National Radiation Protection Committee Report

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HEALTH SERVICE EXECUTIVEREPORT OF THENATIONAL RADIATION PROTECTION COMMITTEE2019NATIONAL RADIATION PROTECTION OFFICE

NATIONAL RADIATION PROTECTION COMMITTEEEXECUTIVE SUMMARYa policy to manage routine occupational radiationexposures which may meet Category A statusunder the new legislation.IntroductionThis report details the work undertaken by thenewly established National Radiation ProtectionCommittee (NRPC) of the Health Service Executive(HSE) in promoting radiation protection forpatients and staff across public hospital andcommunity healthcare locations. It acknowledgesthe hard work, dedication and commitment ofall stakeholders in promoting robust governance,collaboration and safe practice.Radiation safety incidentsProactive risk management is fundamental topromoting the safe administration of medicalionising radiation and the welfare of staff andpatients. This requires staff to report all adverseevents candidly on the National IncidentManagement System (NIMS), to review incidentsin line with the HSE Incident ManagementFramework (IMF) and to share any learning froman event promptly in order to improve practice andreduce the likelihood of recurrence.The national framework for radiation protectionchanged considerably in 2019 with the enactmentof new legislation and subsequent changes toregulatory requirements. A strong collaborativerelationship was established between the NRPC,the Health Information and Quality Authority(HIQA) and the Environmental Protection Agency(EPA) which supported the transition process andmaintained continuity for radiological services.All radiation safety incidents must be reportedon the NIMS and managed in accordance withthe HSE Incident Management Framework.All hospitals and Community HealthcareOrganisations (CHOs) providing a medical ionisingradiation service to patients were registered withHIQA.In addition to reporting on NIMS, radiation safetyincidents involving staff or members of the publicexceeding a dose of 1 millisevert must be reportedto the EPA. And radiation incidents involvingpatients that meet notifiable criteria established byregulator must be reported to HIQA and includean investigation report and evidence of qualityimprovement, within the specified timeframe.NRPC work programme for 2019The Terms of Reference for the NRPC wasfinalised and approved by the National Directorsof Acute Operations and Community Operationsrespectively. The roles and responsibilities of theNRPC and its secretariat, the National RadiationProtection Office (NRPO), are outlined in thefollowing pages. A comprehensive programme ofwork for the NRPC based on radiation protectionpriorities, was consolidated and initiated. Thesepriorities included:This year saw the introduction of the online HIQAportal which enabled locations to submit radiationsafety data, including incident notifications,investigation reports and relevant governanceinformation directly to HIQA.The NRPO undertook a review of radiation safetyincidents reported on the NIMS in 2019 and themain themes identified from the analysis were asfollows: Governance of radiation protection Analysis of incidents Education and training initiatives Inappropriate referrals for diagnostic procedures Patient, staff and population dosimetry Incomplete or inadequate documentation Communication plan Patient identification issues Best practice guidelines for referrers andpractitioners Equipment failure issues Poor communicationIn late 2019, the NRPO met with the HSE Healthand Wellbeing Unit to discuss the development ofIt was noted from the analysis that some of thePage 2

NATIONAL RADIATION PROTECTION COMMITTEEradiotherapy centres did not consistently reportincidents on the NIMS. To understand how theselocations managed incidents, the NRPO initiateda survey in late 2019 and this is expected becompleted in early 2020. In addition, the NRPOadapted the incident guidance template formallydeveloped by the Medical Exposure Radiation Unitto assist locations in identifying and managingincidents. This template will be submitted to theHSE for inclusion in the forthcoming revision ofthe Incident Management Framework in 2020.cardiology, present a risk to patients and staff. Anational audit of radiation protection practicesin cardiac catheterisation laboratories wascommissioned by the NRPO and commenced by theHSE Healthcare Audit Team in late 2019. This is thefirst time a national review of radiation protectionpractices in interventional cardiology has beencommissioned and it is anticipated that this auditwill be completed in early 2020.CommunicationThe NRPO proposes to convene a workshop in 2020to promote incident management in radiotherapyand to highlight the requirement to report allincidents on the NIMS.Finally a communications plan was proposedto inform and engage all stakeholders in theimportant work of the NRPC. This will necessitatethe development of a web-based platform whichwill include portal access and subscription to amailing list for the sharing of radiation protectioninformation and guidance, NRPO surveys, incidenttrending data and other such relevant reports. Workis on-going between the NRPO, HSE Acute HospitalOperations Division and HSE CommunicationsDivision in this regard.Radiation equipmentRadiation protection legislation requires theundertaking to maintain a database of radiationequipment, implement an appropriate qualityassurance programme and ensure there is areplacement policy in operation. In addition, theequipment must have the capability of recordingthe radiation dose delivered to the patient and thisdose must inform the medical report.In the interim, information pertaining to the workof the NRPO and NRPC is available by contactingthe NRPO directly at radiation.protection@hse.ie .A review of radiology and radiotherapy equipmentwas commenced in 2019 by the NRPO with supportfrom the EPA and is expected to be completed in2020. This review will result in the generation ofa national database of radiation equipment whichlists the make, model, dose tracking capability,year of commission, scheduled replacement dateand purpose of use. The NRPO will update theinformation on an annual basis thereafter.ConclusionIn conclusion, the work of the NRPC builds onprevious achievements in radiation protectionmade by the HSE both nationally and at the pointof service delivery. To enhance these achievementsgoing forward, NRPC endeavours to reflect theprinciples of radiation safety which can be applieduniversally across all medical specialities in itspriorities identified for 2020.National audit of radiation protection in cardiaccatheterisation laboratoriesFocussing on these tenets will go some way toproviding reasonable assurance to the regulators,all staff and most importantly, to our patients,that medical radiation exposure is maintained atoptimum levels and that safe practice is prioritised.It is known that imaging procedures whichroutinely deliver a high dose of radiation, such asthose performed in the speciality of interventionalPage 3

NATIONAL RADIATION PROTECTION COMMITTEEFOREWORD FROM THE CHAIRAs co-chairs of the newly established NationalRadiation Protection Committee (NRPC), it is withgreat pleasure that we present to you this inauguralreport detailing the good work in promotingradiation safety undertaken by our colleaguesthroughout 2019. The success of this committeein bringing radiation protection to the forefront isattributed to the tireless support of frontline staffwho engage with our patients on a daily basis andwithout whom this important work would not havebeen achieved.under the auspices of the HSE. This includedproviding the name and contact details ofdesignated managers in all locations whom HIQAwould engage with on subsequent inspections.The NRPO, on behalf of the NRPC, worked closelywith both the EPA and HIQA throughout the year toensure a smooth regulatory transition, continuityin supporting and advising frontline staff of theprogress being made and collaboration in thepromotion of safe practice and positive outcomesfor patients.Five meetings of the NRPC were convened in 2019and we would like to take this opportunity to thankthe members of the committee for their positivity,commitment and enthusiasm throughout the year.We would also like to acknowledge the support ofthe National Radiation Protection Office (NRPO)which has proven instrumental in achieving ourobjectives.A detailed programme of work based on numerousradiation safety priorities identified by the NRPCwas developed and approved by the HSE seniormanagement team. This plan was informed by theguidance received from the National RadiationSafety Committee which had been stood down inearly 2019, the NRPO analysis of incident reportson the National Incident Management System(NIMS) and the extensive regulatory requirementsoutlined in the new legislation.This year brought considerable change to the Irishregulatory landscape for radiation protection withtransposition of the European Basic Safety StandardDirective 2013/59/EURATOM and promulgationof Statutory Instrument (SI) 256 (2018) and SI30 (2019). The Environmental Protection Agency(EPA) remained the regulator and competentauthority for protection of workers and the publicunder SI 30 (2019). However, a new approach toregulation was instigated whereby locations musthold an EPA authorisation, as required. That is,authorisation by either registration or licensing,depending on the exposure risk associated with thepractice for workers and members of the public.There were a number of key ventures initiated in2019 and included, for example, the analysis ofincidents reported on the NIMS and the sharingof learning nationally; a review of radiotherapyincident management; the development of adedicated radiation protection website to enhancecommunication with stakeholders; and thegeneration of a national inventory of radiologyand radiotherapy equipment. In addition, anaudit of radiation protection practices in cardiaccatheterisation laboratories was commissioned andcommenced in late 2019.SI 256 (2018) identified the Health Informationand Quality Authority (HIQA) as the competentauthority and regulator for patient radiationprotection. This was the first time that a regulatorfor patient radiation protection had been delegatedinspection and enforcement powers and itnecessitated the establishment of a new regime formonitoring patient radiation protection practices.Finally, this report outlines the key themeshereunder, which are not exclusive, for the NRPCto focus on going forward into 2020: Governance of radiation protection Education and training of staff Promoting best practiceThe Health Service Executive (HSE) as a providerof medical radiological services was consideredan undertaking under SI 256 (2018) and as aconsequence, had clearly defined responsibilitiesand obligations. The NRPO was allocated theonerous task of registering with HIQA all radiologyand radiotherapy locations providing a service Communication with stakeholders Quality assurance of equipment Incident monitoring and sharing the learning Patient and staff dosimetryPage 4

NATIONAL RADIATION PROTECTION COMMITTEEPromoting safe, efficient and evidence basedpractice in the best interest of the patient is theaim of all those who work with medical ionisingradiation. For this to manifest, we need robustgovernance with clear lines of accountability; anopen culture that promotes a proactive approachto risk management; a system in which staff areappropriately trained and competent to undertakethe role to which they are assigned; and mostimportantly, the continued support and positiveengagement of all stakeholders in promoting andprioritising safe radiation protection practices forall who work in the field and avail of the service.the HSE, EPA and HIQA during this difficult andoften confusing transition period has proven verysuccessful and we are confident that this positiveengagement will continue in 2020. We are also inno doubt that going forward the important workinitiated by the NRPC will continue to be endorsedby local radiation safety committees and supportedby our frontline colleagues who work tirelessly toprovide safe radiology and radiotherapy servicesin hospitals and community locations nationwide.We are proud to confirm that the strongcollaborative relationship established betweenIn conclusion, we are mindful of the NRPCs dutyto provide reasonable assurance that medicalradiation exposure is maintained at optimum levelsand that staff and patient safety are prioritised.Dr. Ciaran Browne, Co-chairMr. Jonathon Paul Nolan, Co-chairHSE National Radiation Protection CommitteeHSE National Radiation Protection CommitteePage 5

NATIONAL RADIATION PROTECTION COMMITTEEINTRODUCTIONThis report details the establishment of the NationalRadiation Protection Committee (NRPC) by theHealth Service Executive (HSE) in 2019 and the workundertaken by this committee to promote radiationsafety for patients and staff in public hospitalsand Community Healthcare Organisations (CHOs).It acknowledges the hard work, commitmentand dedication of all stakeholders in prioritisingradiation safety and outlines the priorities for theNRPC going forward into 2020.Environmental Protection Agency (EPA) as theregulator and introduced several changes, forexample, a new registration and licensing regime,new dose constraint levels for practitioners andregulation of non-medical imaging procedures.SI 256 (2018) regulates radiation safety of patientswhich was formerly governed by SI 478 (2002).Under the previous regime, the National RadiationSafety Committee (NRSC) and the HSE MedicalExposure Radiation Unit (MERU) provided adviceand guidance, and undertook radiation safetyinitiatives across public and private locations, andworked in the interest of best practice and patientsafety. With ratification of SI 256 (2018) in January2019, the NRSC and MERU were stood down.1. CHANGES IN THE REGULATORYLANDSCAPE FOR RADIATION PROTECTIONThis year brought considerable change forradiation protection practices in Ireland throughthe transposition of the European Basic SafetyStandard (BSS) Directive 2013/59/EURATOM withenactment of Statutory Instrument (SI) 256 (2018)and SI 30 (2019) (herein known as IRR19).SI 256 (2018) delegates the roles of competentauthority and regulator for patient radiationprotection to the Health Information and QualityAuthority (HIQA) and provides HIQA withinspection and enforcement powers. The HSE as aprovider of medical ionising radiation services isconsidered an undertaking under SI 256 (2018).IRR19 repealed SI 125 (2000) which regulated forthe protection of workers and the general publicfrom radiation exposure. IRR19 maintained theThe framework for radiation protection in Ireland is legislative based, incorporating various Irish laws andEuropean Directives, including the following:European Basic Safety Standard Directive 2013/59/EURATOM – This directive establishes radiation safetystandards across Europe for patients, workers and the Serv.do?uri OJ:L:2014:013:0001:0073:EN:PDFIt was transposed into Irish law in January 2019 through ratification of the following statutes:SI 256 (2018) – This SI regulates the radiation exposure of patients, appoints HIQA as the competentauthority and regulator and provides enforcement 256/made/en/pdfIRR19 – This SI regulates the radiation exposure of workers and the public, appoints the EPA as thecompetent authority and regulator and maintains the enforcement powers from previous 9/si/30/made/en/pdfPage 6

NATIONAL RADIATION PROTECTION COMMITTEE2. REQUIREMENTS OF THE REGULATORS3. GOVERNANCE OF RADIATION PROTECTIONHIQABoth IRR19 and SI 256 (2018) require a clearlydocumented line of accountability from thedesignated manager to frontline staff who workdirectly with medical ionising radiation and delivera radiation dose to the patient. Therefore thedesignated manager must sub-delegate authorityin writing to the relevant professionals andmust ensure that these people are appropriatelytrained and competent. All staff working withionising radiation must ensure they have a clearunderstanding of their roles and responsibilities inregards radiation safety for both patients and theircolleagues, including what to do in the event of anincident.The HSE, as a provider of radiological services,was required to register with HIQA as the legalundertaking in accordance with SI 256 (2018).The NRPO was tasked with co-ordinatingthis registration process on behalf of the HSEundertaking representative, Ms. Anne O’Connor,Deputy Director General.In early 2019, with support from hospitals and thenine CHOs, all locations administering medicalionising radiation to patients under the auspices ofthe HSE were identified by the NRPO and formallyregistered with HIQA. These locations consistedof 37 HSE hospitals, the National BreastcheckScreening Service, 14 diagnostic communityfacilities and 230 dental surgeries.A local radiation safety committee must beestablished by all locations to maintain oversight ofradiation protection practices and promote qualityand safety in all aspects of radiation exposure.This forum supports existing governance structureswithin the location; provides guidance on bestpractice for radiation safety; ensures referrers andpractitioners have the necessary supports availableto them and a clearly defined scope of practice; andit provides assurance to management, patients andthe public that radiation exposures are delivered ina safe, effective and appropriate manner.Voluntary hospitals, although they receive fundingfrom the HSE, are separate legal entities andas such, were required to individually registerwith HIQA and nominate their own undertakingrepresentative.HIQA required the nomination of a nameddesignated manager in each location who wasof appropriate seniority and could facilitate sitevisits. The designated managers were also requiredto ensure that operational plans were implementedto address any recommendations made followingan inspection. The designated managers for HSElocations were identified as the chief officers in eachCHO area and general managers, or equivalent, ineach hospital location.The HSE National Director of Acute HospitalOperations issued guidance in relation to thegovernance of radiation protection and the newregulatory requirements in late 2019.A diagram of radiation protection governance inthe HSE can be found in Appendix 2.HSE NATIONAL RADIATION PROTECTIONCOMMITTEEEPAThe HSE established the NRPC in March 2019 toprovide national oversight of radiation protectionpractices and support the work of the localcommittees in both CHO and acute hospital services.The committee is co-chaired by Dr. Ciaran Browne,Acute Hospital Operations and Mr. Jonathon PaulNolan, Community Operations.The regulatory framework established under IRR19is different to SI 256 (2018).For the purpose of IRR19, each individual hospital orCHO is defined as an undertaking. This means thatall hospitals (HSE or voluntary) and each relevantCHO must hold an EPA authorisation, as required.The EPA requires either registration or licensingdepending on the exposure risk associated with thepractice for workers and members of the public.EPA registrations are issued on an indefinite basiswhile licences must be renewed every 10 years.The NRPC consists of no more than 19 members,appointed by the National Directors of AcuteHospital Operations and Community Operationsrespectively, for a period not exceeding three years.The NRPC was convened five times in 2019.Page 7

NATIONAL RADIATION PROTECTION COMMITTEEPlease see Appendix 1 for details of the NRPCmembership.both the National Director of Acute HospitalOperations and National Director of CommunityOperations.The roles of the NRPC include, for example: To provide assurance to all stakeholders thatbest practice in relation to radiation protection ispromoted and adhered to; and that radiologicallocations are compliant with SI 256 (2018) andIRR19.HSE NATIONAL RADIATION PROTECTION OFFICEThe National Radiation Protection Office (NRPO)was established in 2019 to support the work ofthe NRPC in promoting best practice in radiationprotection for patients and staff. To develop and disseminate relevant policies,protocols and guidelines on radiationprotection practices which support legislativerequirements.The NRPO team consists of Dr. Ciaran Browne,National Office of Acute Hospital Operations, Ms.Janet Wynne, manager and Ms. Rose Lindsay,senior administrator. To monitor, track and report on population doseand cumulative exposure to workers. To act as the principle interface for issuespertaining to radiation protection between theHSE and various regulators, external agenciesand professional bodies.The office falls under the remit of the HSE AcuteHospital Operations Division and has manyfunctions, for example: Support and manage the work of the NRPC. To work with the relevant professional bodiesto develop a range of radiation safety trainingmaterial which will be made available throughthe HSE online training platform and tailoredto specific cohorts of staff, depending on theirexposure risk. Develop and provide guidance for locations ontheir legislative responsibilities. Review, analyse and report on incident datarecorded on the NIMS and reported to HIQA fortrending purposes. To develop and implement a nationalcommunication plan to ensure patients andrelevant stakeholders are informed of therisks associated with radiation exposure, thelatest research to promote best practice andrelevant initiatives that champion radiationsafety. Share best practice initiatives nationally andshare learning from incidents. Maintain an up-to-date repository of contactdetails of all relevant staff working inradiation protection to ensure that informationbeing circulated reaches the correct peopleand that a valuable resource of experiencedstaff is available to assist the NRPO with itsendeavours. To monitor incidents reported to HIQA and onthe NIMS in order to identify trends and informaction plans to mitigate risks. To develop and communicate key performanceindicators to services and generate periodicreports on these nationally. To gather data on radiological equipment andprovide an assurance that each item is recordedas being maintained and safe to operate. Ensure that the HSE is registered with HIQA asthe undertaking for radiological locations whichoperate under its remit. And that informationpertinent to this registration is maintained asaccurate and up-to-date as possible. To monitor and report on radiation dosediagnostic reference levels as established byHIQA. Maintain a national inventory of equipment inoperation across all radiology and radiotherapylocations. To support HSE emergencyplanning initiatives.managementThe NRPC and NRPO build on previous workin radiation protection undertaken by theaforementioned NRSC and MERU which werestood down in early 2019 with promulgation of thenew legislation.The NRPC is an advisory committee only andoperational responsibility for the implementationof radiation safety recommendations lies withPage 8

NATIONAL RADIATION PROTECTION COMMITTEEThis programme of work is on-going and theinformation herein outlines the progress made to date.RADIATION SAFETY INITIATIVES UNDERTAKENIN 2019To support the transition process, a comprehensivereport detailing radiation protection priorities forsafe practice was presented to the committee by theChair of the NRSC when that committee was stooddown. This report, together with the new regulatoryrequirements and on-going incident trendinganalysis undertaken by the NRPO, informed theNRPC work objectives for 2019.1. RADIATION SAFETY INCIDENTS REPORTEDON THE NATIONAL INCIDENT MANAGEMENTSYSTEM IN 2019A fundamental factor to facilitating safe practicein the management of medical ionising radiationis the prompt reporting and analysis of incidentsand near miss events. All adverse events must bereported on the NIMS and managed in accordancewith the HSE Incident Management -guidance-stories.pdf. In addition, it isa statutory requirement to report radiation safetyincidents to the respective regulator.The programme of work identified namedindividuals on the committee who were delegatedresponsibility for leading on specific actions relatedto the five domains outlined hereunder: Governance of radiation protection Education and training initiatives Patient, staff and population dosimetryIt is the ethos of the HSE to support both staff andpatients when an adverse event occurs, therebypromoting an open, transparent, non-punitiveapproach to reporting and managing failures incare. Communication Plan Best practice guidelines for referrers andpractitionersALL INCIDENTS AND NEAR MISS EVENTS MUST BE REPORTED ON THE NIMS AND MANAGED INACCORDANCE WITH THE HSE INCIDENT MANAGEMENT FRAMEWORK.In addition, incidents must be reported to the relevant regulators, as follows: Adverse events of clinical significance involving patients are reported to the Health Information andQuality Authority.https://www.hiqa.ie/ Adverse events involving staff and members of the public are reported to the Environmental ProtectionAgencyhttps://www.epa.ie/ Adverse events involving equipment failure are reported to the Health Products Regulatory Authorityhttps://www.hpra.ie/Page 9

NATIONAL RADIATION PROTECTION COMMITTEEThis year, HIQA introduced an online portal whichenabled locations to submit radiation safety data,including incident notifications, investigationreports and relevant governance informationdirectly to the regulator. The NRPO was grantedaccess to this portal for the purpose of generatingnational reports on locations working under theauspices of the HSE.use this information to inform NRPC priorities.ANALYSIS OF NIMS REPORTSThe information provided in the tables hereindetails the radiation safety incidents reported onthe NIMS from January to December 2019 by bothHSE and voluntary locations. The figures listeddo not include incidents related to ultrasound,magnetic resonance imaging or issues pertainingto the administration of contrast via peripheralvascular catheters.Analysis of incidents reported on the NIMSthroughout 2019 by all HSE and voluntary locationsenabled the NRPO to identify trends in radiationsafety, highlight emerging risks and subsequently1. Category of radiation safety incidentCategory of incidentRadiologyRadiotherapyActual incidents39688Near miss events371252Total number of reports766340In total, there were 1106 adverse events involvingmedical ionising radiation reported on the NIMSin 2019.not cause harm to patients or staff. The relativelyhigh number of near miss events recorded on theNIMS is considered a positive finding and indicativeof a strong culture of radiation safety. Identifyingtrends when processes fail and putting in placemeasures to mitigate risks in a timely fashion isparamount to protecting patients and staff fromthe harmful effects of radiation exposure.The majority of actual incidents were consideredminor or negligible, the details of which areprovided in the tables hereunder and as such, did2. Category of person affected by the radiation safety incidentCategory of personRadiologyRadiotherapyAdult patient / service user696340Paediatrics270Neonates180Member of staff or member of the public250Page 10

NATIONAL RADIATION PROTECTION COMMITTEEThe majority of medical ionising radiation servicesare provided in the adult hospital setting thereforeit is no surprise that most of the incidents reportedon the NIMS involved adult service users.The inadvertent exposure of staff to radiation ismanaged locally in accordance with the HSE IMFand reported to the EPA, as required. Even thoughthe risk to staff from an individual exposure maybe low, the damage sustained from radiationexposure is cumulative and may appear over theduration of employment. The regulations regardingstaff exposure, in particular the monitoringrequirements for Category A workers and doselimits to eye exposure, were changed in 2019.It is anticipated that the EPA will publish newguidance in 2020 to address these changes and inpreparation the NRPO has commenced engagementwith the HSE Occupational Health Department tosupport the development of a policy for managingrisks to Category A workers.The use of ionising radiation is expandingacross many specialities, including for example,interventional cardiology, orthopaedics, renal andendoscopy. However this is not reflected in theNIMS reports as the majority of incidents recordedin 2019 occurred in radiology and radiotherapydepartments. This suggests that, whilst there isclearly a focus on radiation protection in radiologyand radiotherapy departments, there is a need topromote this ethos across all specialities which useionising radiation.3. Details of the process involved in the incidentsRadiology incidents reported on the NIMS in 2019ProcessSeverity RatingExtremeMajorTotalModerate MinorNegligibleChecking patient identification6565Clinical details on referral12502513132136Communication/consent issues4646Equipment failure119395Performing procedure33119126Pregnancy status99*Not Applicable/Other4547Documentation/medical records issues1111The category ‘Not applicable /Other’ refers to incidents which did not fit a single listed category on the NIMS andinclude: Inadvertent staff exposures Incorrect treatment protocols being followed which necessitated repeat procedures Unjustified referralsPage 11

NATIONAL RADIATION PROTECTION COMMITTEEThe combination of inappropriate or inadequateclinical details recorded on referrals, poordocumentation and other medical record issuesaccount for the majority of incidents reported in2019.raise awar

NATIONAL RADIATION PROTECTION COMMITTEE As co-chairs of the newly established National Radiation Protection Committee (NRPC), it is with great pleasure that we present to you this inaugural report detailing the good work in promoting radiation safety undertaken by our colleagues throughout 2019. The success of this committee

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