(1) The form contained in Schedule 1 is (1) The form contained in Schedule 1 is the approved form of undertaking to be given by persons who wish to become approved pathology practitioners.
(1) The form contained in Schedule 1 is the approved form of undertaking to be
given by persons who wish to become approved pathology practitioners.
(2) The form contained in Schedule 2 is the approved form of undertaking to
be given by persons who wish to become approved pathology authorities.
SCHEDULE 1
APP Undertaking APP Undertaking
APP Undertaking
1.1 I have read and familiarised myself with the provisions of the legislation listed in Schedule 1: Legislation (the legislation) as summarised in the Medicare Benefits Schedule Book current at the date of my giving this undertaking.
1.2 I undertake to comply with the legislation, as in force from time to time and set out in Schedule 1: Legislation, or any legislation made in substitution for that legislation.
1.3 I undertake not to take any action that would constitute a relevant offence as defined in subsection 124B(1) of the Act.
1.4 I acknowledge that a failure to comply with the requirements of Parts 1.2 or 1.3 constitutes a breach of this undertaking whether or not that failure has been, or is likely to be, proven in court proceedings.
1.5 I undertake to comply with the outline of arrangements and assessment criteria set out in the Medicare Benefits Schedule Book, as in force and amended from time to time.
1.6 I am aware that if the Minister grants the application in support of which this undertaking is given the undertaking may outlast the period for which the Minister’s approval is given.
2.1 I acknowledge that it is my obligation, subject to Parts 2.2 and 2.4, personally to supervise any person who renders any service on my behalf and I undertake to accept person responsibility for the rendering of that service under the following conditions of personal supervision:
(i) Subject to the following conditions, I will usually be physically available in the laboratory while services are being provided at the laboratory;
(ii) I may, subject to paragraph (vi) below, be physically absent from the laboratory while services are being rendered outside its normal hours of operation but in that event I will leave with the person rendering the service particulars of the manner in which I may be contacted while the service is being rendered and I must be able to personally attend at the laboratory while the service is being rendered or formally designate another APP present while I am absent;
(iii) I may, subject to paragraph (vi) below, be absent from the laboratory for brief periods due to illness or other personal necessity, or to take part in activities which, in accordance with normal and accepted practice, relate to the provision of services by that laboratory;
(iv) I will personally keep a written log of my absences from the laboratory that extend beyond one workday in respect of that laboratory and will retain that log in the laboratory for 18 months from date of last entry;
(v) If I am to be absent from the laboratory for more than 7 consecutive workdays, I will arrange for another APP to personally supervise the rendering of services in the laboratory. That arrangement shall be recorded in writing and retained in the laboratory for 18 months from date of last entry. Until such person is appointed, and his or her appointment is recorded in writing, I will remain personally responsible to comply with this undertaking;
and no person in the above groups is physically present in the laboratory, then I must be physically present in the laboratory and closely supervise the rendering of the service;
(vii) I accept responsibility for taking all reasonable steps to ensure that in regard to services rendered by me or on my behalf:
(b) all services which are to be rendered in the laboratory are allocated to persons employed by the APA and, these persons shall have appropriate qualifications and experience to render the services;
(c) the methods and procedures in operation in the laboratory for the purpose of rendering services are in accordance with proper and correct practices;
(d) for services rendered, proper quality control methods are established and reviewed to ensure their reliability and effectiveness; and
(e) results of services and tests rendered are accurately recorded and sent to the treating practitioner and, where applicable, a referring practitioner;
(viii) If I perform, or there is performed on my behalf, a service which consists of the analysis of a specimen which I know, or have reason to believe, has been taken other than in accordance with the provisions of section 16A(5AA) of the Act I will endorse, or cause to be endorsed, on the assignment form or the account for that service, as the case may be, particulars of the circumstances in which I believe, or have reason to believe, the specimen was taken.
2.2 Where services are to be rendered on my behalf in a Category B laboratory as defined in the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002, I undertake to take all reasonable measures to ensure that the service is rendered under the supervision of an appropriate person as required by those Principles as in force from time to time.
2.3 I acknowledge to the best of my ability that any act or omission by a person, when acting with my authority, whether express or implied, that would, had it been done by me, have resulted in a breach of this undertaking, constitutes a breach of this undertaking by me.
2.4 Parts 2.1(i) to 2.1(vi) and 2.2 of this undertaking do not apply where a laboratory is limited to services (and associated equipment for those services) as detailed in Schedule 3.
3.1 Where I can reasonably be expected to know, I undertake to inform the Manager Pathology if any of the following circumstances occur:
(v) I am required to appear before the state or territory body which has jurisdiction to affect my registration as a medical practitioner for misconduct or unprofessional conduct.
3.2 Where I should reasonably know a person is a relevant person, I undertake not to employ that person or enter into a contract or understanding with that person.
4.1 I undertake to ensure that information provided to HIC for services performed by me or on my behalf, including information relating to claims for payment, is accurate and complete.
4.2 If I become aware that information which has been provided to HIC is or becomes inaccurate or incomplete, I undertake to provide HIC with such further information as will correct the earlier information as soon as possible.
4.3 If information provided to HIC is inaccurate or incomplete I undertake to provide HIC with such further information as HIC requests. The information will be provided in such reasonable form as HIC requires.
4.4 I undertake to advise the Manager Pathology in writing of any change in information already provided for the purpose of approval as a pathology practitioner.
5.1 On request of an independent body, I undertake to provide the independent body with copies of all quality assurance program reports and related information relating to the conduct of my activities as an APP.
5.2 Where I participate in a quality assurance program for the purpose of proficiency testing, I undertake to authorise the provider of any such quality assurance program to release information and reports generated as part of the quality assurance program to an independent body.
6.1 If the Manager Pathology makes a written request, I undertake to provide any relevant information specified in the request relating to services provided by or on my behalf, including any matter arising out of this undertaking.
6.2 I acknowledge that information provided pursuant to this undertaking may be copied, disseminated or otherwise made available to officers and the independent body.
7.1 I undertake to notify in writing any practitioner, patient or other person requesting or relying on services provided by me or on my behalf if approval to perform those services has been revoked, varied or refused by the Minister.
7.2 A notice under Part 7.1 shall be restricted to services provided to practitioners, patients or other persons who, according to a report of the independent body, may have received inaccurate or otherwise unreliable reports.
7.3 I undertake to provide a notice pursuant to Part 7.1 within 5 working days of being notified that my services have been revoked, varied or refused.
7.4 In the event that I am unable to comply with Part 7.1, I undertake to provide such assistance as requested by the Manager Pathology that will enable such a notice to be given on my behalf.
8.1 I undertake not to provide any service in a laboratory in the absence of an agreement, arrangement or contract of employment between the laboratory proprietor and me.
8.2 I undertake to ensure that any contract of employment or other agreement or arrangement between myself and an Authority and any amendment or variation thereto, is in writing signed by all the parties and does not, in any way, control me in the discharge of my responsibilities as set out in this undertaking.
9.1 Where a service has been rendered by or on my behalf, I undertake to ensure that an account for that service is raised on my behalf by the APA, being the proprietor of the
laboratory in which the service was rendered and that, no further account will be raised by me. I undertake to ensure that such account includes, and is supported by, information and particulars required by the Act and the Medicare Benefits Schedule Book.
10.1 I undertake not to accept a request for services by or on my behalf where any benefit or incentive (other than an item set out in Schedule 2) has been directly or indirectly offered or supplied to the requesting practitioner or employer of that practitioner by the APA with which I have an agreement, arrangement or contract of employment.
10.2 The obligation under Part 10.1 only arises where I ought reasonably to have known that such benefit or incentive has been supplied.
11.1 Where an obligation is placed upon me by this undertaking, I undertake to comply with that obligation within 14 days of the event occurring that gives rise to the obligation, or such other time as specified in the relevant part.
11.2 Where an obligation is placed upon me by this undertaking that requires me to give information to the Manager Pathology, the information must be:
(iv) if I am to use Email to give such a notice, I undertake to take adequate steps to ensure that only myself, and persons authorised in writing, have access to the Email function on my computers and such notices shall be addressed to pathology.section@hic.gov.au
11.3 I acknowledge that Section 163 of the Evidence Act 1995 (Cth) will apply to any document posted to me by HIC at the address nominated in the application in support of which this undertaking is given or at such other address as may later be provided by me in writing to HIC.
“Account” means an itemised list of pathology services performed that may be eligible for payment under medicare including a claim for assigned benefits pursuant to the Act;
“Certified” means a copy of a document where the copy has been authenticated by a referee as a as a true and accurate reproduction of the original. A referee may include persons such as – a member of the Institute of Chartered Accounts, Certified Practising Accountant, Barrister, Solicitor, legal practitioner, medical practitioner, justice of the peace and other persons ordinarily qualified to witness a statutory declaration;
“HIC” means the Health Insurance Commission or a member of staff of the Health Insurance Commission engaged pursuant to subsection 28(1) of the Health Insurance Commission Act 1973;
“Independent body” has the same meaning as in the Health Insurance (Accredited Laboratories – Approval) Principles 2002, or any legislation made in substitution for those Principles;
“Manager Pathology” means the person for the time being holding, acting in, or performing the duties of the position titled Manager Pathology within the Health Insurance Commission;
“Medicare Benefits Schedule Book” means the book published by the Commonwealth Department of Health and Ageing generally in November of each year and forwarded to all medical practitioners;
“Minister” means the Minister of the Commonwealth for the time being administering the Act and includes an officer holding a valid delegation to make a particular decision in place of the Minister;
“Premises” means the premises of the Authority signing this undertaking and shall include laboratory premises, administrative premises, collection centre premises and any other place where the authority conducts business for the purpose of providing a pathology service pursuant to the Act;
“Quality assurance program” means a program offered for the purpose of testing proficiency in the testing of pathology specimens;
“Relevant person” means a person defined in paragraphs (a) to (f) of section 23DA of the Act, which, in summary, includes a person who: has been given a notice; received a determination; been convicted of a relevant offence; or, whom the Minister, on reasonable grounds, believes may have committed a relevant offence;
“Referring practitioner” means a medical practitioner who refers a request from a treating practitioner onto another APP or APA for testing;
“Service” means pathology service(s) to which an item in the Medical Benefits Schedule Book relates and in respect of which Medicare benefit is payable;
(ii) in relation to a laboratory which is situated in Victoria – an accredited pathology laboratory under the Pathology Services Accreditation Act 1984 of Victoria;
“Treating practitioner” means a medical practitioner responsible for the care, diagnosis and treatment of a patient;
A reference in this undertaking to writing, documents and records includes material in electronic form where recorded and submitted in accordance with Information Technology Standards of the Health Insurance Commission established pursuant to the Electronic Transactions Act 1999.
In general, these are items, which can only be used for the collection of specimens for pathology testing or, if other uses are possible, when supplied by Pathologists to referrers, will only be used for collection purposes. These are mostly single use items employed in the collection of pathology samples.
Appropriate containers and media for urine, sputum and other body fluid cytology and cytology samples collected directly from tissues by the procedure of Fine Needle Aspiration Cytology (FNA);
Centrifuges, but to remain the property of APA, and only if practice demographics (in terms of time) from laboratory are such that failure to separate sera/plasma will damage specimen;
Fridge, where refrigeration is vital for the preservation of specimens (ie Laboratory being a long distance from collection point). Fridge should be labelled with Pathology Company name, and used exclusively for pathology purposes;
Insulated containers such as eskies for specimen transport, wet ice/dry ice (must be labelled as property of laboratory);
Pathology Down Load Software specifically to retrieve pathology results for the laboratory. Pathology download software which is part of a larger suite should not be provided – where additional functionality cannot be separated from the software, a written licence agreement at normal commercial rates must exist between the APA and referring practitioner or, agreement must be established in writing prohibiting use of non-pathology software reporting components.
These are the only items/services an APP/APA may supply free of charge, discounted or on a non-commercial basis, to a practitioner that requests or, intends to request, pathology services. This list may be updated from time to time in consultation with the Royal College of Pathologists Australasia.
a medical practitioner who is or wishes to become an approved pathology practitioner, hereby give this undertaking recorded in pages 5 to 15 of this instrument to the Minister. I acknowledge that a breach of this undertaking may be referred to a Medicare Participation Review Committee (MPRC) in accordance with the Act and, pursuant to section 124FB of the Act, the MPRC may make a number of determinations including that Medicare payments should not be payable for up to 5 years.
I request the Minister or a delegate of the Minister to accept the undertaking under section 23DC of the Act. I certify that all information in this application is true and correct.
I, ______________________, hereby assert that the applicant is known to me or, if not known, am satisfied as to her/his identity, and did witness the signing of this instrument before me on this day.
1.1 I have read and familiarised myself with the provisions of the legislation listed in Schedule 1: Legislation (the legislation) as summarised in the Medicare Benefits Schedule Book current at the date of my giving this undertaking.
1.2 I undertake to comply with the legislation, as in force from time to time and set out in Schedule 1: Legislation, or any legislation made in substitution for that legislation.
1.3 I undertake not to take any action that would constitute a relevant offence as defined in subsection 124B(1) of the Act.
1.4 I acknowledge that a failure to comply with the requirements of Parts 1.2 or 1.3 constitutes a breach of this undertaking whether or not that failure has been, or is likely to be, proven in court proceedings.
1.5 I undertake to comply with the outline of arrangements and assessment criteria set out in the Medicare Benefits Schedule Book, as in force and amended from time to time.
1.6 I am aware that if the Minister grants the application in support of which this undertaking is given the undertaking may outlast the period for which the Minister’s approval is given.
Part 2 Personal supervision
2.1 I acknowledge that it is my obligation, subject to Parts 2.2 and 2.4, personally to supervise any person who renders any service on my behalf and I undertake to accept person responsibility for the rendering of that service under the following conditions of personal supervision:
(i) Subject to the following conditions, I will usually be physically available in the laboratory while services are being provided at the laboratory;
(ii) I may, subject to paragraph (vi) below, be physically absent from the laboratory while services are being rendered outside its normal hours of operation but in that event I will leave with the person rendering the service particulars of the manner in which I may be contacted while the service is being rendered and I must be able to personally attend at the laboratory while the service is being rendered or formally designate another APP present while I am absent;
(iii) I may, subject to paragraph (vi) below, be absent from the laboratory for brief periods due to illness or other personal necessity, or to take part in activities which, in accordance with normal and accepted practice, relate to the provision of services by that laboratory;
(iv) I will personally keep a written log of my absences from the laboratory that extend beyond one workday in respect of that laboratory and will retain that log in the laboratory for 18 months from date of last entry;
(v) If I am to be absent from the laboratory for more than 7 consecutive workdays, I will arrange for another APP to personally supervise the rendering of services in the laboratory. That arrangement shall be recorded in writing and retained in the laboratory for 18 months from date of last entry. Until such person is appointed, and his or her appointment is recorded in writing, I will remain personally responsible to comply with this undertaking;
and no person in the above groups is physically present in the laboratory, then I must be physically present in the laboratory and closely supervise the rendering of the service;
(vii) I accept responsibility for taking all reasonable steps to ensure that in regard to services rendered by me or on my behalf:
(b) all services which are to be rendered in the laboratory are allocated to persons employed by the APA and, these persons shall have appropriate qualifications and experience to render the services;
(c) the methods and procedures in operation in the laboratory for the purpose of rendering services are in accordance with proper and correct practices;
(d) for services rendered, proper quality control methods are established and reviewed to ensure their reliability and effectiveness; and
(e) results of services and tests rendered are accurately recorded and sent to the treating practitioner and, where applicable, a referring practitioner;
(viii) If I perform, or there is performed on my behalf, a service which consists of the analysis of a specimen which I know, or have reason to believe, has been taken other than in accordance with the provisions of section 16A(5AA) of the Act I will endorse, or cause to be endorsed, on the assignment form or the account for that service, as the case may be, particulars of the circumstances in which I believe, or have reason to believe, the specimen was taken.
2.2 Where services are to be rendered on my behalf in a Category B laboratory as defined in the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002, I undertake to take all reasonable measures to ensure that the service is rendered under the supervision of an appropriate person as required by those Principles as in force from time to time.
2.3 I acknowledge to the best of my ability that any act or omission by a person, when acting with my authority, whether express or implied, that would, had it been done by me, have resulted in a breach of this undertaking, constitutes a breach of this undertaking by me.
2.4 Parts 2.1(i) to 2.1(vi) and 2.2 of this undertaking do not apply where a laboratory is limited to services (and associated equipment for those services) as detailed in Schedule 3.
Part 3 Dealings with relevant person
3.1 Where I can reasonably be expected to know, I undertake to inform the Manager Pathology if any of the following circumstances occur:
(v) I am required to appear before the state or territory body which has jurisdiction to affect my registration as a medical practitioner for misconduct or unprofessional conduct.
3.2 Where I should reasonably know a person is a relevant person, I undertake not to employ that person or enter into a contract or understanding with that person.
Part 4 Information to be accurate
4.1 I undertake to ensure that information provided to HIC for services performed by me or on my behalf, including information relating to claims for payment, is accurate and complete.
4.2 If I become aware that information which has been provided to HIC is or becomes inaccurate or incomplete, I undertake to provide HIC with such further information as will correct the earlier information as soon as possible.
4.3 If information provided to HIC is inaccurate or incomplete I undertake to provide HIC with such further information as HIC requests. The information will be provided in such reasonable form as HIC requires.
4.4 I undertake to advise the Manager Pathology in writing of any change in information already provided for the purpose of approval as a pathology practitioner.
5.1 On request of an independent body, I undertake to provide the independent body with copies of all quality assurance program reports and related information relating to the conduct of my activities as an APP.
5.2 Where I participate in a quality assurance program for the purpose of proficiency testing, I undertake to authorise the provider of any such quality assurance program to release information and reports generated as part of the quality assurance program to an independent body.
Part 6 Request and use of information
6.1 If the Manager Pathology makes a written request, I undertake to provide any relevant information specified in the request relating to services provided by or on my behalf, including any matter arising out of this undertaking.
6.2 I acknowledge that information provided pursuant to this undertaking may be copied, disseminated or otherwise made available to officers and the independent body.
Part 7 Notice to practitioners, patients or other persons
7.1 I undertake to notify in writing any practitioner, patient or other person requesting or relying on services provided by me or on my behalf if approval to perform those services has been revoked, varied or refused by the Minister.
7.2 A notice under Part 7.1 shall be restricted to services provided to practitioners, patients or other persons who, according to a report of the independent body, may have received inaccurate or otherwise unreliable reports.
7.3 I undertake to provide a notice pursuant to Part 7.1 within 5 working days of being notified that my services have been revoked, varied or refused.
7.4 In the event that I am unable to comply with Part 7.1, I undertake to provide such assistance as requested by the Manager Pathology that will enable such a notice to be given on my behalf.
Part 8 Agreements, arrangements and contracts of employment with Approved Pathology Authority
8.1 I undertake not to provide any service in a laboratory in the absence of an agreement, arrangement or contract of employment between the laboratory proprietor and me.
8.2 I undertake to ensure that any contract of employment or other agreement or arrangement between myself and an Authority and any amendment or variation thereto, is in writing signed by all the parties and does not, in any way, control me in the discharge of my responsibilities as set out in this undertaking.
Part 9 Accounts for services rendered by employed APP
9.1 Where a service has been rendered by or on my behalf, I undertake to ensure that an account for that service is raised on my behalf by the APA, being the proprietor of the
laboratory in which the service was rendered and that, no further account will be raised by me. I undertake to ensure that such account includes, and is supported by, information and particulars required by the Act and the Medicare Benefits Schedule Book.
Part 10 No inducement to use services
10.1 I undertake not to accept a request for services by or on my behalf where any benefit or incentive (other than an item set out in Schedule 2) has been directly or indirectly offered or supplied to the requesting practitioner or employer of that practitioner by the APA with which I have an agreement, arrangement or contract of employment.
10.2 The obligation under Part 10.1 only arises where I ought reasonably to have known that such benefit or incentive has been supplied.
Part 11 Time and method of complying with undertakings
11.1 Where an obligation is placed upon me by this undertaking, I undertake to comply with that obligation within 14 days of the event occurring that gives rise to the obligation, or such other time as specified in the relevant part.
11.2 Where an obligation is placed upon me by this undertaking that requires me to give information to the Manager Pathology, the information must be:
(iv) if I am to use Email to give such a notice, I undertake to take adequate steps to ensure that only myself, and persons authorised in writing, have access to the Email function on my computers and such notices shall be addressed to pathology.section@hic.gov.au
11.3 I acknowledge that Section 163 of the Evidence Act 1995 (Cth) will apply to any document posted to me by HIC at the address nominated in the application in support of which this undertaking is given or at such other address as may later be provided by me in writing to HIC.
“Account” means an itemised list of pathology services performed that may be eligible for payment under medicare including a claim for assigned benefits pursuant to the Act;
“Certified” means a copy of a document where the copy has been authenticated by a referee as a as a true and accurate reproduction of the original. A referee may include persons such as – a member of the Institute of Chartered Accounts, Certified Practising Accountant, Barrister, Solicitor, legal practitioner, medical practitioner, justice of the peace and other persons ordinarily qualified to witness a statutory declaration;
“HIC” means the Health Insurance Commission or a member of staff of the Health Insurance Commission engaged pursuant to subsection 28(1) of the Health Insurance Commission Act 1973;
“Independent body” has the same meaning as in the Health Insurance (Accredited Laboratories – Approval) Principles 2002, or any legislation made in substitution for those Principles;
“Manager Pathology” means the person for the time being holding, acting in, or performing the duties of the position titled Manager Pathology within the Health Insurance Commission;
“Medicare Benefits Schedule Book” means the book published by the Commonwealth Department of Health and Ageing generally in November of each year and forwarded to all medical practitioners;
“Minister” means the Minister of the Commonwealth for the time being administering the Act and includes an officer holding a valid delegation to make a particular decision in place of the Minister;
“Premises” means the premises of the Authority signing this undertaking and shall include laboratory premises, administrative premises, collection centre premises and any other place where the authority conducts business for the purpose of providing a pathology service pursuant to the Act;
“Quality assurance program” means a program offered for the purpose of testing proficiency in the testing of pathology specimens;
“Relevant person” means a person defined in paragraphs (a) to (f) of section 23DA of the Act, which, in summary, includes a person who: has been given a notice; received a determination; been convicted of a relevant offence; or, whom the Minister, on reasonable grounds, believes may have committed a relevant offence;
“Referring practitioner” means a medical practitioner who refers a request from a treating practitioner onto another APP or APA for testing;
“Service” means pathology service(s) to which an item in the Medical Benefits Schedule Book relates and in respect of which Medicare benefit is payable;
(ii) in relation to a laboratory which is situated in Victoria – an accredited pathology laboratory under the Pathology Services Accreditation Act 1984 of Victoria;
“Treating practitioner” means a medical “Treating practitioner” means a medical practitioner responsible for the care, diagnosis and treatment of a patient;
APP Undertaking
1.1 I have read and familiarised myself with the provisions of the legislation listed in Schedule 1: Legislation (the legislation) as summarised in the Medicare Benefits Schedule Book current at the date of my giving this undertaking.
1.2 I undertake to comply with the legislation, as in force from time to time and set out in Schedule 1: Legislation, or any legislation made in substitution for that legislation.
1.3 I undertake not to take any action that would constitute a relevant offence as defined in subsection 124B(1) of the Act.
1.4 I acknowledge that a failure to comply with the requirements of Parts 1.2 or 1.3 constitutes a breach of this undertaking whether or not that failure has been, or is likely to be, proven in court proceedings.
1.5 I undertake to comply with the outline of arrangements and assessment criteria set out in the Medicare Benefits Schedule Book, as in force and amended from time to time.
1.6 I am aware that if the Minister grants the application in support of which this undertaking is given the undertaking may outlast the period for which the Minister’s approval is given.
2.1 I acknowledge that it is my obligation, subject to Parts 2.2 and 2.4, personally to supervise any person who renders any service on my behalf and I undertake to accept person responsibility for the rendering of that service under the following conditions of personal supervision:
(i) Subject to the following conditions, I will usually be physically available in the laboratory while services are being provided at the laboratory;
(ii) I may, subject to paragraph (vi) below, be physically absent from the laboratory while services are being rendered outside its normal hours of operation but in that event I will leave with the person rendering the service particulars of the manner in which I may be contacted while the service is being rendered and I must be able to personally attend at the laboratory while the service is being rendered or formally designate another APP present while I am absent;
(iii) I may, subject to paragraph (vi) below, be absent from the laboratory for brief periods due to illness or other personal necessity, or to take part in activities which, in accordance with normal and accepted practice, relate to the provision of services by that laboratory;
(iv) I will personally keep a written log of my absences from the laboratory that extend beyond one workday in respect of that laboratory and will retain that log in the laboratory for 18 months from date of last entry;
(v) If I am to be absent from the laboratory for more than 7 consecutive workdays, I will arrange for another APP to personally supervise the rendering of services in the laboratory. That arrangement shall be recorded in writing and retained in the laboratory for 18 months from date of last entry. Until such person is appointed, and his or her appointment is recorded in writing, I will remain personally responsible to comply with this undertaking;
and no person in the above groups is physically present in the laboratory, then I must be physically present in the laboratory and closely supervise the rendering of the service;
(vii) I accept responsibility for taking all reasonable steps to ensure that in regard to services rendered by me or on my behalf:
(b) all services which are to be rendered in the laboratory are allocated to persons employed by the APA and, these persons shall have appropriate qualifications and experience to render the services;
(c) the methods and procedures in operation in the laboratory for the purpose of rendering services are in accordance with proper and correct practices;
(d) for services rendered, proper quality control methods are established and reviewed to ensure their reliability and effectiveness; and
(e) results of services and tests rendered are accurately recorded and sent to the treating practitioner and, where applicable, a referring practitioner;
(viii) If I perform, or there is performed on my behalf, a service which consists of the analysis of a specimen which I know, or have reason to believe, has been taken other than in accordance with the provisions of section 16A(5AA) of the Act I will endorse, or cause to be endorsed, on the assignment form or the account for that service, as the case may be, particulars of the circumstances in which I believe, or have reason to believe, the specimen was taken.
2.2 Where services are to be rendered on my behalf in a Category B laboratory as defined in the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002, I undertake to take all reasonable measures to ensure that the service is rendered under the supervision of an appropriate person as required by those Principles as in force from time to time.
2.3 I acknowledge to the best of my ability that any act or omission by a person, when acting with my authority, whether express or implied, that would, had it been done by me, have resulted in a breach of this undertaking, constitutes a breach of this undertaking by me.
2.4 Parts 2.1(i) to 2.1(vi) and 2.2 of this undertaking do not apply where a laboratory is limited to services (and associated equipment for those services) as detailed in Schedule 3.
3.1 Where I can reasonably be expected to know, I undertake to inform the Manager Pathology if any of the following circumstances occur:
(v) I am required to appear before the state or territory body which has jurisdiction to affect my registration as a medical practitioner for misconduct or unprofessional conduct.
3.2 Where I should reasonably know a person is a relevant person, I undertake not to employ that person or enter into a contract or understanding with that person.
4.1 I undertake to ensure that information provided to HIC for services performed by me or on my behalf, including information relating to claims for payment, is accurate and complete.
4.2 If I become aware that information which has been provided to HIC is or becomes inaccurate or incomplete, I undertake to provide HIC with such further information as will correct the earlier information as soon as possible.
4.3 If information provided to HIC is inaccurate or incomplete I undertake to provide HIC with such further information as HIC requests. The information will be provided in such reasonable form as HIC requires.
4.4 I undertake to advise the Manager Pathology in writing of any change in information already provided for the purpose of approval as a pathology practitioner.
5.1 On request of an independent body, I undertake to provide the independent body with copies of all quality assurance program reports and related information relating to the conduct of my activities as an APP.
5.2 Where I participate in a quality assurance program for the purpose of proficiency testing, I undertake to authorise the provider of any such quality assurance program to release information and reports generated as part of the quality assurance program to an independent body.
6.1 If the Manager Pathology makes a written request, I undertake to provide any relevant information specified in the request relating to services provided by or on my behalf, including any matter arising out of this undertaking.
6.2 I acknowledge that information provided pursuant to this undertaking may be copied, disseminated or otherwise made available to officers and the independent body.
7.1 I undertake to notify in writing any practitioner, patient or other person requesting or relying on services provided by me or on my behalf if approval to perform those services has been revoked, varied or refused by the Minister.
7.2 A notice under Part 7.1 shall be restricted to services provided to practitioners, patients or other persons who, according to a report of the independent body, may have received inaccurate or otherwise unreliable reports.
7.3 I undertake to provide a notice pursuant to Part 7.1 within 5 working days of being notified that my services have been revoked, varied or refused.
7.4 In the event that I am unable to comply with Part 7.1, I undertake to provide such assistance as requested by the Manager Pathology that will enable such a notice to be given on my behalf.
8.1 I undertake not to provide any service in a laboratory in the absence of an agreement, arrangement or contract of employment between the laboratory proprietor and me.
8.2 I undertake to ensure that any contract of employment or other agreement or arrangement between myself and an Authority and any amendment or variation thereto, is in writing signed by all the parties and does not, in any way, control me in the discharge of my responsibilities as set out in this undertaking.
9.1 Where a service has been rendered by or on my behalf, I undertake to ensure that an account for that service is raised on my behalf by the APA, being the proprietor of the
laboratory in which the service was rendered and that, no further account will be raised by me. I undertake to ensure that such account includes, and is supported by, information and particulars required by the Act and the Medicare Benefits Schedule Book.
10.1 I undertake not to accept a request for services by or on my behalf where any benefit or incentive (other than an item set out in Schedule 2) has been directly or indirectly offered or supplied to the requesting practitioner or employer of that practitioner by the APA with which I have an agreement, arrangement or contract of employment.
10.2 The obligation under Part 10.1 only arises where I ought reasonably to have known that such benefit or incentive has been supplied.
11.1 Where an obligation is placed upon me by this undertaking, I undertake to comply with that obligation within 14 days of the event occurring that gives rise to the obligation, or such other time as specified in the relevant part.
11.2 Where an obligation is placed upon me by this undertaking that requires me to give information to the Manager Pathology, the information must be:
(iv) if I am to use Email to give such a notice, I undertake to take adequate steps to ensure that only myself, and persons authorised in writing, have access to the Email function on my computers and such notices shall be addressed to pathology.section@hic.gov.au
11.3 I acknowledge that Section 163 of the Evidence Act 1995 (Cth) will apply to any document posted to me by HIC at the address nominated in the application in support of which this undertaking is given or at such other address as may later be provided by me in writing to HIC.
“Account” means an itemised list of pathology services performed that may be eligible for payment under medicare including a claim for assigned benefits pursuant to the Act;
“Certified” means a copy of a document where the copy has been authenticated by a referee as a as a true and accurate reproduction of the original. A referee may include persons such as – a member of the Institute of Chartered Accounts, Certified Practising Accountant, Barrister, Solicitor, legal practitioner, medical practitioner, justice of the peace and other persons ordinarily qualified to witness a statutory declaration;
“HIC” means the Health Insurance Commission or a member of staff of the Health Insurance Commission engaged pursuant to subsection 28(1) of the Health Insurance Commission Act 1973;
“Independent body” has the same meaning as in the Health Insurance (Accredited Laboratories – Approval) Principles 2002, or any legislation made in substitution for those Principles;
“Manager Pathology” means the person for the time being holding, acting in, or performing the duties of the position titled Manager Pathology within the Health Insurance Commission;
“Medicare Benefits Schedule Book” means the book published by the Commonwealth Department of Health and Ageing generally in November of each year and forwarded to all medical practitioners;
“Minister” means the Minister of the Commonwealth for the time being administering the Act and includes an officer holding a valid delegation to make a particular decision in place of the Minister;
“Premises” means the premises of the Authority signing this undertaking and shall include laboratory premises, administrative premises, collection centre premises and any other place where the authority conducts business for the purpose of providing a pathology service pursuant to the Act;
“Quality assurance program” means a program offered for the purpose of testing proficiency in the testing of pathology specimens;
“Relevant person” means a person defined in paragraphs (a) to (f) of section 23DA of the Act, which, in summary, includes a person who: has been given a notice; received a determination; been convicted of a relevant offence; or, whom the Minister, on reasonable grounds, believes may have committed a relevant offence;
“Referring practitioner” means a medical practitioner who refers a request from a treating practitioner onto another APP or APA for testing;
“Service” means pathology service(s) to which an item in the Medical Benefits Schedule Book relates and in respect of which Medicare benefit is payable;
(ii) in relation to a laboratory which is situated in Victoria – an accredited pathology laboratory under the Pathology Services Accreditation Act 1984 of Victoria;
“Treating practitioner” means a medical practitioner responsible for the care, diagnosis and treatment of a patient;
A reference in this undertaking to writing, documents and records includes material in electronic form where recorded and submitted in accordance with Information Technology Standards of the Health Insurance Commission established pursuant to the Electronic Transactions Act 1999.
In general, these are items, which can only be used for the collection of specimens for pathology testing or, if other uses are possible, when supplied by Pathologists to referrers, will only be used for collection purposes. These are mostly single use items employed in the collection of pathology samples.
Appropriate containers and media for urine, sputum and other body fluid cytology and cytology samples collected directly from tissues by the procedure of Fine Needle Aspiration Cytology (FNA);
Centrifuges, but to remain the property of APA, and only if practice demographics (in terms of time) from laboratory are such that failure to separate sera/plasma will damage specimen;
Fridge, where refrigeration is vital for the preservation of specimens (ie Laboratory being a long distance from collection point). Fridge should be labelled with Pathology Company name, and used exclusively for pathology purposes;
Insulated containers such as eskies for specimen transport, wet ice/dry ice (must be labelled as property of laboratory);
Pathology Down Load Software specifically to retrieve pathology results for the laboratory. Pathology download software which is part of a larger suite should not be provided – where additional functionality cannot be separated from the software, a written licence agreement at normal commercial rates must exist between the APA and referring practitioner or, agreement must be established in writing prohibiting use of non-pathology software reporting components.
These are the only items/services an APP/APA may supply free of charge, discounted or on a non-commercial basis, to a practitioner that requests or, intends to request, pathology services. This list may be updated from time to time in consultation with the Royal College of Pathologists Australasia.
a medical practitioner who is or wishes to become an approved pathology practitioner, hereby give this undertaking recorded in pages 5 to 15 of this instrument to the Minister. I acknowledge that a breach of this undertaking may be referred to a Medicare Participation Review Committee (MPRC) in accordance with the Act and, pursuant to section 124FB of the Act, the MPRC may make a number of determinations including that Medicare payments should not be payable for up to 5 years.
I request the Minister or a delegate of the Minister to accept the undertaking under section 23DC of the Act. I certify that all information in this application is true and correct.
I, ______________________, hereby assert that the applicant is known to me or, if not known, am satisfied as to her/his identity, and did witness the signing of this instrument before me on this day.
“Workday” means, in respect of a laborat “Workday” means, in respect of a laboratory, a calendar day during which the laboratory provides pathology services;
A reference in this undertaking to writi A reference in this undertaking to writing, documents and records includes material in electronic form where recorded and submitted in accordance with Information Technology Standards of the Health Insurance Commission established pursuant to the Electronic Transactions Act 1999.
A reference in this undertaking to writing, documents and records includes material in electronic form where recorded and submitted in accordance with Information Technology Standards of the Health Insurance Commission established pursuant to the Electronic Transactions Act 1999.
Schedule 2 Items an Authority may provide requesting practitioners
In general, these are items, which can only be used for the collection of specimens for pathology testing or, if other uses are possible, when supplied by Pathologists to referrers, will only be used for collection purposes. These are mostly single use items employed in the collection of pathology samples.
Appropriate containers and media for urine, sputum and other body fluid cytology and cytology samples collected directly from tissues by the procedure of Fine Needle Aspiration Cytology (FNA);
Centrifuges, but to remain the property of APA, and only if practice demographics (in terms of time) from laboratory are such that failure to separate sera/plasma will damage specimen;
Fridge, where refrigeration is vital for the preservation of specimens (ie Laboratory being a long distance from collection point). Fridge should be labelled with Pathology Company name, and used exclusively for pathology purposes;
Insulated containers such as eskies for specimen transport, wet ice/dry ice (must be labelled as property of laboratory);
Pathology Down Load Software specifically to retrieve pathology results for the laboratory. Pathology download software which is part of a larger suite should not be provided – where additional functionality cannot be separated from the software, a written licence agreement at normal commercial rates must exist between the APA and referring practitioner or, agreement must be established in writing prohibiting use of non-pathology software reporting components.
These are the only items/services an APP/APA may supply free of charge, discounted or on a non-commercial basis, to a practitioner that requests or, intends to request, pathology services. This list may be updated from time to time in consultation with the Royal College of Pathologists Australasia.
a medical practitioner who is or wishes to become an approved pathology practitioner, hereby give this undertaking recorded in pages 5 to 15 of this instrument to the Minister. I acknowledge that a breach of this undertaking may be referred to a Medicare Participation Review Committee (MPRC) in accordance with the Act and, pursuant to section 124FB of the Act, the MPRC may make a number of determinations including that Medicare payments should not be payable for up to 5 years.
I request the Minister or a delegate of the Minister to accept the undertaking under section 23DC of the Act. I certify that all information in this application is true and correct.
I, ______________________, hereby assert that the applicant is known to me or, if not known, am satisfied as to her/his identity, and did witness the signing of this instrument before me on this day.
1.1 As an authorised representative of the Authority, I have read and familiarised myself with the provisions of the legislation listed in Schedule 1: Legislation (the legislation) as summarised in the Medicare Benefits Schedule Book current at the date of my giving this undertaking.
1.2 The Authority undertakes to comply with the legislation, as in force from time to time and set out in Schedule 1: Legislation, or any legislation made in substitution for that legislation.
1.3 The Authority undertakes not to take any action that would constitute a relevant offence as defined in subsection 124B(1) of the Act.
1.4 The Authority acknowledges that a failure to comply with the requirements of Parts 1.2 or 1.3 constitutes a breach of this undertaking whether or not that failure has been, or is likely to be, proven in court proceedings.
1.5 The Authority undertakes to comply with the outline of arrangements and assessment criteria set out in the Medicare Benefits Schedule Book, as in force and amended from time to time.
1.6 I am aware that if the Minister grants the application in support of which this undertaking is given the undertaking may outlast the period for which the Minister’s approval is given.