Pathology Services Accreditation Act 1984 (Vic)
Version No. 030
Pathology Services Accreditation Act 1984
Act No. 10083/1984
Version incorporating amendments as at 13 June 2002
TABLE OF PROVISIONS
Section Page
PART 1—PRELIMINARY
Division 1—Commencement and Interpretations
1.Short title
2.Commencement
3.Definitions
Division 2—Objects
4.Objects of Act
PART 2—PATHOLOGY SERVICES ACCREDITATION BOARD
5.Pathology Services Accreditation Board
6.Composition of Board
7.Meetings
8.Disclosure of interest
9.Functions of the Board
10.Staff
PART 3—REGISTRATION
11.Register of Accredited Pathology Services
12.Certificate to be prima facie evidence
PART 4—ACCREDITATION OF PATHOLOGY SERVICES
13.Application for accreditation
14.Categories of accredited pathology services
15.Display of accreditation certificate
16.Renewals
17.Alterations of category
17A.Restrictions and limitations on accreditation
18.Suspension and cancellation
18A.Deemed accreditation
PART 5—PROPRIETORSHIP OF PATHOLOGY SERVICES
19.Persons who may and may not own pathology service
20.Information to be given to the Board
21.Copy of partnership agreement to be lodged with registrar
PART 6—INSPECTORS AND INSPECTIONS
22.Inspectors
23.Powers and duties of an inspector
24.Random inspections
24A.Inspection fees
PART 7—INQUIRIES AND APPEALS
25.Board may hold inquiries
26.Appeals
27.Return of accreditation certificate
PART 8—FINANCE
28.Accredited pathology services to pay fees to the Board
29.Repealed
PART 9—GENERAL
30.Prohibition on performance of certain tests
30A.Non-regulated tests
31.Notice of fees
32.Directions
33.Pathology service ceases to be accredited when accreditation suspended or cancelled
PART 10—OFFENCES
34.Offences concerning fraud
35.Offences relating to premises which are not accredited pathology services
36.Offence for performing tests which are not permitted
37.Repealed
38.Proceedings
PART 11—CATEGORIES OF ACCREDITED PATHOLOGY SERVICES AND REGULATIONS
39.Governor in Council may amend Schedule 1 by Order
40.Regulations
PART 12—TRANSITIONALS
41.Transitionals—limitations etc. on current accreditations
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SCHEDULE 1—Categories of accredited pathology services
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ENDNOTES
1. General Information
2. Table of Amendments
3. Explanatory Details
Version No. 030
Pathology Services Accreditation Act 1984
Act No. 10083/1984
Version incorporating amendments as at 13 June 2002
An Act to establish the Pathology Services Accreditation Board, to provide for the accreditation of pathology services and for other purposes.
BE IT ENACTED by the Queen's Most Excellent Majesty by and with the advice and consent of the Legislative Council and the Legislative Assembly of Victoria in this present Parliament assembled and by the authority of the same as follows (that is to say):
PART I—PRELIMINARY
Division 1—Commencement and Interpretations
1.Short title
This Act may be cited as the Pathology Services Accreditation Act 1984.
2.Commencement
The several provisions of this Act shall come into operation on a day or the respective days to be fixed by proclamation or successive proclamations of the Governor in Council published in the Government Gazette.
3.Definitions
(1)In this Act unless inconsistent with the context or subject-matter—
"accredited pathology service" means a pathology service accredited under section 13(8) or deemed to be accredited under section 18A;
"applicant" in respect of an application under section 13 for accreditation of a pathology service means the proprietor of an existing pathology service or, in the case of a proposed pathology service, the person who will be the proprietor of the pathology service when it comes into existence;
"approved inspection agency" means any university, corporation, body or person in respect of which there is in force an arrangement with the Board under section 22(2) to carry out inspections of pathology services;
"Board" means the Pathology Services Accreditation Board constituted under this Act;
"medical practitioner" means a person who is a registered medical practitioner within the meaning of the Medical Practice Act 1994;
"pathologist" means a person who is a medical practitioner with a higher qualification in pathology recognized by the National Specialist Qualification Advisory Committee of Australia;
"pathology service" means a service in which human tissue, human fluids or human body products are subjected to analysis for the purposes of prevention, diagnosis or treatment of disease in human beings and includes any premises from which a service is conducted;
"prescribed" means prescribed by this Act or the regulations;
"Register" means the Register of Accredited Pathology Services;
"regulations" means regulations made under this Act;
"scientist" means—
(a)a person who holds a degree or a diploma obtained from a university or other academic institution in Australia after at least three years of full-time study in a prescribed science or prescribed sciences;
(b)a person who holds an associate qualification from the Australian Institute of Medical Laboratory Scientists granted before 1 January 1974; or
(c)a person who holds a qualification obtained from a university or other academic institution outside Australia which, in the opinion of the Board, is a qualification equivalent to a qualification set out in paragraph (a) or (b);
"test" means that part of a pathology service which relates to the analysis of a sample of human tissue, fluid or other body product.
(2)For the purposes of this Act each pathology service conducted from separate premises (notwithstanding that it may bear the same name as another pathology service) shall be a separate pathology service.
Division 2—Objects
4.Objects of Act
The objects of this Act are—
(a)to ensure that proper standards of practice and technical procedures are observed routinely in pathology services;
(b)to ensure adequate standards of record keeping in pathology services;
(c)to encourage the use of safe working practices in pathology services and to discourage the use of unsafe or potentially unsafe practices; and
(d)to ensure that staff employed in pathology services have had adequate and appropriate training.
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PART II—PATHOLOGY SERVICES ACCREDITATION BOARD
5.Pathology Services Accreditation Board
For the purposes of this Act there shall be a Board which shall be called the "Pathology Services Accreditation Board".
6.Composition of Board
(1)The Board shall consist of nine members appointed by the Governor in Council of whom—
(a)one shall be a person representing the Government of Victoria, who shall be appointed as chairperson;
(b)three shall be pathologists appointed from a panel of six names submitted by the Victorian State Committee of the Royal College of Pathologists of Australia;
(c)three shall be scientists of whom—
(i)one shall be appointed from a panel of three names submitted by the Australian Association of Clinical Biochemists; and
(ii)one shall be appointed from a panel of three names submitted by the Victorian Branch of the Australian Institute of Medical Laboratory Scientists; and
(iii)one shall be appointed from a panel of three names submitted by the Medical Scientists Association of Victoria; and
(d)two shall be medical practitioners of whom—
(i)one shall be a member of the Royal Australian College of General Practitioners appointed from a panel of three names submitted by the Victorian Branch of the Australian Medical Association; and
(ii)one shall be a specialist physician appointed from a panel of three names submitted by the Victorian Branch of the Australian Medical Association.
(2)The Minister shall appoint times within which nominations from organizations referred to in sub-section (1)(b), (c) or (d) shall be submitted to him and if the nominations are not received by him in a particular case within the appointed time, the Governor in Council may appoint a person to the Board who shall be a member of the Board notwithstanding the lack of nomination.
(3)Subject to this Act a member of the Board shall hold office for such period not exceeding three years as is specified in the instrument of his appointment, and shall be eligible for re-appointment.
(4)A person shall cease to be a member of the Board when he reaches the age of 72 years.
(5)A member of the Board may resign his membership in writing signed by him and delivered to the Governor in Council.
(6)The Governor in Council may at any time remove a member of the Board from office.
(7)If the office of any member of the Committee becomes vacant otherwise than by the retirement of the member at the expiration of his term of office, a qualified person shall, in accordance with this section, be appointed to fill the extraordinary vacancy and that person shall be entitled to hold office for the remainder of the term of the person in whose place he is appointed.
(8)The chairperson and the other members shall each be entitled to receive such fees allowances and expenses as are from time to time fixed by Order of the Governor in Council.
(9)A member of the Board is not, in respect of his office as a member, subject to the provisions of the Public Sector Management and Employment Act 1998.
7.Meetings
(1)The Board shall meet at least once in each year, and shall also meet at such other times as are fixed by the chairperson or by a majority of the members.
(2)At a meeting of the Board the chairperson shall preside, and where the chairperson is absent a member elected by the members present shall preside.
(3)The quorum for a meeting of the Board shall be a majority of the members for the time being holding office.
(4)The decision on any question of the majority of the members present at any meeting is the decision of the Board on that question.
(5)The person presiding at the meeting shall have a deliberative vote and, in the case of an equality of votes, a casting vote.
(6)Subject to the presence of a quorum the Board may act notwithstanding any vacancy in the office of a member or of a defect or irregularity in the appointment of a member.
(7)Subject to this Act and the regulations the Board may regulate its own procedure.
8.Disclosure of interest
(1)A member of the Board who in any way has a direct or an indirect pecuniary interest in any matter being or to be discussed or decided upon by the Board shall—
(a)as soon as the relevant facts have come to his knowledge refrain from taking part in any discussion concerning that matter, whether at a meeting or otherwise, with any other member of the Board;
(b)as soon as practicable disclose his interest to the Board and take no part in a discussion or decision of the Board in respect of that matter; and
(c)be disregarded for the purpose of constituting a quorum for the purpose of such discussion or decision.
(2)The disclosure of an interest made by a member of the Board at a meeting shall be recorded in the minutes of the meeting.
9.Functions of the Board
The functions of the Board shall be—
(a)to grant accreditation to pathology services and place each accredited pathology service in one of the categories specified in Schedule 1 to this Act;
(b)to recommend to the Minister proposals for regulations for or with respect to—
(i)the minimum standards required for; and
(ii)the types of tests that may be carried out at—
each category of accredited pathology service;
(c)to recommend to the Minister proposals for regulations for or with respect to—
(i)the minimum qualifications required for the person in charge of each category of accredited pathology service;
(ii)the minimum qualifications required for any person conducting tests in each category of accredited pathology service;
(iii)the minimum qualifications required for any other person working in each category of accredited pathology service for whom, in the opinion of the Board, minimum qualifications should be prescribed;
(d)to recommend to the Minister which tests should be prescribed to be exempted tests and which exempted tests should be prescribed to be non-regulated tests;
(e)to supervise the keeping of such registers and records as it is required to keep by or under this Act; and
(f)to carry out any other functions which it is required to carry out by or under this Act.
10.Staff
A registrar and such employees as are necessary for the purposes of this Act are to be employed under Part 3 of the Public Sector Management and Employment Act 1998.
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PART III—REGISTRATION
11.Register of Accredited Pathology Services
(1)The registrar shall keep a register to be called the "Register of Accredited Pathology Services" in which there shall be entered—
(a)the address of each accredited pathology service, and if it has a name, that name;
(b)the name and address of the proprietor of each accredited pathology service;
(c)the name and address and the qualifications of the person in charge of each accredited pathology service and of such other staff as are prescribed;
(d)the category in which each accredited pathology service has been placed by the Board; and
(da)any limitation or restriction imposed on the accreditation of the pathology service by the Board; and
(e)any other particulars that are prescribed.
(2)The registrar shall keep the register up to date and for that purpose shall make any necessary alterations therein.
(3)The register may be inspected at the office of the Board by any person during office hours without charge.
(4)A person may obtain a copy of, or an extract from, the register on payment of the prescribed fee.
12.Certificate to be prima facie evidence
A certificate purporting to be signed by the registrar stating—
(a)that a pathology service is or is not or at any particular date or period was or was not accredited as a pathology service;
(b)that the person mentioned in the certificate is or is not or at any particular date or period was or was not the proprietor or the person in charge of the accredited pathology service; or
(c)the category in which an accredited pathology service is placed; or
(d)that the accreditation of a pathology service is or is not or was or was not at any particular date or period subject to any limitation or restriction; or
(e)any limitation or restriction that the accreditation of the pathology service is or was subject to at any particular date or period—
shall be prima facie evidence of the facts stated in the certificate.
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PART IV—ACCREDITATION OF PATHOLOGY SERVICES
13.Application for accreditation
(1)An applicant for accreditation of a pathology service shall apply to the Board for accreditation in the prescribed form and send to the Board the prescribed fee.
(2)In an application under sub-section (1) the applicant shall state the name and the qualifications of the person who is to be the person in charge of the pathology service and shall nominate the category in respect of which accreditation is sought.
(3)The person who is or is to be the person in charge of a pathology service—
(a)shall be a pathologist, a medical practitioner or a scientist; and
(b)shall be the person in charge of no more than three accredited pathology services.
(3A)If there is an approved inspection agency for the category of pathology service for which accreditation is sought under this section, an application must be accompanied by—
(a)a copy of an inspection report from an approved inspection agency for that category; or
(b)evidence acceptable to the Board that the applicant has made arrangements with such an agency to submit an inspection report to the Board.
(3B)The Board may request an approved inspection agency which has inspected a pathology service for the purposes of accreditation to submit to the Board any additional documentation or information which the Board requests in relation to the application for accreditation within a period of time specified in the request.
(3C)Where a pathology service has been inspected for the purpose of accreditation of the pathology service under a Commonwealth Act within a period of two years before the commencement of sub-section (1) and an inspection report has been prepared—
(a)an applicant for accreditation of a pathology service is deemed to have complied with sub-section (3A)(a) if the applicant submits a copy of that inspection report to the Board; and
(b)the Board may request the applicant to obtain and submit to the Board any additional documentation or information which the Board requests in relation to the application for accreditation within a period of time specified in the request.
(4)If there is no approved inspection agency for the category of pathology service for which accreditation is sought under this section, on receipt of the application the Board shall as soon as practicable appoint two or more inspectors (one of whom shall be nominated by the Board to be the chief inspector) consisting of—
(a)a person who is a peer of the person who is or is to be the person in charge of the pathology service;
(b)where the person appointed under paragraph (a) is—
(i)a pathologist or a medical practitioner, a scientist; and
(ii)a medical practitioner or a scientist, a pathologist; and
(c)such other persons (if any) as the Board thinks fit—
to inspect on behalf of the Board the pathology service for which accreditation is sought.
(5)The Board or, if an approved inspection agency is to carry out the inspection, the approved inspection agency, shall give the applicant not less than fourteen days notice of the day on which the pathology service is to be inspected for the purposes of granting accreditation.
(6)The inspectors appointed under sub-section (4) shall carry out the inspection as they consider fit, and shall submit a report on the inspection to the Board within a period of time specified by the Board in each case.
(7)The Board may require the applicant (or, where the applicant is a body corporate, a nominee of the applicant) to appear before the Board to assist it in making its determination with regard to accreditation.
(8)When the Board has considered an inspection report and any additional documentation or information submitted at the request of the Board and has concluded any further inquiries it shall—
(a)grant accreditation to the pathology service place it in the category the Board considers appropriate and issue to the applicant an accreditation certificate; or
(b)refuse to grant accreditation to the pathology service.
(9)For the purposes of sub-section (4)(a) "a peer of the person who is or is to be the person in charge of the pathology service" means—
(a)where the person in charge is a pathologist, a member of the same or an equivalent learned college;
(b)where the person in charge is a medical practitioner, a medical practitioner in the same field of practice; and
(c)where the person in charge is a scientist, a scientist.
14.Categories of accredited pathology services
(1)For the purposes of this Act the categories of accredited pathology services shall be those specified in Schedule 1 to this Act.
(2)The proprietor and the person in charge of an accredited pathology service which is placed in a category by the Board shall comply with all the current requirements prescribed in relation to a pathology service of that category.
(3)The proprietor and the person in charge of an accredited pathology service shall take all steps necessary to see that the standards prescribed for a pathology service of the relevant category are maintained.
15.Display of accreditation certificate
The proprietor of an accredited pathology service shall display the accreditation certificate of the pathology service in a prominent place at the pathology service.
16.Renewals
An accreditation shall remain in force for a period of twelve months and may, by application in the prescribed form and on payment of the prescribed fee, be renewed.
17.Alterations of category
The Board—
(a)on the application of the proprietor; or
(b)in consequence of a report by one or more inspectors—
and after such other inquiries as the Board considers necessary, may at any time by notification in writing to the proprietor of a pathology service, alter the category in which the pathology service is placed.
17A.Restrictions and limitations on accreditation
(1)The Board may impose any limitation or restriction on—
(a)granting accreditation to a pathology service under section 13(8);
(b)deeming a pathology service to be accredited under section 18A(1) or (3);
(c)renewing the accreditation of a pathology service under section 16.
(2)Without limiting sub-section (1), the Board may impose a limitation or restriction that relates to the type of tests the pathology service can perform.
(3)The Board may impose any limitation or restriction on an accreditation or deemed accreditation during the period of that accreditation in accordance with sub-section (4).
(4)The Board must not impose any limitation or restriction on the accreditation or deemed accreditation of a pathology service unless the Board has—
(a)given notice in writing to the pathology service of the Board's intention to impose the limitation or restriction; and
(b)considered any submissions whether oral or in writing made to the Board by the pathology service within 7 days after the giving of the notice; and
(c)considered any other submissions and any other matters the Board considers appropriate.
(5)If the Board decides to impose any limitation or restriction on an accredited pathology service the Board must give notice in writing of the limitation or restriction to the pathology service.
18.Suspension and cancellation
(1)Where the Board is satisfied that—
(a)the accreditation of a pathology service has been obtained by fraud;
(b)the proprietor or the person in charge of an accredited pathology service has been convicted of two or more offences against this Act or the regulations in respect of that pathology service—
the Board may suspend or cancel the accreditation of the service.
(2)The Board may suspend or cancel the accreditation of an accredited pathology service if it is of the opinion that there is or could be a serious risk to the public health because there has been a serious breach of a limitation or restriction imposed on the accreditation.
18A.Deemed accreditation
(1)If an application under section 13 for accreditation of a pathology service is made, the Board may deem the pathology service to be accredited, although an inspection report on the service has not been submitted to the Board and any further enquiries proposed to be made by the Board have not been concluded.
(2)A pathology service deemed to be accredited under this section continues to be deemed to be accredited—
(a)until the service is granted or refused accreditation under section 13(8);
(b)for twelve months; or
(c)until the deemed accreditation is suspended or cancelled—
whichever first occurs.
(3)On receipt of an application in the prescribed form and on payment of the prescribed fee, the Board may again deem to be accredited a pathology service which has ceased to be deemed to be accredited under this section.
(4)A pathology service deemed to be accredited under this section—
(a)need not be placed in a category by the Board under section 13(8)(a); and
(b)need not comply with the standards prescribed under section 14(3).
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PART V—PROPRIETORSHIP OF PATHOLOGY SERVICES
19.Persons who may and may not own pathology service
* * * * *
(8)Where the proprietor of an accredited pathology service dies it shall be lawful, notwithstanding anything to the contrary in this Act, for the executor or administrator of his estate or for the surviving spouse or the next of kin to continue the business under the name and style as accredited for such period as the Board thinks fit.
20.Information to be given to the Board
(1)The Board may require a proprietor of a pathology service, a pathologist, medical practitioner or a scientist to give the Board any information or to produce to the Board any documents relating to the proprietorship of or to any proprietary or pecuniary interests held in any pathology service.
(2)A person who fails or refuses to give the Board any information required under sub-section (1) or who wilfully misleads the Board when giving such information, or fails or refuses to produce any document required to be produced under sub-section (1) shall be guilty of an offence against this Act and liable to a penalty not exceeding 60 penalty units.
21.Copy of partnership agreement to be lodged with registrar
(1)A copy of every partnership agreement with respect to the proprietorship of a pathology service (other than a pathology service in which only exempted tests within the meaning of section 30 are performed) that is executed after the commencement of this Part or not more than one month before such commencement shall be lodged with the registrar within two months after execution.
(2)Where a copy of a partnership agreement is not lodged with the registrar as required by sub-section (1), the parties to the agreement shall severally be guilty of an offence against this Act and liable to a penalty not exceeding 60 penalty units.
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PART VI—INSPECTORS AND INSPECTIONS
22.Inspectors
(1)A person appointed as an inspector under this Act shall be—
(a)a pathologist;
(b)a medical practitioner who is not a pathologist but who has, in the opinion of the Board, sufficient experience of work in a pathology service; or
(c)a scientist.
(2)The Board may from time to time enter into arrangements with—
(a)a university, corporation or other body; or
(b)a person qualified to be an inspector under sub-section (1)—
to carry out inspections of pathology services.
(3)The Board must cause to be published in the Government Gazette—
(a)the names of the approved inspection agencies with whom the Board has entered into arrangements under sub-section (2); and
(b)the categories of pathology services for which the agencies are approved; and
(c)if an arrangement under sub-section (2) is terminated, notice of that termination.
(4)If an approved inspection agency carries out an inspection of a pathology service for the purposes of accreditation under section 13, the agency must ensure that the inspection is carried out by two or more persons consisting of—
(a)a person who, within the meaning of section 13(9), is a peer of the person who is or is to be the person in charge of the pathology service; and
(b)where the person appointed under paragraph (a) is—
(i)a pathologist or a medical practitioner, a scientist; and
(ii)a medical practitioner or a scientist, a pathologist; and
(c)such other persons (if any) as the agency determines.
(5)The Board may from time to time require the proprietor of an accredited pathology service to obtain and submit to the Board a report from an approved inspection agency on whether the prescribed requirements or the prescribed standards which apply to a pathology service of that category are being observed by that pathology service.
23.Powers and duties of an inspector
(1)An inspector may for the purpose of carrying out an inspection, with the written authority of the Board—
(a)during ordinary business hours enter and inspect premises which are an accredited pathology service or for which accreditation is sought;
(b)require the person who appears to be the person in charge of the pathology service to produce such certificates records and other documents as the inspector considers necessary for carrying out his duties by or under this Act; and
(c)take copies of or extracts from any documents so produced.
(2)A person who prevents or hinders an inspector in the performance of his duties under this Act or the regulations shall be guilty of an offence against this Act.
(3)In this section and in section 24 "inspector" includes any person carrying out an inspection pursuant to an agreement entered into under section 22(2).
(4)An inspector appointed by the Board is not, in respect of the office of inspector, subject to the Public Sector Management and Employment Act 1998.
24.Random inspections
One or more inspectors, with the written authority of the Board setting out the nature of the authorized inspection and the reasons for that inspection may, at any time, carry out inspections at an accredited pathology service without informing the proprietor or the person in charge of the pathology service of the pending inspection.
24A.Inspection fees
(1)A pathology service must pay to the Board the prescribed fee for an inspection of the pathology service by the Board.
(2)A pathology service must pay to an approved inspection agency for an inspection of the pathology service by that agency fees in accordance with the arrangement entered into under section 22(2).
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PART VII—INQUIRIES AND APPEALS
25.Board may hold inquiries
(1)The Board may for any of the purposes of this Act or the regulations hold an inquiry into any matter it considers necessary.
(2)For the purpose of conducting an inquiry referred to in sub-section (1), the Board shall have all the powers conferred by sections 14, 15, 16, 20 and 20A of the Evidence Act 1958 upon a Board appointed by the Governor in Council.
26.Appeals
(1)Where—
(a)an applicant for accreditation of a pathology service is aggrieved by the refusal of the Board to grant accreditation to his pathology service; or
(b)the proprietor of an accredited pathology service is aggrieved—
(i)by the placing of the pathology service in a particular category; or
(ii)by the suspension or cancellation of the accreditation of the pathology service; or
(c)the proprietor of an accredited pathology service is aggrieved by the imposition of any limitation or restriction on the accreditation—
that applicant or proprietor of a pathology service may appeal to the County Court within three months after receiving notification of the refusal or of the placement in that category or of the suspension or cancellation of that accreditation or the imposition of the limitation or restriction or within such extended time as the County Court allows, on the application of the proprietor made either before or after the expiration of that period of three months.
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27.Return of accreditation certificate
(1)Where the accreditation of a pathology service has been suspended or cancelled by the Board or the Board has imposed any limitation or restriction on an accreditation, the proprietor of the pathology service shall within fourteen days after receiving notification of the suspension, cancellation or imposition of a limitation or restriction surrender to the Board the current accreditation certificate issued to him by the Board.
(2)A proprietor of a pathology service who without reasonable excuse fails to comply with sub-section (1) shall be guilty of an offence against this Act.
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PART VIII—FINANCE
28.Accredited pathology services to pay fees to the Board
(1)The proprietor of each accredited pathology service shall pay to the Board the prescribed fee for accreditation or renewal of accreditation as is appropriate for the category of accredited pathology service in which the pathology service is placed by the Board.
(2)The Board shall cause all moneys received by it in payment of fees under this Act to be paid into the Consolidated Fund.
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PART IX—GENERAL
30.Prohibition on performance of certain tests
(1)Subject to this section a person who—
(a)other than in an accredited pathology service performs a test other than an exempted test;
(b)in an accredited pathology service which is placed by the Board in a particular category performs a test which pursuant to this Act or the regulations is not permitted to be performed in an accredited pathology service of that category;
(c)in an accredited pathology service or a pathology service that is deemed to be accredited performs a test which it is not permitted to perform because of a limitation or restriction placed on its accreditation—
is not entitled to recover in any court any fee or charge for or in relation to the performance of that test.
(2)An exempted test may be performed by or under the supervision of—
(a)a medical practitioner on behalf of a patient of that medical practitioner in the course of the medical practitioner's practice as such; or
(b)a registered dentist within the meaning of the Dental Practice Act 1999 on behalf of a patient of that dentist in the course of the dentist's practice as such—
whether or not the test is performed in an accredited pathology laboratory.
(3)In this Act "exempted test" means any test which upon the recommendation of the Board is for the time being prescribed by the Governor in Council to be an exempted test.
(4)A medical practitioner in a specialist field of medicine may perform tests relevant to his area of expertise which are not exempted tests provided that the tests and the laboratory in which he performs the tests have been approved by the Board.
30A.Non-regulated tests
(1)The Governor in Council, on the recommendation of the Board, may prescribe any exempted test to be a non-regulated test.
(2)The provisions of this Act, including the provisions relating to exempted tests, shall not apply to a test for the time being prescribed to be a non-regulated test.
(3)Regulations made under this section may be disallowed in whole or in part by resolution of either House of Parliament in accordance with the requirements of section 6(2) of the Subordinate Legislation Act 1962.
(4)Disallowance under sub-section (3) is deemed to be disallowance by Parliament for the purposes of the Subordinate Legislation Act 1962.
31.Notice of fees
Notwithstanding any rule of law or practice to the contrary the proprietor of an accredited pathology service may display at the pathology service a notice of the fees payable in respect of pathology services rendered by that pathology service.
32.Directions
(1)Where the Board is of the opinion that—
(a)any prescribed requirement; or
(b)any prescribed standard—
which applies to a particular accredited pathology service is not being observed by that pathology service, the Board may give to the proprietor of that pathology service such directions in writing as it thinks necessary to enable the requirement or the standard to be observed, and shall state in the direction a period within which the proprietor shall comply with the direction.
(1A)If the Board is of the opinion that a limitation or restriction that is imposed on the accreditation or deemed accreditation of a pathology service is not being complied with by the pathology service, the Board may give to the proprietor of the pathology service any directions in writing that it thinks necessary to enable the limitation or restriction to be complied with and must state in the direction the time within which the proprietor must comply with the direction.
(2)Where the proprietor of an accredited pathology service fails to comply with the direction within the stated period, the Board may—
(a)suspend or cancel the accreditation or deemed accreditation of the pathology service; or
(b)alter the category in which the pathology service is placed; or
(ba)impose a further limitation or restriction on the accreditation or deemed accreditation of the pathology service; or
(c)take such other action it thinks fit.
33.Pathology service ceases to be accredited when accreditation suspended or cancelled
(1)Where the accreditation or deemed accreditation of a pathology service is—
(a)suspended by the Board, the pathology service shall cease to be an accredited pathology service for the period of the suspension; and
(b)cancelled by the Board, the pathology service shall cease to be an accredited pathology service.
(2)Where the Board suspends or cancels the accreditation or deemed accreditation of a pathology service, it shall place a notice to that effect in the Government Gazette.
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PART X—OFFENCES
34.Offences concerning fraud
A person who—
(a)procures or attempts to procure accreditation or deemed accreditation of a pathology service by making or causing to be made or produced a false or fraudulent declaration, certificate or representation either in writing or otherwise; or
(b)wilfully makes or causes to be made any falsification in or in any manner relating to the register—
shall be guilty of an offence against this Act and liable to a penalty not exceeding 60 penalty units.
35.Offences relating to premises which are not accredited pathology services
A person who—
(a)other than in an accredited pathology service performs or causes to be performed any test which pursuant to this Act or the regulations is permitted to be performed only in an accredited pathology service; or
(ab)other than in an accredited pathology service performs or causes to be performed any test unless that test is permitted by or under this Act to be performed outside an accredited pathology service; or
(b)advertises or holds out or causes to be advertised or to be held out in any way that a pathology service which is not an accredited pathology service is so accredited; or
(c)falsely advertises that he is or holds himself out as being—
(i)a pathologist; or
(ii)a scientist or a medical practitioner practising at an accredited pathology service—
shall be guilty of an offence against this Act and liable to a penalty not exceeding 60 penalty units.
36.Offence for performing tests which are not permitted
(1)A person who in an accredited pathology service which is placed by the Board in a particular category performs or causes to be performed any test which pursuant to this Act or the regulations is not permitted to be performed in an accredited pathology service of that category, shall be guilty of an offence against this Act and liable to a penalty not exceeding 60 penalty units.
(2)A person who in an accredited pathology service performs or causes to be performed a test which is not permitted to be performed in that pathology service because of a limitation or restriction placed on its accreditation is guilty of an offence and liable to a penalty not exceeding 60 penalty units.
* * * * *
38.Proceedings
Proceedings under this Act may be taken by a person authorized by the Board either generally or in a particular case and proof shall not, in the absence of evidence to the contrary, be required of the giving of that authority by the Board.
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PART XI—CATEGORIES OF ACCREDITED PATHOLOGY SERVICES AND REGULATIONS
39.Governor in Council may amend Schedule 1 by Order
(1)The Governor in Council on the recommendation of the Board may at any time by Order amend the categories specified in Schedule 1 to this Act.
(2)An Order under sub-section (1) shall—
(a)be published in the Government Gazette; and
(b)take effect from such day as is specified in the Order being a day not less than one month after the making of the Order.
40.Regulations
(1)The Governor in Council may make regulations for or with respect to any matter relating to the accreditation of pathology services and in particular without affecting the generality of the foregoing, for or with respect to—
(a)the minimum standards to apply to accredited pathology services generally and the special minimum standards to apply to the different categories of pathology services;
(b)the standards required of services with respect of specimen collection, analysis, reporting, records, safety and staff amenities;
(ba)prescribing ethical standards of conduct to apply to the proprietor and staff of pathology services;
(c)acceptable quality control programmes;
(d)the persons who under the supervision of a medical practitioner may perform specified exempted tests;
(e)the tests or types of tests which may or may not be performed in particular categories of accredited pathology services;
(f)the minimum qualifications required for the person in charge of each category of accredited pathology service, and for a person conducting tests in each category of accredited pathology services, and for any other person working in each category of accredited pathology service;
(g)inspections and the special qualifications required generally or in special cases for chief inspectors and inspectors;
(h)registers and records to be kept by or under or for the purposes of this Act;
(i)the collection and supply to the Board of statistical information;
(j)forms for the purposes of this Act (and forms to the like effect shall be sufficient in law);
(ja)prescribing fees to be paid by a pathology service—
(i)for an application for accreditation of the service or for the Board to again deem the service to be accredited;
(ii)for a grant of accreditation to the service or for the deeming of the service to be accredited;
(iii)for the renewal of accreditation of the service; and
(iv)for the inspection of the service by the Board.
* * * * *
(k)the prohibiting or controlling of the advertising of pathology services;
(l)directions given by the Board;
(m)prescribing penalties not exceeding 5 penalty units for contraventions of the regulations; and
(n)generally prescribing any matter or thing authorized or required to be prescribed under this Act or necessary to be prescribed for the purposes of this Act.
(2)The regulations may apply, adopt or incorporate (with or without modification)—
(a)the provisions of any document, code, standard, rule, specification or method formulated, issued, prescribed or published by any authority or body whether as formulated, issued, prescribed or published at the time the regulation is made, or at any time before then; or
(b)the provisions of any Act of the Commonwealth or of another State or of a Territory or the provisions of any subordinate instrument under any such Act, whether as in force at a particular time or from time to time.
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PART XII—TRANSITIONALS
41.Transitionals—limitations etc. on current accreditations
The Board may impose any limitation or restriction on an accreditation or deemed accreditation that is in force at the commencement of the Pathology Services Accreditation (Amendment) Act 2002 during the period of that accreditation in accordance with section 17A.
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SCHEDULE 1
CATEGORIES OF ACCREDITED PATHOLOGY SERVICES
Category G (General)
A pathology service consisting of one laboratory or a group of laboratories at the one location, where tests in one or more divisions of pathology are performed, and where there is direct, full-time or equivalent full-time professional and scientific accountability and supervision by a pathologist or pathologists or by a scientist or scientists.
Category B (Branch)
A pathology service in which the range of pathology tests provided and the standard of work is under the direction and control of a designed pathologist or scientist employed in an accredited Category G pathology service. The pathology service must have an on-site scientist providing day-by-day supervision and a written agreement with the Category G pathology service for direction and control as required for this Category and be either an integral part of the Category G laboratory, except for its location, or a part of a regional pathology service.
Category M (Medical Practitioner)
A pathology service in which test approved by the Board are performed by or under the supervision of a registered medical practitioner for patients only of the medical practice in which the practitioner works.
Category S (Specialised)
A pathology service in which is performed a limited range of pathology tests approved by the Board, where those tests are either conducted on a particular target population or are of a specialised nature and are performed under the supervision of a person having special qualifications or skills, acceptable to the Board, in the field of those tests.
Category U (Unspecified)
Services approved by the Board of a type which do not fall within any other Category.
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ENDNOTES
1. General Information
The Pathology Services Accreditation Act 1984 was assented to on 22 May 1984 and came into operation as follows:
Sections 1–10, 29, 40 on 26 February 1985: Government Gazette 20 February 1985 page 368; section 22 on 10 December 1989: Government Gazette 6 December 1989 page 3128; rest of Act on 2 March 1990: Government Gazette 28 February 1990 page 586.
2. Table of Amendments
This Version incorporates amendments made to the Pathology Services Accreditation Act 1984 by Acts and subordinate instruments.
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Pathology Services Accreditation (Amendment) Act 1986, No. 40/1986
Assent Date: 20.5.86 Commencement Date: 20.5.86: s. 2 Current State: All of Act in operation
Pathology Services Accreditation (Amendment) Act 1988, No. 25/1988
Assent Date: 17.5.88 Commencement Date: 17.5.88: s. 2 Current State: All of Act in operation
Magistrates' Court (Consequential Amendments) Act 1989, No. 57/1989
Assent Date: 14.6.89 Commencement Date: S. 4(1)(a)–(e)(2) on 1.9.89: Government Gazette 30.8.89 p. 2210; rest of Act on 1.9.90: Government Gazette 25.7.90 p. 2217 Current State: All of Act in operation
Pathology Services Accreditation (Further Amendment) Act 1991, No. 9/1991
Assent Date: 16.4.91 Commencement Date: 16.4.91: s. 2 Current State: All of Act in operation
Medical Practice Act 1994, No. 23/1994
Assent Date: 17.5.94 Commencement Date: S. 118(Sch. 1 item 41) on 1.7.94: Government Gazette 23.6.94 p. 1672 Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Financial Management (Consequential Amendments) Act 1994, No. 31/1994
Assent Date: 31.5.94 Commencement Date: S. 4(Sch. 2 item 62) on 1.1.95: Government Gazette 28.7.94 p. 2055 Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Health Acts (Amendment) Act 1996, No. 19/1996
Assent Date: 2.7.96 Commencement Date: Pt 3 (s. 5) on 2.7.96: s. 2(1) Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Public Sector Reform (Miscellaneous Amendments) Act 1998, No. 46/1998
Assent Date: 26.5.98 Commencement Date: S. 7 (Sch. 1) on 1.7.98: s. 2(2) Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Dental Practice Act 1999, No. 26/1999
Assent Date: 1.6.99 Commencement Date: S. 107(Sch. item 7) on 1.7.00: s. 2(3) Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Statute Law (Further Revision) Act 2002, No. 11/2002
Assent Date: 23.4.02 Commencement Date: S. 3(Sch. 1 item 50) on 24.4.02: s. 2(1) Current State: This information relates only to the provision/s amending the Pathology Services Accreditation Act 1984
Pathology Services Accreditation (Amendment) Act 2002, No. 28/2002
Assent Date: 12.6.02 Commencement Date: 13.6.02: s. 2 Current State: All of Act in operation
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Government Gazette 21 December 2000 page 3047
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3. Explanatory Details
No entries at date of publication.
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