Key priorities for implementation

Quality assurance

  • Use Hazard Analysis and Critical Control Point (HACCP) principles in all quality assurance processes.

  • Validate, calibrate and maintain all equipment used in donor milk handling and processing and keep records of this. Ensure that the equipment is used according to the manufacturer's instructions.

  • All milk bank staff should have ongoing training that is relevant to their job and is recorded. Training should cover good practice and should ensure that each staff member:

    • is competent in performing their job

    • understands the technical processes relevant to their job

    • understands how the milk bank is organised and how its health and safety and quality systems work

    • understands the regulatory, legal and ethical aspects of their work.

  • All donor milk administered in the NHS should be from milk banks that can demonstrate adherence to the NICE guidance on the operation of donor milk banks.

Screening and selecting donors

  • Follow the stepped screening process detailed in recommendations 1.12 to 1.21 when recruiting donors.

  • Do not routinely repeat serological tests while the donor is donating milk.

Handling donor milk at the milk bank

  • Before pasteurisation, test a sample from each batch of pooled donor milk for microbial contamination and discard if samples exceed a count of:

    • 105 colony-forming units (CFU)/ml for total viable microorganisms or

    • 104 CFU/ml for Enterobacteriaceae or

    • 104 CFU/ml for Staphylococcus aureus.

  • Regularly test pasteurised donor milk for microbial contamination. Base the testing schedule on the volume and throughput of milk. Test:

    • either at least once a month or every 10 cycles, depending on which comes first


    • on an ad-hoc basis if any new processes, equipment or staff are introduced, or if there are concerns about any part of the process.

Tracking and tracing

  • At all stages, donor milk containers should be labelled clearly for identification. Clearly identify milk that is ready to be used.

  • Only supply donor milk to hospitals or neonatal units that agree to comply with the tracking procedures for milk outlined by the milk bank.