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This study aims to examine the reliability and validity of Home-visit Nursing Quality Indicators for Children (HNQIC) with medical complexity in Japan that will enable measuring the quality of services provided by home-visit nursing agencies (HNA) for children with medical complexity (CMC) and their families. This study employed a model that measures medical quality as proposed by Donabedian in a conceptual framework. The HNQIC is comprised of a total of 42 items with responses in 5-point Likert scale: 8 items in "Structure", 24 items in "Process", and 10 items in "Outcome". A self-rating questionnaire survey was administered and responses from 57 home-visit nursing agencies were analyzed. An exploratory factor analysis was performed to examine the validity of the construct, and a covariance structure analysis was performed to examine the structural validity of the model that measures medical quality. The "Structure" and "Process" sections included 28 items in 5 factors, and the "Outcome" section included 7 items in 3 factors. The Cronbach's α coefficient for all of the items of "Structure" and "Process" was 0.93, and that of "Outcome" was 0.76. As a result of a covariance structure analysis, we obtained following goodness-of-fit indices: χ2 / df = 1.41, GFI =.897, AGFI =.794, CFI =.926, and for the coefficient of determination.14 ≤ R2 ≤.68. As the statistical validity of the HNQIC was confirmed, we determined the goodness-of-fit indices of the model to be acceptable. The findings suggested that the HNQIC can be used as a quality indicator to access care effects objectively to provide better support. • Home-visit nursing plays important roles to support increasing number of CMC. • Home-visit nursing quality indicator guidelines exclusive to CMC are needed. • Developed Home-visit Nursing Quality Indicators for Children with medical complexity. [ABSTRACT FROM AUTHOR]