Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The regulations may require approved pathology authorities to prepare and maintain records of pathology services rendered in accredited pathology laboratories of which they are proprietors, and, in particular, may impose requirements relating to:
(a) the form in which the records are to be prepared; and
(b) the information that must be included in the records; and
(c) the manner in which the records must be kept.
(2) An approved pathology authority must not, without reasonable excuse, contravene a requirement imposed by regulations made for the purposes of subsection (1).
(3) If the regulations require an approved pathology authority to prepare and maintain a record of a pathology service rendered in an accredited pathology laboratory of which he or she is a proprietor, the approved pathology authority must retain the record for the period of 2 years commencing on the day on which the service was rendered.
(4) Subject to subsection (7), an approved pathology authority must, if requested to do so by the Chief Executive Medicare, produce to a Departmental employee (within the meaning of the Human Services (Medicare) Act 1973 ):
(a) as soon as practicable and in any case within 7 days after the day on which the request is made; and
(b) at the place specified in the request;
a record retained by the approved pathology authority under subsection (3).
(5) Subject to subsection (7), a Departmental employee (within the meaning of the Human Services (Medicare) Act 1973 ) may make and retain copies of, or take and retain extracts from, any record produced to the employee under subsection (4).
(6) An approved pathology authority who contravenes subsection (2), (3) or (4) commits an offence.
(6A) Subsection (6) does not apply if the authority has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (6A). See subsection 13.3(3) of the Criminal Code .
(6B) An offence under subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(7) This section does not:
(a) require an approved pathology authority to produce to a Departmental employee (within the meaning of the Human Services (Medicare) Act 1973 ) who is not a medical practitioner a record containing clinical details relating to a patient; or
(b) authorise a Departmental employee (within the meaning of the Human Services (Medicare) Act 1973 ) who is not a medical practitioner to exercise powers under subsection (5) in relation to such a record.