Interim Guidelines (Word 414 KB)

DIAGNOSTIC IMAGING ACCREDITATION SCHEME

STAGE II

INTERIM GUIDELINES FOR PRACTICES SEEKING ACCREDITATION AGAINSTENTRY LEVEL STANDARDS

1 May 2010

CONTENTS

BACKGROUND 3

Purpose of these Guidelines 3

Practice Accreditation Standards 3

ACCREDITATION AGAINST ENTRY LEVEL STANDARDS 5

INFORMATION ABOUT ENTRY LEVEL STANDARDS 7

Standard 1.2 Registration and Licensing Standard 7

Standard 1.3 Radiation Safety Standard 9

Standard 1.4 Equipment Inventory Standard 11

ATTACHMENT A – Diagnostic Imaging Accreditation Standards 13

ATTACHMENT B – Relevant State and Territory Legislation 22

ATTACHMENT C – Sample LSPN Equipment Details Report and Equipment Update Form

30

ATTACHMENT D – Glossary of Terms 32

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BACKGROUND

The Diagnostic Imaging Accreditation Scheme (the Scheme) was established by the Health Insurance Amendment (Diagnostic Imaging Accreditation) Act 2007 to ensure Medicare funding is directed to diagnostic imaging services that are safe, effective and responsive to the needs of health care consumers. The Scheme has been implemented in two stages to allow practices ample time to prepare for accreditation and to enable the continuation of Medicare benefits during the transition to the Scheme.

The Stage I Scheme was introduced on 1 July 2008, with accreditation arrangements applying to practices providing radiology services. Stage I of the Scheme concludes on 30 June 2010.

The Stage II Scheme, which provides the mechanism for the ongoing operation of the Scheme, comes into effect from1 July 2010. The second stage will allow practices accredited under Stage I to be automatically accredited for Stage II for a period of two years. It also broadens the Scheme to cover non-radiology services such as cardiac ultrasound and angiography; obstetrics and gynaecological ultrasound; and nuclear medicine imaging services, and increases the level of mandatory accreditation standards to a full comprehensive suite of standards. The Stage II Scheme offers an incremental approach to accreditation against these standards.

From 1 July 2010, any practices intending to render any diagnostic imaging services for the purpose of Medicare benefits must be accredited under the Stage II Scheme. Practices that do not have accreditation cannot provide Medicare funded diagnostic imaging services and must inform clients prior to carrying out services that the practice is not accredited and a Medicare benefit is not payable.

Purpose of these Guidelines

These interim guidelines have been developed to assist diagnostic imaging practices apply for entry level accreditation under Stage II of the Diagnostic Imaging Accreditation Scheme. The guidelines provide an explanation of the entry level standards and how an applicant can demonstrate their practice’s compliance against these standards.

Practice Accreditation Standards

The Stage II Scheme Practice Accreditation Standards were developed by a Consultative Working Group, comprising individuals with expertise and demonstrated experience in the delivery of diagnostic imaging services, health administration, technical standards and health consumer advocacy.

A copy of the Standards is at Attachment A for information. Guidance material in relation to these standards will be available in October 2010.

The Stage II Scheme initially provides for the following three levels of accreditation: deemed accreditation; accreditation against entry level standards; and accreditation against the full suite of standards.

Deemed Accreditation prior to 30 June 2010

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This is available only to non-radiology practices that do not hold Stage I accreditation for radiology services. Non-radiology practices can register for deemed accreditation between 1 April and 30 June 2010. Deemed practices must apply for and obtain, at a minimum, accreditation against entry level standards by 30 June 2011.

Entry Level Standards

There are three entry level Stage II standards. These standards cover existing regulatory requirements regarding the licensing and registration of staff and equipment and radiation safety. Accreditation against these standards is available from 1 July 2010.

Non-radiology practices that registered for deemed accreditation prior to 30 June 2010 will have until 30 June 2011 to obtain accreditation against entry level standards.

Practices that were accredited under Stage I of the Scheme, but had their accreditation withdrawn, are not eligible to apply for accreditation under Stage II against entry level standards.

Stage I accredited radiology practices already have accreditation in Stage II against these standards. All other practices can apply for accreditation against these standards any time after 1 July 2010.

All practices must receive accreditation against the full suite of standards within two years of receiving accreditation against entry level standards in order to retain their accreditation.

Full Suite Standards

The full suite of Stage II standards comprise of the three entry level standards, plus an additional 12 standards relating to organisational, pre-procedure, procedure and post-procedure standards. Accreditation against the full suite of standards is available from 1 July 2010 for both non-accredited and entry level accredited practices. Note that practices do not have to obtain accreditation against entry level standards before applying for accreditation against the full suite of comprehensive standards.

MIAP Accredited Practices

The Medical Imaging Accreditation Program (MIAP) is recognised under the Stage II Scheme. Practices with MIAP accreditation can seek recognition of their MIAP accreditation under the Stage II Scheme and this recognition will accredit MIAP accredited practices against the full suite of Stage II Scheme standards. Under the Stage II Scheme, recognition for MIAP accreditation can be sought by practices with MIAP accreditation recognised under the Stage I Scheme, as well as practices applying for the first time.

Accreditation under the Stage II Scheme will be granted until the date of the expiration of the recognised MIAP accreditation. By this date, practices will need to either provide their accreditor with evidence of renewal of MIAP accreditation or have been granted accreditation against the full suite of standards.

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ACCREDITATION AGAINST ENTRY LEVEL STANDARDS

How to Become Accredited

Selecting an Accreditor

The first step for practices seeking accreditation is to select an approved accreditor. The following three organisations have been approved as accreditors under the Stage II Scheme -

Health and Disability Auditing Australia Pty Ltd National Association of Testing Authorities Australia Quality in Practice Pty Ltd

You may select any one of these three organisations to provide accreditation services to your practice. Each of these accreditors operates independently within the guidelines provided by the Department of Health and Ageing, and as such, has its own application forms and sets its own fees. The accreditor you select will be able to provide:

the application form/package; information on the application process and fees; advice on the entry level standards and the evidence you need to lodge to demonstrate

compliance with these standards; and advice regarding access to Medicare benefits where your practice does not have deemed

accreditation.

Should you wish, you can change your accreditor at any time. In order to transfer to another accreditor approved under the Stage II Scheme, you must notify your current accreditor of your intention to transfer and request (in writing) that all records relating to your practice’s accreditation be released to you or your new accreditor. There should not be any interruption to your practice’s accreditation during this transfer period.

Submitting an Application

An application form/package will be available from your accreditor. The application document(s) will specify, amongst other things, the evidence will you need to lodge at the time of application in support of your practice’s compliance with the entry level standards.

The entry level standards form part of the full suite of comprehensive standards and are listed below. These entry level standards comprise existing State and Territory regulatory requirements covering the registration of staff and equipment, and radiation safety.

Standard 1.2 Registration and licensing standardStandard 1.3 Radiation safety standardStandard 1.4 Equipment inventory standard

Once your application has been lodged, your accreditor has 15 business days to conduct an off-site desktop audit to determine the extent of your practice’s compliance with entry level standards and make an accreditation decision. Your accreditor must notify you within 2 business days of reaching a decision regarding your application for accreditation.

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If your practice demonstrates that it meets the entry level standards in relation to the diagnostic imaging modalities for which accreditation is sought, you will be granted entry level accreditation for a period of two years. Within this period, you must apply for, and be awarded, accreditation against the full suite of standards. Guidance material to hep practices meet the full suite of standards will be available in October 2010.

If your practice is not awarded accreditation due to its inability to meet the entry level standards, you can request a reconsideration of the decision. An application for reconsideration must be submitted to your accreditor within 28 days of the date of the notification of the decision not to grant accreditation.

Providing Evidence to your Accreditor

You must provide any information your accreditor reasonably requires in support of your application for accreditation. However, your accreditor must have authorisation from you in order to check the accuracy of information you have provided and to store and use the information for the purposes of the Scheme.

Requests for authorisation will be included in the application pack provided by your accreditor. An example of the wording that may be used is provided below.

I authorise [name of accreditor] to check the accuracy of information provided in this application for accreditation and to store and use the information for the purposes of the Scheme.

SignatureNameQualificationDate

Making a Declaration

Your accreditor may require you to provide a written declaration which attests that the statements you have made and any documentation you have provided in your application for accreditation are true and correct.

An example of the possible wording that may be used in a written declaration is provided below:

I certify that the statements made in this application are true and correct in every detail and that copies of all registration certificates and licences accompanying this application are true copies of original documents shown to me on [date].

SignatureNameQualificationDate

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INFORMATION ABOUT ENTRY LEVEL STANDARDS

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.

Explanation

Standard 1.2 sets out the requirements regarding the registration and licensing of medical1 and non-medical personnel2 who either undertake diagnostic imaging procedures and/or who interpret images for the site which is seeking accreditation.

Medical and non-medical personnel covered by Standard 1.2 would potentially include:

medical practitioners/specialists/dentists; radiographers and licensed x-ray operators; allied health professionals such as chiropractors, physiotherapists, podiatrists and

osteopaths; sonographers; nurses; and medical physicists and medical technologists.

Subject to some exemptions, diagnostic imaging procedures generally need to be undertaken under the supervision of a medical practitioner who is able to monitor and influence the conduct of the imaging. The term ‘diagnostic imaging procedure’ is defined in legislation and generally means the procedure for capturing or producing images. (See the glossary of terms at Attachment D.)

There are different requirements regarding the licensing and registration of staff in the various jurisdictions. Licensing requirements generally relate to an authorisation for a person to use or operate radiation producing diagnostic imaging equipment such as x-ray, computed tomography or fluoroscopy equipment which is used in a diagnostic imaging procedure.

Where reporting services are provided under sub-contracting arrangements (i.e. by a separate organisation), the proprietor of the Location Specific Practice Number (LSPN) site seeking accreditation is required to provide evidence of the registration of those practitioners providing the reporting service. Further, where the reporting service is done in a different jurisdiction, the reporting practitioner must be registered in the jurisdiction where the image is captured (i.e. the jurisdiction where the LSPN site is located).

1 Medical personnel means any medical practitioners such as a radiologist, general practitioner, medical specialist or dentist.2 Non-medical personnel includes radiographers, sonographers, nurses and allied health professionals such as chiropractors, physiotherapists, podiatrists and osteopaths.

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The documentary evidence requirements for a practice in one jurisdiction may be different from that of a similar practice in another jurisdiction. Where registration and/or licensing is required in the jurisdiction in which accreditation is sought, evidence of that registration or licence must be provided by the applicant. Refer to Attachment B which lists the relevant legislation in each of the jurisdictions which deal with the registration and licensing of personnel.

Where relevant, the documentary evidence provided by the applicant to demonstrate compliance with Standard 1.2 could be either:

a copy of the registration certificate/documentation or licence, where one is issued, which can be verified by the accreditor; or

a registration or licence number, where one is issued, and where registration information is held in a public register which can be verified by the accreditor.

Where registration information is not available in a public register, the applicant must instead provide a copy of the registration certificate or licence. As an alternative, the accreditor may require that applicants provide a copy of all relevant registration certificates or licences.

Where a LSPN site sub-contracts to another practice in the same jurisdiction to report on diagnostic imaging, the LSPN site could provide a copy of the reporting practice’s accreditation certificate as evidence of reporting practitioners’ registration. This approach would benefit small independent practices that sub-contract reporting to large corporate practices that are already accredited. The small practice would not be burdened with having to obtain and submit copies of registrations for every practitioner in the large corporate practice who may potentially report on images. However, if the LSPN site and reporting practice are not in the same jurisdiction, the LSPN site would need to provide copies of the reporting practitioners’ registration certificates for the jurisdiction where the image is captured.

Sonographers

Rule 8 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2007 prescribes that for the purposes of Medicare eligibility, ultrasound services can only be performed by a medical practitioner or a registered sonographer on behalf of a medical practitioner. The definition of a registered sonographer is a person whose name is entered on the Register of Sonographers kept by the Medicare Australia CEO.

As the Register of Sonographers is not a public register, applicants required to provide evidence of the registration of a sonographer should, as an interim measure, provide as evidence of their registration, an Australasian Sonographer Accreditation Registry (ASAR) registration number along with the full name of the sonographer. The 4-digit ASAR registration contains the same information contained on the Register of Sonographers held by Medicare Australia.

It is also possible that the Diagnostic Imaging Section of the Department of Health and Ageing could, in the short term, verify whether or not a sonographer is registered with Medicare Australia on the Register of Sonographers. An authorisation from the sonographer would be required for this check to be undertaken, together with the ASAR registration number and the name and address of the sonographer.

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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.

Explanation

Standard 1.3 deals with safety legislation for practices using ionising radiation and specifically relates to: radiation producing diagnostic imaging equipment such as radiographic, fluoroscopic,

mammographic, computed tomography and positron emission tomography systems; and the premises where this equipment is located and used.

It should be noted that sites that provide only ultrasound services do not need to comply with Standard 1.3.

Radiation Safety Legislation

Radiation safety legislation varies between the jurisdictions, as do the authorities responsible for that legislation. Details of the relevant authorities are provided below, while details of the relevant State and Territory legislation regarding radiation safety can be found at Attachment B.

Australian Capital Territory ACT HealthNew South Wales Department of Environment and Climate ChangeNorthern Territory Department of Health and Community ServicesQueensland Department of HealthSouth Australia Environment Protection AuthorityTasmania Department of Health and Human ServicesVictoria Department of Human ServicesWestern Australia Radiological Council

Registration of equipment

Some State and Territory radiation protection legislation may require that each piece of radiation producing diagnostic imaging equipment is registered for use with the relevant regulatory authority. Where relevant, a Certificate of Registration or similar3 from the relevant regulatory authority would be issued to the owner of the equipment after information about each piece of equipment, the location of the equipment and the ownership of the equipment is registered with that authority. The period of registration may vary depending on the type of equipment. An applicant could provide a copy of a current Certificate of Registration or similar as evidence of compliance with Standard 1.3. Alternatively, a registration number for the Certificate could be provided where registration information is held in a public register and can be verified by the accreditor.

Registration based on compliance of equipment

3 In Victoria legislation requires a Management Licence which specifies what activities can be carried out at the site and what radiation producing equipment is operating from the site.

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Some State and Territory radiation protection legislation may require that registered equipment meets certain standards regarding quality, safety and performance. Where relevant, a Certificate of Compliance or similar may be issued by the relevant regulatory authority following an inspection of the equipment by a person authorised by the relevant regulatory authority.

A Certificate of Compliance or similar may be a condition of registration for radiation producing diagnostic imaging equipment. Where this is the case, an applicant could provide both a copy of a current Certificate of Registration and a current Certificate of Compliance as evidence of compliance with Standard 1.3. Alternatively, a registration number for each Certificate of Registration could be provided where this information is held in a public register.

In some States and Territories while testing of radiation producing diagnostic imaging equipment is required, a Certificate of Compliance or similar may not be issued. Where the relevant regulatory authority affixes a Compliance Testing Sticker to the equipment to verify compliance, an applicant could provide a written log of the information contained on each piece of equipment as evidence of compliance with Standard 1.3.

Radiation Safety Plan

In early May 2008, the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) published a Code of Practice for Radiation Protection in the Medical Applications of Ionizing Radiation (2008) (Code). The Code establishes the regulatory requirements for the use of ionising radiation in medicine and includes a requirement for a site with radiation producing diagnostic imaging equipment to develop, implement and regularly review a Radiation Management Plan. Guidance about the preparation of a Radiation Management Plan is included in the Code.

The Code has been developed for adoption into State and Territory radiation safety legislation. Although this has not as yet occurred, the Code is a guide to good practice to ensure that the risks of radiation exposure to patients, staff and other persons are as low as reasonably achievable.

Radiation Safety Officer

A Radiation Management Plan is not yet mandatory, however, the premises from which radiation producing diagnostic imaging equipment is operated, may be required to have a Radiation Safety Officer under State or Territory radiation safety legislation. An applicant could provide a Duty Statement describing the responsibilities of the Radiation Safety Officer and identify in that Statement who the nominated officer is for the site.

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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.

Explanation

To be eligible to provide diagnostic imaging services under Medicare, sites with diagnostic imaging equipment must register that equipment with Medicare Australia. Registered sites and bases for mobile equipment are allocated a Location Specific Practice Number (LSPN). The LSPN is a unique seven digit identifier, specific to the site, which must be included on all accounts, receipts and assignment of benefits forms.

Equipment to be registered with Medicare Australia which is relevant to the entry level accreditation standards includes individual:

Ultrasound units and transducers; Computed tomography units; Positron emission tomography scanners; Gamma cameras; Angiography systems; General x-ray equipment; Fluoroscopy equipment; Mammography equipment; Orthopantomography equipment; and Magnetic resonance imaging units.

To maintain registration, sites must annually confirm or update equipment information. The following information is generally provided to Medicare Australia when registering diagnostic imaging equipment:

Serial No; Model type/No; Manufacturer (Company); Date manufactured or date installed in Australia; and Date operational.

Some diagnostic imaging equipment must meet specifications in order to be used for certain diagnostic imaging services provided under Medicare. For example:

ultrasound machines used for urological ultrasound must be equipped with transducers of a frequency of 7.0 – 7.5 MHz;

ultrasound machines for musculoskeletal ultrasound must be equipped with transducers of a frequency of 7.5 MHz or greater; and

ultrasound machines used for vascular studies must be capable of colour doppler imaging.

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To demonstrate compliance with Standard 1.4, an applicant could provide one of the following:

a current copy of the annual LSPN Declaration and Update Details Form from Medicare Australia including:

- Attachment A, Practice Details Report;- Attachment B, Equipment Details Report; - Attachment C, Declaration; and where relevant, - Attachment D, Equipment Update Form;

provided the Update Details Form accurately indicates all the diagnostic imaging equipment located at the site;

copy of a current LSPN Registration Form, where an application for a LSPN has been made to Medicare Australia but has not been issued at the time the applicant applies for accreditation; or

a current equipment inventory held by the practice which comprises, at a minimum, all the information which would otherwise be held by Medicare Australia in the LSPN record and includes all the diagnostic imaging equipment located at the site.

Where this information is not already provided in the documents referred to above, the applicant could provide a copy of the manufacturer’s equipment specifications to demonstrate that equipment operated from the LSPN site complies with any specifications prescribed for relevant diagnostic imaging services in the Diagnostic Imaging Services Table of the Medicare Benefits Schedule.

A sample display of the information contained in Attachment B, Equipment Details Report and Attachment D, Equipment Update Form from the annual LSPN Declaration and Update Details Form is provided at Attachment C.

NOTE: An annual LSPN Declaration and Update Details Form or a copy of a LSPN Registration Form provided as evidence may contain equipment information which is not relevant to the Standards. The equipment may be for radiation oncology services which fall outside the scope of the Scheme.

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ATTACHMENT A

Diagnostic Imaging Accreditation Scheme – Standards

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


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.

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(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


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

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(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).

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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.

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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.

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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.

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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.

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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; andiii. 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.

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Diagnostic Imaging Accreditation Scheme – Diagnostic Imaging Modalities

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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Attachment B

ATTACHMENT B

References to the relevant State or Territory legislation as it relates to the second edition Standards and supporting documentation – as at 8 October 2009

Diagnostic Imaging Accreditation Scheme

Standards

Documentary Evidence

Relevant State / Territory/ Commonwealth Legislation

Standard 1.1

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

(i) – (ii) - Any relevant State/Territory/Commonwealth legislation for this standard is covered in the following standards.

Standard 1.2 (i) ACT - Health Professionals Act 2004


NSW - Medical Practice Act 1992

NT - Health Practitioners Act 2004

QLD - Medical Practitioners Registration Act 2001

SA - Medical Practice Act 2004

TAS - Medical Practitioners Registration Act 1996

VIC - Health Professions Registration Act 2005

WA - Medical Act 1984

(ii) ACT - Radiation Protection Act 2006 and Radiation Protection Regulation 2007

NSW - Radiation Control Act 1990 and Radiation Control Regulations 2003

NT - Radiation (Safety Control) Act 1978 (note this Act is to be repealed in 2009 as a result of the Radiation Protection Act 2004 – see the transitional provisions)

QLD - Radiation Safety Act 1999 and Radiation Safety Regulation 1999

SA - Radiation Protection and Control Act 1982, Radiation and Control (Ionising Radiation) Regulations 2000

TAS - Radiation Protection Act 2005, Radiation Protection Regulations 2006

VIC - Radiation Act 2005 and Radiation Regulations 2007

WA - Radiation Safety Act 1975

(iii) NT - Radiographers Act (NT) 1976 (note this Act is to be repealed at a future date as a result of the Radiation Protection Act 2004 – see the transitional provisions)

QLD - Medical Radiation Technologists Registration Act 2001 and the Medical Radiation Technologists Registration Regulation 2002 and the Health

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Standards



Practitioners (Professional Standards) Act 1999

[Note: There is no relevant legislation in the ACT, NSW or SA.]

TAS - Medical Radiation Science Professionals Registration Act 2000

VIC - Health Professions Registration Act 2005 and Health (Medical Radiation Technologists Regulations 1997)

WA - Medical Radiation Technologists Act 2006

(iv) Cth - Health Insurance Act 1973 and Health Insurance (Diagnostic Imaging Services Table) Regulations 2005

(v) ACT - Radiation Protection Act 2006 and Radiation Protection Regulation 2007


NT - Exempt under the Radiation (Safety Control) Act 1978 where use and operation of irradiating apparatus is in accordance with the Radiographers Act (note both Acts are in the transition period and are to be repealed at a future date by the Radiation Protection Act 2004 which is already in force and which does not contain this exemption).

QLD - Radiation Safety Control Act 1999 and Radiation Safety Regulation 1999

SA - Radiation Protection and Control Act 1982, Radiation and Control (Ionising Radiation) Regulations 2000



WA - Radiation Safety Act 1975

(vi) ACT - Health Professionals ACT 2004 and the Health Professionals Regulation 2004

NSW - Nurses and Midwives Act 1991


QLD - Nursing Act 1992

SA - Nurses Act 1999

TAS - Nursing Act 1995

VIC - Health Professionals Registration Act 2005

WA - Nurses and Midwives Act 2006

(vii) ACT - Radiation Protection Act 2006 and Radiation

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Standards



Protection Regulations 2007


NT - Exempt under the Radiation (Safety Control) Act 1978 (note this Act is to be repealed at a future date as a result of the Radiation Protection Act 2004 – see transitional provisions)


SA - Radiation Protection and Control Act 1982 and Radiation and Control (Ionising Radiation) Regulations 2000



WA - Radiation Safety Act 1975 and Radiation (General) Regulations 1983

Standard 1.3


(i) – (ii) ACT - s.119 Radiation Protection Act 2006 and Radiation Protection Regulations 2007

NSW - s. 36 Radiation Control Act 1990 and Radiation Control Regulations 2003

NT - s.81 Radiation Protection Act 2004

QLD - s.198 Radiation Safety Act 1999 and Radiation Safety Regulation 1999

SA - s. 49 Radiation Protection and Control Act 1982 and Radiation and Control (Ionising Radiation) Regulations 2000

TAS - s. 76 Radiation Protection Act 2005, Radiation Protection Regulations 2006

VIC - s.131 Radiation Act 2005 and Radiation Regulations 2007

WA - s.50 Radiation Safety Act 1975 and Radiation (General) Regulations 1983

Standard 1.4

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

(i) Cth - Medicare Benefits Schedule a separate document created pursuant to the Health Insurance Act 1973

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Standards



Benefits Schedule.

Standard 1.5

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

(i) – (ii) ACT - Radiation Protection Act 2006 and Radiation Protection Regulations 2007


NT - Exempt under the Radiation (Safety Control) Act 1978 (note this Act is to be repealed at a future date as a result of the Radiation Protection Act 2004 – see transitional provisions)






Standard 1.6

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.

- [Note: This standard is based on the Department of Health and Ageing, 'Infection Control Guidelines' made under the auspices of the Communicable Diseases Network Australia (CDNA). The guidelines have also been endorsed by the Australian Health Ministers’ Advisory Council. There is no relevant Commonwealth, State or Territory legislation.]

Standard 2.1

Diagnostic imaging procedures are only

(i) Cth - Health Insurance Act 1973

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Standards



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.

Standard 2.2

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.

- [Note: ACT and NT legislation does not deal with medical or health professional's duty to inform or the requirement to obtain patient consent.]

(i) - (iv) NSW - Civil Liability Act 2002.

NT - NT legislation does not deal with medical or health professional's duty to inform or the requirement to obtain patient consent.

QLD - Civil Liability Act 2003.

SA - Wrongs Act 1936 – now referred to as the Civil Liability Act 1936.

TAS - Civil Liability Act 2002.

VIC - Wrongs Act 1958.

WA - Civil Liability Act 2002, Civil Liability Amendment Act 2003 and Civil Liability Amendment Act 2004.

Standard 2.3

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

- [Note: This standard is based on the Australian Standard AS 5017-2006 Health Care Client Identification and the Australian Commission on Safety and Quality in Health Care, 'Protocols on Ensuring Correct Patient, Correct Site, Correct Procedure in Radiology, Nuclear Medicine, radiation Therapy and Oral Surgery: Review of implementation and proposals for action'. There is no relevant Commonwealth, State or Territory legislation.]

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Standards



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.

Standard 2.4

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 the 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.

- [Note: This standard is based on the Australian Pharmaceutical Advisory Council 'Guiding principles for medication management in the community' and the Department of Health and Ageing 'Quality Use of Medicines created under the National Medicines Policy 2000'. There is no relevant Commonwealth, State or Territory legislation.]

Standard 3.1

The diagnostic imaging practice must have documented protocols which describe the required projection/s and/or

Cth - Health Insurance Act 1973.

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Standards



manoeuvre/s required for the acquisition of diagnostic quality images.

Standard 3.2

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.

ACT - Radiation Protection Act 2006 and Radiation Protection Regulations 2007


NT - Radiation Protection Act 2004

QLD - Radiation Safety Act 1999 and Radiation Safety Regulation 1999





Standard 4.1

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

(a) providing timely, clear and concise written reports which addresses 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.

ACT - Health Professionals Act 2004








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Standards



Standard 4.2

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

Cth - Health Insurance Act 1973 and the Health Insurance Regulations 1975.

Standard 4.3

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.

ACT - Health Professionals Act 2004








Cth - [Note: There is no relevant Commonwealth legislation. The standard is reflected in the Australian Commission on Safety and Quality in Health Care, 'Australian Charter of Healthcare Rights: A Guide for Healthcare Providers' and Australian Commission on Safety and Quality in Health Care, 'Better Practice Guidelines on Complaints Management for Healthcare Services'.]

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ATTACHMENT C

SAMPLE DISPLAY: For a site with ultrasound equipment only registered

ATTACHMENT B – Equipment Details Report

Location Specific Practice Number 0005111

Ultrasound Amendments (if any)Equipment: Non-doppler Serial Number: 12345Model type/no: CYPRESSManufacturer: SIEMANSDate operational at site*: 01.01.08Date removed:Other interest in equipment: N

* Date operational at site is usually the start date of your LSPN registration, except for equipment that has been installed after registration.

SAMPLE DISPLAY: Extract only

ATTACHMENT D – Equipment Update Form

Only to be used to advise Medicare Australia of the details relating to any additional or new equipment not contained in Attachment B.

LSPN and Practice Name

Equipment: Transducer (7.5MHz or higher)

Equipment: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

Equipment: Ultrasound Unit (please tick appropriate type)

Type: Doppler__ or Non-Doppler__ AND with Echocardiography ___ or without__Serial Number: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

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Equipment: CT Gantry (details of Gantry only required)Serial Number: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date manufactured: or* _________________________________Date first installed in Aust: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

* For equipment previously used outside Australia provide the date of manufacture* For new equipment or equipment previously used in Australia only provide the first date installed.

Equipment: PET scanner Serial Number of the ring: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

Equipment: Gamma CameraSerial Number: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date manufactured: or* _________________________________Date first installed in Aust: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

Equipment: AngiographySerial Number of the generator: _________________________________Model type/no: _________________________________Manufacturer: _________________________________Date manufactured: or* _________________________________Date first installed in Aust: _________________________________Date operational at site: _________________________________Date removed (if applic): _________________________________Other interest in equipment: Yes_______ No__________

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ATTACHMENT D

GLOSSARY OF TERMS

accreditor an independent organisation appointed by the Minister for Health and Ageing as an accreditor for the Stage II Diagnostic Imaging Accreditation Scheme

base for mobile diagnostic imaging equipment

premises, under a single business name, where diagnostic imaging equipment is ordinarily located when not in use and where the diagnostic imaging procedures carried out using the equipment are not carried out at the premises, or are frequently carried out off the premises

business day a day that is not a Saturday, Sunday, public holiday or bank holiday in the place where the accreditation decision is received

deemed accreditation

for the purposes of the payment of Medicare benefits, means the same as accreditation. Only non-accredited practices providing non-radiology services prior to 30 June 2010 are eligible for deemed accreditation

desktop audit a review by an approved accreditor carried out other than in a diagnostic imaging practice to assess whether the diagnostic imaging practice is complying with the entry level practice accreditation standards

diagnostic imaging modality

a set of diagnostic imaging procedures such as ultrasound; computed tomography, diagnostic radiology; magnetic resonance imaging; and nuclear medicine imaging

diagnostic imaging practice

a convenient term to cover a "diagnostic imaging premises" and a "base for mobile diagnostic imaging equipment”. These terms are defined in the Act

diagnostic imaging premises

a building, or part of a building, at which diagnostic imaging procedures are carried out under a single business name

diagnostic imaging procedure

the production of images such as x-rays, computed tomography scans, ultrasound scans, magnetic resonance imaging scans and nuclear imaging scans for use in rendering "diagnostic imaging services"

diagnostic imaging service

an item in the Diagnostic Imaging Services Table (DIST) of the Medicare Benefits Schedule and includes the production of images

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and the report

entry level accreditation standards

refers to Standard 1.2, Standard 1.3 and Standard 1.4 of the Stage II Diagnostic Imaging Practice Accreditation Standards

full suite accreditation standards

refers to the fifteen standards of the Stage II Diagnostic Imaging Practice Accreditation Standards, namely, Standards 1.1 to 1.6; Standards 2.1 to 2.4; Standards 3.1 to 3.2 and Standards 4.1 to 4.3

Location Specific Practice Number (LSPN)

Location Specific Practice Number, which is a site specific, unique 6 digit identifier issued by Medicare Australia to a practice which registers diagnostic imaging equipment for the purposes of Medicare. Individual LSPNs are considered to be practices for the purposes of accreditation

Medical Imaging Accreditation Program (MIAP)

the diagnostic imaging accreditation program jointly administered by the National Association of Testing Authorities Australia (NATA) and the Royal Australian and New Zealand College of Radiologists (RANZCR)

proprietor generally is the person or government agency that has effective control of the premises or base for mobile diagnostic imaging equipment, the use of the diagnostic imaging equipment and the employment of staff connected with the premises or base for mobile diagnostic imaging equipment

non-radiology services

means cardiac ultrasound and angiography; obstetric and gynaecological ultrasound; and nuclear medicine imaging services

radiology services all items in the Diagnostic Imaging Services Table of the Medicare Benefits Schedule with the exception of cardiac ultrasound and angiography; obstetric and gynaecological ultrasound; and nuclear medicine imaging services

Stage I Scheme means the Diagnostic Imaging Accreditation Scheme which commenced on 1 July 2008 and concludes on 30 June 2010

Stage II Scheme means the Diagnostic Imaging Accreditation Scheme which commences on 1 July 2010

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Documents

Interim Guidelines (Word 414 KB)