Development of a patient safety culture scale for maternal and child health institutions in China: a cross-sectional validation study

OBJECTIVE: This study aimed to develop a patient safety culture (PSC) scale for maternal and child healthcare (MCH) institutions in China. METHODS: A theoretical framework of PSC for MCH institutions was proposed through in-depth interviews with MCH workers and patients and Delphi expert consultations. The reliability and validity of the PSC scale were tested in a cross-sectional survey of 1256 MCH workers from 14 MCH institutions in Zhejiang province of China. The study sample was randomly split into half for exploratory and confirmatory factor analyses, respectively. Test–retest reliability was assessed through a repeated survey of 63 voluntary participants 2 weeks apart. RESULTS: The exploratory factor analysis extracted 10 components: patient engagement in patient safety (six items), managerial response to patient safety risks (four items), perceived management support (five items), staff empowerment (four items), staffing and workloads (four items), reporting of adverse events (three items), defensive medical practice (three items), work commitment (three items), training (two items) and transfer and handoff (three items). A good model fit was found in the confirmatory factor analysis: χ(2)/df=1.822, standardised root mean residual=0.048, root mean square error of approximation=0.038, comparative fit index=0.921, Tucker-Lewis index=0.907. The PSC scale had a Cronbach’s α coefficient of 0.89 (0.59–0.90 for dimensional scales) and a test–retest reliability of 0.81 (0.63–0.87 for dimensional reliability), respectively. The intracluster correlation coefficients confirmed a hierarchical nature of the data: individual health workers nested within MCH institutions. CONCLUSION: The PSC scale for MCH institutions has acceptable reliability and validity. Further studies are needed to establish benchmarking in a national representative sample through a multilevel modelling approach.