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

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.

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.

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.

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.

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.