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Anatomical examination

What is an anatomical examination?

Anatomical examination is where  a body or parts of a body, such as organs, are cut apart to allow a person to look at the inside of the body or body part. Anatomical examination may take place as part of research, education or training for health professionals.

Who can conduct anatomical examinations in NSW?

Under the Anatomy Act 1977 (NSW)only a person who holds a licence to practice anatomy (or their delegates) may conduct anatomical examinations.

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Applying for a licence for anatomy teaching, training, and research

 

How do I apply for a licence?

Written applications for an anatomy licence must be submitted to the Secretary, NSW Health.

An application is submitted by a person who oversees anatomical examinations conducted at an educational, medical or research facility.

Is there an application form?

An Application to conduct anatomical examinations can be completed.

Who approves and issues a licence?

The Secretary, NSW Health.

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What happens when my application is received?

The NSW Ministry of Health’s Regulatory and Compliance Unit will advise the local anatomy inspector to contact the applicant to arrange an inspection before assessing the application.

The time frame for assessing applications and issuing an anatomy licence may vary (often between two weeks to a month). Time frames are dependent on the complexity of the facility and the current workload experienced by the local public health unit.

What will the audit by the local anatomy inspector involve?

The inspection will involve:

  • an audit of the physical environment of the facility and
  • a review of the policies and procedures of the facility and the register of specimens.

After auditing the facility, an inspection report is forwarded to the NSW Ministry of Health's Regulatory and Compliance Unit with a recommendation to issue a licence or not. A licence may be issued with standard or additional conditions, depending on the outcome of the report.

The Anatomical examination inspection checklist includes a comprehensive overview of the inspection process.

How long will it take to assess my application?

The time frame for assessing applications and issuing an anatomy licence may vary (often between two weeks to a month). Time frames are dependent on the complexity of the facility and the current workload experienced by the Public Health Unit.

How long is a licence valid for?

An anatomy inspector determines how long a licence is valid based on their assessment of the inherent risk of a facility and compliance observed during an inspection. Newly issued licences will include an expiration date.

The risk assessment to determine the duration of licence and frequency of inspection is as follows:

  • Low/no risk: three-year licence (low or no inherent risks identified, and no non-compliances observed during the inspection).
  • Medium/some risk: two-year licence (the laboratory includes wet processes and anatomical examinations of human tissue and specimens with low to medium risks).
  • High risk: one-year licence (the laboratory primarily includes wet processes and examinations of human tissue and specimens that present a higher level of risk and the need to employ comprehensive infection control procedures. Also, several non-compliances were identified during the laboratory inspection with consequent breaches of the Anatomy Act 1977 (NSW) and Human Tissue Act 1983 (NSW)).

Holding an anatomy licence

The person who holds the anatomy licence at our facility is leaving. Do we need to apply for a new licence?

The Secretary, NSW Health must be notified in writing of any change to the designated licence holder of an institution. For example, if a licence holder no longer works at the licensed facility or has moved to another area within the same organisation.

A re-issue of a licence can be requested at any time to accurately reflect changes to staff or duties within the licensed facility. Re-issuing a licence should be considered when the current licence holder will be absent from their regular duties for a period of time greater than three months.

 

I hold an anatomy licence in NSW and would like to use a body from an anatomical licence holder in another Australian state/territory. What do I need to do?

Bodies or tissues acquired from interstate facilities must meet:

Applicants who source tissue from interstate institutions are responsible for obtaining documentation from the supplying institution that shows that the acquired tissue meets these standards.

All documentation and details of bodies/tissues acquired from overseas institutions must be added to the anatomy register and be available for audit by the anatomy inspector.

Examples of a Register of anatomical specimens and a Register for the transfer of anatomical specimens are available.

 

I hold an anatomy licence in NSW and would like to use a body or human tissue from another NSW anatomy licence holder. What do I need to do?

NSW anatomy licence holders can transfer bodies to other anatomy licence holders within NSW without prior approval from an anatomy inspector. The details of the transfer must be entered into the anatomy register and be available for audit by the anatomy inspector.

However, a licence holder cannot transfer the body if they believe that doing so would be against the wishes of the deceased or the senior available next of kin of the deceased person.

 

Re-applying for a licence

Can we apply for an extension if our anatomy licence is about to expire?

It is suggested that licence holders wishing to renew a licence reapply for their licences at least three months in advance to avoid licences lapsing during the assessment period.

An Application to conduct anatomical examinations should be completed.

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Inspecting a licensed anatomy facility

What is an inspection audit?

Inspection audits assess the physical environment of the facility, review the policy and procedure protocols of the facility, and the register of specimens.

The licence holder (or prospective licence holder) must be available at the location to ensure compliance and supervision.  

The Anatomical examination inspection checklist includes a comprehensive overview of the inspection process.

How frequently are licensed anatomy facilities inspected?

The frequency of inspections corresponds to the duration of the licence. For example, if a licence holder is issued a three-year licence, this means the licence facility will be inspected in three years from the time of issue. Facilities are notified of the day and time of the inspection. 

However, anatomy inspectors can inspect a licensed facility at any time.

What do anatomy inspectors look for when inspecting a facility?

The inspector audits the physical environment of the licensed facility and reviews its policy protocols (for example, policy for handling infectious bodies) and the register of specimens.

 The inspection will involve:

  • ensuring the designated holder of the licence is still applicable.
  • ensuring compliance with any standard and additional licence conditions.
  • reviewing the register of specimens to ensure it conforms with the requirements of the Anatomy Act 1977 (NSW); and
  • ensuring the facility conforms to required standards related to body preparation, waste disposal, management of chemicals, storage, anatomy rooms and security.

Are anatomy facilities advised of the anatomy inspector’s findings?

Yes. After each inspection a report is sent to the facility that may include recommendations to ensure compliance with licence conditions and/or the requirements of the Anatomy Act 1977 (NSW).

The report is also sent to the​ NSW Ministry of Health's Regulatory and Compliance Unit as part of the assessment of a licence (or re-issuing a licence) application. Anatomy inspectors continually monitor facilities to follow up on the progress of any recommendations.

Use of donated bodies and tissues

I have the body of a child and I have consent to use it for anatomical examination. Can I use it?

If the body of the child is not that of a child who was in the care of the state, you may use the body for anatomical examination. However the use of a body is subject to any specific conditions that the donor may have given as part of their consent. For example, parents may donate the body of their stillborn child to a program with the condition that it is to be used specifically for the purpose of teaching midwifery students.

A person must not authorise the anatomical examination of the body of a child if the child was, immediately before his or her death, in the care of the State.

I have an anatomy licence. Can I store human and animal tissue for anatomical examination in the same place?

NSW Health has allowed human and animal anatomical material to be stored and used within the same licensed facilities if an anatomy inspector is satisfied that the facility can meet these requirements:

  • the animal tissue is stored separately to the human tissue
  • the animal tissues are disposed of separately to the human tissue
  • appropriate infection control policies are in place and infection control is always maintained.

I would like to use a body or tissues from a donated body from an overseas institution for anatomical examination. What do I need to do?

Bodies or tissue acquired from international institutions must meet the consent and other provisions of the Anatomy Act 1977 (NSW) and the relevant policy requirements outlined in

PD 2023_044  Anatomical Examinations and Anatomy Licensing.

Applicants who source bodies and/or tissue from overseas are responsible for obtaining documentation from the supplying institution that shows that the bodies and/or tissue meets the NSW standards. All documentation and details of bodies and/or tissues acquired from overseas institutions must be added to the anatomy register and available for audit by the anatomy inspector.

For how long can I retain a body?

A body can be retained for a maximum of four years. An application may be made for an anatomy inspector to authorise the retention of a body for an additional four years. The body must be disposed of within eight years from the date of death of the deceased.

Is there a time limit for disposing tissue?

The time limit for retention of tissue is similar to retaining a dead body.

If there is written consent by the deceased for the permanent retention of tissue, then there is no need to dispose of the tissue. Where consent to permanently retain tissues has not been given and the wishes of the deceased are unknown, the senior available next of kin may consent in writing to permanently retain the tissues.

If there is either no consent for permanent retention or the senior next of kin does not give consent, then the tissue must be disposed of within the timeframes given above.

This requirement for disposal does not apply to the retention of small samples of tissue in the form of tissue blocks and slides.

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One off workshops/meetings/forums

I plan on using a body for a medical exhibition or a conference. Can I get a time limited licence?

Yes. Licences may be issued for a one-off event or for a limited time, for example for a conference or exhibition. An application is required which addresses the criteria set out in PD 2023_044 Anatomical Examinations and Anatomy Licensing in NSW.

As an inspection of the conference/exhibition venue may be necessary, individuals or institutions wishing to apply for one-off licences should ensure that they apply well in advance of the event.

I do not hold an anatomy licence but I would like to use a body for a surgical skills workshop. What do I need to do?

You will need to apply for a licence from the Secretary, NSW Health and comply with the Anatomy Act 1977(NSW) as well as other relevant laws. The process for this is set out in PD 2023_044 Anatomical Examinations and Anatomy Licensing in NSW. Your application should include an outline of the activities that you propose to undertake, the facility which you propose to use and how the body will be stored, accessed and disposed.

I would like to use a body for research. What do I need to do?

To use a human body for research you will need to apply for a licence from the Secretary, NSW Health and comply with the Anatomy Act 1977(NSW) as well as other relevant laws. Your 'Application to conduct anatomical examinations' should include an outline of the activities that you propose to undertake, as well as how the body will be stored, accessed and disposed. For more details see PD 2023_044 Anatomical Examinations and Anatomy Licensing in NSW.

Found specimens

Our anatomy facility has found a number of older anatomical specimens without any provenance or documentation. Is the facility able to add these specimens to their anatomy register?

Specimens that are found without consent documentation or other proof of donation should be reported to the anatomy inspector. Options that may be considered include discussion about whether the specimen can be potentially used for teaching purposes, retained, or appropriately disposed of.

​I would like to dispose of unidentified human remains. What do I need to do?

Facilities wishing to dispose of unidentified human remains (including tissue) in their possession may make an application to the Coroners Court requesting 'authorisation for disposal' in accordance with s.101 of the Coroners Act 2009.

Prior to making an application, facilities are required to:

  • make detailed inquiries regarding the origins of the unidentified human remains to try and determine their identity; and
  • update (to the extent possible) and maintain a record of the unidentified human remains in their register.

Where human remains are unable to be identified after making the inquiries referred to above, then an application can be made to the Coroners Court for a s.101 Disposal Order.

An application to the Coroners Court for a s.101 Disposal Order is to include, at a minimum, the following information:

  • a description of the unidentified human remains and their current storage arrangements;
  • all information or records held or obtained concerning the acquisition and use of the unidentified human remains;
  • where the facility is a licence holder under s.6 of the Anatomy Act 1977, confirmation from the facility as to whether there is any record of authorisation being issued to an anatomy licence holder under the Anatomy Act 1977 (e.g. under ss. 8, 8A, 12(2) or 12(5)) to retain the unidentified human remains;
  • details of all inquiries made by the facility (including the date of those inquiries and the outcome of those inquiries) as to the provenance of the unidentified human remains, including:
    • details and results of inquiries made to locate any records regarding the unidentified human remains concerning functions exercised pursuant  to the Anatomy Act 1901 or the Anatomy Act 1977 (e.g. records relating to quarterly returns provided to the Registrar-General by inspectors under s.9 of the Anatomy Act 1901); and
    • any other relevant inquiries.
  • any other information which may assist the Coroners Court to consider the application for a s.101 Disposal Order.

Applications for a s.101 Disposal Order are to be lodged with the Coroners Court, accompanied by all information, by email lidcombe.coroners@justice.nsw.gov.au [Attention: State Coroner] or post at Coroners Court, 1A Main Avenue, Lidcombe NSW 2141. 

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Current as at: Wednesday 15 May 2024