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12 Approval in absence of assessment report

(1) Where no independent body has provided an assessment report in relation to premises, the Minister may consider an application for approval under section 23DN of the Act in relation to those premises and otherwise deal with the application taking into account these Principles if: (a) subsection (2) applies; and (b) an advisory report is provided with the application. (2) This section applies if an application for approval in relation to premises under section 23DN of the Act is made in relation to: (a) a kind of service; or (b) a category; not subject to an approval in principle or an approval under section 23DN of the Act held by the applicant for those premises at the time of making the application. (3) In the absence of exceptional circumstances, the Minister must approve in principle an application which relies on this section if the application is supported by a report from an independent body which states: (a) that a representative of the independent body has visited the premises; and (b) that the independent body confirms that there is an appropriately equipped pathology laboratory at the premises; and (c) that the independent body is satisfied with a high level of confidence, taking into account the arrangements in relation to the operation of the premises, that: (i) the premises can be expected to meet relevant standards for a 6 month period; and (ii) the premises are, or will be, appropriately staffed with persons to carry out, and persons to direct, control and supervise, the pathology services to be performed at the premises; and (iii) the laboratory is, or will be at the relevant time, participating in a quality assurance program of an independent quality assurance body designed to ensure that the laboratory operates in accordance with the accreditation materials applicable to the kinds of pathology services to which approval of the premises would relate; and (d) the kind of pathology services in respect of which the premises should be approved (identified by reference to items in the pathology services table or by reference to groups of items in the pathology services table); and (e) the category to which the premises should be allocated.

Note: The independent quality assurance body mentioned in subparagraph (3) (c) (iii) might not be an independent body within the meaning of subsection 5 (1).