% (95% confidence interval (CI), 7.2-33.7%; P = 0.003) and teamwork and communication conversations by 33.3% (95% CI, 5.7-60.8%; P = 0.02) in intervention facilities compared to control facilities. Maternal sepsis rates reduced significantly by 1% (95% CI, 0.1-1.9%; P = 0.02). Documentation completeness improved by 41.8% (95% CI, 27.4-56.1%; P < 0.001) for sepsis and 22.3% (95% CI, 4.7-39.8%; P = 0.01) for SSIs. CONCLUSION: Our findings demonstrate the benefit of the SS2020 approach. Improvement was observed in adherence to safety practices, teamwork and communication, and data quality, and there was a reduction in maternal sepsis rates. Our results support the emerging evidence that improving surgical quality in a low-resource setting requires a focus on the surgical system and culture. Investigation in diverse contexts is necessary to confirm and generalize our results and to understand how to adapt the intervention for different settings. Further work is also necessary to assess the long-term effect and sustainability of such interventions.

The Situation of Safe Surgery and Anaesthesia in Tanzania: A Systematic Review.

BACKGROUND: Improvement in the surgical system requires intersectoral coordination. To achieve this, the development of National Surgical, Obstetric, and Anaesthesia Plans (NSOAPS) has been recommended. One of the first steps of NSOAP development is situational analysis. On the ground situational analyses can be resource intensive and often duplicative. In 2016, the Ministry of Health of Tanzania issued a directive for the creation of an NSOAP. This systematic review aimed to assess if a comprehensive situational analysis could be achieved with existing data. These data would be used for evidence-based priority setting for NSOAP development and streamline any additional data collection needed. METHODS: A systematic literature review of scientific literature, grey literature, and policy documents was performed as per PRISMA. Extraction was performed for all articles relating to the five NSOAPS domains: infrastructure, service delivery, workforce, information management, and financing. RESULTS: 1819 unique articles were generated. Full-text screening produced 135 eligible articles; 46 were relevant to surgical infrastructure, 53 to workforce, 81 to service delivery, 11 to finance, and 15 to information management. Rich qualitative and quantitative data were available for each domain. CONCLUSIONS: Despite little systematic data collection around SOA, a thorough literature review provides significant evidence which often have a broader scope, longer timeline and better coverage than can be achieved through snapshot-stratified samples of directed on the ground assessments. Evidence from the review was used during stakeholder discussion to directly inform the NSOAP priorities in Tanzania.

Safe Surgery for All: Early Lessons from Implementing a National Government-Driven Surgical Plan in Ethiopia.

Recognizing the unmet need for surgical care in Ethiopia, the Federal Ministry of Health (FMOH) has pioneered innovative methodologies for surgical system development with Saving Lives through Safe Surgery (SaLTS). SaLTS is a national flagship initiative designed to improve access to safe, essential and emergency surgical and anaesthesia care across all levels of the healthcare system. Sustained commitment from the FMOH and their recruitment of implementing partners has led to notable accomplishments across the breadth of the surgical system, including but not limited to: (1) Leadership, management and governance-a nationally scaled surgical leadership and mentorship programme, (2) Infrastructure-operating room construction and oxygen delivery plan, (3) Supplies and logistics-a national essential surgical procedure and equipment list, (4) Human resource development-a Surgical Workforce Expansion Plan and Anaesthesia National Roadmap, (5) Advocacy and partnership-strong FMOH partnership with international organizations, including GE Foundation's SafeSurgery2020 initiative, (6) Innovation-facility-driven identification of problems and solutions, (7) Quality of surgical and anaesthesia care service delivery-a national peri-operative guideline and WHO Surgical Safety Checklist implementation, and (8) Monitoring and evaluation-a comprehensive plan for short-term and long-term assessment of surgical quality and capacity. As Ethiopia progresses with its commitment to prioritize surgery within its Health Sector Transformation Plan, disseminating the process and outcomes of the SaLTS initiative will inform other countries on successful national implementation strategies. The following article describes the process by which the Ethiopian FMOH established surgical system reform and the preliminary results of implementation across these eight pillars.

A Comprehensive Approach to Medical Oxygen Ecosystem Building: An Implementation Case Study in Kenya, Rwanda, and Ethiopia.

Medical oxygen is an essential treatment for life-threatening hypoxemic conditions and is commonly indicated for the clinical management of most leading causes of mortality in children aged younger than 5 years, obstetric complications at delivery, and surgical procedures. In resource-constrained settings, access to medical oxygen is unreliable due to cost, distance from production centers, undermaintained infrastructure, and a fragmented supply chain. To increase availability of medical oxygen in underserved communities, Assist International, the GE Foundation, Grand Challenges Canada, the Center for Public Health and Development (Kenya), Health Builders (Rwanda), and the National Ministries of Health and Regional Health Bureaus in Kenya, Rwanda, and Ethiopia partnered to implement a social enterprise model for the production and distribution of medical oxygen to hospitals at reduced cost. This model established pressure swing adsorption (PSA) plants at large referral hospitals and equipped them to serve as localized supply hubs to meet regional demand for medical oxygen while using revenues from cylinder distribution to subsidize ongoing costs. Since 2014, 4 PSA plants have successfully been established and sustained using a social enterprise model in Siaya, Kenya; Ruhengeri, Rwanda; and Amhara Region, Ethiopia. These plants have cumulatively delivered more than 209,708 cylinders of oxygen to a network of 183 health care facilities as of October 2022. In Ethiopia, this model costs an estimated US$7.34 per patient receiving medical oxygen over a 20-year time horizon. Altogether, this business model has enabled the sustainable provision of medical oxygen to communities with populations totaling more than 33 million people, including an estimated 5 million children aged younger than 5 years.

Applying the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to Safe Surgery 2020 Implementation in Tanzania's Lake Zone.

BACKGROUND: Access to safe, high-quality surgical care in sub-Saharan Africa is a critical gap. Interventions to improve surgical quality have been developed, but research on their implementation is still at a nascent stage. We retrospectively applied the Exploration, Preparation, Implementation, Sustainment framework to characterize the implementation of Safe Surgery 2020, a multicomponent intervention to improve surgical quality. METHODS: We used a longitudinal, qualitative research design to examine Safe Surgery 2020 in 10 health facilities in Tanzania's Lake Zone. We used documentation analysis with confirmatory key informant interviews (n = 6) to describe the exploration and preparation phases. We conducted interviews with health facility leaders and surgical team members at 1, 6, and 12 months (n = 101) post initiation to characterize the implementation phase. Data were analyzed using the constant comparison method. RESULTS: In the exploration phase, research, expert consultation, and scoping activities revealed the need for a multicomponent intervention to improve surgical quality. In the preparation phase, onsite visits identified priorities and barriers to implementation to adapt the intervention components and curriculum. In the active implementation phase, 4 themes related to the inner organizational context-vision for safe surgery, existing surgical practices, leadership support, and resilience-and 3 themes related to the intervention-innovation-value fit, holistic approach, and buy-in-facilitated or hindered implementation. Interviewees perceived improvements in teamwork and communication and intra- and inter-facility learning, and their need to deliver safe surgery evolved during the implementation period. CONCLUSIONS: Examining implementation through the exploration, preparation, implementation, and sustainment phases offers insights into the implementation of interventions to improve surgical quality and promote sustainability.

Development and content validation of the Safe Surgery Organizational Readiness Tool: A quality improvement study.

BACKGROUND: Recent efforts to increase access to safe and high-quality surgical care in low- and middle-income countries have proven successful. However, multiple facilities implementing the same safety and quality improvement interventions may not all achieve successful outcomes. This heterogeneity could be explained, in part, by pre-intervention organizational characteristics and lack of readiness of surgical facilities. In this study, we describe the process of developing and content validating the Safe Surgery Organizational Readiness Tool. MATERIALS AND METHODS: The new tool was developed in two stages. First, qualitative results from a Safe Surgery 2020 intervention were combined with findings from a literature review of organizational readiness and change. Second, through iterative discussions and expert review, the Safe Surgery Organizational Readiness Tool was content validated. RESULTS: The Safe Surgery Organizational Readiness Tool includes 14 domains and 56 items measuring the readiness of surgical facilities in low- and middle-income countries to implement surgical safety and quality improvement interventions. This multi-dimensional and multi-level tool offers insights into facility members' beliefs and attitudes at the individual, team, and facility levels. A panel review affirmed the content validity of the Safe Surgery Organizational Readiness Tool. CONCLUSION: The Safe Surgery Organizational Readiness Tool is a theory- and evidence-based tool that can be used by change agents and facility leaders in low- and middle-income countries to assess the baseline readiness of surgical facilities to implement surgical safety and quality improvement interventions. Next steps include assessing the reliability and validity of the Safe Surgery Organizational Readiness Tool, likely resulting in refinements.

Reducing surgical site infections and mortality among obstetric surgical patients in Tanzania: a pre-evaluation and postevaluation of a multicomponent safe surgery intervention.

INTRODUCTION: Despite ongoing maternal health interventions, maternal deaths in Tanzania remain high. One of the main causes of maternal mortality includes postoperative infections. Surgical site infection (SSI) rates are higher in low/middle-income countries (LMICs), such as Tanzania, compared with high-income countries. We evaluated the impact of a multicomponent safe surgery intervention in Tanzania, hypothesising it would (1) increase adherence to safety practices, such as the WHO Surgical Safety Checklist (SSC), (2) reduce SSI rates following caesarean section (CS) and (3) reduce CS-related perioperative mortality rates (POMRs). METHODS: We conducted a pre-cross-sectional/post-cross-sectional study design to evaluate WHO SSC utilisation, SSI rates and CS-related POMR before and 18 months after implementation. Our interventions included training of inter-professional surgical teams, promoting use of the WHO SSC and introducing an infection prevention (IP) bundle for all CS patients. We assessed use of WHO SSC and SSI rates through random sampling of 279 individual CS patient files. We reviewed registers and ward round reports to obtain the number of CS performed and CS-related deaths. We compared proportions of individuals with a characteristic of interest during pre-implementation and post implementation using the two-proportion z-test at p≤0.05 using STATA V.15. RESULTS: The SSC utilisation rate for CS increased from 3.7% (5 out of 136) to 95.1% (136 out of 143) with p<0.001. Likewise, the proportion of women with SSI after CS reduced from 14% during baseline to 1% (p=0.002). The change in SSI rate after the implementation of the safe surgery interventions is statistically significant (p<0.001). The CS-related POMR decreased by 38.5% (p=0.6) after the implementation of safe surgery interventions. CONCLUSION: Our findings show that our intervention led to improved utilisation of the WHO SSC, reduced SSIs and a drop in CS-related POMR. We recommend replication of the interventions in other LMICs.

Improving surgical quality in low-income and middle-income countries: why do some health facilities perform better than others?

BACKGROUND: Evidence on heterogeneity in outcomes of surgical quality interventions in low-income and middle-income countries is limited. We explored factors driving performance in the Safe Surgery 2020 intervention in Tanzania's Lake Zone to distil implementation lessons for low-resource settings. METHODS: We identified higher (n=3) and lower (n=3) performers from quantitative data on improvement from 14 safety and teamwork and communication indicators at 0 and 12 months from 10 intervention facilities, using a positive deviance framework. From 72 key informant interviews with surgical providers across facilities at 1, 6 and 12 months, we used a grounded theory approach to identify practices of higher and lower performers. RESULTS: Performance experiences of higher and lower performers differed on the following themes: (1) preintervention context, (2) engagement with Safe Surgery 2020 interventions, (3) teamwork and communication orientation, (4) collective learning orientation, (5) role of leadership, and (6) perceived impact of Safe Surgery 2020 and beyond. Higher performers had a culture of teamwork which helped them capitalise on Safe Surgery 2020 to improve surgical ecosystems holistically on safety practices, teamwork and communication. Lower performers prioritised overhauling safety practices and began considering organisational cultural changes much later. Thus, while also improving, lower performers prioritised different goals and trailed higher performers on the change continuum. CONCLUSION: Future interventions should be tailored to facility context and invest in strengthening teamwork, communication and collective learning and facilitate leadership engagement to build a receptive climate for successful implementation of safe surgery interventions.

Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzania's Lake Zone: protocol for a quasi-experimental study.

INTRODUCTION: Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term. METHODS AND ANALYSIS: Our design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania's Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance. ETHICS AND DISSEMINATION: The study has received ethical approval from Harvard Medical School and Tanzania's National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania's Lake Zone region and other similar contexts.

Towards equitable surgical systems: development and outcomes of a national surgical, obstetric and anaesthesia plan in Tanzania.

Despite emergency and essential surgery and anaesthesia care being recognised as a part of Universal Health Coverage, 5 billion people worldwide lack access to safe, timely and affordable surgery and anaesthesia care. In Tanzania, 19% of all deaths and 17 % of disability-adjusted life years are attributable to conditions amenable to surgery. It is recommended that countries develop and implement National Surgical, Obstetric and Anesthesia Plans (NSOAPs) to systematically improve quality and access to surgical, obstetric and anaesthesia (SOA) care across six domains of the health system including (1) service delivery, (2) infrastructure, including equipment and supplies, (3) workforce, (4) information management, (5) finance and (6) Governance. This paper describes the NSOAP development, recommendations and lessons learnt from undertaking NSOAP development in Tanzania. The NSOAP development driven by the Ministry of Health Community Development Gender Elderly and Children involved broad consultation with over 200 stakeholders from across government, professional associations, clinicians, ancillary staff, civil society and patient organisations. The NSOAP describes time-bound, costed strategic objectives, outputs, activities and targets to improve each domain of the SOA system. The final NSOAP is ambitious but attainable, reflects on-the-ground priorities, aligns with existing health policy and costs an additional 3% of current healthcare expenditure. Tanzania is the third country to complete such a plan and the first to report on the NSOAP development in such detail. The NSOAP development in Tanzania provides a roadmap for other countries wishing to undertake a similar NSOAP development to strengthen their SOA system.