X-Ray Images Written Evaluation Policy Version 4 Name of responsible (ratifying) committee Radiology IRMER Group through Medical Radiation Committee to Trust Clinical Governance Date ratified 12 February 2015 Document Manager (job title) Louis Merton – Clinical Director Diagnostic Imaging Martin Firth – Consultant Radiologist and IRMER lead Janine Hatch – Imaging Services Manager Catrin Ferioli – Trust Radiation Protection Adviser Date issued 13 February 2015 Review date 12 February 2016 Electronic location Clinical Policies Related Procedural Documents See section 8 of this policy Key Words (to aid with searching) IRMER Written Evaluation Evaluation; Reporting procedures; Radiologists; Medical staff; Reports. Version Tracking Version Date Ratified Brief Summary of Changes Author 4 12/02/2015 Change of document manager names, change of document format IRMER GROUP X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 1 of 13 CONTENTS QUICK REFERENCE GUIDE ...................................................................................................... 3 1. INTRODUCTION ......................................................................................................................... 4 2. PURPOSE ................................................................................................................................... 4 3. SCOPE ........................................................................................................................................ 4 4. DEFINITIONS .............................................................................................................................. 4 5. DUTIES AND RESPONSIBILITIES .............................................................................................. 5 6. PROCESS ................................................................................................................................... 6 7. TRAINING REQUIREMENTS ...................................................................................................... 6 8. REFERENCES AND ASSOCIATED DOCUMENTATION ............................................................ 7 9. EQUALITY IMPACT STATEMENT .............................................................................................. 7 10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS .......................................... 8 APPENDICES: Appendix 1: PHT Radiology department, other departments and procedures supported with X-ray equipment…..9 Appendix 2: PHT Radiology reporting schedule and specialty arrangements……………………………………… 10 Appendix 3: Specialties with arrangements for medical staff to undertake the role of IRMER Practitioner………11 Appendix 4: Exceptions……………………………………………………………………………………………………12 Appendix 5: Access to Radiologists……………………………………………………………………………………..13 X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 2 of 13 QUICK REFERENCE GUIDE This policy must be followed in full when developing or reviewing and amending Trust procedural documents. For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy. The quick reference can take the form of a list or a flow chart, if the latter would more easily explain the key issues within the body of the document 1. This document details means by which statutory responsibilities for making a written record of the evaluation of radiological examinations/procedures are met. 2. The primary duty to ensure that the written record of the evaluation of a radiological examination/procedure is made rests with the referring specialty – referrer (Appendix 2) 3. Written evaluations may be undertaken by others on behalf of the Referrer where documented agreements are in place, e.g. with Radiology for radiologists reports. 4. Referrers are able to seek specialist opinions, assistance or support from Radiologists in the Radiology Access Unit (RAU) (Appendix 5). 5. Referrals for radiological procedures constitute one part of the patient’s management. It is the responsibility of the referrer to ensure that the request is documented to ensure the use of resultant information to inform decisions concerning further management of the patient. 6. Elements of the process may be delegated to a suitably trained and qualified professional but the ultimate responsibility for the quality of medical care rests with the Consultant (Practitioner) responsible for the patients care. 7. Application and effectiveness of this policy is monitored through Audit and overseen through Audit reports and exceptions by the Quality and Governance Committee X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 3 of 13 1. INTRODUCTION All X-ray images taken as part of diagnosis, treatment, ongoing medical management and research must have a traceable record of the image being evaluated by a recognised medical practitioner or allied health professional delegated with this responsibility. This is a legal duty under the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER)1. Any exposure to X-rays is unjustifiable if it is known in advance that the images will not be evaluated. http://www.opsi.gov.uk/si/si2000/20001059.htm 2. PURPOSE This policy will ensure the implementation of the statutory requirement for written evidence of clinical evaluation of medical X-rays in all clinical areas, contributing to appropriately documented medical records. 3. SCOPE The policy applies to the evaluation of all X-ray images of patients referred to and examined in Portsmouth Hospitals Radiology departments, by PHT Radiology staff or by others using X-ray equipment on Portsmouth Hospitals NHS Trust premises, extending also to other departments and services where X-ray imaging is employed in diagnosis and treatment, e.g. Cardiology, Pain Clinic, Radiotherapy, Nuclear Medicine. These are listed in detail in Appendix 1. ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognizes that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ 4. DEFINITIONS Evaluation: A documented evaluation is a record that evidences the examination of an X-ray image, or analysis of X-ray data, leading to a decision concerning the clinical status of the subject related to the initial purpose for which the X-ray exposure was undertaken. From IRMER: "evaluation" means interpretation of the outcome and implications of, and of the information resulting from, a medical exposure; Referrers: All Portsmouth Hospitals and MoD MDHU medical and dental staff are eligible to refer patients for x-ray examinations. Individual allied health professionals can be authorized as referrers for specified examinations by arrangement with the Radiology department. Medical staff using image intensifier equipment are considered to be referrers, unless covered by specified arrangements detailed in Appendix 3 Referrals should conform to the Portsmouth Hospitals Radiology Referral Guidelines (available via the intranet) or be by prior discussion with a Radiologist. Internal departmental procedures will apply where X-rays are part of other investigations or treatments in Nuclear Medicine and Radiotherapy. From IRMER: "referrer" means a “registered healthcare professional” who is entitled in accordance with the employer's procedures to refer individuals for medical exposure X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 4 of 13 to a practitioner; "registered health care professional" means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002." Record: The record may be a Radiologists report, clinicians record in the patients notes which indicates use of the radiological information in diagnosis or treatment, marking up of films or images, treatment decisions or outcomes (e.g. “wires correctly located”) related to the procedure, printed data from analysis of X-ray data (e.g. DEXA scan results). A list of procedures that constitute exceptions is given in Appendix 4 5. DUTIES AND RESPONSIBILITIES Referring specialties are responsible for recording the evaluation of all radiographs, whether returned as films or on PACS. This may be by a delegated allied health professional within the specialty. The responsibility extends to evaluation of features relevant to the clinical question / reason for referral, against which the examination has been carried out.. Exceptions to this are where a report is provided by a radiologist, or as specified in Appendix 2 - PHT Radiology reporting schedule and specialty arrangements. Supporting opinion: Referrers may at any time seek assistance or support from more experienced colleagues within their own specialty, on request from a radiologist in the RAU (Appendix 5 – Access to Radiologists), or by making a specific request to a Radiologist. This may include seeking an opinion concerning a suspicion of abnormal pathology that is beyond the reason for the original referral. Ongoing clinical care of the patient: It is the referrers / referring medical practitioner’s responsibility to make it clear in the notes that a referral for a radiological investigation has been requested. Where images are subsequently provided by radiology, these must be evaluated and a record made in the notes / on PACS by the medical practitioner dealing with the patient at the time, and in consultation with colleagues within the medical team where additional expertise is required. Liability: Medical staff (not trained as radiologists) shall only be responsible for the validity of the evaluation as it relates to the reason for referral and within the scope of their own expertise. Suspicious pathology should however be identified wherever possible and a supporting opinion sought in such cases. Elements of the process may be delegated to a suitably trained and qualified professional but the ultimate responsibility for the quality of medical care rests with the Consultant responsible for the patients care. The referring clinician should liaise with colleagues to discuss interpretation of routine referrals and seek opinions from experienced and senior colleagues in cases where their experience is limited. Use should be made of the RAU (Appendix 5 – Access to Radiologists) to discuss individual cases, areas of suspicious pathology etc. Requests for radiologist’s reports should be the exception where there is no reporting agreement in place. The Patient Safety Steering Group, with support from the Medical Radiation Committee, will oversee the application of this policy in conjunction with agreements and referral practices as monitored by Radiology. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 5 of 13 6. PROCESS ACTION All investigations or treatments using Xrays must have documented evaluation in the patient’s notes. RATIONALE EVIDENCE Adoption of best practice in clinical management of patients. 1 Reference Compliance with statutory obligations under IRMER. ASPECT OF CARE / OUTCOMES EXPECTED STANDARD / TARGET Potential Risks/Harms Unnecessary use of radiological investigations and exposure to X-rays. Inadequate clinical care Risk of enforcement action /prosecution for non-compliance with statutory responsibilities SOURCE OF DATA COLLECTION Periodic audit Written evaluation of X-ray procedure in the patient’s notes 100% of investigations / treatments Radiologists report where required within existing agreements 100% of investigations / treatments External inspection by the CQC IRMER team Periodic audit External inspection by the CQC IRMER team 7. TRAINING REQUIREMENTS Medical staff will have received basic training in the interpretation of X-ray images during the undergraduate and foundation years. Further training relevant to their specialty is acquired during the SPR appointment. Competency will be achieved through completion of the CCST (Certificate of Completion of Specialist Training). This is under the jurisdiction of the Specialty Training Schemes. Non-medical staff undertaking evaluation of images are trained through individual training plans under the supervision of a Reporting Radiographer and a nominated Radiologist. Allied Health Professionals undertaking X-ray procedures within departments of Nuclear Medicine and Radiotherapy will adhere to local procedures approved by their lead Practitioner. Specialty Consultants undertaking the role as IRMER Practitioner must have qualifying training as detailed in IRMER Schedule 2. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 6 of 13 8. REFERENCES AND ASSOCIATED DOCUMENTATION 1 Ionising Radiations (Medical Exposures) Regulations 2000. Statutory Instrument 2000 no 1059 http://www.opsi.gov.uk/si/si2000/20001059.htm also The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006 Statutory Instrument 2000 No. 2523 http://www.opsi.gov.uk/si/si2006/20062523.htm 2 DOH Guidance for IRMER [ARCHIVED CONTENT] The Ionising Radiation (Medical Exposure) Regulations 2000 (together with notes on good practice) : Department of Health - Publications 3 RCR Guidelines – Making the Best Use of a Department of Clinical Radiology Guidelines for Doctors. Sixth Edition http://www.rcr.ac.uk/content.aspx?PageID=995 4 Portsmouth Plain Film Referral Guidelines X-Ray Request Form 9. EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been assessed accordingly Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviour our employees display in the workplace. Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do. We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust: Respect and dignity Quality of care Working together Efficiency This policy should be read and implemented with the Trust Values in mind at all times. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 7 of 13 10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS Minimum requirement to be monitored Lead Tool Frequency of Report of Compliance 100% of investigations / treatments will have written evaluation in patient’s notes CSC Management Team Periodic Audit Annually 100% of investigations / treatments will have Radiologists report where required within existing agreements CSC Management Team Periodic Audit Reporting arrangements Lead(s) for acting on Recommendatio ns Policy audit report to: Annually IRMER Group Annually Policy audit report to: Annually IRMER Group Janine Hatch Imaging Services Manager Janine Hatch Imaging Services Manager This document will be monitored to ensure it is effective and to assurance compliance. The effectiveness in practice of this Written Evaluation of X-rays Policy will be routinely monitored (audited) to ensure the document objectives are being achieved. The standards against which such audits are undertaken are defined in section 6 – Process. In addition: Additional entitlements to non-medical referrers will be developed by the Radiology department and confirmed in IRMER Standard Operating Procedures through the Radiology IRMER Group Exceptions will be identified and reviewed by the Radiology IRMER Group and where significant reported to Patient Safety Steering Group in the IRMER compliance report. Adverse incident forms will be raised for significant non-compliances. All incidents involving ionising radiation exposure are reviewed by the Trust Radiation Protection Adviser and where required, notified to the Care Quality Commission according to requirements of IRMER legislation. The Medical Radiation Committee will be responsible for receiving the results and monitoring action plans as required. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 8 of 13 APPENDIX 1: PHT Radiology departments, other departments and procedures supported with X-ray equipment This appendix lists the Portsmouth Hospitals facilities to which this policy applies for radiological procedures. Radiology departments at Queen Alexandra Hospital (QAH) o Emergency Department at QAH o Dental Units at QAH o Paediatric Department o RDCU o X-ray and scanning Gosport War Memorial Petersfield Hospital Fareham Community Hospital Radiographic procedures on wards and in theatres using mobile Xray equipment at QAH Fluoroscopy assisted procedures in theatres and in departments using mobile C-arm image intensifier systems at QAH Fluoroscopy assisted procedures using permanently installed equipment, or mobile equipment owned by specialties, e.g. Cardiology, Orthopaedics, Radiotherapy Radiographic procedures undertaken with a department’s own Xray equipment, e.g. Orthodontics/Maxillofacial, Nuclear Medicine, Radiotherapy. Breast screening and breast imaging procedures undertaken with mammographic equipment in mobile trailers as part of the Portsmouth Breast Screening programme Radiotherapy treatment planning simulators, CT scanning, and portal imaging devices CT scanning equipment installed at QAH Any additional facility leased, owned or rented by Portsmouth Hospitals is support of its own clinical activity. In addition to the above, this policy shall also apply to individual procedures undertaken by any other organization where a specific arrangement has been made for patients under the care of Portsmouth Hospitals NHS Trust. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 9 of 13 APPENDIX 2 PHT Radiology reporting schedule and specialty arrangements The following investigations and procedures are all the responsibility of Portsmouth Hospitals Radiology department Radiologists; CT Interventional procedures undertaken in the X-ray departments at QAH Fluoroscopy procedures undertaken in the X-ray department at QAH (may also be undertaken by an Advanced Practitioner Radiographer) All General Practitioner imaging procedures referred directly to Radiology Emergency Department radiography (may also be undertaken by a reporting radiographer) Paediatric procedures undertaken in the radiology department (appendix 1) (may also be undertaken by a reporting radiographer) All imaging requested by Non-medical referrers. General adult in and out patient films will not be routinely reported by a Radiologist. Reference should be made to the PHT Plain Film Reporting and Evaluation Policy which discusses this in detail. This list may be added to by agreement with the relevant speciality Unreported inpatient films can be discussed in the Radiology Access Unit (RAU), at regular MDT or clinico-radiological meetings. To avoid unnecessary interruptions to Radiologists in the RAU with attendant risk of errors and reduced efficiency, routine requests for opinions on inpatient or outpatient images can be made by emailing X-ray.scanningresults@porthosp.nhs.uk This group mailbox is reviewed regularly throughout the day and images added to the PACS HOTSEAT worklist for Radiologist review. Clinicians can also request a Radiological report on images by completing a ‘Request for Report on Plain X-ray’ form, available at the reception desk in Radiology Day Case Unit at QAH. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 10 of 13 APPENDIX 3 Specialties with arrangements for medical staff to undertake the role of IRMER Practitioner The following specialties are responsible for the documentation of the evaluation of the radiological procedures, other than those where a referral is made directly to PHT Radiology services. Specialty Consultants undertake the role of IRMER Practitioner for their field by virtue of eligible training (also section 8) and/or local agreement. Radiotherapy / Oncology Cardiology Respiratory Medicine Pain Clinic Gastroenterology Orthopaedics (use of Fluoroscan only) Urology General and Vascular Surgery X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 11 of 13 APPENDIX 4 Exceptions: The following lists those radiological procedures where a documented evaluation is not required; Individual fluoroscopy and electronic radiographic images taken as part of a complex procedure where the information is used to assist a surgical intervention. However the outcome of the procedure must be recorded, and which may include reference to any final image taken for verification or for the patient records. CT fluoroscopy procedures undertaken as part of an interventional procedure. However the outcome of the procedure must be recorded, and which may include reference to any final image taken for verification or for the patient records. Procedures aborted owing to patient or technical factors where no useful information could be obtained. A record must however be made of the fact that the procedure could not be successfully completed. Repeat radiographs as a result of patient or technical factors where image quality is inadequate for the purpose of the procedure. Films or images taken as part of planning a subsequent procedure, e.g. CT ‘scanogram’, testshots for subtraction Angiography Films or images marked up for the purpose of planning subsequent treatment or intervention, including also images for radiotherapy treatment planning. A marking on the image and demonstrable use of the data is sufficient to demonstrate compliance. Examinations undertaken where results are analyzed by computer and retained in storage systems with the original procedure data, e.g. Dual-energy X-ray Absorptiometry scans (DEXA scans) for osteoporosis. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 12 of 13 APPENDIX 5 Access to Radiologists - Radiologist Availability Monday to Friday: RAU 0900 -1700 In the main x-ray dept (RDCU) QAH Saturday and Sunday: 09:00-17:00 – Radiologist available on QAH site – contact via CT. Out of hours – On-call Radiologist at the request of a senior clinician. Community sites – Urgent cases via PACS and request to radiologist at QAH. X-ray Images – Written Evaluation Policy Version: 4 Issue Date: 13 February 2015 Review Date: 12 February 2016 (unless requirements change) Page 13 of 13