 So, my topic is quality assurance program in radio therapy. I told yesterday it is very important part of the medical physics, medical physicist and this short time I will try to explain the five terms. The definition needs of quality assurance in radio therapy, requirements on accuracy in radio therapy and accident in radio therapy. This is a very important term and legal, legal and other aspects and this is the management of quality assurance program and may be a small example from the how it construct here. In Germany many, many hospital in Europe also they have the quality management program. You have learnt yesterday what are many of you I think also experience to create quality assurance program in their hospital yes and so you have the experience. So, I think the beginners can start such types of program in your hospital. First of all some definitions you can find every medical physics book. These are the terms, sometimes you mix it, sometimes it is not difficult to differentiate it, but they have a clear definition and we should aware with this. The quality assurance and quality control in everybody medical physics actually know the quality control every machine, every TPS there is a quality control, quality control QC, but the quality assurance is more than that and quality system and quality assurance in radio therapy and quality standard. These are all the definitions come from ISO 6000 and it is actually applicable for every product and process, but we apply this one in the radio therapy just I go one by one. What is quality assurance? It is actually the definition from book it is all those plant and systematic action. Every hospital they have their actions they do everything I think what is possible and what is needed, but it is actually the plant and systematic can we follow your program in the hospital can follow the other hospital can come and audits can follow all the things you are doing. This that is why it is called plant and systematic action necessary to provide adequate confidence that a product or service will satisfy the given requirements for quality. Such as quality assurance is ranging and covering all this your procedures, activities, actions, groups of staffs. This is actually the management of quality assurance program is called quality management quality systems management. This is the last chapter I will explain the quality system management. Here then quality system it is again have defined and it consists an organizational structure responsibilities is given very different to peoples in the department or an inter department and the procedures is also defined very clear and processes they have many many processes in the hospital and of course the resources. When there is no many resource some hospital they show we have many less manpower we cannot realize such types of programs. So, resources also important of course these people are very flexible when they are working with the people so they can convince the people such types of people make a group and these are the resources not only the manpower, but also resources to do. We have a manual maybe for the quality control brachytherapy then should have should we have all the QC equipments therefore the resources is important to realize the quality assurance program. And here is the quality control I do not go to details we know every medical phase is the quality control for pacific machines and pacific software they have also quality control. When actually for the quality control to check that quality requirements are met to adjust a correct performance if the requirements are found not or have not met. We have a standard manuals or protocols or recommendations there they clarify the procedures and actually the limits value we should always adjust we control it and when the limits value exceeded we have some actions and to re again make the things quality standard without quality standard quality cannot be assessed. This is a quality standard and quality assurance in radiotherapy now we come in radiotherapy is all procedures that ensure constancy of the medical prescription and safe full movement that radiotherapy related prescription yeah it is you see here is quality assurance these are the prescription yeah we know everybody the optimal dose to the PTV or the target volume minimum dose to the normal tissue adequate patient monitoring aimed at determining the optimal end result of the treatment and minimal exposure of the personnel so these are the requirements for the quality assurance this is the outcome or the prescription and these are all the quality standard in radiotherapy various national international organization have issued recommendation from standard radiotherapy you see the world health organization European Society for Therapeutic Radiation Oncology they have also such types of standard and clinical oncology information network and here is important where recommend recommended standards are not available local standard need to be developed based on the local assignment of the requirements as you can develop your own standard naturalities is very easy when you have some here the recommendations you can also take the recommendations or any protocol any quality standards radiotherapy from other hospital and check it through one of the protocols in Europe we use most the European Society for here yeah the need of quality assurance in radiotherapy I have shown I do not know you have seen sometimes the heart man maybe have you showed this one no okay actually it is from the Germany there is a very nice one I got to project is always you have learnt the localized tumor 58 percent and metastatic in 42 and most of the European country even America may be the same statistic you see here the other modalities the chemotherapy surgery and radiotherapy and radiotherapy combination here 18 percent but very important you see here these two two column one palliative treatment in 37 percent and here is the failure of local control in 18 percent when when you have quality through quality control on other instances you can have the potential to increase the improvement of therapy yes when here is actually palliative therapy this is also potential to improvement diagnostic that mean we have a huge potential to improve the things of diagnostic and radiotherapy to increase the number of control localized or metastatic tumor yeah everybody knows this safety series upon IEA and here they are advised or recommended that the compressive quality assurance program for medical exposure is needed it should be established with the participation of appropriate qualified expert in the relevant fields such as radio physics taking into account the principle established by Wu and PAHO from South America these actually is we must established a quality program when again here for the other paragraph they are giving more specified and quality assurance program for medical exposure shall include measurements of the physical parameters of the radiation generators linear accelerator and imaging devices and irradiation installation at the time of commissioning and periodically thereafter there is a specified it we should do established a quality assurance program verification of the appropriate physical and clinical factors used in patient diagnostic and treatment yeah this is actually this is safety series and in nationally we have also ordinance they are given also the same recommendations and here it helps to provide the best treatment yes it is a characteristic feature of modern radiotherapy process that this process is a multi-disciplinary process therefore it is extremely important that the radiation therapist in this case radiation oncologist cooperates with specialist in various discipline in close and effective manner the various procedures will be subjected to careful quality control and the establishment and use of comprehensive quality system is adequate measure to meet these requirements so and main objectives yeah you see it provides measure to approach the following objectives reduction or uncertainty errors yes this is what we have done every day and reduction of the livelihood of accident errors yeah it is also important that the accident should be done and provided a reliable intercomparison of results among different radiotherapy centers and the exploitation of improved technology and more complex treatment in radiotherapy these are all the objective provide to approach in the following in the quality assurance program yeah everybody knows these are complex radiotherapy is a very multi-disciplinary complex equipment system and in quality assurance and quality control is always needed otherwise you cannot use such types of complex machines of equipments so yesterday I have shown is also in radiotherapy is a huge chain so all the chains in quality control is important yesterday we have learned the positioning and the accuracy in dosimetry on treatment planning and the huge impact for the patient when there is a no quality control is there is some quality is not there so it is actually needed to the radiotherapy and now the requirement of accuracy in radiotherapy how we define the accuracy we always calibrate our radiation and you see which accuracy is needed for absolute absolute absorptors and which accuracy is needed in special distribution of dose geometrical accuracy of treatment unit and patient positioning these two and here actually the ICRO report 24 includes an uncertainty of 5 percent is tolerable in the delivery of absorbed dose to the target volume every hospital fix our hospital photon radiation we have fixed 2 percent and electron radiation 5 percent yeah we control it when more than 2 percent then we try to adjust it again so you can also add more tightly than this yes so the example because electron photon radiation you can handle it better so we have to fixed it 2 percent yeah and more than 2 percent in quality control we adjust the machine when electron is 5 so this is the value generally interpreted to represent a confidence level of 1 comma 5 to 2 times of standard deviation and currently you know this minus 5 to 7 percent recommended delivery of dose in the 95 confidence level and in geometric uncertainty yeah for example a systematic error on the field position block position relative to target volume or organotrics also lead to dose problem it is an under dosing of the required volume when the decreasing the TCP TCP and overdosing of nearly organotrics for example increasing the end CTP 5 to 10 millimeter are usually given the tolerance geometrical uncertainty yes we have also discussed yesterday 5 centimeter how we take the boundary of the PTV here you know when there is here is a very stiff curve and when you change a little dose here then this end CTP TCP changes rigorously therefore the uncertainty in delivered dose translate into either reduction in the TCP or increase the end TCP both of which are chosen in clinical outcome yeah in here in radio therapy actually we have two things when we exit the limits it also overdose and under dose but it is in radio therapy an accident or mid miss administration is significant if it results in either an under dose or an overdose whereas in conventional radiation protection only overdose are generally concerned yeah here is a two-fold the under dose is also problem overdose is also problem but radiation protection actually the overdose so how we define the accident in radio therapy from the general aim of accuracy approaching pipe a definition for accidental exposure can be derived here there is a clear definition a generally accepted limit is about twice the accuracy requirement that is 10 percent difference should be taken as a accidental exposure we have limited the 5 percent when the deviation is more than 10 percent this is accident and it can be observed in the normal tissue when such types of differences is there so accident in radio therapy you can also download the safety report series 17 and they have incidents all over the world is listed there and discuss about such types of miss accidents and give some recommendation how can you work on this and here the direct causes of miss administration contribution factors preventability of misarrangement and classification of potential hazards I can draw here these are the taken some snap from this book you see the calculation error of time and dose in 15 places they have found it and inadequate review of the chart these are all the parameters can be even here error in calibration of cobalt 60 sources technologies misread the treatment time in monitor unit and these are all the mistakes and misadministration come every day so we should be very alert and a quality control program with very systematic and organized way so that we can overcome such types of mistake in our hospital even in Germany some hospital they have breast cancer in right side when they treated the patient in left side we have the report it just this same patient they do not document or like this or they have a stress and so treated the other best even the patient do not recognize our breast of cancer so German legislation actually the legal and other aspect is given we have already seen IAA and here in addition to this regional recommendation and quite practical reason there is also crucial legal regulations because they are normally subjected to national laws the following two example for refer to German legislation here the social gazettes book on German social security and it is a radiation protection ordinance I think so yeah and see here in the social security book the services organization are obliged to maintain and develop the quality of their services yeah there is a clear defined in these laws of these countries and hospitals have to implement a quality management system so you must do that and again here radiation protection law in German here the Stalin's far or no and you see here the quality maintenance for medical application of radiation yeah this is the paragraph 83 here the quality maintenance as this quality assurance actually in the laws defined and in Europe a form policy statement document the core curriculum for medical phases in radiotherapy and in following these are the principle of quality management you see here all the things are given very way the quality management requires an organizational structure this is very important and quality system wherein responsibilities procedures process resources are clearly defined yeah the hospital also applies to give you some equipments yeah sometimes in the hospital when every two years there is a external audit when they come you can have good relational medical thesis and ask them we we need this instrument and that instrument they write their report so the administration is obliged to to give you the permission to buy such types of equipment yeah so sometimes you are waiting yeah the next check will tell them when they write in the protocol yes they need a TLD TLD readers so the next in three months you have the TLD readers but sometimes you apply for the TLD readers there's no money why you are don't give us the first in the beginning of the accelerator it is 30 30 thousand euro we do not have this money but when this external audit right and you have this it is one of our medical physics we are very happy to have this audits but actually you have also your work yeah the whole things actually the quality assurance program the medical physicist is there the driving role yeah not the chief physicist but one of the physicist who is very good cooperation sometimes the second man or third man they have better better entrance to the all the technician and a doctor so he actually the team leader yeah select anybody in team leader they have very good contact with the all departments personnel so here actually defined everything I will not read the details it is also boring yeah this lectures is all the terms and definitions but the next lecture you find your own work I think Dr. Tung can explain what is your daily checks on everything the quality assurance it is more than the quality yes managing a quality assurance program this is very important how you manage it it must be understood that the quality required quality system essential a total management system for the total organization and for the total radiation therapy process that is the whole hospital equality assurance program will read it that is a part of that and when you have a very good quality assurance program then we'll get also certificate from the from the government and this certificate is actually you can take a monogram from this certificate and put in the hospital uh hospital to uh registered and so even the patient uh and even the patient they want to say not only in this hospital do you do have AMRT yes sometimes the patient come to ask do you AMRT in your department have what is what is mean AMRT is the best qualified treatment now they are also asked your quality assurance program certificate so the people are always more conscious yeah they they are very conscious on select such types of hospital who have a very good quality assurance program yeah even sometimes small and medium medium hospital had quality assurance program than the very big university hospital yeah so the select such types of hospital so here the total radiation therapy process includes clinical radiation oncology service supporting care services and all issues related to radiation treatment and here radiation oncologist uh facist engineer maintenance and management yeah these are recommendation documents uh you know many of us uh uh we know this documents and for in Europe this is a astro in nineteen hundred ninety five and so in this report you can use in Europe and have your quality assurance program but we have also very important interesting documents from here from America on other countries so here actually multi-disciplinary radiotherapy team the team should be multi-disciplinary you see not the physics facist themselves to do the quality control but the whole team and here the radiotherapy process for for a radiotherapy process to control it radiation oncologist medical physics these are dosimetrics is not famous in Europe but in America they have the medical facist and dosimetrist I think it is sometimes very good yeah because somebody had only only bachelor in medical physics they do not do any master and somebody's master how can you apply them in the clinical I have my own experience I try to introduce a dosimetrist in Bangladesh it is not easy yeah but I think when you have dosimetrist sometimes you can division of work is better yeah there's advantages and disadvantages I do not know but in America they have the dosimetrist and our next speaker can maybe tell better and engineering and of course RTTR is group has an important part in the output of the entire process and their overall role their overall roles as well as their specific quality assurance role are independent requiring close cooperation and it is the quality system it is widely appreciated that the concept of quality system radiotherapy is brought yeah this is actually the I have already described it is not restricted to the definition of technical maintenance and quality control of equipments and delivery actually what is quality assurance instead it should compromise a comprehensive approach to all activities it is a department starting from the moment of passion entrance in it and until the moment it leaves also the continuing into the follow up period here you have seen actually this is the quality management program it is an input here and these are the organizational structure and the output and always in the process inside the quality process and again it is actually the quality assurance program this is the organizational structure and for this we need a quality manual it is a written quality manual and in the department in the hospital and the quality manual has a double purpose in external and internal the external to collaborates in other departments in management and in other institution it helps also integrate the department is strongly concerned with quality and internally always it needs improvement so this is actually the astro booklet yeah you can also download it from the www astro.be and they have not only this they have many many good books and and this is actually the practical guideline for the implementation of a quality system in radio therapy and here in the following we will consider in this document important arguments are why we need once again the construction of the quality system we have to implement the quality system however we are free to implement the system any system which appears appropriate for us yeah we do not need this document you can you can actually create your own system this means in principle we can develop any system but it is actually save of time and mistakes we use this book how we construct with the help of this book every hospital can construct a quality system the first step the head of the department institution support this whole process he should not be the team leader but he supports sometimes there is head of the department he is eager to do that then you have easy but you must convince him otherwise the you make a team and he is not allow the people to work in this time so it is absurd things like this so it is actually the consent of the department that is very important but he should not be the team leader at all earlier because sometimes the communication gap with the head of the department so nobody is free to do their own opinions and reviews so you have somebody actually the medical physicist is the right person the team leader of the whole assurance program or or an assistant medical doctors it is also possible yeah they will give free hand and time for that so the next one implementation step of quality process in this book is the booklet clear defined how you prepare this preparation, development, implementation and consulidation yeah these are all steps are given very accurately here the preparation setting up the team informing the department inverter of the existing structure many hospital we have the existing structure but not concise with each other so on here policy preparing procedures preparing what instruction and of course is very important training and validation yes in training we needs money and we have many many hospital equipments but no money for the training the people so sometimes in a big hospital you arrange the trainer from outside and trained in your hospital so the training is very important I have written scientific America or something a medical doctor needs in every day three to four hours only to read the publications and development yeah and but I have asked my doctors in one month they have never read a single report yeah so this is actually the information we needed and we have every hospital there is a equipment so very very sophisticated equipment but what is the education yes education is very very negligible still and here yeah preparation one by one I go not go to details you see when you have this manuscript booklet you can follow them and kind of draft and discuss your team people and you can change it it should be changed always because it's improve and improve and improve and here involving and inform the department team adjusted the project team and here's the head of the department would not usually a team leader so I hope it tail and here actually the detailed preparation in planning construction how can you detail preparation and planning you see here the whole process it start maybe in one year in January and it's in in the April of next year that means one and a half year need these four steps to realize yeah in the beginning this team they had always had this work yeah sometimes you do not find them for any other tax so it's a this investigation is once and you have this structure and you can always improve it yeah they're meeting together I will show you a practical example here here setting the priority for example the brachytherapy everybody knows how the brachytherapy is the passion come from outside your passion is stationary in the other departments you need a simulator you need treatment planning involved many many people medical faces doctors nurses gynecologist yeah sometimes a very very hectic so when you have a structured and function it's very well then you can also time to have a very good treatment yes otherwise we have sometimes in hospital it is your daily experience you put the patient yeah now the gynecologist to go to somewhere in delivery we are waiting and waiting and waiting so they have a clear chart in who is gynecologist in this time to brachytherapy I have the own experience yeah we have started we have not started to put the applicator in the patient on the gynecologist's delivery there is a baby anywhere and one two three hours nothing the applicator again out of the patient and wait for him yeah such types of experience and so the quality management and the manual is very very important so everybody should and you have always the education teaching this course how we realize it and sometimes they can know you are doing the brachytherapy in Monday in Monday is not possible Monday we have many many things why not you do the brachytherapy in the even in the afternoon of Wednesday so they and the Wednesday maybe the radiotherapist is not available so these are all are very good discussion and do a clear program so you can realize better these are the problem yes here you see how it construct everything which is the priority and put sometimes there is no brachytherapy protocol how can you do that so the quality management system they collect it from anywhere sometimes different mistakes or failures if so here in the case booking theater room may fall may fail if sources are not ordered in time to mess in with later steps yeah the every quarter here we have the new sources maybe iridium and it should be also plan fit in the plan in here may fail if there is no system systematic approach to recording and communicating the decision our own words to subsequent state these are failure the every person is the team right in this position what is actually and discuss once again and re divide the process here is a actually in them astro protocol they have given the given the index yeah you have recognized some problem and you be critically the index point between 1 to 10 and then again discuss and which can be realized earlier than the others so you do this yeah and development quality management system have already is a manual very important it is a written manual yeah the manual is the central part of the implement in fixation standard or method of complaints with the standard and there are three here actually levels in quality management system level one level two and level three it can be also done according to this protocol implementation there is a training I told you earlier this is very important and validation process inside the hospital yeah we validate it whether it is fit our requirements our potential and the training is huge things are right in how can you have the training the hospital is obliged to take it free and the training it can be internal training and external training and validation process it is very also important to construction of quality system and consolidation one times the internal audits and of course the external audits external audits is actually the mandatory I told you earlier than every two years they control it the whole process radiotherapy even yeah the external audit they come on the check the or the control of organ of ricks yeah we sit together the whole team and so you have drawn the organ of ricks like this in which stage and we discuss here so they recommend is the next time to do that sometimes there is a treatment volume in some organ of ricks we do not draw they recommend us to draw the next time so they we have always the control external therefore the after the after the visit of the external control we write everything and through the internal control we make it clear so that in next two years again we have more improvement when there is a good cooperation with the external audit then is also a advantage for you internal audits I do not really explain you know this and then external audit and all are summarized in this letters and all the process is given we have writing in the in which paragraphs and summary a quality management system can be implemented according to their stroke booklet yeah we have also in different countries I have seen in America and the practical implementation of quality system in radiotherapy the key masses of this recommendation are construct and formalize a quality system which is sensible practical economical and active reactive convince the department the need of quality system this important not only department also the administration should work together maybe when you have in team anybody for the administration is also very good because he can mediate your needed to the hospital authority respect the initial planning and timing encourage confidence of the personnel in the quality system listen to comments or personnel on it encourage participation in it and develop in it every person in the team their own responsibility when we grow also the respect so that the the climate of the discussion so everybody want to come the discussion yes it is not easy to achieve but the team leader should be competent enough to bring all the personnel together to have a very quality quality assurance program when it is actually at the end and a very good outcome for cancer treatment patient thank you very much for your attention