Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 2) 2018 (Cth)
Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 2) 2018
I, DAVID WEISS, delegate for the Minister of Health, make the following instrument.
Dated 28 November 2018
David Weiss
First Assistant Secretary
Medical Benefits Division
Department of Health
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 2
Schedule 2—Amendments
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 6
1 Name
This instrument is the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 2) 2018.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. Sections 1 to 4 and anything in this instrument not elsewhere covered by this table | The day after this instrument is registered. | |
| 2. Schedule 1 | Immediately after the commencement of Schedule 2 to the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment Instrument (No. 1) 2018 | 1 December 2018 |
| 3. Schedule 2 | 1 August 2019 | 1 August 2019 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in Column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 23DNA(1) of the Health Insurance Act 1973.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1— Amendments commencing 1 December 2018
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017
Subsection 5(2) (definition of designated person)
Repeal the definition.
Subsection 5(2) (definition of group of pathology testing)
Repeal the definition.
Subsection 5(2) (definition of relevant standards)
Omit “section 18”, substitute “relevant requirements of these Principles including sections 17 and 18”.
Subsection 5(2) (definition of scope of practice)
Repeal the definition.
5 Subsection 5(2)
Insert the following:
scientist means a person who possesses one of the following qualifications:
(a) a degree in science or applied science with subjects relevant to the field of pathology awarded after not less than three years full-time study, or an equivalent period of part-time study, at a university in Australia, that provides for direct entry or following examination to a professional class of membership of the Australasian Association of Clinical Biochemists, Australian Institute of Medical Scientists, Australian Society for Microbiology, Australian Society of Cytology, Human Genetics Society of Australasia;
(b) an associate qualification conferred by the Australian Institute of Medical Technologists before 1 December 1973.
senior scientist means a scientist who has had not less than 10 years full-time relevant laboratory experience and who possesses one of the following qualifications:
(a) a Doctorate of Philosophy in a subject relevant to the field of pathology; or
(b) a Fellowship of the Australasian Association of Clinical Biochemists; or
(c) a Fellowship of the Australian Institute of Medical Scientists; or
(d) a Fellowship of the Australian Society for Microbiology (medical/clinical microbiology); or
(e) a Fellowship of the Human Genetics Society of Australasia.
6 Subsection 17(1) (table)
Repeal the table, substitute
| Item | Category | Criteria |
| 1 | Category GX (General) | premises comprising a laboratory, or a number of co‑located laboratories, rendering services in 1 or more groups of pathology: (a) under the direction, control and full‑time supervision of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and (b) at which the number of working pathologists (whether full‑time or part‑time) is equivalent to more than 2 full‑time pathologists; |
| 2 | Category GY (General) | premises comprising a laboratory, or a number of co‑located laboratories, rendering services in 1 or more groups of pathology: (a) under the direction, control and full‑time supervision of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and (b) at which the number of working pathologists (whether full‑time or part‑time) is equivalent to not more than 2 full‑time pathologists; |
| 3 | Category B (Branch) | premises comprising a laboratory rendering services in 1 or more groups of pathology, being a laboratory related, by appropriate arrangement, to an accredited pathology laboratory of category GX or GY, as: (a) a branch, integral (except in its location) with the category GX or GY laboratory; or (b) a member of participating laboratories in a regional pathology service; operating under: (c) the direction and control of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and (d) the supervision of at least a scientist, who is expert in the group, or groups, concerned; |
| 4 | Category M (Medical) | premises comprising a laboratory rendering a limited range of pathology services under the direction, control and supervision of a medical practitioner, being services only for the patients of the medical practice operated by, or that employs, the medical practitioner, where the medical practice is co-located with the laboratory; |
| 5 | Category S (Specialised) | premises comprising a laboratory rendering a limited range of pathology tests under the supervision of a person with special qualifications or skills in the field of those tests, that are tests: (a) performed for a particular target population or are of a specialised nature; and (b) are performed in the field of those special qualifications or skills. |
7 Subsection 17(2)
Repeal the subsection, substitute:
(2) In the description of category B premises in Item 3 of the table in subsection (1), appropriate arrangement means a written arrangement that includes provisions for the direction and control of the premises by a pathologist, or senior scientist, employed in the related category GX or GY laboratory.
8 Section 18
Repeal the section, substitute:
18 Standards of direction, control, etc, of premises required
Arrangements for categories GX and GY
(1) For a category GX or GY pathology laboratory, a supervising pathologist or senior scientist must usually be present during normal working hours and available for telephone (or other electronic) consultation at other times.
Arrangements for category B
(2) For a category B pathology laboratory, the pathologist or senior scientist under whose direction and control pathology services are rendered must:
(a) be employed in the related category GX or GY laboratory; and
(b) have qualifications and experience relevant to the laboratory’s operations; and
(c) attend the laboratory, in accordance with subsections (3) and (4) (or arrange for the attendance of a scientist under his or her direction and control); and
(d) be available for telephone (or other electronic) consultation when not personally attending the laboratory; and
(e) monitor a system of electronic supervision of the quality of services rendered.
(3) The attendance requirement for paragraph (2)(c) is time amounting to, in a year:
(a) if the electronic supervision is effected by way of online reports from the supervised laboratory to the related category GX or GY pathology laboratory—the equivalent of 10 full‑time days; or
(b) otherwise—the equivalent of 50 full‑time days.
(4) However, attendance at supervised training, or professional development, that is conducted in the related category GX or GY laboratory and is relevant to the supervision of the laboratory is taken to satisfy the laboratory attendance requirement to the extent of the time so spent, up to the equivalent of:
(a) if paragraph (3)(a) applies—5 full‑time days; and
(b) if paragraph (3)(b) applies—20 full‑time days.
(5) In addition:
(a) externally administered quality assurance programs must be monitored by a pathologist or senior scientist employed at the related category GX or GY pathology laboratory who must endorse, in writing, the reports generated by the programs; and
(b) an internal quality assurance system integrated between the laboratory and the related category GX or GY laboratory must be in place.
Arrangements for category M
(6) For a category M pathology laboratory, the supervising medical practitioner must:
(a) usually be present when a pathology service is rendered; and
(b) be available for telephone (or other electronic) consultation when not present; and
(c) have a working knowledge of the procedures for the pathology services rendered and an involvement in the resolution of any problem encountered in rendering those services; and
(d) ensure that the only services rendered are services appropriate for a category M laboratory.
Arrangements for category S
(7) For a category S pathology laboratory, the supervisor must:
(a) usually be present when a pathology test is performed, unless, because of the training and experience of medical, scientific or technical support staff present, he or she need not be present; and
(b) be available for telephone (or other electronic) consultation when not present; and
(c) ensure that the only tests performed are tests appropriate for a category S laboratory.
9 Schedule 1 (table item 17)
Repeal the item, substitute:
| 17 | Requirements for Medical Pathology Services (Third Edition 2018) | 2018 |
10 Schedule 1(table item 19)
Repeal the item, substitute:
| 19 | Requirements for the Supervision of Pathology Laboratories | 2007 |
Schedule 2—Amendments commencing 1 August 2019
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017
Subsection 5(2)
Insert:
designated person means a person who is designated in an application for approval under section 23DN of the Act as the person responsible for a premises’ compliance with relevant standards.
Subsection 5(2)
Insert:
group of pathology testing means a group of items in the pathology services table.
Subsection 5(2) (definition of relevant standards)
Omit “relevant requirements of these Principles including sections 17 and 18” substitute “section 18”.
Subsection 5(2)
Insert:
scope of practice means the discipline and areas of testing in which a person has:
(a) been trained and successfully examined or assessed as competent by the relevant College, professional society, or credentialing body; and
(b) met current Continuing Professional Development and recency of practice requirements.
Subsection 5(2) (definition of scientist)
Repeal the definition.
6 Subsection 5(2) (definition of senior scientist)
Repeal the definition.
7 Subsection 17(1) (table)
Repeal the table, substitute:
| Item | Category | Criteria |
| 1 | Category GX (General) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is under the full-time onsite direction and control of a designated person, who is a pathologist; and (b) renders services in 1 or more groups of pathology testing under the full-time onsite supervision of a pathologist (whether or not the designated person) with the relevant scope of practice. |
| 2 | Category GY (General) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is related by an appropriate arrangement to a GX laboratory; and (b) is under the direction and control of the designated person of the related GX laboratory; and (c) renders services in 1 or more groups of pathology testing under the full‑time onsite supervision of a pathologist with the relevant scope of practice; whether or not the premises also renders services in 1 or more groups of pathology testing under the supervision of a pathologist with the relevant scope of practice who is situated in: (d) the related GX laboratory (whether or not the pathologist is the designated person); or (e) another GY laboratory that is related to that GX laboratory. |
| 3 | Category B (Branch) | Premises comprising a laboratory, or a number of co‑located laboratories, that: (a) is related by an appropriate arrangement to a GX laboratory or GY laboratory; and (b) is under the direction and control of the same designated person as the related laboratory; and (c) renders services in 1 or more groups of pathology testing under the supervision of a pathologist (whether or not the designated person) from a laboratory within the pathology network. |
| 4 | Category M (Medical) | Premises comprising a laboratory that: (a) is under the full-time onsite direction, control and supervision of a designated person, who is a medical practitioner; and (b) renders a limited range of pathology testing only for the patients of a medical practice that: (i) is operated by, or employs, the designated person; and (ii) is co-located with the laboratory. |
| 5 | Category S (Specialised) | Either of the following: (a) premises comprising a laboratory that: (i) is under the full-time onsite 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. |
8 Subsection 17(2)
Repeal the subsection, substitute:
(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.
9 Section 18
Repeal the section, substitute:
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 (Fifth Edition 2018), 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 (Fifth Edition 2018).
Note: The Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018) is listed in Schedule 1.
10 Schedule 1(table item 19)
Repeal the item, substitute:
| 19 | Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018) | 2018 |
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