Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021 (Victoria)

These Regulations, made under s 64 of the Non‑Emergency Patient Transport and First Aid Services Act 2003, set out detailed regulatory mechanics for licensing, staffing, clinical governance, record keeping, equipment, infection control, event planning and insurance for first aid services in Victoria (reg 1, reg 2). They come into operation on 30 November 2021 (reg 3). Mechanically, the Regulations:

prescribe three regulated classes of first aid service for licensing: basic, intermediate and advanced (regs 5-8);
require written scopes of clinical practice for each licensed service and for each staff member, with penalties for treating outside scope (regs 10-12);
impose competency, supervision, annual skills maintenance and identification requirements for staff, with record and attestation obligations (regs 13-16, reg 14(2)-(3));
specify application forms and fees for approval in principle, licence grant, renewal, transfer and variation in Schedules 1-6 and regs 17-23, with fee units and fee amounts tied to the Monetary Units Act process (regs 17(2), 19(2), 21(2), 22(2); Endnotes);
require development and maintenance of a quality assurance plan for intermediate and advanced services, and accreditation of advanced service plans by an accreditation body (regs 24-27);
require establishment of a clinical oversight committee with prescribed membership, responsibilities and meeting frequency (regs 30-33);
set out detailed record keeping and reporting obligations for patient care, staff records, complaints, sentinel events and annual reports (regs 28, 29, 35-39);
prescribe infection control management plan requirements consistent with the NHMRC Guidelines and annual review obligations for intermediate and advanced services (reg 41; reg 4 definition);

Version No. 001

Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

S.R. No. 149/2021

Version as at
30 November 2021

TABLE OF PROVISIONS

Regulation Page

Part 1—Preliminary 1

1 Objective 1

2 Authorising provision 1

3 Commencement 1

4 Definitions 1

5 Definition of basic first aid service 5

6 Definition of intermediate first aid service 6

7 Definition of advanced first aid service 6

Part 2—First aid services 8

Division 1—Classes of first aid service 8

8 Classes of first aid service 8

9 Licence holder must comply with licence 8

Division 2—Scope of clinical practice 8

10 Licence holder must have written scope of clinical practice 8

11 Licence holder must have written scope of clinical practice for each staff member 9

12 Staff member must work within scope of clinical practice 9

Part 3—Staffing of first aid services 11

13 Competencies for staff members of first aid services 11

14 Ongoing assessment of competency 12

15 Skills maintenance training 12

16 Staff identification 12

Part 4—Licensing 13

Division 1—Applications 13

17 Application for approval in principle 13

18 Application for variation or transfer of approval in principle 13

19 Application for a first aid service licence 13

20 Conditions on licences 14

21 Application to renew a licence 14

22 Application to transfer a licence 15

23 Application to vary a licence 15

Division 2—Quality assurance plans 15

24 Development, contents and accreditation of quality assurance plan 15

25 Compliance with quality assurance plan 17

26 Audit of quality assurance plan 17

27 Revocation, suspension or expiry of accreditation 17

Division 3—Other matters during course of licence 18

28 Sentinel events 18

29 Annual report 18

Part 5—Clinical governance 19

30 Clinical oversight committee 19

31 Responsibilities of committee 19

32 Meetings of committee 21

33 Staff surveys 21

34 Clinical nominee 21

Part 6—Records 23

35 Records to be kept 23

36 Patient care records 23

37 Staff records 24

Part 7—Patient rights and information 26

38 Establishment of complaints register 26

39 Investigation of complaints 26

40 Contact details of a licence holder 27

Part 8—Infection control 28

41 Infection control management plan 28

Part 9—Provision, inspection and maintenance of equipment 29

42 Maintenance of equipment 29

43 Records of maintenance 29

44 Equipment 29

45 Communication devices 30

Part 10—Event planning 31

46 Planning for provision of first aid services at an event 31

Part 11—Insurance 32

47 Public and professional liability insurance 32

Schedule 1—Application for approval in principle to operate a first aid service 33

Schedule 2—Application for variation or transfer of certificate of approval in principle to operate a first aid service 34

Schedule 3—Application for a first aid service licence 36

Schedule 4—Application for the renewal of a first aid service licence 37

Schedule 5—Application for transfer of a first aid service licence 38

Schedule 6—Application for variation of a first aid service licence 39

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Endnotes 40

1 General information 40

2 Table of Amendments 42

3 Amendments Not in Operation 43

4 Explanatory details 44

Version No. 001

Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

S.R. No. 149/2021

Version as at
30 November 2021

Part 1—Preliminary

1 Objective

The objective of these Regulations is to prescribe standards, requirements and other matters relating to the provision of first aid services under the Non‑Emergency Patient Transport and First Aid Services Act 2003.

2 Authorising provision

These Regulations are made under section 64 of the Non‑Emergency Patient Transport and First Aid Services Act 2003.

3 Commencement

These Regulations come into operation on 30 November 2021.

4 Definitions

(1) In these Regulations—

accreditation body means a body that is accredited by—

(a) the Joint Accreditation System of Australia and New Zealand; or

(b) the International Society for Quality in Healthcare; or

advanced first aid service has the meaning given in regulation 7;

adverse patient safety event means an event that results in harm or injury to a patient;

automated external defibrillator means an automated external defibrillator that provides the operator with an audible or visible prompt to discharge the defibrillator to deliver a shock to the patient when it recognises a shockable rhythm;

basic first aid service has the meaning given in regulation 5;

certificate of roadworthiness means a certificate of roadworthiness issued under Division 5 of Part 6 of the Road Safety (Vehicles) Regulations 2021[1];

clinical matter means any process, treatment or procedure of a medical nature;

emergency stabilisation treatment means the provision of care to preserve life and relieve suffering before referral to another health care provider;

epinephrine means injectable adrenaline;

first aid station means a fixed, mobile or temporary place at which first aid is to be provided by a licence holder;

infection control guidelines means the National Health and Medical Research Council's Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) published by the Commonwealth;

intermediate first aid service has the meaning given in regulation 6;

intervention means any treatment that may be administered by staff members providing the treatment of a patient and includes any invasive procedure;

licence holder means a person who holds a first aid service licence issued or renewed on or after the commencement of these Regulations;

management, in relation to the treatment of a patient, includes the administration of those drugs that may be administered by staff members involved in treating the patient, and other general treatment, not including intervention;

monitoring, in relation to the treatment of a patient, includes—

(a) monitoring of cardiac, respiratory, metabolic, neurological or fluid status or any combination of them; and

(b) monitoring of equipment used for the patient;

public road has the same meaning as in the Road Management Act 2004;

registered health practitioner means an individual who is registered under the Health Practitioner Regulation National Law to practise a health profession, other than as a student;

registered nurse means a person registered in Division 1 of the Register of Nurses kept by the Nursing and Midwifery Board of Australia under the Health Practitioner Regulation National Law, other than as a student;

registered paramedic means a person registered in the Register of Paramedics kept by the Paramedicine Board of Australia under the Health Practitioner Regulation National Law, other than as a student;

registered training organisation means an organisation registered by—

(a) the National Vocational Education and Training Regulator established under section 155 of the National Vocational Education and Training Regulator Act 2011 of the Commonwealth; or

(b) the Tertiary Education Quality and Standards Agency established under section 132 of the Tertiary Education Quality and Standards Agency Act 2011 of the Commonwealth;

Schedule 2 poison has the same meaning as in section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981;

Schedule 3 poison has the same meaning as in section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981;

Schedule 4 poison has the same meaning as in section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981;

Schedule 8 poison has the same meaning as in section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981;

sentinel event means an unexpected adverse patient safety event that occurs infrequently in the provision of services by a first aid service and results in the death of, or serious physical or psychological injury to, a patient as a result of system and process deficiencies at the first aid service;

significant patient risk means a risk to patients—

(a) where there is high probability of a substantial adverse impact; and

(b) that is sufficiently serious to warrant an immediate response to reduce the risk;

statutory ambulance service means an ambulance service created under section 23 of the Ambulance Services Act 1986 or listed in Schedule 1 to that Act;

the Act means the Non‑Emergency Patient Transport and First Aid Services Act 2003.

(2) The Secretary, by notice published in the Government Gazette, may nominate as an accreditation body a body that, in the opinion of the Secretary, is nationally or internationally recognised and experienced in the accreditation of health care services.

5 Definition of *basic first aid service*

A basic first aid service is a service that is equipped and has staff trained to provide first aid services that adequately cater for—

(a) minor injuries or illnesses that do not usually require referral to another health care provider or transportation to a hospital; and

(b) minor illnesses that can be treated with over‑the‑counter medications, rest, hydration or similar non‑invasive treatment; and

(d) injuries or illnesses requiring emergency stabilisation treatment before referral to another health care provider or transportation to a hospital.

6 Definition of *intermediate first aid service*

An intermediate first aid service is a service that is equipped and has staff trained to provide the first aid services referred to in regulation 5 and first aid services that adequately cater for—

(a) significant injuries or illnesses that may require intervention and referral to another health care provider or transportation to a hospital, such as injuries involving broken bones; and

(b) significant injuries or illnesses that may be managed with Schedule 2 poison, Schedule 3 poison, Schedule 4 poison, observation or similar non‑invasive treatment.

7 Definition of *advanced first aid service*

An advanced first aid service is a service that is equipped and has staff trained to provide the first aid services referred to in regulations 5 and 6 and first aid services that adequately cater for—

(a) serious injuries or illnesses that often require intervention and referral to another health care provider or transportation to a hospital; and

(b) serious injuries or illnesses that may be managed with Schedule 8 poison (in addition to the poisons referred to in regulation 6), intravenous therapies, invasive monitoring or similar invasive treatment; and

Note

An advanced first aid service is usually staffed by registered health practitioners.

Part 2—First aid services

Division 1—Classes of first aid service

8 Classes of first aid service

The following classes of first aid service are prescribed for the purpose of licensing under Part 2A of the Act—

(a) basic first aid service;

(b) intermediate first aid service;

9 Licence holder must comply with licence

A licence holder must not provide first aid services unless the first aid services provided are within the scope of the licence holder's first aid service licence.

20 penalty units.

Division 2—Scope of clinical practice

10 Licence holder must have written scope of clinical practice

(1) A licence holder must prepare and maintain a written scope of clinical practice for the safe provision of the first aid service by the licence holder.

Penalty: 20 penalty units.

(2) The scope of clinical practice of a first aid service must be consistent with—

(a) the class or classes of first aid service that the licence holder is licensed to operate; and

(b) any conditions to which the first aid service licence is subject.

(3) A licence holder must not treat patients for any condition, illness or injury that is outside the scope of clinical practice of the first aid service.

Penalty: 20 penalty units.

11 Licence holder must have written scope of clinical practice for each staff member

(1) A licence holder must prepare and maintain a written scope of clinical practice for the safe provision of first aid services by each staff member of the first aid service.

Penalty: 20 penalty units.

(2) The scope of clinical practice of a staff member of a first aid service must be—

(a) consistent with the qualifications, competency, training and experience of the staff member; and

(b) within the scope of clinical practice of the first aid service.

(3) A licence holder must verify and record the qualifications held by a staff member.

(4) A licence holder must ensure that a staff member has access to clinical advice when treating patients.

Penalty: 20 penalty units.

12 Staff member must work within scope of clinical practice

(1) A staff member of a license holder must not provide any management or intervention that is outside the scope of clinical practice of the staff member.

Penalty: 20 penalty units.

(2) A staff member of a first aid service may, at the direction of a statutory ambulance service, move a patient to meet an ambulance or facilitate referral to another health care provider.

(3) Subject to subregulation (4), a staff member of a first aid service may move a patient of the first aid service within the vicinity of an event (including on a public road) to facilitate provision of care.

(4) If a staff member uses a vehicle to move a patient in accordance with subregulation (3), the vehicle must—

(a) be a vehicle for which a certificate of roadworthiness has been issued (and remains in effect); and

(b) comply with the requirements of AS/NZS 4535:1999 (Ambulance restraint systems).

Part 3—Staffing of first aid services

13 Competencies for staff members of first aid services

(1) A licence holder must ensure that all staff members, on their initial engagement by the first aid service, have the skills, competency and knowledge appropriate to their duties in treating patients of the first aid service.

Penalty: 20 penalty units.

(2) A licence holder must ensure that each staff member of the first aid service is clinically supervised until the licence holder is satisfied the staff member is competent to work unsupervised.

(3) If a licence holder is satisfied that a staff member is competent to work unsupervised, the licence holder must make a record of the date from which the person may work unsupervised.

(4) Nothing in subregulation (2) prevents a staff member from providing first aid in an attempt to save the life of a person.

(5) A person who is required to work under supervision in an area of practice cannot be a supervisor in that area of practice.

(6) In this regulation, clinically supervised means supervised by a person who—

(a) has the same clinical qualifications as, or higher clinical qualifications than, the person being supervised; and

(b) is competent to work unsupervised.

14 Ongoing assessment of competency

(1) A licence holder must ensure that the competency of all staff members referred to in regulation 13 is maintained throughout the course of their service as staff members with the first aid service.

Penalty: 20 penalty units.

(2) A licence holder must ensure that the competency of a staff member who has received training for the purpose of subregulation (1) is recorded and attested to by the person who provided the training.

20 penalty units.

(3) A licence holder must keep the record and attestation referred to in subregulation (2) available for production to an authorised officer under section 48 of the Act.

Penalty: 20 penalty units.

15 Skills maintenance training

All staff members of a first aid service who provide first aid services must complete annual skills maintenance training appropriate to the qualifications that they hold and the duties that they carry out.

16 Staff identification

A licence holder must ensure that each staff member referred to in regulation 13 while on duty wears an identification tag that shows—

(a) the staff member's name and position; and

(b) the trading name of the licence holder.

Penalty: 15 penalty units.

Part 4—Licensing

Division 1—Applications

17 Application for approval in principle

(1) For the purposes of section 42M(2)(a) of the Act, the prescribed form is the form set out in Schedule 1.

(2) For the purposes of section 42M(2)(b) of the Act, the prescribed fee is 17 fee units.

18 Application for variation or transfer of approval in principle

(1) For the purposes of section 42M(2)(a) of the Act, the prescribed form of application for variation or transfer of an approval in principle under section 42Q of the Act is the form set out in Schedule 2.

(2) For the purposes of section 42M(2)(b) of the Act, the prescribed fee for variation or transfer of an approval in principle under section 42Q of the Act is 10 fee units.

19 Application for a first aid service licence

(1) For the purposes of section 42S(2)(a) of the Act, the prescribed form is the form set out in Schedule 3.

(2) For the purposes of section 42S(2)(b) of the Act, the prescribed fee is—

(a) for a basic first aid service licence—17 fee units; and

(b) for an intermediate first aid service licence—54 fee units; and

(3) Without limiting section 42S(3) of the Act, the applicant for an advanced first aid service licence under section 42S of the Act must submit with the application—

(a) a copy of a certificate certifying that the applicant's quality assurance plan developed in accordance with regulation 24 has been accredited by an accreditation body; or

(b) a draft quality assurance plan developed in accordance with regulation 24 and a report from an accreditation body that sets out the steps that the applicant must take for the quality assurance plan to be accredited by that body within 3 months after the applicant is granted the licence.

20 Conditions on licences

For the purposes of section 42V(1)(a) of the Act, an advanced first aid service licence granted to an applicant who does not have a current certificate of quality accreditation from an accreditation body is subject to the condition that the applicant must, within 3 months after being granted the licence—

(a) obtain a certificate of quality accreditation; and

(b) submit a copy of the certificate to the Secretary.

21 Application to renew a licence

(1) For the purposes of section 42Z(2)(a) of the Act, the prescribed form is the form set out in Schedule 4.

(2) For the purposes of section 42Z(2)(b) of the Act, the prescribed fee is—

(a) for a basic first aid service licence—17 fee units; and

(b) for an intermediate first aid service licence—54 fee units; and

22 Application to transfer a licence

(1) For the purposes of section 42ZC(2)(a) of the Act, the prescribed information is the information in the form set out in Schedule 5.

(2) For the purposes of section 42ZC(2)(b) of the Act, the prescribed fee is—

(a) for a basic first aid service licence—14 fee units; and

(b) for an intermediate first aid service licence—28 fee units; and

23 Application to vary a licence

(1) For the purposes of section 42ZI(2)(a) of the Act, the prescribed form to vary a first aid service licence is the form set out in Schedule 6.

(2) For the purposes of section 42ZI(2)(b) of the Act, the prescribed fee is 17 fee units.

Division 2—Quality assurance plans

24 Development, contents and accreditation of quality assurance plan

(1) A person who applies for an intermediate first aid service licence or an advanced first aid service licence under section 42S of the Act must develop a quality assurance plan in accordance with subregulation (2).

(2) A quality assurance plan must include provisions in relation to the following matters—

(a) infection control, including an infection control management plan;

(b) active clinical monitoring of patients;

(d) management of deteriorating patients;

(e) staff qualifications and training, assessment of qualifications and maintenance of the currency of qualifications;

(f) competencies of staff members, including maintenance and assessment of competencies by a registered training organisation;

(g) recognition of prior learning and overseas qualifications of staff members providing clinical care and advice;

(h) access to clinical advice for staff members;

(i) drug security, including in relation to storage, use, disposal and record‑keeping;

(j) manual handling of patients;

(k) patient records;

(l) management of complaints;

(m) clinical handover processes;

(n) maintenance of equipment;

(o) records of all maintenance and repairs to equipment;

(p) cleaning of equipment;

(q) a complaints register;

(r) a process for investigating complaints.

(3) A quality assurance plan of an advanced first aid service must be accredited by an accreditation body.

25 Compliance with quality assurance plan

A licence holder must maintain and comply with any quality assurance plan developed and accredited (if required) in accordance with regulation 24.

26 Audit of quality assurance plan

(1) Subject to subregulation (2), if at any time during the period of a first aid service licence the quality assurance plan of the licence holder is audited by an accreditation body, the licence holder must submit a copy of the audit report to the Secretary no later than 14 days after the licence holder receives a copy of the report from the accreditation body.

Penalty: 15 penalty units.

(2) If an audit report referred to in subregulation (1) identifies the existence of a significant patient risk, the licence holder must report that risk to the Secretary no later than 24 hours after the licence holder receives a copy of the report from the accreditation body.

20 penalty units.

27 Revocation, suspension or expiry of accreditation

(1) A licence holder must not provide an advanced first aid service if the accreditation of the licence holder's quality assurance plan is revoked or suspended or has expired.

Penalty: 20 penalty units.

(2) A licence holder must report immediately to the Secretary any revocation or suspension of accreditation of the licence holder's quality assurance plan.

Division 3—Other matters during course of licence

28 Sentinel events

A licence holder must report any sentinel event to the Secretary immediately after its occurrence.

29 Annual report

For the purposes of section 62A(2) of the Act, the prescribed information is the following—

(a) the number of events attended by the service to provide each of the following—

(i) basic first aid services;

(ii) intermediate first aid services;

(iii) advanced first aid services;

(b) the number of days of attendance by the service at each event referred to in paragraph (a);

(d) the estimated number of people attending events attended by the service;

(e) any other information that the Secretary has, by notice given to the licence holder, requested the licence holder to include.

Part 5—Clinical governance

30 Clinical oversight committee

(1) A licence holder must establish and maintain a clinical oversight committee.

(2) The clinical oversight committee must have at least—

(a) one member who is a representative of the management of the licence holder; and

(b) one member who is a registered paramedic, if the licence holder employs registered paramedics as part of providing the service; and

(c) one member who is a registered nurse, if the licence holder employs registered nurses as part of providing the service; and

(d) one member who is a registered medical practitioner, if the licence holder does not employ a registered paramedic or a registered nurse as part of providing the service.

(3) Each registered health practitioner who is a member of the clinical oversight committee must have appropriate clinical experience in the out‑of‑hospital environment.

31 Responsibilities of committee

(1) The clinical oversight committee has the following responsibilities in relation to the first aid service provided by the licence holder—

(a) overseeing processes to set the scope of clinical practice of the service to ensure that the licence holder does not provide services beyond its competencies and ability;

(b) overseeing processes to set the scope of clinical practice of all clinical staff members;

(d) overseeing and documenting the clinical supervision provided to each newly qualified staff member;

(e) reviewing matters of clinical concern, including each adverse patient safety event or sentinel event;

(f) maintaining records of all clinical reviews, including decisions taken and the rationale for those decisions;

(g) reviewing each occasion on which a patient required transportation to a hospital or another medical facility, to receive care that could not be provided by the first aid service, and documenting any review of changes to practice made as a result of the review;

(h) reviewing whether the services provided by the first aid service were appropriate for the risk profile of events attended by the service and the patients it could have expected to receive at those events;

(i) overseeing processes to continually assess the capacity of the service to provide safe patient‑centred care.

(2) In addition to the responsibilities set out in subregulation (1), the clinical oversight committee for an intermediate first aid service or an advanced first aid service has the following responsibilities in relation to the service provided by the licence holder—

(a) overseeing the verification of the credentials of all registered health practitioners engaged by the service in any capacity—

(i) when their engagement commences; and

(ii) subsequently every 3 years;

(b) overseeing the auditing of patient care records and reviewing all measures taken as a result of reviews of those records;

(c) keeping and reviewing all staff survey data and reviewing any measures taken as a result of reviews of those surveys;

(d) setting rules for how clinical practice at the service will be implemented and overseen by the licence holder.

32 Meetings of committee

(1) The clinical oversight committee must meet at least once in each 3 month period.

(2) The clinical oversight committee must maintain records of its meetings including its decisions and the reasons for its decisions.

33 Staff surveys

(1) A licence holder must conduct a staff survey at least once a year.

(2) The primary purpose of a staff survey is to ascertain the views of staff members on staff and patient safety.

34 Clinical nominee

(1) A licence holder must nominate a person who is responsible for assessing all clinical matters for the service.

(2) The licence holder must, within 28 days after nominating a person under subregulation (1), notify the Secretary of the name and business contact details of the nominee.

Part 6—Records

35 Records to be kept

(1) A licence holder must ensure that patient care records are maintained in accordance with regulation 36.

15 penalty units.

(2) A licence holder must ensure that staff records are maintained in accordance with regulation 37.

15 penalty units.

36 Patient care records

(1) A patient care record in relation to a patient must include the following information—

(a) the patient's name;

(b) the patient's address;

(d) the patient's gender;

(e) the time and date of the provision of the first aid service to the patient;

(f) all relevant clinical details of the patient, including any co‑morbidities;

(g) details of any monitoring or treatment provided to the patient;

(h) if an ambulance is called for the patient—

(i) the reason for calling the ambulance; and

(ii) the patient's pick up location and intended destination; and

(iii) the names and titles of the staff members attending to the patient.

(2) If a patient is to be transported by ambulance to a medical service, the licence holder must ensure that—

(a) the information contained in the patient care record is communicated orally to the person receiving the patient for transport, if reasonably practicable; and

(b) a copy of the patient care record is provided to the person receiving the patient for transport.

(3) The licence holder must ensure that the patient care record is reviewed for any patient of the service who—

(a) is transported to a hospital by ambulance; or

(b) is given any Schedule 3 poison, Schedule 4 poison or Schedule 8 poison; or

37 Staff records

(1) Staff records must include the following information in relation to each staff member—

(a) full name;

(b) date of birth;

(d) qualifications;

(e) relevant clinical experience;

(f) if registered with the Australian Health Practitioner Regulation Agency, the relevant registration details, including the staff member's registration number;

(g) immunisation records as recommended in the infection control guidelines;

(h) information about the staff member's mandatory skills maintenance training and accreditation.

(2) A licence holder must retain the staff records in relation to a staff member for a period of not less than 2 years following the staff member ceasing to be a staff member of the first aid service.

Penalty: 15 penalty units.

Part 7—Patient rights and information

38 Establishment of complaints register

(1) A licence holder must establish a complaints register for recording all complaints received about the first aid service, including—

(a) complaints made in writing; and

(b) complaints made orally.

Penalty: 10 penalty units.

(2) A licence holder must ensure that the complaints register contains as a minimum the following information in relation to each complaint made—

(a) the name of the patient;

(b) the place where first aid was provided to the patient;

(d) the date of the complaint;

(e) details of any investigation of the complaint;

(f) the outcome of any investigation of the complaint;

(g) details of any action taken.

Penalty: 10 penalty units.

(3) The complaints register must be included as part of the quality assurance plan for the first aid service.

39 Investigation of complaints

A licence holder must ensure that any investigation of a complaint is carried out in a manner that is not detrimental to the complainant.

Penalty: 10 penalty units.

40 Contact details of a licence holder

A licence holder must ensure that, as far as practicable, contact details for the first aid service are provided to each patient to whom first aid is provided by the service at the time of the provision of first aid to the patient.

Penalty: 10 penalty units.

Part 8—Infection control

41 Infection control management plan

(1) A licence holder who is licensed to provide an intermediate first aid service or an advanced first aid service must ensure its quality assurance plan includes an infection control management plan that is developed in compliance with the infection control guidelines.

Penalty: 20 penalty units.

(2) Without limiting subregulation (1), the infection control management plan must—

(a) identify all possible areas where there is a risk of transmission of infection and the actions to be taken to control any such risk; and

(b) identify the steps to be followed if any action referred to in paragraph (a) is not taken; and

(c) identify the type of education to be provided to staff members involved in the provision of first aid to patients; and

(d) state the name and qualifications of the person responsible for identifying areas of risk; and

(e) identify the mechanism by which compliance with the infection control management plan will be monitored; and

(f) set out a process for the use, disposal and laundering of linen.

(3) A licence holder must ensure that the infection control management plan is reviewed annually.

Penalty: 20 penalty units.

Part 9—Provision, inspection and maintenance of equipment

42 Maintenance of equipment

(1) A licence holder must ensure that an annual maintenance schedule is developed to ensure all equipment used in the course of providing first aid to patients is kept in good working order in accordance with the manufacturers' specifications.

Penalty: 10 penalty units.

(2) A licence holder must ensure all equipment used in the course of providing first aid to patients is kept in good working order at all times in accordance with the manufacturers' specifications.

Penalty: 10 penalty units.

43 Records of maintenance

(1) A licence holder must keep an accurate record of all maintenance of and repairs to equipment used in the course of providing first aid to patients.

Penalty: 10 penalty units.

(2) A licence holder must ensure that the record referred to in subregulation (1) is kept and maintained for the lifespan of the equipment to which it relates.

Penalty: 10 penalty units.

44 Equipment

A licence holder must ensure that a first aid station provided by the first aid service has all the equipment and supplies needed to provide first aid within its scope of clinical practice, including the following—

(a) drinking water for patient and staff use;

(b) sanitiser and hand washing facilities;

(d) an epinephrine device or equivalent adrenaline ampoules (if staff members are legally authorised to administer ampoules of adrenaline);

(e) a means of waste management, including for the safe disposal of sharps and contaminated waste;

(f) external signposting enabling the first aid station to be readily identified and located;

(g) if the licence holder is an intermediate first aid service licence holder or an advanced first aid service licence holder, a salbutamol MDI and spacer;

(h) if the licence holder is an intermediate first aid service licence holder or an advanced first aid service licence holder, suitable patient transfer equipment.

Penalty: 20 penalty units.

45 Communication devices

A licence holder must ensure that communication devices are available at all times so that a staff member providing first aid services at an event can reasonably communicate with—

(a) the head office representative of the licence holder; and

(b) the on‑site event headquarters or the person with overall command of the first aid service at the event; and

(d) other emergency services.

Penalty: 20 penalty units.

Part 10—Event planning

46 Planning for provision of first aid services at an event

(1) This regulation applies if a licence holder proposes to provide a first aid service at an event.

(2) Before providing the service at the event, the licence holder must—

(a) communicate with the event provider to ensure that the licence holder has a clear description of—

(i) the event; and

(ii) the anticipated health risks of the event; and

(iii) the circumstances in which a 000 telephone call may be required; and

(b) ensure that the first aid service can meet the first aid needs for the event.

Part 11—Insurance

47 Public and professional liability insurance

(1) A licence holder must obtain public liability insurance to the value of not less than $20 000 000.

(2) A licence holder must obtain professional indemnity insurance to the value of not less than $20 000 000.

Schedule 1—Application for approval in principle to operate a first aid service

Regulation 17(1)

Application for approval in principle to operate
a first Aid service

SECTION A

(1) Full name of applicant:

(2) Postal address of applicant:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

(4) If the applicant is a body corporate, the name and street address of each director or officer of the body corporate who may exercise control over the first aid service:

SECTION B

(1) The name (or proposed name) of the first aid service and its street address:

(2) This application is for an approval in principle for—

a basic first aid service; or
an intermediate first aid service; or
an advanced first aid service.

Signature of applicant:

Name of each signatory:

Date:

*Delete if inapplicable.

Schedule 2—Application for variation or transfer of certificate of approval in principle to operate a first aid service

Regulation 18(1)

Application for variation or transfer of certificate of approval in principle to operate a FIRST AID service

SECTION A

(1) Full name of applicant:

(2) Postal address of applicant:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

SECTION B

(1) The name (or proposed name) of the first aid service and its street address:

(2) This application is for—

variation of the certificate of approval in principle or any condition to which it is subject; or
transfer of the certificate of approval in principle to another person.

(3) If the application relates to the variation of the certificate of approval in principle, the reason for the proposed variation:

(4) If the application relates to the transfer of the certificate of approval in principle to another person—

(a) the name of that person; and

(b) the postal address of that person; and

(5) If the proposed transferee is a body corporate, the name and street address of each director or officer of the body corporate who may exercise control over the first aid service:

Signature of applicant:

Name of each signatory:

Date:

*Delete if inapplicable.

Schedule 3—Application for a first aid service licence

Regulation 19(1)

Application for a first aid service licence

SECTION A

(1) Full name of applicant:

(2) Postal address of applicant:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

(4) If the applicant is a body corporate, the name and street address of each director or officer of the body corporate who may exercise control over the first aid service:

SECTION B

(1) The class of first aid service for which a licence is sought—

a basic first aid service; or
an intermediate first aid service; or
an advanced first aid service.

(2) The name (or proposed name) of the first aid service and its street address:

Signature of applicant:

Name of each signatory:

Date:

*Delete if inapplicable.

Schedule 4—Application for the renewal of a first aid service licence

Regulation 21(1)

Application for the renewal of a first aid service licence

SECTION A

(1) Full name of applicant:

(2) Postal address of applicant:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

(4) If the applicant is a body corporate, the name and street address of each director or officer of the body corporate who may exercise control over the first aid service:

SECTION B

(1) The class of first aid service for which a licence is sought—

a basic first aid service; or
an intermediate first aid service; or
an advanced first aid service.

(2) The name (or proposed name) of the first aid service and its street address:

Signature of applicant:

Name of each signatory:

Date:

*Delete if inapplicable.

Schedule 5—Application for transfer of a first aid service licence

Regulation 22(1)

Application for Transfer of a first aid service licence

SECTION A

(1) Full name of transferor:

(2) Postal address of transferor:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

SECTION B

(1) The name of the first aid service and its street address:

(2) The proposed name and street address of the first aid service on transfer:

(3) Date of expiry of current first aid service licence:

(4) Class of licence to be transferred:

a basic first aid service; or
an intermediate first aid service; or
an advanced first aid service.

(5) The following information in relation to the transferee—

(a) the name of that person;

(b) the postal address of that person;

(6) If the proposed transferee is a body corporate, the name and street address of each director or officer of the body corporate who may exercise control over the first aid service:

Signature of transferor and transferee:

Name of each signatory:

Date:

*Delete if inapplicable.

Schedule 6—Application for variation of a first aid service licence

Regulation 23(1)

Application for variation of a first aid service licence

SECTION A

(1) Full name of applicant:

(2) Postal address of applicant:

(3) The name, telephone number and email address of a contact person for the purposes of the application:

SECTION B

(1) The nature of the variation sought (variation of licence or variation of condition to which licence is subject):

(2) Details of the variation sought:

Signature of applicant:

Name of each signatory:

Date:

═════════════

Endnotes

1 General information

See www.legislation.vic.gov.au for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.

The Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021, S.R. No. 149/2021 were made on 30 November 2021 by the Governor in Council under section 64 of the Non-Emergency Patient Transport and First Aid Services Act 2003, No. 69/2003 and came into operation on 30 November 2021: regulation 3.

The Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021 will sunset 10 years after the day of making on 30 November 2031 (see section 5 of the Subordinate Legislation Act 1994).

INTERPRETATION OF LEGISLATION ACT 1984 (ILA)

Style changes

Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.

References to ILA s. 39B

Sidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression "(1)" at the beginning of the original regulation, rule or clause.

Interpretation

As from 1 January 2001, amendments to section 36 of the ILA have the following effects:

• Headings

All headings included in a Statutory Rule which is made on or after
1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.
This includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.
See section 36(1A)(2A)(2B).

• Examples, diagrams or notes

All examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).

• Punctuation

All punctuation included in a Statutory Rule which is made on or after
1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.
See section 36(3B).

• Provision numbers

All provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after
1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).

• Location of "legislative items"

A "legislative item" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.

• Other material

Any explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).

2 Table of Amendments

There are no amendments made to the Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021 by statutory rules, subordinate instruments and Acts.

3 Amendments Not in Operation

This version does not contain amendments that are not yet in operation.

4 Explanatory details

Reg. 4 def. of certificate of roadworthiness: S.R. No. 116/2021.

——

Fee Units

These Regulations provide for fees by reference to fee units within the meaning of the Monetary Units Act 2004.

The amount of the fee is to be calculated, in accordance with section 7 of that Act, by multiplying the number of fee units applicable by the value of a fee unit.

The value of a fee unit for the financial year commencing 1 July 2021 is $15.03. The amount of the calculated fee may be rounded to the nearest 10 cents.

The value of a fee unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a fee unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.

Penalty Units

These Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the Sentencing Act 1991. The amount of the penalty is to be calculated, in accordance with section 7 of the Monetary Units Act 2004, by multiplying the number of penalty units applicable by the value of a penalty unit.

The value of a penalty unit for the financial year commencing 1 July 2021 is $181.74.

The amount of the calculated penalty may be rounded to the nearest dollar.

The value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.

——

Table of Applied, Adopted or Incorporated Matter

The following table of applied, adopted or incorporated matter was included in S.R. No. 149/2021 in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2014.

| **Statutory rule provision** | **Title of applied, adopted or incorporated document** | **Matter in applied, adopted or incorporated document** |
| --- | --- | --- |
| Regulation 4(1) (definition of ***infection control guidelines***) | National Health and Medical Research Council's Australian Guidelines for the Prevention and Control of Infection in Healthcare published by the Commonwealth in 2019 | The whole |
| Regulation 12(4) | Australian/New Zealand Standard AS/NZS 4535:1999 Ambulance restraint systems, published by Standards Australia and Standards New Zealand on 5 February 1999 | The whole |
| Regulation 37(1)(g) | National Health and Medical Research Council's Australian Guidelines for the Prevention and Control of Infection in Healthcare published by the Commonwealth in 2019 | Section 4.2.1 |
| Regulation 41(1) | National Health and Medical Research Council's Australian Guidelines for the Prevention and Control of Infection in Healthcare published by the Commonwealth in 2019 | The whole |

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1 Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

Version No. 001

Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

S.R. No. 149/2021

Version as at
30 November 2021

TABLE OF PROVISIONS

Regulation Page

Part 1—Preliminary 1

1 Objective 1

2 Authorising provision 1

3 Commencement 1

4 Definitions 1

5 Definition of basic first aid service 5

6 Definition of intermediate first aid service 6

7 Definition of advanced first aid service 6

Part 2—First aid services 8

Division 1—Classes of first aid service 8

8 Classes of first aid service 8

9 Licence holder must comply with licence 8

Division 2—Scope of clinical practice 8

10 Licence holder must have written scope of clinical practice 8

11 Licence holder must have written scope of clinical practice for each staff member 9

12 Staff member must work within scope of clinical practice 9

Part 3—Staffing of first aid services 11

13 Competencies for staff members of first aid services 11

14 Ongoing assessment of competency 12

15 Skills maintenance training 12

16 Staff identification 12

Part 4—Licensing 13

Division 1—Applications 13

17 Application for approval in principle 13

18 Application for variation or transfer of approval in principle 13

19 Application for a first aid service licence 13

20 Conditions on licences 14

21 Application to renew a licence 14

22 Application to transfer a licence 15

23 Application to vary a licence 15

Division 2—Quality assurance plans 15

24 Development, contents and accreditation of quality assurance plan 15

25 Compliance with quality assurance plan 17

26 Audit of quality assurance plan 17

27 Revocation, suspension or expiry of accreditation 17

Division 3—Other matters during course of licence 18

The Regulations organise regulatory responsibilities around a few core concepts, each implemented by prescriptive rules.

Classes and scope

Three classes of service are defined by capability and permitted clinical interventions: basic, intermediate and advanced (regs 5-7, reg 8). The delineation is clinical and resource based, for example advanced services may manage life threatening conditions and use Schedule 8 poisons, intravenous therapies and invasive monitoring (reg 7(b)-(c)). The class drives licensing fees, accreditation and other obligations (reg 19(2); reg 24(3); reg 20).

Scope of clinical practice

Licence holders must have a written scope of clinical practice for the service and for each staff member, and must not treat outside those written scopes (regs 10-11). Scope must be consistent with the class of licence and any licence conditions (reg 10(2)). Each staff member’s scope must be consistent with their qualifications, competency, training and experience (reg 11(2)).

Clinical governance

The Regulations embed clinical governance obligations: a clinical oversight committee, responsibilities including review of sentinel events and clinical audits, quarterly meetings, staff surveys and a nominated clinical nominee responsible for assessing clinical matters (regs 30-34). For intermediate and advanced services the committee must verify registered health practitioner credentials every three years and audit patient care records (reg 31(2)).

Quality assurance and accreditation

Intermediate and advanced licence applicants must develop a quality assurance plan with a specified list of components including infection control, active clinical monitoring, drug security and complaints processes (reg 24(2)). Advanced service plans must be accredited by an accreditation body, and accreditation must be maintained while operating as an advanced service (reg 24(3), reg 27(1)-(2)). The Secretary may be notified of audit findings and significant risks (reg 26).

Staff competency and supervision

Initial competency and ongoing assessment are mandated, with clinical supervision until a licence holder records competency to work unsupervised (regs 13-15). Annual skills maintenance training is required (reg 15). Staff must wear identification tags on duty (reg 16).

Records, reporting and complaints

Patient care records must capture prescribed clinical and demographic details and be reviewed in specified circumstances such as transport to hospital or administration of certain scheduled poisons (reg 36). Complaints registers and investigation processes must be maintained as part of the quality assurance plan (regs 38-39). Sentinel events must be reported immediately (reg 28).

Equipment, infection control and logistics

Minimum equipment lists for first aid stations are set, including AEDs, epinephrine or equivalent, hand hygiene, waste management and signage; intermediate and advanced services must carry salbutamol MDI and spacer and patient transfer equipment (reg 44). Annual maintenance schedules and maintenance records are required (regs 42-43). Infection control plans must follow the NHMRC Guidelines and be reviewed annually for intermediate and advanced services (reg 41; reg 4).

Fees, insurance and administrative forms

Fees for approval in principle and licences are expressed in fee units with tiered rates by class (regs 17-23; Schedules 1-6). Licence holders must hold $20,000,000 minimum public liability and $20,000,000 professional indemnity insurance (reg 47).

Enforcement and penalties

The Regulations use penalty units to enforce requirements, with penalties ranging across provisions from 10 penalty units to 20 penalty units for breaches of key obligations such as providing services outside scope, failure to have scopes, and failure to maintain infection control (multiple regs). The Endnotes provide the relevant fee and penalty unit values for the financial year commencing 1 July 2021 (Endnotes).

In short, the Regulations convert statutory licensing into a prescriptive regulatory model centred on scope, accreditation, governance, staff competency, record keeping, equipment and insurance, with reporting lines to the Secretary and specified enforcement penalties.

The Regulations affect four principal groups and several intermediaries.

Licence holders and prospective licence applicants

Any person who holds a first aid service licence issued or renewed on or after commencement is a licence holder under these Regulations (reg 4 definition). Prospective operators are affected by the approval in principle and licence application processes (regs 17-19; Schedules 1 and 3). Fees differ by class, with basic, intermediate and advanced fees set in fee units (reg 19(2)).

Staff and clinical practitioners

All staff members providing first aid services to patients are directly regulated, through competency, supervision, annual training, identification and scope of practice requirements (regs 13-16, reg 11). Registered health practitioners engaged by intermediate and advanced services are subject to credential verification every three years by the clinical oversight committee (reg 31(2)(a)).

Event providers and venues

Event providers are indirectly affected because licence holders must communicate with event providers about the event description, anticipated risks and circumstances that require an emergency 000 call before providing services at an event (reg 46). The Regulations also require that first aid stations be identifiable and have communications capable of contacting event headquarters and emergency services (reg 44(f), reg 45).

Accreditation bodies and auditors

Accreditation bodies play a role for advanced services because advanced quality assurance plans must be accredited by an accreditation body, and the Secretary may nominate an accreditation body (reg 24(3); reg 4(2)). Where audits by an accreditation body occur, licence holders must submit audit reports to the Secretary and report significant patient risks within 24 hours (reg 26).

Statutory ambulance services and other health providers

Statutory ambulance services retain operational direction in certain circumstances because a staff member may, at the direction of a statutory ambulance service, move a patient to meet an ambulance or facilitate referral (reg 12(2)). Licence holders must ensure continuity of information when a patient is transported by ambulance, including oral handover and provision of patient care records where practicable (reg 36(2)).

Government and regulators

The Secretary and authorised officers under the Act receive audit reports, sentinel event notifications, annual reporting data and may be notified of accreditation changes, giving regulators information and enforcement channels (regs 26, 27(2), 28, 29, 34(2)).

Insurers and suppliers

Insurers are implicated because licence holders must hold minimum public and professional indemnity policies of $20,000,000 each (reg 47). Equipment suppliers and service technicians are implicated because the Regulations mandate maintenance schedules and records kept for the life of the equipment (regs 42-43).

Who pays and who decides

Licence holders pay the fees, maintain the insurance, run QA plans and bear penalties for non compliance (regs 17-23; reg 47; multiple penalty provisions). The Secretary decides accreditation nominations for accreditation bodies and receives reports and audit material (reg 4(2); regs 26, 27).

The distribution shows concentrated obligations on licence holders and their staff, recurring compliance costs for accreditation and QA processes, and administrative burdens on licence applicants and operators. Event providers may absorb planning costs and coordination time, while insurers and accreditation bodies receive concentrated business if demand for accreditation and high value insurance increases.

Key duties are prescriptive and cross multiple Parts; the Regulations specify rights only indirectly by imposing obligations on licence holders that protect patient safety and require information flows.

Core duties of licence holders

Operate within licence scope: Licence holders must not provide first aid services outside the scope of their first aid service licence (reg 9). There is a specific offence for treating outside the written scope of clinical practice, with a penalty of 20 penalty units for operating outside the written scope (regs 10(1), 10(3)). Licence holders must prepare and maintain a written scope of clinical practice for the service (reg 10(1)) and for each staff member (reg 11(1)).
Maintain quality assurance plans: Intermediate and advanced applicants must develop a quality assurance plan containing an enumerated set of elements such as infection control, drug security and equipment maintenance (reg 24(1)-(2)). Advanced service QA plans must be accredited by an accreditation body (reg 24(3)). Licence holders must maintain and comply with their QA plan (reg 25).
Clinical governance: Establish and maintain a clinical oversight committee with at least specified membership and responsibilities (regs 30-31). The committee must meet at least quarterly and keep records of its meetings (reg 32).
Staff competencies and records: Ensure initial competency, supervised practice until competency is recorded, ongoing assessment and annual skills maintenance training for staff (regs 13-15). Verify and record staff qualifications and maintain staff records with specified content and retention periods (regs 11(3), 37(1)-(2)).
Records, complaints and reporting: Keep patient care records that include specified demographic and clinical data and review records where transport or certain drugs are given (reg 36). Maintain a complaints register and ensure investigations are not detrimental to complainants (regs 38-39). Report sentinel events immediately to the Secretary and submit annual reports with specified items (regs 28, 29).
Equipment and infection control: Keep equipment in good working order with annual maintenance schedules and lifetime maintenance records, and ensure first aid stations are equipped per reg 44. Intermediate and advanced services must include an infection control management plan in their QA plan consistent with NHMRC Guidelines and review it annually (reg 41; reg 4 definition).
Insurance and fees: Maintain public liability and professional indemnity insurance minima of $20,000,000 each (reg 47). Pay application, renewal, transfer and variation fees prescribed in fee units (regs 17-23).

Specific staff duties and limited rights

Staff must work within their own scope of clinical practice, with a 20 penalty unit offence for providing management or intervention outside scope (reg 12(1)). Staff may move patients to meet ambulances or within the vicinity of an event subject to vehicle roadworthiness and restraint standards if using a vehicle (reg 12(2)-(4)).

Secretary’s powers and licence conditions

The Secretary receives accreditation and audit reports, may be nominated to accept accreditation bodies by Gazette notice and may request annual report information from licence holders (reg 4(2); regs 26, 29(e)). Advanced licences granted without current accreditation are subject to the condition that the applicant obtain accreditation within three months and submit the certificate to the Secretary (reg 20).

Penalties and enforcement follow from duties

A suite of penalties applies across obligations, typically 10 to 20 penalty units depending on the provision (multiple regs). The Endnotes provide penalty unit monetary values for the financial year 2021-22.

Rights for patients

The Regulations embed patient protections indirectly by mandating clinical governance, complaint registers and specific patient care record content and handover obligations where ambulance transport occurs (regs 31, 38-39, 36(2)). Patients therefore have the right, through regulatory means, to expect documentation, complaint handling and that services operate within written scope.

The duties create a compliance architecture that combines administrative, clinical and insurance requirements, placing ongoing obligations on licence holders and their clinical governance structures.

Penalties are expressed throughout in penalty units, and enforcement is administered under the Act via authorised officers and the Secretary. The Regulations specify offences with penalties and procedural reporting obligations.

Penalty structure and examples

The Regulations impose penalties ranging commonly from 10 penalty units to 20 penalty units. Examples include:
- 20 penalty units for providing first aid services outside a licence’s scope (reg 10(3), reg 9 refers);
- 20 penalty units for failure to prepare a written scope of clinical practice for the service or for each staff member (regs 10(1), 11(1));
- 20 penalty units for staff practising outside their scope (reg 12(1));
- 20 penalty units for not developing an infection control management plan where required, and for failing to review it annually (reg 41(1), reg 41(3));
- 15 penalty units for failing to maintain patient care records or staff records per reg 35(1) and (2) respectively;
- 10 penalty units for failing to establish and keep a complaints register per reg 38.
The Endnotes state the monetary value of a penalty unit for the financial year commencing 1 July 2021 is $181.74. Using that value, a 20 penalty unit sanction would be approximately $3,634.80 before rounding to the nearest dollar as required by the Endnotes. A 10 penalty unit sanction would be approximately $1,817.40. The Regulations specify rounding rules in the Explanatory details and Monetary Units Act references in the Endnotes.

Enforcement mechanisms and reporting

The Secretary is the recipient of certain mandatory notifications and reports, including immediate reporting of sentinel events (reg 28), reporting of revocation or suspension of accreditation (reg 27(2)), and submission of audit reports and annual reports (regs 26, 29). The licence holder must submit audit reports from an accreditation body within 14 days, and report significant patient risk identified by such audits within 24 hours (reg 26(1)-(2)).
Authorised officers under the Act may require production of records, and the Regulations require that competence records and attestations be available for production to an authorised officer under s 48 of the Act (reg 14(3)). Penalties apply where records are not maintained or where required actions are not taken.

Licence conditions and suspension implications

Advanced licence holders who lack current accreditation are subject to a licence condition to obtain accreditation within three months and submit proof to the Secretary (reg 20). If accreditation is revoked, suspended or expires, the licence holder must not provide an advanced first aid service (reg 27(1)), creating an operational enforcement consequence beyond monetary penalties.

Administrative discretion and audit triggers

The Secretary has administrative discretion in relation to accreditation bodies by Gazette notice (reg 4(2)). Audits by accreditation bodies trigger reporting duties to the Secretary and may produce rapid reporting obligations where significant risk is identified (reg 26(2)).

Practical enforcement considerations

Monetary penalties are set by reference to penalty units, which may change over time as the Treasurer fixes values under the Monetary Units Act. The presence of immediate reporting obligations and operational prohibitions for loss of accreditation indicates the regime relies both on traditional monetary penalties and on administrative controls that can suspend service provision for advanced services if accreditation lapses or is revoked (regs 26-27).

Overall enforcement blends civil/regulatory fines with administrative controls (licence conditions, reporting, suspensions) and inspectorate powers for production and oversight.

The Regulations are explicitly designed to work within a network of other statutory instruments and standards. They refer to and import concepts and requirements from federal and state law and external standards.

Parent Act: Non‑Emergency Patient Transport and First Aid Services Act 2003

These Regulations are made under s 64 of the Act and operationalise the licensing scheme and regulatory powers in Part 2A and related sections, for example prescribing forms and fees for approval in principle and licences under sections referenced in regs 17-23. The Secretary and authorised officers under the Act receive reports and audit material specified by the Regulations (reg 26(1); reg 28).

Health Practitioner Regulation National Law

Definitions for registered health practitioners, registered nurses and registered paramedics are taken from the Health Practitioner Regulation National Law, and the Regulations impose obligations related to verification of registration and credentials for such practitioners (reg 4 definitions; reg 31(2)(a)). The clinical oversight committee must verify credentials for registered health practitioners when engagement commences and every three years thereafter (reg 31(2)(a)).

Drugs, Poisons and Controlled Substances Act 1981

The Regulations rely on the schedules in the Drugs, Poisons and Controlled Substances Act for the classification of poisons that intermediate and advanced services may use (reg 4 definitions, regs 6-7). The administration of Schedule 3, 4 and 8 poisons triggers record reviews and clinical governance obligations (reg 36(3)(b)).

Road Safety and Vehicle Standards

If staff move patients using a vehicle within the vicinity of an event, that vehicle must have a current certificate of roadworthiness under the Road Safety (Vehicles) Regulations 2021, and comply with AS/NZS 4535:1999 Ambulance restraint systems (reg 12(4); reg 4 definition of certificate of roadworthiness). This creates an interaction with road transport legislation and national standards for ambulance restraint systems.

National standards, guidelines and accreditation

The Regulations adopt NHMRC's Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) for infection control planning and specific immunisation recommendations referenced in staff records (reg 4, reg 41, reg 37(1)(g); Endnotes "Table of Applied, Adopted or Incorporated Matter"). They also refer to accreditation bodies recognised by the Joint Accreditation System of Australia and New Zealand and the International Society for Quality in Healthcare, and allow the Secretary to nominate other bodies by Gazette notice (reg 4(1)-(2)).

Monetary Units and Sentencing Acts

Fees and penalties are expressed in fee units and penalty units respectively, thereby interacting with the Monetary Units Act 2004 and the Sentencing Act 1991. The Endnotes set the fee unit and penalty unit monetary values for the 2021-22 financial year and state rounding rules (Endnotes).

Ambulance Services Act 1986 and Statutory Ambulance Services

The Regulations refer to statutory ambulance services created under s 23 of the Ambulance Services Act 1986 and listed in Schedule 1 to that Act, specifically permitting staff to follow direction from a statutory ambulance service to move patients for transfer (reg 12(2); reg 4 definition).

Local government, workplace safety and other laws

The Regulations do not remove obligations under workplace health and safety, local council event approvals, or other regulatory regimes. For example, event providers and venue operators may have separate obligations for crowd safety and medical provision; the Regulations require interaction with event providers in planning (reg 46), but do not displace other legal duties.

Taken together, the Regulations build a layered regulatory architecture by referencing national professional registration regimes, drug scheduling legislation, vehicle and roadwork standards, national infection control guidelines and national accreditation frameworks. Licence holders must therefore satisfy an integrated set of compliance obligations that bridge health, transport, drug control and administrative law.

The Regulations were made on 30 November 2021 and came into operation the same day (reg 3; Endnotes). The Endnotes include a "Table of Amendments" section which states there are no amendments made to the Regulations by statutory rules, subordinate instruments or Acts as at the version date (Endnotes, Table of Amendments). The Endnotes also include an "Amendments Not in Operation" section which notes that this version does not contain amendments not yet in operation.

Key procedural points about future amendment mechanics are in the Endnotes:

The instrument will sunset 10 years after making, on 30 November 2031, under s 5 of the Subordinate Legislation Act 1994 (Endnotes).
The Regulations reference fee units and penalty units, whose monetary values are set annually by the Treasurer under the Monetary Units Act 2004 and the Sentencing Act 1991 respectively, meaning that fee and penalty dollar amounts will vary over time as fixed by executive action rather than by amendment to these Regulations (Endnotes, Explanatory details on Fee Units and Penalty Units).

There is also an administrative mechanism allowing the Secretary to nominate additional accreditation bodies by Gazette notice (reg 4(2)), which adds regulation‑level flexibility without formal amendment to the Regulations.

No statutory rule numbers or amendment dates are recorded in the Table of Amendments in the Endnotes. Users should therefore treat this instrument as unamended since commencement, but recognise fees and penalty dollar amounts will vary each financial year as set by relevant executive instruments. For up to date legislative history and whether any future amendments have occurred after the version date, the Endnotes direct readers to the official legislation website (Endnotes).

The Regulations themselves do not list any cases. The Endnotes and the body of the Regulations contain no references to judicial decisions, and the Table of Amendments records no amendments or litigation entries. Therefore, as of the version date provided (30 November 2021) there is no litigation history recorded in the instrument, and no case law cited or incorporated into the Regulations.

Practitioners should note two practical implications:

Because there is no recorded litigation history in the instrument, legal interpretation of ambiguous provisions will initially rely on statutory construction principles, the parent Act, parliamentary materials and administrative practice rather than precedent specific to these Regulations.
If disputes arise over application or enforcement, cases would likely engage the Act, administrative law remedies, and possibly intersectional regulatory frameworks such as health practitioner disciplinary regimes, ambulance or vehicle statutes and professional indemnity coverage disputes.

Users seeking case law should search court and tribunal databases for decisions referencing the Non‑Emergency Patient Transport and First Aid Services Act 2003 or the Regulations after the version date, because any litigation arising later will not appear in this instrument’s Endnotes.

This section flags practical traps that arise from the Regulations’ drafting and interaction with other instruments, with references so readers can confirm the textual sources.

Scope rigidity and criminal liability

Written scopes of clinical practice are mandatory for both the service and each staff member, and treating outside those scopes attracts a 20 penalty unit fine (regs 10-12). Licence holders must therefore be precise and conservative about scopes, and must have processes to update scopes in line with training and experience. A mismatch between practice and written scope creates an offence risk even for well‑intentioned staff.

Accreditation timing pressure for advanced services

Advanced applicants without current accreditation may be granted a licence subject to the condition that they obtain accreditation within 3 months and provide the certificate to the Secretary (reg 20). This creates a timing pressure: operators will have to secure accreditation quickly or face a licence condition breach. Also, if accreditation is revoked or suspended the licence holder must not provide the advanced service (reg 27(1)), which can be operationally disruptive.

Audit reporting short timelines

If an audit by an accreditation body identifies a significant patient risk, the licence holder must report that risk to the Secretary within 24 hours after receiving the audit report (reg 26(2)). The combination of short timelines and the need to collate and validate audit findings requires licence holders to have immediate reporting processes and designated contacts.

Credential verification and three year cycle

For intermediate and advanced services, the clinical oversight committee must oversee verification of registered health practitioner credentials on commencement and every three years thereafter (reg 31(2)(a)). This is an explicit cyclical compliance duty that can be overlooked if credentialing is treated as a one off.

Record retention lifespans differ

Equipment maintenance records must be kept for the lifespan of the equipment (reg 43(2)), whereas staff records must be retained for at least two years after cessation of employment (reg 37(2)). Different retention horizons increase record management complexity and costs.

Vehicle compliance when moving patients

Staff may move patients within an event vicinity and on a public road if the vehicle has a certificate of roadworthiness and complies with AS/NZS 4535:1999 Ambulance restraint systems (reg 12(3)-(4)). In practice, event operators using non‑ambulance vehicles must ensure compliance with vehicle standards and restraint systems, which may require expensive vehicle upgrades or use of statutory ambulance services.

Insurance minimums are high

The mandatory insurance thresholds are $20,000,000 for both public liability and professional indemnity (reg 47). For small operators this may significantly increase operating costs, or lead to market exits where insurers decline to offer cover at those levels.

Quality assurance plan content is detailed

The QA plan must address a long list of items (reg 24(2)(a)-(r)), including drug security, manual handling, clinical handover and cleaning. Failing to include any required element may create compliance exposure and could affect accreditation for advanced services.

Staff surveys and clinical oversight meeting cadence

Clinical oversight committees must meet at least once each three month period and staff surveys must be conducted annually (regs 32(1), 33(1)). These recurring obligations require ongoing administrative effort, minutes and follow up actions.

Interaction with other legal duties

The Regulations do not displace other statutory obligations. For example, compliance with NHMRC infection control Guidelines is required, but licence holders still must satisfy workplace health and safety or local council event requirements. Assume multiple parallel compliance regimes.

Conversion of units to dollars changes over time

Fees and penalties are set in fee and penalty units. The Endnotes give values for 2021-22 but those values change annually as the Treasurer fixes them. Financial planning must allow for future changes in unit values (Endnotes).

Together these "gotchas" highlight that the Regulations create a precise, procedural compliance regime with short reporting deadlines, high insurance minima and tight credentialing, all of which impose recurring administrative and cost burdens that operate in parallel with other legal obligations.

This section sets out practical, source‑grounded steps a prospective or existing licence holder should follow to reduce compliance risk and operationalise the Regulations.

Determine licence class and read the associated duties

Start by selecting the appropriate class: basic, intermediate or advanced (regs 5-8; Schedule 3). The class determines fee levels (reg 19(2)), QA and accreditation obligations (reg 24), equipment lists (reg 44) and restrictions on treatment and poisons (regs 5-7). Document the rationale for class choice and ensure planned services fit the class definitions.

Prepare written scopes of clinical practice at both service and staff levels

Draft and maintain a written scope for the service consistent with the licence class and any licence conditions (reg 10(1)-(2)). For each staff member prepare a scope aligned with their qualifications and experience, and verify and record qualifications at engagement (reg 11(1)-(3)). Ensure change control processes exist to update scopes when staff training or duties change, because treating outside the scope attracts a 20 penalty unit penalty (reg 10(3), reg 11(2), reg 12(1)).

Build competency, supervision and training systems

Implement initial competency checks, clinical supervision until competent is recorded, ongoing competency assessment and annual skills maintenance training (regs 13-15). Maintain attestations of training and keep records available for authorised officers (reg 14(2)-(3)). Create a supervisor registry that ensures supervisors have equal or higher qualifications and are competent to work unsupervised (reg 13(6)).

Develop and accredit the quality assurance plan where required

For intermediate and advanced licences develop a QA plan covering all enumerated elements in reg 24(2). For advanced services secure accreditation from a recognised accreditation body and build an audit calendar to respond to accreditation processes (reg 24(3); reg 4(1)-(2)). If operating advanced services without current accreditation, plan to obtain accreditation within three months or avoid providing advanced services until accredited (reg 20, reg 27(1)).

Establish clinical governance and oversight

Constitute a clinical oversight committee meeting quarterly, with required membership including management and appropriate registered practitioners, and document responsibilities such as reviewing sentinel events and audits, and verifying credentials every three years for registered health practitioners (regs 30-32, reg 31(2)(a)). Nominate a clinical nominee and provide contact details to the Secretary within 28 days (reg 34).

Implement record keeping and complaints processes

Design patient care record templates to capture all elements required by reg 36 and ensure review triggers are embedded for ambulance transport, administration of Schedule 3, 4 or 8 poisons, and clinical deterioration (reg 36(1), (3)). Set retention schedules: staff records for at least two years post cessation (reg 37(2)), and maintenance records for the life of the equipment (reg 43(2)). Establish a complaints register meeting the minimum fields in reg 38 and integrate it into the QA plan (reg 38(3)).

Infection control compliance

For intermediate and advanced services produce an infection control management plan compliant with the NHMRC Guidelines, identifying risk areas, controls, education, responsible person and monitoring mechanisms and review it annually (reg 41(1)-(3); reg 4 definition). Ensure staff immunisation records are collected consistent with the Guidelines and recorded in staff records (reg 37(1)(g)).

Equipment, maintenance and communications

Audit equipment lists against reg 44 and maintain an annual maintenance schedule in line with manufacturers’ specifications (regs 42-44). Keep maintenance records throughout equipment life and ensure AEDs, epinephrine and supplies are available and stored securely with documented drug security procedures in the QA plan (reg 24(2)(i), reg 44). Provide communication devices that enable contact with head office, event HQ, statutory ambulance services and other emergency services at all times (reg 45).

Insurance and financial planning

Obtain public liability and professional indemnity policies at or above $20,000,000 each before operating (reg 47). Budget for licence fees and for potential increases in fee unit or penalty unit values over time; use the Monetary Units Act process as the basis for fee planning and review the Government Gazette for annual fee unit values (Endnotes).

Event planning and liaison

Prior to attending events, communicate with event providers to document the event description, anticipated health risks and circumstances that require a 000 call, and confirm the service can meet event needs (reg 46). Record these communications as part of the event plan.

Prepare for reporting and audit timelines

Create processes to deliver audit reports to the Secretary within 14 days of receipt from an accreditation body, and to report identified significant patient risks within 24 hours (reg 26). Ensure personnel and procedures are in place to rapidly collate relevant findings and notify the Secretary.

Maintain continuous compliance monitoring

Schedule quarterly clinical oversight committee meetings, annual staff surveys, annual review of infection control plans and scheduled credential re‑verification every three years for registered practitioners (regs 32(1), 33(1), 41(3), 31(2)(a)).

Practical implementation checklist

Licence selection confirmed, application form completed (Schedules 1-6); fees paid in fee units and tracked across fiscal years (regs 17-23).
Written scopes for service and staff documented and accessible.
Competency and supervision records created and attested.
QA plan drafted, fully populated to reg 24(2) elements and accredited if required.
Clinical oversight committee constituted with minutes filing system.
Patient care and staff record templates implemented, retention policies set.
Infection control plan aligned to NHMRC Guidelines and annual review scheduled.
Equipment audited, maintenance schedule and lifetime records established.
Insurance policies bound to minimums and reviewed annually.
Reporting protocols established for sentinel events, audits and accreditation changes.

Following these concrete, source‑grounded steps aligns operations with the specific text and timelines of the Regulations and reduces exposure to fines, licence conditions and operational interruptions arising from lapses in accreditation or reporting.

Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

Plain English Summary

Deep Dive

What it does

Current sections

Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

Source text: opening excerpt

1 Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply