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Interim protocol for the safe processing of donated human breast milk Queensland

Contents Context ................................................................................................................................. 4

Introduction ........................................................................................................................... 4

Regulation and quality assurance ......................................................................................... 5

Donor recruitment ................................................................................................................. 6

Serological and Nucleic Acid Test (NAT) testing for infectious diseases ............................ 7

Milk donation ......................................................................................................................... 8

Training and supporting donors ......................................................................................... 8

Stopping or suspending milk donations ............................................................................. 8

Expressing milk at home for donation ................................................................................ 9

Handling donor milk at home ............................................................................................. 9

Transporting donor milk to milk bank ............................................................................... 10

Processing of donor milk at the Milk Bank ........................................................................... 10

Receival .......................................................................................................................... 10

Processing ...................................................................................................................... 10

Pasteurisation .................................................................................................................. 11

Dispatch .......................................................................................................................... 12

Tracking and tracing ........................................................................................................ 13

Recipients ........................................................................................................................... 14

Prioritisation during supply shortage ................................................................................ 14

Consenting for use of pasteurised donor milk .................................................................. 14

Managing issues ................................................................................................................. 14

Reporting and management of suspected adverse events .............................................. 14

Managing recalls of donated human milk ......................................................................... 15

Managing expired or discarded pasteurised donor milk ................................................... 15

Appendix 1 Donor Questionnaire .................................................................................. 16

References ......................................................................................................................... 23

Context Breastfeeding has been acknowledged by the World Health Organisation (WHO) as the

normal way of providing infants with nutrients that they need for health, growth and

development. The WHO and United Nations International Children’s Emergency Funds

(UNICEF) issued a joint statement stating that in situations where mother’s own milk is not

available, provisions of pasteurised, screened donor (human) milk is the best option

particularly for ill or high-risk infants (WHO & UNICEF, 1980).

Necrotising enterocolitis (NEC) is one of the most common gastrointestinal emergencies in

newborns, with the highest risk factors being preterm birth (particularly <32 weeks gestation)

and very low birth weight. NEC has considerable morbidity and mortality implications. Human

milk feeding has been shown to decrease the risk of NEC, and WHO recommends that low

birth weight infants who cannot be fed a mother’s own milk should be fed pasteurised donor

human milk (PDHM). In this protocol, donor breast milk is defined as a breast milk expressed

by a mother that is then processed by a donor milk bank for use by a recipient that is not the

mother’s own baby. The use of pasteurised donor milk may also be effective in protecting

against other high-risk conditions in vulnerable infants, such as late onset sepsis.

The aim of this document is to present a protocol for the safe supply of donated human breast

milk for vulnerable infants across Queensland. The document is based on the New South

Wales Health and Australian Red Cross Blood Service Partnership Service Protocol,

Pasteurised Donor Human Milk (PDHM) for Vulnerable Infants (2018) and the United Kingdom

National Institute for Health and Clinical Excellence NICE guideline, Donor breast milk banks:

the operation of donor milk bank services (2010).

Introduction This protocol sets minimum standards for the safe, equitable and ethical service delivery of

donated human breast milk.

To ensure the safety of donated human breast milk, all donated human breast milk must be

pasteurised as articulated in this protocol or via another process that provides an equivalent or

greater lethal effect on any pathogenic microorganisms which is approved by Queensland

Department of Health.

Regulation and quality assurance All milk banks will operate in accordance with the provisions of Australia New Zealand Food

Standards Code (Food Standards Code) and use a Hazard Analysis Critical Control Point

(HACCP) process to develop a food safety program and in all quality assurance processes.

Matters to be addressed include:

• Clean and store all donor milk containers and equipment according to 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.

• Ensure temperature measuring devices comply with tolerances required in the Food

Standards Code (+/-1°C).

• 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 must have ongoing training that is relevant to their job and is recorded.

Training should cover best practice and ensure each staff member:

o is competent in performing their job

o understands the technical processes relevant to their job

o understands how the milk bank is organised and how its health, safety and quality

systems work

o understands the regulatory, legal and ethical aspects of their work

o have appropriate skills and knowledge in food safety and food hygiene commensurate

with their work activities.

• Train staff in HACCP principles, food hygiene and pasteurisation, and provide ongoing

support so that practices reflect these principles.

• Implement a food safety program that is followed by all staff and is reviewed regularly. It

should encompass:

o collecting, testing, processing, storing and transporting human milk

o personnel, required documentation, premises and equipment

o batch recall, external and internal auditing, non-conformance to processes and self-

inspection

o continuous quality improvement

o support programs including calibration, testing, traceability and recall, good

manufacturing practices, pest control, training, hygiene and sanitation, construction

and maintenance, internal audit, approved suppliers, allergen management, and

chemical suitability.

Donor recruitment The welfare of the donor’s own infant is a key priority when considering a donor’s eligibility as

a milk donor. A mother’s own breast milk should be used exclusively for her own infant for the

first four weeks after birth. After this period a breastfeeding mother is eligible to donate if she

has excess milk supply beyond the nutritional requirements of her infant.

A potential milk donor may be a mother whose infant is currently an inpatient of a hospital or

who is expressing milk in the community.

A potential donor is not eligible to donate milk if she:

• currently smokes or uses nicotine replacement therapy

• uses illegal drugs or other prohibited substances

• routinely consumes more than three cups of coffee, tea or other caffeinated stimulant

drinks per day (including cola and stimulant soft drinks)

• regularly exceeds recommended alcohol levels for breastfeeding mothers (2 or more

standard drinks more than once a week)

• has previously tested positive for Human Immunodeficiency Virus (HIV), hepatitis B or C,

Human T-Lymphotropic Virus (HTLV) or syphilis

• is at an increased risk of Creutzfeldt-Jakob disease, including being a resident in the

United Kingdom for 6 months or more between 1 January 1980 and 31 December 1996.

Using a process of formal interview, the clinician, doctor or milk bank staff shall obtain

information from a potential donor to assess her eligibility to donate, based on possible risks to

her, her baby, or recipients. If a potential donor is donating previously expressed breast milk,

the screening questions should also relate to the period when the milk was expressed. Donor

confidentiality shall be maintained. All questions included in the Donor Questionnaire included

as Appendix 1 must be used as a minimum to screen potential donors.

If the potential donor is found to be not eligible to donate milk, it is important to reassure the

mother that her own breast milk is the best food source for her baby, unless there are reasons

why the mother should not be breastfeeding her own infant. Specialised medical support shall

be made available for the management of adverse screening results, any safety or health

concerns relating to the donor or the infant of the donor, and when a batch recall is required.

Ideally this should be undertaken in person by the clinician caring for the mother or infant.

Donors must not receive any reward whether monetary or another form for donating breast

milk.

Serological and Nucleic Acid Test (NAT) testing for infectious

diseases

Serological and NAT testing is mandatory for all donors to reduce the risk of passing on

infections.

Informed consent must be obtained before collecting blood samples for testing along with

advice that any positive test results are notifiable to the Department of Health under law;

therefore, it is important the donor considers the consequences of abnormal results. A blood

sample shall be obtained from a potential donor at the time she is enrolled as a milk bank

donor. Antenatal test results must not be used. The sample shall be tested for:

• HIV 1 & 2

• Hepatitis B & C

• HTLV 1 & 2

• syphilis

Women who test positive for these microorganisms shall be excluded from donating milk.

Medical reporting to Queensland Health is required. If needed, referrals and support based on

local protocols shall be provided, including information about counselling and local support

groups. The milk bank must ensure the donor’s infant is also referred to appropriate services

where required.

Before accepting a donor’s milk, her written consent for the processing and intended use of

the donated milk shall be obtained. The donor is to be advised that, once donated, milk will not

be returned to her.

While a donor continues to donate, she must be asked regularly about her general health and

the exclusion criteria. She must be advised that if her status or circumstances change in

relation to these, she should contact the milk bank immediately.

Donor blood testing is only required once per lactation period, unless the donor discloses a

new infectious disease risk.

Milk donation Training and supporting donors

All donors are to be provided with ongoing training, preferably face-to-face with additional

information available by telephone and in writing.

Training for new donors will cover:

• hand washing and the importance of hand hygiene

• good personal hygiene

• expressing and collecting milk, including cleaning and using breast pumps and containers

• storing donated milk (including freezing)

• labelling donated milk, and compliance with required storage conditions

• transportation of donated milk

Ongoing support is to be provided 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

• continued support for maintaining lactation

The milk bank will supply donors with appropriate milk storage containers.

The milk bank will offer additional support and information on milk collection to donors whose

milk has significant or repeated microbial contamination.

Stopping or suspending milk donations

The milk bank will no longer accept breast milk from donors who, despite support, consistently

supply:

• breast milk that does not meet the microbiological criteria

• small volumes of breast milk (less than 2L) Note this does not apply to bereaved donors.

Donors must be advised 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 (eg measles, chicken pox, German measles, and other viral infections that produce

skin eruptions).

Advise donors who begin taking any medication that they should contact the milk bank to

discuss whether they need to suspend or stop their breast milk donation.

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 infective mastitis or

herpes).

Provide donors who are stopping their breast milk donations with 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. Preference is given for

donors to be breastfeeding an infant that is less than six months old, however breast milk may

be accepted from women breastfeeding an infant up to 12 months of age.

Expressing milk at home for donation

Donors may be recruited who are breastfeeding from home. They should be given clear

instructions on how to collect and store expressed milk to minimise contamination risk and

preserve the nutritional quality.

Donors are to collect expressed milk rather than ‘drip’ milk (milk that is passively collected

from one breast while the infant feeds at the other) for donation. ‘Drip’ milk has lower fat and

energy content and is likely to have significant microbial contamination.

Handling donor milk at home

Donors must be advised that expressed milk collected for donation should be placed in the

freezer immediately after expression to maintain the nutritional and microbiological quality of

the milk.

Donors must ensure that expressed milk for donation remains hard 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.

Frozen hard expressed milk should be provided to the milk bank within 10 weeks of the date

of expression to allow sufficient time for processing before expiration.

Expressed milk can only be accepted by the milk bank if it has been collected and stored in

the storage containers provided or approved by the milk bank.

Collection containers for expressed milk must be used according to instructions provided by

the milk bank.

Donors are required to routinely check their freezer temperature to ensure that stored breast

milk remains hard frozen.

Transporting donor milk to milk bank

Milk shall be transported by the donor. If a contracted third party is used, a documented

agreement shall be in place to ensure that the donor milk is transported under temperature

control at -18°C and is protected from the likelihood of contamination.

Milk shall remain hard-frozen during storage. Ideally temperature of the freezer compartment

should be logged during transport. If not, the milk should be hard-frozen at pick-up and on

receipt by the milk bank. Temperature data and the journey time should be recorded. Donors

may deliver their own milk, in which case they should follow the above transport criteria and

other criterion imposed by the milk bank.

Processing of donor milk at the Milk Bank Receival

Donor milk shall arrive at the milk bank hard-frozen, display no evidence of tampering and be

labelled with the donor’s name and date of expression. After recording these details, donor

milk shall be transferred to a dedicated donor milk freezer, maintained at a temperature of -

18°C. Freezer temperatures shall be continuously monitored using a data logger. Ideally, they

should be fitted with sensors and/or alarms to alert staff of a problem with the freezer. Donor

milk shall be stored for a maximum period of 3 months from the date of expression.

Donor milk from donors who do not meet the selection criteria shall be discarded.

Processing

Based on proven scientific studies, all international and Australian guidelines require human

breast milk to be pasteurised to inactivate life-threatening viral and bacterial agents prior to

distribution.

This protocol requires all human breast milk to be processed by the pasteurisation process

described below.

Alternative methods of processing human breast milk are not to be used unless expressly

permitted by the Queensland Department of Health. This includes novel technologies such as

high temperature-short time pasteurisation; high pressure processing; ultraviolet-C irradiation;

and ultrasonic and thermoultrasonic processing.

Pasteurisation

When required, frozen donor milk shall be thawed in a refrigerator. Milk temperature during

thawing shall be less than 5°C, and the total time in the refrigerator, including thawing, shall

not exceed 24 hours. Thawed milk in a refrigerator for longer than 24 hours must be

discarded. Thawed pasteurised donor milk must not be refrozen.

Pre-pasteurised milk from the same donor may be pooled; milk from different donors must not

be pooled.

Pooled donor milk will be aseptically sampled prior to pasteurisation and tested for:

• Staphylococcus aureus,

• Enterobacteriaceae and

• total viable count (TVC).

Milk shall be discarded if:

• Staphylococcus aureus counts and/or Enterobacteriaceae counts exceed 104 cfu/mL

and/or

• TVC exceeds 105 cfu/mL

Significant or unusual results shall be investigated.

Donor milk is to be pasteurised by heating to 62.5°C for 30 minutes, or with a heat treatment

known or shown to give an equivalent microbial kill, in a human milk pasteuriser.

Pasteurised donor milk must be cooled from 60°C to 21°C within 2 hours, and from 21°C to

5°C in the next 4 hours.

Times and temperatures of pasteurisation and cooling must be recorded.

Remove one bottle of cooled pasteurised donor milk for testing if required; remaining bottles

shall be placed in a dedicated pasteurised donor milk freezer, maintained at a temperature of -

18°C and equipped with a data logger.

Pasteurised donor milk from the same or different donors shall not be pooled post-

pasteurisation.

Cooled pasteurised donor milk shall be tested for TVC on a regular basis. The NICE guideline

(2010) suggests a testing frequency of either at least once a month or every ten pasteurisation

cycles, depending on which comes first, provided all the recommendations in their guideline

are followed.

Pasteurised donor milk shall also be tested if a new process or equipment is used, or when

there are concerns about the pasteurisation process. The bottle of pasteurised donor milk

used for testing shall be discarded. The entire batch of pasteurised donor milk shall be

discarded if a TVC of 10 cfu/mL is recorded post-pasteurisation for that batch.

Frozen pasteurised donor milk shall be discarded 3 months after pasteurisation, if it is not

used.

Dispatch

The milk bank shall use first-in, first-out principle of stock rotation to ensure that the freshest

batch of pasteurised donor milk is always used last.

Pasteurised donor milk should be dispatched in a hard-frozen state. It should be labelled with

a unique identification number, expiry date (3 months post-pasteurisation) and with the

instructions Keep frozen and Use within 24 hours once defrosted.

The milk bank is responsible for tracking donated milk from donation to the recipient infant.

Table 1 tabulates information that should be available to facilitate both tracking and trouble-

shooting, should a recall be necessary.

Table 1 Information required for traceability and trouble shooting

Information required

Donor milk pre-pasteurisation Pasteurised Donor Milk

Labelled with donor identification; time & date when milk expressed

Labelled with a unique identifier, expiry date, as pasteurised, and with instructions to Keep frozen and Use within 24 hours once defrosted.

Donor milk hard-frozen when received by Milk Bank

Pasteurisation date & time/temperature of pasteurisation

Donor medical history including test results for HIV 1 & 2, Hepatitis B & C, HTLV 1 & 2 and syphilis

Cooling times/temperatures

Log of freezer temperatures pre-pasteurisation Log of freezer temperatures

Date of thawing TVC results

Time to thaw/maximum temperature of thawed milk

Date of discard of milk which has not been pasteurised correctly (non-compliant time/temperature monitoring and/or TVC test)

Dates of expression for each milk if milk from same donor is pooled pre-pasteurisation

Date of discard of pasteurised donor milk which has not been continuously stored at -18°C

Staphylococcus aureus, Enterobacteriacea and total viable count results

Date PDHM is provided to recipient & recipient details, or discard date if pasteurised donor milk is not used

Date of discard of donor milk from donors who do not meet selection criteria or for milk which has not been continuously stored hard-frozen or at -18°C

Donor milk hard-frozen at dispatch

Tracking and tracing

The milk bank is responsible for tracking donated milk from the donation point through to

receipt of delivery. If delivery is to a NICU, the NICU is then responsible for tracking

pasteurised donor milk to the recipient infant.

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

pasteurised donor milk that is ready to be used.

For each donor milk batch, the following records must be kept:

About the donor:

• donor identification

• consent

• relevant medical history

• results of serological and NAT tests

About each batch before pasteurisation:

• donor identification

• pre-pasteurisation bacterial screening 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 recipient the pasteurised donor milk

• the distribution or discard date of the pasteurised donor milk

Each container of pasteurised donor milk must be labelled as per Food Standards Code

Standard 2.9.5 Food for special medical purposes. This must also include the following

information:

• a unique identification number

• instructions to “Keep frozen” and “Use within 24 hours of thawing”

• an expiry date (no later than 3 months from date of pasteurisation)

Recipients Prioritisation during supply shortage

During periods of supply shortage of pasteurised donated human milk, there should be a

stepped prioritisation that ensures infants at the highest risk will continue to have access to

pasteurised donated human milk.

Consenting for use of pasteurised donor milk

Pasteurised donor milk will only be supplied to the parent or guardian of an infant of up 12

months of age.

A signed informed consent form must be obtained from the parent or guardian. The mother

must receive support to establish and maintain her own lactation while her infant is receiving

pasteurised donor milk.

The consent form for pasteurised donor milk should be part of a broader informed consent

process, as per National Health and Medical Research Council (NHMRC) Guidelines, where

the milk bank must discuss:

• the proposed administration of pasteurised donor milk

• the expected benefits

• common side effects and material risks

• the required handling of the pasteurised donor milk.

Information should be provided in a manner that is appropriate to the parent or guardian.

A copy of the information should be given to the parent or guardian to keep.

The mother should be provided with ongoing support to establish and maintain her own

lactation while her infant is receiving pasteurised donor milk.

Managing issues Reporting and management of suspected adverse events

Any adverse events suspected to be a result of pasteurised donor milk must be reported to the

relevant authority within 24 hours of identification.

The recipient and milk bank must immediately quarantine the pasteurised donor milk causing

a suspected adverse event. This involves storing the milk container separately to non-affected

stock and clearly marking “Do not use”.

The relevant authority will arrange to collect the quarantined pasteurised donor milk directly

from the recipient for further evaluation and testing.

Managing recalls of donated human milk

Pasteurised donor milk which has been distributed may need to be recalled due to a

previously undisclosed risk to the safety of the milk. In this instance the milk bank will initiate a

batch recall of the affected product.

The milk bank is responsible for informing the recipients that have received the affected

product of the recall.

Once informed, recipients must immediately quarantine the affected product. This involves

storing the milk container separately to non-affected stock and clearly marking “Do not use”.

The milk bank will arrange to collect the recalled pasteurised donor milk directly from the

recipient.

If the recalled pasteurised donor milk has been administered the infant’s nominated general

practioner/specialist must be notified for the purposes of immediate clinical risk assessment,

management plan and open disclosure.

The milk bank will organise any required testing of the recalled pasteurised donor milk. Once

recalled, the pasteurised donor milk can no longer be used for consumption.

The milk bank is responsible for notifying Queensland Health in the event of a recall.

Managing expired or discarded pasteurised donor milk

Pasteurised donor milk can be stored hard-frozen for 3 months after pasteurisation, or for 24

hours once thawed if kept in a refrigerator.

Once the pasteurised donor milk has expired it is no longer to be used for consumption.

The bottle and batch number of any unused PDHM container discarded must be recorded for

auditing and tracing purposes in a registry. This process is not necessary for discarding

pasteurised donor milk from previously opened containers.

Appendix 1 Donor Questionnaire

Donor Questionnaire

About these questions

We will ask you some questions about your general health to help us to decide if it’s safe for

you and your baby. You should ensure the milk is excess to your baby’s needs.

All of these questions are important, and you need to answer each one honestly and the best

you can. This will ensure your safety and the safety of the babies who receive your breastmilk.

Blood testing

Your blood is tested primarily to ensure the safety of the baby who receives your breastmilk.

You should not rely on this testing for your own personal health screening purposes.

Before a donor is eligible to donate breastmilk for the first time the donor is tested for hepatitis

B, hepatitis C, HIV (AIDS virus), HTLV (human T-lymphotropic virus) and syphilis. If your

blood tests positive or shows a significantly abnormal result, we will notify you. If this is the

case, we will not use your breastmilk and you will not be eligible to continue to donate.

Donating Milk

You have the option to change your mind about donating breastmilk, though you cannot

retrieve your milk after you give it to the milk bank. Simply tell a staff member if you want to

stop donating.

Privacy statement

Your answers and anything you tell us in the interview are CONFIDENTIAL. The personal

information collected on this form allows the milk bank to register you as a breastmilk donor.

Further, your information will be used to assess your eligibility to donate breastmilk and to

enable us to contact you. De-identified information may be used for research. All information

collected will be handled in the strictest confidence in accordance with the Privacy Act 1988

(Cth).

For more information, please ask for our Privacy Policy.

On the Day

The first time you make a donation you should have photo ID with you.

Part A: New and returned donors Please complete this section only if:

• you are a new donor, or • you are a repeat donor with a new baby.

Otherwise, proceed to section B.

Have you: Yes No Comments (staff use only)

1 Ever volunteered to donate breastmilk before?

If yes, when? .

where .

2 Ever been advised not to donate breastmilk or blood?

3 Ever had a serious illness or operation requiring hospitalisation, except for a Caesarean?

4 Ever had a bowel disease, stomach or duodenal problems or ulcers?

5 Ever had kidney, liver or lung problems including tuberculosis (TB)?

6 Ever had diabetes, a thyroid disorder or an autoimmune disease e.g. rheumatoid arthritis or lupus?

7 Ever had cancer of any kind including melanoma?

8 Ever had jaundice (yellow eyes/skin) or hepatitis?

9 Been aware of anyone in your immediate family who had Creutzfeldt-Jakob disease or have you been told you are at increased risk of CJD?

10 Regularly consumed 2 or more standard drinks of alcohol more than once a week in the last six months?

11 Recently been a vegan who is not taking vitamin B12 supplementation?

Travel questions

12 Have you ever been outside of Australia?

If your answer to question 12 is ‘No’ please go straight to Section B

13 Have you ever received a transfusion or injection of blood or blood products outside Australia?

14

From 1 January 1980 through to 31 December 1996 inclusive, have you spent (visited or lived) a total time which adds up to 6 months or more in England, Scotland, Wales, Northern Ireland, the Channel Islands, the Isle of Man, or the Falkland Islands?

Part B Medical Questionnaire

15 Today and since the milk was expressed, have you been feeling well?

In the week prior to and up to expressing the donated milk, have you:

16 Had any sores or rashes on your body or your breasts including cold sores?

17 Had gastric upset, diarrhoea, abdominal pain or vomiting?

18 Consumed 1 or more standard drinks of alcohol in a single day?

19 Had a fever?

20 Consumed 4 or more caffeinated drinks (e.g. coffee, tea, cola, energy drinks) in one day?

Since your last donation, have you?

21 Had any serious illness outside of your routine pregnancy care?

22

Taken any medication, including over the counter medication, regular or clinical trial medication including herbal preparations and vitamin supplements?

23 Had any immunisations or vaccinations including as part of a clinical trial?

24 Had or been exposed to shingles or chickenpox?

25 Had any breast infections such as mastitis?

26 Been told you have been exposed to any toxic chemicals?

Since your last donation has your baby – or if you’re a new donor has your baby in the last 12 months

27 Had a serious infection or received a blood transfusion?

28 Received any form of nutrition other than breastmilk if under 4 months of age?

29 Grown poorly or not gained enough weight?

Part C Donor Declaration All donors must complete this section

There are some people who MUST NOT donate breastmilk as it may cause harm to the babies who receive it.

To determine if your donated milk will be safe, we would like you to answer some questions. All of the

questions are important to answer. Answer each question on the form as honestly as you can and to the best of your knowledge. To the best of your knowledge, have you EVER:

30 Thought you could be infected with HIV or have AIDS?

31 “Used drugs” by injection or been injected, even once, with drugs not prescribed by a doctor or dentist?

32 Had a test which showed you tested positive for hepatitis B, hepatitis C, HIV or HTLV or syphilis?

33 Engaged in sexual activity either as a sex worker or with someone you think would answer “yes’ to any of questions 1-3?

34 Been held in a prison, a lock-up or a detention centre?

35 Used any recreational/party drugs such as cannabis, speed, ice, cocaine or ecstasy?

36 Had a blood transfusion or injection of blood products (excluding anti-D)?

In the last 6 months have you:

37 Had (yellow) jaundice or hepatitis or been in contact with someone who has?

38 Had a tattoo (including cosmetic tattooing), body and/or ear piercing, electrolysis or acupuncture (including dry-

needling) or been injured with a used needle

39 Smoked cigarettes, used tobacco products, or used nicotine replacement therapy in any form e.g. gum, patches or nicotine inhalers?

This declaration is to be initialled and signed as below (Please read the following

conditions)

Thank you for answering these questions. If you are uncertain about any of your answers, please

discuss them with your interviewer.

You are required to initial and sign this declaration to show that you have understood the information on

this form and have answered the questions in the declaration to the best of your knowledge. If this is the

first time you have filled out this form this will be done in the presence of a milk bank staff member.

Should you become aware of any reason why your milk should not be used after your donation, please

call the milk bank on XXXX XXXX

In particular, notify the milk bank immediately if:

• you develop a fever, diarrhoea or other infection within a week after the milk was

expressed

• you are diagnosed or hospitalised with a serious infection within two months of donating.

Thank you for your gift of breastmilk. Most of the time it will be used to feed premature babies, though

occasionally the milk may need to be discarded for safety reasons. In some circumstances your

donation may be used by the milk bank or other organisations for the purposes of research, teaching or

quality assurance. Approval from an appropriate Human Research Ethics Committee is required before

any research is undertaken on your donation or any part of it.

Declaration

All donors must sign the declaration at each donation.

First time donors only - Please initial and sign in the presence of the interviewer.

I agree to donate my breastmilk and declare that the milk I have donated is sourced only from me. I

understand I cannot retrieve breastmilk once it has been donated by me.

I declare that I have read the donation information sheet and the blood tests for milk donors’ information

sheet and I agree to be tested as described.

I declare that I have understood the information on this form and have had the opportunity to ask

questions and that I have answered the questions in the declaration honestly and to the best of my

knowledge.

Donor, please print:

Surname/Family name: Given name:

Date of birth:

Staff check (please print) – for first time donors

Donor identify verified? Yes ☐ No ☐

Checked spelling of name? Yes ☐ NA ☐

Supplementary questions

answered? Yes ☐ No ☐

Surname/Family name: Given name:

Signature

Date / / Time

Donation number/reference:

References National Institute for Health and Clinical Excellence (2010) Donor breast milk banks: the

operation of donor breast milk bank services. London: National Institute for Health and Clinical

Excellence. Available from: https://www.nice.org.uk/guidance/cg93/evidence/full-guideline-

243964189

New South Wales Health and Australian Red Cross Blood Service Partnership Service

Protocol (September 2018) Pasteurised Donor Human Milk (PDHM) for Vulnerable Infants.

Available from: https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2018_043.pdf