Quality Management Systems in Radiotherapy based on ISO 9001 standard


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Presentation on the main building blocks of a Quality Management System in Radiotherapy based on the international ISO 9001 standard. The presentation provides internal hyperlinks to bookmarked material for easy navigation.

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  • This is a presentation about the basic components of a quality management system in the context of a radiotherapy department. Radiotherapy department includes all sections such as the radiation therapists team, nursing, ROs, physics, clerical, engineers and management. Before I continue who knows what a quality management system (QMS) is? Not too many people think that they know what a QMS however you will all be very glad to hear that each of you works within the framework of a QMS and that a large part of the QMS is already in place. We just need to define what a QMS is.
  • I guess you may be thinking “Why is Val wasting my time with a talk about quality? A talk about quality is always blurry and vague anyway. All I have to do is to perform my job well and I will get a good quality outcome”. Isn’t that what you are thinking? Well, you are right about doing the job well and getting a good quality outcome. But: What is your job – your job description usually gives a broad overview of what you are expected to do but it rarely lists all your individual tasks and functions. A job description is not supposed to do this anyway. How do you know that you are doing your job well – do you always know what the criteria or the standard is that you are working against? How do you know that you are achieving a good quality outcome? – do you always get to see an analysis of the outcome of your work? Maybe it is not as simple as “I just have to do my work well”. Accreditation against a quality standard will be mandatory from 1 Jan 2013 QMS improves quality QMS reduces risk - injury to patient, injury to self, missing a payment from a patient etc. QMS improves efficiency – a QMS strives to achieve the most effective and efficient way of doing things
  • This presentation is about: Definitions Importance of documenting the system What control of documents is What control of records is What corrective action is What preventive action is The importance of an organisation chart How it all fits together This presentation is not about How to set up a QMS – this is the topic of another conversation.
  • What are the building blocks of a quality management system? At this stage of the presentation the definition of quality management system has been left out on purpose. Present the building blocks of the system and at the hopefully everyone will have a fair idea of what a quality management system is at the end of this presentation. I will offer the definition at the end anyway. Definitions: Quality Quality Policy Process Procedure Work instructions Quality Manual
  • Have you been in a situation when you are trying to find the answer to a radiotherapy planning question and you ask someone? That someone tells you how she does it. A few days later you overhear another person asking the same question and getting a different answer from someone else? It is only human that we want certainty. You know what I am talking about don’t you? What if you are a very experienced professional and you just started work with a new employer? Do you think that the employer expects you to hit the ground running in your new role? Yes they do. However, no matter how experienced you are your new employer most likely does things differently from how you did them before. I am not saying that the outcome is different, but that to get to the final you have to take a different route.
  • Records differ from other forms of documentation in that they prove that required work was performed and record results. Medical records describe the care process for the individual patient. They should allow for an evaluation of how well the process has been carried out, and whether it has produced the desired outcome. Examples of records to support the quality management system, in addition to the patient health record, are: lab results, imaging results, admitting records, pharmacy records, purchase requisitions and purchase orders, calibration records for measuring devices, quality indicator data, forms and checklists once completed, customer/patient/client complaints, corrective and/or preventive action results records, internal and external audit/ survey reports, evidence of management reviews, quality planning records, personnel records (including training and competence) records, records of equipment and facility maintenance, billing and coding records and logs used by various departments.
  • Quality Management Systems in Radiotherapy based on ISO 9001 standard

    1. 1. Quality Management SystemsIn RadiotherapyBased on ISO 9001 principlesVal Antoff
    2. 2. Accreditation against the National Safety andQuality Health Service (NSQHS) Standards will bemandatory for all hospitals and day surgeries from 1January 2013. In WA this includes both public andprivate facilities.Why do we need to know aboutQuality Management Systems(QMS)?
    3. 3. 1. Definitions2. Documentation requirements of QMS3. Importance of organisation chart4. Measuring quality5. Making improvements6. The documentation pyramid7. SummaryScope of this presentation
    4. 4. QualityManagementSystemMeasurements&ImprovementsDefinitionsDocumentationRequirementsProcedureProcessQuality PolicyQualityWorkInstructionsQuality ManualSystemDocumentedControl ofRecordsControl ofDocumentsAnalysisMonitoringInternal AuditPatientSatisfactionCorrective ActionPreventive ActionNon-conformanceWhat todocument?
    5. 5. Quality“Quality is fitness for use“, the service should meet its specificationsQuality PolicyThe quality policy is a general statement made by top management that it intendsto achieve quality as a result of the companys operation.ProcessA series of activities, actions or functions designed to bring about a specific result.DefinitionsProcedureThe procedure documents the step-by-step detail for the process activities andactions that must be executed in the same manner in order to always obtain thesame result under the same circumstances.They typically include what, when, where, and who should do the activity identified.We are committed to Total Patient Satisfaction byproviding services which meet or exceed our patientsexpectations.It is our policy to ensure that all patients undergoingsimulation have a signed treatment consent.
    6. 6. DefinitionsQuality ManualThe quality manual outlines the policies, procedures, work instructionsand requirements of the Quality Management System and describes the interactionbetween the processes.Work instructionWhilst a procedure documents the step-by-step detail for the process, a workinstruction defines further details of one or several process step(s) that thebusiness has put in place.Work instructions are for work performed in one area or function and typically tellyou “how” to do the activity.
    7. 7. “Without documentation, all your tasks, functions, processes, and proceduresthe way that we habitually do everything – are nothing more than goodintentions. Processes that have not been documented are only rumours aboutthe way we do things”.“If the process is not written down, how can you train others to create the sameresults? How do you ensure that everyone does it the same way? How do youknow if that way is the best way? If it is not written down it did not happen”.Michael Gerberwww.e-myth.comSystem DocumentedWhy do we need to document our procedures and workinstructions?
    8. 8. What to document?Warm up CTMake a vac bagCapture fee codesSim RT roleUpdate databaseTasksRole Warm up CTDatabaseVac bagCaptureProcedureDefine the rolesDefine tasks and functions for each roleEnsure that a procedure covers each task and functionShut down CT CTCTPrinciple – “Say what you do and do what you say”
    9. 9. Task and Functions of Treatment RTTask or Function/What is done When or howoften is thisfunction doneKey Area Subelement thisfunction relates toRole responsiblefor this functionLinac warm up Daily QA RTCheck Dr’s notes Daily QA RTCheck images Daily QA RTCheck all new starts are ready Daily QA RTTreat patients Daily Treatment RTAuthorise new files Daily QA RTIcom/iView new files Daily QA RTLoad reference data new files Daily QA RTPerform imaging requirements Daily QA RTWeekly chart checks Daily QA RTSummarise finished patients Weekly QA RTEnsure all accessory equipments issafeWeekly Supplies RTOrder new supplies Weekly Supplies RTEnsure linen stocked in room Weekly Supplies RTPerform monthly QA films Monthly QA Senior RTPerform monthly QA MLC checks Monthly QA Senior RTUse the form below to workshop individually the tasks that each person carries out.These will make up the headings of the future content of policies & procedures that willbe written in full later. It is important to ‘drill down’ into the tasks so that the headings areall micro parts of a large process.
    10. 10. Organisation ChartChief RTSenior Treatment RTSenior Sim RT Senior Planner RTSim RT Treatment RT Planner RTGeneral ManagerNursing Manager
    11. 11. Control ofDocuments What Control? Approval, review andupdate, status, version, obsoletedocumentsHow? Document Control ProcedureControl of Documents and RecordsControl ofRecordsWhat Control? Identification, storage,protection, retrieval, retention time anddisposition of recordsHow? Records Control ProcedureWhat Records? Patient health andaccounting records and others includingcalibration, maintenance, training, survey,audit, licensing, certifications, and othercompetency records.Why? To assure legibility and accuracyof data and records, to assure thatrecords are identifiable and retrievableWhat Documents? Meeting minutes,procedures, pathways or protocols, workinstructions, forms, equipment operatinginstructions, regulations, local treatmentprograms
    12. 12. Measurements&ImprovementsAnalysisMonitoringInternal AuditPatientSatisfactionCorrective ActionPreventive ActionMeasurements and ImprovementsThank you cards,chocolates, cakes etcSurveys and opinion pollsAudit Policies andProceduresE.g. calibration, incidentreportingDataReview nonconformitiesDetermine the causesImplement action neededRecord the resultsReview effectivenessDetermine potentialNeed for actionImplementation actionRecord resultsReview effectiveness
    13. 13. Documentation Pyramid
    14. 14. What are your responsibilitiesin relation to the QMS?1) Quality Policy – management2) Processes – you & your supervisor3) Procedure – you & your supervisor4) Work instruction – you & your supervisor5) Quality Manual – management to ensurethat there is a seamless interactionbetween the processes.
    15. 15. A quality management system (QMS) isthe organisational structure, procedures,processes and resources needed toimplement quality managementWhat is a QMS?
    16. 16. Summary• Accreditation will become mandatory from 1 January 2013 –a QMS is a prerequisite;• Unless a QMS is documented the procedures that we followare only rumours about the way we do things;• It is essential that every role has a list of tasks and functionsassigned to it;• The results from the analysis of the measurements andreporting data are the main indicators for quality;• Improving the way we do things can be achieved only afterwe analyse any nonconformities and take action;• It is everyone’s responsibility to follow an up-to-date set ofprocedures and work instructions and participate in themaintenance and development of the QMS;