Processed Donor Human Milk Notices – Donor Human Milk Banks (DHMB)

The Supply of Processed Donor Human Milk in Western Australia Code of Practice 2024 (the Code) came into effect on 19 August 2024.

Under clause 43(5) of the Code, a Donor Human Milk Bank will provide to the Chief Health Officer, no later than 14 days after occurrence, notice of any:

  • adverse event where supply of processed donor human milk has posed a serious clinical risk to donors or recipients, or
  • recall of processed donor human milk, or
  • event that poses a serious risk of disrupting the supply of processed donor human milk to eligible recipients in WA, or
  • failed audit results, or
  • if an adverse event has been notified, steps or actions undertaken by the Donor Human Milk Bank to address or mitigate risks identified from the adverse event.

Adverse event:

A non-exhaustive list of adverse events where supply of processed donor human milk has posed a serious clinical risk to donors or recipients has been provided below:

  • an event that results in death
  • an event that is life threatening
  • an event that requires hospitalisation or prolongation of existing hospitalisation
  • an event that results in persistent or significant disability/incapacity
  • an event that is the result of or related to an infectious disease
  • an event that is a medically important event or reaction
  • any incident involving clinical incident management review
Relevant legislation

The statutory requirement to make notices to the Chief Health Officer for occurrences relating to processed donor human milk is specified in clause 43(5) of the Code.

The Code is issued by the Chief Health Officer under section 32A of the Human Tissue and Transplant Act 1982 and applies to donor human milk banks prescribed under the Human Tissue and Transplant Regulations 2024 (WA) and the treating hospitals which dispense donor human milk supplied by those milk banks.

Responsibility for notification

The person or persons assigned by the Donor Human Milk Bank as administratively responsible for all Donor Human Milk Bank operations under the Code.

Who must the notice be made to?

A notice must be made to the Chief Health Officer.

How to notify
Notification may be made via the e-form Processed Donor Human Milk (PDHM) Notice Report Form

Contact

For further information, please contact:

Office of the Chief Health Officer

Department of Health

PO Box 8172

Perth Business Centre WA 6849

Telephone: 6373 3902

Email: EDPHWA@health.wa.gov.au

Last reviewed: 02-09-2024