REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

REMOTE HEALTH ATLAS X-RAY EQUIPMENT

1. General Information
X-Ray facilities are not standard in all remote health centres. While local X-Ray facilities can reduce the need for patient travel and contribute to improving client care and clinical outcomes, there are also stringent criteria and significant costs involved in establishing and maintaining these facilities. It is likely that only larger health centres will meet the criteria to justify placement in the remote setting. Remote Health supports the purchase of new X-Ray equipment that produces a digital image. Traditional equipment reliant on wet processing of film is only supported if it is already installed in health centres and is still in use. In the Northern Territory legislation relating to the use and operation of radiographic equipment includes the Radiation Protection Act and Radiation Protection Regulations. Radiation Protection information, codes of practice, application forms and related information are available on the Department of Health (DoH) Environmental Health - Radiation Protection website, including: - Radiation Protection Fact Sheet No 800 which provides a useful summary of the Radiation Protection Act and Regulations - Radiation Protection Information Sheet No. 802 which provides information on the criteria to obtain a radiation licence to use a radiation apparatus in Diagnostic Radiography, Therapy and Nuclear Medicine. This includes information on licensing criteria and conditions of use for a Medical Practitioner or Registered Nurse. Staff are not permitted to perform X-Rays unless they have a current license to use a radiation source. Clients requiring complex or extensive X-Rays should be referred to a hospital or directly to a radiologist.

2.

Definitions

Computed Radiography (CR): the process of creating a diagnostic digital image from data acquired with an imaging plate and reader. Radiation Operator / Operator / Licensee: a person with a current licence issued under section 27 of the Radiation Protection Act authorising the holder to participate in activities related to a radiation source (X-Ray equipment). Radiation Protection Plan: a plan containing the information prescribed by the Radiation Protection Regulations authorising a health centre to possess a radiation source. 20mSv: the occupational dose limit per year for an operator averaged over five consecutive years. LSPN: the Location Specific Practice Number issued by the Dept. of Health and Ageing in order to claim Medicare benefits for diagnostic imaging services. See Section 4.4.1.

3.
3.1

Responsibilities
All Radiation Operators

Only undertake radiological procedures at sites where there is a pending or current certificate of compliance for a radiation place
Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009 Page 1 Reviewed: Sept 10, Oct 11, Apr 12, Oct 12,

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REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

Undertake radiological procedures only if licensed to do so by DoH Environmental Health - Radiation Protection Take all relevant steps to protect clients and/or staff in the vicinity of radiological equipment Be aware of requirements under the Radiation Protection Plan In conjunction with the Primary Health Care Manager, ensure that all records of compliance, licensing and registration of X-Ray equipment and other relevant matters are maintained at the health centre Obtain personal radiation monitoring dosemeter to wear when operating X-Ray equipment 3.2 Primary Health Care Manager (PHCM) Complete Registration for Radiation Source and Place online forms as detailed in 4.3.2 In conjunction with the Radiation Operator, ensure that all records of compliance, licensing and registration of X-Ray equipment and other relevant matters are maintained at the health centre Ensure that X-Ray equipment is only operated by licensed operators Ensure that X-Ray equipment is stored in a secure room, inaccessible to the general public Be aware of requirements under the Radiation Protection Plan and act upon these, if required 3.3 All Health Centre Staff Familiarise themselves with safety procedures for staff and clients in the vicinity of X-Ray equipment 3.4 Area Service Manager (ASM) Facilitate training for clinical staff selected to undertake radiological procedures in consultation with the Director of Nursing and SRMP - Operations 3.5 Management / Remote Health Capital Equipment Group (RHCEG) Adhere to capital equipment purchasing arrangements where new equipment is considered 3.6 Director Remote Health Branch Receive Personal Radiation Monitoring Reports of all RHB Radiation Operators and disseminate to relevant ASMs Maintain the Remote Health Radiation Protection Plan per requirements in the Radiation Protection Regulations

4.
4.1

Procedure
Assessing Health Centre Capacity for X-Ray Equipment

When considering the procurement of X-Ray equipment it is important to consider that X-Ray equipment is not viable in all situations. Having access to X-ray facilities does not necessarily equate to improved access to better health services. Health centres proposing the purchase of X-Ray equipment must seriously assess various significant considerations, including:
Physical capability of the health centre When assessing the capability of the health centre, consider that the room utilised for X-Ray facilities: ~ must be large enough to accommodate an X-Ray table or examination couch, a wall mounted cassette holder / bucky, chair for the client, a mobile X-Ray machine, a computed radiography unit, small storage area for positioning wedges and a small desk to hold computer hardware ~ must comply with radiation shielding design standards in regard to building construction for the X-Ray room, such as the thickness of walls, whether lead lining is required, etc
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Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009

Next Review: October 2015

REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

Information Technology infrastructure & capability Budget

Legislative and Accreditation requirements Staff (Medical / RAN)

~ preferably have an outside wall for the wall mounted cassettes / bucky to be mounted, or able to be modified to meet radiation shielding design standards ~ must be lockable. An accredited assessor must assess whether the room meets the appropriate radiation shielding design standards. See Certificate of Compliance for a Radiation Place for requirements for the assessment process. Rooms that do not meet the requirements for certification will have to be modified to meet these requirements, ideally prior to the purchase of XRay equipment. Including utilisation of the Picture Archiving and Communication System (PACS) for transmitting and retrieving digital X-Ray images Costs of equipment, annual service and ongoing maintenance and recurrent requirements such as training balanced against usual rates of referral involving diagnostic radiology Ability to comply with requirements in an ongoing capacity

Stability of staff in the health centre who are licensed Radiation operators

4.2

Procurement of X-Ray Equipment

The basic equipment requirements include the X-Ray machine, CR reader, console and imaging plates, and wall mounted cassette holder / bucky. A number of ancillary items will also be required including: - radiographic table or trolley or, if the room cannot accommodate this, an examination couch - a chair suitable for positioning clients - positioning wedges / sandbags - lead protection (see the OH&S Section for details) - table or desk for computer hardware - 2 x active computer ports with Internet Protocol (IP) addresses to enable connection to PACS for transmitting and retrieving digital X-Ray images. Ideally, prior to the purchase of X-Ray equipment a Certificate of Compliance for a Radiation Place must be obtained. X-Ray equipment is invariably deemed capital equipment, and therefore proposals for purchase must be channelled via the Remote Health Capital Equipment Group by submitting a request using the Capital Equipment Request Form. Once approved and installed, a New Asset Advice Form needs to be completed and returned to the Department of Business and Employment (DBE) Asset Accounting. DBE will then register the equipment as a Capital Equipment Item and forward out to the PHCM asset labels to be applied to the X-Ray equipment. 4.3 Radiation Protection Regulatory Requirements RHB abides by the requirements of the Radiation Protection Act and Regulations. Detailed information, Codes of Practice and all forms related to diagnostic imaging are available on the DoH Environmental Health - Radiation Protection website. The following information provides the requirements for each health centre with X-Ray facilities: - Certificates of Compliance. See 4.3.1 - Registration of Diagnostic X-Ray Equipment. See 4.3.2 - Licensing Requirements. See 4.3.3

Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009

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REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

4.3.1

Certificates of Compliance

A Certificate of Compliance is required for both the Radiation Place and Radiation Source. These certificates must be renewed at least three yearly. Certificate of Compliance for a Radiation Place When Remote Health Branch is considering the purchase of X-Ray equipment the building plans of the proposed X-Ray room at the health centre and an estimation of X-Ray usage will need to be assessed by an accredited assessor. If the room meets the appropriate standards, the accredited assessor will issue a Certificate of Compliance for a Radiation Place. To meet legislative requirements the Certificate of Compliance for a Radiation Place must be displayed in a prominent location, such as on the wall of the X-Ray room. All other license and registration applications must be accompanied by a copy of a Certificate of Compliance for a Radiation Place. See Radiation Protection Code of Practice: Certificate of Compliance for a Radiation Place. Certificate of Compliance for a Radiation Source Each radiation source must comply with applicable Australian Standards. The Certificate is a letter clearly stating that the radiation source complies with applicable codes. The letter must identify the codes, place and radiation source/s with make, model, serial number or any appropriate identifier if it fully describes the radiation source. The Certificate of Compliance must be placed near or with the unit. See Radiation Protection Code of Practice: Approved Form for Certificate of Compliance. 4.3.2 Registration for Radiation Source and Place 1 All diagnostic X-Ray equipment must be registered. Registration is required once only and there is no cost to DoH Remote Health. There are two registration online forms which must be completed for each health centre with X-Ray facilities. These must be completed by the PHCM and include: - Registration for Radiation Source Online Form - Registration for Radiation Place Online Form. The first two fields in the Registration Forms should be completed per the example provided below. The remaining fields should be completed with health centre specific details.
Owner * Co. Trading Name
First name of Director, RHB Last name of Director, RHB First Name / Last Name Company Name (if applicable

<name> Health Centre, Remote Health Branch

* Mandatory Reporting Field 4.3.3 Licensing Requirements The Radiation Source and Operators must be licensed. All licences must be renewed at least three yearly. Licence to Possess a Radiation Source and Radiation Protection Plan In accordance with the Radiation Protection Act and Regulations a Radiation Protection Plan (RPP) is required. A RPP provides a comprehensive description of all operating or planned radiation related procedures and is linked to a relevant licence to possess a radiation source. The Director Remote Health Branch is the designated person to hold the license to possess a radiation source which includes the requirement to have a RPP for Remote Health. The form Application and Guidelines for a Licence for a Radiation Related Activity in the Northern Territory included as a Radiation Protection Plan and Application for a Licence to Possess should be completed and submitted.
1

Note: Online Registration facility is currently unavailable. Complete forms and send by e-mail / fax to register a Source / Place. Developed by: Quality & Safety Team Page 4 Reviewed: Sept 10, Oct 11, Apr 12, Oct 12, Endorsed by: Remote Executive Leadership Group Release Date: April 2009 Next Review: October 2015

REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

Individual Licence to use a Radiation Source All Medical Practitioners or Remote Area Nurses (RANs) who meet eligibility criteria must obtain a licence to use a radiation source. Eligibility criteria for MOs and RANs differ but both include: - national registration under the Health Practitioner Regulation National Law Act - successful completion of training in performing radiographic procedures recognised and approved by DoH Environmental Health - Radiation Protection. Each individual Medical Practitioner or RAN who meets eligibility criteria must submit an Application for a Licence to the Chief Health Officer to DoH Environmental Health - Radiation Protection. Once the license is granted, staff may perform X-Rays: - within the limitations of the licence conditions. See Radiation Protection Information Sheet No. 802 Diagnostic Radiography, Therapy and Nuclear Medicine - within the limitations of the available X-ray equipment - within the competence of the operator. 4.4 Other Regulatory Requirements 4.4.1 Location Specific Practice Number (LSPN) Health centres where diagnostic imaging procedures are performed, or bases from which mobile diagnostic imaging is used (eg the Medical Practitioner home bases), must obtain a LSPN by registering with Medicare (Diagnostic Imaging Register) if the services are to be claimable. When an LSPN is obtained, this number is utilised for all diagnostic imaging services provided at that site. As of January 2012 all DoH Remote Health LSPNs have been registered by I-MED Network Ltd. I-MED is a private radiology company which reads and reports on DoH Remote Health X-Ray images. I-MED has taken on the responsibility for the accreditation of DoH Remote Health X-Ray facilities (see Section 4.4.2 below), and will claim the entire Medicare fee for X-Rays taken in DoH Remote Health Centres. For details see Diagnostic Imaging Accreditation Scheme. Information specific to the LSPN can be found in Location Specific Practice Number Q&A. 4.4.2 Diagnostic Imaging Accreditation To remain eligible for Medicare Benefit Claiming all health centres providing diagnostic imaging services (X-Rays and ultrasounds) must gain accreditation against the Diagnostic Imaging Accreditation Scheme Practice Accreditation Standards. For details see Diagnostic Imaging Accreditation Scheme and the website of the Department of Health and Ageing approved accreditor, Quality in Practice (QIP). I-MED Network Ltd will claim Medicare fees for X-Rays taken in DoH Remote Health Centres. The following documentation is essential for I-MED to submit for the accreditation process and must be collated and kept in a secure location at the health centre: - equipment licence and registration numbers - equipment service reports - copies of the Radiation Protection Plan - copies of the Certificate of Compliance for Radiation Place - copies of the Certificate of Compliance for Radiation Source - an equipment inventory including the name of each relevant item of equipment, name of the manufacturer and serial number as well as information on registration on the (Medicare) Diagnostic Imaging Register, including LSPN - certified copies of radiation operators licence - certified copies of radiation operators registration with the relevant National Health Registration Board

Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009

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4.5

Training Requirements

Medical Practitioners and RANs must undertake an approved course of training in performing radiographic procedures as one of the requirements in obtaining a licence to use a radiation source. In addition Radiation Operators must undertake appropriate training in relation to the Picture Archiving and Communication System (PACS). Medical Practitioners and Registered Nurses may conduct chest and extremity X-rays after passing a remote operators course, which is available at Royal Darwin Hospital (RDH). This is the preferred training for Remote Health Practitioners as it provides training in performing radiographic procedures, training on PACS and NT legislation. Training provided at RDH includes: - at least 40 hours practical component working with a registered radiographer at Royal Darwin Hospital, and - successful completion of a 3 hour examination. For further details contact the Chief Radiographer at RDH on (08) 8922 8545. The Radiographic Procedures Manual compliments the practical training and can also be used as a reference for the Radiation Operator. This training contributes to ongoing Continuing Professional Development (CPD) required for registration with the relevant National Health Board. This training is also the equivalent of 30 Professional Development Points for Medical Practitioners with the Australian College of Rural and Remote Medicine (ACRRM).
Note: Health Practitioners who undertake / have previously undertaken the course provided interstate will continue to be accepted for an NT Radiation License.

4.6

Occupational Health and Safety

Operators must take all reasonable steps to ensure the safety of staff and clients when operating X-Ray equipment. 4.6.1 Protective Devices Protective devices for clients and staff must meet AS/NZS 4543.3:2000, Protective Devices against Diagnostic Medical X-Radiation. RHB mandates a thickness of 0.5 mm of lead equivalent for these devices. Operators and anyone else who is required to stay in the room must wear protective devices during radiological examination of clients. These devices should be designed so that they can be put on and taken off without assistance. In remote health centres a protective apron must be worn to protect the main part of the body of the operator, including gonad shielding. The limited range of permitted radiological procedures in remote health centres precludes the need for full body protection, gloves or masks. Clients must be provided with protective devices as required, for example, abdominal protection for women of childbearing age and gonad aprons for men. These devices should be designed so that they can be easily applied, be properly placed and where necessary, fixed by the clients themselves. All protective devices must be maintained in good working condition and kept in appropriate storage. Aprons must be hung on a strong hanger (some X-Ray units have a built in hanger). Protective squares should be stored flat. Incorrect storage will reduce the protective qualities of the devices. All surfaces of protective devices must be cleaned with clean soapy water or with alcohol wipes after they have been in contact with a client. 4.6.2 Personal Radiation Monitoring Requirements All operators of radiographic equipment in remote health centres must wear personal radiation dosemeters during their first year of operation as an investigative measure to confirm that the
Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009 Page 6 Reviewed: Sept 10, Oct 11, Apr 12, Oct 12, Next Review: October 2015

REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

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annual acceptable level is not exceeded. After the first year, and following consultation with Management, further monitoring may not be required if the personal radiation dose has not exceeded 1mSv. RHB requires radiation operators to register with Australian Radiation Services (ARS). In line with Australian regulations, ARS will provide the radiation operator and Remote Health Branch with a copy of all dose reports. A final copy will also be filed confidentially and remain at ARS for 50 years. A copy of all dose results is also submitted to the National Dose Registry. Operators are advised to maintain their personal radiation dose records. The Personal Radiation Monitoring Service Registration Form should be utilised to register with the ARS. In the first section of the form, give the contact details of the Director, Remote Health Branch, PO Box 40596, Casuarina, NT 0811. Follow standard procurement processes as per Internal Requisitions to purchase personal radiation dosemeters. For details on management of radiation dosemeters, see the ARS website. 4.6.3 Preventing Accidental Exposure to X-Ray Beam Mobile X-Ray equipment may be used in situations where additional staff or clients are in the vicinity at the time of the procedure. If it is possible for staff and other clients or relatives to leave the room, this should be encouraged. If there is any danger of exposure, the operator must provide appropriate protective devices for those remaining in the room. 4.7 Picture Archiving and Communication System (PACS) All NT Regional Hospitals have made the transition to digital diagnostic imaging. PACS is now in place with provision for storage of Remote Health X-Ray images. The PACS system allows transmission, storage, printing and retrieval of X-Ray images. All remote health X-Ray images will now be transmitted to Alice Springs Hospital and Royal Darwin Hospital for a Radiologist report and storage. Staff must fax the following information to the relevant hospital Radiology Department: - a Radiology Request, providing client and clinical history and noting report only see PACS on the request form - a Medicare Assignment Form signed by the client. When a hard copy of an X-Ray report is received this should be scanned into the clients Primary Care Information System (PCIS) record and filed in the appropriate documents folder. The original hard copy of the report must be placed in the storage archive box. Education and training for PACS will be provided in RDH X-Ray training course.
Note: X-Ray images taken prior to the use of PACS and saved to an individual client identified CD, must remain stored alphabetically in boxes of a suitable size, located in a secure place such as a lockable filing cabinet or cupboard. For appropriate retention and disposal processes see Archiving & Disposal of Records.

4.8

Universal Serial Bus (USB)

Use of USB devices pose a risk of introducing viruses into any ICT systems and this may include Computed Radiography equipment that possesses a USB port. Computer viruses on the Medical Imaging equipment have the potential to cause major service issues in Medical Imaging. To minimise the risk of any infection, no USB is allowed to be placed directly into any Medical Imaging device located in the NT, without the express approval of the NT Manager, Medical Imaging. 4.9 Billing, Reading and Reporting X-Rays I-MED Network Ltd, a private radiology company has undertaken LSPN registration and Diagnostic Imaging Accreditation for all DoH Remote Health X-Ray sites. I-MED also undertake the reading and reporting of DoH Remote Health X-Ray images. I-MED claims the
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REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

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entire Medicare fee when licensed staff undertake an X-Ray in a DoH Remote Health Centre, and it is essential that a Medicare Assignment Form signed by the client is faxed along with the completed radiology request form. 4.10 Repairs and Maintenance Routine maintenance, quality checks and repairs are carried out by the contracted service provider/s. Since different components of the equipment may come from different sources, individual components may be serviced / repaired by different companies. Refer to health centre records for details.

5.

Forms

Radiology Request Form, available in PCIS & Communicare Medicare Assignment Form (MAF), available in PCIS & Communicare Registration for Radiation Source Online Form Registration for Radiation Place Online Form Australian Radiation Services Personal Radiation Monitoring Service Application Form Capital Equipment Request Form Application and Guidelines for a Licence for a Radiation Related Activity in the Northern Territory included as a Radiation Protection Plan and Application for a Licence to Possess Application for a Licence to the Chief Health Officer

6.

References and Supporting Documents

Internal Requisitions Urgent Minor Repairs

Related Atlas Items: Capital Equipment

PCIS User Reference Guide Pathology and Radiology Requests Radiation Protection Act / Regulations Australian Health Practitioner Regulation Agency Health Practitioner Regulation National Law Act applicable for Medical Practitioners & Registered Nurses Health Practitioners Act applicable for Radiographers DoH Radiation Protection website Radiographic Procedures Manual Radiation Protection Fact Sheet No 800 - Radiation Protection Radiation Protection Information Sheet No. 802 - Diagnostic Radiography, Therapy and Nuclear Medicine DoH Radiation Protection Code of Practice Certificate of Compliance for a Radiation Place Approved Form for Certificate of Compliance Australian Institute of Radiography Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) National Directory for Radiation Protection, July 2011 Radiation Protection in the Medical Applications of Ionizing Radiation Australian Radiation Services - provides the following information on request: Quick Overview of the ARS Personal Radiation Monitoring Service Personal radiation Monitoring Service Information Sheet Films Standard Service Charges Australian Government - Department of Health and Ageing
Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009 Page 8 Reviewed: Sept 10, Oct 11, Apr 12, Oct 12,

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REMOTE HEALTH ATLAS Section 23: EQUIPMENT & OTHER ASSETS

X-RAY EQUIPMENT

Diagnostic Imaging Accreditation Scheme About Medicare and Diagnostic Imaging Location Specific Practice Number Q&A Quality in Practice Australian Standards Online Premium - search by standard name or number: AS/NZS 3200.1.3:1996 - Approval & Test Specifications for Medical Electrical Equipment AZ/NZS 4184.3.1:2002 - Evaluation and routine testing in medical imaging departments AS/NZS 4543.3:2000 - Protective Devices against Diagnostic Medical X-Radiation

Developed by: Quality & Safety Team Endorsed by: Remote Executive Leadership Group Release Date: April 2009

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Next Review: October 2015