Surgical Skills and Anatomy

Surgical Skills and Anatomy

SUMMARY

The Surgical Skills and Anatomy Policy and Procedure establishes the requirements and required activities for receipt, handling, tracking, storage and disposal of Bodies/Human Tissue in the Surgical Skills and Anatomy Centre (SSAC) in the Faculty of Medicine and Health Sciences (FMHS).

POLICY

1    PURPOSE

To specify the requirements for receipt, handling, tracking, storage and disposal of Bodies/Human Tissue in the Surgical Skills and Anatomy Centre (SSAC) in the Faculty of Medicine and Health Sciences (FMHS).

2     BACKGROUND

Macquarie University conducts teaching and research activities in the fields of health sciences, including surgical skills training, medical research and anatomy.  Some of these activities require anatomical examinations, which are carried out in the SSAC, using human Bodies/Human Tissues that have been provided for anatomical examination through its Body Donation Program or other sources.

Macquarie University recognises the magnitude and solemnity of the contribution that is made by those who donate their Bodies for medical or scientific purposes and is committed to treating the human remains entrusted to its care with the utmost respect and professionalism and in accordance with Relevant Laws and, where applicable, its Body Donation Program.

ANATOMICAL ACTIVITIES
The SSAC is used:
  • for learning and teaching in the University’s undergraduate and postgraduate courses
  • by internal and external clients running educational surgical skills workshops
  • by internal and external researchers.

Surgical skills training is analogous to human surgery using similar anatomical approaches, techniques and equipment to that used in a hospital operating theatre.

3   SCOPE

This Policy applies to all University staff, students and visitors to Macquarie University.

4     DEFINITIONS

Commonly defined terms are located in the University Glossary. The following definitions apply for the purpose of this Policy:

Anatomical examination:  the examination of a Body/Human Tissue, including the dissection of a Body/Human Tissue, for medical or scientific purposes, but not including post-mortem examination.

Anatomy Act:  the Anatomy Act 1977 (NSW).

Anatomy Licence:  a licence to conduct anatomical examinations, as issued by the Director-General of NSW Health in accordance with the Anatomy Act.

Authorised User:  a person who is authorized by any SSAC Staff member to access SSAC facilities.

Body/Bodies:  a deceased human body.

Body Register:  a register as prescribed by the Anatomy Act and that records:
  • receipt of a Body/Human Tissue
  • transfer of a Body/Human Tissue
  • disposal of a Body/Human Tissue.

Human Tissue:  part of a deceased human Body.

Inspector:  an officer of NSW Health.

Notifiable Disease:  as defined in the Public Health Act 2010 (NSW).

NSW Health:  the New South Wales Ministry of Health.

Prescribed Infectious Disease:  as defined in the Public Health Regulation 2012 (NSW).

Relevant Laws:  the Anatomy Act, the Tissue Act, the Public Health Regulation 2012 (NSW) and any associated subordinate legislation or guidelines.

Senior Available Next-of-Kin:  as defined in the Relevant Laws.

SSAC Staff:  a Macquarie University staff member employed at the SSAC.

Student:  a student of Macquarie University or another institution who requires access to the SSAC for the purpose of their training/research.

Tissue Act:  the Human Tissue Act 1983 (NSW)

Tissue Supplier:  an interstate or international Body donation facility authorized by NSW Health that holds a valid import licence from the Department of Agriculture, Fisheries and Forestry, Australian Quarantine and Inspection Service.

University:  Macquarie University.

5   POLICY STATEMENT

LEGISLATION AND LICENSING
The University will only conduct anatomical examinations, or allow other parties to do so, when the person in charge of the conduct of anatomical examinations at the university is in possession of a valid and current Anatomy Licence.

The University must comply with the terms and conditions of the Anatomy Licence.

SSAC Staff, Students and Authorised Users are required to comply with the Relevant Laws, public health and ethical standards and guidelines associated with the receipt, tracking, handling, storage and disposal of Bodies and Human Tissue.

The University must not operate the Body Donation Program unless it holds an Anatomy Licence.

The Executive Dean, FMHS is responsible for monitoring the University’s compliance with the terms and conditions of the Anatomy Licence and ensuring that the Licence is renewed on time.  The Director of SSAC is responsible for assisting the Executive Dean FMHS.

APPROVALS

Consent
The University must have the Tissue Suppliers’ approval for anatomical examinations using internationally sourced Human Tissue.

The University will only perform anatomical examinations of a Body/Human Tissue when consent has been given in accordance with the Relevant Laws, and only in accordance with the terms of that consent.

The University will only use transferred Human Tissue for anatomical examination when consent has been obtained in accordance with the Relevant Laws, and only in accordance with the terms of that consent.

The University will establish the terms of the consent from the University’s Body Donation Program Consent Forms or an equivalent form from the institution from which a Body/Human Tissue is transferred to the University.

If the Anatomical Examination is for research purposes, the research must have had prior approval of a human research ethics committee if required.

Transfer
Bodies/Human Tissue will only be transferred to another Anatomy Licence holder and only if this is in accordance with the relevant consent.

Bodies/Human Tissue will only be transferred outside New South Wales with the prior approval of an Inspector and only if this is in accordance with the relevant consent of the donor or the donor's Senior Next-of-Kin.

If a Body/Human Tissue is transferred to another Anatomy Licence Holder or outside New South Wales, when it is time for disposal it must be returned to the University for disposal in accordance with the consent of the donor.

Ethics
Where it is not clear that the Anatomical Examination is within the boundaries of consent, the matter must be referred to the Macquarie University Human Research Ethics Committee (Medical Sciences) (HREC (Medical Sciences)) for advice.

The boundaries of consent in the Body Donation Program may only be expanded after referral to the HREC (Medical Sciences) for advice.

ACCESS TO ANATOMY FACILITIES
The SSAC facilities are to be secured at all times.

Only SSAC Staff, Students and Authorised Users are permitted to access SSAC facilities.

Access and supervision of Students and Authorised Users is at the discretion of the Director, SSAC.

INDUCTION
SSAC Staff, Students and Authorised Users are required to complete an induction prior to being admitted to the SSAC if they are likely to see and/or handle a Body/Human Tissue.

RECEIPT, TRACKING, STORAGE AND DISPOSAL OF BODIES/HUMAN TISSUE

Receipt
Only SSAC Staff are authorised to receive a Body/Human Tissue.

A Body/Human Tissue will be obtained:
  • from a New South Wales institution which holds a current Anatomy Licence, or
  • internationally, from a Tissue Supplier, or
  • via the Macquarie University Body Donation Program.

A Body/Human Tissue must be screened for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C and/or such other diseases as are specified as conditions to the Anatomy Licence prior to transfer to SSAC.  If the screening for those diseases is positive, the Bodies/Human Tissue will not be accepted into the SSAC, except where the Body/Human Tissue has been bequeathed to the University under the Body Donation Program, in which case the screening will occur after the Body is accepted into the SSAC.  If that Body/Human Tissue screens positive, it must be dealt with in accordance with the Surgical Skills and Anatomy Centre Procedure.

Bodies/Human Tissue will not be accepted into SSAC if SSAC has reason to believe that the Body/Human Tissue is infected with any other Prescribed Infectious Disease or Notifiable Disease.

Storage
SSAC Staff are the only persons authorised to:
  • receive a Body/Human Tissue into the mortuary
  • retrieve a Body/Human Tissue from storage
  • return a Body/Human Tissue to storage.

Handling
SSAC Staff, Students and Authorised Users must wear appropriate personal protective equipment when handling a Body/Human Tissue.

Tracking
A Body/Human Tissue must have a unique identification number.  Human Tissue from the same Body must have the same identification number.

Disposal
A Body/Human Tissue must be disposed of within four years of the donor’s death, or according to written authorisation by an Inspector and in accordance with the Relevant Laws.

Disposal of a Body sourced within New South Wales will be in accordance with the relevant consent.

A Body/Human Tissue sourced internationally or from interstate will be disposed of in accordance with the agreement with the Tissue Supplier and the requirements of NSW Health.

Body Register
The SSAC will maintain a current and complete Body Register for five (5) years from the date of the last entry.

RECORDING OF A BODY/HUMAN TISSUE

The SSAC Director must give prior written approval for recording, by any means, of a Body/Human Tissue.

‘Recording’ includes capturing images, data or information by any electronic or other means including by use of a camera or digital recording device.

Authorised Users are not permitted to bring recording equipment into the SSAC unless such prior written approval has been obtained.

Recording is only permitted if allowed under the relevant consent of the donor or their Senior Next-of-Kin and the recording is:
  • used for diagnostic, demonstrative or teaching purposes
  • of a Body/Human Tissue that has been de-identified.

Anatomical sketches, such as those used for course notes, are permitted, provided they do not identify the donor.

6     RELEVANT LEGISLATION

Anatomy Act 1977 (NSW)
Human Tissue Act 1983 (NSW)
Public Health Act 2010 (NSW)
Public Health Regulation 2012 (NSW)
State Records Act 1998 (NSW)
National Statement on Ethical Conduct in Human Research, National Health and Medical Research Council, 2007 (Cth)

7     KEY RELATED DOCUMENTS

Surgical Skills and Anatomy Procedure
Macquarie University Body Donation Program
Australian Guideline for the Prevention and Control of Infection in Healthcare, National Health and Medical Research Council, 2010 (Cth)
Conduct of Anatomical Examinations and Anatomy Licensing in New South Wales, New South Wales Department of Health, 2011 (NSW)
Infection Control Policy, 2007 NSW Health (NSW)

8    NOTES

8.1
Contact Officer
Director, Surgical Skills and Anatomy Centre, Faculty of Medicine and Health Sciences
8.2
Implementation Officer
Director, Surgical Skills Training
8.3
Approval   Authority / Authorities
Deputy Vice-Chancellor (Academic)
8.4
Date   Approved
10 July 2013
8.5
Date   of Commencement
10 July 2013
8.6
Date   for Review
July 2016
8.7
Documents Superseded by this Policy
Nil
8.8
Amendment   History
November 2015 – updated ASAM to Faculty of Medicine and Health Sciences; updated Approval Authority from DVC (Provost); alignment with new Policy Framework template

PROCEDURE

1 PURPOSE

To specify the activities for receipt, tracking, handling, storage and disposal of Bodies/Human Tissue in the Surgical Skills and Anatomy Centre (SSAC) in the Faculty of Medicine and Health Sciences (FMHS).

2     SCOPE

This Policy applies to all University staff, students and visitors to Macquarie University.

3     DEFINITIONS

Commonly defined terms are located in the University Glossary. Definitions specific to this Procedure are contained in the accompanying Policy.

4     RESPONSIBILITIES AND REQUIRED ACTIONS

This procedure requires actions by the following:

  • Authorised User
  • Executive Dean, Faculty of Medicine and Health Sciences
  • Director, SSAC
  • Human Research Ethics Committee (Medical Sciences)
  • Staff Member (SSAC)

The procedure covers the following activities:

  • Oversight of the Anatomy Policy and Body Donation Program
  • Obtain and maintain anatomy licence
  • Monitor compliance
  • Induction into SSAC
  • Obtain consent
  • Receive delivery of a Body/Human Tissue
  • Transfer a Body/Human Tissue
  • Dispose of a Body/Human Tissue
  • Approve an application for recording an anatomical examination or      body/human tissue
  • Report illegal activity
  • Access to the SSAC
  • Track/store/transport a Body/Human Tissue

HUMAN RESEARCH ETHICS COMMITTEE (Medical Sciences)

Oversight of the Anatomy Policy and Body Donation Program
When requested by the Executive Dean, FMHS and/or the Director SSAC, advise on whether or not new areas of teaching or research go beyond the established boundaries of consent given under the University’s Body Donation Program.

When requested by the Executive Dean, FMHS  and/or the Director SSAC, advise on reviews of the terms of the Body Donation Program Consent forms.

DIRECTOR, SSAC

Obtain and Maintain Anatomy Licence
Obtain a current Anatomy Licence to conduct anatomical examinations from NSW Health.

When the named Anatomy Licence holder is absent for more than three (3) months, apply to NSW Health for reissue of the Anatomy Licence in the name of the holder’s delegate.

Monitor the University's compliance with the Licensing provisions and the Relevant Laws and ensure that the University retains or, where necessary, updates its Anatomy Licence.

Monitor Compliance
Ensure the Body Donation Program and Anatomical Examinations are conducted in accordance with:

  • the Relevant Laws
  • the Anatomy Licence
  • the University’s contractual obligations to third parties, in particular the terms and conditions of a Tissue Supplier
  • consents to Anatomical Examinations.

Induction
Ensure that all SSAC Staff, Students and Authorised Users are provided with the relevant induction into the SSAC.

Obtain Consent
View consent to use a Body/Human Tissue as follows:

  • on receipt of donated Body/Human Tissue
  • prior to using a donated Body/Human Tissue for any Anatomical Examination, view relevant consent for the procedures that may be applied. The consent may be:
    • a Body Donation Program Consent Form
    • an equivalent consent/agreement form obtained from the Anatomy Licence holder; or
    • documented in the terms and conditions of the Tissue Supplier from which a Body/Human Tissue has been procured or transferred.
    • in the event that a new area of consent arises - eg where it is believed that an activity will go beyond the consent, refer the matter to the University’s Human Research Ethics Committee (Medical Sciences) for advice
  • if consent is revoked by a donor, complete the section at the bottom of the revocation form acknowledging that receipt of the revocation has been received and return a copy to the donor.

Receive Delivery of a Body/Human Tissue
Coordinate the receipt of a Body/Human Tissue from the contracted funeral director or Tissue Supplier, as appropriate.

Ensure that a Body/Human Tissue is delivered to SSAC for verification and receipting purposes.

Prior to accepting a Body/Human Tissue into the SSAC, ensure that:

  • the Body has been delivered by an accredited funeral director in accordance with the Anatomy Act or in the case of tissue sourced internationally or from interstate, the tissue is delivered by an approved courier
  • the Body/Human Tissue is accompanied by all necessary documentation pertaining to the consent/authority to conduct an anatomical examination
  • the Body/Human Tissue is consistent with the accompanying paperwork, as far as can be determined by visual inspection
  • the transfer of Bodies/Human Tissue into the SSAC is conducted discreetly
  • the required screening for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C and any other prescribed infectious disease has been performed prior to or on receipt of the Body/Human Tissue
  • an infected Body/Human Tissue received through the Macquarie University Body Donation Program is quarantined in accordance with any Relevant Laws and not used for teaching/research and NSW Health is notified
  • there is sufficient storage capacity to take the Body/Human Tissue.

On accepting a Body/Human Tissue:

  • complete a numbered identification tag and attach this to the Body/Human Tissue
  • record all prescribed details pertaining to receipt of the Body/Human Tissue, in the Body Register
  • place the Body/Human Tissue in the refrigerator/freezer storage, where the Body/Human Tissue remains until required.

After receiving a Body/Human Tissue that SSAC has reasons to believe is infected with a prescribed infectious disease, clearly label the body bag “prescribed infectious disease – handle with care” before removing the Body/Human Tissue from SSAC in accordance with the Australian Guidelines for the Prevention and Control of Infection in Health Care.

Transfer
Transfer a Body/Human Tissue to another Anatomy Licence holder within NSW only if this is in accordance with the relevant consent or Tissue Suppliers’ terms and conditions.

Transfer a Body/Human Tissue to a licence holder outside NSW only if approval has been received from NSW Health.

Ensure the University retains control over the disposal of Bodies/Human Tissue.

Dispose of a Body/Human Tissue
Arrange for the disposal of the Body/Human Tissue in accordance with the Relevant Laws and, as far as possible, with the relevant consent.

Body sourced in New South Wales
Co-ordinate collection of a Body with the funeral director. Schedule collection to ensure the Director, SSAC, or SSAC Staff delegate is present at the time of collection.

At the time of collection of a Body, ensure the Funeral Director is provided with:

  • a Medical Certificate of Cause of Death
  • an Attending Physician’s Cremation Certificate
  • a Transfer Authority Form for ashes collection
  • any additional documentation relevant to the wishes of the deceased.

Immediately following collection of the Body:

  • update the Body Register, ensuring that details of any disposed Body/Human Tissue are clearly described in accordance with the Relevant Laws
  • where applicable, notify the Anatomy Licence holder from which the Body was procured of the actions that have been taken in disposing of the Body.

For a locally donated Body, when requested in the consent forms, notify the Senior Available Next-of-Kin when cremation has taken place and when the ashes are available for collection.

Body/Human Tissue sourced from Tissue Supplier
In order to cremate Human Tissue obtained from a Tissue Supplier:

  • submit a written application to NSW Health requesting permission to dispose of the identified Body/Human Tissue
  • place the identified Body/Human Tissue in a coffin
  • provide the funeral director collecting the coffin with a copy of the letter of authority from NSW Health.
  • update the Body Register, ensuring that details of any disposed Body/Human Tissue are clearly described in accordance with the Relevant Laws.

Approve an Application for Recording an Anatomical Examination of Body/Human Tissue
On receiving a Recording Agreement – Anatomy Laboratory form, check that:

  • the application is complete and clearly addresses each of the requirements
  • the relevant consent has been provided.

Then either:

  • return the application for completion/clarification
  • reject an application and advise the applicant in writing
  • approve the application.

Report Illegal Activity
Instruct a user who is authorized to be in the SSAC and is acting unlawfully or inappropriately to leave the SSAC, if appropriate.

If there is any activity that directly or indirectly breaches State or Commonwealth law, report illegal activity to the appropriate authorities (eg the police). Inform the Manager, Security Services, in all cases of potential offences under the Crimes Act 1900 (NSW).

Liaise with external bodies, including law enforcement agencies, as needed.

Oversight of the Anatomy Policy and Body Donation Program
Provide advice to the Executive Dean, FMHS and seek advice from the HREC (Medical Sciences) as necessary.

In consultation with the Executive Dean, FMHS and other SSAC Staff, conduct regular and ongoing reviews of the terms of the Body Donation Program to ensure that it:

  • encompasses all Anatomical Examinations conducted or to be conducted at the University, and
  • addresses statutory requirements.

Disposal of Records
Records relating to the Anatomy Licence (including applications for the Anatomy Licence) may be disposed of one (1) year after expiry.

The Body Register may be destroyed after five years from the date of transfer or disposal of a Body or Human Tissue.

Records relating to the acquisition, storage, maintenance and management of Bodies or Human Tissue may be disposed of one (1) year after the transfer or disposal of the Body or Human Tissue.

All other records must be retained as required by the State Records Act 1998 (NSW) and disposed of as authorised by that Act.

STAFF MEMBER, SSAC

Grant access to the SSAC only if able to confirm:

  • the identity of the individual seeking access
  • the individual's authority to gain access
  • that appropriate supervision is in place, where required.

Ensure that all users wear appropriate personal protective equipment.

Students
Prior to granting a Student access to the SSAC:

  • confirm a Student's formal enrolment in a relevant unit
  • verify a Student's identity against their Student identification card
  • ensure that a Student completes or has completed induction
  • supervise a Student at all times or ensure supervision is in place.

Do not grant access to the SSAC to a Student who is not formally enrolled in a relevant unit or who fails to produce a valid Student identification card. Accept no other form of identification.

Contractors
Admit contractors only if they:

  • have booked repairs and general maintenance through the Director, SSAC
  • have completed an induction in order to be granted access to the SSAC
  • carry formal photographic identification with them during the course of the repairs or maintenance
  • present their formal photographic identification on each entry to the SSAC and/or upon request of the Director, SSAC or a campus security officer.

Auditors/Inspectors
Admit auditors/inspectors as follows:

  • confirm the identity of the auditor/inspector by sighting their staff identification card
  • confirm that each auditor/inspector has completed the necessary induction
  • confirm that supervision is in place to monitor and assist the auditor/inspector while they are in the SSAC.

Departure of admitted parties
Supervise an admitted party until such time as:

  • supervisor responsibility is handed to another SSAC Staff member, or
  • the admitted party has departed the facility.

Secure the SSAC following the departure.

Track/Store/Transport a Body/Human Tissue
Track
Allocate an identification number to each Body/Human Tissue received into the SSAC, so that the SSAC Staff and the Inspector can identify all Bodies/Human Tissue and cross reference with the Body Register.

Tag each Body part with the Body's identification number as the Body is dissected. Immediately following the dissection, update the Body Register with details of the dissection. Replace a tag which is removed, lost or damaged.

Store
On completion of an anatomical examination, place a Body/Human Tissue in appropriate storage equipment in accordance with the Relevant Laws.

Remove a Body/Human Tissue from storage:

  • when required for anatomical examination
  • to enable repairs, maintenance or upgrade of facilities
  • in preparation for disposal
  • to satisfy requirements of an internal audit
  • to satisfy requirements of an external inspection conducted by an Inspector
  • as otherwise required by Relevant Laws.

When retrieving a Body/Human Tissue from storage, adhere to any applicable safe work procedure.

On retrieving a Body/Human Tissue from storage, prior to handling any other Body or Human Tissue, ensure that the identification tag is firmly affixed to the Body or bag.

Handling
Handle and arrange transportation of Bodies/Human Tissue in accordance with the Public Health Regulation 2012 (NSW) and the Australian Guidelines for the Prevention and Control of Infection in Healthcare published by the National Health and Medical Research Council.

Dispose of a Body/Human Tissue
Retain the Body/Human Tissue for the period specified in the relevant consent, Relevant Laws or as permitted by NSW Health.

Defer Disposal of a Body / Human Tissue
Where the need arises and consent is available, submit via the Dean, ASAM or nominee a request to NSW Health to extend the approved retention period. Submit all requests at least six months in advance of expiry of the approved retention date to ensure the SSAC receives a decision before the approved retention date lapses.

Upon receipt of written approval to extend the retention date from NSW Health, update the Body Register to reflect the amended retention details.

In the event that NSW Health refuses to grant the extension, arrange disposal of the Body/Human Tissue in accordance with the Relevant Laws.

Prepare for Disposal
Re-unite all Human Tissue from a Body in preparation for disposal, except where:

  • the Human Tissue is sourced from a Tissue Supplier which allows Human Tissue to be disposed of separately
  • the University has obtained written consent to permanently retain the Human Tissue
  • the Human Tissue being retained is a small sample of Human Tissue, in the form of tissue slides or tissue blocks that enable microscopic examination of the tissue
  • Tissue is removed during prosection and not identifiable (refer to NSW Health Policy Directive [PD2011_052])

AUTHORISED USER

Induction
Participate in appropriate induction before entering the SSAC.

Personal Protective Equipment (PPE)
Ensure that PPE is worn while conducting or participating in anatomical examinations.

Report Distress
Inform SSAC Staff as soon as possible when experiencing anxiety, distress or grief when

  • first encountering a Body/Human Tissue, or
  • recognising a Body as a person known prior to that person's death (eg a relative, friend or neighbour).

Apply to Record an Image of a Body/Human Tissue
Submit a completed Recording Agreement – Anatomy Laboratory form to the Director, SSAC to request approval to record an image of a Body/Human Tissue.

EXECUTIVE DEAN, FMHS

Oversight of the Anatomy Policy and Body Donation Program

Monitor:

  • the University’s compliance with the Anatomy Policy and this Procedure and all Relevant Laws, including compliance with the conditions of the Anatomy Licence; and
  • the University’s Body Donation Program.

5     RELEVANT LEGISLATION

Anatomy Act 1977 (NSW)
Crimes Act 1900 (NSW
Human Tissue Act 1983 (NSW)
Public Health Act 2010 (NSW)
Public Health Regulation 2012 (NSW)
NSW Health Policy Directive PD2011_052: Conduct of Anatomical Examinations and Anatomy Licensing in NSW
NSW Health Policy Directive PD2007_036: Infection Control
Australian Guidelines for the Prevention and Control of Infection in Healthcare 2010

6     KEY RELATED DOCUMENTS

Surgical Skills and Anatomy Policy
Macquarie University Body Donation Program

7     NOTES

7.1
Contact Officer
Director, Surgical Skills and Anatomy Centre
7.2
Implementation Officer
Director, Surgical Skills Training
7.3
Approval Authority / Authorities
Deputy Vice Chancellor (Academic)
7.4
Date Approved
10 July 2013
7.5
Date of Commencement
10 July 2013
7.6
Date for Review
July 2016
7.7
Documents Superseded by this Procedure
Nil
7.8
Amendment History

14 February 2017 – updated information required for funeral directors, removed reference to Dean ASAM

November   2015 – updated ASAM to Faculty of Medicine and Health Sciences; updated   Approval Authority from Director SSAC; aligned with Policy Framework   template.

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