EURATOM Booklet. Ready for February 6th 2018?

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1 EURATOM Booklet Ready for February 6th 2018? February 6 th 2018 will see the introduction of the new EURATOM directive 201/59/. This is the deadline when you must have the necessary framework in place as per the EURATOM directive that was enacted on December 6 th 201.

2 What is the EURATOM 201/59/ Directive? The New EURATOM 201/59/ Directive comes into Force on February 6th 2018 The EU directive-regulation is responsible for establishing EU legislation for nuclear radiation known as the EURATOM Treaty. The EURATOM Treaty creates and enforces basic safety standards for the protection against dangers arising from exposure to ionizing radiation A replacement for existing EURATOM safety standard directive: 96/29/Euratom Integration of the following into one comprehensive directive repealing the 96/29/ Euratom &..»» 89/618/Euratom - informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency»» 90/641/Euratom - operational protection of outside workers exposed to the risk of ionizing radiation»» 97/4/Euratom (Medical Exposures) - general principles of the health protection of people against the dangers of ionizing radiation from medical exposures»» 200/122/Euratom - prevent exposure to ionizing radiation arising from inadequate control of high-activity sealed radioactive sources and to harmonize controls in the EU Member States Enacted December 6th 201 The directive establishes uniform basic safety standards for the protection of the health of individuals subject to occupational, medical and public exposures against the dangers arising from ionizing radiation 6 February Why is this important to your radiotherapy service? Requires you to establish new safety standards for ensuring the safety of patients and staff exposed to radiation Changes in terminology presents a new meaning to achieve compliance, which will expose 99% of radiotherapy centers in terms of current working practice Equipment providers must now also comply with the directive, but it will be your responsibility to ensure that they do when purchasing their equipment What are the consequences of the directive? All findings of an inspection will be made public Failure to comply with the directive could result in the withdrawal of your license to operate Need help? Want to find out more? Contact us at info@humediq.com for a consultation 2

3 Key changes in EURATOM 201/59/ Directives regarding Medical Exposures 11 New requirement for External Beam Radiotherapy Equipment such equipment shall have device-design solution to verify treatment parameters 12 New requirements added for Equipment used in Interventional Radiology - such equipment shall have device-design solution for: a. Confirming quantity of radiation produced by the equipment during the procedure b. CT, Planning; Equipment for planning, positioning, treatment verification Providing relevant parameters for assessing dose delivered at end of procedure c. Ability to capture and export all treatment information for the purpose of an audit 1 Under section Special Practices (e.g. involving high doses radiotherapy) responsible persons shall undergo continuous education 14 Introduction of comprehensive requirements for Accidental & Unintended Exposures a. Concept of minimization is introduced. No longer acceptable to to just reduce b. For radiotherapy practice, a complete Risk Analysis shall be undertaken & documented considering the risk minimization principle c. Establish system(s) for the record keeping and analysis of events involving such exposures d. Documented procedure to inform the practitioner of such exposures 1 Strong emphasis on Quality Assurance and Risk Assessment in radiotherapy to include recording, reporting, corrective actions 2 Now Includes the provision of exposures to asymptomatic individuals which shall be justified & optimized Optimization principle for non-target volumes & tissues to include risk minimization approach with a focus on as low as possible mandate 4 Optimization is no longer considered as a process, but now as an absolute necessity 5 Responsibilities now explicitly state that a practitioner, medical physics expert or others delegated shall be involved in ensuring optimization 6 Responsibilities now explicitly state that a Practitioner provides information to patients, or associated representative, with adequate information pertaining to the benefits and risks associated from medical exposures 7 Part of QA procedures functional protocols to be established for each equipment item, including those specific for patients 8 Part of QA procedures reports to be generated that include information about patient exposure 9 Equipment acceptance testing is to be done after every maintenance based assessment of liability of such maintenance on performance 10 For defective equipment, it is no longer acceptable to only take remedial action, but now also to take corrective actions e. Establish system(s) to allow for the reporting of accidental or unintended exposures, including results of an investigation and/or corrective actions taken to include specified timelines set for compliance by authorities 15 For any equipment acquired, you will be responsible to ensure you have received from the manufacturer adequate information about its potential radiological hazards and its proper use, testing and maintenance protocols, and design permits confirming how the device restricts exposures to a level which is as low as reasonably achievable 16 For equipment acquired, you will be responsible to ensure you have received from the manufacturer adequate information pertaining to the risk assessment relating to patients, as well as available elements of the clinical evaluation 17 Under the section of Transparency a new requirement is introduced that requires justification and that risks-benefit information is adequately provided to everyone involved in medical exposure situation 18 Introduction of a new role called Radiation Protection Expert and associated key responsibilities 19 Role & responsibilities of Medical Physics Expert is expanded to now include: a. QA programmes with risk based approach including equipment b. Surveillance, investigations & corrective preventive actions against incidents and adequate optimisation 20 Increased system for inspections 21 Stricter enforcement provisions 4 5

4 Patient Identification The Risk-Minimization Principle & IDENTIFY s Risk-based-approach The IDENTIFY Palm Reader identifies the patient through IDENTIFY AT A the scan of her or his unique hand vein profile. On each treatment day, IDENTIFY verifies that the right patient will be GLANCE treated with the right setup. If the wrong patient scans their palm, IDENTIFY will alert the therapist and will prevent the workflow from proceeding. Accessory Identification The Risk-Minimization Principle The aim of risk minimization is NOT only to reduce an identified risk, but to minimize it as far as is possible. Minimization is the key word used within the new EURATOM Directive and is defined as reducing the risk to the lowest means possible. In principal, the process to ensure risk minimization is to first identify the failure modes and hazards within your processes and procedures. This will highlight the corresponding potential rootcauses and why they occur, which in turn will direct you to the corrective actions that need to be taken. It is important to note that the introduction of risk minimization within the new Directive provides a new emphasis that has to be seriously considered when devising your solution(s) to resolve the risk/ cause(s). IDENTIFY S Risk-based-approach IDENTIFY has been designed to assist care providers in delivering safer, more accurate treatments for their patients. At its heart, IDENTIFY is focused on mitigating risk. Through automation, IDENTIFY delivers an optimized solution for streamlining processes resulting in significant efficiency gains, while at the same time doing so in a safe and effective manner. Effectiveness IDENTIFY Automation Simplification Checklists Policies Training How IDENTIFY addresses compliance of EURATOM 201/59/ Directive? The new EURATOM Directive is clear in its mission and purpose to reduce risk to the lowest means possible. With the introduction of highly precise, potentially lethal technologies / medications, combined with an ever increasing workload, the associated risk factor is magnified from a number of perspectives. humediq s IDENTIFY solution will provide you with the ability to achieve compliance of the directive through automation in relation to: Correctly identify the patient Correctly ensure the correct equipment / medication is being provided IDENTIFY uses a RFID reader, which automatically recognizes accessories while they are being positioned on the treatment couch. IDENTIFY will display a shopping list of accessories required for that specific treatment. IDENTIFY clearly indicates missing or wrong accessories. Accessory Navigation/Positioning Using Augmented Reality Guidance, IDENTIFY also assists therapists with correct navigation and positioning of accessories. Therapists are given the green light when the correct accessories are correctly positioned. Patient positioning & Motion IDENTIFY guides the clinical staff to the ideal position at isocenter using 6 degrees of freedom. Continuous monitoring of your patients using the state of the art IDENTIFY cameras is the next level of precision in radiotherapy. From Setup Confirmation, IDENTIFY monitors the patient position and shows the clinical staff the degree of motion. Risk Minimization will inevitably result in the need to incorporate automation to remove, where possible, the human factor, as well as to simplify the deployment of the new processes and procedures. Highest Safety Standard Distractions in busy clinics can potentially lead to errors. Interlock provides the highest safety standard. The IDENTIFY Interlock ensures that the treatment cannot start if the patient, location, or setup have not been confirmed. Correctly and consistently reproduce the positioning of the patient Continued monitoring of the patient throughout treatment Full audit documentation (both in text and trough images) of all activity site ready for inspection Tracking of Target Volume & Patient Motion IDENTIFY cameras allow full head-to-toe orthopedic surface capture enhanced with a defined region of interest. These features assist in easy and accurate patient positioning. 6 7

5 Patient Identification Patient Identification with IDENTIFY PALM RISK MITIGATION Wrongly identified patient Correct patient identification Incorrect documenting/record keeping of patient ID Correct record keeping of patient ID Welcome desk Treatment Suite Missing to ask the identification questions Patient confirmation questions not missed or integrated Incorrect data entry of answer(s) provided to asked questions Answers cannot be entered incorrectly Patient purposely giving incorrect information for identification questions Patient information records cannot be mixed Patient information (records) mix-up Errors in documenting Full audit trail of patient registration, time and date; and any overrides. Several images of the patient saved in reporting. IDENTIFY SAFETY MEASURES ENSURE: With IDENTIFY PALM now you can have a simple, easy and extremely SAFE patient identification system throughout the entire department. In the Treatment Suite, only when the right patient is recognized the system shows patient data and orthopedic setup guidance. Accurate identification of the patient using our PALM scanner Eradication of patient mix-ups wrong patient being treated Accurate data entry by automating with the patient identification with PALM scan Prevention of manually asking questions, removing the human risk factor Eradicating data entry errors relating to patient identification through the use of automation 8 9

6 Accessory Identification Accessory Identification with IDENTIFY RFID RISK MITIGATION Incorrect accessories being brought in/used for treatment Correct identification of accessories Incorrect number of accessories used Ensuring that only correct accessories are brought in Incorrectly documenting about accessory identification Correct documenting of accessories used Missing or omission accessories Proper dose distribution with correct accessories Wrong volume Full audit trail of accessories used, positioning and any overrides Incorrect dose distribution Error in data entry Incorrect (mistakes) in archiving or filing about accessory identification Scheduling mistakes for alternating bolus or other accessories Correct, digital tracking and documentation of alternating bolus or other accessories right accessory, right position right accessory, wrong position wrong accessory IDENTIFY s RFID technology guarantees the right devices, for the right patient are selected every time and documents it. It also verifies which treatment fraction requires bolus and which one doesn t. This eliminates mistakes and increases confidence in your quality processes. IDENTIFY SAFETY MEASURES IDENTIFY s RFID technology guarantees the right devices, for the right patient are selected every time IDENTIFY automatically records all devices and there positioning. Full audit trail IDENTIFY eradicates data entry risk through automation site inspection ready IDENTIFY removes the risk of forgetting something E.g Bolus 10 11

7 Accessory Navigation/Positioning Accessory Navigation with IDENTIFY s Augmented Reality RISK MITIGATION Incorrectly placing accessories or wrong position or inclination of accessories Correct positioning of accessories Incorrect dose distribution Proper dose distribution Error in data entry Correct data entry regarding accessory position Error in data acquired in imaging system Proper data acquisition from imaging systems Incorrect isocenter or isocenter positioning error Locating proper target Incorrect identification of previously treated volumes Incorrect target Proper isocenter positioning Proper patient positioning to ensure correct dose data With IDENTIFY s augmented reality user experience, the therapist can quickly place correct accessories in the correct position, reproducing precisely the initial setup in the imaging suite. Only when all accessories are in the right indexing location the setup will proceed for the patient to lay down on the couch. IDENTIFY SAFETY MEASURES IDENTIFY with our Accessory Navigation feature guarantees to locate the correct position of the accessories every time IDENTIFY erradicates data entry errors regarding accessory location Through accurate reproducibility, patient treatments are enhanced IDENTIFY documents every aspect of the positioning process, including photographs, for a full audit report site inspection ready 12 1

8 Patient Positioning & Motion Patient Positioning with IDENTIFY s Surface Based Orthopedic Setup RISK MITIGATION Incorrect couch position Correctly positioning couch Wrong treatment area Correct treatment site/area Error in data acquisition within imaging system Proper data acquisition Incorrect isocenter or isocenter positioning error Correctly positioning isocenter Incorrect identification of previously treated volumes Proper identification of previously treated volume Incorrect target Proper target identification Incorrect dose data in calculating monitor units Patient motion or movement Patient positioning to identify any geometry or dose errors Patient is fixed and no movements IDENTIFY s Orthopedic Setup Reproduction with it s easy-to-understand color scheme, depicts which parts of the body are out of position. When the patient is perfectly located, the surface color becomes transparent. Once the patient is in the optimal orthopedic position, the patient and couch will be moved to their isocentric position. IDENTIFY SAFETY MEASURES IDENTIFY delivers accurate, reproducible patient positioning IDENTIFY monitors for incorrect couch position IDENTIFY automated data capture removes the human factor risk IDENTIFY involves the patient to actively take control of their positioning IDENTIFY prevents any positional errors even if there are incorrect data acquisition from imaging systems IDENTIFY prevents any record keeping errors as it needs no additional records for patient positioning IDENTIFY by ensuring proper positioning & tracking patient movements enhance target volume identification IDENTIFY can prevent erroneous dose data by ensuring proper patient positioning thereby enhancing identification of visual signs 14 15

9 Tracking of target volume & patient motion RISK MITIGATION Isocenter positioning & Intra- Fraction Motion Management with IDENTIFY s Surface Guided Technology Incorrect site/area treated Proper area/site being treated continuously Using incorrect portal images Correct images identified and used Problems with immobilization patient movements during fractioning Prevention monitoring against patient movements Incorrect isocenter Properly identifying, positioning at isocenter Incorrect identification of previously treated volumes, site Proper identification of previously treated volume Difference between delivered dose and calculated dose Correct delivery of calculated dose Laser alignment errors (alignment changed) Laser alignment not changed (means stable) IDENTIFY SAFETY MEASURES IDENTIFY automates accurate positioning of patients through its feature risk tools including: Patient identification, Accessory identification, Accessory navigation / positioning, Surface based positioning of patients (pose verification), Surface based patient body movements, Respiratory motion management. IDENTIFY delivers independent tools for reproducible patient positioning IDENTIFY eradicates data entry risks through its automated data capture capabilities. Delivering a comprehensive audit trail site inspection ready IDENTIFY by ensuring proper positioning & tracking patient movements enhance target volume identification IDENTIFY can prevent erroneous dose data by ensuring proper patient positioning thereby enhancing identification of visual signs IDENTIFY guides the clinical staff to the ideal position at isocenter using DICOM RT Structure Set Data or a Reference Surface. The setup is guided by the 6 degrees of freedom. IDENTIFY Intra-Fraction motion tracking shows a clear representation of the patient posture changes, so you always return the patient to the perfect position at isocenter

10 Case-scenario regarding particular Regulatory requirements in NEW EURATOM Directive 201/59/ Regulatory requirement considered Article 60 () (b): Equipment used for external beam radiotherapy with a nominal beam energy exceeding 1MeV has a device to verify key treatment parameters. Equipment installed prior to 6 February 2018 may be exempted from this requirement. Risk analysis approach: Treatment Decision Prescription Immobilization Positioning I. QA P. QA A. QA Simulation Imaging Volume Determination Planning M. QA P. QA M. QA I. QA A. QA I. QA Treatment Info Transfer Patient Setup M. QA M. QA Delivery Following/ Evaluation M. QA P. QA A. QA I. QA M. D M. QA P. QA A. QA I. QA M. D Successful Treatment M. QA = Machine QA parameter M. D = Machine design parameter I. QA = Identification parameter P. QA = Positioning parameter A. QA = Accessory parameter Categories The parameters should be grouped categories to further streamline the process. Examples of categories could be Machine design, Machine QA, Patient relevant, per treatment etc. Machine Design Machine QA Patient relevant Beam geometry Beam symmetry MLC leaf MLC calibration Jaw calibration Leaf sequence Leaf position accuracy Leaf motion Dose rate Gantry angle MU/segment Mechanical isocenter Radiation isocenter Data into electronic database Immobilization device design Accessory device design Accessory device production Accessory shape, form, fit Patient ID Patient position Treatment site Electronic chart preparation Accessory set-up An adequate approach to risk analysis can be made by mapping the clinical workflow in detail and identifying possible risks contained within each major process step or segment. All corresponding variable or influencing factors also need to be highlighted. A review is done to confirm all possible failure modes / hazards that can occur with each of the detailed process steps or segment. Relevant to each of the failure mode(s), an evaluation is performed to determine the potential causes. Thereafter a discussion can be made to apply on principles of risk minimization approach adequate risk-control measures! Note: To perform the risk assessment, there are several methods that can be considered including, but not limited to specific FMEA, Risk-Matrix method. Process sequence & influencing parameter example in Radiotherapy Considering the above diagram, we can identify numerous parameters. A few examples are cited below: Dose rate Gantry angle MU/segment Beam geometry Beam symmetry MLC leaf MLC calibration Jaw calibration Leaf sequence Leaf position accuracy Lead motion Mechanical isocenter Radiation isocenter Data into electronic database Immobilization device design Accessory device design Accessory device production Accessory shape, form, fit Patient ID Patient position Treatment site Electronic chart preparation Accessory set-up When establishing your QA processes, the above parameters shall be considered during each step of the treatment process. Using your Risk Analysis tool(s), a detailed and thorough evaluation can be performed to deliver a solution that achieves the new requirements of minimization of any risks. One major area of concern in adequately applying a detailed and thorough risk analysis relates to its application towards analogue based systems. More often than not, an analogue process relates to human activity. Such activity may be seen as the norm, or been seen as a behavior that cannot change as this is the way we have always done it! 18 19

11 Patient ID Patient ID: Palm Scan D.S Accessory ID Accessory Setup D.S Accessory ID: RFID Accessory Setup: Navigation Interlock Patient Loading Setup Patient Loading Setup: Surface Verification Patient Setup at Isocenter Patient Setup at Isocenter: Surface Guided Patient Movement Patient Movement: Surface Guided A.I D.S D.S D.S D.S = Digital System D.S = Digital System D.I = Digital Interface D.I = Digital Interface D.I OIS E A.I = Analog Interface D.I OIS E A.I = Analog Interface Illustration A. Illustration B. Illustration A. shows both the digital and analog components in a radiotherapy treatment environment. Based on principles of risk management discussed previously, the analog components could pose potential source of hazards due to a variety of causes. The way to eradicate these known issues would be to digitize the processes. Illustration B. demonstrates how the process would alter as a result of digitization. Using the revolutionary IDENTIFY solution will deliver the digitization of your processes and procedures. In doing so, all elements regarding QA, process & procedure are united to remove inherent known risks, and therefore deliver a solution that would be in compliance of the new EURATOM Directive. This is how to acheieve minimizing the risk to the lowest possible level. IDENTIFY Automated Time-Out Workflow CT CAPTURE OF SETUP AT CT 00 OFFLINE PREPARATION 01 PATIENT CHECK-IN 02 ACCESSORY SETUP SURFACE BASED ORTHOPEDIC SETUP IN LOADING POSITION SURFACE GUIDED POSITIONING AT ISOCENTER CONFIRM SETUP INTERLOCK CLEARED SURFACE GUIDED INTRA- FRACTION MOTION MANAGEMENT AUTOMATIC DOCUMENTATION IN OIS 20 21

12 References: 1 97/4/EURATOM -- health protection of individuals against the dangers of ionizing radiation in relation to medical exposure [Medical Exposure Directive] 2 201/59/EURATOM -- basic safety standards for protection against the dangers arising from exposure to ionizing radiation [EU Basic Safety] Summary of the European Directive 201/59/Euratom: essentials for health professionals in radiology European Society of Radiology 4 Radiation protection N General guidelines on risk management in external beam radiotherapy 5 Radiotherapy safety: the key role of QA medicalphysicsweb 6 Radiotherapy quality assurance: progress and needs - medicalphysicsweb 7 ACCIDENTS IN RADIOTHERAPY: XA LACK OF QUALITY ASSURANCE IAEA Publication J.Novotny 8 IAEA TECDOC Series 1685 FORO--Application of the Risk Matrix Method to Radiotherapy 9 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards 10 Chapter 16 of (Review of Radiation Oncology Physics: A Handbook for Teachers and Students) RADIATION PROTECTION AND SAFETY IN RADIOTHERAPY 11 AAPM TG100 report Application of risk analysis methods to radiation therapy quality management 12 QUALITY ASSURANCE OF EXTERNAL BEAM RADIOTHERAPY 19 ASN Guide N Significant radiation protection events affecting patients in radiotherapy 20 Patient safety in an environment of rapidly advancing technology in radiation therapy 21 ww.ncbi.nlm.nih.gov/books/nbk22722/ Radiation in Medicine: A Need for Regulatory Reform 22 [Risk analysis in radiation therapy: state of the art]. 2 RISK ANALYSIS METHODS: THEIR IMPORTANCE FOR SAFETY ASSESSMENT OF PRACTICES USING RADIATION - FORO 24 in%20radiation%20therapy.pdf Tools for risk assessment in radiation therapy 25 Quality Assurance in Radiotherapy Patrizia Ciammella 26 Quality Assurance in Radiotherapy -- A guide prepared following a workshop held at Schloss Reisensburg 27 The Practice Standards for Medical Imaging and Radiation Therapy 28 Radiation%20Oncologist.pdf The role of radiation oncologist in the process of care for patients undergoing radiation therapy: An update 1 AAPM Code of Practice for Radiotherapy Accelerators TG COMPREHENSIVE QA FOR RADIATION ONCOLOGY TG Medical Accelerator Safety Considerations TG AccidentPrevention.htmAccident prevention in radiotherapy 17 ICRP publication Preventing accidental exposures Preventing accidental exposures from new external beam from new external beam radiation therapy technologies 18 ASN Guide N 4 -- Guide to risk self-assessment in external beam radiotherapy 22 2

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