[MUSIC] Hello, welcome. My name is Lina Cavaco and I'm here to present your lecture that is in a new module for this antimicrobial resistance course. And we have added this module on quality assurance and quality management because when we are testing antimicrobial susceptibility, it's very important the standardization and quality of the data. So we thought that well of course there are quality assurance courses by themselves. But that we could add two small lectures into this course about what is related to this particular testing. And the issues that are quite important. On this first lecture and we have here our outline, we are going to have sort of a helicopter view of the quality management as a whole. If we think that we could be a manager of a laboratory or of a clinical facility that does this test. What are kind of the things that we have to think of that we should manage the quality in so that we are sure that the results are good? So we look into some of the particularities of antimicrobial susceptibility testing in relation to other tests. And we are looking into some elements that we are going to focus on when doing this overview of the management. And we take some final considerations about quality in general, and how it is important for the testing. So starting, if we are a manager and we want to be having a good quality of any kind of activity. We want to coordinate everything to direct and control, and make everything to be good quality. While that works for making any kind of thing, from nails to whatever kind of product you have, but it also works for testing in a laboratory. So you want that the services that you provide are good, you want that the products that you make are good. So these quality assurance and quality management systems define are following standards, and main standards for quality are, followed from easel. When we are looking particularly into antimicrobial susceptibility testings, a lot of the standards are following CLSI, or ill cast methods. But they are still look, transcribed to easel standards as well. And the management system would include everything that could influence the results in somehow. So even the structure of the organization could influence the processes, the procedures, everything. So we are really looking at from the top. When we are looking at quality assurance we are more describing the procedures and what is happening. So, we are describing exactly we are doing and we are documenting what we are doing. Every time that something happens you can go back and find out what was done, you have validated what you have done and you even have participated in some ring trials. So that you have external evaluation of what you have done. But taking it from the very overview we are focused on the method and that the results of the method are good, so that the services the lab provides are good. But there's many things influencing. We have people. We have validation, ring trials, equipment, documents, all of it. So, if we take one at a time, staff is a very important issue. We need motivated staff that knows what they are doing. So, we would like to provide some training and we should provide some training for our staff, so that they are doing it well. We can document what we are training, we should document what we are training and how we are training. And the staff should also be able to show that they have been trained and they have the competences in this area. And that they can take responsibilities for some parts of these processes or the whole process. So, the most important thing in the lab is that people know what they are doing, they like what they are doing, and they are doing it well. So, but it's not enough that they do it well they also should have to show it. And by showing it they need to document what they are doing, they need to have procedures, standard operating procedures. They need to keep documentation of what has been done. They need to know where these procedures are and who has read them and how they are defined, and they also need to trace back the information, both the subs but also the procedures. So that everybody knows what they are doing. And when they actually doing the tests, they also need to follow up what is happening with the things that I need to use. Like, media reagents [COUGH] they can describe how they produce them if they do it themselves. They can also describe how they buy them from a provider that already has the control. Even if they buy that, they might need to test every batch for making sure that it's right. They need to have some acceptance criteria to make sure that what they are using is fine. And they also have to have procedures, how to keep it and how to save it and store it and also when they do things, who did what, when did they do it. How did they do it? Which media and reagents have been used? How does the result look like? Etc. So when they have the results, and the results look strange, they look out of the range or deviating, they need to have also some procedures for that. Many times when you go, for example, and visits to some of the laboratory we asked them, well do you have a procedure if something looks different? For example, we asked them, well, do you have a procedure when the pH of the median is outside of range? Then they tell us, well, it never happened. Well, [LAUGH] if it happens, you should have a procedure, and that is the case. So if we have some deviations that can happen, it's not that they will happen frequently, but then you have something to do when it happens. Also, we need to know what this influence of the result, if it happens. So, would it go up, would it go down, would it look strange? And we need also to check in these deviations make some reports and check if you can do something that avoids them to happening again. Here for example, we have an example if you are in the lab and you find something that is very rare. Chances are that you're extremely lucky or that you did something wrong. So what we have normally chosen to do is to check the reading again. Did you do it right? Check the purity as the control, the culture right. Check everything on the plates again. Take it up, maybe do it again. Verify the identification of the species and so on. If you've done all of this and you're absolutely sure of the results, then you can report it further. Maybe you still ask an expert about this or another lab to take another look but maybe it's so new and so nice that you are going to publish this and be famous about it but you really need to check. And that's also why, when you are in the lab, you not only check your own results and your own procedures, but sometimes you have audits that come in and check it for you. Some of these audits are internal from the same institute or something, but some of them you are external, that they are looking over your shoulders and really looking at what you are doing. So they will look for your validations, they will look into your old system, all the documentation, and look through what you are doing. >> Especially, of course, if you have accreditation, then you have these accreditation visits that will check everything for you. As in final considerations, well, this was just in helicopter view, but the Quality Management procedures are the Quality Management does such. It's quite important and because you have it, of course, it doesn't guarantee that you don't have mistakes. It can happen. The only thing is that if you have a Quality Management you will detect your mistakes in time, and you might be preventing them from occurring the next time. However, if you don't have anything like that, you will doing the mistakes, you will noticing them. So probably you only have undetected errors and you think things are going fine. And that was it. Thank you very much for this, and I have a next lecture about more particular part of the susceptibility testing as such in quality assurance. [MUSIC]