Obstetric Care Made High Reliabile: Perception of Staff on Factors Associated with Practice of High Reliability Organization Principles in a Selected Tertiary Care Maternity Hospital

Introduction: Patient safety and high reliability related to obstetric care has become a global concern especially during this COVID-19 pandemic period.Aim of this study is to assess the components of Socio Technical system as the factors affecting while adopting High-Reliability Organization (HRO) Principles as perceived by staff. Methodology: This is a hospital based descriptive cross-sectional study conducted using a self-administered questionnaire.Results: Out of the five factors affecting HRO practices as perceived by staff, "Organizational Safety Culture" (Mean- 4.25., SD-0.454 Significant at <0.01 level), Communication (SD-4.15, SD-0.579), and Teamwork (Mean:3.95, SD:0.499). are having a statistically significant (p <0.05 corresponding to Spearman’s correlation Coefficient positive association with the practice of HRO principles. According to Multiple linear regression model explains 29% of the variability of the HRO practices (dependent variable) can be explained by the factors affecting HRO practices (independent variables) if all the factors operate together. Gender, age, educational level, designation and working experience act as moderating variables to Organizational Safety Culture. There is a significant (p <0.05) difference of HRO practices among female gender, nursing category of staff which is better than other categories.Conclusion: Organizational safety culture, communication and Teamwork and work environment show significant effect on determining HRO practices which is important for policy makers and administrators to pay attention on above three factors to improve reliability. But these five factors (including leadership and working environment) explains only one third of variability of HRO practices), hence need to study other factors affecting reliability of performance.


Background
Globally there is a growing concern regarding Patient safety, due to the potential catastrophic nature of medical errors. Up to four out of every ten patients are harmed in health care in primary and ambulatory care settings according to a report by World Health Organization (2018) indicating the gravity of errors.
Due to the disastrous nature of errors, healthcare institutions has started applying High-Reliability Organizations Principles (HROs) (Spath, 2011). Sri Lanka has demonstrated the commitment HRO in Healthcare by implementing the Continuous Quality Improvement programme, which is centrally coordinated by the Directorate of Healthcare Quality and Safety (DHQS) (Ministry of Health Sri Lanka, 2016).
The National Strategic Plan on Maternal and Newborn Heath 2017-2025 emphasizes the importance of improving the quality and safety of maternal care (Ministry of Health Sri Lanka, 2016). The policy on Healthcare Quality and Safety (Ministry of Health, 2015), circular on reporting of adverse event quality review programmes and monitoring visits conducted by DHQS are some instruments for operationalizing safety strategies. Studies have been conducted on "factors associated with patient safety practices (Sridharan, 2017) and quality improvementz (Somatunga, Sridharan, Refai, Malavige, & Gamini, 2015). But assessment of the progress of the healthcare institutions on adopting HRO principles, is a necessity as it is mentioned under process auditing element of HRO practices (Roberts, Madsen, Desai, & Van Stralen, 2005).
Obstetric units are more prone to adverse events. Catastrophic consequences are death of a person in economically productive age, disability and prolong stay, leading to increased cost of care. Hospital staff is at risk of litigation and bad reputation to the healthcare institution.
Although precise data is lacking regarding the cost implications of medical errors in Sri Lanka, according to the Centers for Disease Control, there are 2 million acquired infections in hospitals in the United States every year and between 44,000 and 98,000 preventable medical deaths occur in healthcare facilities in the United States each year (IOM, 2000). In the Lower Middle Income Countries (LMICs) 134 million medical errors annually hospitals), associated with to 2.6 million deaths because of unsafe health care (World Health Organization, 2018 billion USD annually) (World Health Organization, 2018). Hence, it is important to understand causality of adverse events to remedy the errors in healthcare (Sridharan, 2012).
Initially many initiatives were made to understand patient safety (Spath, 2011).The studies of James Reason have a major contribution on systemic accident model (Spath, 2011). It was found there are organizations in which errors have the potential of catastrophic consequences but which seem to avoid such errors (Spath, 2011), which were known as High Reliability organizations. These HRO principles are, "Preoccupation with failure, Reluctance to simplify interpretations, Sensitivity to operations, Commitment to resilience, Deference to expertise" (Spath, 2011). Elements of HROs are, process auditing, appropriate reward, avoiding degradation of quality, risk perception and command and Control (Roberts, Madsen, Desai, & Van Stralen, 2005).
This study aims to understand staff perception on factors associated with the practice of High Reliability Principles in Obstetric Wards in a selected Tertiary Care Maternity Hospital.
Therefore, the implementation of HRO principles is essential to reduce the number of adverse events and consequently to obtain better outcome from clinical care.

Methodology
This is a hospital based descriptive cross-sectional study which was conducted in Obstetric wards in De Soysa Hospital for Women. Calculation of the sample size was done according to the formula for cross sectional survey standard formula by Lwanga and Lemeshow (1991) and sample size was 384. With the assumption of 10% non-response rate the sample size was 422 in this study.
Stratified random sampling technique was used to select the participants from the population.
Population proportionate sampling was done to select required number participants within each stratum.
The strata consisted of five staff categories: assumed to influence the Practice of High-Reliability Organization (HRO) namely Organizational Safety culture, Leadership, Communication, Teamwork, and Work Environment under section "B" of the questionnaire. Part "C" was used to capture the demographic features of the respondents as well.

Conceptualization
Patient Safety is determined by many factors in a hospital. The organizing framework that was selected for assessing HRO principles were based on Moray's model of the organizational, human and technical components of socio-technical systems (Lwanga & Lemeshow, 1991).
Factors affecting patient safety programme in Government Hospital in Sri Lanka have been Studied based on this model and it was revealed "Organizational Safety Culture, Leadership, Communication, Teamwork, and Work Environment" as main factors associated with patient Safety programme (Sridharan, 2007).
Therefore, other two elements of this model (legal and regulatory rules, and societal and cultural pressures) were not included.

Results
With a 90% response rate the final sample size ended up with 384 responses. The analysis was carried out with two sections; descriptive data analysis was focused on understanding the demographic features of the respondents while inference data analysis was focus on the constructing compositive variables and testing associations and formulating multiple linear regression. The content validity assessed whether all the components of the concept being measured by the tool. A validated questionnaire was used in this study; hence it is assumed that the tool satisfies the minimum requirement of the content validity.

Multiple Linear Regression Analysis
The multiple linear regression was performed selecting Principles of HRO practices as the dependent variable and Organizational Safety culture, Leadership, Communication, Teamwork, and Work Environment as the independent variables.    leadership and work environment is not a significant influence on Principles of HRO practices as the probability values are not less than 0.05. Out of significant factors, Organization Safety Culture was the most influential factor while teamwork and communication were followed second and third.

Testing the Hypothesis for Moderator Effect
Testing moderation tests were carried out using PROCESS Macros for SPSS, which was developed by Andrew F. Hayes which does the centering and interaction terms automatically. The macro allows us to select 74 different types of moderator models. Model 1 was selected for this study, which is the simplest model in line with the conceptual model of this study.  Table 11 shows the impact of gender as a moderator variable into factors. It was found that gender influence as a moderator variable only to organization Safety Culture as the corresponding probability of T-statistic (2.660) is less than 0.05. Gender is not a moderator variable for any other factor as the probability value is not less than 0.05 (at 90% significant level Gender is a moderator variable for Work Environment as the corresponding probability is 0.06, which is less than 0.10). Further, it was found that the moderating effect of females is significant while the male moderating impact is insignificant.
The gender moderate effect improves the overall R 2 of the model by 2.35%. Communication 0.008 1.076 0.28 n/a n/a n/a 0.03% Teamwork 0.007 0.623 0.53 n/a n/a n/a 0.01% Work Environment -0.002 -0.226 0.81 n/a n/a n/a 0.00% The Table 12 indicates the impact of age as a moderator variable into factors. It was found that age influence as a moderator variable only to organization Safety Culture and Leadership as the corresponding probability of T-statistic (-2.387, -1.996) is less than 0.05. Interestingly the moderator effect is negative as the corresponding coefficient of the interaction is negative (-0.023, -0.017). Further the analysis suggest the moderate impact is higher and significant in younger age than the older age.

Discussion
The study was designed to determine the organizational factors affecting with the practice of High Reliability Principles as perceived by staff.
A total of 422 were invited to participate in the study, 385 participated giving a response rate of 91%.
Out of 385 who participated in the survey that. Majority of the participants (52.3%) were between the age of 31-40 years, indicating relatively young healthcare staff composition which is cost effective to involve in interventions yielding beneficial outcome of interventions (i.e., training). Assuming all will remain up to the retirement age is (60 years) will remain in service for another 20 years indicating long term yield of investment of interventions on human resources. The fact female dominant workforce (n=342 89.1% of total population) shows importance of more female staff in interventions.
Practice of HRO principles higher among females can be due to higher female proportion among nursing officers. This is a positive finding in female dominant workforce. It was found the mean value Regarding current designation, the majority (49.5%) were Nursing Officers, 24.2% of them were Supportive staff. This finding shows the importance of getting the involvement of Nursing Officers and supportive staff in training and patient safety interventions. It was also found the mean value of Principles of HRO Practices is higher among nursing officers compare with all the other designations which is favourable the given population and needs to be further studied.
Following components of socio-technical system/ were studied ("organizational patient safety culture, work environment, leadership, team structure, and Communication") as independent variables to determine the factor affecting HRO practices.
Therefore, a multiple linear regression was carried out. That indicates 29% of the variance in the Principles of HRO practices can be explained by the five factors together as a linear combination. In the previous study, the linear regression model explains 23% of the variability of the HRO practices (Malavige, 2018). In a descriptive cross-sectional study carried out using the same methodology showed 40% effect of same factors on patient safety programme (Sridharan, 2017). All three studies show the need of further studies to find the difference.
Organizational safety culture, Communication and Teamwork shows a significant effect of variability of HRO practices. Out of significant factors, Organization Safety Culture was the most influential factor while teamwork and communication were followed second and third. Further it was revealed gender (female) age, educational level, designation and working experience as a moderating variable to organizational safety culture, which needs to be considered in future studies designing phase (restriction of the study population, matching and randomization) or in analysis face(stratification and multivariate analysis).
Limitations of this study are, generalizability of the findings is a limitation as this study was carried out in a tertiary care Line Ministry specialized (maternity) Hospital. Provincial General Hospitals, District Hospitals, and Base Hospitals were not included in this study.
Due to the prevailing patient safety culture as being indicated as reactive in a previous study, reluctance of the staff to answer the questionnaire (Sridharan, 2017).
Lack of awareness among staff regarding patient safety concepts and HRO principles and the implications. Lack of interest in participating for training and updating on patient safety due to heavy workload and work-related stress can affect the awareness and knowledge of practice of HRO principles.
Other two elements of Moray's model of Socio technical system (legal and regulatory rules, and societal and cultural pressures) which can affect the variability HRO principles, were not assessed.

Conclusions and Recommendations
The components of Socio-Technical system namely "Organizational safety culture, Communication" and "Team Work" show significant effect on determining HRO practices together with the other two factors conceptualized to associated with patient safety (i.e., leadership and Work Environment), 29% of the variability of the HRO practices (dependent variable) can be explained by Organizational Safety Culture, communication and teamwork emphasizing the importance of improving these to enhance the reliability of Healthcare Institutions. Further research is needed to find other factors affecting HRO practices to improve the reliability of Obstetric care.