Response to the Proposed Changes to DIAS Standards Introduction The Faculty of Clinical Radiology of the Royal Australian and New Zealand College of Radiologists (RANZCR) is the peak bi-national body for setting, promoting and continuously improving the standards of training and practice in diagnostic and interventional radiology for the betterment of the people of Australia and New Zealand. The Faculty undertakes a range of activities to exercise its responsibility for setting, promoting and continuously improving standards practice in diagnostic and interventional radiology. The chief of these activities is to maintain a structured suite of standards, The RANZCR Standards of Practice for Diagnostic and Interventional Radiology. While these standards are designed for Radiologists, they are relevant to all practice settings where diagnostic imaging is performed. RANZCR welcomes the opportunity to provide feedback on the proposed revisions to the Diagnostic Imaging Accreditation Scheme (DIAS) Standards. As the Department will be aware, RANZCR has advocated for many years for improvements to DIAS. As the Department is aware, we are also advocating for prompt implementation of The DI Reform Package: A Quality Framework to underpin sustainable quality Medical Imaging which advocates for regulatory reform to the Diagnostic Imaging Services Table (DIST). We are disappointed that the proposed revisions to DIAS do not go far enough. RANZCR recently submitted a list of priority standards which we believe can and should be incorporated into DIAS, which is attached below for ease of reference. We would be grateful if the Department could consider going further with this revision to DIAS. We have made reference to specific changes which we believe could easily be incorporated in our comments below. We would be happy to meet with you in person to discuss any aspect of this response in more detail if that would help. General Comments on Proposed Changes Notwithstanding the position outlined above, RANZCR welcomes the improvements to the structure and clearer layout proposed for the DIAS Standards. We also welcome the explicit references to tasks that must be completed by the provider. We have significant concerns about the requirements for self-audit. We believe these are too weak, in particular where the provider self-selects a sample for audit which features in Standards 2.1, 4.1 and 4.2. This is not best practice as it allows a provider to pick and choose which records it wishes to share for DIAS accreditation, rather than adopt a systematic approach to their record keeping. It would be more appropriate for the random selection of records to be assessed to determine compliance with the applicable standard. We have provided specific examples of this below. We would also welcome greater specificity on the frequency with which certain tasks be completed. This should not be left open to interpretation. For example, there appears to be no requirement to check the registration status of practitioners annually in Standard 1.2. As the Department will no doubt recognise, APHRA registration is an annual process and practitioners might lose their registration at any time in between. We believe that Standard 1.2 should require annual checks of APHRA registration to ensure that practitioners providing services under the DIST are registered appropriately. Level 9, 51 Druitt Street, Sydney NSW 2000, Australia Ph: +61 2 9268 9777 Fax: +61 2 9268 9799 Web: www.ranzcr.edu.au Email: ranzcr@ranzcr.edu.au ABN 37 000 029 863 Specific Comments on Each Standard DIAS Standard 1.1 This standard is consistent with the RANZCR Standards of Practice and we have no further comment. DIAS Standard 1.2 We are concerned that the term ‘where relevant’ is open to local interpretation. We would favour a statement outlining that ‘the evidence required varies according to the services being provided. The practice must ensure that all relevant requirements are met.’ The accreditation requirements for sonographers should be specified for regional locations in the same manner as it is for metropolitan locations. We also recommend expanding the qualification standard to include professional competence requirements, as per the RANZCR Standard 5.2 Professional Competence: The practice shall ensure that where there are specific competencies required for a particular imaging examination, the personnel involved with that imaging examination are suitably qualified and experienced. DIAS Standard 1.3 This standard is consistent with the RANZCR Standards of Practice and we have no further comment. DIAS Standards 1.4 This standard is consistent with the RANZCR Standards of Practice and we have no further comment. DIAS Standard 1.5 RANZCR has no issue with the proposed wording for Standard 1.5, however we strongly recommend that the requirements for equipment maintenance be expanded. RANZCR appreciates that there may be some cost involved in the application of a more robust equipment maintenance standard incorporating quality assurance activities, however we do not feel that these would be onerous, and believe the benefits to patient safety would outweigh these costs. Programs such as the RANZCR quality assurance for Mammography and MRI equipment are available, as outlined below. These programs are required under the RANZCR Standards and participants regularly voice appreciation for the feedback and subsequent improvements to the quality of service they provide. - Mammography Quality Assurance Program (MQAP) supports the provision of consistent, high quality mammography services. It provides sites with: o Assurance to patients that diagnostic mammography services are performed using lowest possible radiation dose while maximising diagnostic quality. o Expert peer advice and support to imaging teams to support continuous quality improvement in mammography practice. o A mechanism to allow the life of mammography equipment to extend from 10 to 15 years (capital sensitivity). Further information about MQAP is available on the RANZCR website - MRI Quality Program provides a quality framework for the professional supervision and quality assurance of clinical images produced by MRI services. o Patients and referrers are assured MRI services meet quality benchmarks. o Provides expert peer advice/support imaging teams to support continuous quality improvement in MRI practice. o Medicare Regulations require participation in the program as a condition of Medicare license for individual MRI systems. Further information about the MRI Quality Program is available on the RANZCR website 2 - RANZCR has also produced several equipment specific guidelines to assist practices in implementing quality assurance programs. These provide practical instructions on quality control testing, and have received very positive feedback from practices, who consider them a very helpful resource in maintaining the performance and safety of equipment. It is RANZCR’s intention to expand the range of guidelines to progressively cover other modalities in future. o Guidelines for Quality Control Testing for Digital (CR/DR) Mammography V3 o General X-ray QA and QC Guideline o CT Image Review Self-audit o Fluoroscopy QA and QC Guidelines – due to be published in early 2015. If it is not possible to include such requirements in DIAS at this stage, we would welcome the inclusion of a footnote which signposts providers to the RANZCR quality assurance programs, QA and QC guidelines and any other such programs. The RANZCR Standards of Practice recognise the critical role of monitor quality in the diagnostic imaging process and we strongly recommend the inclusion in DIAS of RANZCR Standard 3.6.3 Monitors. We would also like to remind the Department of the existence of RANZCR Standard 3.11.2 Quality Control Testing – Diagnostic Workstations and Teleradiology which we would like to see incorporated in future revisions. DIAS Standard 2.1 RANZCR recommends including a third subclause (c) which should read: The identified clinical need should be clearly noted in the patient record, for example by retaining a copy of the request or clinical notes which determine its necessity and benefit to the patient. RANZCR recommends addressing inappropriate requests with RANZCR Standard 5.3.2 Review of the Request, Indicator 5, therefore replacing paragraph two under Required Evidence with the following: When a request contains insufficient information to determine the appropriateness of the request, the practice has documented procedures which ensure that all reasonable attempts are made to obtain the required information as necessary from the referring practitioner, and/or consultation with the patient to clarify information provided in the request is carried out as necessary. DIAS Standard 2.2 Under Required Evidence the dash point list has a layout error and the following should read as one point: - Allergies – medical conditions such as diabetes, kidney disease or heart disease The following sentence is unclear as the sample is not intended to be shown to the patient, rather it should be available to the accrediting body. RANZCR recommends rewriting this line: From: A sample of records documenting risks have been advised to the patient. To: A sample record must be provided that demonstrate that these risks have been advised to the patient. Please refer to paragraph two of our General Comments on Proposed Changes above on selfselected audit. DIAS Standard 2.3 This standard is consistent with the RANZCR Standards of Practice and we have no further comment. DIAS Standard 2.4 This standard is consistent with the RANZCR Standards of Practice; however RANZCR recommends expanding it to include specific requirements for the administration of contrast media due to the risk of adverse reactions, which in extreme cases may result in death. These requirements should only be applicable to practices that perform examinations using contrast. 3 The Standard should therefore include: Requirement for resuscitation equipment – see RANZCR Standard 3.5 – Equipment Resuscitation Requirement for protocols for screening patients – see RANZCR Standard 5.4.2 – Performance of the Imaging Examination – Administration of Contrast Requirement for safety protocols for managing adverse reactions, including a designated staff member who holds current CPR certification – see RANZCR Standard 6.5 Use of Contrast Media. DIAS Standard 3.1 As mentioned in paragraph two of the Introduction, RANZCR is committed to advocating for the implementation of the Quality Framework. One of the priorities addressed in this paper is professional supervision. As an incremental approach to achieving more robust professional supervision requirements in future iteration of DIAS, RANZCR recommends including a requirement for professional supervision in line with RANZCR Standard 5.4.1 Performance of the Imaging Examination, which states: Documented imaging protocols shall be available and include all necessary information for the proper conduct of the examination taking into account any specifications for the required qualifications, experience and specialisation of the personnel. Where specific tasks are delegated to members of the medical imaging team, the protocols shall indicate any specific circumstances under which personnel shall seek further guidance and/or input from the supervising medical practitioner. DIAS Standard 3.2 RANZCR supports the expansion of this standard to require practices to monitor radiation dose, however we believe that a step-by-step guide on how to meet this standard is required for practices to be able to meet the requirements. RANZCR is available to support the development of this guide. A stepwise approach may be initially to require practices to implement quality control testing, for example implementing a guideline such as the RANZCR Fluoroscopy QA and QC Guideline (currently in development). The subsequent iteration of DIAS could consider more robust dose monitoring requirements. DIAS Standard 4.1 Please refer to paragraph two of our General Comments on Proposed Changes above on selfselected audit. DIAS Standard 4.2 We have major concerns that the provisions for self-determined service providers to document the diagnostic imaging procedure ‘in the form of a report, letter or other correspondence’ is wide open to local interpretation. This standard should more closely follow the requirements set out in Standard 4.1, for example by requiring a clear and concise written report to be included in the patient record. This change would deliver consistency with the stated requirement in the note DIG of the DIST which states: The records must include the report by the providing practitioner on the diagnostic 1 imaging service (see Page 36 of the DIST). We believe this would have several benefits for patient care as it would: provide consistency for patients and GPs allow other clinicians subsequently to benefit from the imaging procedure assist in preventing duplicate imaging. 1 Medicare Benefits Schedule Book, Category 5, March 2014 http://www.health.gov.au/internet/mbsonline/publishing.nsf/Content/2F8294726E8247C8CA257C7000 1292AD/$File/201403-Cat5.pdf 4 Moreover, diagnostic imaging is anticipated to be added to the Personally Controlled Electronic Health Record (PCEHR) in December 2014. As other specialties are added to the PCEHR, their reports can in due course be made available to the patient and subsequent clinicians. In the meantime, the patient’s GP could upload a copy of the report to the PCEHR therefore allowing others to benefit from the procedure. Guidance has already been issued by RANZCR on the provision of written reports in diagnostic imaging which we would be happy to make available. We would strongly recommend rewording Standard 4.2 as follows: When the service is a self-determined service, information about the findings of the diagnostic imaging procedure must be documented in the form of a clear and concise written report which is retained in the patient record. Please refer to paragraph two of our General Comments on Proposed Changes above on selfselected audit. Conclusion We look forward to the development of new standards and await proposals from the Department for: NSQHS, Ultrasound, Supervision and eHealth, as outlined in the Minutes of the DIAS Monitoring and Implementation Committee meeting on 26 March 2014. RANZCR is happy to assist in any way we can in the development of these standards. We hope these comments are helpful to the Department. As noted above, we would be happy to meet with you to discuss this in further detail. We intend to publish this response on the RANZCR website in due course. Please let us know if this causes you any difficulty. The Royal Australian and New Zealand College of Radiologists August 2014 Attachment: Priority Standards List 5