Document ID: chunk:federal_register_of_legislation:F2025C00118:reg:18
Version: federal_register_of_legislation:F2025C00118
Segment Type: reg
Provision Reference: reg 18
Character Range: 31871–33624

18  Standards of direction, control and supervision of premises required
 (1) Premises must be under the direction, control and supervision of a designated person, who:
 (a) possesses appropriate qualification; and
 (b) is competent; and
 (c) has relevant scope of practice;
  to fulfil their obligations under this section.
 (2) The designated person is responsible for premises' compliance with relevant standards.
 (3) Without limiting subsection (2), the designated person is responsible for compliance with the standards of direction, control and supervision that apply to the relevant category of laboratory under the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Seventh Edition 2023), including in relation to:
 (a) the clinical governance of the laboratory; and
 (b) oversight and management of the laboratory's staff and processes to ensure ethical patient care and the provision of accurate and timely test results.
 (4) The designated person may only supervise pathology testing within his or her scope of practice.
 (5) The responsibilities of the designated person for premises under this section may be delegated, but only in accordance with the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Seventh Edition 2023).
Note: The Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Seventh Edition 2023) is listed in Schedule 1.
 (6) Paragraph (1)(c) and subsection (4) do not apply to a designated person of a premises that:
 (a) comprises a category S laboratory; and
 (b) renders services in 1 or more groups of pathology testing that are in 1 or more pathology disciplines with a national workforce shortage.