Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020

This instrument establishes the diagnostic imaging accreditation regime that applies to diagnostic imaging practices from 1 April 2020 (s 2, s 3). It replaces the 2010 Instrument (s 5) and sets out who the responsible accreditor is (s 7), how practices obtain accreditation (ss 9-11), what standards apply (Schedule 1), what diagnostic imaging modalities are recognised (Schedule 2), the processes for application and decision making (s 12), conditions of accreditation and access powers for accreditors (s 14), fee rules for approved accreditors (s 15), and the processes for variation, suspension and revocation including emergency powers (s 16). It also provides reconsideration rights (s 18) and transitional arrangements for existing accreditations and pending applications (s 19). The instrument is made by the Minister under subsection 23DZZIAA(1) of the Health Insurance Act 1973 (s 4) and defines terms that link the regime to other statutory frameworks, including Medicare benefits, AHPRA registration and radiation safety legislation (s 6 and Schedule 1 required evidence).

Mechanically, the instrument creates three accreditation routes. First, entry level accreditation is available to practices that have never previously been accredited under the prior or relevant earlier schemes (s 9). Entry level accreditation requires compliance with three entry level Standards in Schedule 1 (Standards 1.2-1.4) and lasts no more than two years because the responsible accreditor must revoke such accreditation after two years (s 9(7)). Second, full accreditation under s 10 requires compliance with the full set of Standards in Schedule 1 and is subject to revocation if four years pass since last accreditation (s 10(6)). Third, practices that hold MIAP approval (the Medical Imaging Accreditation Program jointly administered by NATA and RANZCR, as defined in s 6) may obtain accreditation under s 11 by evidencing MIAP approval, but that accreditation is tied to the MIAP approval period and will be revoked if MIAP approval lapses or on the MIAP expiry date (ss 11(2), 11(6)-(8)).

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Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020

I, GREG HUNT, the Minister for Health, make this legislative instrument under subsection 23DZZIAA(1) of the Health Insurance Act 1973.

Dated 23 March 2020

GREG HUNT

Minister for Health

Contents

1 Name of instrument

2 Purpose of instrument

3 Commencement

4 Authority

5 Repeal of previous instrument

6 Interpretation

7 Responsible accreditor

8 When application can be made for re-accreditation

9 Accreditation against entry level standards

10 Accreditation against standards

11 Accreditation based on Medical Imaging Accreditation Program

12 Applications for accreditation

13 Diagnostic imaging modalities

14 Conditions of accreditation

15 Fees

16 Variation, suspension or revocation of accreditation

17 Date of effect of decisions

18 Reconsideration of decisions

19 Transitional provisions

Schedule 1— Diagnostic Imaging Accreditation Scheme Standards

Part 1—Organisational Standards

Part 2—Pre-procedure standards

Part 3—Procedure standards

Part 4—Post procedure standards

Schedule 2—Diagnostic Imaging Accreditation Scheme Diagnostic Imaging Modalities

1 Name of instrument

This legislative instrument is the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020.

2 Purpose of instrument

This instrument establishes a scheme under which diagnostic imaging practices may be accredited for diagnostic imaging procedures.

3 Commencement

This instrument commences on 1 April 2020.

4 Authority

This instrument is made under subsection 23DZZIAA(1) of the Act.

5 Repeal of previous instrument

The Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010 is repealed.

6 Interpretation

Note: Unless a contrary intention appears, an expression used in this instrument has the same meaning as in the Act — see section 13 of the Legislative Instruments Act 2003. Terms that are defined in the Act and used in this instrument include the following:

(a) approved accreditor;

(b) base for mobile diagnostic imaging equipment;

(d) diagnostic imaging premises;

(e) diagnostic imaging procedure;

(f) diagnostic imaging service;

(g) diagnostic imaging services table;

(h) Medicare benefit;

(i) proprietor.

(1) In this instrument:

Act means the Health Insurance Act 1973.

adverse event has the meaning given in subsection 16(1).

applicant means an applicant for accreditation of a diagnostic imaging practice under section 9, 10 or 11.

desktop audit means a review by an approved accreditor carried out other than in a diagnostic imaging practice to assess whether the diagnostic imaging practice meets the entry level standards or the standards in Schedule 1 or has MIAP approval.

diagnostic imaging modality means a set of diagnostic imaging procedures identified as a modality in Schedule 2.

diagnostic imaging practice means diagnostic imaging premises or a base for mobile diagnostic imaging equipment.

entry level standards means Standard 1.2, Standard 1.3 and Standard 1.4 in Schedule 1.

initial decision has the meaning given in subsection 18(1).

Medical Imaging Accreditation Program means the diagnostic imaging accreditation program that:

(a) is jointly administered by NATA and RANZCR;

(b) relates to the Version 11-2019 RANZCR standards as at 30 June 2019; and

MIAP approval means accreditation under the Medical Imaging Accreditation Program.

MIAP expiry date means the date the diagnostic imaging practice's MIAP approval is due to end as most recently evidenced under subsection 11(2).

NATA means the National Association of Testing Authorities Australia, Australian Company Number 004 379 748.

previous instrument means the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010.

prior accreditation has the meaning given in section 8.

RANZCR means The Royal Australian and New Zealand College of Radiologists, Australian Company Number 000 029 863.

re-accreditation has the meaning given in section 8.

reconsideration decision has the meaning given in subsection 18(4).

responsible accreditor has the meaning given in section 7.

(2) Unless the contrary intention appears, the standards in Schedule 1 apply in relation to a diagnostic imaging practice to the extent that services provided at the diagnostic imaging practice are diagnostic imaging services in respect of which a Medicare benefit is or is expected to be payable.

7 Responsible accreditor

(1) The responsible accreditor for a diagnostic imaging practice is:

(a) the approved accreditor who last granted the diagnostic imaging practice accreditation under this instrument; or

(b) if, since the diagnostic imaging practice was last accredited under this instrument, the proprietor or an approved accreditor has notified Services Australia that an approved accreditor is the responsible accreditor for the diagnostic imaging practice, the approved accreditor last notified to Services Australia.

(2) Where:

(a) immediately before the end of the day on 31 March 2019 a diagnostic imaging practice was accredited under the diagnostic imaging accreditation scheme established by the previous instrument; and

(b) the approved accreditor who granted that accreditation is approved to accredit diagnostic imaging practices under this instrument,

that approved accreditor is the responsible accreditor for the diagnostic imaging practice until an approved accreditor becomes the responsible accreditor in accordance with subsection (1).

(3) The proprietor of a diagnostic imaging practice must ensure that the diagnostic imaging practice has a responsible accreditor at all times while it is accredited under this instrument.

8 When application can be made for re-accreditation

(1) Where a diagnostic imaging practice is accredited under section 9, 10 or 11 (prior accreditation), it may apply for further accreditation under section 10 or 11 (re-accreditation) before the expiry date of the prior accreditation.

(2) Where the application for further accreditation is made more than 6 months before the expiry date of the prior accreditation, the re-accreditation must commence within 6 months after the application date.

(3) If a diagnostic imaging practice that has prior accreditation is granted re-accreditation before the expiry date of the prior accreditation, the prior accreditation ceases when the re-accreditation takes effect.

9 Accreditation against entry level standards

Accreditation

(1) The diagnostic imaging practice is an entry level practice if it has not had at any time accreditation under:

(a) this section or section 10 or 11; or

(b) section 8, 9 or 10 of the previous instrument; or

(c) the diagnostic imaging accreditation scheme established by the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008.

(2) The proprietor of an entry level practice may apply to an approved accreditor for accreditation of the diagnostic imaging practice under this section.

(3) In considering whether or not to grant accreditation under this section the approved accreditor must assess the application against the entry level standards.

(4) The approved accreditor must grant accreditation under this section if satisfied that the diagnostic imaging practice meets the entry level standards.

(5) The proprietor of a diagnostic imaging practice that has accreditation under this section must:

(a) ensure that the diagnostic imaging practice complies with the entry level standards; and

(b) provide to the responsible accreditor the required evidence in relation to the entry level standards as specified in Schedule 1 on request by the responsible accreditor from time to time.

Revocation

(6) Where a diagnostic imaging practice that has accreditation under this section does not continue to meet the entry level standards or satisfy a condition of accreditation, the proprietor must notify the responsible accreditor immediately after the proprietor becomes aware of the failure to meet the entry level standards or the condition of accreditation.

(7) Where a diagnostic imaging practice has been accredited under this section for a period of two years, the responsible accreditor must revoke the accreditation of the diagnostic imaging practice.

10 Accreditation against standards

Accreditation

(1) The proprietor of a diagnostic imaging practice may apply to an approved accreditor for accreditation of the diagnostic imaging practice under this section.

(2) In considering whether or not to grant accreditation under this section the approved accreditor must assess the application against the standards in Schedule 1.

(3) The approved accreditor must grant accreditation under this section if satisfied that the diagnostic imaging practice meets the standards in Schedule 1.

(4) The proprietor of a diagnostic imaging practice that has accreditation under this section must:

(a) ensure that, at all times, the diagnostic imaging practice complies with the standards in Schedule 1; and

(b) provide to the responsible accreditor the required evidence as specified in Schedule 1 on request by the responsible accreditor from time to time.

Revocation

(5) Where a diagnostic imaging practice that has accreditation under this section does not continue to meet the standards in Schedule 1 or satisfy a condition of accreditation, the proprietor must notify the responsible accreditor immediately after the proprietor becomes aware of the failure to meet the standards in Schedule 1 or the condition of accreditation.

(6) Where:

(a) a diagnostic imaging practice has accreditation under this section; and

(b) four years have passed since the diagnostic imaging practice was last accredited,

the responsible accreditor must revoke the accreditation of the diagnostic imaging practice.

11 Accreditation based on Medical Imaging Accreditation Program

Accreditation

(1) The proprietor of a diagnostic imaging practice that has MIAP approval may apply to an approved accreditor for accreditation of the diagnostic imaging practice under this section.

(2) The approved accreditor must grant accreditation under this section if the proprietor provides the approved accreditor with a document evidencing:

(a) that the diagnostic imaging practice has MIAP approval; and

(b) the date the diagnostic imaging practice's MIAP approval is due to end.

(3) The proprietor of a diagnostic imaging practice that has accreditation under this section must ensure that the diagnostic imaging practice complies with the standards and requirements of the Medical Imaging Accreditation Program.

Notification

(4) The proprietor of the diagnostic imaging practice must notify the responsible accreditor of any renewal, revocation, lapsing, suspension or variation of the diagnostic imaging practice's MIAP approval.

(5) Where a diagnostic imaging practice that has accreditation under this section does not continue to satisfy a condition of accreditation, the proprietor must notify the responsible accreditor immediately after the proprietor becomes aware of the failure to meet the condition of accreditation.

Revocation, variation and suspension

(6) Where:

(a) a diagnostic imaging practice has accreditation under this section; and

(b) the diagnostic imaging practice's MIAP approval lapses or is revoked under the Medical Imaging Accreditation Program,

the responsible accreditor must revoke the accreditation of the diagnostic imaging practice.

(7) Where:

(a) a diagnostic imaging practice has accreditation under this section; and

(b) the diagnostic imaging practice's MIAP approval is varied or suspended under the Medical Imaging Accreditation Program,

the responsible accreditor must vary or suspend, as the case may be, the accreditation of the diagnostic imaging practice.

(8) Where a diagnostic imaging practice has accreditation under this section on the MIAP expiry date, the responsible accreditor must revoke the accreditation of the diagnostic imaging practice.

12 Applications for accreditation

(1) This section applies to an application for accreditation made under section 9, 10 or 11.

Application

(2) An application must:

(a) be made in writing to an approved accreditor; and

(b) be lodged by the proprietor of the diagnostic imaging practice or an employee of the proprietor; and

(d) specify the diagnostic imaging practice that is to be granted accreditation; and

(e) specify the diagnostic imaging modalities for which the diagnostic imaging practice is to be granted accreditation.

(3) An applicant must provide the approved accreditor with such information as the approved accreditor reasonably requires in support of the application.

(4) An application must authorise the approved accreditor:

(a) to check the accuracy of the information provided by whatever means the approved accreditor sees fit; and

(b) to store and use the information for the purposes of Division 5 of Part IIB of the Act and for the purposes of this instrument.

Decision

(5) The approved accreditor must decide an application for accreditation in accordance with this instrument by:

(a) granting accreditation to the diagnostic imaging practice for the diagnostic imaging modalities for which accreditation was sought, with or without conditions; or

(b) granting accreditation to the diagnostic imaging practice for only some of the diagnostic imaging modalities for which accreditation was sought, with or without conditions; or

(6) The approved accreditor must assess an application for accreditation in accordance with the section under which accreditation is being sought.

(7) Without limiting subsection (5), the conditions referred to in paragraphs (5)(a) and (b) may include a condition requiring the proprietor of the diagnostic imaging practice to notify the responsible accreditor of any changes that occur relating to the certifications or approvals affecting the diagnostic imaging practice, staff or equipment.

Notification

(8) As soon as practicable after deciding an application, the approved accreditor must notify the applicant in writing of the decision setting out:

(a) the decision (specifying any conditions imposed); and

(b) the reasons for the decision; and

(d) if the diagnostic imaging practice is granted accreditation for some or all of the diagnostic imaging modalities referred to in the application:

(i) the date from which the diagnostic imaging practice is accredited; and

(ii) the diagnostic imaging modalities for which accreditation is granted.

13 Diagnostic imaging modalities

(1) It is a condition of accreditation under this instrument that the proprietor of the diagnostic imaging practice notifies the responsible accreditor of any change in the diagnostic imaging modalities carried out by the diagnostic imaging practice.

(2) After a diagnostic imaging practice has been granted accreditation the responsible accreditor may make a decision to vary a diagnostic imaging practice's accreditation so that the diagnostic imaging practice is accredited for additional or fewer diagnostic imaging modalities by written notice to the proprietor that sets out:

(a) the diagnostic imaging modalities for which the diagnostic imaging practice is accredited; and

(b) the reasons for the variation; and

14 Conditions of accreditation

(1) After a diagnostic imaging practice has been granted accreditation the responsible accreditor may impose conditions of accreditation on the diagnostic imaging practice by written notice to the proprietor that sets out:

(a) the terms of the conditions; and

(b) the reasons for imposing the conditions; and

Note: The power to impose a further condition after the grant of accreditation may be utilised where, for example, a diagnostic imaging practice loses a staff member with technical expertise and it is important that the diagnostic imaging practice recruits a replacement staff member with appropriate skills, training and experience.

(2) It is a condition of accreditation under this instrument that the proprietor of the diagnostic imaging practice permits the responsible accreditor to, at any time:

(a) access and inspect the premises and equipment of the diagnostic imaging practice;

(b) access, inspect and copy documents, materials, books and records, however stored, in the custody or under the control of the proprietor, its officers, employees, agents or contractors; and

for the purpose of the responsible accreditor determining whether the diagnostic imaging practice meets, or continues to meet, requirements for accreditation under this instrument.

15 Fees

(1) Subject to subsections (2) and (3), an approved accreditor may charge proprietors the following fees for services the approved accreditor provides to diagnostic imaging practices:

(a) fees for work performed in receiving and processing applications under this instrument;

(b) fees for undertaking desktop audits;

(d) fees for re-issuing accreditation certificates.

(2) An approved accreditor may not charge a separate fee for:

(a) work performed in considering taking action, or taking action, under section 16; or

(b) work performed in receiving and processing an application for reconsideration under section 18.

(3) When charging fees, an approved accreditor must not discriminate against a diagnostic imaging practice on the basis of its geographic location.

16 Variation, suspension or revocation of accreditation

(1) Subsections (2), (3) and (4) apply where one or more of the following events (an adverse event) occurs:

(a) the responsible accreditor considers that a diagnostic imaging practice that has accreditation under section 9 may no longer meet the entry level standards;

(b) the responsible accreditor considers that a diagnostic imaging practice that has accreditation under section 10 may no longer meet the standards in Schedule 1;

(c) the responsible accreditor considers that the proprietor of a diagnostic imaging practice that has accreditation under section 9, 10 or 11 may have breached or not fulfilled a condition of accreditation;

(d) the responsible accreditor becomes aware that a diagnostic imaging practice that was given accreditation under section 9 was not an entry level practice.

(2) Where subsection (1) applies, the responsible accreditor must give the proprietor notice in writing giving details of:

(a) the adverse event or events to which the notice relates; and

(b) any material taken into account by the responsible accreditor in forming the view referred to in subsection (1),

and allow the proprietor 28 days after receiving the notice to make written submissions, including in relation to rectification of the adverse event.

(3) Within 28 days after the end of the 28 day period referred to in subsection (2) and after considering any written submissions made by the proprietor under subsection (2), the responsible accreditor, if satisfied that the standards are not met or that a condition of accreditation has been breached or not fulfilled or that the diagnostic imaging practice was not an entry level practice, must require the proprietor to rectify the breach of the standards or the failure to comply with the condition or make a new application under section 10 or 11, as the case may be, within a nominated period.

(4) If, after requiring the proprietor under subsection (3) to rectify the breach of the standards or breach or non-fulfilment of the condition or make a new application within a nominated period, the responsible accreditor is satisfied that the adverse event has occurred and has not been rectified, then the responsible accreditor must make a decision to vary, suspend or revoke the accreditation of the diagnostic imaging practice.

(5) In spite of anything in subsections (1), (2), (3) or (4), the responsible accreditor may make a decision to immediately vary, suspend or revoke an accreditation where the responsible accreditor considers that there is a potential danger to public health or safety if the accreditation is not varied, suspended or revoked.

(6) Where the responsible accreditor makes a decision to:

(a) vary or suspend the accreditation of a diagnostic imaging practice under subsection (4) or (5) or under subsection 11(7); or

(b) revoke the accreditation of a diagnostic imaging practice under this instrument,

the responsible accreditor must notify the proprietor in writing of the decision setting out:

(d) the reasons for the decision; and

(e) a statement of the proprietor's reconsideration rights under section 18.

17 Date of effect of decisions

(1) Subject to subsection (2), a decision made under this instrument by an approved accreditor (including a reconsideration decision) takes effect on the day specified in the decision or, if a day is not specified, on the day on which the decision is made.

(2) The following decisions (whether initial decisions or reconsideration decisions) do not take effect until the proprietor's rights to reconsideration by the responsible accreditor under section 18 (if any) and by the Minister in accordance with section 23DZZIAD of the Act are exhausted or have expired:

(a) a decision to impose a condition of accreditation under subsection 12(5) or 14(1) (other than a decision made on the ground that there is a potential danger to public health or safety if the condition is not imposed);

(b) a decision to refuse to grant accreditation to a diagnostic imaging practice that already has accreditation;

(c) a decision to grant, to a diagnostic imaging practice that already has accreditation, accreditation for only some of the diagnostic imaging modalities for which accreditation was sought;

(d) a decision to vary accreditation so that a diagnostic imaging practice is accredited for fewer diagnostic imaging procedures;

(e) a decision to suspend accreditation in whole or in part; and

(f) a decision to revoke accreditation in whole or in part (other than a decision made on the ground that there is a potential danger to public health or safety if the accreditation is not revoked).

18 Reconsideration of decisions

(1) If an approved accreditor makes a decision under this instrument in relation to a diagnostic imaging practice (initial decision), the proprietor may apply to the approved accreditor who made the initial decision for reconsideration of the initial decision.

(2) The application must be made in writing:

(a) within 28 days after the date of the initial decision; or

(b) if the approved accreditor is satisfied that special circumstances exist, within such further period (if any) as the approved accreditor, either before or after the expiration of that period, allows.

(3) The proprietor must set out the reasons for the application and, in doing so, may provide new material for the approved accreditor to consider.

(4) An approved accreditor:

(a) must, within 28 days after receipt of an application made in accordance with subsection (1); and

(b) may, on its own motion, whether or not the proprietor has applied for reconsideration,

reconsider the initial decision and make a new decision (reconsideration decision):

(d) varying the initial decision; or

(e) setting aside the initial decision and making a decision in substitution for it.

(5) The approved accreditor must give a proprietor notice in writing of a reconsideration decision setting out:

(a) the decision;

(b) the reasons for the decision;

19 Transitional provisions

Accreditation under the previous instrument continues

(1) Where a diagnostic imaging practice was, immediately before the commencement of this instrument, accredited under section 8, 9 or 10 of the previous instrument, the practice is taken to have been accredited under the corresponding provision of this instrument:

(a) with the same end date; and

(b) for the same diagnostic imaging modalities; and

(d) if at that time the accreditation was under suspension, subject to the same suspension;

as under the previous instrument.

Application for accreditation made under previous instrument to be determined under that instrument

(2) Where:

(a) the proprietor of a diagnostic imaging practice applied to an approved accreditor for accreditation of a diagnostic imaging practice under the previous instrument; and

(b) the approved accreditor had not yet decided the application immediately before the commencement of this instrument;

the approved accreditor must:

(c) determine the application in accordance with the standards in force under the previous instrument immediately before the commencement of this instrument.

Reconsideration of decisions under previous instrument

(3) Where:

(a) an approved accreditor made a decision under the previous instrument in relation to a diagnostic imaging practice; and

(b) the proprietor made an application to the approved accreditor for reconsideration of the approved accreditor’s decision; and

the approved accreditor must reconsider the earlier decision and make a new decision in accordance with the standards in force under the previous instrument immediately before the commencement of this instrument.

Schedule 1— Diagnostic Imaging Accreditation Scheme – Standards

(sections 9 and 10)

Part 1—Organisational Standards

Standard 1.1 Safety and Quality Manual Standard

The diagnostic imaging practice must prepare a comprehensive Safety and Quality Manual that includes all diagnostic imaging accreditation scheme (DIAS) related policies and addresses DIAS standards, including the title and /or names of the persons at the diagnostic imaging practice who develop, approve, implement, maintain, and review these policies.

Required Evidence

A documented Safety and Quality Manual for the diagnostic imaging practice which addresses the practice’s:

• governance, policies and procedures regarding DIAS (Standard 1.1);

• registration and licensing of personnel (Standard 1.2);

• radiation safety and optimised radiation technique charts (Standards 1.3 and 3.2);

• diagnostic imaging equipment and servicing (Standards 1.4 and 1.5);

• healthcare associated infection policies and procedures (Standard 1.6);

• provision of diagnostic imaging services and reporting and recording image findings policies (Standards 2.1, 4.1 and 4.2);

• consumer consent and information policies (Standard 2.2);

• patient identification and procedure matching policies (Standard 2.3);

• medication management policies (Standard 2.4);

• diagnostic imaging protocols (Standard 3.1); and

• consumer and stakeholder feedback and complaints policies (Standard 4.3).

Evidence which demonstrates that mechanisms are in place to evaluate, audit, review and monitor each one of the Standards and their specific requirements.

Standard 1.2 Registration and Licensing Standard (Entry Level Standard)

Staff, students, contractors or locums and any other practitioner eligible to provide or assist in the provision of diagnostic imaging services to the practice must provide evidence of and maintain all appropriate and current registration and/or licences to undertake diagnostic imaging procedures.

Required Evidence

Copies of each registered health practitioner's Australian Health Practitioner Regulation Agency (AHPRA) registration documentation, or an AHPRA registration number which can be verified on the public register. These practitioners include:

• medical practitioners;

• dentists;

• medical radiation practitioners;

• nurses; and

• allied health practitioners (including podiatrists, osteopaths, chiropractors and physiotherapists).

Copies of the AHPRA registration documentation of each student who is registered on the AHPRA student register.

Where the practice provides imaging modalities that involve ionising radiation, copies of each registered health practitioner's Commonwealth, State or Territory radiation user licence (or similar), or a registration number which can be verified on the public register, if required in the relevant jurisdiction.

Copies of each non-registered health practitioner's Commonwealth, State or Territory radiation use licence, or a licence number which can be verified, if required in the relevant jurisdiction.

Where the practice provides ultrasound services, copies of each sonographer's statement of accreditation on the Australian Sonographer Accreditation Register (ASAR) or a registration number which can be verified on the ASAR register for the purpose of determining registration on the Services Australia Register of Sonographers.

Evidence that the registration status of practitioners is reviewed annually, in line with AHPRA's annual registration process.

Standard 1.3 Radiation Safety Standard (Entry Level Standard)

Where a diagnostic imaging practice uses ionising radiation, the practice must comply with the requirements of the relevant Commonwealth, State or Territory radiation safety legislation.

Required Evidence

Copies of relevant Commonwealth, State or Territory Radiation Safety Regulator equipment licences and registrations (or similar) or registration numbers which can be verified.

Copies of radiation safety plans and all other relevant radiation safety documents required by Commonwealth, State or Territory radiation safety legislation, with evidence that they are reviewed a minimum of once per accreditation cycle.

Standard 1.4 Equipment Inventory Standard (Entry Level Standard)

The diagnostic imaging practice must maintain a current diagnostic imaging equipment inventory demonstrating that relevant equipment used to provide diagnostic imaging services is registered with Services Australia and complies with specifications in the Health Insurance Act 1973 and the Health Insurance Regulations 2018.

Required Evidence

A current, documented equipment inventory which includes:

• the name of item;

• manufacturer; and

• serial number (or other identifier).

A copy of the most recent DHS Location Specific Practice Number (LSPN) register equipment record.

Standard 1.5 Equipment Servicing Standard

The diagnostic imaging practice must demonstrate that equipment used to acquire, manipulate, print or report images for diagnostic imaging procedures is safe and appropriate for its intended use.

Required Evidence

Records and service reports, demonstrating the equipment used to provide images is serviced according to manufacturer’s guidelines by qualified persons and the requirements of applicable radiation safety legislation, including the:

• date of service, details and results of the service and the date of the next service; and

• actions taken at the practice in response to the results of the service.

A record of the service provider’s qualifications is to be provided to the approved accreditor, however they do not need to appear on every service report. The service provider shall:

• hold a radiation use licence (or similar) for service and repair (if servicing ionising radiation equipment) issued by the Commonwealth, State or Territory regulator relevant to where the service is performed; and

• provide evidence of successful completion of a recognised service training course appropriate to the equipment being serviced.

NOTE:

A “service” in this context refers to “maintenance carried out at predetermined intervals, or according to prescribed criteria, and intended to reduce the probability of failure or the degradation of the functioning of an item” (AS/NZS 3551:2012 §1.4.36). A breakdown repair is not a service. The service frequency would normally be as defined by the medical equipment manufacturer however a variation can exist “supported by a documented rationale for the deviation” (AS/NZS 3551:2012 §6.4.2).

Standard 1.6 Healthcare Associated Infection Standard

The diagnostic imaging practice must mitigate the risk of the transmission of infectious agents to patients, carers, healthcare workers, support staff and other visitors, by:

identifying, assessing and managing and reporting the risk of the transmission of infectious agents;

meeting the requirements specified in infection control guidelines/policies produced by Commonwealth, State and Territory government authorities;

reporting, investigating, and responding to incidents at the diagnostic imaging practice arising from the transmission of infectious agents; and

ensuring consumer-specific information on the management and reduction of healthcare associated infections is available at the point of care.

Required Evidence

A documented policy and procedure for preventing the transmission of infectious agents to patients and carers, healthcare workers, support staff and other visitors which includes the process for identifying, assessing and managing risks and reporting, investigating and responding to the transmission of infectious agents when they occur. (Standard 1.1)

Where relevant, documented quality improvement activities, which describe the actions taken in response to the transmission of an infectious agent(s).

Where ultrasound services are being provided, a documented policy for reprocessing ultrasound transducers that is consistent with national standards and guidelines relating to disinfection.

Copies of consumer-specific information on the management and reduction of healthcare associated infections.

Part 2—Pre-procedure standards

Standard 2.1 Provision of Service Standard

The diagnostic imaging practice must demonstrate that diagnostic imaging services are only undertaken where there is an identified clinical need and:

upon receipt of an appropriate request from a medical practitioner or a practitioner who is able under the Health Insurance Act 1973 to request services of that kind as a service for which a Medicare benefit is payable; or

where the providing and reporting practitioner self-determines the service in accordance with requirements of the Health Insurance Act 1973.

Required Evidence

For practitioners providing requested services:

• the practice must have a documented policy and procedure in response to inappropriate requests for diagnostic imaging procedures. (Standard 1.1)

• a sample of de-identified requests documenting the clinical need for the diagnostic imaging procedures rendered at the diagnostic imaging practice.

For practitioners providing self-determined services:

• a sample of de-identified records documenting clinical need.

Standard 2.2 Consumer Consent and Information Standard

Prior to a diagnostic imaging procedure being rendered, except in cases of emergency, the diagnostic imaging practice must ensure that:

patients have access to information about the diagnostic imaging procedure;

risks are advised to the patient or substitute decision maker;

practice staff obtain and record relevant information about the patient’s health status and individual patient risk factors;

consent for each diagnostic imaging procedure is obtained from the patient or the substitute decision maker; and

patient consent requirements reflect the risk attached to the diagnostic imaging procedure.

Required Evidence

A documented policy and procedure for obtaining patient consent prior to a diagnostic imaging procedure being provided, ensuring that the consent requirements reflect the level of risk attached to each procedure. It is expected that practices obtain written patient consent prior to invasive or high risk procedures. (Standard 1.1)

A sample of de-identified records of consent obtained from the patient in respect of the diagnostic imaging procedure.

A sample of de-identified records documenting the patient’s health status, relevant to the diagnostic imaging procedure being undertaken, with regard to:

- asthma;

- previous exposure to intravenous contrast;

- allergies;

- medical conditions such as diabetes, kidney disease or heart disease;

- pregnancy status;

- medications such as metformin hydrochloride;

- breastfeeding; and

- medical devices and implanted devices such as intra- cranial aneurysm clips, cardiac pacemaker, coronary stents, intra ocular foreign bodies and cochlear implants.

Examples of service specific information for the diagnostic imaging services available at the practice.

A sample of de-identified records must be provided which demonstrate that risks have been advised to the patient.

Standard 2.3 Patient Identification & Procedure Matching Standard

The diagnostic imaging practice must ensure that all patients are correctly identified and matched to their intended procedure or treatment by:

using at least three (3) approved patient identifiers to match a patient to their request or medical record from the time the patient presents and through all stages of the diagnostic imaging service and when transferring responsibility of care;

correctly matching patients with their intended diagnostic imaging service and the anatomical site and side (if applicable) of the diagnostic imaging procedure;

utilising the 'time-out' technique for high risk procedures, including confirming the patient’s allergy status; and

reporting, investigating, and responding to patient care mismatching events when they occur and implementing changes, where relevant, to reduce the risk of future incidents.

Required Evidence

A documented policy and procedure for matching patients to their intended diagnostic imaging procedure including the report for that procedure, through all stages of the service and when transferring responsibility of care. (Standard 1.1)

A sample of appropriately de-identified records documenting the use of three patient identifiers.

A documented policy and procedure which sets out the process for reporting, investigating and responding to patient care mismatching events when they occur.

Where relevant, documented quality improvement activities, which describe the actions taken in response to patient care mismatching events.

Standard 2.4 Medication Management Standard

The diagnostic imaging practice must ensure that medication risks are managed by:

correctly and safely storing, preparing and disposing of medications in accordance with manufacturer’s guidelines and relevant Commonwealth, State or Territory requirements;

identifying patients at risk from adverse reactions;

administering medication safely, actively monitoring the effects of medication, and all relevant details recorded in the patient's records;

personnel capable of providing timely and appropriate care in the event of an adverse reaction to medication; and

reporting, investigating and responding to incidents arising from adverse reactions or medication mismanagement.

Required Evidence

A documented policy and procedure describing the procedures for:

- storing, preparing and disposing of medications;

- identifying at risk patients;

- administering medications safely;

- monitoring and recording the effects of medication; and

- reporting, investigating, and responding to adverse reactions or medication mismanagement incidents when they occur.

A documented management plan which identifies the procedures for managing adverse reactions at the time they occur;

• the type and location of resuscitation equipment and associated drugs at the practice; and

• the personnel certified in basic life support and qualified to use resuscitation equipment and drugs. (Standard 1.1)

Where a practice performs examinations using contrast, a documented protocol which ensures the appropriate use and administration of contrast.

A sample of de-identified records for relevant diagnostic imaging procedures documenting the information collected about the patient’s medication use and/or history regarding previous reactions to medications.

Example of records demonstrating managing adverse reactions at the time they occur.

Where relevant, documented quality improvement activities, which describe the actions taken in response to incidents related to medication management.

NOTE:

A 'medication' in this context refers to anything administered to a patient:

• to create or enhance a diagnostic quality image; and/or

• where imaging is used as part of an interventional procedure.

Part 3—Procedure standards

Standard 3.1 Diagnostic Imaging Protocol Standard

The diagnostic imaging practice must have documented protocols which describe the required projections, list of anatomy to be visualised, contrast injection requirements and/or positioning required for the acquisition of optimised quality images.

Required Evidence

Documented protocols for routine diagnostic imaging procedures or groups of diagnostic imaging procedures rendered at the diagnostic imaging practice, with evidence that they have been reviewed a minimum of once per accreditation cycle, which include all necessary information for the proper conduct of the examination taking into account any specifications for the required qualifications, experience and specialisation of the personnel. Where specific tasks are delegated to members of the imaging team, the protocols shall indicate any specific circumstances under which personnel shall seek further guidance and/or input from the supervising medical practitioner.

Standard 3.2 Optimised Radiation Technique Charts Standard

A diagnostic imaging practice which uses ionising radiation must ensure that patient radiation exposure is kept as low as reasonably achievable (ALARA) by selecting equipment and techniques for diagnostic imaging procedures sufficient to provide the required clinical information.

Required Evidence

A technique chart, consistent with the ALARA principle, for each unit of ionising radiation equipment located at the diagnostic imaging practice.

Ionising radiation equipment where settings are entered manually:

• evidence must be supplied that demonstrates the settings have been reviewed and authorised by a qualified person, annually for each episode.

Ionising radiation equipment where settings are embedded in the software and operators select a protocol:

• evidence must be supplied that demonstrates the underlying settings have been reviewed and authorised by a qualified person annually.

For each item of screening fluoroscopy equipment:

a copy of a log of screening times, and evidence that the log has been reviewed by a qualified person annually.

For each item of interventional angiography equipment:

evidence that system generated dose metrics have been logged and reviewed by a qualified person annually. If the interventional angiography equipment is not capable of generating dose metrics alternatively a copy of a log of screening times, and evidence that the log has been reviewed by a qualified person annually should be provided.

The practice must establish a program to ensure that radiation doses administered to a patient for diagnostic purposes are:

annually compared with diagnostic reference levels (DRLs) for diagnostic procedures for which DRLs have been established in Australia; and
if DRLs are consistently exceeded, reviewed to determine whether radiation protection has been optimised.

Part 4—Post procedure standards

Standard 4.1 Communicating Results and Reports Standard

The diagnostic imaging practice effectively communicates the results of a requested diagnostic imaging procedure by:

providing timely, clear and concise written reports which address the information:

• requested by the requesting practitioner;

• required by the diagnostic imaging service; and

• that is necessary for the interpretation of the images;

taking all reasonable steps to personally advise the requesting practitioner (or another practitioner where necessary) about urgent and unexpected findings; and

responding to feedback and requests from requesting practitioners about the content or provision of reports and/or advice provided.

Required Evidence

A documented policy for the provision of reports to requesting practitioners and patients. (Standard 1.1)

A sample of de-identified imaging reports, consistent with the practice’s documented policy for reporting.

Where relevant, documented quality improvement activities, which describe the actions taken in response to feedback from requesting practitioners.

Standard 4.2 Findings of Self-Determined Services Standard

When the service is a self-determined service, information about the findings of the diagnostic imaging procedure must be documented in a report and retained in the patient record.

Required Evidence

A sample of de-identified records documenting the image findings and that show that it has been retained in the patient records.

Standard 4.3 Consumer and Stakeholder Feedback and Complaints Management Standard

The diagnostic imaging practice must provide opportunities for, and respond to, feedback and complaints from consumers, requestors and all other stakeholders about the provision of a diagnostic imaging service.

Required Evidence

A documented policy for inviting, recording, managing and responding to feedback and complaints which is consistent with the principles of open disclosure and fairness, accessibility, responsiveness, efficiency and integration. (Standard 1.1)

Evidence of publicly accessible information for inviting, managing and responding to feedback and complaints which is consistent with the principles of open disclosure and fairness, accessibility, responsiveness, efficiency and integration.

Evidence of training practice staff in managing and responding to feedback and complaints.

A sample of de-identified feedback and complaints received and records of the actions taken.

Schedule 2—Diagnostic Imaging Accreditation Scheme—Diagnostic Imaging Modalities

(section 6)

A diagnostic imaging modality is one of the following groups of diagnostic imaging procedures:

Modality	Relevant items in the diagnostic imaging services table	Medicare Code
Ultrasound	All items in Group I1.	ULT
Computed Tomography	All items in Group I2.	CTG
Diagnostic Radiology including General Radiology (X-ray), Mammography, Angiography, Fluoroscopy and Orthopantomography (OPG)	All items in Group I3.	RAD
Nuclear Medicine Imaging	All items in Group I4.	NME
Magnetic Resonance Imaging (MRI)	All items in Group I5.	MRI

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Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020

I, GREG HUNT, the Minister for Health, make this legislative instrument under subsection 23DZZIAA(1) of the Health Insurance Act 1973.

Dated 23 March 2020

GREG HUNT

Minister for Health

Contents

1 Name of instrument

2 Purpose of instrument

3 Commencement

4 Authority

5 Repeal of previous instrument

6 Interpretation

7 Responsible accreditor

8 When application can be made for re-accreditation

9 Accreditation against entry level standards

10 Accreditation against standards

11 Accreditation based on Medical Imaging Accreditation Program

12 Applications for accreditation

13 Diagnostic imaging modalities

14 Conditions of accreditation

15 Fees

16 Variation, suspension or revocation of accreditation

17 Date of effect of decisions

18 Reconsideration of decisions

19 Transitional provisions

Schedule 1— Diagnostic Imaging Accreditation Scheme Standards

Part 1—Organisational Standards

Part 2—Pre-procedure standards

Part 3—Procedure standards

Part 4—Post procedure standards

Schedule 2—Diagnostic Imaging Accreditation Scheme Diagnostic Imaging Modalities

1 Name of instrument

This legislative instrument is the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020.

The instrument embeds a standards-based accreditation model with defined modalities, evidence requirements, and administrative pathways. Core concepts are:

Diagnostic imaging practice and modalities. The operative object is the diagnostic imaging practice (premises or base for mobile equipment), with modalities defined in Schedule 2 (ultrasound, CT, diagnostic radiology, nuclear medicine, MRI) and linked to the diagnostic imaging services table and Medicare codes (s 6 definition; Schedule 2).
Standards and entry-level standards. Schedule 1 contains a set of organisational, pre-procedure, procedure and post-procedure Standards. Three parts of Schedule 1 are designated as entry level standards (Standards 1.2 Registration and Licensing, 1.3 Radiation Safety, 1.4 Equipment Inventory) and are the minimum for entry level accreditation (s 9(3), Schedule 1 Part 1).
Responsible accreditor. The responsible accreditor is the approved accreditor who last granted accreditation or the one notified to Services Australia by proprietor or accreditor (s 7(1)). The proprietor must ensure a responsible accreditor is in place at all times (s 7(3)). The responsible accreditor makes decisions on variation, suspension and revocation under ss 16-17, and must follow notice and reconsideration requirements.
MIAP route. Accreditation can be granted on the basis of MIAP approval, which is defined at s 6 and described as being jointly administered by NATA and RANZCR and relating to specific RANZCR standards (s 6). Accreditation based on MIAP approval requires documentary evidence of MIAP approval and ties accreditation to MIAP expiry and variations (s 11).
Procedural protections and timelines. Applicants must apply in writing via proprietor or employee and specify the section and modalities sought; accreditors must give written reasons and reconsideration rights (s 12). Where adverse events are identified the responsible accreditor must give notice and allow 28 days for submissions, then allow 28 days after submissions to require rectification; failure to rectify can lead to variation, suspension or revocation (s 16(2)-(4)). Certain decisions do not take effect until reconsideration and Ministerial review rights are exhausted (s 17(2)).
Access and compliance powers. Conditions of accreditation include permitting the responsible accreditor to access premises, inspect equipment and copy records (s 14(2)). Schedule 1 enumerates required documentary evidence across governance, registration and licensing, radiation safety, equipment servicing, infection control, consent, procedure protocols, radiation technique charts, reporting and complaints handling.
Fees. Approved accreditors may charge specified fees for application processing, desktop audits, membership and reissuance of certificates, subject to limitations (s 15). They may not charge separate fees for work associated with enforcement or reconsideration (s 15(2)) and must not discriminate based on geographic location (s 15(3)).

These structures combine to create a regime that conditions accreditation on documentary compliance, periodic review, and an accreditation lifecycle tied to time limits and MIAP status. The instrument links accreditation outcomes to regulator-driven inspections and audits, and sets out procedural stages for notice, submissions, rectification and, ultimately, sanction.

Primary parties affected by the instrument are proprietors of diagnostic imaging practices, approved accreditors, and indirectly practitioners and patients receiving diagnostic imaging services.

Proprietors. The proprietor is the primary actor required to apply for accreditation (s 12(2)(b)) and to ensure ongoing compliance with the applicable standards after accreditation is granted (ss 9(5)(a), 10(4)(a), 11(3)). Specific ongoing obligations include maintaining evidence specified in Schedule 1 and providing it on request (ss 9(5)(b), 10(4)(b)), permitting access and inspection by the responsible accreditor (s 14(2)), notifying the responsible accreditor of changes to modalities (s 13(1)) and notifying the responsible accreditor about changes to MIAP approval (ss 11(4), 11(5)). A proprietor also bears financial cost exposure to fees allowed by approved accreditors (s 15(1)) and administrative burdens related to record keeping and evidence provision across many Standards in Schedule 1.
Approved accreditors and responsible accreditors. Approved accreditors decide applications, undertake desktop audits, inspect premises, grant, vary, suspend and revoke accreditation, and provide notice and reasons (ss 7, 12, 14, 16). The instrument defines the responsible accreditor as the last approved accreditor to grant accreditation or the accreditor notified to Services Australia (s 7). These bodies have both discretionary and mandatory powers: they must grant accreditation if satisfied (ss 9(4), 10(3), 11(2)), but they must also revoke entry level or full accreditation after specified intervals (ss 9(7), 10(6)).
Practitioners and staff. Schedule 1 imposes verification and ongoing checking requirements for practitioners: evidence of AHPRA registration, sonographer accreditation, radiation use licences or registration numbers, and annual review of registration status (Standard 1.2). Personnel are affected by policies for infection control, consent, procedure protocols, medication management, and the requirement for appropriately qualified staff to supervise or perform tasks (Schedule 1 Standards).
Suppliers and service providers. Equipment service providers must provide records and demonstrate qualifications under Standard 1.5, and the practice must maintain an equipment inventory and service logs (Standards 1.4, 1.5). For practices using ionising radiation, technical staff must maintain technique charts and dose logs (Standard 3.2). These requirements create demand for compliant maintenance and record-keeping services.
Patients and requesting practitioners. The Standards specify obligations around consent (Standard 2.2), patient identification (Standard 2.3), reporting and communication of results (Standards 4.1-4.2), and complaints handling (Standard 4.3). While the instrument does not directly create private rights of action, it mandates processes and documentation that affect patient experience and clinical governance.
MIAP participants. Practices with MIAP approval interact with the instrument by providing MIAP evidence to an approved accreditor (s 11(2)), keeping MIAP approval current, and notifying accreditors of MIAP changes (s 11(4)). MIAP-approved practices are subject to automatic revocation if MIAP approval lapses or expires (ss 11(6), 11(8)).

The instrument also references other regulatory regimes and organisations, such as AHPRA, Commonwealth/State/Territory radiation safety regulators, NATA and RANZCR. Those entities are indirectly implicated because evidence and compliance with their licences, authorisations, and standards are required under Schedule 1 (e.g. Standard 1.2, Standard 1.3, Standard 1.5).

Duties and rights are set out primarily in ss 9-16 and Schedule 1. They include:

Duties of proprietors

Apply for accreditation in writing by proprietor or employee, specifying the section and modalities, and provide required supporting information; authorise accreditor to verify and store information (s 12(2)-(4)).
Ensure ongoing compliance with the standards relevant to the type of accreditation: entry level (s 9(5)(a)), full standards (s 10(4)(a)), or MIAP requirements (s 11(3)).
Provide evidence specified in Schedule 1 on request, including governance manuals, practitioner registrations and licences, equipment inventories and service logs, infection control policies, consent records, protocols, technique charts, reporting examples and complaints records (ss 9(5)(b), 10(4)(b); Schedule 1).
Permit the responsible accreditor to access and inspect premises, equipment and records and to require information at any time (s 14(2)).
Notify the responsible accreditor of changes to modalities (s 13(1)) and, for MIAP-based accreditation, of renewal, revocation, lapsing, suspension or variation of MIAP approval (s 11(4)) and of breaches of conditions or failures to meet standards (ss 9(6), 10(5), 11(5)).

Rights of proprietors

To written reasons and notification of reconsideration rights when an accreditor decides an application or imposes conditions, varies accreditation or revokes or suspends accreditation (s 12(8); s 14(1); s 16(6)).
To seek reconsideration from the accreditor who made the initial decision within 28 days, and the right to provide new material and seek extensions where special circumstances exist (s 18(1)-(3)).
Where an initial decision is subject to reconsideration and Ministerial review rights, certain adverse decisions do not take effect until those rights are exhausted (s 17(2)).

Duties and powers of approved accreditors and responsible accreditors

Decide applications in accordance with the instrument and grant accreditation if satisfied the standards are met (s 12(5)-(6); ss 9(4), 10(3), 11(2)).
Assess against the entry level or full Standards as applicable (ss 9(3), 10(2)).
Grant, refuse, grant for some modalities, or impose conditions (s 12(5)). Conditions may require notification of certification or approval changes (s 12(7)) and may be imposed after grant via written notice with reasons and reconsideration rights (s 14(1)).
Require rectification following notice of an adverse event, allow specified periods for submissions and rectification, and vary, suspend or revoke accreditation where rectification does not occur (s 16(2)-(4)).
Immediate suspension, variation or revocation is allowed if there is a potential danger to public health or safety (s 16(5)). When decisions are made accreditors must provide reasons and reconsideration rights (s 16(6)).
Charge specified fees subject to limitations and non-discrimination by geography (s 15).

Procedural safeguards

Written notice, reasons and statement of reconsideration rights must be provided for decisions and variations (s 12(8); s 14(1); s 16(6); s 18(5)).
Reconsideration processes exist before an accreditor, with timelines (s 18). The instrument refers to Ministerial review rights under the Act (s 17(2)(c) and s 18(5)(c)), showing a further tier of administrative review available under the Health Insurance Act 1973.

Specific standards-based obligations

Maintain a Safety and Quality Manual covering all Standards (Schedule 1 Standard 1.1).
Ensure practitioner registration, licences and sonographer accreditation are current and reviewed annually (Standard 1.2).
Comply with relevant radiation safety legislation and maintain relevant licences and safety plans (Standard 1.3).
Maintain an equipment inventory and ensure devices are serviced to manufacturer and regulator requirements with records and qualified service providers (Standards 1.4-1.5).
Maintain policies and records for infection control, consent, patient identification, medication management, imaging protocols, technique charts and dose monitoring, reporting and complaints handling (Schedule 1 Parts 2-4).

These duties and rights establish a compliance architecture based on documentary evidence, inspections and procedural fairness through notice and reconsideration processes.

The instrument does not create criminal penalties or civil fines within its text. Enforcement is administrative and operates through accreditation status, conditions, inspection and information powers, and procedural steps leading to variation, suspension or revocation. The primary enforcement mechanisms are:

Variation, suspension and revocation. Where an adverse event is identified (defined at s 6(1) and outlined in s 16(1)), the responsible accreditor must notify the proprietor, give 28 days for written submissions, and may require rectification or a new application (s 16(2)-(3)). Failure to rectify within the nominated period authorises the responsible accreditor to vary, suspend or revoke accreditation (s 16(4)). Entry-level accreditations are automatically revoked after two years (s 9(7)); full accreditations are revoked if four years have passed since last accreditation (s 10(6)). MIAP-based accreditation is revoked when MIAP approval lapses or on MIAP expiry (ss 11(6), 11(8)). These administrative sanctions affect a practice’s accredited status.
Immediate action for public health or safety. The responsible accreditor may immediately vary, suspend or revoke accreditation if it considers there is a potential danger to public health or safety if the accreditation is not varied, suspended or revoked (s 16(5)). Decisions made on this basis take effect immediately rather than being stayed pending reconsideration (cf. s 17(2) exceptions).
Access and information powers. Conditions of accreditation permit the responsible accreditor to access and inspect premises and equipment and to inspect and copy documents and require information from the proprietor or associated persons at any time (s 14(2)). Non-cooperation would be a breach of a condition of accreditation and may trigger enforcement steps under s 16.
Procedural protections that limit immediate effect. Many adverse decisions do not take effect until reconsideration and Ministerial review rights are exhausted (s 17(2)). Those categories include refusals to grant accreditation to an already accredited practice, variations resulting in fewer modalities, suspensions and revocations (s 17(2)(b)-(f)). This matters operationally because an accreditor’s power to remove accreditation is counterbalanced by procedural stays pending reconsideration.
Financial measures. Approved accreditors may charge fees for applications, desktop audits and other specified services (s 15(1)). They may not charge separate fees for enforcement action or for reconsideration applications (s 15(2)). The instrument also forbids geographic discrimination in fee setting (s 15(3)). Non-payment of fees is not expressly tied to automatic revocation in the instrument, but fees are a cost of participation and failure to pay may be addressed contractually or under accreditation conditions.

The instrument therefore relies on administrative levers, inspection and documentary compliance rather than on embedding pecuniary penalties or criminal sanctions within its own text. The practical enforcement consequence of adverse findings is loss or limitation of accreditation, which may affect a practice’s ability to operate in contexts where accreditation is required by funders or other regimes. The instrument also references other statutory licences and approvals (e.g. radiation safety licences, AHPRA registrations) that have their own enforcement regimes; failure to maintain those licences is captured as non-compliance with the Standards (Schedule 1) and may lead to accreditation action under this instrument (Standards 1.2-1.3).

The instrument is explicitly linked to and anticipates interaction with several other statutory and regulatory frameworks.

Health Insurance Act 1973. The instrument is made under subsection 23DZZIAA(1) of the Health Insurance Act 1973 (s 4). Terms defined in the Act are used throughout (s 6 note and definition list) including “approved accreditor”, “diagnostic imaging services table”, “Medicare benefit” and “proprietor”. The instrument applies to services that are diagnostic imaging services in respect of which a Medicare benefit is or is expected to be payable, insofar as Schedule 1 applies to such services (s 6(2)). The instrument references ministerial review rights under the Act (s 17(2)(c) and s 18(5)(c)), indicating a statutory appeals layer beyond accreditor reconsideration.
Medical Imaging Accreditation Program. The instrument accepts MIAP approval as a basis for accreditation (s 11). MIAP is defined as a joint program administered by NATA and RANZCR and linked to RANZCR Version 11-2019 standards (s 6). Accreditation granted under s 11 is conditional on the practice complying with MIAP standards and is automatically tied to MIAP approval duration; variation or suspension under MIAP must be notified and will trigger corresponding variation, suspension or revocation under this instrument (ss 11(3)-(7)). Thus the MIAP regime is effectively ported into this instrument as a delegated path to accreditation.
State, Territory and Commonwealth radiation safety legislation. Schedule 1 requires compliance with relevant radiation safety legislation where ionising radiation is used (Standard 1.3). Required evidence includes radiation safety plans and licences issued by Commonwealth, State or Territory regulators (Standard 1.3). Equipment servicing requirements reference radiation use licences for service providers (Standard 1.5). Therefore an operator’s obligations under radiation safety law feed into the accreditors’ assessment.
Professional registration regimes. Schedule 1 requires evidence of AHPRA registration, sonographer accreditation on ASAR, and other practitioner licences or registration numbers (Standard 1.2). These external registers form part of evidentiary checks that approved accreditors may carry out; the application must authorise accreditors to check information by any means (s 12(4)(a)).
Services Australia processes. The responsible accreditor can be the approved accreditor notified to Services Australia (s 7(1)(b)), and equipment inventory evidence includes the DHS Location Specific Practice Number (LSPN) register equipment record (Standard 1.4). The instrument therefore interacts directly with Services Australia record keeping and registration systems.
Legislative Instruments Act 2003. The instrument states that expressions used have the same meaning as in the Act unless a contrary intention appears, cross-referencing s 13 of the Legislative Instruments Act 2003 (s 6 note).

These interactions mean compliance with this instrument often requires corresponding compliance with other statutory duties. For example, failure to maintain AHPRA registration or radiation licences will show up as non-compliance with Schedule 1, which can ground accreditation sanctions under s 16. Similarly, MIAP decisions and accreditor actions are coordinated: MIAP lapsing triggers revocation under s 11(6), and MIAP variations/suspensions require notification and will lead to parallel accreditation actions (ss 11(4), 11(7)).

The instrument also structures administrative review by cross-referencing the appeals and reconsideration framework under the Health Insurance Act 1973. Certain accreditor decisions do not take effect until reconsideration and Ministerial review avenues are exhausted (s 17(2)), integrating this instrument into the broader administrative law framework relating to accreditation under the Act.

The instrument records a single explicit change to the prior legislative architecture: it repeals the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010 (s 5) and commences on 1 April 2020 (s 3). The definitions include “previous instrument” to denote the 2010 Instrument, and the transitional provisions in s 19 preserve existing accreditations and pending processes from the previous instrument into the new regime.

Key transitional mechanics are:

Continuity of accreditation. For practices accredited under the previous instrument immediately before commencement, the practice is taken to have been accredited under the corresponding provision of this instrument with the same end date, modalities, conditions and any suspensions carried across (s 19(1)).
Pending applications and reconsiderations. Applications made under the previous instrument but undecided at commencement must be determined under the standards in force under the previous instrument immediately before commencement (s 19(2)(c)). Similarly, applications for reconsideration that were pending immediately before commencement must be reconsidered under the then-applicable previous standards (s 19(3)).
Responsible accreditor transitional rule. Where a practice was accredited under the previous instrument immediately before 31 March 2019 and the accreditor who granted accreditation is approved under this instrument, that accreditor remains the responsible accreditor until changed under the rules in s 7(1) (s 7(2)).

The instrument does not record any subsequent amendments or repeal dates beyond the repeal of the prior instrument. There is no schedule of policy changes in a legislative amendment history beyond what the instrument itself contains. The instrument defines MIAP with reference to RANZCR Version 11-2019 as at 30 June 2019 (s 6), thereby fixing a particular external standard unless the instrument is amended.

Because this instrument is a legislative instrument made under the Health Insurance Act, any future amendments would require the same legal procedure used for legislative instruments, but no further amendment history is present in the text provided. The transitional provisions create legal continuity and provide that pending assessments and reconsiderations initiated under the previous instrument are to be finalised against the prior standards, avoiding retroactive change of legal standardmid-process (s 19(2)-(3)).

The instrument itself does not record or cite any litigation or judicial decisions. The text contains no references to cases, court determinations, or published litigation outcomes. Procedural features indicate reliance on administrative review rather than judicial processes within the instrument: accreditors must provide reasons and reconsideration rights (s 12(8); s 16(6)), proprietors may apply for reconsideration to the accreditor (s 18), and references are made to Ministerial review rights under the Health Insurance Act 1973 (s 17(2)(c), s 18(5)(c)). Those provisions suggest established administrative review pathways are available.

If litigation were to occur, the instrument provides the typical administrative law pathways that litigants would exhaust before judicial review: internal reconsideration by the same accreditor, followed by Ministerial review under the Act, and then any available merits review or judicial review avenues outside the instrument would depend on the Health Insurance Act, the Administrative Decisions (Judicial Review) Act 1977, or other federal jurisdictional bases. The instrument does not itself create a right to merits review in a tribunal; it only prescribes internal reconsideration and references ministerial review rights. Any claim about actual judicial outcomes or precedent would need to be drawn from external case law, which the instrument does not provide.

Practitioners assessing litigation risk should note the instrument’s procedural protections (written reasons, reconsideration timelines at s 18, and deferral of effect for certain decisions at s 17(2)) which create administrative records and pauses that will matter if disputes progress to external review. The instrument’s requirement that accreditors give reasons and set out reconsideration rights (s 12(8), s 16(6), s 18(5)) produces material that a court or tribunal would consider in any challenge alleging procedural unfairness or failure to follow statutory process. The instrument itself does not describe judicial remedies, pecuniary penalties, or specific civil enforcement orders.

The instrument contains several elements that can produce practical surprises for proprietors and advisers if not anticipated:

Entry level accreditation is temporary. An “entry level practice” accreditation is explicitly limited: the responsible accreditor must revoke accreditation of such a practice after two years (s 9(7)). A proprietor relying on entry level status must plan to reapply for full accreditation under s 10 or obtain MIAP-based accreditation before the two year ceiling is reached, or risk automatic revocation.
Time limits and effect of decisions. Many adverse decisions do not take effect until internal reconsideration and Ministerial review rights are exhausted (s 17(2)). However, an accreditor may make an immediate decision where there is a potential danger to public health or safety (s 16(5)), and such emergency decisions take effect immediately. Practitioners must distinguish between decisions that are stayed pending review and those that are immediately effective in the public safety scenario (compare s 16(5) with s 17(2)).
MIAP dependence. For practices relying on MIAP approval, accreditation under this instrument is tightly coupled to MIAP status. If MIAP approval lapses or expires the accreditor must revoke accreditation (ss 11(6), (8)). That revocation is automatic in effect and therefore MIAP maintenance is not merely parallel compliance: it is a direct gating condition.
Scope of Schedule 1. The standards in Schedule 1 apply to the extent that the services provided are diagnostic imaging services in respect of which a Medicare benefit is or is expected to be payable (s 6(2)). That linkage means the evidentiary burden may differ depending on the modal scope of services rendered and whether Medicare benefits are relevant. Proprietors should not assume the same evidentiary expectations apply to non-Medicare diagnostic imaging activity.
Broad information and access power. Conditions of accreditation require proprietors to permit responsible accreditors to access premises and copy documents “at any time” (s 14(2)). That is broad and ongoing. Proprietors must have information governance and record-keeping procedures to ensure readiness for unannounced or ad hoc inspections. The application must also authorise accreditor checks “by whatever means the approved accreditor sees fit” (s 12(4)(a)), expanding the accreditors’ ability to verify information.
Fees and what cannot be charged. Approved accreditors may charge for application processing, desktop audits, membership and reissuing certificates (s 15(1)). They may not charge a separate fee for enforcement work or for reconsideration applications (s 15(2)). However accreditors can bundle costs into membership or processing fees, and the instrument prohibits geographic discrimination but not differential charging by modality or size. Proprietors should scrutinise accreditor fee schedules.
Automatic revocation timelines. Full accreditations are subject to a four year maximum between accreditations such that the accreditor must revoke after four years since last accreditation (s 10(6)). Practices must track accreditation expiry and reapplication windows to avoid gaps that lead to automatic revocation.
Evidence and record-keeping detail. Schedule 1 specifies granular evidence: e.g., technique charts reviewed annually by a qualified person, logs of screening times or dose metrics for fluoroscopy/interventional equipment, annual comparison of doses with diagnostic reference levels (Standard 3.2), and annual review of practitioner registration status (Standard 1.2). Small practices without robust quality systems may struggle to meet these ongoing documentation requirements.
Application content and delegation limits. Applications must be lodged by the proprietor or an employee (s 12(2)(b)). This forbids external consultants applying in their own name; the proprietor remains the responsible legal applicant and therefore carries ultimate responsibility for accuracy and authorisations.
No express criminal or pecuniary penalties in the instrument. Because the instrument focuses on accreditation status rather than fines or criminal sanctions, enforcement consequences are primarily reputational and operational (loss of accreditation). If a proprietor assumes the instrument imposes statutory fines it will be surprised; remedies against non-compliance come through administrative actions, licensing regimes outside this instrument, or other statutory laws referenced in Schedule 1.

Understanding these specific mechanical features helps manage compliance calendars, evidence collection, and risk of abrupt operational impacts arising from suspension, variation or revocation.

Compliance requires operational, documentary and governance actions aligned to Schedule 1 and the instrument’s procedural rules. Steps a proprietor or adviser should implement:

Identify the accreditation route and modalities. Determine whether the practice is an entry level practice (never previously accredited) and whether MIAP approval is the intended pathway (ss 9-11). From Schedule 2, identify the modalities (ULT, CTG, RAD, NME, MRI) the practice will seek accreditation for and list the corresponding diagnostic imaging services (s 12(2)(e); Schedule 2).
Assign a responsible accreditor and maintain the relationship. Ensure an approved accreditor is registered as responsible with Services Australia where required, and if changing accreditors follow the notification process outlined in s 7. The proprietor must ensure a responsible accreditor is in place at all times (s 7(3)).
Prepare the Safety and Quality Manual and map evidence to Standards. Develop a comprehensive Safety and Quality Manual covering all DIAS-related policies as required by Standard 1.1 and include governance, roles, policy owners and review schedules. Map required evidence from Schedule 1: practitioner registrations and licences (Standard 1.2), radiation safety plans and licences (Standard 1.3), equipment inventory with serial numbers and LSPN records (Standard 1.4), service records and service provider qualifications (Standard 1.5), infection control policies (Standard 1.6), consent procedures (Standard 2.2), patient identification procedures (Standard 2.3), medication management and adverse reaction protocols (Standard 2.4), imaging protocols (Standard 3.1), technique charts and dose monitoring processes (Standard 3.2), reporting protocols and examples (Standards 4.1-4.2), and complaints handling procedures (Standard 4.3).
Establish registry-check processes. Implement annual verification of practitioner registration and licences in line with Standard 1.2. For sonographers, ensure ASAR accreditation is recorded. For ionising radiation modalities, maintain evidence of radiation user licences and annual review of radiation safety plans.
Maintain equipment inventories and servicing schedules. Keep a contemporaneous inventory with manufacturer, serial numbers and LSPN entries (Standard 1.4). Ensure service records document dates, test results, next service dates and actions in response to service outcomes. Validate service providers’ qualifications and regulatory licences for servicing ionising radiation equipment (Standard 1.5). Record rationale for any deviation from manufacturer service schedule per Standard 1.5 note.
Implement clinical governance processes. Develop and evidence protocols for clinical justification or self-determination of services (Standard 2.1), informed consent processes scaled to procedure risk (Standard 2.2), three-identifier patient matching and time-out protocols for high risk procedures (Standard 2.3), and medication handling, storage and adverse reaction management including resuscitation arrangements (Standard 2.4).
Create imaging protocols and dose optimisation programmes. Document imaging protocols for commonly performed examinations and review them at least once per accreditation cycle (Standard 3.1). For ionising radiation, compile technique charts consistent with ALARA and review annually by a qualified person; implement annual dose comparison with diagnostic reference levels and a process to review when DRLs are consistently exceeded (Standard 3.2).
Document reporting and feedback mechanisms. Produce sample de-identified reports consistent with the reporting policy, capture urgency escalation pathways for unexpected findings, and maintain a documented and publicly accessible complaints and feedback process (Standards 4.1, 4.3).
Prepare for inspections and desktop audits. Ensure all documents and records are stored in accessible formats and authorise accreditors to verify information as part of application (s 12(4)). Maintain records in a way that permits copying and inspection by responsible accreditors under s 14(2).
Budget for fees and schedule re-accreditation. Review the fee schedule of the approved accreditor, bearing in mind permissible charges under s 15 and the prohibition on separate fees for enforcement and reconsideration (s 15(2)). Track accreditation end dates and plan re-accreditation applications in line with s 8 to avoid lapses. For entry level accreditations, plan for transition to full accreditation well before the two year revocation deadline (s 9(7)). For full accreditation ensure re-accreditation applications are made within timelines before the four year revocation trigger (s 10(6)).
Implement incident reporting and rectification workflows. Create templates and workflows to respond quickly to any notice of adverse event from the responsible accreditor, prepare written submissions within the 28 day period under s 16(2), and implement corrective actions with documentation ready for evidence to avoid escalation to variation, suspension or revocation.
Use the reconsideration procedure when necessary. If an initial decision is adverse, lodge a written application for reconsideration within 28 days and provide new material where relevant (s 18). Expect the accreditor to make a reconsideration decision within 28 days after receipt (s 18(4)(a)).
Coordinate MIAP and accreditor obligations where applicable. If relying on MIAP approval, ensure MIAP renewal dates are tracked, change notifications are sent to the responsible accreditor, and that MIAP-related variations or suspensions are reflected in a parallel accreditation response (s 11(4)-(7)).
Document compliance policies and assign roles. Appoint accountable persons for each Standard (as required in the Safety and Quality Manual) and document policies for evidence review cycles, audits, and governance meetings to demonstrate mechanisms for evaluation and monitoring (Standard 1.1).

A compliance plan aligned to these steps will address the documentary, governance, operational and financial elements required by the instrument. Regular internal audits against Schedule 1, clear ownership of evidence streams and timely communication with the responsible accreditor reduce the risk of enforcement action under ss 16-17.

Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020

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