CENTRAL ADELAIDE LOCAL HEALTH NETWORK SOUTH AUSTRALIAN MEDICAL IMAGING
LMH MEDICAL IMAGING Department Guideline: Services for Clinical Trials CALHNPr:[xxxxx] [SUBJECT]
1. PROCEDURE INTENT/OVERVIEW To explain the Services provided for Clinical Trials and Research To explain the Process for Trial support and associated Fee structures
2. SCOPE All LMH Medical Staff All LMH Medical Imaging Staff
3. WORK HEALTH AND SAFETY The responsible manager requesting that the employee undertakes this instruction must ensure the individual receives adequate information, direction / supervision, induction, training and support to fulfil their responsibilities in line with requirements documented in this procedure.
Personnel following this procedure have a duty of care for taking reasonable steps to protect their own health safety while at work, ensuring they understand the purpose of this instruction and risk based control measures introduced to eliminate, or minimise harm as far as practicable.
4. PROCEDURE DETAIL 4.1 Services
Page 1 of 10 The Medical Imaging Department provides services for research for departments across The Lyell McEwin Hospital. Imaging modalities include:
o General X-ray o Computed Tomography (CT) o Magnetic Resonance Imaging (MRI) o Fluoroscopy o Ultrasound o Mammography o Angiography o Digital Imaging (PACS)
4.2 To Obtain Imaging for Trials / Research Projects: 4.2.1 Please complete the ‘MEDICAL IMAGING DEPARTMENT CLINICAL RESEARCH QUESTIONNAIRE’ Form. To assess if Medical Imaging can provide you with the services you need, the Medical Imaging Department will need to know the imaging modality, how many subjects are expected, the frequency of visits, duration of the study and any other study specific requirements. 4.2.2 The Medical Imaging Department will assess the request and seek more information if required 4.2.3 Imaging Protocol A copy of your imaging protocol is essential. If your imaging protocol is different to the standard protocol used by the department it will be incorporated into the suite of protocols programmed into the appropriate imaging system. A meeting with the modality supervisor to discuss your imaging protocol should be arranged prior to the commencement of your study. Please contact Medical Imaging on 8182 9999. 4.2.4 Please note that all studies involving either diagnostic or therapeutic ionising radiation are to be reviewed by the Medical Physicist of the hospital.
Page 2 of 10 CENTRAL ADELAIDE LOCAL HEALTH NETWORK SOUTH AUSTRALIAN MEDICAL IMAGING
4.3 Once Preliminary Approval is provided by Medical Imaging: 4.3.1 Please fill in and submit the ‘MEDICAL IMAGING TRIAL APPROVAL’ form (only once Ethics and Governance approval has been obtained). 4.3.2 Please do not begin to book patients for examinations until this form has been completed and required signatures obtained.
4.4 Request Forms 4.4.1 The request forms must have the technical and trial information required for correct registration and imaging. This ensures that the correct imaging is performed on all your participants and must specify whether the imaging should be bulk billed or charged to the trial.
4.4.2 Please note: even if the required imaging is ‘standard of care’ there are trials where the Sponsor or Investigators require the imaging to be done differently to what is routinely done at LMH. This technical information MUST be captured on your Request Form , so please ensure that you use it for all your participants, -- i.e for both standard and additional to standard of care imaging. You will not be billed for standard of care imaging when the Request Form stipulates ‘standard care’ and examinations are medicare billable. The Request Form must specify if the imaging should be charged to the trial.
4.5 Scheduling / Booking 4.5.1 Every effort will be made to provide you with reliable scheduling for research Imaging. Often designated days are set aside for research appointments. You can discuss streamlining your booking requirements with the modality supervisor and trail coordinator.
4.6 Copies of Images and Reports 4.6.1 Imaging at LMH Medical Imaging is digital. Copies of de-identified images on CD can be requested. (The Trial agreement form will reflect these requirements prior to the trial commencing). 4.6.2 If you require the study name, participant and site ID number to be to be printed on the CD/DVD this MUST be included on your Request Form. 4.6.3 For reporting, please specify the number of reports you require and to whom they should be forwarded.
4.7 Imaging Equipment 4.7.1 Sponsors of clinical trials often require information regarding the type of imaging equipment that is available at the site. Any Site Survey Forms required by sponsors will be completed for you on request. Equipment maintenance logs are available on request.
Page 3 of 10 4.7.2 A list of the equipment as of April 2016 is below: Computed Tomography Scanner 1 Hardware Toshiba– Helical, multislice (320 slice) Software Aquilion ONE version 4.63 Slice thicknesses available 0.5, 1, 2, 4, 5, 7, 8, 10mm Contrast power injector Medrad Stellant Scanner 2 Hardware Toshiba– Helical, multislice (64 slice) Software Aquilion 64 V3.5 ER 004 Slice thicknesses available 0.5, 1, 2, 4, 5, 7, 8, 10mm Contrast power injector Medrad Stellant
Magnetic resonance imaging (MRI) Philips Intera 1.5 Tesla
Ultrasound 6 x GE Voluson E8 and E9
General X-Ray Siemens Ysio System
Page 4 of 10 CENTRAL ADELAIDE LOCAL HEALTH NETWORK SOUTH AUSTRALIAN MEDICAL IMAGING
Carestream Evolution Philips Optimus (x 2)
Fluoroscopy Siemens Artis Zee MP
Angiography Toshiba Infinix (Cardiology Cath Lab)
Mammography Philips Mammo Diagnost
Page 5 of 10 4.8 FEES 4.8.1 Setup Fee $500 (for trials other than MRI), $1000 (for MRI trials) 4.8.2 The site setup fee is to cover the administration of the imaging required for any research project. It is broad in nature and each trial has specific demands. The fee is an average of the costs associated with this work.
4.8.3 The setup fee covers the costs associated with: o review of research and imaging protocol including any specific imaging and reporting requests o training imaging staff as per the study protocol o coordination with investigators and/or liaising with sponsors and patients as required o completing site survey forms, ethics information, radiation advice o attending trial / initiation / review meetings as required o maintaining digital records and issuing billing o maintaining records, data storage, handling of confidential information o disposal of trial information on completion of trial period o cancellation of a trial once commenced o loss of revenue due to inability to bill Medicare for certain Imaging exams. (E.g. MRI)
Please note that additional setup fees may be required for some Nuclear Medicine services. In addition, setup fees may be negotiated from time to time under special circumstances.
Page 6 of 10 CENTRAL ADELAIDE LOCAL HEALTH NETWORK SOUTH AUSTRALIAN MEDICAL IMAGING
4.8.4 Imaging Fee
The imaging required for a research study can be classified as either ‘additional to standard of care’ or as ‘standard of care’. Imaging that is above standard of care will be billed to the trial. (Exceptions to this are if the imaging is unable to be billed to Medicare – e.g. Non rebateable MRI scans)
In addition to the imaging, including that which is standard of care, you may require other trial specific services to be completed for compliance with the study protocol e.g. providing de-identified images, data dumps, specified reporting. These activities are additional to the standard procedures in imaging; they take time to complete and if required a fee will be calculated and charged to the study.
The imaging fee applies on a per examination request basis, as determined using the Medicare Benefits Scheme and the time required for any other study specific requirements. The fee will be specified prior to the trial / research commencing.
4.8.5 Fees for research trials may include but are not limited to:
Page 7 of 10 o Copies of images on CD or hard drive - $50 per study (+ $10 each copy CD) o 3D reconstructions of images (1/2 hour of AHP3 time incl oncosts) - $43.10 o Data dumps (AHP2 hourly rate incl oncosts) - $52 / hr o Hard copy Film - $50 per study + $2 per sheet o 100% of Medicare scheduled fee for each relevant item number (contact Medical Imaging) o Overtime for AHP staff where trials have been negotiated to occur outside regular working hours - $78 / hr per staff member o Recall rates for AHP staff where trials have been negotiated to occur outside regular working hours as a recall ($78x3)- $234 per recall per staff member o Radiologist Consultant reporting time - $250 / hr
Page 8 of 10 CENTRAL ADELAIDE LOCAL HEALTH NETWORK SOUTH AUSTRALIAN MEDICAL IMAGING
5. RESEARCH / TRIAL IMAGING HOURS OF OPERATION Regular Hours: Monday – Friday: 08:30 – 17:00 After Hours: Refers to all Public Holidays and all times outside regular hours. Recalled to work: A Staff member who has been asked to return to work outside of their regular hours.
6. SUPPORTING MATERIAL
6.1 Resources and Forms ‘MEDICAL IMAGING DEPARTMENT CLINICAL RESEARCH QUESTIONNAIRE’ ‘MEDICAL IMAGING DEPARTMENT TRIAL APPROVAL’ ‘MBS Fees for Trials’ spreadsheet
7. REFERENCES Medicare Benefits Schedule
8. VERSION TRACKING The most recent version details should appear first on the list Revision of this document subsequent to date of printing or downloading may render hard copy text obsolete. Check Version Number on the eCentRAHl System. Version Effective From Change Summary Effective To 1.0 Apr 2016 First draft Apr 2017
9. AUTHORISATION
Author/Originator: Authorisation: [Ms. Stav Kondopoulos [Prof. Michael Sage Campus Operations Manager Campus Clinical Head Medical Imaging - LMH Medical Imaging - LMH
END OF INSTRUCTION
Page 9 of 10 Appendix 1
TITLE OF APPENDIX
END OF APPENDIX 1
Page 10 of 10