Federal Register of Legislation - Australian Government

Primary content

Other as made
This instrument establishes an accreditation scheme for diagnostic imaging premises and bases for mobile diagnostic imaging equipment.
Administered by: Health
Made 24 Mar 2010
Registered 31 Mar 2010
Tabled HR 11 May 2010
Tabled Senate 11 May 2010

Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010

I, NICOLA ROXON, the Minister for Health and Ageing, make this legislative instrument under subsection 23DZZIAA(1) of the Health Insurance Act 1973.

Dated   24/3/10

NICOLA ROXON

Minister for Health and Ageing

 

 



  

1               Name of instrument

          This legislative instrument is the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010.

2               Purpose of instrument

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

3               Commencement

(1)      Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1.  Sections 1 to 6 and anything in this instrument not elsewhere covered by this table 

The earlier of:

(a) immediately after the commencement of Schedule 1 to the Health Insurance Amendment (Diagnostic Imaging Accreditation) Act 2010; and

(b) the start of the day on 1 July 2010.

 

2.  Sections 7 to 9

1 July 2010.

1 July 2010

3.  Sections 10 to 17

The earlier of:

(a) immediately after the commencement of Schedule 1 to the Health Insurance Amendment (Diagnostic Imaging Accreditation) Act 2010; and

(b) the start of the day on 1 July 2010.

 

4.  Schedule 1

1 July 2010.

1 July 2010

5.  Schedule 2

The earlier of:

(a) immediately after the commencement of Schedule 1 to the Health Insurance Amendment (Diagnostic Imaging Accreditation) Act 2010; and

(b) the start of the day on 1 July 2010.

 

Note 1 This table relates only to the provisions of this instrument as originally made. It will not be expanded to deal with provisions inserted in this instrument after making.

(2)      Column 3 of the table contains additional information that is not part of this instrument. Information in this column may be added to or edited in any published version of this instrument.

4               Interpretation

(1)      In this instrument:

Act means the Health Insurance Act 1973.

adverse event has the meaning given in subsection 15(1).

applicant means an applicant for accreditation of a diagnostic imaging practice under section 8, 9 or 10.

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 17(1).

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

(a)      is jointly administered by NATA and RANZCR;

(b)      relates to either of the following standards:

          (i)     ISO/IEC 17025:2005 as at 30 June 2010; or

          (ii)    Version 9 RANZCR standards as at 30 June 2010; and

(c)      provides diagnostic imaging practices with accreditation under the program for a period of no more than four years.

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 10(2).

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

prior accreditation has the meaning given in section 6.

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 6.

reconsideration decision has the meaning given in subsection 17(4).

relevant time has the meaning given in subsection 7(1).

responsible accreditor has the meaning given in section 5.

Note 1   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.

Note 2   Terms defined in the Act and which are used in this instrument include approved accreditor, base for mobile diagnostic imaging equipment, diagnostic imaging accreditation scheme, diagnostic imaging premises, diagnostic imaging procedure, diagnostic imaging service, diagnostic imaging services table, medicare benefit and proprietor.

(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.

5               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 Medicare Australia that an approved accreditor is the responsible accreditor for the diagnostic imaging practice, the approved accreditor last notified to Medicare Australia.

(2)      Where:

(a)         immediately before the end of the day on 30 June 2010 a diagnostic imaging practice was accredited under the diagnostic imaging accreditation scheme established by the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008; 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.

6               Re-accreditation

If a diagnostic imaging practice which is accredited under section 7, 8, 9 or 10 (prior accreditation) is granted accreditation under section 9 or 10 (re-accreditation), the prior accreditation ceases when the re-accreditation takes effect.

7               Accreditation under Health Insurance (Diagnostic Imaging Accreditation) Determination 2008

Accreditation

(1)      Where immediately before the end of the day on 30 June 2010 (relevant time) a diagnostic imaging practice was accredited under the diagnostic imaging accreditation scheme established by the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008:

(a)         the diagnostic imaging practice has accreditation under this section for the diagnostic imaging modalities carried out at the diagnostic imaging practice as at the relevant time; and

(b)        any conditions which were imposed on the accreditation of the diagnostic imaging practice under the diagnostic imaging accreditation scheme established by the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008 as at the relevant time are taken to be conditions of accreditation under this section.

(2)      The proprietor of a diagnostic imaging practice which 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

(3)      Where a diagnostic imaging practice which 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 the proprietor becomes aware of the failure to meet the entry level standards or the condition of accreditation.

(4)      Where on 30 June 2012 a diagnostic imaging practice has accreditation under this section, the responsible accreditor must revoke the accreditation of the diagnostic imaging practice.

8               Accreditation against entry level 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 unless:

(a)         the diagnostic imaging practice had at any time accreditation under the diagnostic imaging accreditation scheme established by the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008; or

(b)        the diagnostic imaging practice had at any time accreditation under this section or section 9 or 10.

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

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

(4)      The proprietor of a diagnostic imaging practice which 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

(5)      Where a diagnostic imaging practice which 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 the proprietor becomes aware of the failure to meet the entry level standards or the condition of accreditation.

(6)      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.

9               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 which has accreditation under this section must:

(a)         ensure that 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 which 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 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.

10          Accreditation based on Medical Imaging Accreditation Program

Accreditation

(1)      The proprietor of a diagnostic imaging practice which 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)      Accreditation under this section cannot take effect before 1 July 2010.

(4)      The proprietor of a diagnostic imaging practice which 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

(5)      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.

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

Revocation, variation and suspension

(7)      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.

(8)      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.

(9)      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.

11          Applications for accreditation

(1)      This section applies to an application for accreditation made under section 8, 9 or 10.

Application

(2)      An application must:

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

(b)        specify the diagnostic imaging practice which is to be granted accreditation; and

(c)         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;

(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

(c)         refusing to grant accreditation.

(6)      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

(7)      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);

(b)        the reasons for the decision;

(c)         a statement of the applicant's reconsideration rights under section 17; 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.

12          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;

(b)        the reasons for the variation; and

(c)         a statement of the proprietor's reconsideration rights under section 17.

13          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;

(b)        the reasons for imposing the conditions; and

(c)         a statement of the proprietor's reconsideration rights under section 17.

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

(c)         require the provision of information by the proprietor, its officers, employees, agents or contractors,

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

14          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;

(c)         membership fees; and

(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 15; or

(b)        work performed in receiving and processing an application for reconsideration under section 17.

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

15          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 which has accreditation under section 7 or 8 may no longer meet the entry level standards;

(b)        the responsible accreditor considers that a diagnostic imaging practice which has accreditation under section 9 may no longer meet the standards in Schedule 1; and

(c)         the responsible accreditor considers that the proprietor of a diagnostic imaging practice which has accreditation under section 7, 8, 9 or 10 may have breached or not fulfilled a condition of accreditation.

(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, must require the proprietor to rectify the breach of the standards or the failure to comply with the condition 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 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 10(8); 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:

(c)         the decision;

(d)        the reasons for the decision; and

(e)         a statement of the proprietor's reconsideration rights under section 17.

16          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 17 (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 11(5) or 13(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 which already has accreditation;

(c)         a decision to grant, to a diagnostic imaging practice which 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).

17          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):

(c)         affirming the initial 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;

(c)         a statement of the proprietor's reconsideration rights under section 23DZZIAD of the Act.

 


Schedule 1                                                        

Diagnostic Imaging Accreditation Scheme – Standards

(sections 8 and 9)

 

PART 1             ORGANISATIONAL STANDARDS

 

Standard 1.1          Safety and Quality Governance Standard

 

The diagnostic imaging practice’s governance structure must be effective and comprehensive to ensure the delivery of safe, quality diagnostic imaging services.

 

Required Evidence

 

A documented safety and quality manual for the diagnostic imaging practice which includes at a minimum:

 

(i)              the practice’s policies and procedures regarding:

- governance;

- the registration and licensing of personnel;

- diagnostic imaging equipment and servicing;

- radiation safety and radiographic technique charts;

- infection control;

- provision of diagnostic imaging services and reporting and recording image  findings;

- consumer information;

- patient identification and procedure matching;

- medication management;

- diagnostic imaging protocols; and

- consumer feedback and complaints; and

 

(ii)            the names of the persons at the diagnostic imaging practice who develop, approve, implement, maintain, and review these policies.

 

Standard 1.2          Registration and Licensing Standard

 

Staff, contractors and any other practitioners providing services to the diagnostic imaging practice must have and maintain the appropriate and current registration and/or licence to undertake the diagnostic imaging procedures for which accreditation is sought in the State or Territory.

 

Required Evidence

 

Where relevant:

 

(i)                   Copies of State or Territory registration, or a registration number which can be verified, for all medical practitioners and other registered health professionals (such as dentists) employed by or providing services to the diagnostic imaging practice.

 

(ii)            Copies of each medical practitioner's State or Territory radiation operator’s licence, or a registration number which can be verified.

 

(iii)           Copies of each radiographer's State or Territory registration documentation, or a registration number which can be verified, if required in the State or Territory.

 

(iv)           Copies of each nuclear medicine technologist’s or similar State or Territory registration documentation, or a registration number which can be verified, if required in the State or Territory.

 

(v)             Copies of each non-medical imaging practitioners’ State or Territory registration documentation, or a registration number which can be verified, if required in the State or Territory.

 

(vi)           Copies of the diagnostic imaging practice's radiographers’, nuclear medicine technologists' or other non-medical imaging practitioners’ State or Territory radiation operator’s licence, or a licence number which can be verified, if required in the State or Territory.

 

(vii)          Copies of each sonographer's statement of registration on the Australian Sonographer Accreditation Register or a registration number which can be verified for the purpose of determining registration on the Medicare Australia Register of Sonographers.

 

(viii)        Copies of each nurse's registration documentation or a registration number which can be verified, if the nurse undertakes or assists in the provision of a diagnostic imaging service.

 

(ix)        Copies of a medical physicist’s State or Territory radiation operator’s licence, or licence number which can be verified, if required in the State or Territory.

 

Standard 1.3          Radiation Safety Standard

 

A diagnostic imaging practice which uses ionising radiation must comply with the requirements of the current State or Territory radiation safety legislation.

 

Required Evidence

 

1.         Copies of current State or Territory Radiation Safety Regulator equipment licences and registrations or registration numbers which can be verified.

 

2.         Copies of radiation safety plans and all other relevant radiation safety documents required by State or Territory radiation safety legislation.

 

Standard 1.4          Equipment Inventory Standard

 

The diagnostic imaging practice must maintain a current equipment inventory demonstrating that relevant equipment used to provide diagnostic imaging services is registered with Medicare Australia and complies with specifications in the Medicare Benefits Schedule.

 

Required Evidence

 

A current equipment inventory which includes information relating to:

 

(i)             name of item, manufacturer, serial number (or other identifier); and

 

(ii)           registration on the Diagnostic Imaging Register (including citation of the relevant Location Specific Practice Number (LSPN)).

 

Standard 1.5          Equipment Servicing Standard

 

Equipment used to acquire or print images for diagnostic imaging procedures must be safe and appropriate for its intended use.

 

Required Evidence

 

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

 

(i)                   date of service, who provided the service and their relevant qualifications, details and results of the service and the date of the next service; and

 

(ii)                 actions taken at the practice in response to the results of the service.

 

Standard 1.6          Infection Control 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:

 

(a)     assessing and managing the risk of the transmission of infectious agents;

 

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

 

(c)      reporting, investigating, and responding to incidents at the diagnostic imaging practice arising from the transmission of infectious agents.

 

Required Evidence

 

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

 

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

 


PART 2             PRE-PROCEDURE STANDARDS

 

Standard 2.1          Provision of Service Standard

 

Diagnostic imaging procedures are only undertaken at the diagnostic imaging practice where there is an identified clinical need and:

 

(a)             upon receipt of a request from a medical practitioner or a practitioner specified in the Act for the purpose of requesting services of that kind and for which a medicare benefit is payable; or

 

(b)             where the practitioner interpreting the image is permitted to self determine the service for which a medicare benefit is payable under the Act.

 

Required Evidence

 

A sample of requests or records documenting the clinical need for the diagnostic imaging procedures rendered at the diagnostic imaging practice.

 

Standard 2.2          Consumer Information Standard

 

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

 

(a)     patients have access to information about the diagnostic imaging procedure;

 

(b)     risks are advised to the patient or substitute decision maker;

 

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

 

(d)     consent for the diagnostic imaging procedure is obtained from the patient or the substitute decision maker.

 

Required Evidence

 

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

 

2.             A sample of 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

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

 

3.             A sample of records documenting risks have been advised to the patient.

 

4.             A sample of records of consent obtained from the patient in respect of the diagnostic imaging procedure.

 

Standard 2.3          Patient Identification & Procedure Matching Standard

 

The diagnostic imaging practice must ensure that all patients are correctly identified when rendering a diagnostic imaging service by:

 

(a)     using at least three (3) 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;

 

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

 

(c)      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

 

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

 

2.            A sample of records documenting the use of three patient identifiers.

 

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

 

4.            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:

 

(a)     correctly and safely storing, preparing and disposing of medications in accordance with manufacturer’s guidelines;

 

(b)     identifying patients at risk from adverse reactions;

 

(c)      administering medication safely and actively monitoring the effects of medication;

 

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

 

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

 

Required Evidence

 

1.            A documented policy describing the procedures for:

 

- storing, preparing and disposing of medications;

- identifying at risk patients;

- administering medications safely;

- monitoring the effects of medication; and

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

 

2.            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 Cardiac Pulmonary Resuscitation (CPR) and qualified to use resuscitation equipment and drugs.

 

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

 

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

 


PART 3             PROCEDURE STANDARDS

 

Standard 3.1          Diagnostic Imaging Protocol Standard

 

The diagnostic imaging practice must have documented protocols which describe the required projections and/or manoeuvres required for the acquisition of diagnostic quality images. 

 

Required Evidence

 

Documented protocols for common diagnostic imaging procedures or group of diagnostic imaging procedures rendered at the diagnostic imaging practice.

 

Standard 3.2          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 radiographic equipment located at the diagnostic imaging practice.

 


PART 4             POST PROCEDURE STANDARDS

 

Standard 4.1          Communicating with Requesting Practitioners Standard

 

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

 

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

i.        requested by the requesting practitioner;

ii.      required by the diagnostic imaging service; and

iii.    necessary for the interpretation of the images;

 

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

 

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

 

Required Evidence

 

1.              A documented policy for the provision of reports.

 

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

 

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

 

Standard 4.2          Results of Self-Determined Services Standard

 

When the service is a self-determined service, information about the results of the diagnostic imaging procedure must be documented.

 

Required Evidence

 

A sample of records documenting the image findings.

 

Standard 4.3          Consumer Feedback and Complaints Management Standard

 

The diagnostic imaging practice must provide opportunities for, and respond to, feedback and complaints from patients or carers about the provision of a diagnostic imaging service.

 

Required Evidence

 

1.              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.

 

2.              A sample of feedback and complaints received and records of the actions taken.


Schedule 2 

Diagnostic Imaging Accreditation Scheme – Diagnostic Imaging Modalities

(section 4)

 

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