introduction - department of health,...

17
Introduction These Guidelines for the governance of schools of anatomy in Victoria (Guidelines) were prepared to clarify the responsibilities of Victorian schools of anatomy (SoA) under the Human Tissue Act 1982. During 2009 representatives of all SoAs throughout Victoria were consulted and an overview of current practices obtained. A number of recommendations were adopted that clarify the basic operational requirements for SoAs and provide a framework for improved self-regulation and quality assurance. A companion document, Audit and evaluation tool for schools of anatomy in Victoria, has also been prepared. This is designed to assist SoAs and Inspectors of Anatomy in ensuring that agreed processes and operational requirements are being consistently implemented across all schools. The tool provides a checklist that can be used for both internal monitoring and review as well as formal audit that will meet the authorisation requirements of the Human Tissue Act. Purpose 1. To document the process and operational requirements for SoAs in Victoria from a governance perspective. 2. To identify recommendations to be: (i) incorporated into a new set of universal standards for the gazettal, inspection and review of SoAs in Victoria by the Inspector of Anatomy; and (ii) the basis for an audit tool for use by the Inspector of Anatomy. 1. Sourcing cadaveric material for use by schools of anatomy The University of Melbourne Body Donor Program (BDP) currently operates as the principal source of cadaveric materials for use by SoAs in Victoria. There is currently no barrier to SoAs in Victoria sourcing cadaveric materials from interstate. It is important to ensure there is accountability in the use of cadavers for the study and teaching of anatomy and that a mechanism for ensuring appropriate use of cadavers by SoAs is in place from the time of application (to use cadaveric materials). The University of Melbourne BDP is the only BDP in Victoria, and SoAs in Victoria should source their cadavers from this program in the first instance in order to ensure compliance with requirements under the Human Tissue Act. Use of cadavers from other sources (for example, interstate BDPs) must meet appropriate standards of practice (for example, consent, and declaration of intended use, identification and tracking of body parts). It is a Victorian jurisdictional responsibility under the Human Tissue Act to ensure appropriate standards are met. Applications for use of cadaveric materials are currently made to the University of Melbourne Body Donor Programme (UMBDP). Guidelines for the governance of schools of anatomy in Victoria October 2014 Department of Health

Upload: others

Post on 09-Apr-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

Introduction These Guidelines for the governance of schools of anatomy in Victoria (Guidelines) were prepared to clarify the responsibilities of Victorian schools of anatomy (SoA) under the Human Tissue Act 1982. During 2009 representatives of all SoAs throughout Victoria were consulted and an overview of current practices obtained. A number of recommendations were adopted that clarify the basic operational requirements for SoAs and provide a framework for improved self-regulation and quality assurance.

A companion document, Audit and evaluation tool for schools of anatomy in Victoria, has also been prepared. This is designed to assist SoAs and Inspectors of Anatomy in ensuring that agreed processes and operational requirements are being consistently implemented across all schools. The tool provides a checklist that can be used for both internal monitoring and review as well as formal audit that will meet the authorisation requirements of the Human Tissue Act.

Purpose 1. To document the process and operational requirements for SoAs in Victoria from a governance perspective.2. To identify recommendations to be: (i) incorporated into a new set of universal standards for the gazettal,

inspection and review of SoAs in Victoria by the Inspector of Anatomy; and (ii) the basis for an audit tool foruse by the Inspector of Anatomy.

1. Sourcing cadaveric material for use by schoolsof anatomy • The University of Melbourne Body Donor Program (BDP) currently operates as the principal source of

cadaveric materials for use by SoAs in Victoria. There is currently no barrier to SoAs in Victoria sourcingcadaveric materials from interstate.

• It is important to ensure there is accountability in the use of cadavers for the study and teaching of anatomyand that a mechanism for ensuring appropriate use of cadavers by SoAs is in place from the time ofapplication (to use cadaveric materials).

• The University of Melbourne BDP is the only BDP in Victoria, and SoAs in Victoria should source theircadavers from this program in the first instance in order to ensure compliance with requirements under theHuman Tissue Act. Use of cadavers from other sources (for example, interstate BDPs) must meetappropriate standards of practice (for example, consent, and declaration of intended use, identification andtracking of body parts). It is a Victorian jurisdictional responsibility under the Human Tissue Act to ensureappropriate standards are met.

• Applications for use of cadaveric materials are currently made to the University of Melbourne Body Donor Programme (UMBDP).

Guidelines for the governance of schools of anatomy in Victoria

October 2014

Department of Health

Page 2: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

• All applications to the UMBDP are currently reviewed by the Department of Anatomy and Neuroscience Anatomy Committee, endorsed by the head of department, and reviewed by the departmental HEAG (Human Ethics Advisory Group), which reports to the central University of Melbourne Human Research Ethics Committee.

• When sourcing cadaveric material from overseas or interstate, SoAs are responsible for ensuring thatdocumentation relating to chain of custody, validity/scope of donor consent, disease screening andarrangements for handling remnant cadaveric material and disposal of hard and soft tissue are clear andagreed.

• The Inspector, Schools of Anatomy, should be informed of the above.

• There is no legal or ethical reason why human tissue cannot or should not be sourced from overseas for the purpose of studying anatomy.

• The broad principles outlined in these criteria for inspection of schools should apply to all tissue regardless of its origin.

• Where an SoA is sourcing cadaveric material from a place other than the University of Melbourne BDP thenthat other material is to be kept identifiable and distinct from that of material originating from the university’sBDP.

With respect to overseas and interstate sourced tissue: • Evidence of an appropriate governance system for accessing human tissue from the source country is

required.• Any human tissue donor requirements that are specified by the donor or donor’s family are to be adhered to.• The recipient of human tissue must ensure all costs associated with acquiring the tissue are clearly made on

a cost-recovery basis only and that payments made are not for the tissue itself. Appropriate costs meanpayment for the acquisition, treatment, storage, transport and disposal of the tissue.

• The heads of SoAs are responsible for obtaining documentation indicating that tissue has been obtained ona cost-recovery basis.

Recommendations

1. The University of Melbourne BDP continues to be recognised as the principal program for sourcing cadavericmaterials for use by SoAs in Victoria.The current application requirements for acquiring and using cadaveric materials by SoAs through theUniversity of Melbourne BDP be retained and universally required.

2. Where a SoA intends to or has obtained cadaveric material from a source other than the UMBDP, the Head of School should notify the Inspector that they intend to be or are in possession of such material and that in being so, they are otherwise in compliance with the requirements of the Human Tissue Act and the Guidelines. Applications to the University of Melbourne BDP for use of cadaveric materials will be reviewed by the Department of Anatomy and Neuroscience HEAG (human ethics advisory group) for approval.

3. The University of Melbourne has a requirement to cremate two-thirds of a body. It is imperative that thisinclude at least two-thirds of the skeleton and two-thirds of associated soft tissue to ensure a suitable volumeof ashes is obtained at cremation. Should this require clarification, please contact the Department ofAnatomy and Neuroscience, The University of Melbourne. Where practicable, all human tissue waste shouldbe returned to the University of Melbourne with the individual donor specimen(s) from which it was sourced.

Page 2 Department of Health

Page 3: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

2. Transportation protocolsBasic requirements • Standard procedures for transporting cadaveric materials must ensure optimum security arrangements are in

place that facilitate the tracking and monitoring of all body parts. Transporting body parts creates risks thatthe chain of custody will be broken.

• The University of Melbourne BDP uses a single funeral director (Lonergan and Raven) for all transportrequirements. Subcontracting of transport is generally not acceptable; however, when a donor dies in aVictorian country location, the University of Melbourne BDP may opt to use a subcontracted funeral director,but only on prior advice from Lonergan and Raven.

• All specimens must be fully labelled for transport, with a description of the specimen and identifier linked tothe University of Melbourne BDP cadaver number.

• All specimens despatched from the University of Melbourne BDP must be returned to the university’s BDPusing the university’s funeral director.

• The transfer of all human specimens from the University of Melbourne BDP requires a record of the dispatch and receipt of all specimens as intended.

• The return transfer of all human specimens to the University of Melbourne BDP also requires a record of the dispatch and receipt of all specimens as intended.

• Transportation arrangements for cadaveric specimens (including potted specimens) between campuses ofthe same university are currently variable across institutions.

Transportation of cadaveric materials across state borders • Managing the conditions of use of cadavers or body parts transferred across state borders will principally be

the responsibility of the jurisdiction from which the specimen is sourced. This relates to the consentarrangements entered into through the relevant BDP.

• The Victorian Inspector of Anatomy is required to oversee the handling of cadaveric materials by SoAs inVictoria including those that have been sourced from interstate or overseas. In such cases, SoA must eitherhave copies of the consent conditions relating to cadavers or a notice from the source jurisdiction that noconstraints were placed by consent on the use of the cadavers for teaching and study. These documentsshould be available to the Inspector upon request.

• Victorian SoAs sourcing cadaveric materials from interstate are responsible for ensuring the intended use ofthose materials is adhered to.

• Documentation that monitors all uses of such cadaveric materials and the chain of custody for thesematerials must be maintained.

Recommendations 1. A memorandum of understanding (MoU) or other written agreement must be completed between any

interstate BDP and any Victorian SoA in receipt of cadaveric materials from interstate. The purpose of thisagreement/MoU is to ensure and document: that the transportation of body parts from interstate to anyVictorian SoA is only for the intended purpose; that all basic transportation requirements (as per section 2aabove) are met; that full written donor consent is in place; and, that a chain of custody in managing therespective body parts is guaranteed, including full identification and registration of all specimens through thereceiving SoA.

2. The above written agreement should provide evidence that the Inspector of Anatomy (or equivalent) from thestate of origin of the cadaveric material(s) has approved the body part(s) being sent to Victoria.

Page 3 Department of Health

Page 4: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

3. Transportation of cadaveric specimens (including potted specimens) within campuses of the same universityshould be managed by that university. However, such transportation must occur in a secure manner that isout of public view.

4. Transportation of cadaveric materials between campuses or within campuses that involves any security riskor risk of public exposure must be undertaken by Lonergan and Raven funeral directors.

3. Management of plastinated specimens• Plastinated specimens are impregnated in silicone (or other curable polymer) and are not considered as wet

specimens. They are able to be retained permanently as teaching resources.The University of Melbourne SoA and RMIT are currently the only centres in Victoria that plastinate humanbody parts.

• Body parts may be sent from interstate to the University of Melbourne to be plastinated – and subsequentlyreturned. There is no formal process in place (or explicitly required under the Human Tissue Act) to ensurethe chain of custody for plastinated specimens is appropriately maintained and that the intended purpose insending a body part to another university to be plastinated is actually adhered to (see recommendation 2below).

• Body donor consent arrangements provide for the University of Melbourne to retain tissue for teaching purposes. Such tissue may be plastinated and consequently never cremated.

• There should be a record kept of all body parts that are permanently retained and that will not be cremated.

Recommendations 1. The University of Melbourne continues to maintain a specific register of all body parts sourced through the

University of Melbourne BDP, including those used for plastination (see labelling requirements below). Theintended permanent location/destination and identity of all plastinated specimens should be documented onthis register.

2. All specimens submitted to the University of Melbourne Department of Anatomy and Neuroscience, or theRMIT School of Anatomy from interstate for plastination must be fully identifiable (secure and adequatelabelling including identity and place of origin) and documented on a register maintained by the University ofMelbourne or RMIT respectively. These specimens, once plastinated, must be securely labelled with theiridentity and returned to their place of origin, unless prior approval has been agreed between the parties.

3. Victorian SoAs must ensure all plastinated specimens retained on site for the teaching of anatomy or anyother purpose are permanently and clearly identifiable and documented on a register maintained by the SoA.

4. The Victorian Inspector of Anatomy should be advised of the intention by any SoA in Victoria to establish aplastination facility in order to ensure that:a. appropriate procedures are in place to permanently identify and register plastinated body partsb. mechanisms are in place to secure the chain of custody of all specimensc. mechanisms are in place for plastination to be identified prospectively as an intended use of any body

part sourced through the University of Melbourne BDP or any other BDPd. plastination of body parts is compliant with donor consent.

4. Identification and tracking of body partsMonitoring arrangements • All plastinated specimens/materials retained for any use in a Victorian SoA should be clearly and

permanently identifiable and registered with the SoA.

Page 4 Department of Health

jcha0407
Highlight
Page 5: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

• All specimens submitted to a Victorian SoA for plastination should be fully and securely labelled (pre- andpost-plastination) with their identity and place of origin.

• All potted and other anatomical specimens are ideally microchipped (or identified using an alternative securelabelling system such as barcoded tags) and registered. This should apply to all specimens in storage/use atall SoAs in Victoria.

• All SoAs in Victoria receiving cadaveric materials for the purposes of anatomical examinations and/or theteaching of anatomy should be able to demonstrate a secure specimen labelling and tracking system. Thisshould incorporate documentation through a secure (backed-up) register of all cadavers and body parts instorage at the SoA.

• The identity of all cadaveric specimens stored or in use by SoAs should be clearly linked to the register ofdonor cadavers maintained by the University of Melbourne BDP.Separated body parts (for example, severed hands) should all be labelled in such a way that it is possible toidentify the body to which the part belongs. The identity of all such specimens should be clearly documentedin the SoA’s register.

• All SoA are to ensure there is a system in place to secure the chain of custody of all body parts located at each school. This system must be reliably maintained and documented.

Recommendations

1. All plastinated, potted and other anatomical specimens in storage should be permanently and securelylabelled (for example, microchipped and/or with barcoded tags) and their identity recorded in a registermaintained by the University of Melbourne BDP.

2. All SoAs that retain plastinated, potted or other cadaveric specimens in storage (long or short term) for anypurpose should ensure these specimens are identifiable through microchipping or have an alternative securelabelling system (for example, barcodes and physical tags).

3. All SoAs should maintain a register of all stored cadaveric specimens that contains identifying informationthat is linked to the register of donor cadavers maintained by the University of Melbourne BDP. This registershould contain full documentation of the chain of custody of all specimens stored or in use at the SoA.

5. Uncertain origin of body parts

• Within the University of Melbourne BDP/SoA (and likely within other SoAs), there are historical teaching andprosected specimens and specimen pots that are not identifiable – that is, it would never be possible toidentify the donor origin of such specimens.

• Dry bones that are unidentifiable should be treated in the same manner as any other tissues of unknowndonor origin.

• There is a need for transparency and a declaration regarding all unidentifiable specimens stored in SoAs.• These specimens should always be treated with the same level of respect as all other cadaveric specimens.• There should be a reliable mechanism in place within Victorian SoAs to ensure:

– any specimens with unknown origins are identifiable as such– there are strategies in place to ensure mixing with or confusion with other specimens is prevented.

• This is relevant to managing the chain of custody of all specimens and the requirement that the identity of allbody parts submitted for disposal/cremation is known and certain.

• Body parts of unknown origin are only to be disposed of using high temperature Medi-Waste disposalarranged through the University of Melbourne BDP (facility located in Dandenong).

• Local Medi-Waste disposal of dissecting laboratory clean-up waste (for example, swabs and towels) isacceptable at the discretion of the school.

Page 5 Department of Health

Page 6: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

• Cremation (through a public cemetery trust) can only be performed on a body or body parts of a knownidentified person.

Recommendations 1. Where applicable, Victorian SoAs should be able to demonstrate to the Inspector of Anatomy the existence

of strategies to ensure that (i) specimens with unknown origins are identifiable as such, and (ii) there arestrategies in place to ensure mixing with or confusion with other specimens is avoidable.

2. SoAs wishing to dispose of unidentifiable body parts should only do so through the University of MelbourneBDP to ensure chain of custody requirements are adhered to and complete.

6. Infection prevention and control measures• All SoAs should have established and fully documented infection prevention and control procedures in place.

For example: students handling cadaveric specimens should observe appropriate personal hygienemeasures such as hand washing and use of protective clothing when necessary; students should receive aninduction program (incorporating infection prevention and control advice); a higher level of infectionprevention and control should be in place for handling of non-embalmed specimens.

• Notifiable infectious diseases: It is a requirement under the Public Health and Wellbeing Act 2009, PublicHealth and Wellbeing Regulations (Exposure Draft – 2009) that a medical practitioner or laboratory notifyspecified conditions (Regulation 63). The University of Melbourne BDP ensures that all cadavers receivedare screened for specific infectious diseases (for example, blood-borne viruses) prior to any processing oruse by SoAs. Those with positive results are rejected.

• The infection prevention and control requirements (and protocols) for BDPs will differ from those in SoAs.Bodies and body parts can only be released from a BDP if certain infection control requirements have beenmet.

• The University of Melbourne BDP infection control requirements are documented in Safe work procedures#2 Department of Anatomy and Neurology, The University of Melbourne.

• The Inspector of Anatomy must be satisfied that all SoAs have adequate infection prevention and controlprotocols in place.

Recommendation All SoAs must have established and fully documented infection prevention and control procedures in place.

7. Ensuring a school of anatomy is fit for purposea. Security requirements should include:• managed authorised access – that is, ability to ensure there is no unauthorised public access• specific identification for all authorised staff and students – that is, that they are a current authorised student

of anatomy or a current staff member of the school• storage facilities for all cadaveric materials that are specifically secured.

b. Privacy arrangements:• Design of all locations (for example, labs, dissecting rooms, museums) should facilitate private and restricted

access to authorised persons to settings where cadavers will be stored and/or used for anatomicalexaminations and teaching.

c. Capacity to support appropriate infection prevention and control procedures should include attentionto:

• laboratory hardware being appropriate

Page 6 Department of Health

Page 7: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

• availability of clean gowns, gloves and dissection instruments• staff/student facilities (for example, change rooms and washing areas).• ventilation of all rooms where cadaveric materials are used for anatomical examinations/teaching• existence of clearly documented infection prevention and control protocols and/or procedures accessible to

all staff, students and/or researchers.

d. Facilities and guidelines are required for the secure storage and handling of embalmingmaterials/chemicals and all other toxic chemicals and substances.

e. For the benefit of teaching staff, students of anatomy and researchers, the SoA must be located closeto a parent or central teaching facility or institution, or one of its campuses.

• The rationale for this requirement is to ensure that SoAs are functionally integrated into the research andteaching environment of the teaching institution.

Recommendations 1. That the above arrangements be used as the basis for endorsement of an SoA being fit for purpose by the

Inspector of Anatomy.2. The Inspector of Anatomy should obtain evidence through site visits to all SoAs of compliance with the

above arrangements (section 7 above).

8. Respectful handling of cadavers and body parts• All cadavers and cadaveric specimens should be stored in a secure environment and used for teaching

and/or anatomical examinations in a secured setting with restricted staff/student access.• All personnel with access rights to such settings within SoAs must complete an induction program and be

aware of all conditions of access to the setting and requirements for personal conduct (Code of conduct) inthe performance of anatomical examinations and/or the teaching of anatomy.

• Any public open-day sessions to SoAs, including anatomy museums or public displays of anatomicalspecimens, should be fully supervised by authorised staff.

• Restrictions on personnel within settings where anatomical examinations and/or the teaching of anatomyinvolving cadavers or cadaveric specimens are performed include prohibition of all unauthorisedphotography, videos and use of mobile phones.

• SoA are to ensure there is no improper use of cadavers or body parts. For example, use for entertainmentpurposes as such or as facilitated by electronic or print media, use for financial gain, the use of specimensfor personal reasons or use of specimens by unauthorised personnel.

• 2D and 3D digital imaging must be authorised by the SoA.• Reproduction of cadavers or cadaveric parts, including via 2 & 3 D imaging, must not permit identification of

the deceased.

Recommendations

1. All SoAs should have documentation of a code of conduct for all those participating in anatomicalexaminations and/or the teaching of anatomy involving cadavers or cadaveric specimens. This includesparticipation in laboratory-based work including research, the conduct and/or observation of dissections orthe viewing of anatomical specimens in museums or special purpose viewing rooms.

– The code of conduct should acknowledge: (i) the altruistic donation of bodies for the purposes of teaching,research and study; (ii) the need for respectful handling of all bodies and/or body parts as an ethicalrequirement; and (iii) the conditions of consent agreed to by body donors.

Page 7 Department of Health

Page 8: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

2. All SoAs should have specific documentation describing the security arrangements in place for all premisesused for anatomical examinations and/or the teaching of anatomy involving cadavers or cadavericspecimens.

3. All SoAs should have documentation of the induction program(s) used for all users including staff, studentsand all external personnel.

4. All SoAs should be able to provide evidence of the completion of a suitable induction program for all usersincluding staff, students and all external personnel.

5. All public access to SoAs should be fully supervised by authorised personnel. SoAs should have adocumented protocol outlining the requirements for public access to their premises.

9. Anatomical examinationsAnatomical examinations may involve the use of cadavers or cadaveric specimens for the teaching and study of anatomy at various levels, for example, undergraduate and postgraduate students, doctors, surgeons and other specialists and allied health personnel. ‘Examination’ may or may not include use of cadavers for dissection.

Recommendations

1. Cadavers may only be used for anatomical examination through an application that is endorsed by the headof the SoA and meets the audit and evaluation requirements of the Inspector of Anatomy (refer to Audit andevaluation tool for schools of anatomy in Victoria).

2. Prior to any use of a cadaver or cadaveric specimen within an SoA or any other setting for the purpose of ananatomical examination, there must be documentation of processes that:a. identify cadavers and cadaveric materials to be usedb. define the intended use of all body parts for anatomical examinationsc. identify all students, researchers and staff to be involved in anatomical examinations.This statement should be endorsed by the appropriate institutional delegate and be available for review by the Inspector of Anatomy.

3. SoAs should be able to provide evidence to the Inspector of Anatomy of compliance with internallyconsistent application procedures for the use of cadavers or cadaveric specimens in anatomicalexaminations.

4. There should be no use, within anatomy laboratories, of digital recording devices (such as phones, camerasor videos) unless the production of cadaveric images is authorised by the head of school).

5. Such images and reproductions must remain under the direction of authorised SoA teachers and staff andonly made available to students for study purposes via a formal undertaking by the student.

6. SoAs should ensure appropriate signage indicating that unauthorised production of images is prohibited.7. Where, for purposes of the teaching and study of anatomy it is necessary or desirable that images or

representations of cadavers or cadaveric material be made, such reproductions (including 2 & 3 D imaging)must not permit identification of the deceased.

8. SoAs have a duty to properly inform students of their obligations in accepting authorised, non-identifyingimages of cadaveric materials:a. Students must not permit transfer of images into the public domain under any circumstances.b. Images are not to be reproduced or shown to persons not enrolled in the SoA.c. At the end of their assignment and following assessment, these images will be either destroyed or

retained for teaching purposes by the SoA.d. Images must be treated with respect. Any violation of the above conditions will result in disciplinary action

by the SoA.e. Students should be reminded of their privileged position in accessing cadavers for study purposes and

the ethical conduct this privilege imposes on them.

Page 8 Department of Health

Page 9: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

Recommendation It is the responsibility of the heads of SoAs to ensure the above requirements (1–8) are understood by all students including the disciplinary consequences of any breaches of these conditions.

Authorised by the Victorian Government, Melbourne. To receive this publication in an accessible format phone (03) 9096 5239

Page 9 Department of Health

Page 10: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

AUDIT AND EVALUATION TOOL FOR SCHOOLS OF ANATOMY IN VICTORIA

October 2014

Page 11: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

PURPOSE The Audit and Evaluation Tool for Schools of Anatomy in Victoria is now available to be used by both Schools of Anatomy and Inspectors of Schools of Anatomy to assist in ensuring that agreed processes and operational requirements are being implemented across all schools. This is intended to ensure that all Schools of Anatomy in Victoria comply with requirements pursuant to s36(4) of the Human Tissue Act 1982. The audit and evaluation tool is based on the policy document Guidelines for the governance of schools of anatomy in Victoria (2014)

The audit and evaluation tool is intended to: (i) support routine internal monitoring and review as well as formal inspection

and audit of established schools, and (ii) assist Inspectors of Anatomy in determining that prospective schools of

anatomy meet minimum standards that would permit their authorisation as schools for the lawful conduct of the teaching, study and practice of anatomy.

The intent is to clearly identify the minimum required standards for Schools of Anatomy and a transparent process by which these standards can be monitored and maintained. While Inspectors of Anatomy operate under the provisions of the Human Tissue Act 1982, the Audit and Evaluation Tool provides a new framework for the voluntary oversight, monitoring and quality assurance of all Schools of Anatomy in Victoria.

STRUCTURE The tool comprises a check list that identifies policy, protocol and process requirements for all schools. It also includes items for review during an inspection of the physical environment of the school, to ensure that it is fit for purpose. The final element is an assessment of a school’s compliance with standards overall. The assessment makes provision for the identification of any problem areas, for an agreed response by the school and an associated timeframe for any remedial actions required.

CHAIN OF CUSTODY Chain of Custody refers to all processes in handling cadavers or cadaveric materials from the time of delivery to a body donor programme and despatch to a School of Anatomy to the time of return of the remains for respectful cremation. During this period, all cadavers and cadaveric materials should be handled in such a way that their identity and location are always known or able to be ascertained. A loss of the identity of cadavers or cadaveric specimens or an inability to know their location constitutes a breach in the Chain of Custody. The ability to maintain the Chain of Custody is a fundamental requirement and is a central aspect of the audit and evaluation of Schools of Anatomy in Victoria.

2

Page 12: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

AUDIT AND EVALUATION TOOL FOR SCHOOLS OF ANATOMY

Name of School:

Name of Inspector:

Interviewee and designation:

Date:

Items YES NO N/A

1 POLICY AND PROTOCOL

1.1 Is there a guided induction process for staff and students new to the SoA laboratory?

1.2 Is there a Register of those who have completed the induction? 1.3 Is there an induction manual for staff and students? 1.4 Is the manual readily accessible? 1.5 Is the manual available in hard copy? 1.6 Is the manual available on-line?

2. CADAVERS AND CADAVERIC MATERIAL YES NO N/A

2.1 Are cadavers and cadaveric materials sourced from the UMBD Programme?

2.2 Are any cadavers or cadaveric materials sourced from an interstate BDP? If Yes, Name of BDP:

2.3 Is there a Memorandum of Understanding or other written agreement in place between the SoA and the interstate BDP?

2.4 Does the MOU / Agreement cover: • Transportation requirements (Y/N)• Cadaver identity and donor consents requirements (Y/N)• Requirement for mechanisms to ensure chain of custody (Y/N)

3. TRANSPORTATION YES NO N/A

(a) Basic Requirements 3.1 Are there documented procedural guidelines in place for the transportation of

cadavers and cadaveric materials (to/from the SOA)?

3.2 Are all specimens for transport fully labelled, including a specimen description and identifier that can be linked to the UMBDP cadaver identification number?

3.3 Are there documented records for the despatch and receipt of specimens from the UMBDP?

3.4 Are there documented records of despatch and receipt for the return of specimens to UMBDP?

3.5 Are records and procedures (as per 3.1, 3.2, 3.3 and 3.4) in place for specimens from non-UMBD Programmes?

(b) Transportation of cadaveric materials across State borders 3.6 Is there documentation of strategies required to preserve the chain of custody of

all specimens being transported?

3.7 Is there documentation detailing the purposes to which these specimens will be put?

4. PLASTINATED SPECIMENS YES NO N/A

4.1 Are there plastinated specimens in the anatomy collection? 4.2 Is there a register of plastinated specimens at this SOA?

4.3 Are all plastinated specimens clearly and permanently labelled eg bar code, microchip, other?

4.4 Is there a plastination facility at the school?

3

Page 13: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

5. IDENTIFICATION AND TRACKING OF CADAVERS AND CADAVERICMATERIAL YES NO N/A

5.1 Is there a register of all cadavers and cadaveric specimens in the SoA whether stored or in use?

5.2 Is the Register linked (via the UMBDP Cadaver number) with that of the Body Donor Programme at the University of Melbourne or other relevant BDP?

5.3 Are all cadavers and cadaveric materials properly identified via a bar code, microchip, secure label or other such device?

5.4 Are separated body parts labelled in such a manner that the body to which the part belongs can be identified?

5.5 Are separated specimens documented on the School’s anatomy register?

5.6 Are there documented mechanisms to ensure preservation of the chain of custody of cadavers and cadaveric specimens at all times?

6. CADAVERIC MATERIAL OF UNCERTAIN ORIGIN YES NO N/A

6.1 Can the SoA demonstrate that material of unknown origin (including bone) is identifiable as such?

6.2 Are there processes in place to ensure that cadaveric material of unknown origin is not mixed or confused with specimens of known origin?

6.3 Is there a documented process of authorisation for the disposal of routine dissection clean –up waste at the SoA?

6.4 Are there documented processes in place for either disposal at the University of Melbourne or some other means?

7. FIT FOR PURPOSE YES NO N/A

(a) Security 7.1 Is there managed authorised access to all the anatomy school facilities used for

anatomical examinations and the teaching and study of anatomy?

7.2 Is there specific identification for all authorised staff and students, that is, they are a current authorised student of anatomy or a current staff member of the school?

7.3 Are all cadavers and cadaveric materials securely stored when not in use?

7.4 Are chemicals associated with use of anatomy laboratories, such as embalming fluids, and other dangerous materials appropriately stored in accord with handling guidelines?

(b) Privacy

7.5 Do the physical arrangements / design of laboratories, dissecting rooms, storage rooms and museums ensure that private and restricted access to these facilities is possible, where cadavers and cadaveric materials are/will be stored and/or used for anatomical examinations and the teaching and study of anatomy?

(c) Capacity to support Infection Prevention and Control (IPC) 7.6 Are there established and documented IPC procedures/guidelines in place at this

SOA? 7.7 Are students and staff inducted into these IPC procedures/guidelines? 7.8 Are IPC guidelines readily accessible to students and staff? 7.9 Are appropriate IPC measures in place for fresh vs embalmed specimens?

7.10 Are rooms where cadavers and cadaveric materials used for teaching and research purposes appropriately ventilated?

7.11 Are dissecting instruments routinely cleaned after each use to infection control standards specified in the procedures/guidelines?

7.12 Are there designated washing areas? 7.13 Are gowns and gloves available as needed? 7.14 Are receptacles available for managing biohazard and waste disposal?

7.15

Which of the following are considered to be appropriately maintained for IPC purposes?

• Floor surfaces;• Dissecting surfaces and stainless steel implements;• Biohazard management;• Washing basins;• Sharps bins;• Ventilation

4

Page 14: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

8. ETHICAL CONSIDERATIONS YES NO N/A

8.1 Is there an ethical code of conduct or equivalent for staff and students? 8.2 Is there an induction process to familiarise people with the code?

8.3 Does the code emphasise the altruistic and generous nature of the donation of bodies for research and teaching purposes?

8.4 Does the code emphasise that cadavers as bodies of deceased persons are at all times to be handled with respect?

8.5 Are cadavers used strictly in accord with any limitations made in donor consent records?

8.6 Does the code prohibit improper and disrespectful use of cadavers and cadaveric materials?

8.7 Does the code prohibit the use of cadavers for entertainment, profit, use for personal purposes and being the subject of unauthorised photography, electronic imaging?

9. ANATOMICAL EXAMINATIONS YES NO N/A

Prior to use of cadavers or cadaveric materials for research, teaching or workshop purposes, are there documented processes to confirm:

9.1 (i) the identity of all cadavers and cadaveric materials to be used? 9.2 (ii) the intended use of all body parts for anatomical examinations?

9.3 (iii) the identity of students, researchers and staff to be involved in anatomical examinations?

9.4 Is the above documentation endorsed by an appropriate institutional delegate? 10. ASSESSMENT

10.1 Problem areas identified (cite item number/s)

10.2 Any other problem areas identified

5

Page 15: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

10.3 Remedial actions agreed

10.4 Timeline agreed (Review date)

11. OVERALL ASSESSMENT DECISION

11.1 Comments

6

Page 16: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

11.2 School meets requirement for gazettal or continued authorisation? (Inspector to circle and initial answer)S sisingature

YES NO

Department of Health - Inspector of Anatomy

Name (Print in Full):

Date:

Signature: ______________________________________________________________

Representative of School of Anatomy

Name (Print in Full):

Title and Institution:

Date:

Signature:

7

Page 17: Introduction - Department of Health, Victoriadocs2.health.vic.gov.au/docs/doc/B2E2C16E50BE79FECA257D77001… · Introduction . These . Guidelines for the governance of schools of

APPENDIX I

NON UMBDP* CADAVERS

The use of cadavers and cadaveric materials sourced from a BDP other than that of the University of

Melbourne must comply with the following additional conditions:

Documentation must be available for review by the Inspector, attesting:

• Chain of custody• Validity and scope of donor consent• Disease screening• The handling and disposal of cadavers and remnant cadaveric materials• As part of chain of custody requirements, cadavers and cadaveric materials from sources

other than the UMBDP must be kept identifiable and distinct from those of the UMBDP

Governance Requirements for non UMBDP source cadavers:

• Payment for this material must be on a cost recovery basis only, that is, for the acquisition,storage, treatment and transfer of bodies – tissue itself cannot be purchased

• Cost recovery documentation must be available to the Inspector• Schools of anatomy must make the inspector aware of their possession and use of non

UMBDP cadavers and in doing so, attest that they are otherwise compliant with the HumanTissue Act and the Guidelines and Audit Tool for use of Schools of Anatomy.

Conclusion

The Inspector and delegate of the SOA must check off on the 8 points above as part of routine

inspections or inspections aimed at gazettal of a new school.

*University of Melbourne Body Donor Programme