MULTI TRAINING AREA PS VD

Greetings on behalf of Siemens Healthineers. Welcome to another segment of PP shorts. The title of this segment is Iqc P. What is it all about? This segment is designed to give you a quick overview of ekpeye and how we can relate to your laboratory. Our speaker for this segment is Miss Christine Arruda. Miss Arruda is currently senior product specialist for the Siemens Healthineers Critical care business. Responsible for the growth and quality of critical care products in the United States. Prior roles at Siemens include product marketing Manager and 1st and level support. Technical Support in the in the United States for molecular Siemens products. She began her career as an ACP Certified Medical Technologist and holds the Bachelor Science degree from Salvay Regina University in Newport, RI. Welcome Miss arruda. Thank you. Hi everyone, we're going to go down the road today of discussing the individual quality control plan. So let's begin by talking about what is this individual quality control plan. See Ms implemented guidelines around quality control and they were to be put in place by January of 2016. These this quality control plan involves risk assessment and mitigation within your facility, so we're going to talk today about how you develop that plan and how you can develop the plan for your particular facility, as well As for the individual departments within that facility. So let's take a look at the three pieces that you need to look at when you're developing. This plan will start with risk assessment. When you think about risk assessment, it goes far beyond the capabilities of an analyzer and how and analyzer runs. Most people have looked at developing a quality control plan all around the quality control piece itself in regards to the platform and reagents that you're running. This plan goes far beyond the scope of that when you think about risk assessment. You think about all the different errors that can take place within the continuum of running a particular test. And if you think about that, it's not just about that analyzer or those reagents on that analyzer. There are other pieces involved in that test, whether it be the person who's running the test, whether it be the area where the test is being run, whether it's how you're reporting those particular results, whether it be through a hospital information system, or whether you're actually manually. Entering those results into your hospital information system, there are all types of areas that you have to look at for risk assessment. As of right now, you already are doing these types of things. You are already monitoring. You are already checking you already have plans in place to avoid mistakes, but what you wanna do is you wanna take this a step. Further, so that when you have your regulatory bodies walk into the door, you are completely prepared to show them how you avoid errors within your facility. So thinking about risk assessment is going down that Rd of thinking about all the different areas of testing and where those mistakes are made and what are involved in those mistakes. That is the most important piece to looking down towards an individual quality control plan. So once you have defined what errors take place in your facility, whether that be mistakes and specimen labeling, whether that be mistakes and entering results. What are you gonna do now to make sure that those things don't happen with the frequency of occurrence? When you go down this road, you now want to start looking at implementing that quality control plan. Before you jump into that. Whoever is developing the plan within your area of your facility has to make sure that the medical Director that laboratory director, that respiratory director, whoever is responsible for that particular Department, signs off on you going down the road of developing a quality control plan. Keep that in mind. So let's talk about the quality control plan itself. Quality control when you think about it is in three separate areas. When you're looking at the continuum of running a test. CNS looked at it this way. There's a pre analytical piece, there's an analytical piece, then there's a post analytical piece to every test that you run. So when you develop this plan, you have to cover all three of those areas. Within those three areas that pre analytical that analytical and that post analytical see MF also defined where most mistakes are made there around the specimen itself, around the testing personnel around the reagents around the test system and around the environment. So within those three areas you have to cover those five categories of testing. What I'm going to do for you is give you a few examples of what you could think about when you're developing that quality control plan. First, let's talk about specimen quality. That's example number one. What does specimen quality mean to you? To me it means that sample that I'm drawing is drawn. In the manner for which it has to be drawn. For example of arterial blood gas. There are particular instructions on how to draw an arterial blood gas step one, Step 2. What are the types of syringes that you're using when you're drawing that arterial blood gas? What are the preservatives within that syringe? Are they the correct ones? Step three, when you're thinking about that specimen quality around that blood gas specimen. Are you mixing appropriately? Is it being delivered to the area of testing in time for you to get that quality of results? That's example one. Example 2. Monitoring your environment. Monitoring the environment can mean several things. We talk about those five categories. What about my system? Is the environment that my system is currently being run in? Does it meet the requirements for what the vendor says within their operators manual? Monitoring environment reagents are those reagents stored appropriately in the correct temperature per the package insert. Are you monitoring that freezer or that refrigerator to make sure that it stays within specifications? Are you documenting that? Example #3. Quality control itself. What is the number type and frequency of quality control that you're running on that particular analyzer? Does it meet the requirements of CLIA 88? At a minimum, doesn't meet the requirements that are outlined by your vendor. Does it meet the requirements of the regulatory bodies that may be coming into your facility to inspect whether that be cap, whether that be jeco, whether that be local agencies? Example #4. Instrument calibration and maintenance. That calibration of that analyzer is it within the specifications defined by that vendor. Are you doing it with the frequency that that vendor provides to you in their operators manual? Are you verifying that the specifications are meeting the claim? Maintenance are you documenting the maintenance on that analyzer? Are you performing the maintenance that the vendor recommends within their operators manual? Those are four great examples of what you should be looking at within your quality control plan. Once you have put this quality control plan into place. You then have to verify that your medical Director, Laboratory director, respiratory Therapy director, signed off on this quality control plan before you implement the plan itself. Very important. Now the third piece. Is quality assessment. You cannot assume that once you put this quality control plan into place, that that you're done. This is an Evergreen document you're going to constantly look at this document at a minimum on an annual basis from the time you implemented it to look for other issues that you may be having within your facility around that testing, identify those errors and put that mitigate that risk by putting that plan in place. You won't may also find that what you have in place right now may not be working. It's an opportunity to improve what you already have in place. That is what the quality assessment piece is about. You wanna make sure that whatever you have in place at your facility is working? And I will end with this. Most importantly is that you have to have those individuals who perform that testing trained. To this individual quality control plan, because implementing it is not the same as training it, make sure the individuals within your facility are trained accordingly. That is a very brief overview of an individual quality control plan and enjoy the rest of the annual meeting. Thank you Miss Arruda after the conclusion of the annual meeting. Please complete any of the collection of pee pee shorts available on Pypi Connect and take a quick assessment to qualify for certificates. Thank you and good day.

SIEMENS IQCP: What Is It All About? Risk Control Assess ment Plan Quality Christine Arruda Sr. Product Marketing Specialist for Critical Care Siemens Healthcare Diagnostics @ Modical Solutions USA, 2016 Page I