The following four conditions are imposed on the supply of COVID-19 rapid antigen tests included in the Register:

1. The person in whose name the device is included in the Register (the sponsor) may only supply the device to one or more of the following:
   1. a laboratory that is an accredited pathology laboratory within the meaning of the Health Insurance Act 1973;
   2. a medical practitioner who is registered under a law of a state or territory to practice medicine, a person registered under a law of a state or territory to practice paramedicine (a paramedic), or an organisation, business or institution that employs or engages a medical practitioner or a paramedic, where:
      1. the medical practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other person acting under their supervision to perform the test have received training in the correct use of the device and the interpretation of the test result; and
      3. device is only used to test employees or contractors of the organisation, business or institution; or a patient under the direct care of the medical practitioner or the paramedic;
   3. a residential care or aged care facility, or a home care service provider, that employs or engages a health practitioner within the meaning of the Therapeutic Goods Act 1989 or a paramedic (as defined in paragraph (b)), where:
      1. the health practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other person acting under their supervision to perform the test have received training in the correct use of the device and the interpretation of the test result; and
      3. the device is only used to test residents, employees or contractors of, or visitors to, the residential care or aged care facility, or clients, employees, or contractors of the home care service provider;
   4. an organisation, business or institution that employs or engages a health practitioner within the meaning of the Therapeutic Goods Act 1989 or a paramedic (as defined paragraph (b)) where:
      1. the health practitioner or the paramedic is responsible for performing or supervising the performance of the test; and
      2. the person mentioned in subparagraph (i) and any other person acting under their supervision to perform the test have received training in the correct use of the device and the interpretation of the test result; and
      3. the device is only used to test employees, contractors or students of the organisation, business or institution, or a person who is a patient of a practitioner registered under a law of the state or territory to practice dentistry and who requires an emergency dental procedure;
   5. a department of the Commonwealth, state or territory, with responsibility for health, or a department or other agency of the Commonwealth, state or territory acting on its behalf.
2. The device must not be supplied for the purpose of self-testing.
3. The sponsor of the device must provide training to a person mentioned in subparagraphs (1)(b)(ii), (1)(c)(ii) or (1)(d)(ii) in the correct use of the device and the interpretation of the test result, prior to that person performing or supervising the performance of the test.
4. The sponsor must maintain records that demonstrate the device has been supplied in compliance with these conditions.

Condition (1)(a)

Accredited pathology laboratories (link is external) in this context are pathology laboratories accredited by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA) for Human Pathology Testing (under the Health Insurance Act 1973) and are eligible for claiming medicare benefits for approved pathology services.

Condition (1)(b)

Condition (1)(b) includes supply to medical practitioners, paramedics or organisations, businesses or institutions that employ or engage a medical practitioner or paramedic registered with the Australian Health Practitioner Regulatory Agency (AHPRA) under the Health Practitioner National Law as is in force in each state and territory. A medical practitioner or paramedic may perform or oversee the performance of the test by a person under their supervision, for example a registered or enrolled nurse. The medical practitioner or paramedic remains responsible for the conduct of the testing and must be available to provide assistance or advice as required to persons under their supervision in the use of the device and the interpretation of the test results. All staff need to be trained in the correct use of the test.

Condition (1)(c)

Condition (1)(c) includes supply to residential care (i.e. disability and rehabilitation facilities),aged care facilities and home care providers that employ or engage paramedics or health practitioners (including but not limited to medical practitioners or registered (Division 1) or enrolled (Division 2) nurses) who are responsible for conducting or overseeing the performance of the test. The reference to health practitioner in this condition is a reference to a person within the meaning of that term in section 3 of the Therapeutic Goods Act 1989. A paramedic is a person registered under a law of a state or territory to practice paramedicine. Personal care and disability support workers are not health practitioners for the purposes of this condition.

Condition (1)(d)

Condition (1)(d) allows supply organisations, businesses or institutions that employ or engage paramedics or health practitioners who are responsible for performing or supervising the performance of a test on their staff. The reference to health practitioner in this condition is a reference to a person within the meaning of that term in section 3 of the Therapeutic Goods Act 1989. A paramedic is a person registered under a law of a state or territory to practice paramedicine.

All health practitioners including paramedics, and persons under their supervision must be trained in the correct use of the device and the interpretation of the test results. The health practitioner or paramedic remains responsible for the conduct of testing and must be available to provide assistance or advice as required to persons under their supervision in the correct use of the device and the interpretation of the test results.

Condition (1)(e)

Condition (1)(e) allows for supply of the device to a department or other agency of the Commonwealth, a state or territory, that has arrangements in place to procure COVID-19 test kits on behalf on the Commonwealth, state or territory departments with responsibility for health. For reference, a general list of government departments and agencies may be accessed at Australian government departments and agencies.

Conditions (3) and (4)

Conditions (3) and (4) require the sponsor to provide health practitioners training in the correct use of the device and interpretation of results and keep records of such training.

Once trained, a health practitioner can train persons under their supervision to conduct the test. The health practitioner would be responsible for maintaining records of this training.

What is meant by supervision of testing?

Supervision is a key responsibility for controlling the risks to patient safety and welfare that may arise while providing a testing service. Supervision of testing goes to the professional conduct of a practitioner. Failure to appropriately supervise testing may amount to professional misconduct. The practitioner remains liable at all times for the conduct of the testing.

Once appropriately trained in the correct use of the device, persons under the supervision of a health practitioner (as specified in Conditions (1)(b) to (1)(d)) may perform the test. The relevant health practitioner responsible for supervision of testing is required to ensure all persons performing the test (including sample collection, performing tests and interpreting test results) under their supervision are appropriately trained in all matters related to good testing practice, including:

• infection control practices, including assessment of any site specific work, health and safety risks;
• the collection of samples, or where applicable the supervision of self-collection in order to verify patient identification, sample collection, test performance and test results;
• the correct use of the device and interpretation of test results;
• protocols for recording results and requirements for notification of positive results;
• protocols and referral processes for recollection and confirmatory testing; and
• protocols for reporting any problems or adverse events associated with performance of the test to the Therapeutic Goods Administration.