Health Practitioner Regulation National Law (South Australia) Regulations 2010 (SA)
South Australia
under the
These regulations may be cited as the
Health Practitioner Regulation National Law (South Australia) Regulations 2010 .
In these regulations—
Act means theHealth Practitioner Regulation National Law (South Australia) Act 2010 ;
PRASA means the Pharmacy Regulation Authority SA constituted under Part 4 of the Act;
therapeutic goods has the same meaning as in theTherapeutic Goods Act 1989 of the Commonwealth;
Uniform Poisons Standard means the current Poisons Standard as defined in theTherapeutic Goods Act 1989 of the Commonwealth.
The following bodies are declared to be
representative bodies for the purposes of the Act:
(aaa) Ambulance Employees Association SA Inc;
(a) Australasian College of Podiatric Surgeons;
(aa) Australian Acupuncture and Chinese Medicine Association;
(ab) Australian and New Zealand Society of Nuclear Medicine (SA Branch) Limited;
(b) Australian College of Mental Health Nurses (SA Branch) Incorporated;
(c) Australian College of Midwives (SA Branch) Incorporated;
(d) Australian Dental Association South Australian Branch Incorporated;
(e) Australian Dental Prosthetists Association (SA) Incorporated;
(f) Australian Friendly Societies Pharmacies Association Incorporated;
(fa) Australian Institute of Radiography;
(g) Australian Medical Association (South Australia) Incorporated;
(ga) Australian Natural Therapists Association;
(h) Australian Nursing and Midwifery Federation (SA Branch);
(i) Australian Osteopathic Association;
(j) Australian Pharmacy Council Ltd;
(k) Australian Physiotherapy Association;
(l) Australian Physiotherapy Council;
(m) Australian Podiatry Association SA Incorporated;
(n) The Australian Psychological Society (SA Branch) Ltd;
(na) Australian Traditional‑Medicine Society;
(nb) Chinese Medicine and Acupuncture Society of Australia;
(o) Chiropractors' Association of Australia (South Australia) Limited;
(p) Council on Chiropractic Education Australasia Incorporated;
(q) The Dental Hygienists' Association of Australia (SA Branch) Incorporated;
(qa) Federation of Chinese Medicine and Acupuncture (SA Branch);
(r) Health Consumers Alliance of South Australia Incorporated;
(s) Institute of Private Practising Psychologists Inc.;
(sa) National Aboriginal and Torres Strait Islander Health Worker Association;
(sb) Occupational Therapy Australia Limited, South Australia Division;
(t) Optometry South Australia Incorporated;
(ta) Paramedics Australasia Ltd (SA Chapter);
(u) Pharmaceutical Society of Australia (South Australian Branch) Incorporated;
(v) The Pharmacy Guild of Australia (SA Branch);
(w) Royal College of Nursing, Australia;
(x) The Society of Hospital Pharmacists of Australia (SA & NT Branch);
(xa) Society of Natural Therapists and Researchers Incorporated;
(y) South Australian Dental Therapists' Association Incorporated;
(z) SA Salaried Medical Officers Association.
For the purposes of section 82(3)(c) of the Act, Standards Australia is a prescribed body.
For the purposes of the definition of
restricted pharmacy services in section 26(1) of the Act, the following services are declared to be restricted pharmacy services:
(a) the assessment of a medication, whether on account of a prescription, recommendation or request, followed by the selection and preparation of the medication and its supply (with or without information about health outcomes associated with the medication);
(b) the custody, control or dispensing, provision and management of therapeutic goods, health care products and other products or items commonly associated with the practice of a pharmacist;
(c) the provision of information and other services commonly associated with the practice of a pharmacist.
(1) For the purposes of section 41(3)(a) of the Act, premises proposed to be registered as a pharmacy must—
(a) consist of an enclosed area with access to a public place; and
(b) contain an area set aside for the dispensing of items on prescription that is not less that 9 square metres; and
(c) be kept in a hygienic condition and be adequately ventilated; and
(d) have provision for adequate lighting; and
(e) have provision for temperature control of therapeutic goods and health care products; and
(f) contain adequate provision for the safe, secure and hygienic storage of therapeutic goods and health care products; and
(g) contain adequate provision for the safe and secure storage of confidential and sensitive information; and
(h) be constructed in such a manner as to allow a pharmacist to supervise effectively the whole of that part of the premises used in the provision of restricted pharmacy services and the activities of persons in that part of the premises.
(2) For the purposes of the definition of
supermarket in section 41(10) of the Act, a supermarket is a store or market the primary business of which is the sale of a range of food, beverages, groceries and other domestic goods.
(1) For the purposes of section 43(1b)(a) of the Act, an area in this State that is classified under the
Modified Monash Model (MMM) 2019 of the Commonwealth (as in force from time to time) as category MM 5, MM 6 or MM 7 is a prescribed area.
Note— Information about the
Modified Monash Model (MMM) 2019 is available at the purposes of section 43(1c)(a) of the Act, the following conditions apply to an authorisation granted under section 43(1a)(a) of the Act in respect of a pharmacy:
(a) a substance listed in Schedule 8 of the Uniform Poisons Standard must not be dispensed or otherwise supplied to a person at the pharmacy at a time when a pharmacist is not physically in attendance at the pharmacy;
(b) a compounded medicine must not be dispensed or otherwise supplied to a person at the pharmacy at a time when a pharmacist is not physically in attendance at the pharmacy;
(c) a pharmacy service may only be provided at the pharmacy while a pharmacist is not physically in attendance at the pharmacy if a pharmacist who is in attendance by means of Internet or other electronic communication is satisfied that there is a need for immediate provision of the service;
(d) each day that the pharmacy operates and is open to the public without a pharmacist physically in attendance, a pharmacist must physically attend at the pharmacy on at least 1 occasion while it is open to the public and check on its operations;
(e) a member of staff undertaking official duties at the pharmacy while a pharmacist is not physically in attendance must hold qualifications in accordance with the requirements of the Authority (which may differ according to the duties to which they apply).
For the purposes of section 45(2)(a) of the Act, premises proposed to be registered as a pharmacy depot must—
(a) have provision for temperature control of therapeutic goods and health care products; and
(b) contain adequate provision for the safe, secure and hygienic storage of therapeutic goods and health care products; and
(c) contain adequate provision for the safe and secure storage of confidential and sensitive information.
(1) For the purposes of section 49 of the Act, the following information must be provided to PRASA by a pharmacy services provider if the pharmacy services provider, or a prescribed relative of the pharmacy services provider, has an interest in a prescribed business:
(a) the full name and residential and postal address of the person who has the interest; and
(b) if the person who has the interest is a prescribed relative of a registered person—the relationship of the person to the registered person; and
(c) the name, address and nature of the prescribed business in which the person has the interest; and
(d) the nature of the interest and of any benefit derived from the interest; and
(e) if the interest consists of a shareholding in a prescribed business—the number, nominal value and class of shares held and particulars of any voting rights exercisable by the holder at a meeting of shareholders.
(2) A pharmacy services provider must, within 30 days after a change in the nature or extent of an interest under subregulation (1), give to PRASA information about the change (in accordance with any requirements determined by PRASA).
Maximum penalty: $5 000.
(3) In this regulation—
health product means a pharmaceutical product;
health service means—
(a) hospital, nursing home or aged care facility services; or
(b) medical, dental or pharmaceutical services; or
(c) chiropractic, occupational therapy, optometry, osteopathy, physiotherapy, podiatric or psychology services;
prescribed business means a business consisting of or involving—
(a) the provision of a health service; or
(b) the manufacture, sale or supply of a health product;
prescribed relative has the same meaning as in Part 4 of the Act.
Pursuant to section 51(3)(a) of the Act, restricted pharmacy services may be provided by the Little Company of Mary Health Care Limited at Calvary Hospital at North Adelaide through the instrumentality of a pharmacist who holds a current practising certificate.
(1) For the purposes of section 69(1)(a) of the Act, the information relating to a claim referred to in that section to be provided to PRASA within 30 days after the claim is made is—
(a) the nature of the pharmacy service that is alleged to have been carried out negligently; and
(b) full details of the alleged negligence; and
(c) the address of the premises at which the negligence is alleged to have occurred; and
(d) the time at which and the date on which the negligence is alleged to have occurred; and
(e) full details of the injury suffered or allegedly suffered by the claimant as a result of the alleged negligence; and
(f) the date of the claim.
(2) For the purposes of section 69(1)(b) of the Act, the information relating to the claim referred to in that section to be provided to PRASA within 30 days after any order is made by a court to pay damages or other compensation in respect of that claim or any agreement has been entered into for payment of a sum of money in settlement of that claim (whether with or without a denial of liability) is—
(a) information adequate to identify the claim; and
(b) details of any change in information previously provided to PRASA relating to the claim; and
(c) details of the order or agreement (including the amount ordered or agreed to be paid).
(1) The PRASA may fix—
(a) fees or charges for the purposes of Part 4 of the Act;
(b) fees or charges for services provided by PRASA in the exercise of its functions under Part 4 of the Act.
(2) PRASA may recover a fee or charge fixed under this regulation by action in a court of competent jurisdiction as a debt due to PRASA from the person liable for payment of the fee or charge.
(1) For the purposes of section 74(2)(c) of the Act and subject to the modifications set out in subregulation (2), glasses are manufactured to the prescribed standard if they are manufactured in accordance with
Australian/New Zealand Standard ISO 16034:2011 (as in force from time to time).(2)
Australian/New Zealand Standard ISO 16034:2011 is modified such that—
(a) clause 4.2 does not apply; and
(b) the following requirements of clause 5.2 do not apply:
(i) the requirement that a warning of the unsuitability of the glasses for driving or road use be indicated by the symbol given in Figure 1;
(ii) the requirement that a legible warning notice (as set out in the box entitled "WARNING" in clause 5.2) be given in the form of a label or swing tag affixed to the glasses.
Note— Regulation 11AA(3) sets out the prescribed warning to be attached to the glasses.
(3) For the purposes of section 74(2)(d) of the Act—
(a) the following warning is prescribed:
WARNING
These glasses are for near‑vision and reading use only.
The lenses in these glasses are NOT prescription lenses. They are not intended as a substitute for glasses specifically prescribed for you.
These glasses are not suitable—
for use whilst driving or operating a vehicle; or
for use as eye protection.
Poor vision may be the result of a disease of the eye and a regular examination by an optometrist is recommended to ensure that any eye disease is detected early.
(b) the prescribed warning in paragraph (a) must be attached to the glasses—
(i) by a string or cord; or
(ii) by sticking the warning onto the glasses; or
(iii) in any other manner such that the warning does not detach from the glasses in the ordinary course of inspecting and selecting the glasses.
Nothing in regulations 11B to 11G (inclusive), being regulations made under Part 5A of the Act, derogates from the requirements of the
Work Health and Safety Act 2012 in respect of a person conducting a business or undertaking (within the meaning of that Act).
Note— See section 77B of the Act.
(1) For the purposes of paragraph (b) of the definition of
health practitioner in section 77A(1) of the Act, a health service provider within the meaning of theHealth Practitioner Regulation National Law (South Australia) (other than a health practitioner within the meaning of theHealth Practitioner Regulation National Law (South Australia) ) is prescribed.
Note— Health practitioners (within the meaning of the
Health Practitioner Regulation National Law (South Australia) ) are already included in the definition ofhealth practitioner in section 77A(1) of the Act.(2) For the purposes of section 77A(2)(d) of the Act, the following areas are included in the ambit of the definition of
remote area :
(a) the area of the District Council of Coober Pedy;
(b) the area of the Municipal Council of Roxby Downs.
For the purposes of section 77C(1)(d) of the Act, the following health practitioners are prescribed:
(a) a health practitioner registered under the
Health Practitioner Regulation National Law (South Australia) to practise in the medical profession;(b) a health practitioner registered under the
Health Practitioner Regulation National Law (South Australia) to practise in the midwifery profession as a midwife;(c) a health practitioner registered under the
Health Practitioner Regulation National Law (South Australia) to practise as a nurse in the registered nurses division of the nursing profession;(d) a health practitioner employed by, or otherwise providing a health service on behalf of, a person or body wholly or partly funded (by grant, service agreement or other such arrangement) by the Commonwealth Government.
(1) For the purposes of section 77D(1) of the Act, a health practitioner engages a person as a second responder for the purposes of a particular callout by—
(a) contacting the person by telephone or in person; and
(b) advising the person of—
(i) the general nature of the callout including the location and an estimate of the time required; and
(ii) the designated time and place for the health practitioner and the person to meet for the purposes of the callout; and
(c) confirming the eligibility, availability and agreement of the person to attend the callout as a second responder; and
(d) advising that the person is engaged as a second responder for the callout.
(2) Subject to subregulation (3), for the purposes of section 77D(2) of the Act a second responder—
(a) must hold a current Australian driver's licence; and
(b) must have been subject to a working with children check (within the meaning of the
Child Safety (Prohibited Persons) Act 2016 ) within the preceding 5 years; and(c) must not be prohibited from working with children under the
Child Safety (Prohibited Persons) Act 2016 or a law of the Commonwealth or of another State or Territory.(3) The requirements of subregulation (2) do not apply in respect of a person to be engaged by a health practitioner as a second responder for a particular callout where—
(a) the health practitioner has taken all reasonable steps to engage as a second responder a person who satisfies the requirements of subregulation (2) but has been unable to do so; and
(b) the health practitioner believes on reasonable grounds that the risk to the health of a person to whom health services are to be provided in relation to the callout is high; and
(c) the person is known to the health practitioner and is, in the opinion of the health practitioner, a suitable person to be engaged as a second responder in the circumstances.
(4) Pursuant to section 77D(3)(a) of the Act, a person is engaged to act as a second responder from the time that a health practitioner advises the person that they are engaged as a second responder pursuant to subregulation (1)(d).
(5) Pursuant to section 77D(3)(b) of the Act, a callout is completed in respect of a second responder when, after leaving the location of the callout or any other place at which the second responder attended in relation to the callout, the second responder arrives at their place of residence or other destination nominated by the second responder and advised to the health practitioner.
(6) For the purposes of subregulation (3)(b), the risk to the health of a person to whom health services are to be provided in relation to a callout is not high if the health practitioner is of the opinion that treatment of the person can be delayed—
(a) until the normal operating hours of an available clinic or health facility commence; or
(b) for a period of more than 24 hours.
(1) For the purposes of section 77E(3)(a) of the Act, premises approved by the Minister are prescribed premises.
(2) For the purposes of section 77E(3)(b) of the Act, the following circumstances relating to a callout by a health practitioner are prescribed:
(a) where the callout is to a police station and, before attending the callout, the health practitioner is satisfied, taking into account all information available to the health practitioner in relation to the callout, that at least 1 police officer or special constable will be present at the police station at all times while the health practitioner attends the callout;
(b) where the callout is in response to an emergency and, before attending the callout, the health practitioner is satisfied, taking into account all information available to the health practitioner in relation to the callout, that at least 1 emergency services worker (other than the health practitioner) will be present at the location of the emergency at all times while the health practitioner attends the callout.
(3) In this regulation—
emergency services worker means any of the following persons:
(a) a police officer;
(b) a special constable;
(c) a member of an emergency services organisation within the meaning of the
Fire and Emergency Services Act 2005 ;(d) persons engaged in the provision of emergency ambulance services authorised under the
Health Care Act 2008 ;(e) any other person, or person of a class, approved by the Minister to be an emergency services worker;
special constable has the same meaning as in thePolice Act 1998 .
(1) For the purposes of section 77G(d) of the Act, the following persons and bodies are prescribed:
(a) if a designated person provides a health service on behalf of another person or body—that other person or body;
(b) in any other case—a designated person.
(2) The following persons are
designated persons for the purposes of subregulation (1):
(a) a person registered under the
Health Practitioner Regulation National Law (South Australia) to practise in the medical profession;(b) a person registered under the
Health Practitioner Regulation National Law (South Australia) to practise in the midwifery profession as a midwife;
(c) a person registered under the
Health Practitioner Regulation National Law (South Australia) to practise as a nurse in the registered nurses division of the nursing profession.
For the purposes of section 77H(2)(c) of the Act, the following kinds of provisions are required to be included in policies and procedures under section 77H of the Act:
(a) provisions to assist in assessing the eligibility and selection of persons to be second responders;
(b) provisions to manage risks to the safety and security of health practitioners identified as being specific to the provision of health services—
(i) at, or from, a specific location; or
(ii) by a specific health service provider.
(1) The Minister must cause a review of the operation of the amendments made to these regulations by the
Health Practitioner Regulation National Law (South Australia) (Remote Area Attendance) (No 2) Variation Regulations 2019 to be conducted and a report on the review to be prepared and submitted to the Minister.(2) The review and the report must be completed after the first anniversary of the commencement of the
Health Practitioner Regulation National Law (South Australia) (Remote Area Attendance) (No 2) Variation Regulations 2019 but no later than 6 months after that anniversary.(3) The Minister must cause a copy of the report submitted under subregulation (1) to be laid before both Houses of Parliament within 6 sitting days after receiving the report.
(1) For the purposes of the definition of
designated period in clause 37(4) of Schedule 1 of the Act, the period of 3 months from the day on which the person is determined by the National Agency to be excess to the requirements of the National Agency is prescribed.(2) For the purposes of the definition of
qualifying member of the staff of a prescribed body , 30 June 2010 is prescribed in relation to each prescribed body.
(1) The National Agency must, on or before 30 September 2012, deliver to the Minister a report on the activities of the Occupational Therapy Board of South Australia during the 2011/2012 financial year.
(2) The report must—
(a) contain the following information in relation to the 2011/2012 financial year:
(i) the number of persons registered by the Board in each category of registration under the
Occupational Therapy Practice Act 2005 , as at 30 June 2012;(ii) the number of complaints received by the Board against registered persons or service providers under the
Occupational Therapy Practice Act 2005 , and the outcome of each complaint (including, if relevant, progress as at 30 June 2012);(iii) the number of disciplinary proceedings commenced by or on behalf of, or before, the Board under the
Occupational Therapy Practice Act 2005 , and the outcome of each of those proceedings (including, if relevant, progress as at 30 June 2012); and(b) incorporate the audited accounts of the Board for the 2011/2012 financial year.
(3) The Minister must, within 12 sitting days after receiving the report under subregulation (1), have copies of the report laid before both Houses of Parliament.
(4) In this regulation—
National Agency means the Australian Health Practitioner Regulation Agency.
(1) The Occupational Therapy Board of South Australia is brought within the ambit of the definition of
prescribed body in clause 29 of Schedule 1 of the Act.(2) No application may be made to the Occupational Therapy Board of South Australia under Part 3 Division 2 of the
Occupational Therapy Practice Act 2005 on or after 1 July 2012.(3) For the purposes of clauses 42 and 43 of Schedule 1 of the Act, the
Occupational Therapy Practice Act 2005 will be taken to be a relevant Act that has been repealed under that schedule on 1 July 2012.
• Please note—References in the legislation to other legislation or instruments or to titles of bodies or offices are not automatically updated as part of the program for the revision and publication of legislation and therefore may be obsolete.
• Earlier versions of these regulations (historical versions) are listed at the end of the legislative history.
• For further information relating to the Act and subordinate legislation made under the Act see the Index of South Australian Statutes or revoked by principal regulations
The
Health Practitioner Regulation National Law (South Australia) Regulations 2010 revoked the following:
Chiropractic and Osteopathy Practice (Election) Regulations 2006
Chiropractic and Osteopathy Practice (General) Regulations 2006
Dental Practice (Election) Regulations 2007
Dental Practice (General) Regulations 2007
Medical Practice (Elections) Regulations 2005
Medical Practice (General) Regulations 2005
Nursing and Midwifery Practice Regulations 2009
Occupational Therapy Practice (Election) Regulations 2006
Occupational Therapy Practice (General) Regulations 2006
Optometry Practice (Elections) Regulations 2007
Optometry Practice (General) Regulations 2007
Pharmacy Practice Regulations 2007
Physiotherapy Practice (Election) Regulations 2006
Physiotherapy Practice (General) Regulations 2006
Podiatry Practice (Election) Regulations 2006
Podiatry Practice (General) Regulations 2006
Psychological Practices Regulations 1996
Principal regulations and variations New entries appear in bold.
Year
No
Reference
Commencement
2010
169
Gazette 1.7.2010 p3363 1.7.2010: r 2
2012
168
Gazette 28.6.2012 p2935 1.7.2012: r 2
2012
275
Gazette 20.12.2012 p6251 20.12.2012: r 2
2014
225
Gazette 14.8.2014 p4042 1.9.2014: r 2
2018
47
Gazette 13.2.2018 p797 12.3.2018: r 2
2018
230
Gazette 29.11.2018 p4094 1.12.2018: r 2
2019
38
Gazette 16.5.2019 p1293 1.7.2019: r 2—disallowed on 16.10.2019 (
Gazette 24.10.2019 p3547 )2019
239
Gazette 8.11.2019 p3836 7.11.2019: r 2
2021
176
Gazette 25.11.2021 p4168 1.12.2021: r 2
2022
16
Gazette 17.2.2022 p499
17.2.2022: r 2
Provisions varied New entries appear in bold.
Entries that relate to provisions that have been deleted appear in italics.
Provision
How varied
Commencement
r 2
omitted under Legislation Revision and Publication Act 2002
1.7.2012
r 3
Uniform Poisons Standard
inserted by 16/2022 r 3
17.2.2022 r 4
varied by 168/2012 r 4(1)—(7)
1.7.2012
varied by 47/2018 r 4(1), (2)
12.3.2018
r 4A
inserted by 47/2018 r 5
12.3.2018
r 6A
inserted by 176/2021 r 4
1.12.2021
r 6A(1)
r 6A redesignated as r 6A(1) by 16/2022 r 4
17.2.2022
r 6A(2)
inserted by 16/2022 r 4
17.2.2022 r 11
r 11(1)
varied by 275/2012 r 4
20.12.2012
r 11AA
inserted by 47/2018 r 6
12.3.2018
r 11A before disallowance of 38/2019
inserted by 225/2014 r 4
1.9.2014
deleted by 230/2018 r 4
1.12.2018
inserted by 38/2019 r 4
1.7.2019—disallowed 16.10.2019
rr 11B—11F before disallowance of 38/2019
inserted by 38/2019 r 4
1.7.2019—disallowed 16.10.2019 rr 11A—11H
inserted by 239/2019 r 4
7.11.2019
r 13
r 13(1) and (2)
substituted by 168/2012 r 5(1)
1.7.2012
r 13(4)
prescribed body
deleted by 168/2012 r 5(2)
1.7.2012
relevant Act
deleted by 168/2012 r 5(2)
1.7.2012 r 14
inserted by 168/2012 r 6
1.7.2012
Sch 1
cl 1
substituted by 168/2012 r 7
1.7.2012
Sch 1
omitted under Legislation Revision and Publication Act 2002
17.2.2022
Historical versions
1.7.2012
20.12.2012
1.9.2014
12.3.2018
1.12.2018
1.7.2019
16.10.2019
7.11.2019
1.12.2021
0
0
0