What are the steps to establish a human milk bank to serve very low birth weight infants (<1500 g), preterm infants (<34 weeks gestation), and other medically fragile newborns?

Establishing a Human Milk Bank for High-Risk Infants

To establish a human milk bank serving very low birth weight infants (<1500 g), preterm infants (<34 weeks gestation), and medically fragile newborns, you must implement standardized donor screening protocols, pasteurization procedures, and quality control measures while integrating the milk bank within a Level III or IV NICU facility that provides subspecialty neonatal intensive care. 1, 2, 3

Target Population and Clinical Justification

Very low birth weight infants (<1500 g) and those born <32 weeks gestation should receive human milk as it significantly reduces necrotizing enterocolitis, late-onset sepsis, and improves neurodevelopmental outcomes. 4, 5, 6 When mother's own milk is unavailable, donor human milk is the next best choice and should be prioritized over formula for this vulnerable population. 4, 2

Facility Requirements and Integration

Level of Care Designation

• The milk bank must be integrated within or closely affiliated with a Level III or IV NICU facility that has continuously available neonatologists, neonatal nurses, respiratory therapists, and equipment to provide sustained life support. 4
• Level III facilities are specifically designed to care for infants <32 weeks gestation and <1500 g birth weight with comprehensive subspecialty services, advanced respiratory support, and nutrition/pharmacy support with pediatric expertise. 4
• Level IV regional NICUs add surgical capabilities for complex congenital conditions and facilitate transport/outreach education, making them ideal hubs for regional milk banking operations. 4

Physical Infrastructure

• Establish dedicated space for milk collection, processing, storage, and distribution with appropriate temperature control and monitoring systems. 1, 3
• Install commercial-grade pasteurization equipment capable of standardized heat treatment (typically Holder pasteurization at 62.5°C for 30 minutes). 1, 2
• Provide separate areas for donor screening, milk handling, and bacteriological testing to prevent contamination. 1, 3

Donor Screening and Selection

Mandatory Serological Testing

All donor women must be screened for HIV-1, HIV-2, human T-cell leukemia virus 1 and 2, hepatitis B, hepatitis C, and syphilis before milk donation is accepted. 2, 3 This represents universal consensus across international guidelines and is non-negotiable for safety.

Donor Eligibility Criteria

• Select lactating mothers who are nursing their own infants and have milk supply exceeding their infant's needs. 2, 6
• Conduct comprehensive health history screening including medication use, substance use, and infectious disease risk factors. 1, 3
• Prioritize donors who delivered prematurely when possible, as preterm donor milk more closely matches the nutritional requirements of preterm recipients (personalized nutrition approach). 6

Milk Collection, Processing, and Storage

Collection and Transport

• Provide donors with sterile collection containers and detailed instructions for hygienic milk expression. 1, 3
• Establish safe transport protocols maintaining cold chain integrity from donor home to milk bank. 1, 3
• Implement standardized record-keeping systems tracking each donation from donor to recipient. 1, 3

Pasteurization Protocol

• Use standardized Holder pasteurization (62.5°C for 30 minutes) as the accepted method for pathogen inactivation. 1, 2 While this process diminishes some anti-infective properties, cellular components, growth factors, and nutrients, the beneficial effects remain significant and donor milk remains highly preferable to formula. 2
• Pool milk from multiple donors after pasteurization to standardize composition, or consider personalized matching by gestational age and lactation stage for optimal nutritional targeting. 6

Bacteriological Testing

• Perform pre-pasteurization bacterial screening to identify contaminated donations. 1, 3
• Conduct post-pasteurization bacterial testing to verify pasteurization effectiveness and ensure safety. 1, 3
• Establish clear rejection criteria for milk that fails bacteriological standards. 1, 3

Operational Requirements

Staffing and Training

• Hire dedicated milk bank coordinator with specialized training in lactation, microbiology, and quality control. 1, 3
• Train all staff in proper handling techniques, equipment operation, and infection control procedures. 1, 3
• Ensure continuous availability of personnel for milk processing and distribution aligned with NICU feeding schedules. 3

Equipment Maintenance

• Establish preventive maintenance schedules for pasteurization equipment, freezers, and refrigeration units. 1
• Implement backup power systems to prevent milk loss during power failures. 3
• Calibrate temperature monitoring devices regularly and maintain continuous temperature logs. 1

Quality Control and Accreditation

• Develop comprehensive standard operating procedures for all milk bank operations. 1, 3
• Seek accreditation through recognized organizations (Human Milk Banking Association of North America in North America, European Milk Bank Association in Europe). 1, 3
• Implement regular internal audits and participate in external inspections. 1, 3

Distribution and Clinical Integration

Prioritization Algorithm

• First priority: Very low birth weight infants (<1500 g) and infants <32 weeks gestation when mother's own milk is insufficient or unavailable. 4, 5, 6
• Second priority: Other medically fragile newborns with specific indications (surgical conditions, feeding intolerance, necrotizing enterocolitis risk). 2, 3
• Maintain clear documentation of medical indications for donor milk use. 3

Feeding Implementation

• Provide donor milk at normal concentrations (not diluted) to ensure adequate nutrition. 7
• Target feeding volumes of 500-600 mL/day by days 4-5 for term infants, with adjustments for preterm infants based on weight and tolerance. 5, 7
• Integrate donor milk feeding with comprehensive NICU nutritional support including fortification when needed for preterm infants. 6

Critical Pitfalls to Avoid

• Do not establish a milk bank without adequate pasteurization equipment and bacteriological testing capabilities—this creates unacceptable safety risks. 1, 2
• Avoid overly burdensome guidelines in resource-limited settings that make milk banking prohibitively expensive; acceptable modifications must balance safety with feasibility. 1, 3
• Do not use donor milk as a substitute for optimizing mother's own milk production—always prioritize supporting direct breastfeeding and maternal milk expression first. 5, 7
• Ensure donor milk is not used indiscriminately for healthy term infants when mother's milk is available, as this depletes supply for high-risk infants who benefit most. 4, 2

Resource Considerations for Different Settings

High-resource settings should implement comprehensive screening, advanced pasteurization technology, and extensive quality control with formal accreditation. 1, 3

Low- and middle-resource settings must maintain core safety measures (donor screening, pasteurization, bacterial testing) while adapting operational procedures to available resources, potentially using simplified equipment and modified protocols that still ensure safety. 3 The World Health Organization recommends donor human milk for vulnerable infants globally, and scale-up requires policy support and integration with newborn care systems. 3