Document ID: chunk:federal_register_of_legislation:F2025C00118:reg:5
Version: federal_register_of_legislation:F2025C00118
Segment Type: reg
Provision Reference: reg 5
Character Range: 28612–31871

5     Category S (Specialised)  Any of the following:
                                (a) premises comprising a laboratory that:
                                (i) is under the full‑time direction, control and supervision of a designated person, who is:
                                (A) a medical practitioner with specialised scope of practice; and
                                (B) not a pathologist; and
                                (ii) renders a limited range of pathology testing:
                                (A) for a target patient population or of a specialised nature; and
                                (B) that is restricted to the field of pathology testing directly related to the scope of practice of the designated person;
                                (b) premises comprising a laboratory that:
                                (i) operates as a branch of a laboratory which meets the criteria in paragraph (a); and
                                (ii) is under the direction, control and supervision of the designated person of that laboratory;
                                (c) premises comprising a laboratory that:
                                (i) is under the full‑time direction, control and supervision of a designated person, who is:
                                (A) a medical practitioner; and
                                (B) not a pathologist; and
                                (ii) renders a limited range of pathology testing:
                                (A) for a target patient population or of a specialised nature; and
                                (B) that is in 1 or more pathology disciplines with a national workforce shortage;
                                (d) premises comprising an S(FC) laboratory that:
                                (i) is under the full‑time direction, control and supervision of a designated person, who is:
                                (A) a medical practitioner with a specialised scope of practice; and
                                (B) not a pathologist; and
                                (ii) renders a limited range of pathology testing that is:
                                (A) restricted to tests related to fertility control testing; and
                                (B) under the full‑time supervision of the designated person.

 (2) In the table in subsection (1), appropriate arrangement means a written arrangement that includes provision for the direction, control and supervision of the relevant laboratory.
 (3) The category of accreditation allocated to premises that is specified by the Minister in an approval under section 23DN of the Act must be the category set out in the table in subsection (1) that is appropriate to the premises having regard to the criteria applicable to that category.
Note: For the purpose of determining the fee payable for an application for approval as a particular category of laboratory, the categories set out below correspond to the categories specified in section 6 of the Health Insurance (Pathology) (Fees) Act 1991:
(a) category GX—paragraph 6(3)(a);
(b) category GY—paragraph 6(3)(b);
(c) category B—paragraph 6(3)(c);
(d) category M—paragraph 6(3)(d);
(e) category S—paragraph 6(3)(d).