South Australian Numbered Acts

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HEALTH CARE ACT 2008 (NO 3 OF 2008) - SECT 64

64—Declaration of authorised activities and authorised persons

        (1)         Subject to this Part, the Minister may, by notice published in the Gazette—

            (a)         declare an activity described in the declaration to be—

                  (i)         an authorised quality improvement activity; or

                  (ii)         an authorised research activity;

            (b)         declare a person or group of persons (including a group formed as a committee) described in the declaration to be an authorised entity for the purposes of carrying out—

                  (i)         an authorised quality improvement activity; or

                  (ii)         an authorised research activity.

        (2)         The Minister must—

            (a)         in the case of a declaration under subsection (1)(a)(i)—relate the declaration to any activity that involves—

                  (i)         an assessment or evaluation of the quality of services provided by prescribed health-sector bodies, including by assessing or evaluating clinical practices or by conducting studies of the incidence or causes of conditions or circumstances that may affect the quality of any such services; or

                  (ii)         the making of recommendations about the provision of services provided by prescribed health-sector bodies after taking into account the outcome of any activity of a kind described in paragraph (a); or

                  (iii)         the monitoring of the implementation of any recommendations or other initiatives that are relevant to improving the quality of services provided by prescribed health-sector bodies;

            (b)         in the case of a declaration under subsection (1)(a)(ii)—relate the declaration to research activities that relate to the causes of mortality or morbidity;

            (c)         in the case of a declaration under subsection (1)(b) that relates to a person—ensure that the person holds an appropriate authorisation from the governing body of the prescribed health-sector body and, if relevant, an appropriate approval from a research ethics committee;

            (d)         in the case of a declaration under subsection (1)(b) that relates to a group of persons—ensure—

                  (i)         that the group is established in accordance with the rules of the governing body of the prescribed health-sector body; and

                  (ii)         that the functions of the group include activities involved in carrying out a quality improvement activity or research activity within the contemplation of this Part; and

                  (iii)         that each member of the group will hold a qualification or have experience or training that is relevant to the performance of its functions in relation to a quality improvement activity or research activity; and

                  (iv)         if the relevant rules so require—that the group holds an appropriate authorisation from the governing body of the prescribed health-sector body and, if relevant, an appropriate approval from a research ethics committee.

        (3)         The Minister must, in acting under this section, make the health and safety of the public the primary consideration.

        (4)         In addition, the Minister must not make a declaration under this section unless satisfied—

            (a)         that the performance of an activity within the ambit of the declaration, or the functions or activities of a person or group of persons within the ambit of the declaration, would be facilitated by the making of the declaration; and

            (b)         that the making of the declaration is in the public interest.

        (5)         The Minister must also take into account any criteria prescribed by the regulations for the purposes of this section.

        (6)         To avoid doubt, the Minister may—

            (a)         make a declaration under subsection (1)(a) without specifying a particular person or group of person as being an authorised entity to which the declaration is to apply at that particular time;

            (b)         make a declaration under subsection (1)(b)—

                  (i)         without specifying a particular authorised quality improvement activity or authorised research activity that is to be carried out by the authorised entity at any particular time;

                  (ii)         by defining the group rather than by specifying particular members (on the basis that the constitution of the group may change from time to time).

        (7)         A declaration under this section does not confer authority on a person or group of persons to conduct an investigation for the purpose of determining the competence of a particular person in providing services.

        (8)         The Minister may, by subsequent notice in the Gazette, vary or revoke a declaration under this section.

        (9)         A declaration, unless sooner revoked, ceases to be in force at the end of 3 years after it is made, but this subsection does not prevent the Minister from making a further declaration in respect of the same activity or person or group of persons.

        (10)         The Minister may, as the Minister thinks fit, determine various protocols or procedures that must be complied with by a person or group of persons acting under this Part.



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