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Guideline Summary
Guideline Title
Donor breast milk banks: the operation of donor milk bank services.
Bibliographic Source(s)
Centre for Clinical Practice. Donor breast milk banks: the operation of donor milk bank services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 132 p. (Clinical guideline; no. 93). 
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Donor breast milk for infant nourishment

Guideline Category
Evaluation
Management
Prevention
Screening
Clinical Specialty
Family Practice
Nursing
Nutrition
Obstetrics and Gynecology
Pediatrics
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Dietitians
Hospitals
Nurses
Patients
Physician Assistants
Physicians
Guideline Objective(s)
  • To offer best practice advice on the operation of donor breast milk bank services
  • To protect the safety of donor breast milk
Target Population
  • Infants who receive donor breast milk
  • Mothers and carers of infants who receive donor breast milk
  • Women who donate breast milk
  • Staff involved in the collection, storage, and handling of donor milk
  • Donor breast milk banks
  • Special care baby units, neonatal units, transitional care units, and other settings (such as paediatric wards) that require access to donor breast milk
  • Community services that support breast milk donors and mothers or carers of infants receiving donor milk
Interventions and Practices Considered
  1. Quality assurance
    • Collection, storage, and handling of donor breast milk
    • Training and competencies of milk bank staff and other staff working with mothers
    • Maintenance of equipment
  2. Recruiting assessment and selection of donor women
    • Screening and selecting donors
    • Eligibility criteria
  3. Informal interview
  4. Serological testing of donors for infectious diseases
  5. Obtaining consent and continued eligibility
  6. Training and supporting donors
  7. Stopping or suspending milk donations
  8. Expressing and handling donor milk at home
  9. Handling donor milk during transportation
  10. Handling donor milk at the milk bank
  11. Tracking and tracing donated milk
Major Outcomes Considered
  • Safety of donor milk, defined as the minimisation of transmission risk for specific conditions, such as Creutzfeldt–Jakob disease
  • Levels of contamination in donor milk
  • Infant health outcomes
  • Infant morbidity and mortality
  • Process measures of service delivery
  • Cost-effectiveness

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Searches of Unpublished Data
Description of Methods Used to Collect/Select the Evidence

Searching for the Evidence

Scoping searches identified the United Kingdom Association for Milk Banking (UKAMB) and the Human Milk Bank Association of North America (HMBANA) guidelines. Full-text copies of all references in the UKAMB guidelines and those references assessed as relevant from the title and abstract from the HMBANA guidelines were ordered and checked for inclusion or exclusion.

Key words for the search were identified by the Guideline Development Group (GDG). See also Appendix 5 for the evidence reviews by clinical question in the full version of the guideline.

Literature Search

A focussed search was conducted by information services and 5,236 references retrieved (with 2 additional from Medline Update – 5,238 in total). These were scanned (see the review protocol below) and 406 references were selected on the title and abstract. These were imported into the master database, and any duplication with the UKAMB/HMBANA guidelines corrected. This left a set of core references for full-text examination (525 in total).

References were added from reference lists of relevant articles and where published versions of unpublished/grey reports were found.

Any excluded papers (including those excluded from the HMBANA guidelines) were documented in the 'Excluded Studies' table in the full version of the guideline.

Number of Source Documents

A focussed search was conducted by information services and 5,236 references retrieved (with 2 additional from Medline Update – 5,238 in total). These were scanned (see the review protocol below) and 406 references were selected on the title and abstract. These were imported into the master database, and any duplication with the United Kingdom Association for Milk Banking (UKAMB) and the Human Milk Bank Association of North America (HMBANA) guidelines were corrected. This left a set of core references for full-text examination (525 in total).

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Weighting According to a Rating Scheme (Scheme Not Given)
Rating Scheme for the Strength of the Evidence

Not stated

Methods Used to Analyze the Evidence
Systematic Review
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Extrapolation from Other Evidence

From the initial scoping work, it was clear that there were many areas where there is limited or no high-quality evidence. One solution was to extrapolate from evidence in other areas. In this case, there was a wealth of evidence related to breastfeeding that could inform the development of recommendations on donor milk. For example, on the question of transmission of human immunodeficiency virus (HIV) through milk, the Guideline Development Group (GDG) searched for evidence on transmission via donor milk, and as no evidence was identified, they extrapolated from current UK guidance on breastfeeding for HIV-positive mothers. Authors also referred to other relevant NICE or Department of Health (DH) guidance, and health and safety guidance as appropriate.

Lack of Evidence Specific to Donor Breast Milk Banking

Where appropriate, the evidence was limited to studies of donor milk banking, but, where there was no evidence, findings were extrapolated from existing evidence-based guidelines or DH guidance on maternal breastfeeding. If no evidence was identified, consensus from within the GDG was applied. However, the GDG was aware that, for most topics, there was limited or no high-quality evidence. The GDG therefore used formal consensus techniques when drafting and considering the recommendations.

Even in the absence of high-quality evidence, GDGs are generally able to reach agreement through informal consensus. However, because there was also the need for detailed service guidance, and the potential for a large number of recommendations, it was agreed that there was a role for formal consensus development techniques. The GDG used a modified RAND approach to reach consensus.

Methods Used to Formulate the Recommendations
Expert Consensus (Delphi)
Description of Methods Used to Formulate the Recommendations

Agreeing the Recommendations

Usually, where good evidence exists, a Guideline Development Group (GDG) can reach consensus through informal methods; however, formal consensus methods are increasingly being used to develop clinical guidelines.

A modified version of the Delphi method – the RAND method – is often used in guideline development. This involves several stages including the mailing of questionnaires, elicitation of private decisions, formal feedback of group choices, face-to-face contact, structured interaction, and an explicit aggregation method.

Cues and Clinical Scenarios

In the RAND process, cues are defined as "factors which influence clinical decision making", and these are used as dimensions (or indications) that group members are asked to take into account when making their decisions. Cues are used to develop and refine clinical scenarios which are then rated by the group. This guideline does not lend itself easily to the development of cues (because interventions for a specific condition or indications for using an intervention are not within the remit). Even if it were possible to define cues for one topic area, these would not be relevant for other topics. Therefore, the guideline developers considered that if the aim of the cues is to systematically describe all the possibilities that may occur, they could explore the "extremes" and range of possible options through the ratings of recommendations which reflect these.

Rating the Recommendations

The GDG were asked to rate the draft recommendations on the scale below. The authors did not ask the GDG to rate these via a postal questionnaire, but did this at the meeting, keeping individual responses anonymous.

1 2 3 4 5 6 7 8 9 Don't Know
Strongly disagree   Somewhat disagree   Uncertain   Somewhat agree   Strongly agree  

The rating was repeated for a second round. It should be noted however, that although two or more rating rounds are likely to result in some convergence of individual judgments, it is unclear whether this increases the accuracy of the group decision.

Structuring the Interaction

After the initial rating (round 1) results, both individual and summary results were revealed to the GDG and a discussion held about each recommendation that did not achieve consensus. This discussion was facilitated by the Chair as would other GDG discussions, adopting the ground rules specified in chapter 3 of "The Guidelines Manual" (2009) (section 3.1, box 3.2 in Appendix C of the original guideline).

Synthesising Individual Judgements

The guideline developers adopted an explicit definition of "agreement" based on the median of the ratings to determine the decision, with a measure of strength of consensus.

The GDG decision on a recommendation was:

  • AGREE where the median >6
  • DO NOT AGREE where the median <4
  • NOT SURE where the median 4–6

The measure of consensus stated that there was a group consensus if at least 75% of the responses lay in any one range, and there was group uncertainty if this range lay in the 4–6 response. So if 75% of GDG responses:

  • Lay in 1–3 then DO NOT AGREE
  • Lay in 7–9 then AGREE
  • Otherwise, NOT SURE

This is the same method as applied in the NICE clinical guideline on feverish illness. However, the developers also calculated a measure of consensus as described in the RAND manual. This measure, "D9R" considers all ratings and if at least one rating falls in the 1–3 (do not agree) range and at least one falls in the 7–9 range (agree), then there is considered to be a lack of consensus.

The GDG planned to discuss any recommendation that did not achieve consensus based on either criteria. In practice, the GDG tended to discuss all recommendations regardless of consensus. If a recommendation did not achieve consensus (on either measure), members who had rated against the majority were asked if they wanted to explain why they had done so, and a full discussion of the recommendation then ensued, with revisions made to the wording as agreed. If the recommendation did achieve consensus, GDG members often still discussed it, and made minor revisions to the recommendation.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Health Economic Modelling

It was not considered appropriate or possible to construct a health economic model for this guideline. However, the Guideline Development Group (GDG) was mindful of the need to consider both costs and benefits. These considerations are documented, where relevant, in the 'Evidence to recommendations' sections (for example, see sections 2.6.4 on the screening and selection of donors and 2.16.4 on testing donor milk in the full version of the guideline).

Screening Donors

The cost of screening donors is likely to vary for individual units. For the purpose of this document the developers contacted a large teaching hospital to enquire about the costs of individual screening tests; they also received costs from a donor milk bank for all tests in a 'package' price (see Table 1). A midpoint of 58.50 pounds has been used.

Table 1. Estimated Cost of Donor Screening per Test

Description Unit Cost £ Source
HIV £6.18 Personal communication
Hep B £5.28 Personal communication
Hep C £6.51 Personal communication
HTLV 1/2 £19.93 Personal communication
Syphilis £3.82 Personal communication
     
Total £42.00  
     
Screening – per patient £75.00 Donor milk bank
     
Midpoint £58.50  

Hep B, hepatitis B; Hep C, hepatitis C; HTLV, human T-lymphotrophic virus

Expert opinion indicates that milk banks currently screen donors a maximum of 3 times a year, with some milk banks screening at the time of enrolment and not routinely repeating. Acknowledging the limited data available, for the purpose of this piece of work the developers have assumed that currently donors are tested 3 times a year, screening costs can be estimated at approximately 176 pounds per donor. Reducing screening to once per donor would result in annual screening costs of 58.50 pounds. Estimating the potential national saving is challenging and subject to significant uncertainty. The survey reported that the median number of donors per milk bank was 48 (range 7 to 139), and, as previously reported, there are 15 milk banks operating in England; using this data and the costs above, the potential annual saving is 84,000 pounds (see Table 2, below).

Table 2. Estimated National Savings Through a Reduction in Screening Tests

  Number of Milk Banks in England Median Donors per Bank Total Donors Annual Screening Costs £ Total Costs £000s
Current 15 48 720 176.00 126
Proposed 15 48 720 58.50 42
  Potential Saving       -84
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The guideline was validated through two consultations.

  1. The first draft of the guideline (The full guideline guideline and Quick Reference Guide) were consulted with stakeholders and comments were considered by the Guideline Development Group (GDG).
  2. The final consultation draft of the full guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

Recommendations

Major Recommendations

Quality Assurance

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

Clean and store all donor milk containers and equipment according to local protocols based on HACCP principles.

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.

Regularly inspect all equipment used in donor milk handling and processing, following the manufacturer's instructions. Ensure that all equipment that may affect temperature or contamination levels has sensors and alarms so that constant conditions can be maintained.

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

Train milk bank staff in HACCP principles, food hygiene and pasteurisation, and provide ongoing support so that practices reflect these principles.

All donor milk administered in the National Health Service (NHS) should be from milk banks that can demonstrate adherence to NICE guidance on the operation of donor milk banks.

Implement a quality control system that is followed by all staff and is reviewed regularly. It should encompass:

  • Collecting, testing, processing, storing, and transporting milk
  • Personnel, required documentation, premises, and equipment
  • Batch recall, external and internal auditing, non-conformance to processes, and self-inspection
  • Continuous quality improvement

Recruiting Donors

When promoting the donation of breast milk, aim to reach as many potential donors as possible through a variety of channels, including:

  • Providing written information to be left in:
    • General practitioner (GP) surgeries
    • Antenatal clinics and postnatal wards
    • Volunteer and other organisations working in maternity and childbirth
    • Children's or Sure Start centers
    • Maternity shops
  • Direct referrals or recommendations by:
    • Current and previous donors
    • Staff at neonatal intensive care units
    • Pediatricians assessing babies' progress
    • Health visitors (or other health-care professionals providing postpartum care)
    • Childbirth educators
    • Organisers and attendees of prenatal and postnatal classes
    • Breastfeeding mothers' support groups and related organisations
  • Features in the media

Use clear, non-technical language when communicating the use of donor milk and the process of donor milk banking in any written information and activities.

Screening and Selecting Donors

The following strategy of screening and selection is part of the whole process of donor milk handling and therefore is intrinsically linked with the recommendations on testing and treating the donor breast milk.

Advise a potential donor that she is not eligible to donate milk if she:

  • Currently smokes or uses nicotine replacement therapy (NRT)
  • Regularly exceeds recommended alcohol levels for breastfeeding mothers (1 to 2 units, once or twice a week) (see www.dh.gov.uk External Web Site Policy for information on alcohol and breastfeeding)
  • Is using, or has recently used, recreational drugs
  • Has previously tested positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B or C, human T-lymphotropic virus (HTLV) type I or II, or syphilis
  • Is at an increased risk of Creutzfeldt–Jakob disease (CJD) (see www.hpa.org.uk External Web Site Policy for information on the risk of CJD).

Include this information in recruitment material so that potential donors can self-screen for these criteria.

Using a process of informal interview, referring to medical sources (with consent) if necessary, ask the potential donor questions on the topics that follow. Use the information she gives to make a balanced decision about her eligibility to donate based on possible risks to recipients and/or the results of subsequent serological tests. Ask questions about:

  • Her health: to confirm that she is in good general health
  • Her baby: document the age and health of the baby
  • Any exposure to passive smoke: is she exposed to high or sustained levels of passive smoke (for example, do other members of her household smoke heavily)?
  • Any medication that she is taking: is she currently taking any medication or undergoing any other medical therapy?
  • Any significant environmental or chemical exposure (such as contamination of the local water supply): is she exposed to high or sustained levels of environmental or chemical contaminants that can be expressed in breast milk?
  • Any recent exposure to infection (including HIV 1 or 2, hepatitis B or C, HTLV I or II, syphilis, herpes, or acute or chronic infections). Depending on the assessment of level of risk, further testing may be needed.
  • Any recent medical intervention (for example, exposure to diagnostic radioactive isotopes)
    • Refer to guidance from the Department of Health on the safety of recent vaccination when breastfeeding (available from www.dh.gov.uk External Web Site Policy).

Advise the potential donor that depending on her answer to any of these questions she may not be eligible to donate milk.

If a potential donor is donating previously expressed breast milk, ask her to answer the screening questions for the period when the milk was expressed.

Conduct the screening interview, with potential donors at a mutually acceptable time and place, either face-to-face or by telephone.

Serological Testing

When donors first contact the milk bank about donating milk, explain that serological testing is mandatory to reduce the risk of passing on infections. Obtain informed consent before testing.

Undertake serological testing of all potential donors for the following and exclude women from donating who test positive for:

  • HIV 1 or 2
  • Hepatitis B or C
  • HTLV I or II
  • Syphilis

Perform all serological screening tests at the time of enrolling for donor milk banking; do not rely on antenatal test results.

All tests should be undertaken in laboratories with clinical pathology accreditation (CPA).

Ensure that laboratories communicate the results of serological testing clearly and that they provide appropriate interpretive comments.

Give serological test results to potential donors either in person or by telephone (unless they prefer to receive them in writing). If needed, offer further help and support based on local protocols, including information about counselling and local support groups.

Laboratories should archive samples of blood received from donors.

Consent and Continued Eligibility

Before accepting a donor's milk, obtain her consent for the processing and intended use of the donated milk. Advise her that once donated, milk will not be returned to her.

While a donor continues to donate, ask regularly about her general health and the exclusion criteria. Advise her that if her status or circumstances change in relation to these, she should contact the milk bank immediately.

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

Training and Supporting Donors

The recommendations in this section are specific to mothers expressing milk for donation, and may differ from advice given to mothers expressing milk for their own babies.

Provide all new donors with training, preferably face-to-face with additional information by telephone and in writing. Arrange training at a time and place suitable for both donor and trainer.

Training for new donors should cover:

  • Hand washing and the importance of this
  • Good personal hygiene
  • Collecting and expressing milk, including cleaning and using breast pumps and containers
  • Storing donated milk (including cooling and freezing)
  • Labelling donated milk, and documenting storage conditions
  • Transportation of donated milk (if needed)

Provide ongoing support to all donors according to their individual needs until no longer required. This may include:

  • Information and ongoing support on milk bank requirements for their diet and alcohol consumption
  • Continued support for collecting expressed milk and maintaining lactation
  • Emotional support

Offer additional support and information on milk collection to donors whose milk has significant or repeated microbial contamination.

Stopping or Suspending Milk Donations

The recommendations in this section are specific to mothers expressing milk for donation, and may differ from advice given to mothers expressing milk for their own babies.

Consider no longer accepting breast milk from donors who, despite support, consistently supply:

  • Breast milk that does not meet the microbiological criteria
  • Small amounts of breast milk

Advise donors to contact the milk bank to discuss suspending or stopping their breast milk donation if they develop a fever or have contact with a viral exanthematous disease.

Advise donors who begin taking any medication that they should contact the milk bank to discuss suspending or stopping their breast milk donation. Use appropriate reference sources.

Advise donors to contact the milk bank to discuss suspending or stopping their breast milk donation if they develop lesions or infections of the breast (including mastitis or herpes).

Provide donors who are stopping their breast milk donations with as much advice and support as needed.

Consider the size of the recipient population, the milk bank's stock levels, and the preferences of the donor when discussing how long a woman can donate milk.

Expressing Milk at Home for Donation

Advise donors to collect expressed milk rather than 'drip' milk (milk that is passively collected from one breast while the baby feeds at the other) for donation.

Actively encourage donors to hand express milk; however, accept pump-expressed milk if donors prefer this method.

Handling Donor Milk at Home

The recommendations in this section are specific to mothers handling and storing milk for donation, and may differ from advice given to mothers expressing milk for their own babies. This is because donated milk needs to undergo various testing and treatment processes at the donor milk bank, all of which affect the nutritional and immunological composition of the milk. The aim therefore is to make sure that milk for donation reaches the donor milk bank as soon as possible to ensure the highest quality before processing.

Advise donors that expressed milk collected for donation should be frozen as soon as possible to maintain the nutritional and microbiological quality of the milk. If this is not possible (for example, because of storage capacity), advise donors to refrigerate samples collected over 24 hours, and then freeze the batch.

Advise donors that expressed milk for donation should remain frozen during storage at home, and if they have any concerns about storage conditions or freezer temperatures, they should discuss these with the milk bank.

Advise donors that frozen expressed milk should be transported to the milk bank as soon as possible. However, if necessary, expressed milk for donation can be stored before transport to the milk bank for up to 3 months in a domestic freezer, at −18°C or lower. If a donor does not have access to a domestic freezer at her home, she may be able to access freezers for milk storage at local donor milk depots or children's centres.

Advise donors that expressed milk can only be accepted by the milk bank if it has been collected and stored in milk collection containers provided by, or acceptable to, the milk bank.

Advise donors that collection containers for expressed milk should be used according to instructions provided by the milk bank.

Ensure that donors can check and document their freezer temperature every day; this may include providing a thermometer.

Handling Donor Milk During Transportation

Define critical conditions for transport, including temperature and time limit, to ensure that donor milk remains frozen during transport.

Transport donor milk in secure, tamper-evident containers and packaging.

If donor milk is transported to the milk bank by a contracted third party, ensure that a documented agreement is in place to maintain the conditions needed.

Define in writing the milk bank's procedures for transporting and storing donor milk. Ensure that these procedures maintain the quality of the donor milk and allow accurate identification of samples. Keep records of inventory and distribution (see also recommendations on tracking and tracing).

Collect expressed milk from the donors, preferably using an agreed transport provider (ideally a medical courier) or a member of staff from the milk bank. In some instances, donors may be required or may wish to deliver their own milk to the milk bank or depot, in which case they should also follow the milk bank's requirements for transport as outlined. In all cases, use consistent monitoring processes, including recording the journey time.

Collect expressed milk from either the donor's home or from donor milk depots that have practices for monitoring freezers and maintaining standards for quality control, storage and security. Ensure that similar processes are in place in any location where the donor milk is stored.

Handling Donor Milk at the Milk Bank

The following strategy of handling milk at the milk bank, specifically testing and treating donor milk, is part of the whole process of donor milk handling and therefore is intrinsically linked with the recommendations on recruiting and selecting the donors. It is also predicated on the effective functioning of the human milk pasteuriser.

Process all donated milk under hygienic conditions (a sterile environment is not necessary). Practise good hand hygiene at all times, and wear gloves whenever handling donor milk.

Check that donated milk arriving at the milk bank:

  • Is labeled correctly with the donor's name and the date of expression and
  • Has remained frozen and
  • Has not been tampered with

Transfer all donated milk immediately to the freezer.

Store pasteurised and unpasteurised donor milk in separate freezers and refrigerators.

Store donor milk awaiting pasteurisation in the freezer at the milk bank (at −20°C) for no longer than 3 months from the date of expression.

Discard breast milk from donors who do not meet the selection criteria detailed in recommendations.

Before testing and pasteurising, thoroughly thaw the donor milk, and keep in the refrigerator for no longer than 24 hours. Prevent the donor milk from reaching 8°C while thawing.

Only pool pre-pasteurised breast milk from the same donor.

Do not pool:

  • Breast milk from different donors

    or

  • Batches of pasteurised breast milk from the same donor

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

Ensure that laboratories communicate the results of microbial testing clearly and that they provide appropriate interpretive comments.

Seek help from microbiological laboratories to identify and investigate instances of significant or unusual contamination (for example, by undertaking further microbial tests).

Pasteurise donated milk at 62.5°C for 30 minutes in a human milk pasteuriser. Rapidly cool the milk to a temperature of 4°C or lower. Remove one bottle for testing if appropriate, then move the remainder of the batch to the freezer.

After pasteurising, store frozen donor milk for no longer than 6 months after the date of expression.

Do not open the lid of batches of pasteurised donor milk until the milk is to be used, unless it is to test the milk. If the milk is tested, discard the opened bottle.

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

    and

  • 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.

Discard pasteurised donor milk that has a total viable microbial count of 10 CFU/ml or more.

Keep all donor milk in containers made of food grade materials.

Staff at the milk bank should not be responsible for adding anything to the donated milk.

Tracking and Tracing

Track donated milk from the donor through to the recipient hospital.

Tracking and monitoring of donor milk processing should include freezer temperatures, pasteurisation processes and stock control.

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

For each donor milk batch, keep the following records.

  • About the donor:
    • NHS number/donor ID
    • Consent
    • Relevant medical history
    • Results of serological tests
  • About each container before pasteurisation:
    • Donor ID
    • A testing log, including the tests undertaken and their results
  • For each pasteurised container:
    • Samples making up the batch
    • The batch number
    • A testing log, including the tests undertaken and their results
    • Pasteurisation details, including date of the pasteurisation
  • The hospital or neonatal unit that receives the donated milk, or the disposal date of the donated milk, as appropriate.

Label each container of pasteurised donor milk with the following information:

  • A unique identification number
  • Confirmation that it contains pasteurised donor breast milk
  • Instructions to keep frozen, and use within 24 hours if defrosted
  • An expiry date (no later than 6 months from expression)

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

The receiving hospital or neonatal unit should keep a record of how the donor milk is used. It should document for each bottle of donor milk:

  • The baby's name, NHS number and date of birth, and the date administered
  • The batch number and the date the donor milk was used in the patient record of each baby
  • The condition of the donor milk on arrival following transport
  • The storage conditions

Ensure that all records (including raw data) that are critical to the safety and quality of the donor milk are kept for at least 30 years after expiry date, use or disposal. These records should be confidential.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Research has consistently shown that breast milk is the best nourishment for babies and that it is highly beneficial to their health in the short, medium, and long term.
  • A Health Technology Assessment (HTA) report entitled 'Breastfeeding promotion for infants in neonatal units: a systematic review and economic analysis' was published in 2009. The authors concluded that if mechanisms by which donor milk is provided were improved, donor milk would become cost effective compared with using formula.
Potential Harms
  • Harms from contaminated or heavily processed milk need to be considered.
  • All storage processes affect the nutritional and immunological qualities of milk.

Qualifying Statements

Qualifying Statements
  • This guidance represents the view of the National Institute for Health and Clinical Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.
  • Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.
  • Although this guideline does not make recommendations on the configuration of services, it does make recommendations on the safe and effective operation of donor milk services. Throughout development, the safety of donor breast milk was considered to be the aim of the guideline and recommendations were made to minimise the risk to recipients of donor milk. Maximising safety comes at a cost, and recommendations were made to observe the best possible safety standards without exceeding opportunity costs acceptable to society.

Implementation of the Guideline

Description of Implementation Strategy

The Healthcare Commission assesses the performance of National Health Service (NHS) organisations in meeting core and developmental standards set by the Department of Health in 'Standards for better health' (available from www.dh.gov.uk External Web Site Policy). Implementation of clinical guidelines forms part of the developmental standard D2. Core standard C5 says that national agreed guidance should be taken into account when NHS organisations are planning and delivering care.

The National Institute for Health and Clinical Excellence (NICE) has developed tools to help organisations implement this guidance. These are available on the NICE Web site (http://guidance.nice.org.uk/CG93 External Web Site Policy); see also the "Availability of Companion Documents" field).

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 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

      and

    • 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 labeled 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.
Implementation Tools
Audit Criteria/Indicators
Chart Documentation/Checklists/Forms
Patient Resources
Quick Reference Guides/Physician Guides
Resources
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Centre for Clinical Practice. Donor breast milk banks: the operation of donor milk bank services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 132 p. (Clinical guideline; no. 93). 
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Feb
Guideline Developer(s)
National Institute for Health and Care Excellence (NICE) - National Government Agency [Non-U.S.]
Source(s) of Funding

National Institute for Health and Clinical Excellence (NICE)

Guideline Committee

Guideline Development Group

Composition of Group That Authored the Guideline

Guideline Development Group Members: Damien Longson (Chair), Consultant Liaison Psychiatrist, Manchester Mental Health & Social Care Trust; Shel Banks, Patient and carer representative; Paul Cook, Head of Microbiological Hazards and Consumer Protection Branch, Food Standards Agency, London; Lynda Coulter, Senior Neonatal Nurse Practitioner/Human Milk Bank Manager, Countess of Chester Hospital; James Gray, Consultant Microbiologist, Birmingham Children's Hospital/Birmingham Women's Hospital; Wendy Jones, Patient and carer representative; Camilla Kingdon, Consultant Neonatologist, Guy's & St Thomas' NHS Foundation Trust; Neena Modi, Professor of Neonatal Medicine, Chelsea & Westminster Hospital; Gillian Weaver, Milk Bank Manager, Queen Charlotte's & Chelsea Hospital; Nia Williams, Community Midwifery Group Practice Team Leader, Queen Charlotte's & Chelsea Hospital

Short Clinical Guidelines Technical Team: Lynda Ayiku, Information Specialist; Emma Banks, Guidelines Coordinator; Kathryn Chamberlain, Project Manager; Christine Carson, Programme Director, Centre for Clinical Practice; Nicole Elliott, Guidelines Commissioning Manager (until July 2010), Associate Director (from July 2010); Stephanie Reken, Technical Analyst (Health Economics); Judith Thornton, Technical Adviser; Claire Turner, Guidelines Commissioning Manager (from November 2009); Abi Senthinathan, Assistant Technical Analyst (from September 2009); Beth Shaw, Technical Adviser; Tim Stokes, Associate Director, Centre for Clinical Practice (until October 2009)

Financial Disclosures/Conflicts of Interest

A full list of all declarations of interest made by the Guideline Development Group is available on the National Institute for Health and Clinical Excellence (NICE) Web site (www.nice.org.uk External Web Site Policy).

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Donor breast milk banks: the operation of donor breast milk bank services. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 16 p. (Clinical guideline; no. 93). Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.
  • Donor breast milk banks. Audit support. Implementing NICE guideline. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 15 p. (Clinical guideline; no. 93). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Donor breast milk banks. Costing statement. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 6 p. (Clinical guideline; no. 93). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Donor breast milk banks. Slide set. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 15 p. (Clinical guideline; no. 93). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Donor breast milk banks. Baseline assessment tool. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. (Clinical guideline; no. 93). Electronic copies: Available from the NICE Web site External Web Site Policy.
  • Donor breast milk banks. Donor checklist. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 1 p. (Clinical guideline; no. 93). Electronic copies: Available from the NICE Web site External Web Site Policy.
Patient Resources

The following is available:

  • Donor breast milk banks: the operation of donor breast milk bank services. Understanding NICE guidance. Information for people who use NHS services. National Institute for Health and Clinical Excellence (NICE); 2010 Feb. 12 p. (Clinical guideline; no. CG93). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI Institute on January 15, 2011.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their clinical guidelines with the intention of disseminating and facilitating the implementation of that guidance. NICE has not yet verified this content to confirm that it accurately reflects that original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE clinical guidelines are prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk External Web Site Policy.

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