FACULTY OF RADIATION ONCOLOGY THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS

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1 Guidelines Medical and Dosimetry Record Storage FACULTY OF RADIATION ONCOLOGY THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS

2 Name of document and version: Faculty of Radiation Oncology, Guidelines for Medical and Dosimetry Record Storage, Version 1 Approved by: Faculty of Radiation Oncology Board Date of approval: 21 October 2011 Date for next review: 2013 ABN Copyright for this publication rests with The Royal Australian and New Zealand College of Radiologists The Royal Australian and New Zealand College of Radiologists Level 9, 51 Druitt Street Sydney NSW 2000 Australia ranzcr@ranzcr.edu.au Website: Telephone: Facsimile: Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and his/her doctor.

3 Table of Contents Introduction 2 Rationale 2 Late Radiation Effects 2 Survival Prospects for Radiation Oncology Patients 3 Medico-Legal Issues 3 Outcomes Research 3 External Recommendations 3 Components of the radiation oncology record 5 Medical Record 5 Prescription Sheet(s) 5 Localisation Images 5 Dosimetry and Calculation Data 5 Portal Images 6 IMRT and IGRT Record Storage (adapted from ASTRO Reference) 6 Image-guidance (IGRT) Summary 6 Faculty of Radiation Oncology Recommendations 8 Reference material 9 Documentation storage guideline 11

4 The Faculty of Radiation Oncology, RANZCR, is the peak bi-national body advancing patient care and the specialty of Radiation Oncology through setting of quality standards, producing excellent Radiation Oncology specialists, and driving research, innovation and collaboration in the treatment of cancer. Vision To have an innovative, world class Radiation Oncology Specialty for Australia and New Zealand focused on patient needs and quality. Our Values In undertaking our activities and in managing the way we interact with our Fellows, trainees, members, staff, stakeholders, the community and all others with whom we liaise, the Faculty of Radiation Oncology, RANZCR, will demonstrate the following values: Quality of Care - performing to and upholding high standards Integrity, honesty and propriety - upholding professional and ethical values Patient orientation - understanding and reflecting the views of Fellows and members and working with them to achieve the best outcomes Fiscal responsibility and efficiency - using the resources of the College prudently. Our promise to the patients We will advocate for the best possible care for individual patients in multidisciplinary meetings and for all patients with government. Our promise to trainees We ensure the highest standard of training in radiation oncology by combining a world-class curriculum with passionate and supportive supervisors. The voice of trainees is valued in Radiation Oncology. Our promise to our Fellows We are a member based organisation that utilises its resources effectively and strategically to fulfil our vision, purpose and core objectives. We strive for best practice and facilitate life-long learning of our members. Our promise to our partners & stakeholders We are a transparent and collaborative organisation that strives to promote partnerships and participation of all relevant stakeholders to ensure that patients across Australia and New Zealand receive a high-quality, timely and appropriate level of care.

5 Introduction This guideline describes the specific short and long-term documentation storage needs in Radiation Oncology, for both hard-copy and electronic storage media. The unique technical and medical aspects of patient care in this discipline are not well understood outside of the profession and this document has therefore been prepared to provide a national guideline approach. The gold standard must be that it is possible to accurately reconstruct the dose distribution, irrespective of the record-keeping practice or form at the institution. Internationally there is very little explicit documentation on the governance requirements for radiation oncology record storage. The conventional Hospital Medical Record requirement for a seven year storage period (or to age 25 for paediatric patients) is inadequate for many cancer patients, even those apparently cured of their disease. The unique issues pertaining to the radiotherapy record have been identified internationally by multiple expert groups. In particular, late complication risks have an extensive evidence base to support their importance for long-term patient care. Failure to document and/or failure to retrieve documentation consistently produce a small number of catastrophic long term radiation complications due to over dosage or failure to cure due to under dosage. Additionally, the dosimetric and clinical record may be required for research, quality improvement, education, health planning and medico-legal purposes. The only Australian recommendations pertaining to Radiation Oncology treatment records have been published by the Australian College of Physicists in Science, Engineering and Medicine (ACPSEM). This group recommends protocol driven storage guidelines for each centre. Additional related material concerning management and retention aspects of medical records in general, technical and laboratory based material and related reference material is included in the references. Rationale Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology Late Radiation Effects In order to achieve cure in many malignancies, or improve survival rates when given as an adjuvant treatment, radiation therapy will produce a fixed probability of late radiation effects, occurring in a variety of crucial organ systems. These effects may not be made manifest for many years following treatment and, in particular, may remain sub-clinical until an additional form of tissue damage, e.g. infection, surgery, trauma or additional radiotherapy/chemotherapy may bring them to light. That is, many late radiation effects may exhibit the property of latency, remaining completely invisible to the patient or any subsequent treating doctor without knowledge of prior radiotherapy treatment. Ongoing good quality care for oncology patients treated with previous radiotherapy requires a minimum standard of accurate knowledge of the dose, fractionation and anatomical boundaries of the treatment delivered. Effective multidisciplinary care from surgical and medical oncology disciplines requires a similar quality of data from these other cancer care providers. 3

6 Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology Survival Prospects for Radiation Oncology Patients Improving survival prospects for both definitive and adjuvant radiotherapy means that a very significant proportion of treated patients will have a normal or near normal life expectancy. For example, patients treated in their middle decades for pelvic malignancy, with adjuvant radiotherapy may have very good 10 year survival prospect. Any subsequent pelvic surgery requires accurate knowledge of previous dose delivery. Failure to appreciate late radiation damage by the surgeon can result in irreparable pelvic organ damage and case fatalities. Similar considerations apply for re-treating recurrent or new malignancies by radiation oncologists or medical oncologists at second cancer treatment centres. Radiation or chemotherapy overdosage can occur without accurate records of previous dose delivery and produce significant morbidity or mortality, a significant risk without accurate records of previous dose delivery. Medico-Legal Issues Late complications from radiotherapy have the potential for medico-legal consequences. In particular, the latent nature of late radiation effects (sometimes 10 to 20 years) means that good risk management practice in this area requires at least a minimum dataset be stored for the patient s lifetime. Outcomes Research Epidemiological, case finding and disease site related studies require comprehensive radiation technical data to be readily accessible. Retrospective studies reviewing second malignancies, radiation complications, as well as more traditional cancer related outcomes would not be possible without secure long-term storage of basic clinical and technical data. A large number of governmental and non-governmental organisations have indicated that comprehensive and accurate outcomes research will form an important component of an accreditation framework. Effective cancer outcome reporting requires 5,10 and sometimes 20 year reporting. Comprehensive, secure and retrievable data storage is required to achieve this end. External Recommendations There are few published recommendations for oncology record storage internationally, however the following gives some guidance. American Health Information Management Association (AHIMA) Retention Standards Health Information Diagnostic Images (such as x-ray films) Registrar of surgical procedures Recommended Retention Period 5 years Permanently Retention of Laboratory Records (Department of Health & Ageing) Health Information Intraoperative frozen section Paraffin Blocks Autopsy (Standard) Forensic and medico legal Recommended Retention Period 10 years 10 years 10 years 20 years (per jurisdiction requirement) 4

7 National Health and Medical Research Council (NHMRC) Require a minimum of 15 years data storage for trial patients. National Health Service (NHS) Oncology including radiotherapy 8 years after conclusion of treatment especially when surgery only involved. Consideration may wish to be given to BFCO (96)3 issued by The Royal College of Radiologists, which recommends permanent retention on a computer database when patients have received chemotherapy or radiotherapy. New South Wales Department of Health Records documenting radiation dose delivery in respect to patients (admitted and nonadmitted) who have undergone radiotherapy treatment (these records are generally held in radiotherapy departments) retain for a minimum of 10 years after patient would have attained the age of 70 or after last attendance which ever is the longer or whether service has received notification of the date of death, 10 years after the date of death then destroy. National Health Service for Scotland (NHS Scotland) 50 years from the date of the last entry or age 75 which ever is the longer. American College of Radiology (ACR) Documentation of delivered doses to volumes of target and non-target tissues, in the form of dose volume histograms and representative cross-sectional isodose treatment diagrams should be maintained in the patient s written or electronic record. As noted 2/18 above, various treatment verification methodologies, including daily treatment unit parameters, films confirming proper patient positioning, and records of physical measurements confirming treatment dosimetry should also be incorporated into the patient s record. (See references for all the above) Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology 5

8 Components of the radiation oncology record Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology Medical Record The clinical record (traditional or electronic) created by the Radiation Oncologist details history, examination findings, imaging and other staging information and outlines a management plan. Subsequent clinical management and follow up is also detailed in this record. In this respect, the Radiation Oncology record is identical with all other medical case records and should be managed using the principles outlined in current State and Federal documents governing areas such as creation, management, storage and disposal. Oncology units in Australia commonly maintain a separate outpatient cancer record which is then subsequently linked to the main hospital record by scanning, HL7 or photocopying clinical notes and letters. Smaller rural units and mixed public private models will often have no link to a mainframe. Other crucial data (private practitioners referral or follow up letters, private pathology, private radiology, technical data) are commonly not scanned/copied or filed in the hospital medical record. This retention guideline applies to both document sets whether they are created, maintained or stored as a single or separate record. Prescription Sheet(s) The prescription sheet details the patient demographics, diagnosis, treatment intent, dose, fractionation and technique used. It records all basic technical data, anatomical data and verification of the treatment delivered. It will also usually contain clinical notes made during the radiotherapy treatment period. Localisation Images Localisation images will record the intended treatment site and exact anatomical boundaries in relation to bony and soft tissue anatomy. These may be 2D or 3D, digital, film or paper based (digitally reconstructed radiographs). Dosimetry and Calculation Data The treatment, planning and delivery process produce a large additional quantity of dose calculation, verification and associated dose volume data (e.g. isodose plots, dose volume histograms, point doses). These data may be in hard copy or digital form and typically may consist of some pages. The following is a representative list of what might be anticipated: Record and verify data Monitor unit calculation sheet Patient set up sheet Iso-centre calculation sheet Manual calculation sheet Photos and diagram Plan checking sheets (from Medical Physicists and Radiation Therapists) Independent monitor unit check Multi-leaf collimator check Multi-leaf collimator calculation sheet Planned summary sheet Planned set up sheet 6

9 Beam energy and calculation sheets Point of interest and iso-centre calculation sheets Dose volume histograms (organ at risk (OAR), planning target volume (PTV), clinical target volume (CTV), gross tumor volume (GTV)) Mould room procedure sheets Simulator work room sheets CT simulation work room sheets Thermoluminescent dosimeter or diode result sheets Incident notification sheets Portal Images During the treatment delivery process a number of treatment verification images will be produced (up to 10 to 40 images, hard copy film or digital based). IMRT and IGRT Record Storage (adapted from ASTRO Reference) Intensity-Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) have additional data storage needs to enable dosimetric re-creation. These should include the following as indicative examples: D95 of the PTV and CTV D100 of the PTV and CTV (i.e., the minimal dose) Mean and maximal doses within the PTV and CTV Percentage of the PTV and CTV that received the prescribed dose (V100) For each OAR, the maximal, minimal, and mean doses, the volume of the organ receiving that dose, and other relevant dose volume data Plan parameters energy, heterogeneity correction and any inverse planning modelspecific parameters Treatment planning goals provide treatment plan goals such as acceptable target dose uniformity variation and minimum dose-volume constraint; dose-volume limits on OARs Treatment Planning Constraint Summary for inverse planned IMRT treatments Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology IGRT Summary Summary forms for image assessment and moves and or 4D methods. Where possible this should be as an integral part of the Oncology Information System rather than as a separate paper record, text or data file. 7

10 Faculty of Radiation Oncology Recommendations Rational storage recommendations require a balance between cost (time, space and financial) and the risks to the individual and benefits to the community as a whole. This guideline is therefore based on a risk management strategy. High risk, low frequency events such as those outlined above dictate that a minimum data set which will support good patient care must be stored for the patient s lifetime. Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology The minimum required dataset should include: 1. medical record 2. prescription sheet 3. localization images This should minimize the administrative and archiving burden on the health organization and may be achieved through hard copy storage or secure long term scanned format. Older systems such as microfiche and commercial propriety storage formats are not recommended due to known quality and backwards compatibility issues. Dual modality storage is recommended (paper and electronic). It is recommended that 3 dimensional datasets be stored as Digital Imaging and Communications in Medicine (DICOM) radiotherapy format rather than proprietary. Lifetime storage of additional data sets (dosimetry and portal images) is seen as practice excellence, but realistically difficult to achieve due to backwards compatibility problems and sheer volume of storage. The rapid pace of software and hardware evolution dictates that a large amount of this data will be unreadable by proprietary systems in 3-5 years time from its creation and therefore will be generally unrealistic to store. The patient held Electronic (or paper) Health Record may be an appropriate method to overcome some of the above problems and the Faculty supports initiatives in this area. 8

11 Reference Material NSW Department of Health circular number 98/59 (Principles for creation, management, storage and disposal of health care records) European Society for Radiotherapy & Oncology (ESTRO) Recommendation for a Quality Assurance Program in External Radiotherapy booklet no. 2 (European Society for Therapeutic Radiology in Oncology) ACR (American College of Radiology) Department of Standards and Accreditation ACPSEM position paper recommendations for the safe use of external beams and sealed brachytherapy sources in radiation oncology (M Millar et al), vol 20, no 3, September 97 (Australasian Physical and Engineering Sciences in Medicine) The Center for Information Technology Leadership The Australian Record Retention Manual 2007 Edition - American Health Information Management Association (AHIMA) hcsp?ddocname=bok1_ Notice of Information Technology (IT) Standards under the Electronic Transactions Act 1999 or Electronic and Paper Requirements for The Retention of Laboratory Records and Diagnostic Material Appendix 1 - State and territory legislation relating to the retention of laboratory records and diagnostic materials Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology Clinical Information Project Phase I Report Stream 1 Clinical Information framework B7ECC/$File/cipp1aa.pdf Part A Background and Context 31 Nature of Report hconnect/publishing.nsf/content/ba6dce09ca000739ca b7eb1/$file/ehr_pta.pdf k - [ pdf ] - Cached - 20 Jul 2000 Queensland State Archives Discussion paper for meeting RANZCR and DoHA (radiology and Agreement by radiologists that diagnostic image delivery is a core component... image retention policy (how long to keep images); required image quality... Health Record Retention Schedule File Format: PDF/Adobe Acrobat - View as HTML Patient/Client treatment and care State Records NSW 9

12 Records Management: NHS Code of Practice (Scotland) Version 1.0, 1 Jul Cached - Similar Board of the Faculty of Clinical Oncology (BFCO) (96)3 yid=ranzcr&txtfilename=acf4e02 Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology American Society for Radiation Oncology (ASTRO) recommendations on IMRT Documentation 10

13 Documentation storage GUIDELINE ITEM Medical Record: Original or Hardcopy or e copy Oncology Record: Original or Hardcopy or e copy Prescription Sheet, localisation image/drr; isodose distribution, set-up details: Original or hardcopy. Images, portal, EPID image: Original or Hardcopy Images, localisation, portal, EPID image proprietary digital format Tech data: DVH, calc sheets etc. hardcopy Tech data: DVH, calc sheets etc proprietary digital format Minimum Standard of Care lifetime lifetime lifetime 7 years lifetime Compatibility lifetime* - 7 years lifetime Compatibility lifetime* - * Suppliers of digital storage modalities to be requested to ensure onwards compatibility of storage media Excellent Standard of Care lifetime +5 years lifetime +5 years lifetime +5 years Guidelines for Medical and Dosimetry Record Storage Faculty of Radiation Oncology 11

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16 THE ROYAL AUSTRALIAN AND NEW ZEALAND COLLEGE OF RADIOLOGISTS