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Extensive donor screening
A multi-step process: detailed health history, blood testing, and medical and lifestyle risk assessment, modeled after food safety and blood donation standards.
safety standards
The health of medically fragile infants is our highest priority.
Every step of our process, from donor screening to distribution, is designed for the highest standards of safety, quality and transparency. Here is how that commitment shows up at each stage.
critical layers of protection
Four safeguards, on every ounce.
No single check keeps milk safe. These layers work together, from the first health history to the barcode on the bottle.
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Milk pasteurization
All milk is pasteurized using the Holder method, which destroys potential harmful pathogens while preserving key nutrients and immune properties.
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Microbiological testing
Each batch of Pasteurized Donor Human Milk is tested by a third-party accredited lab after pasteurization. Only milk that passes is dispensed.
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Traceability and documentation
Each bottle carries a unique barcode and is tracked throughout its journey, from donor to recipient, ensuring full traceability and accountability.
SAFETY REGULATION
A documented food safety plan, reviewed and refined.
The Milk Bank is registered with the U.S. Food and Drug Administration and operates with a documented Food Safety Plan. HMBANA standards require preventive controls, monitoring, corrective actions, verification, supply-chain management, recall planning and records that support the food-safety system.
Certified Preventive Controls Qualified Individuals conduct verification and validation procedures to assess biological, chemical and physical risks, and implement preventive controls to mitigate them. The plan is continuously reviewed and refined.
What donor screening includes
Our donors are healthy, lactating parents who undergo a rigorous screening process that meets or exceeds the standards set by the Human Milk Banking Association of North America, developed in consultation with the FDA, CDC, and blood banking experts.
- A comprehensive healthcare questionnaire
- Medical and lifestyle history verification
- Blood testing for HIV 1 & 2, HTLV 1 & 2, Hepatitis B & C, and Syphilis
continuous quality improvement
Safety is a daily practice.
A dedicated team oversees compliance, training and operational improvement across four fronts.
people
Staff training and certification
All team members receive regular training in safe handling practices and current milk banking protocols.
standards
Accreditation
The Milk Bank undergoes annual accreditation by HMBANA and adheres to their evidence-based safety and quality standards.
oversight
Audits and oversight
Internal audits, process reviews and quality assurance checks are conducted routinely, covering aseptic technique and quality control.
evidence
Data-driven decisions
The team actively monitors batch safety data to identify opportunities for innovation and improvement.
why pasteurized donor human milk
For the most fragile infants, milk is medicine.
For premature and very low birth weight infants, breast milk is not only nutrition. The American Academy of Pediatrics recommends Pasteurized Donor Human Milk as the preferred feeding choice when a mother's own milk is not available. Research shows PDHM provides protection against Necrotizing Enterocolitis, an often fatal intestinal disease affecting premature infants, and helps shape the development of a preterm infant's gut microbiome.
"Our daughter, Charlotte, was born 6 weeks early and spent 12 days in the NICU. Due to having pre-eclampsia and emergency surgery after delivery, my body was unfortunately unable to produce milk. We used donor milk to help supplement while she was in the NICU to ensure she was receiving the proper nutrients, especially because she was born prematurely."
Lindsey, mother of milk recipient Charlotte
Sources: AAP technical report, PubMed on PDHM and NEC.
common questions
Is donor milk safe? And other questions.
Is donor milk safe for my baby?
Yes. Donor milk from The Milk Bank is screened, pasteurized and tested. Every step of the process is designed to protect your baby, especially if they are medically fragile or premature. Our safety protocols ensure only high-quality milk is dispensed.
How are milk donors screened?
Milk donors are healthy, lactating parents who complete a detailed medical and lifestyle history, fill out a healthcare questionnaire, and provide a blood sample tested for HIV, HTLV, Hepatitis B & C, and Syphilis. Only those who meet strict eligibility criteria are approved to donate.
How is the milk processed?
All approved donor milk is pasteurized using the Holder method to destroy viruses and bacteria, tested after pasteurization to ensure microbial safety, and tracked throughout its journey from donor to recipient.
Are The Milk Bank's safety protocols regulated?
Yes. The Milk Bank is accredited annually by HMBANA, registered with the FDA, and follows guidelines informed by the, CDC, and blood banking experts. Our clinical team ensures milk is dispensed according to a baby's needs and their healthcare provider's guidance, with strict handling and storage protocols whether milk ships to a hospital or a family's door.
committed to safety for all we serve
Whether it goes to a Level IV NICU or a family's front door, it arrives with the same commitment.
Safe, high-quality human milk for the infants who need it most. Your financial gift sustains that work, and the Medical Relief Fund, Bereavement Program and free lactation services alongside it.
