Factors associated with the presence of nonconformities in the certification of hospital clinical management units in Andalusian.

Abstract

Background: Healthcare quality certification models are fundamental for ensuring patient safety and continuous improvement. The appearance of nonconformities (NC) during external audits reflects implementation difficulties. This study analyzes factors associated with the presence of NC in the certification of hospital clinical management units (CMU) in Andalusia over two decades.

Methods: Retrospective observational study of 811 hospital CMU certification projects from the Andalusian Health Service registered between April 2003 and June 2023. Data were obtained from the Andalusian Agency for Healthcare Quality ME_jora C platform. Variables included certification level, project type, standard compliance percentages, temporal metrics, and territorial distribution. Descriptive statistics, bivariate analyses (Chi-square, Mann-Whitney U), and multivariate logistic regression were performed to identify factors associated with the presence of NC.

Results: A total of 811 projects were certified, with 27.7% (225/811) achieving certification without any NC. The majority (86.4%) reached advanced level, 12.5% optimal level, and only 1.1% excellent level. Seville (25.1%) and Málaga (18.7%) concentrated the highest number of projects. Multivariate analysis identified five independent factors: each additional year between registration and certification increased the odds of NC (OR = 3.3; 95% CI: 2.4-4.9; P < .001); each additional year devoted to self-assessment reduced the odds of NC by ∼70% (OR = 0.3; 95% CI: 0.2-0.4; P < .001); higher final self-assessment percentage reduced risk (OR = 0.92; 95% CI: 0.87-0.97; P = .006); more recent certification years were associated with higher odds of NC (OR = 1.25; 95% CI: 1.10-1.43; P < .001); and higher number of self-assessors was associated with a slightly increased likelihood of NC. (OR = 1.06; 95% CI: 1.00-1.13; P = .049).

Conclusion: Longer self-assessment periods were associated with lower odds of NC, whereas longer overall certification processes were associated with higher odds of NC. These findings provide quantitative evidence to optimize certification planning and support healthcare units in achieving successful certification outcomes.