Ten-Year Evaluation of Quality Control Indicators in a Brazilian Human Milk Bank

Abstract

Background: Human milk banks play a critical role in neonatal care by providing donor human milk when maternal milk is unavailable, particularly for preterm and medically vulnerable infants. Despite global expansion, long-term evaluations of discard rates and quality indicators remain limited. Research Aim: To assess discard rates due to nonconformities, temporal trends in quality indicators, and nutritional characteristics of donor human milk processed in a tertiary-care milk bank over a 10-year period. Methods: This retrospective longitudinal study analyzed routinely collected data from a Brazilian tertiary-care human milk bank between January 2014 and December 2023. Outcomes included collected and pasteurized milk volumes, and discard reasons: labeling, storage, packaging, physical contaminants, acidity ≥ 8°D, and microbiological positivity (BGBL+). Nutritional quality was evaluated using crematocrit-derived caloric classification. Temporal trends were examined using linear regression. Results: Over the study period, 11,758.2 L of milk were collected and 7,851 L pasteurized. A total of 387.2 L (3.3%) was discarded due to nonconformities. Storage-related issues accounted for most losses (56.2%), followed by microbiological positivity (21.9%). Overall, discard rates remained low and stable ( p = .924). Labeling errors declined ( p = .044), while physical contaminants ( p < .001) and microbiological positivity increased ( p = .032). Dornic acidity exceeded thresholds in only 0.04% of samples. Among 47,919 pasteurized bottles, caloric composition remained stable: 54.7% normocaloric, 39.7% hypercaloric, 5.6% hypocaloric. Conclusions: Standardized quality-control procedures were associated with consistently low discard rates and stable nutritional quality. Improving cold-chain logistics and microbiological monitoring may further reduce losses and enhance donor milk availability.