Factors Associated with the Presence of Non-Conformities in the Certification of Hospital Clinical Management Units in Andalusia.

BACKGROUND: Healthcare quality certification models are fundamental for ensuring patient safety and continuous improvement. The appearance of Non-Conformities (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 (ACSA) 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 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 Non-Conformities (OR = 3.3; 95%CI:2.4-4.9; p < 0.001); each additional year devoted to self-assessment reduced the odds of Non-Conformities by approximately 70% (OR = 0.3; 95%CI:0.2-0.4; p < 0.001); higher final self-assessment percentage reduced risk (OR = 0.92; 95%CI:0.87-0.97; p = 0.006); more recent certification years were associated with higher odds of NC (OR = 1.25; 95%CI:1.10-1.43; p < 0.001); and higher number of self-assessors was associated with a slightly increased likelihood of Non-Conformities. (OR = 1.06; 95%CI:1.00-1.13; p = 0.049). CONCLUSION: Longer self-assessment periods were associated with lower odds of Non-Conformities whereas longer overall certification processes were associated with higher odds of Non-Conformities. These findings provide quantitative evidence to optimize certification planning and support healthcare units in achieving successful certification outcomes.